EMDSeronoDigest 7thED

EM Serono, EMD Serono, Inc.
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Table of Contents
Letter from President and CEO, (ad interim), EMD Serono . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 Letter from Senior Vice President, Managed Markets, EMD Serono . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 Editorial Advisory Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Survey Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Methodology and Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 Classification of Specialty Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 Current Specialty Pharmacy Management Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Benefit Coverage of Specialty Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 Managing Across Pharmacy and Medical Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Specialty Pharmacy Costs and Financial Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 Member Cost Share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25 Provider Reimbursement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28 Utilization Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30 Oncology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32 Specialty Pharmacy Providers (SPPs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36 Spotlight on Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40 Specialty Pharmacy Program Goals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43 Most Effective Strategies to Manage Specialty Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44 Future Changes in Specialty Pharmacy Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
Glossary of Commonly Used Abbreviations

Abbreviation AWP ASP ESA G-CSF HAE IM IV LOB GH LS MA-PD MS OAA P&T PA PAH RA RSV SAA SC SPP Description Average Wholesale Price Average Sales Price Erythropoietin Stimulating Agent Granulocyte Colony Stimulating Factor Hereditary Angioedema Intramuscular Intravenous Line of Business Growth Hormone Lysosomal Storage Medicare Advantage Prescription Drug plan Multiple Sclerosis Office-Administered Agent Pharmacy and Therapeutics Prior Authorization Pulmonary Arterial Hypertension Rheumatoid Arthritis Respiratory Syncytial Virus Self-Administered Agent Subcutaneous Specialty Pharmacy Provider
Dear Healthcare Colleagues: At EMD Serono, we are committed to understanding and meeting the needs of individual patients. We strive to create value by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology. We are committed to delivering our products to patients to make a difference in their lives, and to continually investing in research and development to build a pipeline that will address the urgent need for innovation in medicine. We also recognize that improving patient care is about more than providing a drug. Its about ensuring that people have access to a full spectrum of resources, including unique delivery devices, emotional support, education, and reimbursement informationall important tools that are integral to managing disease effectively while experiencing rewarding and productive lives. As part of our dedication to improving care, we take pride in our partnerships with health care payers. Our relationships extend broadly and deeply to public and private payers, specialty pharmacies and pharmacy benefit management companies who are all faced with the task of staying current with trends while developing health care benefits and support programs for patients with challenging diseases. EMD Serono is proud to bring you the 7th edition of the EMD Serono Specialty Digest the only dedicated resource available for health care decision makers to identify current and future trends in specialty pharmacy management. We value the contribution of 93 health plan medical and pharmacy directors, representing over 115 million covered lives, whose input makes this digest the most comprehensive tool available in the marketplace to benchmark specialty pharmacy management strategies. We hope that this publication will serve as a valuable resource for health care decision makers to better understand and stay abreast of the evolving specialty pharmaceutical marketplace.
Sincerely,
James E. Hoyes President and CEO (ad interim) EMD Serono, Inc.
Dear Managed Care Colleagues: We are proud to present the 7th edition of the EMD Serono Specialty Digest a testimony of our commitment to you, our managed care partners. The managed markets group at EMD Serono recognizes that payers are faced with many challenges: our goal with this digest series is to bring you the most current trends related to how your colleagues are balancing access to specialty medications with the need to maintain affordable health coverage. Each year our Editorial Advisory Board provides their recommendations on subject matter to include in the survey. As a result, we have included the following new topics of interest to managed care payers: Management of oncology molecular diagnostics Measurement and value of health outcomes Managing across pharmacy and medical benefits
Where possible, we have also included benchmarks to prior years data so that trends can easily be tracked and identified. Our dedicated website (specialtydigest.emdserono.com) provides access to view and download this years digest as well as previous editions. Advances in personalized medicine, new product introductions, and technological innovations are changing the way health care is delivered. As a result, payers are continually updating their management processes to reflect the dynamic nature of the biotechnology industry. We are confident that managed care decision makers will find the information contained in this latest edition both informative and useful to continue the quality management of patients that require treatment with specialty pharmaceuticals. We welcome your input on how EMD Serono can continue to improve upon this report and provide value to your organization. Please contact me or your EMD Serono Account Manager with any questions, comments, or suggestions.
Regards,
Michael Dezelan Senior Vice President, Managed Markets EMD Serono, Inc.
To the Readers: As members of the Editorial Advisory Board for the EMD Serono Specialty Digest, 7th edition, our responsibilities are to: Recommend possible revisions or improvements in the digest content to retain relevance to managed care decision makers Provide editorial feedback on the digest manuscript to ensure clarity, validity, and utility of the data Identify the most significant trends and findings that impact specialty pharmacy management
We are pleased to participate on this Editorial Advisory Board and, based on our review, we offer several comments and observations on the following topics: Specialty Pharmacy Provider (SPP) Offerings: Most SPPs provide therapy management programs to payers to enhance the value of the services they provide, yet, surprisingly, less than 30% of the survey respondents utilize these programs. Additionally, payers indicate they are least satisfied with the ability of their SPPs to provide measurements of outcomes and savings. These findings appear to be at odds with what SPPs consider to be their strengths. Payers need to communicate more to SPPs about their unmet needs, and SPPs need to improve their ability to quantify the value of their programs and services. Oncology and Molecular Diagnostics: Payers are continuing to increase their focus on managing both oral and infused oncology therapies by implementing prior authorization procedures; however, the management of molecular diagnostic testing is still in its infancy. Most payers are not yet tracking whether treatment decisions are in conformance with molecular test results and whether the coverage of these tests actually makes a difference in patient management and outcomes. Measuring Outcomes: Health plan decision makers inherently know that identifying clinical outcomes related to specialty drugs and making formulary decisions based on these outcomes is the optimal process; however, they may not have all the data and tools available to them to track and measure the desired outcomes. It may be necessary for the pharmaceutical industry to not only provide clinical data supporting efficacy and safety on new therapeutics, but to also provide real world comparative effectiveness data to support formulary decisions by payers. As highlighted throughout this digest, advances in pharmaceutical innovation and medical technology are driving current and future payer strategies. We encourage all stakeholders in the specialty pharmacy industry to continue to work together toward a common goal to improve patient outcomes in the most cost-effective manner. Sincerely, Raulo Frear, PharmD Director of Pharmacy Services RegenceRx Boise, ID Larry Georgopoulos, BS, PharmD Associate Dean of Clinical Affairs and Professor of Pharmacy Practice University of New Mexico Albuquerque, NM Patrick Gill, PharmD Manager, Specialty Pharmacy Horizon Blue Cross Blue Shield of New Jersey Newark, NJ Bruce Kutinsky, PharmD Consultant Ann Arbor, MI
David Frobel, PharmD Vice President, Specialty Pharmacy Programs CVS Caremark Northbrook, IL
Kenneth Schaecher, MD, FACP, CPC Medical Director SelectHealth Salt Lake City, UT
Survey questions were independently developed by Rxperts, Inc., which had sole control over the survey terms and content. The content of the EMD Serono Specialty Digest was developed by Rxperts, Inc., and was reviewed and approved by the Editorial Advisory Board prior to publication.
Introduction
Increased knowledge of the genetic basis of disease is changing the landscape of health care, with two critical areas of growth focusing on personalized medicine and the biotechnology pipeline. Personalized medicine and molecular diagnostics are improving the way diseases are diagnosed, treated, and monitored. Biotechnology is advancing the development of specialty pharmaceuticals, particularly those targeting rare and difficult to treat diseases. While personalized health care and novel biopharmaceuticals are both creating an impact on the current market, they have yet to be fully integrated; however, rapid gains in our knowledge will almost certainly lead to reliance on these new technologies within the healthcare delivery system to maximize patient outcomes. Molecular diagnostics are used in a variety of ways to personalize medicine and can provide the following benefits: Better diagnoses and earlier interventions: Molecular biomarkers, including genes and their protein products, provide the ability to detect an individuals susceptibility to certain diseases, allowing for prevention and early intervention strategies.2 A test identifying genetic mutations in BRCA1 and BRCA2, which increase the risk for breast and ovarian cancers, can be used to help guide preventive measures, such as increased frequency of mammography, prophylactic surgery, and chemotherapy in women whose family history includes breast and/or ovarian cancer.2 Another unique diagnostic test helps predict the likelihood of cancer recurrence by measuring the activity of several genes in breast tumors, and assesses the value of adjuvant chemotherapy in patients with recently diagnosed breast cancer.1,2 More effective therapies: By identifying patients who will benefit from specific interventions, molecular diagnostics can help guide treatment and allow for the selection of optimal therapy. One of the most common applications is the detection of overexpression of the human epidermal growth factor receptor 2 (HER2)/neu gene in women with breast cancer to identify patients who will most likely respond to a specific therapy.2,6 Similarly, identification of patients with Philadelphia chromosome-positive (Ph+) types of leukemia, often indicated by a mutation in the BCR-ABL gene, can help to choose the most effective, targeted chemotherapy.2 Additionally, treatments for metastatic colon cancer can be selected using genetic testing to identify patients with mutated forms of the KRAS gene, or patients with EGFR overexpression.2 Reduce adverse events: Variations in metabolizing enzymes can lead to increased adverse events and overdose in slow-metabolizers, or no effect in fastmetabolizers. Biomarkers can be used to tailor medication doses to account for these individual variations to minimize adverse events.2 More efficient drug development: Molecular diagnostics could help to preselect patients for clinical trials by identifying those with susceptibility to certain diseases, or who are likely to respond to treatment, ultimately reducing the size, duration, and cost of clinical trials.2 Additionally, refining inclusion and exclusion criteria using molecular diagnostic testing could help clinically needed therapies - especially those that may seem ineffective in larger populations - receive approval.2,6
Personalized Medicine
Personalized medicine involves the tailoring of medical treatment to specific characteristics of each patient, and the use of genetic information to classify individuals into subpopulations that are either susceptible to a particular disease or are responsive to a specific treatment.1 This information can also play an important role in shifting emphasis to preventive therapy, reducing adverse events, and improving overall health outcomes.2 While most commonly applied in oncology, personalized medicine has more recently expanded beyond cancer to improve treatments in HIV, psychiatry, rheumatology, neurology, and cardiovascular disease.3 Personalized medicine has the potential to transform healthcare over the next several decades by offering the possibility for improved healthcare quality and reduced total healthcare expenditures.
Molecular Diagnostics
Molecular diagnostics and molecular biomarkers are valuable tools to assist in the diagnosis and management of diseases. Table 1 provides examples of selected molecular biomarkers and their applications in personalized medicine. Particularly in oncology, molecular diagnostics are used to create new screening and diagnostic tools based on tumor-specific genes and cell surface proteins, and are improving clinicians ability to diagnose cancers, determine the likelihood of cancer recurrence, and predict a patients response to a particular treatment.4 Biomarkers have also shown promise in multiple sclerosis through the potential for improved diagnostics and identification of disease stages, prediction of disease onset and course, treatment selection and success, and development of novel therapeutics.5
Table 1. Selected Molecular Biomarker Applications in Personalized Medicine1,2
Disease
Better Diagnoses and Earlier Interventions
Breast and Ovarian Cancers Breast and Colon Cancers Heart Transplantation
Biomarker/Test
BRCA1, BRCA2 Uses PCR to measure expression of genes Uses PCR to measure expression of genes HER2/neu Ph+ KRAS EGFR expression CCR5 receptor CYP2D6, CYP2C19 UGT1A1 TPMT HLA-B*5701
Application
Guide preventive measures based on risk for breast and/or ovarian cancer Helps to predict the likelihood of recurrence and assess the value of adjuvant chemotherapy Identify patients at low risk for acute cellular rejection and monitor immune response to guide immunosuppressive therapy Determine eligibility for specific chemotherapy Determine eligibility for specific chemotherapy Determine patients unlikely to respond to specific chemotherapy Determine patients more likely to respond to specific chemotherapy Determine eligibility for specific antiretroviral therapy Adjust treatment and dosing choices based on variations in metabolizing enzymes Select dose of specific chemotherapy to maximize therapeutic effect and minimize adverse events Select dose of specific chemotherapy to maximize therapeutic effect and minimize adverse events Identify patients likely to experience a severe hypersensitivity reaction to a specific antiretroviral agent
More Effective Therapies

