Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers
`
`Trends in Biologic Therapies
`for Rheumatoid Arthritis:
`Results from a Survey of
`Payers and Providers
`
`March/April 2012, Vol 5, No 2 - Business
`
`Rhonda Greenapple, MSPH
`
`Abstract
`
`Background: Advances in therapies for rheumatoid arthritis (RA),
`particularly biologics, have transformed the treatment paradigm for RA.
`However, the associated costs of these therapies result in a significant
`economic burden on the healthcare system. As a chronic disease
`requiring lifelong treatment, most health plans now position RA drugs
`as a high-priority therapeutic category.
`
`Objective: To identify provider and payer practices and perceptions
`regarding coverage of RA biologics in the current marketplace, as well
`as emerging trends in reimbursement practices.
`
`Methods: In November 2011, Reimbursement Intelligence, a
`healthcare research company, collected and analyzed quantitative and
`qualitative data via parallel-structure online surveys of 100
`rheumatologists and 50 health plan payers (medical and pharmacy
`directors) who represent more than 80 million covered lives. The
`surveys included approximately 150 questions, and the surveys were
`designed to force a response for each question.
`
`Results: Payers reported using tier placement, prior authorization, and
`contracting in determining coverage strategies for RA biologics. Among
`providers, experience with older RA agents remains the key driver for
`the choice of a biologic agent. A majority of payers and providers (68%
`and 54%, respectively) reported that they did not anticipate a change in
`the way their plans would manage biologics over the next 2 to 4 years.
`Payers’ responses indicated uncertainty about how therapeutic
`positioning of newer, small-molecule drugs at price parity to biologics
`would affect the current reimbursement landscape. Survey responses
`show that approval of an indication for early treatment of RA is not
`likely to change the prescribing and reimbursement landscape for RA
`biologics. This survey further shows that payers and providers are
`generally aligned in terms of perceptions of current and future
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`Medac Exhibit 2040
`Frontier Therapeutics v. Medac
`IPR2016-00649
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`Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers
`
`treatments for RA.
`
`Conclusion: Advances in RA therapies allow patients increasing
`options for effective disease management. However, the high cost of
`biologic therapies and the need for lifelong treatment raise economic
`concerns. Payer satisfaction with current therapies and uncertainty
`about added value of new therapies will create challenges for new
`medications coming to market.
`
`Am Health Drug Benefits. 2012;5(2):83-92
`
`Rheumatoid arthritis (RA) is a chronic systemic autoimmune disorder
`1
`and the most common form of inflammatory arthritis. RA affects 1% of
`2
`the population, most often adults aged 40 to 70 years.
` Recent
`epidemiologic data indicate that the incidence of RA in women has
`3
`risen in the past 10 years.
` Because RA affects many individuals who
`are of working age and remains a major cause of disability, the
`economic burden of RA adds a significant cost not only to patients and
`1,4
`their families, but also to society as a whole.
` In addition, reduced
`quality of life, loss of work productivity, and substantial healthcare
`utilization are factors that must be considered in RA management.
`
`4,5
`
`Because complications of RA may begin to develop within months of
`disease onset, early and aggressive treatment is considered clinically
`necessary to manage immediate symptoms of pain associated with
`inflammation, but also to slow disease progression to prevent longterm
`1,6,7
`disability.
` Historically, estimates of work disability rates for RA have
`been high, with higher rates associated with longer disease duration;
`work disability estimates have been shown to reach 30% within 2 to 3
`4,5
`years of diagnosis.
` Recent estimates suggest that RA-related work
`disability rates remain high, although potentially lower than in earlier
`8
`estimates. This 2008 longitudinal analysis showed estimates of 23%
`work disability at 1 to 3 years of disease onset and of 35% within 10
`8
`years.
`
`Clinical studies have shown better clinical outcomes when aggressive
`treatment is initiated early, including treatment with a wide range of
`disease-modifying antirheumatic drugs (DMARDs) and non-DMARD
`7-9
`combination therapies.
` A recent joint collaboration of the American
`College of Rheumatology (ACR) and the European League Against
`Rheumatism has led to the development of an updated classification
`system of RA, to shift the focus from late-stage disease features—such
`as structural changes and joint damage that can be determined from
`various imaging techniques—to early-stage disease features that are
`6
`associated with persistent disease.
` Given the advances in treatment
`for RA, including nonbiologic and biologic options, along with the
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`Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers
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`associated improved outcomes, this classification system update to
`include early-disease features marked a major shift in the RA disease
`6
`construct.
`
`The ACR guidelines outline clinical treatment pathways by first defining
`7
`disease duration and activity. Disease duration is divided into 3 major
`categories: <6 months (equivalent to early disease), 6 to 24 months
`(equivalent to intermediate disease duration), and >24 months
`7
`(equivalent to longer disease duration).
` Disease activity measurements
`are often qualitative in early-stage disease, and measures are subject
`7
`to clinical judgment.
`
`Pharmacotherapy for RA often includes a nonsteroidal antiinflammatory
`drug, selected use of glucocorticoids, and initiation of a DMARD early in
`1,7
`the disease course.
` Biologic therapies may be added when adequate
`disease control has not been met by previously initiated drug therapies,
`1,7
`which