Breast Cancer Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia Colon Cancer Lung and Colon Cancer HIV
Reduce Adverse Events

Multiple Diseases Colon Cancer Leukemia HIV
Abbreviations: BRCA breast cancer susceptibility gene; CCR5 chemokine (C-C motif) receptor type 5; CYP cytochrome P450; EGFR epidermal growth factor receptor; HER2 human epidermal growth receptor 2; HIV human immunodeficiency virus; HLA-B - major histocompatibility complex, class I, B (allele); KRAS - v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog; PCR polymerase chain reaction; Ph+ - Philadelphia chromosome positive; TPMT thiopurine S-methyltransferase; UGT1A1 UDP-glucuronosyltransferase 1A1.
Challenges
Incorporating personalized medicine into the healthcare system may ultimately decrease use of total healthcare resources and improve clinical outcomes. However, there are several issues associated with the widespread implementation and adoption of molecular diagnostic tools, particularly with respect to implementation of regulatory policies, laws protecting patient confidentiality, insurance coverage, and reimbursement policies.1,7 Figure 1 illustrates the primary factors that must be considered for the full implementation of personalized medicine into the healthcare system.2 While personalized medicine and molecular diagnostics are becoming more widely accepted, health plans are faced with the challenge of determining strategies to manage the utilization and reimbursement of molecular diagnostic tests and their associated therapies. Among health plans surveyed
Challenges
in this digest, the majority of plans have not yet implemented many strategies to manage oncology molecular diagnostics. Currently, only a small number of payers require molecular diagnostic testing before approval of applicable oncology agents, determine the cost-effectiveness of a molecular diagnostic test for oncology before covering, and/or require a PA for molecular diagnostics for some/all relevant oncology therapies. Most plans do intend to implement additional strategies to manage molecular diagnostics in oncology in the next 12 to 24 months. As molecular diagnostic tests become increasingly available, payers are becoming more aware of the complexities associated with these tests and are beginning to implement strategies to manage them.
Introduction
Figure 1. Primary Factors Involved in the Implementation of Personalized Medicine2
Specialty Drug Pipeline: Spotlight on Orphan Drugs

Healthcare Patient Provider and Confidentiality and Patient Education Genetic Privacy Healthcare Information Technology Insurance Coverage and Reimbursement
Specialty pharmaceuticals and biotechnology are an emerging and expanding sector of the overall pharmaceutical pipeline. Within the category of specialty pharmaceuticals, an estimated one quarter are predicted to be in development for rare diseases.8 According to the National Institute of Health, 25-30 million Americans have one of the nearly 7,000 diseases classified as rare. The Orphan Drug Act of 1983 defined rare diseases as those that affect less than 200,000 patients.9 Since the inception of the act in 1983, over 350 medications have been approved to treat rare diseases compared to only 10 in the 1970s, and the growth continues.9 Since 2006, nearly one third of all new molecular entities (NMEs) and Biologic License Application (BLA) approvals have been for drugs with orphan status for at least one indication.8 This trend continued in 2010 with 6 new orphan drugs approved of the total 21 NMEs and BLAs, representing 28.6% of new approvals.10 In addition, a 2011 report tallied 460 medications in the pipeline for rare diseases, which is an increase from the 303 in 2007, and 176 in 1991 (Figure 2).9,11 The primary area of research, which accounts for one third of the 460 drugs currently in development, is rare cancers, including solid tumors of the liver, thyroid, cancer of the blood, and melanoma. However, other leading areas under development include genetic disorders, neurological disorders and infectious diseases. Examples of diseases in these areas include cystic fibrosis, multiple sclerosis and West Nile Virus, respectively.9 Figure 2 contains a listing compiled by PhRMA of the number of orphan drugs currently in late stage development, which include those in clinical trials or under review by the FDA.9
Regulatory Policies
Technology and Tools for Clinical Review
Expected Impact on Patient Care

Personalized medicine is already influencing the way diseases are identified and managed, and has the potential to change the way future treatments are discovered and used. With an everimproving understanding of molecular diagnostics, the impact of personalized medicine is likely to allow for better diagnoses and earlier interventions, more efficient drug development, and more effective therapies with fewer severe adverse events. However, the growth in personalized medicine will require the development of new and innovative processes to ensure these advancements effectively reach patients.
References
1 Presidents Council of Advisors on Science and Technology. Priorities for Personalized Medicine. September 2008. Available at: http://www.whitehouse.gov/files/documents/ostp/PCAST/pcast_report_v2.pdf. Accessed 3/8/11. 2 Personalized Medicine Coalition. The Case for Personalized Medicine. May 2009. Available at: http://www.personalizedmedicinecoalition.org/about/ about-personalized-medicine/the-case-for-personalized-medicine. Accessed 3/8/11. 3 U.S. Food and Drug Administration. Table of Pharmacogenomic Biomarkers in Drug Labels. January 2011. Available at: http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm. Accessed 3/8/11. 4 National Cancer Institute. Understanding Cancer Series: Molecular Diagnostics. September 2006. Available at: http://www.cancer.gov/cancertopics/ understandingcancer/moleculardiagnostics. Accessed 3/8/11. 5 Martin R, Bielekova B, Hohlfeld R, Utz U. Biomarkers in Multiple Sclerosis. In: Utz U, Ed. Disease Markers. The Netherlands: IOS Press. 2006; 22(4):183-185.
Figure 2. Orphan Drugs in Development9
Cancer, Rare Cancer, Blood Genetic Disorders Misc. Diseases/Conditions Neurological Disorders Infectious Diseases Cancer, Skin Transplantation Autoimmune Disorders Respiratory Disorders Blood Disorders Eye Disorders Gastrointestinal Disorders Cancer-related Conditions Cardiovascular Diseases Growth Disorders 0
107 79 67 37 37 31 31 20 18 14 12 11 10 10 6 5 20 40 60 80 100 120
Number of Orphan Drugs in Development

(Some medications listed in more than one category.)
Conclusions
Advances in personalized medicine and specialty pharmacy will continue to provide novel methods to diagnose and effectively treat diseases. The increase in specialty pharmacy agents within the pharmaceutical pipeline, as evidenced by an increase in orphan drug approvals, is a trend that will likely continue in years to come. Many patients remain with limited or no treatment options, and the growth of specialty pharmacy as well as personalized medicine should only further expand
onclusions
the potential for development of effective therapies for these patients. While advances in biotechnology will continue to make new therapeutics possible and molecular diagnostic testing becomes increasingly available, processes need to be developed to address regulatory policy issues, clinical review, and insurance reimbursement criteria, as well as developing methodology to measure the impact of these advancements on total health outcomes.
References
6 National Institute of General Medical Sciences. Frequently Asked Questions about Pharmacogenomics. January 2011. Available at: http://www.nigms.nih.gov/Initiatives/PGRN/Background/pgrn_faq.htm. Accessed 3/8/11. 7 Personalized Medicine Coalition. Personalized Medicine 101. Available at: http://www.personalizedmedicinecoalition.org/about/about-personalized-medicine. Accessed 3/8/11. 8 Medco Drug Trend Report 2010 9 PhRMA: Orphan Drugs in Development for Rare Diseases. Available at: http://www.phrma.org/sites/default/files/878/rarediseases2011.pdf. Accessed 3/8/11. 10 FDA: CDER New Molecular Entity (NME) & New BLA Calendar Year Approvals. Available at: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/UCM242677.pdf. Accessed 3/8/11. 11 PhRMA: Record Number of Medicines In Development for Rare Diseases. Available at: http://www.phrma.org/media/releases/record-number-medicinesdevelopment-rare-diseases Accessed 3/8/11.
Executive Summary
Methodology and Demographics
The EMD Serono Specialty Digest, 7th edition, contains objective market data, gathered in January 2011, on the management of specialty pharmaceuticals by health plans in 2010. Total enrollment of the 93 health plans participating in this years survey exceeds 115 million lives, with approximately 70 million commercial lives (healthcare maintenance organization [HMO] and preferred provider organization [PPO]), 16 million Medicare Advantage Prescription Drug plan (MA-PD) lives, 14 million managed Medicaid lives, and 15 million other lives. The 93 health plans span the United States: 33% of survey participants represent Midwestern plans, 38% represent Northeastern plans, 26% represent Southern plans, and 34% represent Western plans (total greater than 100% due to business in more than one region).
Current Specialty Pharmacy Management Strategies and Benefit Coverage

Over 70% of payers currently utilize prior authorization (PA) under their pharmacy and medical benefits for specialty drugs and are managing PA in-house, rather than using their PBM or SPP. Other commonly utilized strategies focus on managing provider reimbursement, mandating the use of specialty pharmacy for self-administered agents (SAAs), and selecting preferred products. Similar to last year, this years survey data finds that 73% of plans cover SAAs, including oral and injected medications, under the pharmacy benefit only. Office-administered agents (OAAs), including infused or healthcare practitioneradministered medications, are covered under the medical benefit by 62% of plans. Less than 30% of plans cover OAAs under both the pharmacy and medical benefit, depending on the place of administration or specific provider.
Defining Specialty Drugs

What qualifies a specific drug or therapy to be classified as a specialty pharmaceutical is not clearly defined, as there is no industry standard definition for specialty drugs. Most plans have criteria or a definition to describe these drugs in order to apply the appropriate benefit design and distribution methodology. Survey data indicate that 80% of payers typically classify a drug as specialty if the average monthly cost exceeds $1,200 and may include other factors, such as whether the product treats a rare disease, requires special handling, has a limited distribution network, or requires ongoing clinical assessment and monitoring of response and/or side effects. Over 50% of survey respondents identified 30 therapy categories that are classified under their specialty pharmacy definition.
Figure 3. Percent of Specialty Pharmacy Costs by Benefit (2008-2010)
Drug Spend and Cost Trend

The current survey data identifies that plans have significantly improved their capability to capture specialty drug utilization from their pharmacy and medical claims systems, with 98% and 75% reporting that they currently track their drug spend and cost trends under the pharmacy and medical benefit, respectively. Health plans report that the percent of all specialty drug expenditures that are attributed to the pharmacy benefit and the medical benefit are split almost evenly, which is consistent with data reported in the prior 2 years (Figure 3).
Pharmacy Benefit 100% % of Plans 80% 60% 40% 20% 0% 47%

2008 (n=58)
Medical Benefit 42%
53%
48%
50%
49%
48%
52%
52%
47%
52%
2009 (n=57)
50%
2010 (n=60)
51%
2008 (n=48)
52%
2009 (n=60)
48%
2010 (n=40)
48%
2008 (n=39)
58%
2009 (n=33)
53%
2010 (n=40)
Commercial
MA-PD
Medicaid
(n values represent survey participants who knew and could disclose information)
10
Strategies to Manage Across Pharmacy and Medical Benefits

There are a number of therapy categories with drug offerings that are available under both the pharmacy and medical benefit as illustrated in Table 2.
Table 2. Therapy Categories with Drugs Available under the Pharmacy and Medical Benefit
Member Cost Share - Pharmacy Benefit

For specialty drugs covered under the pharmacy benefit, 96% of commercial and MA-PD plans require cost share. Fifty-two percent of commercial plans and 84% of MA-PD plans assess a flat cost share for specialty products. As part of the flat cost share benefit, a separate fourth copay tier for specialty drugs is identified for 39% of commercial plans and 56% of MA-PD plans. The remaining commercial and MA-PD plans assess a tiered cost share, with a lower cost share for preferred drugs and a higher cost share for non-preferred drugs. The most common tier under the commercial benefit for preferred drugs is tier 2 (47%) and tier 3 (68%) for nonpreferred drugs. The most common tiers under the MA-PD benefit for preferred and non-preferred drugs are tier 3 (43%) and tier 4 (58%), respectively. Under the pharmacy benefit, copays (63%) are more frequent than coinsurance (37%) for the most commonly offered commercial plans, while coinsurance (71%) is more frequent than copays (29%) for the most commonly offered MA-PD plans. The percent of commercial plans with coinsurance that are limiting their members cost share liability by applying a maximum out-of-pocket (MOOP) per RX is declining: 88% of plans with coinsurance had a MOOP per RX in 2008, while 81% and 64% had a MOOP in 2009 and 2010, respectively. The benefit design data collected in this survey is representative of 67% of the reported total commercial lives and 82% of the reported total MA-PD lives.
Various cancers Hereditary angioedema Lysosomal storage diseases Multiple sclerosis Psoriasis Pulmonary arterial hypertension Rheumatoid arthritis/Crohns disease
Payers are developing strategies to manage these drugs across both benefits. Survey results indicate that over 70% of respondents are now requiring their internal pharmacy department to manage all specialty drugs regardless of the benefit. In addition, 76% of health plans are developing clinical criteria for entire drug categories across benefits to eliminate any siloed drug management between the pharmacy and medical benefit.
Member Cost Share

Health plans offer multiple benefit designs, with a variety of member cost-share structures for specialty drugs, including flat cost share, under which all agents are covered at the same cost share amount, and tiered cost share, where specialty agents fall under different tiers based on their formulary status (preferred vs. non-preferred). The cost share can be a fixed dollar copay amount or a coinsurance, where a member pays a percentage of the drug cost, with or without a maximum out-of-pocket (MOOP) amount per prescription.
11
Executive Summary
Member Cost Share - Medical Benefit
The use of cost share for specialty drugs under the medical benefit has increased over the past 3 years. In 2008, only 30% of commercial plans and 36% of MA-PD plans applied a cost share for specialty drugs covered under the medical benefit. In 2009, 37% of commercial plans and 52% of MA-PD plans required cost share. In 2010, 53% of commercial plans and 60% of MA-PD plans now require cost share for specialty drugs covered under the medical benefit (Figure 4). Consistent with previous years, coinsurance for medical benefit cost share is more common than copays: 83% for commercial plans and 85% for MA-PD plans in 2010. specialty pharmacy providers, while health plans are moving away from AWPbased reimbursement and implementing Average Sales Price (ASP)-based reimbursement for medical benefit providers (home health and physicians). The various reimbursement rates across distribution channels could result in a health plan paying different rates for the same drug.
Utilization Management
Health plans employ a variety of utilization management strategies for specialty products, such as implementing online automated step edits and quantity limits, selecting preferred products, and developing coverage criteria that may be enforced through the PA process. Therapy categories that are new to the top ten requiring PA include MS (oral), osteoporosis (SC), botulinum toxins, and immune globulin (SC and IV).
Reimbursement
Specialty drugs are distributed through multiple providers, and health plans utilize a variety of pricing references to reimburse providers for specialty products. Average Wholesale Price (AWP)-based reimbursement is typically used for retail and
Figure 4. Medical Benefit Cost Share (2008-2010)
Q. Describe the most common cost share methodology for specialty drugs covered under the medical benefit for each line of business.
No cost share 100% 80%

% of Plans
Flat cost share 4% 32% 41%
Tiered cost share 5%
5% 25%
3% 34%
12%
9%
47% 51%
60% 40% 20% 0% 2008 (n=57) 2009 (n=64) Commercial 2010 (n=75) 2008 (n=47) 2009 (n=58) MA-PD
70%
63% 47%
64% 48% 40%
2010 (n=65)
12
Preferred Drugs
The majority of participating health plans (88%) have at least one therapy category with preferred drugs. Preferred specialty products are selected most commonly for GH disorders, RA, hepatitis C, MS, and psoriasis. Health plans may utilize a variety of strategies to encourage the use of preferred products, and the type of strategy may vary by therapy category. The most popular strategies are to require a PA and/or deploy an NDC lock-out at the point of sale, followed by using tiered copays and step edits to manage the process.
Specialty Pharmacy Providers (SPPs)

The complexity of specialty drug distribution, handling, and patient support leads most health plans to adopt a custom specialty pharmacy network that may contain one or more SPPs. Similar to previous years, the majority of plans surveyed (88%) have already either contracted with one or more SPPs or are in the process of contracting with them; 7% of respondents manage the distribution of specialty drugs in-house, and only 5% have no contractual relationship with SPPs. This years survey data indicate that 43% of health plans contract with one SPP (not including the contractual relationships required for products with limited or exclusive distribution arrangements), reflecting a decrease from previous years. Correspondingly, there has also been year over year growth in the number of health plans contracting with 3 or more SPPs. Each health plan establishes its own SPP network and rules regarding the use of its contracted SPPs. The use of SPPs to dispense and distribute specialty drugs may be voluntary or mandatory this may be decided for an entire class of medications or for select drugs. The most common therapy categories required by payers to be distributed through a SPP include GH disorders, hepatitis C, MS (all forms), psoriasis and RA/Crohns disease. For commercial payers, 59% of respondents indicate they have at least one therapy category with mandatory SPP distribution, while 64% of MA-PD plans, and 71% of Medicaid plans have at least one therapy category with mandatory SPP distribution. Health plans identified specific areas where they are most satisfied and least satisfied with their SPP. Health plans are most satisfied with their SPPs ability to manage the drug distribution process, coordinate eligibility and reimbursement, ensure the appropriate dose is dispensed, and provide 24/7 access to a pharmacist or nurse. Health plans are least satisfied with their SPPs ability to provide predictive modeling, comparative prescribing data on plan physicians, and measurements of outcomes and savings.
Oncology Management
Health plans continue to develop strategies to manage oncology medications as many new oral and infused therapies are approved to treat a variety of cancers. From a topline strategy perspective, health plans are most likely to adopt nationally recognized guidelines for clinical pathways, increase their focus on palliative or end of life programs, and work with their community oncologists to develop proprietary clinical pathways. The most popular strategies to specifically manage oral and infused oncology agents involve processes to review the drug for appropriate use based on FDA-approved indication or peerreviewed studies to support off-label use. Survey participants also note an ongoing interest in developing strategies related to genetic testing, product distribution, and clinical management for oral and infused therapies.
Oncology Molecular Diagnostics

Payers are developing strategies to manage molecular diagnostic testing associated with oncology therapies. They typically rely on their Medical Technology and Assessment Committee as well as their P&T and Medical Management department to review these tests and develop applicable medical policies. The majority of plans have not implemented many strategies to manage molecular diagnostics; however, the data indicate that most plans expect to implement some management strategies within the next 12-24 months. At this time, some payers are requiring molecular diagnostic testing before approval of select oncology agents, while others are determining whether a molecular diagnostic test is cost effective before covering, or are requiring a PA for some molecular diagnostics. It is apparent that the methods by which health plans are covering and managing these agents is still evolving.
13
Executive Summary
Most SPPs have developed therapy management programs to enhance the value of the services they provide. Although offered to payers, less than 30% of the survey respondents indicate they utilize any of these programs. Therapy management programs are most commonly implemented for hepatitis C, RSV, MS, GH disorders, and RA/Crohns disease. Health plans utilize their specialty pharmacies to manage these therapy categories with one or more specific objectives.
Health Outcomes
Payers indicate they take clinical outcomes into consideration when making formulary decisions about specialty drugs. Outcomes can include information about the benefits, risks, and results of treatments. For hepatitis C, MS, and RA, payers are most interested in outcomes related to reductions in disease progression and severity, health care costs and adverse events, as well as improved adherence and persistency. Payers are most interested in oncology outcomes that demonstrate adherence to clinical guidelines and increased overall survival. Payers typically lack the ability to adequately track and measure most of the desired outcomes. Their expectation of the responsible party varies by outcome measure, as illustrated in Table 3.
Specialty Pharmacy Accreditation

Health care purchasers may require that a SPP become accredited by an independent third party organization to validate the pharmacys commitment to quality management, patient safety and monitoring, and prescriber and consumer communications. Thirty-eight percent of the participating payers state that accreditation is important to their selection of a SPP, with the majority of respondents indicating that URAC Specialty Pharmacy accreditation is the most important type of accreditation.
Table 3. Primary Entity Responsible for Demonstrating and Tracking Outcome Measurements
Q. Who should be primarily responsible for demonstrating and tracking outcome measurements that are valuable to your organization?
Outcome Measurement
Decrease disease progression and severity Prolong life Demonstrate pharmacoeconomic value Reduce adverse reactions Decrease hospitalizations and other health care costs Improve QoL Document comparative effectiveness Follow clinical guidelines Improve adherence and persistency
Pharmaceutical Manufacturer
X X X X
Independent Internal Health Plan Specialty Pharmacy Academic Research Research Provider
X X X X X X X X X X X X
14
Specialty Pharmacy Program Goals and Successes

Payers may periodically update their specialty pharmacy program goals. Depending upon the organization, the goals may be based on specific issues related to customer service, vendor capabilities, financial management, clinical and utilization management, reporting, or benefit design. The most commonly cited goals are related to their ability to reduce inappropriate utilization, reduce drug acquisition cost, and improve adherence and persistency. Several new goals are identified by this years survey respondents that have not been highlighted in previous years: Make formulary decisions based on clinical outcomes and comparative effectiveness data Reduce variations in physician prescribing patterns Reduce variability between pharmacy and medical benefits
Conclusions
The intersection of personalized medicine, a robust biopharmaceutical pipeline and economic pressures on health care systems are driving health plans to regularly update their specialty pharmacy management strategies. A number of significant changes have occurred over the past year when compared to previous editions of the EMD Serono Specialty Digest: As a result of new product approvals, additional therapeutic entities have been added to the list of classes that are categorized as specialty by payers Payers are becoming more aware of the crosscoverage of specialty products under the pharmacy and medical benefit and are developing strategies to link these products together Payers are updating their clinical and utilization management strategies to stay abreast of newly approved drugs Payers indicate that health outcomes data on specialty drugs, such as decreases in disease progression, health care costs, and serious adverse reactions are important measures when evaluating coverage and formulary decisions; however, the majority of plans lack the ability to effectively track and measure these outcomes
Most Effective Strategies

Throughout this digest, it is noted that many strategies are deployed by payers to manage specialty drugs and each year new strategies are identified to meet the changing needs of payers and members. Respondents agree that utilizing their internal pharmacy department to manage specialty drugs, implementing PA to manage utilization according to clinical guidelines under both the pharmacy and medical benefit, and mandating the use of SPPs for SAAs are the most effective strategies to achieve their overall specialty pharmacy management goals.
Future Strategies
Future strategies to manage specialty drugs are geared toward improving overall health care management of patients rather than relying on unit cost reduction strategies, including implementing oncology and other therapy management programs, utilizing outcomes data to make formulary decisions, and creating pay-for-performance incentives for physicians.
Payers will continue to apply micro-level strategies to manage the individual cost and utilization of specialty drugs; however, the survey results indicate that health plans will adopt more macro-level strategies focused on targeted therapies, clinical outcomes, comparative effectiveness, and consensus guidelines to meet the medical needs of their members.
15
Survey Results
The EMD Serono Specialty Digest, 7th edition, contains objective market data, gathered in January 2011, on the management of specialty pharmaceuticals by health plans in 2010. Data was collected via an online survey from 93 health plans representing over 115 million covered lives. Twelve percent of survey respondents represent national plans, 47% represent regional plans, and 41% represent state-wide plans. The online survey was targeted to health plan pharmacy directors (n=72) and medical directors (n=21) who are primarily responsible for overseeing specialty and injectable drugs and specialty pharmacy-related services in their organization. Questions were specific to commercial, Medicare Advantage Prescription Drug plans (MA-PD), and managed Medicaid lines of business in order to identify the similarities and differences in coverage and management of specialty agents between these benefits. Tables 4, 5, and 6 provide a demographic breakdown of the responding health plans according to line of business by percentage of covered lives, by number of plans, and by region.

41% of survey respondents represent plans with 400,000 or less covered lives, 31% of survey respondents represent plans with 400,001 to 999,999 covered lives, and 28% represent plans with 1 million or more covered lives Commercial, MA-PD, and Medicaid lines of business are represented by 78, 69, and 59 plans, respectively 38% of survey respondents represent Northeastern plans, 33% represent Midwestern plans, 26% represent Southern plans, and 34% represent Western plans (total greater than 100% due to business in more than one region)
Table 4. Distribution of Covered Lives by Line of Business Across All Participating Plans
Number of Lives Small (400,000 or less) Medium (400,001-999,999) Large (1,000,000 or more) Total number of lives covered
Commercial 10% 13% 77% 70,053,073
MA-PD 20% 11% 69% 16,457,299
Line of Business Medicaid Other* Percent (%) of Plans 44% 9% 20% 29% 36% 62% 14,023,048 15,125,763
Total 6% 15% 79% 115,659,183
(*Other may include indemnity plans, military health care, state and local low income plans, and Medicare Supplemental and non-Medicare retiree programs)
Table 5. Distribution of Number of Plans by Line of Business Across All Participating Plans
Line of Business Number of Lives Small (400,000 or less) Medium (400,001-999,999) Large (1,000,000 or more) Total number of plans Mean lives covered Commercial 43 15 20 78 898,116 MA-PD 62 3 4 69 238,512 Medicaid Other* Number (#) of Plans 51 26 5 7 3 4 59 37 237,679 408,804 Total Number / Percent 38 / 41% 29 / 31% 26 / 28% 93 1,243,647
Table 6. Distribution of Number of Plans by Line of Business and Region
Line of Business Region Northeast Midwest South West Commercial 26 26 18 25 MA-PD 29 21 19 31 Medicaid Other* Number (#) of Plans 24 15 20 12 13 12 23 13 Total Number / Percent 35 / 38% 31 / 33% 24 / 26% 34 / 34%
16
New to this Issue

This digest builds upon information gathered in previous editions, feedback provided by the Editorial Advisory board, and the general audience of readers. New features in the 7th edition digest include:
Medical Pharmacy Management

Detailed analysis is presented on specialty pharmacy management strategies that are implemented across pharmacy and medical benefits.

Strategies related to the management of molecular diagnostics for oncology are identified and prioritized.
Health Outcomes
Payers provided input on the most important outcomes measures impacting a health plans coverage and formulary decisions for 4 key therapy categories: hepatitis C, MS, oncology, and RA.
17
Survey Results
Classification of Specialty Drugs
With the rapid growth of specialty drugs into the marketplace for the treatment of complex diseases, payers are developing sophisticated benefit designs and management tools to accompany these drugs. To date there is no official definition of specialty drugs, and payers must develop their own definition for the classification of specialty drugs for internal management purposes and to describe to health plan members in their Evidence of Coverage manuals. Figure 5 identifies the most commonly reported factors plans take into consideration when classifying a drug as specialty pharmacy. Eighty percent of respondents note that an average monthly cost of $1,200 or more may qualify a drug to be classified as specialty pharmacy.

In addition to the cost of a drug, payers take into consideration other elements, such as whether the product treats a rare disease, requires special handling, has a limited distribution network, or requires ongoing clinical assessment and monitoring of response and/or side effects. Table 7 lists 19 therapy categories that are considered to be specialty pharmacy by over 70% of the respondents out of a possible list of 36 categories. By comparison there were only 16 therapy categories that were classified as specialty pharmacy in 2009 by 70% of the survey respondents.
Figure 5. Factors Determining Classification as Specialty Pharmacy
Q. On a scale of 1-5, where 1 = no impact at all and 5 = extreme impact, please rate the impact each factor has in determining whether a therapy category is classified as specialty pharmacy.
Mean high cost = $1,200
High cost Requires special handling Limited distribution Requires ongoing assessment of response Treats rare disease Requires monitoring of side effects Self-administered injectable Office-administered injection or infusion Requires patient administration training 0% 20% 49% 47% 46% 42% 41% 38% 37% 40% % of Plans
(sum of rating 4 and 5)
80% 62%
60%
80%
100%
18

Drugs/therapy categories that are newly added by at least 50% of respondents include: Botulinum toxins SC immune globulin Oral MS agents Injectable HAE agents Oral LS disease therapies Orphan disease therapies Injectable HIV/AIDS adjuvant therapies

In addition to the drugs and therapy categories in Table 7, other therapy categories that are considered to be specialty pharmacy by 25-49% of the plans include: Injectable gout therapies Infertility therapy Transplant drugs HIV/AIDS drugs Alcohol dependence agents Vaccines
Although infertility therapy is not listed by all plans, infertility is considered to be part of the specialty pharmacy benefit for plans in states where infertility benefits are mandated.
Table 7. Therapy Categories Classified as Specialty Pharmacy
Q. Indicate which therapy categories are classified as specialty pharmacy within your organization.
Therapy Category
Growth Hormone Disorders
Examples
Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Tev-Tropin
% of Plans 90% 88% 87% 85% 84% 83% 83% 82% 80% 80% 78% 78% 77% 76% 76% 75% 74% 73% 73%
Rheumatoid Arthritis/Crohns Disease (SC) Cimzia , Enbrel, Humira, Simponi Hepatitis C Hemophilia Factor Multiple Sclerosis (IM, SC) Lysosomal Storage Disease Therapies (IV) Multiple Sclerosis (IV) Rheumatoid Arthritis/Crohn's Disease (IV) Asthma Pulmonary Arterial Hypertension (Oral and Inhaled) ESAs G-CSF Oncology (Oral) Immune Globulin (IV) Multiple Sclerosis (Oral) Pulmonary Arterial Hypertension (Injectable*) Respiratory Syncytial Virus Immune Globulin (SC) Psoriasis Infergen, Pegasys, Peg-Intron Advate, Helixate FS, Novoseven, Recombinate Avonex, Betaseron, Copaxone, Extavia, Rebif Cerezyme, Fabrazyme, Myozyme, Vpriv Tysabri Actemra, Orencia, Remicade, Rituxan Xolair Adcirca, Letairis, Revatio, Tracleer, Tyvaso, Ventavis Aranesp, Epogen, Procrit Neulasta, Neupogen Gleevac, Nexavar, Oforta, Revlimid, Sprycel, Sutent, Tarceva, Temodar, Thalmid, Xeloda, Zolinza Gammar, Gammagard Ampyra, Gilenya Flolan, Remodulin Synagis Hizentra, Vivaglobin Amevive, Stelara
(*Injectable requiring health care professional administration)
19
Survey Results
Current Specialty Pharmacy Management Strategies
Specialty drugs have become the standard of care for many complex diseases, including GH disorders, hemophilia, hepatitis C, MS, RA, and various cancers. Unlike traditional oral pharmaceuticals, specialty drugs may be covered under the pharmacy or medical benefit and may be distributed by retail pharmacies, specialty pharmacies, through a physicians office, or by a home health agency. These characteristics pose unique challenges to health plans related to coverage, patient cost share, provider reimbursement, clinical management, and patient access.
Current Specialty Pharmacy Management Strategies

This years survey sought to identify what specialty pharmacy management strategies have become standard among health plans. Figure 6 illustrates the 10 most commonly implemented strategies (out of a list of 20) across commercial, MA-PD and Medicaid plans. In addition to the strategies listed in Figure 6, payers noted in the survey that they are least likely to: Create a separate specialty pharmacy benefit Require use of contracted SPP for some/all OAAs Move prior authorization to outside vendor Move OAAs from medical benefit to pharmacy benefit
Figure 6. Currently Implemented Specialty Pharmacy Management Strategies
Q. Indicate which specialty pharmacy management strategies you currently implement.
Commercial Implement PA under pharmacy benefit Limit specialty products to 30 day supply Implement PA under medical benefit Select preferred products Move management of PA in house Require the use of contracted SPP for distribution of some or all SAAs Utilize outcomes data to make formulary decisions Use ASP-based reimbursement for oncologists Use ASP-based reimbursement for non-oncology physicians 0% 20%
MA-PD
Medicaid
92% 88% 83% 86%
75% 80% 82% 74% 71% 79% 78% 75% 74% 74% 71% 30% 56% 53% 49% 43% 39% 49% 49% 46% 47% 51% 46%
40%
60% % of Plans
80%
100%
20
Benefit Coverage of Specialty Drugs

As noted previously, specialty drugs may be covered under both pharmacy and medical benefits, which is usually dependent upon the specific provider that is billing the drug or the location of drug administration. Similar to last year, this years survey data indicate that 73% of plans cover SAAs, including oral and injected medications, under the pharmacy benefit only (Figure 7). OAAs, including infused or healthcare practitioner-administered medications, are covered under the medical benefit by 62% of plans. Less than 30% of plans cover OAA agents under both the pharmacy and medical benefits depending on the site of administration or specific provider. In addition to SAA and OAA agents, the survey also examined the coverage of agents administered by home health agencies. Similar to previous years, the majority of plans cover these agents under either the medical benefit exclusively or under both the pharmacy and medical benefit.
Figure 7. Coverage of Agents Based on Administration or Provider (2008-2010)
Q. Describe how SAAs, MD OAAs, and home health specialty drugs are typically covered for your most common benefit structure.
Pharmacy Benefit Only
Medical Benefit Only
Both Pharmacy and Medical
Separate Specialty Benefit
100% 80% % of Plans 60% 40% 58% 20% 0% 2008 (n=69) 29% 13%
5% 14% 5%
5% 15% 7%
3%
1%
3%
3%
6% 30%
5% 42%
25%
24%
29%
35%
76%
73%
71%
73%
62%
56%
49%
42% 11% 2010 (n=93)
1% 2009 (n=85) 2010 (n=93) 2008 (n=69)
2% 2009 (n=85)
6% 2010 (n=93)
6% 2008 (n=69)
15% 2009 (n=85)
Self-Administered Agents (SAAs)
Office-Administered Agents (OAAs)
Home Health Administered Agents
21
Survey Results
Figure 8 identifies the benefit coverage of individual specialty therapy categories. Consistent with the concept that oral drugs and SAAs fall under the pharmacy benefit, therapy categories most likely to be covered under the pharmacy benefit include: MS (oral, SC, IM) RA/Crohns disease (SC) Oncology (oral) PAH (oral and inhaled) Hepatitis C GH disorders LS diseases (oral)
Q. Indicate the benefit under which each therapy category is covered for your most common benefit structure.
Categories most likely to be covered under the medical benefit include: RA/Crohns disease (IV) Immune globulin (IV and SC) MS (IV) LS diseases (IV) RSV PAH (IV) Hemophilia factor
Figure 8. Therapy Category Coverage under Pharmacy or Medical Benefit
Pharmacy Multiple Sclerosis (Oral) Rheumatoid Arthritis/Crohns Disease (SC) Oncology (Oral) Multiple Sclerosis (IM, SC) Pulmonary Arterial Hypertension (Oral and Inhaled) Hepatitis C Growth Hormone Disorders Lysosomal Storage Disease Therapies (Oral) ESAs G-CSF Psoriasis Immune Globulin (SC) Asthma Hemophilia Factor Pulmonary Arterial Hypertension (Injectable*) Respiratory Syncytial Virus Lysosomal Storage Disease Therapies (IV) Multiple Sclerosis (IV) Immune Globulin (IV) Rheumatoid Arthritis/Crohn's Disease (IV) 97% 93% 92% 91% 90% 88% 82% 76% 55% 52% 46% 40% 36% 34% 33% 32% 31% 29% 25% 25% 0%
(*Injectable requiring health care professional administration)
Medical 3% 7% 8% 9% 10% 13% 18% 24% 45% 48% 54% 60% 64% 66% 67% 68% 69% 71% 75% 75%
20%
40%
60% % of Plans
80%
100%
22
Managing Across Pharmacy and Medical Benefits

There are a number of therapy categories with drug offerings that are available under both the pharmacy and medical benefit within a health plan including therapies to treat: Various cancers HAE LS diseases MS Psoriasis PAH RA/Crohns disease
Managing Across Pharmacy and Medical Benefits

Past digests have cited a more siloed approach to managing specialty drugs under the pharmacy and medical benefit; however, there has been a growing trend to develop more uniform processes to review and manage these drugs. Survey results indicate that over 70% of respondents now are requiring their internal pharmacy department to manage these drugs across both benefits. In addition, 76% of health plans are developing clinical criteria for entire drug categories across benefits to eliminate any siloed drug management between the pharmacy and medical benefit (Figure 9). In addition to the strategies listed in Figure 9, payers note in the survey that they are least likely to: Create a separate specialty pharmacy benefit Create equal cost share across the benefits Eliminate buy and bill and require mandatory use of SPP across benefits
Figure 9. Strategies to Manage Across Pharmacy and Medical Benefits
Q. Indicate which strategies your organization has implemented to manage specialty drugs across the pharmacy and medical benefit.
Clinical criteria covers the entire therapy category across benefits Pharmacy department manages specialty drug PA across benefits Allow buy and bill with same reimbursement rate for SPPs and physicians Separate specialty drug benefit as part of the pharmacy benefit External vendor manages specialty drug PA across benefits Eliminate buy and bill for physicians with mandatory SPP for some or all drug categories across benefits Equal cost share for specialty drugs across benefits Separate specialty drug benefit as part of the medical benefit 0% 32% 29% 23% 22% 17% 14% 20% 40% 60%
76% 72%
80%
100%
% of Plans
23
Survey Results
Specialty Pharmacy Costs and Financial Trends
Although health plans indicate that specialty pharmacy management is a high priority, they have historically had difficulty isolating specialty drug costs within the pharmacy and medical benefit claim databases. The 2010 survey data identify that plans have significantly improved their capability to capture specialty drug cost and utilization data from their pharmacy and medical claim systems from the past two years (Figure 10). In 2008, only 29% of survey respondents were able to track their specialty drug financials under the medical benefit but in 2010, 75% are now able to track their medical benefit financials for specialty drugs.
Specialty Pharmacy Costs and Financial Trends

Similarly, in 2008, only 65% of survey respondents were able to track their specialty drug financials under the pharmacy benefit and in 2010, 98% are now able to do so. This year, health plans once again report the percent of specialty drug expenditures that are attributed to the pharmacy benefit and the medical benefit are split almost evenly between the benefits (Figure 3, page 10).
Figure 10. Percent of Plans That Track Their Specialty Pharmacy Drug Costs and Trend Rate
Q. Indicate whether you are able to track your specialty pharmacy drug costs and trend under the pharmacy and medical benefit.
Pharmacy Benefit 100% 80% 80%
Medical Benefit 98% 75% 64%
% of Plans
65%
60% 40% 20% 0% 2008 (n=65) 2009 (n=85) 2010 (n=93) 29%
24
Member Cost Share

Health plan members typically share some responsibility for the cost of their health care and, therefore, are usually required to pay a portion of the cost for their prescription medications, including specialty drugs. In most plans, the cost share amount is not the same for drugs covered under the pharmacy and medical benefit even though they may be used to treat the same condition. Each health plan specifies the exact extent of cost share under each benefit. Health plans offer multiple benefit designs, with a variety of cost-sharing structures for specialty drugs, including: Flat cost share, under which all agents are covered at the same cost share amount Tiered cost share, under which agents fall under different tiers based on their formulary status (preferred vs. non-preferred)
Member Cost Share

The cost share can be one of two options: 1. 2. Fixed dollar amount (copay) Percentage of the drug cost (coinsurance)
With the coinsurance option, a members liability may be limited to a maximum out-of-pocket (MOOP) amount per prescription or per calendar year. For purposes of this survey, only a MOOP per prescription is identified. Figure 11 identifies the use of copay vs. coinsurance from 2008-2010 under the pharmacy benefit and medical benefit for commercial and MA-PD plans.
Figure 11. Use of Copay and Coinsurance by Benefit (2008-2010)
$ Copay
100% 80% 27% 43% 37% 78% 73% 63% 22% 29% 29% 71% 71%
% Coinsurance
% of Plans
60% 40% 20% 0% 2008 (n=56) 2009 (n=63) 2010 (n=75)
82%
75%
83% 100%
83%
85%
57%
18%
25%
17%
17%
15% 2010 (n=42)
2008 (n=46)
2009 (n=56)
2010 (n=65)
2008 (n=17)
2009 (n=24)
2010 (n=40)
2008 (n=17)
2009 (n=30)
Commercial Pharmacy Benefit
MA-PD
Commercial Medical Benefit
MA-PD
(n values reflect organizations with flat or tiered cost shares under each benefit)
25
Survey Results
Pharmacy Benefit
Table 8 lists the most commonly offered cost share benefit structures for specialty drugs covered under commercial and MA-PD pharmacy benefits as well as the mean cost share and ranges. The majority of Medicaid plans (63%) do not require any cost share for their members. For those Medicaid plans that do require cost share, the average cost share is $3.00 per RX. For specialty drugs covered under the pharmacy benefit, 96% of commercial and MA-PD plans require cost share.
Tiered Cost Share

44% of commercial plans and 12% of MA-PD plans assess a tiered cost share The most common tiers under the commercial benefit for preferred drugs are tier 2 (47%) and tier 3 (68%) for non-preferred drugs The most common tiers under the MA-PD benefit for preferred and non-preferred drugs are tier 3 (43%) and tier 4 (58%), respectively
Flat Cost Share

52% of commercial plans and 84% of MA-PD plans assess a flat cost share for all specialty products The most common flat cost share tier utilized by commercial (39%) and MA-PD (56%) plans is the 4th tier Commercial Tier 4: 25% of plans assess copay (average $113) and 75% of plans assess coinsurance (average 23%) MA-PD Tier 4: 9% of plans assess copay (average $50) and 91% of plans assess coinsurance (average 29%)
Under the pharmacy benefit, copays (63%) are more common than coinsurance (37%) for commercial plans, while coinsurance (71%) is more common than copays (29%) for MA-PD plans. The percent of commercial plans with coinsurance that are limiting their members cost share liability by applying a MOOP per RX is declining: 88% of plans with coinsurance had a MOOP per RX in 2008, while 81% and 64% had a MOOP in 2009 and 2010, respectively. Note: The data in this table reflect the percent of plans responding and is not a count of the actual number of members enrolled in these benefits. The benefit design data collected in this survey is representative of 67% of the reported total commercial lives and 82% of the reported total MA-PD lives.
Table 8. Pharmacy Benefit Cost Share for Specialty Drugs
Q. Describe the benefit structure according to your most common benefit structure for all pharmacy benefit specialty drugs in your commercial and MA-PD lines of business.
Pharmacy Benefit Cost Share for Specialty

No Cost Share Flat Cost Share Dollar Copay % Coinsurance (w/ no MOOP per RX ) % Coinsurance (w/ MOOP per RX) Tiered Cost Share Preferred Dollar Copay % Coinsurance (w/ no MOOP per RX ) % Coinsurance (w/ MOOP per RX) Non-preferred Dollar Copay % Coinsurance (w/ no MOOP per RX ) % Coinsurance (w/ MOOP per RX) Total All Benefits Dollar Copay % Coinsurance (w/ no MOOP per RX ) % Coinsurance (w/ MOOP per RX)
(MOOP = Maximum out-of-pocket)
% of Plans Commercial MA-PD 4% 4% 52% 84% 59% 23% 12% 77% 29% 44% 12% 67% 15% 18% 56% 23% 21% 63% 13% 24% 75% 25%
Mean Cost Share Commercial MA-PD
Range of Cost Share Commercial MA-PD Min $5 10% 5% Min $20 20% 10% Min $40 20% 15% Min $5 10% 5% Max $250 35% 40% Max $75 33% 30% Max $100 50% 50% Max $250 35% 40% Min $10 10% Max $75 40%
$61 23% 20%
$46 28%
$35 25% 18% $58 34% 31% $48 24% 19%
$52 23%
Min $25 20% Min $60 30% Min $10 10%
Max $75 25% Max $120 60% Max $75 40%
38% 62%
$90 38%
29% 71%
$48 28%
26
Member Cost Share

Health plans offer different benefit designs for specialty pharmacy products with different cost share methodologies. Although the most common benefits are those that apply either flat copay or coinsurance, or a tiered benefit structure with a lower copay for preferred drugs and a higher copay for non-preferred drugs, health plans offer multiple variations of these benefits to their members. Table 9 identifies the various cost share structures for commercial and MA-PD benefits in 2009 and 2010. The most significant change in commercial pharmacy benefits is a decrease in plans offering a coinsurance with a limited MOOP expenditure and an increase in coinsurance plans without MOOP. MA-PD benefits did not change considerably from 2009 to 2010.
Table 9. Pharmacy Benefit Variations for Specialty Drugs
Medical Benefit
The use of cost share for specialty drugs under the medical benefit has increased over the past 3 years. In 2008, only 30% of commercial plans and 36% of MA-PD plans applied a cost share for specialty drugs covered under the medical benefit. In 2009, 37% of commercial plans and 52% of MA-PD plans required cost share. In 2010, 53% of commercial plans and 60% of MA-PD plans now require cost share for specialty drugs covered under the medical benefit (Figure 4, page 12). Consistent with previous years, coinsurance is more common than copays: 83% for commercial plans and 85% for MA-PD plans in 2010. Table 10 identifies the percent of plans utilizing dollar copays and coinsurance, their corresponding mean cost share, and the range provided by the respondents for specialty drugs covered under the medical benefit.
Commercial Pharmacy Benefit Variations for Specialty Drugs

All same $ copay Lower preferred $ copay/Higher non-preferred $ copay All same % coinsurance with MOOP All same % coinsurance with no MOOP Lower preferred % coinsurance with no MOOP/Higher non-preferred % coinsurance with no MOOP Lower preferred % coinsurance with MOOP/Higher non-preferred % coinsurance with MOOP Preferred $ copay/Non-preferred % coinsurance with no MOOP Preferred $ copay/Non-preferred % coinsurance with MOOP Lower preferred % coinsurance with MOOP/Higher non-preferred % coinsurance with no MOOP
MA-PD 2009 (n=56) 25% 4% N/A 69% 2% N/A N/A N/A N/A 2010 (n=65) 20% 5% N/A 67% 3% N/A 5% N/A N/A
2009 (n=63) 36% 20% 26% 5% 3% 6% N/A 1% 3%
2010 (n=75) 32% 25% 16% 7% 7% 7% 3% 3% 1%
Table 10.
Medical Benefit Cost Share for Specialty Drugs
Q. Describe the benefit structure according to your most common benefit structure for all medical benefit specialty drugs in your commercial and MA-PD lines of business.
% of Plans
Mean Cost Share Commercial MA-PD 40% 60% 15% 85% $89 20% $40 22%
Range of Cost Share Commercial Min Max MA-PD Min $20 Max $90 40%
Medical Benefit Cost Share for Specialty

No Cost Share Cost Share Dollar Copay % Coinsurance
Commercial 47% 53% 17% 83%
MA-PD
$5 $250
10% 40% 10%
27
Survey Results
Provider Reimbursement
Specialty drugs are distributed through a variety of providers, and health plans utilize various pricing methodologies to reimburse these providers. There have been several changes in the reimbursement methodologies since the first edition of the specialty digest. Originally, most medical and pharmacy providers were reimbursed based on the Average Wholesale Price (AWP) typically a discount off AWP; however, some providers were reimbursed at a percentage over the AWP. Over time, payers have been increasing the discount off AWP resulting in a lower reimbursement to all providers for specialty drugs. In 2006, a new pricing methodology, Average Sales Price (ASP), was introduced by the Centers for Medicare and Medicaid Services (CMS) to reimburse medical providers for drugs under Medicare Part B. Private health plans also began to adopt this pricing methodology for their medical providers.
Provider Reimbursement
This years survey data reflects a large shift from the use of AWP-based reimbursement to ASP-based reimbursement for all lines of business for medical benefit providers. For example, in Figure 12, the 2010 data found 53% of nononcologists, 55% of oncologists and 28% of home health agencies are reimbursed on an ASP basis. In comparison, the 6th edition EMD Serono Specialty Digest (2009) identified 40% of non-oncologists, 42% of oncologists and 27% of home health agencies were reimbursed on an ASP basis. Figure 13 illustrates the mean and range of ASP-based reimbursement for medical benefit providers within each line of business.
Figure 12. Provider Reimbursement Methodology (Commercial)
Q. What is the most common reimbursement basis for specialty pharmacy products through the various distribution channels for your commercial line of business?
Provider Capitation MD Non-Oncologist (n=49) Oncologist (n=49) Home Health Care (n=39) Specialty Pharmacy (n=51) Retail Pharmacy (n=51) 2% 2% 0% 20% 12% 12% 16% 29% 25%
AWP6% 8% 51% 88% 88% 40%
AWP+
ASP+ 53% 55% 5%
WAC+
28% 4% 6% 6% 4%
60% % of Plans
80%
100%
28
Figure 13. Mean and Range of ASP-Based Reimbursement Rate
High 25% 20% % Over ASP 15% 10% 5% 0%

Commercial (n=26) MA-PD (n=20) Medicaid (n=11) Commercial (n=27)
Mean 20.0%
Low
18.0% 10.3% 6.0%
18.0% 15.0% 8.4% 6.0% 7.7% 6.0%
20.0%
15.0% 10.0% 6.0% 8.7% 6.0%

MA-PD (n=22)
15.0% 9.1% 6.0%
15.0% 8.9% 6.0%

MA-PD (n=8)
15.0% 9.8% 6.0%

Medicaid (n=5)
7.9% 6.0%
Medicaid (n=11)
Commercial (n=11)
MD Non-Oncologist
Oncologist
Home Health Care
(n values represent survey participants who knew and could disclose information)
The average percentage over ASP for specialty pharmacy products reimbursed through physician offices across all lines of business has not changed significantly between 2009 and 2010, with non-oncology MD reimbursement averaging 9% over ASP and oncologist reimbursement averaging 9% over ASP in 2009. The average percentage over ASP for home health care providers was 8% in 2009; however, the range declined from a high of 20% in 2009 to a high of 15% in 2010. The year-to-year change may be due to a lower number of home health respondents in 2010.
Figure 14. Mean and Range of AWP Discount (+/-)
Another change in the reimbursement rate to providers was an adjustment in late 2009 in the calculation of AWP by wholesalers, which resulted in a change in the published AWP price and/or a modification in the AWP discount in payer contracts. Due to the change in AWP calculation, the data for 2010 will not be compared to previous years, nor is it clear that all payers are reporting the revised AWP discount rate. Figure 14 identifies the average discount off AWP reported for each provider by line of business.
High 15% 10% 5% AWP % (+/-) 0% -5% -10% -15% -20% -25% -30% MD Non-Oncologist Oncologist -12.7% -20.0% -12.0% 10.0% 10.0%
Mean
Low
0.0%
-12.0% -14.6% -16.2% -20.0%
-13.0% -17.7% -25.0%
-20.0%
-22.0%
Home Health Care
Retail Pharmacy
Specialty Pharmacy
(Data represents the average from all LOBs for each distribution channel)
29
Survey Results
Prior Authorization
Health plans employ a variety of utilization management strategies for specialty products covered under the pharmacy benefit, such as implementing online automated step edits and quantity limits, selecting preferred products, and developing coverage criteria that may be enforced through the PA process. Traditional pharmacy benefit management tools may not be available for drugs covered under the medical benefit due to the limited capability of medical claims systems to perform pre-adjudication review; however, more plans are implementing some method of PA or post-service pre-payment review for specialty drugs covered under the medical benefit. Figure 15 lists the drug categories that most commonly require PA under the pharmacy and medical benefit. Therapy categories that are newly ranked as one of the top 7 categories requiring PA for each benefit include: Pharmacy Benefit: MS (oral) Osteoporosis (SC)
Medical Benefit: Botulinum toxins Immune globulin (SC and IV)
Preferred Specialty Products

As more drugs become available within a therapeutic category, health plans are increasingly selecting preferred products, thus encouraging utilization of specific products. Consistent with the last few years, 88% of the responding payers designate at least one category with preferred specialty products. Figure 16 identifies drug categories where over 40% of plans have selected preferred products. Although not as common, 35% or less of the respondents indicate they have also selected preferred products in the following categories: Hyaluronic acid derivatives (35%) PAH (28%) Oral oncology (24%) Infertility (22%) G-CSF (20%) Hemophilia factor (14%)
Figure 15. Prior Authorization by Therapy Category
Q. Indicate which of the therapeutic classes/products require PA in order to be covered under each benefit.
Pharmacy Benefit 100% 80% % of Plans 60% 40% 20% 0% 96% 88% 82% 88% 77%
Medical Benefit 86% 86% 84%
81%
80%
80%
80%
76%
75%
Di so rd er s Di se as e( SC ) Ps or ias is M S (O ra l) PA He H pa (O tit ra is la C nd In ha Os led te op ) or os is (S C)
Cr o
RA /
RA /
30
Im
m un e
e( IV ul ) in um Gl ob To xin ul in s (IV an d PA SC H ) (In jec ta bl e)
As th
GH
hn 's
hn 's Cr o
Bo t
Di se as
RS V
a m
(IV )
Figure 16. Therapeutic Categories with Preferred Products
Q. Indicate whether you have preferred products in each drug class.
80%
76% 72% 65%
60%
54%
52% 45% 42% 40%
% of Plans
40%
20%
0% GH Disorders RA/Crohns Disease MS Hepatitis C Psoriasis LMW Heparin Osteoporosis ESAs
Health plans may utilize a variety of strategies to encourage the use of preferred products and the type of strategy may vary by therapy category (Figure 17). The most popular
Figure 17. Methods to Manage Preferred Drugs
strategies are to require PA and/or deploy an NDC lock-out at the point of sale, followed by using tiered copays and step edits to manage the process.
Q. What method(s) are used to manage preferred products?
NDC Lock-out or PA
Tiered Copay
Online Step Edit 85%
GH Disorders ESAs RA/Crohns Disease Psoriasis Osteoporosis Hepatitis C MS LMW Heparin

0%
20% 22%
30% 38% 33% 29% 33% 33% 37% 44% 65% 64% 38% 32% 29% 36% 40% 42% 55% 52% 60% 80% 62% 73% 72%
20%
20%
100%
% of Plans
31
Survey Results
Oncology
Oncology Management Strategies
Health plans are continuing to develop strategies to manage oncology medications as many new oral and infused therapies are approved to treat a variety of cancers. Figure 18 identifies key topline strategies that payers currently implement, plan to implement in the next 12 months, or have no plans to implement. Over 50% of the survey respondents indicate they currently utilize or plan to adopt nationally recognized guidelines for clinical pathways, increase their focus on palliative or end of life programs, and work with their community oncologists to develop proprietary clinical pathways. Payers seem least likely to adopt a 3rd party vendors clinical pathways, outsource oncology care management to vendors, or in-source oncology care management from external vendors.
Oncology
Oncology Management Strategies
The respondents were asked to identify specific management practices implemented by health plans for infused (Figure 19) and oral (Figure 20) oncology agents. The most commonly implemented strategies for managing oncology products are related to the PA review process; 60% of plans require PA for most infused oncology drugs and 80% of plans require PA for most oral oncology drugs. Many plans also stipulate requirements for coverage of nonFDA approved uses of oncology agents, with 69% and 73% of the responding health plans requiring peer-reviewed published studies for infused and oral oncology, respectively. Over 70% of health plans require compendia listing to support the request for off-label use for infused and oral oncology agents.
Figure 18. Most Commonly Implemented Topline Strategies Related to the Management of Oncology
Q. Indicate which strategies your organization has already implemented related to the general management of oncology, expect to implement in the next 12 months, or do not plan to implement.
Currently implement
Plan to implement in next 12 months 52% 25% 23% 10% 9% 5% 8% 16% 29% 27% 36% 19%
No plans to implement 29% 48% 41% 61% 75%
Adopt NCCN and/or ASCO guidelines for clinical pathways Work with community oncologists to develop proprietary clinical pathways Increase focus on use of palliative care/end of life programs Create pay-for-performance incentives for oncologists for following clinical pathways Adopt 3rd party vendors clinical pathways Insource oncology care management from external vendor
87% 85% 20% 40% 60% % of Plans 80% 100%
Outsource oncology care management to vendor 3% 12%
0%
32
Figure 19. Most Commonly Implemented Strategies to Manage Infused Oncology
Q. Indicate which strategies your organization has already implemented related to the management of infused oncology products, expect to implement in the next 12 months, or do not plan to implement.
Currently implement
Plan to implement in next 12 months
No plans to implement
Require compendia listing for off-label use Require peer reviewed published studies to support off-label use Require PA for infused oncology drugs Utilize internal RX department to manage infused oncology Require evidence of meeting genetic testing criteria prior to approving drug therapy where appropriate Select preferred products for some infused oncology products Utilize vendor (SPP or other) to manage PA 0%
71% 69% 60% 44% 33% 23% 19% 6% 20% 40% 16% 15% 32%
10% 10% 15%
19% 21% 25%
41% 35% 61% 75% 60% 80% 100%
% of Plans
Figure 20. Most Commonly Implemented Strategies to Manage Oral Oncology
Q. Indicate which strategies your organization has already implemented related to the management of oral oncology products, expect to implement in the next 12 months, or do not plan to implement.
Currently implement
Plan to implement in next 12 months
No plans to implement
Require PA for oral oncology drugs Require compendia listing for off-label use Require peer reviewed published studies to support off-label use Include oral oncology in specialty definition Require evidence of meeting genetic testing criteria prior to approving drug therapy where appropriate Limit days supply of oral agents for 1st fill Mandate use of SPP for some or all oral oncology drugs Implement Specialty Pharmacy program to monitor adherence and side effects Utilize vendor (SPP or other) to manage oral oncology agents Select preferred products in some oral oncology drug classes Match oral drug cost share to infused drug cost share 0%
80% 74% 73% 61% 48% 42% 41% 36% 32% 28% 17%
20%
6% 14% 7% 5% 15% 21% 25% 25% 25% 19% 22% 24% 31% 33% 34% 39% 53% 52% 60%
60% 80% 100%
15% 20% 23%

40%
% of Plans
33
Survey Results
This years survey explores the methods by which payers have begun to manage molecular diagnotic testing and the therapies associated with these tests for oncology therapy. Figure 21 identifies which departments within a health plan are primarily responsible for reviewing molecular diagnostic testing. The majority of plans utilize their Medical Technology and Assessment Committee to review these tests, while others
logyMolecular Diagnostics
rely on their P&T committee or medical management department. In many cases, plans may use more than one committee or department to review molecular diagnostics. Only 3% of the respondents indicate they do not have a review process for oncology-related molecular diagnostic tests.
Figure 21. Department Responsible for Reviewing Molecular Diagnostic Testing
Q. What department is responsible for reviewing molecular diagnostic testing associated with oncology drugs?
80% 59% 60%
% of Plans
41% 40%
37%
20% 7% 0% Medical Technology and Assessment Committee P T Committee Medical Management Department Other None 3%
(Plans may use more than one committee or department to review molecular diagnostics.)
34
c
Although molecular diagnostics are important tools to identify patients who will achieve optimal clinical outcomes of specific therapies, the methods by which health plans are covering and managing these agents is still evolving. Based on the survey results identified in Figure 22, the majority of plans have not implemented many strategies to manage molecular diagnostics; however, the data indicate that most plans expect to implement some management strategies within the next 12 to 24 months.
O
At this time, the most commonly implemented strategies related to oncology molecular diagnostics include: Determining whether a molecular diagnostic test is cost effective before covering (50%) Requiring molecular diagnostic testing before approval of select oncology agents (40%) Requiring a PA for some molecular diagnostics (40%)
Figure 22. Molecular Diagnostics Management Strategies for Oncology
Q. Indicate which strategies your organization has already implemented related to the management of molecular diagnostics for oncology, expect to implement in the next 12-24 months, or do not plan to implement.
Currently implement
Determine whether a molecular diagnostic test for oncology is cost-effective before covering Require molecular diagnostic testing before approval of some or all oncology agents where applicable Require PA for molecular diagnostics for some or all oncology therapies where applicable Include molecular diagnostic tests in clinical pathways as specified by NCCN/ASCO Restrict use of oncology drugs based on results of companion molecular diagnostic tests Educate providers about appropriate use of molecular diagnostic testing and related drug therapies Conduct retrospective claims review to determine appropriate use of testing Cover and reimburse for all oncology molecular diagnostic testing without PA
Plan to implement in next 12-24 months 50% 40% 40% 37% 32% 24% 19% 17% 16% 20% 40% 60% % of Plans 39% 67% 44% 32% 42% 40% 34% 39%
No plans to implement 18% 18% 20% 29% 29% 32% 42%
0%
80%
100%
35
Survey Results
Specialty Pharmacy Providers (SPPs)
The complexity of specialty drug distribution, handling, and patient support leads most health plans to adopt a custom specialty pharmacy network that may contain one or more SPPs. Similar to last year, the majority of plans surveyed (88%) have already either contracted with one or more SPPs or are in the process of contracting with them; 7% of respondents manage the distribution of specialty drugs in-house, and only 5% have no contractual relationship with SPPs.
Number of SPPs Contracted

Survey data indicate that 43% of health plans contract with only one SPP (not including the contractual relationships required for products with limited or exclusive distribution arrangements), reflecting a decrease from previous years (Figure 23). Correspondingly, there has also been year over year growth in the number of health plans contracting with 3 or more specialty pharmacies.
Figure 23. Number of SPPs Contracted (2008-2010)
Q. Indicate how many SPPs you are currently contracted for non-limited distribution drugs.
1 SPP exclusively 100% 20% 80% % of Plans 60% 40% 20% 0% 2008 (n=64) 45% 35%
2 SPPs
3 or more SPPs
19%
28%
31% 29%
50%
43%
2009 (n=74)
2010 (n=81)
36
Voluntary vs. Mandatory Use of SPPs

Each health plan establishes its own SPP network and rules regarding the use of its contracted SPPs. The use of SPPs to dispense and distribute specialty drugs may be voluntary or mandatory this may be decided for an entire class of medications or for select drugs. For specialty drugs covered under the pharmacy benefit, members may be allowed to utilize either the plans retail network, mail service pharmacy or the contracted SPP(s) on a voluntary basis, or members may be required to obtain their specialty drugs only through the SPP. For specialty drugs covered under the medical benefit, health plans may allow medical benefit providers (physicians and home health agencies) to maintain their own drug inventory and bill the health plan at their contracted rate as described on page 28 (commonly referred to as buy and bill), or they may require the provider to order the drug from the specialty pharmacy and only bill the health plan for their administration and procedure related costs. In this case, the specialty pharmacy bills the health plan and collects any applicable cost share from the patient.
1
Figure 24 identifies the most common therapy classes that are required by payers to be distributed only through the specialty pharmacy. For commercial payers, 59% of respondents indicate they have at least one therapy category with mandatory SPP distribution, while 64% of MA-PD plans and 71% of Medicaid plans have at least one therapy category with mandatory SPP distribution. For plans that do not require mandatory use of the specialty pharmacy network, the majority indicate they have either chosen not to limit the network, they reside in a state with any willing provider legislation which does not allow for a limited network, or their certificate of coverage does not allow a limited network. The any willing provider provision of Medicare Part D could be interpreted to preclude a payer from developing a limited specialty pharmacy network. The majority of MA-PD plans that indicate they mandate the use of their SPP network specify they enforce the use of the network through their PA process.
Figure 24. Mandatory Use of SPP by Therapy Category
Q. For each line of business, indicate if the use of the Specialty Pharmacy Provider is mandatory for some or all agents within the drug categories listed.
Commercial (n=68) Growth Hormone Disorders Hepatitis C Multiple Sclerosis (IM, SC) Psoriasis RA/Crohns Disease (SC) Hemophilia Factor Multiple Sclerosis (Oral) Oncology (Oral) Multiple Sclerosis (IV) 0%
MA-PD (n=59)
Medicaid (n=52)
44% 42% 41% 40% 39% 38% 36% 38% 46% 44% 41% 41% 38% 47% 47% 51% 50%
3 36% 37% 33% 32% 33% 34% 34% 32% 31% 37%
20% % of Plans
40%
60%
37
Survey Results
Services Provided by SPPs
SPPs offer a broad range of services to meet the clinical, billing, distribution, and service requirements of specialty drugs. Respondents were asked to identify the most important services provided by their specialty pharmacy and to rank their level of satisfaction with their contracted SPPs performance related to these services. Figure 25 lists the top 10 most important services out of a list of 26 possible services. The services identified as most important are: Distribution direct to patient and/or MD Ensuring appropriate dose of medication Preventing drug waste, abuse, and misuse
P
Health plans are most satisfied with their SPPs ability to: Distribute drug direct to patients and/or MD Coordinate reimbursement and eligibility Provide 24/7 access to RN or pharmacist Ensure appropriate dose
In addition to the strategies listed in Figure 25, payers note in the survey that they are least satisfied with their SPPs services related to: Predictive modeling Comparative prescribing data on plan MDs Measurement of outcomes and savings
Figure 25. Importance of SPP Services and Health Plan Satisfaction
Q. On a scale from 1 to 5, where 1 = not at all important and 5 = extremely important, please rate the importance of each service provided to your organization by your SPP. On a scale from 1 to 5, where 1 = not at all satisfied and 5 = extremely satisfied, please rate your satisfaction with each service provided to your organization by your SPP.
Satisfaction
Importance
Mean = 3.81 Mean = 4.24 4.14 3.80 3.53 4.07 3.87 3.61 4.13 4.63 4.57 4.49 4.47
Distribution direct to patients home or business Ensure appropriate dose of medication Prevent drug waste, abuse and misuse Distribution direct to MD Provide 24/7 access to RN or pharmacist Implement adherence and persistence programs Reimbursement and eligibility coordination Provide disease specific patient education Dedicated account manager Proactive refill management 1 2 3 Rating
3.64 3.71
4.09 3.98 4.06 4.05
3.98 3.73 3.88
38
SPP Therapy Management Programs

Most SPPs have developed therapy management programs to enhance the value of the services they provide. Although offered to payers, less than 30% of the survey respondents indicate they utilize any of these programs (Figure 26). For these respondents, therapy management programs are most commonly implemented for hepatitis C, RSV, MS, GH disorders, and RA/Crohns disease. Health plans that utilize their specialty pharmacies to manage these therapy categories do so with one or more specific objectives (Table 11).
Figure 26. Most Commonly Utilized Therapy Management Programs Offered by SPPs
P
For example, hepatitis C, GH disorders and RA/Crohns disease programs are utilized to improve adherence, optimize dose, decrease inappropriate use, and reduce product waste. RSV programs are managed to decrease health care costs, improve adherence, optimize dose, and decrease inappropriate use; while MS programs are geared to improve quality of life, improve adherence, optimize dose, and reduce product waste.
Q. Indicate which therapy management programs offered by your SPP your organization utilizes.
30%
27% 25% 22%
% of Plans
20%
19%
17% 14%
10% 6% 6%
0% Hepatitis C Respiratory Syncytial Virus Multiple Sclerosis Growth Hormone Disorders RA/Crohn's Disease Hemophilia Factor Infertility Oncology
Table 11.
Major Program Goals of Specific SPP Drug Therapy Management Programs
Q. Identify the major program goals of the specific Drug Therapy Management programs.
Most Commonly Utilized Programs

Hepatitis C Respiratory Syncytial Virus Multiple Sclerosis Growth Hormone Disorders RA/Crohn's Disease
Decrease Health Care Costs
Improve QoL
Improve Adherence
Optimize Dose
Decrease Inappropriate Use x x
Reduce Product Waste x
x x x x x x x
x x x x x
x x x x x
39
Survey Results
Spotlight on Outcomes
As noted throughout this digest, health plans are implementing a variety of tactics to manage the cost of specialty drugs and to ensure appropriate utilization. Increasingly, payers are also focusing on the outcome, or value of a particular course of therapy to the patient, the physician, and the health care system. Outcomes can include information about the benefits, risks, and results of treatments. This years survey asked payers to identify the most important outcome measures impacting their health plans coverage and formulary decisions for 4 key therapy classes: hepatitis C, MS, oncology, and RA (Figures 27-30) and to indicate whether they are able to effectively track and measure these outcomes. Payers vary in their opinion on what entity should be primarily responsible for demonstrating and tracking outcome measures (Page 14, Figure 3).
Hepatitis C
Hepatitis C is an infectious disease that impacts up to 4.1 million people in the US.12 It is often asymptomatic, yet can lead to fibrosis and cirrhosis. Outcome measures that over 50% of payers identify as impacting coverage and formulary decisions for hepatitis C therapies are identified in Figure 27. Figure 27. Outcome Measures for Hepatitis C
Impacts coverage and formulary decisions 80% % of Plans 60% 40% 20% 0% Decrease disease progression and severity Follow health plan guidelines Decrease hospitalizations and other health care costs Reduce adverse reactions Improve adherence and persistency 34% 40% 74% 71% 62% 38% 13% Organization is able to track 62% 58% 43%
Multiple Sclerosis
Multiple sclerosis is an inflammatory disease that impacts 400,000 people in the US.13 Patients with MS can progress to severe physical and cognitive disability. Outcome measures that over 50% of payers identify as impacting coverage and formulary decisions for MS therapies are identified in Figure 28. Figure 28. Outcome Measures for Multiple Sclerosis
Impacts coverage and formulary decisions 80% % of Plans 60% 40% 20% 0% Decrease disease Decrease progression hospitalizations and and severity other health care costs Follow health plan guidelines 40% 29% 13% Reduce adverse reactions Improve adherence and persistency 40% 69% 66% 65% Organization is able to track 60% 57% 41%
40
Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory disease impacting 1.3 million people in the US.14 RA is a painful and disabling condition, which can lead to significant loss of function and mobility. Outcome measures that over 50% of payers identify as impacting coverage and formulary decisions for RA therapies are identified in Figure 29. Figure 29. Outcome Measures for Rheumatoid Arthritis
Impacts coverage and formulary decisions 80% % of Plans 60% 40% 20% 0% Decrease disease progression and severity Follow health plan guidelines Reduce adverse reactions Decrease Improve adherence hospitalizations and and persistency other health care costs 40% 40% 28% 28% 14% 14% 72% 70% 62% Organization is able to track 57% 33% 33% 54% 41% 41%
Oncology
Outcome measures that over 50% of payers identify as impacting coverage and formulary decisions for oncology therapies are identified in Figure 30. Figure 30. Outcome Measures for Oncology
Impacts coverage and formulary decisions 80% % of Plans 60% 40% 20% 0% Follow health plan guidelines Improve adherence and persistency Decrease disease progression and severity Decrease hospitalizations and other health care costs Reduce adverse reactions 35% 26% 15% 8% 70% 63% 57% Organization is able to track 57% 35% 53%
Although payers responded overwhelmingly to the importance of specific outcome measures to their coverage and formulary decision-making process, they do not appear to have the capability to effectively track most of these outcomes and measure them, with the exception of the ability to track adherence and persistency outcomes. As identified on page 39, specialty pharmacies play a key role in promoting adherence and tracking this information for payers.
12 Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, Management, and Treatment of Hepatitis C: An Update. Hepatology. 2009;49(4):1335-1374. 13 Kalb R, Reitman N. Overview of Multiple Sclerosis. A Clinical Bulletin from the Professional Resource Center of the National Multiple Sclerosis Society. 2010. Available at: http://www.nationalmssociety.org/for-professionals/healthcare-professionals/publications/clinical-bulletins/index.aspx. Accessed 3/8/11. 14 Centers for Disease Control and Prevention. Arthritis Related Statistics. 2010. Available at: http://www.cdc.gov/arthritis/data_statistics/arthritis_related_stats.htm. Accessed 3/8/11.
41
Survey Results
Specialty Pharmacy Accreditation
Health care purchasers are increasingly requesting that a specialty pharmacy become accredited by an independent third party organization to validate the pharmacys commitment to quality management, patient safety and monitoring, and prescriber and consumer communications. A number of different third party organizations provide accreditation to specialty pharmacies, including: URAC for Quality Management URAC for Specialty Pharmacy JCAHO (Joint Commission on Accreditation of Healthcare Organizations) ACHC (Accreditation Commission for Health Care)
Other 5% URAC Disease Management 7%
Figure 31: Most Important Type of SPP 3rd Party Accreditation
Q. Which accreditation is most important to your organization?
None 20%
JCAHO 11%
New to this years survey, respondents were asked to rate the importance of 3rd party accreditation in the selection of their SPP. Thirty-eight percent indicate that accreditation is important (sum of 4 and 5 on a 5-point rating scale) in the selection of a specialty pharmacy (Figure 32), with the majority of respondents indicating that URAC Specialty Pharmacy accreditation is the most important type of accreditation (Figure 31).
URAC Specialty Pharmacy 57%
Figure 32. Importance of SPP 3rd Party Accreditation
Q. On a scale of 1-5, where 1 = not at all important and 5 = extremely important, indicate how important it is for your SPP to have a 3rd party accreditation.
40%
Mean = 3.2
% of Plans
30%
20%
37% 23% 15% 10% 15%
10%
0% 1 2 3 Rating 4 5
42
Specialty Pharmacy Program Goals

Payers may periodically update their specialty pharmacy program goals. Depending upon the organization, the goals may be based on specific issues related to customer service, vendor capabilities, financial management, clinical and utilization management, reporting, or benefit design (Figure 33). Similar to previous years, the top 3 goals are to: 1. 2. 3. Reduce inappropriate utilization Reduce drug acquisition costs Improve patient adherence and persistency
Several new goals were identified by this years survey respondents that were not seen in previous years: Make formulary decisions based on clinical outcomes Make formulary decisions based on comparative effectiveness data Reduce variations in physician prescribing patterns Reduce variability between pharmacy and medical benefits
Figure 33. Specialty Pharmacy Management Goals
Q. On a scale from 1 to 5, where 1 = not at all important and 5 = extremely important, please rate the importance of each of the following goals to your organizations specialty pharmacy management.
Mean = 3.88
Reduce inappropriate utilization Reduce drug acquisition costs Improve patient adherence and persistency Make formulary decisions based on clinical outcomes Improve patient satisfaction Make formulary decisions based on comparative effectiveness data Reduce variations in physician practice patterns Manage oral oncology Increase rebates Reduce variability between pharmacy and medical benefit Manage infused oncology 1 2 3 Rating
4.70 4.61 4.14 3.94 3.86 3.81 3.67 3.60 3.51 3.44 3.38 4 5
43
Survey Results
Most Effective Strategies to Manage Specialty Drugs
Throughout this digest, many strategies are deployed by payers to manage specialty drugs and each year new strategies are identified to meet the changing needs of payers and members. Figure 34 highlights the top 9 strategies (out of a list of 20) that are cited by the respondents to be the most effective overall at helping their organizations achieve their specialty pharmacy goals. Similar to previous years, the top 3 strategies include: 1. 2. 3. Require the use of contracted SPPs for SAAs Move management of PA in house Implement PA under pharmacy and medical benefits
The most significant change from previous years is the ranked order of the strategies. The mandatory use of SPPs for SAAs has moved up from #5 in 2008 and #4 in 2009 to #1 in 2010.
Figure 34. Most Effective Strategies to Manage Specialty Drugs
Q. Indicate whether you use the following strategies, and on a scale from 1 to 5, where 1 = not at all effective and 5 = extremely effective, rate the effectiveness that each of the following programs or services have had in helping your organization achieve its overall specialty pharmacy management goals.
Mean = 4.11
Require the use of contracted SPP for distribution of some or all SAAs (n=52) Move management of PA in house (n=49) Implement PA under pharmacy benefit (n=80) Limit specialty products to 30 day supply (n=70) Implement PA under medical benefit (n=67) Move SAAs from medical benefit to pharmacy benefit (n=48) Select preferred products (n=68) Use ASP-based reimbursement for non-oncology physicians (n=49) Use ASP-based reimbursement for oncologists (n=51) 1 2 3 Rating
4.48 4.33 4.30 4.17 4.12 4.06 3.97 3.82 3.77 4 5
44
Future Changes in Specialty Pharmacy Management

With the introduction of new specialty therapeutics and more overall utilization of specialty drugs across the pharmacy and medical benefit, health plans continue to formulate and refine strategies to enhance specialty pharmacy management. When asked to identify specialty pharmacy management strategies that may be implemented in the next twelve months, respondents appear to be focusing on more sophisticated strategies that are geared toward improving overall health care management of patients, rather than relying on unit cost reduction strategies, such as: Implementing oncology management programs Implementing therapy management programs with SPP Utilizing outcomes data to make formulary decision Creating pay-for-performance incentives for physicians
y P
Figure 35 illustrates the 8 most commonly anticipated future changes (out of a list of 20) across commercial, MA-PD and Medicaid plans. One strategy identified by 36% of the respondents that may have an impact on therapy outcomes is increasing the cost share to patients under the commercial benefit. Numerous published studies cited in earlier editions of the EMD Serono Specialty Digest have identified a direct correlation between increased cost share and lower therapy adherence.15-17
15 Starner C, Gleason P, Gunderson B. Oral Oncology Prescription Abandonment
Association with High Out-of-Pocket Member Expense. J Manag Care Pharm. 2010;16(2):161-162. 16 Gleason P, Gunderson B, Walters C, et all. Association between tumor necrosis factor (TNF), blocker out-of-pocket (OOP) expense, and member decline to fill rate. J Manag Care Pharm. 2008;14(2):210. 17 Gleason P, Gunderson B. Association of multiple sclerosis medication out-ofpocket expense with decline-to-fill rate. J Manag Care Pharm. 2009;15(2):178-179.
Figure 35. Anticipated Future Changes in Specialty Pharmacy Management within the Next 12 Months
Q. Indicate which specialty pharmacy management strategies you anticipate implementing within the next 12 months.
Commercial Implement oncology management programs Increase cost share to patients Implement therapy management program(s) with SPP Utilize outcomes data to make formulary decisions Create pay-for-performance incentives for some physician specialties Create preferred and non-preferred cost share tiers for SAAs Use ASP-based reimbursement for non-oncology physicians Use ASP-based reimbursement for oncologists 0% 10%
MA-PD
Medicaid
38% 33% 31% 36%
7%
17% 32% 29% 31% 28%
23% 25% 28% 32% 22% 27% 5% 16% 17% 19% 19% 19% 26% 24%
20%
30%
40%
50%
% of Plans
45
Survey Results
Conclusions
The intersection of personalized medicine, a robust biopharmaceutical pipeline, and economic pressures on health care systems are stimulating health plans to regularly update their specialty pharmacy management strategies. A number of significant changes have occurred over the past year when compared to previous editions of the EMD Serono Specialty Digest.
Conclusions
Medical Benefit Overall increase in use of cost share under the medical benefit No significant shift of OAAs to pharmacy benefit or mandatory use of SPP
Clinical and Utilization Management

Payers are updating their clinical and utilization management strategies to stay abreast of newly approved drugs: New drug categories requiring PA More plans implementing PA New drug categories with preferred drugs
Newly Approved Drugs

As a result of new product approvals, additional therapeutic entities have been added to the list of classes that are categorized as specialty by payers. These include: Immune globulin SC Oral MS agents HAE therapies HIV/AIDS adjuvant therapies Other orphan disease agents
The Impact of Outcomes

Payers indicate that health outcomes data on specialty drugs, such as decreases in disease progression, health care costs and serious adverse reactions are important measures when evaluating coverage and formulary decisions. However, the majority of plans lack the ability to effectively track and measure these outcomes.
Pharmacy and Medical Benefit Management

Payers are becoming more aware of the cross-coverage of specialty products under the pharmacy and medical benefit and are developing strategies to link these products together: Move prior authorization and clinical management of all specialty drugs to the in-house pharmacy department Develop health plan guidelines across benefits
Future Specialty Pharmacy Management Strategies

Payers will continue to deploy micro-level strategies to manage the individual cost and utilization of specialty drugs; however, the survey results indicate that health plans will adopt more macro-level strategies focused on targeted therapies, clinical outcomes, comparative effectiveness, and consensus guidelines to meet the medical needs of their members.
Benefit Design
Benefit designs for specialty drugs covered under the pharmacy benefit as well as the medical benefit are changing. Pharmacy Benefit Increase in cost share amount Reduction in use of maximum-out-of-pocket (MOOP) per RX on coinsurance plans, resulting in higher cost share per RX.
46
Notes
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Notes
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48
2011 EMD Serono, Inc.
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Glossary of Commonly Used Abbreviations

Table 1. Selected Molecular Biomarker Applications in Personalized Medicine1,2

More Effective Therapies

Reduce Adverse Events

Specialty Drug Pipeline: Spotlight on Orphan Drugs

Technology and Tools for Clinical Review

Expected Impact on Patient Care

Figure 2. Orphan Drugs in Development9

107 79 67 37 37 31 31 20 18 14 12 11 10 10 6 5 20 40 60 80 100 120

Number of Orphan Drugs in Development

Current Specialty Pharmacy Management Strategies and Benefit Coverage

Defining Specialty Drugs

Drug Spend and Cost Trend

Pharmacy Benefit 100% % of Plans 80% 60% 40% 20% 0% 47%

Medical Benefit 42%

Strategies to Manage Across Pharmacy and Medical Benefits

Member Cost Share - Pharmacy Benefit

Member Cost Share

Figure 4. Medical Benefit Cost Share (2008-2010)

No cost share 100% 80%

Flat cost share 4% 32% 41%

Tiered cost share 5%

64% 48% 40%

Specialty Pharmacy Providers (SPPs)

Oncology Molecular Diagnostics

Specialty Pharmacy Accreditation

Specialty Pharmacy Program Goals and Successes

Most Effective Strategies

Methodology and Demographics

Commercial 10% 13% 77% 70,053,073

MA-PD 20% 11% 69% 16,457,299

Total 6% 15% 79% 115,659,183

Table 6. Distribution of Number of Plans by Line of Business and Region

New to this Issue

Medical Pharmacy Management

Oncology Molecular Diagnostics

Classification of Specialty Drugs

Figure 5. Factors Determining Classification as Specialty Pharmacy

Mean high cost = $1,200

Classification of Specialty Drugs

Classification of Specialty Drugs

(*Injectable requiring health care professional administration)

Current Specialty Pharmacy Management Strategies

Figure 6. Currently Implemented Specialty Pharmacy Management Strategies

Q. Indicate which specialty pharmacy management strategies you currently implement.

Benefit Coverage of Specialty Drugs

Figure 7. Coverage of Agents Based on Administration or Provider (2008-2010)

Pharmacy Benefit Only

Medical Benefit Only

Both Pharmacy and Medical

Separate Specialty Benefit

42% 11% 2010 (n=93)

1% 2009 (n=85) 2010 (n=93) 2008 (n=69)

15% 2009 (n=85)

Self-Administered Agents (SAAs)

Office-Administered Agents (OAAs)

Home Health Administered Agents

Figure 8. Therapy Category Coverage under Pharmacy or Medical Benefit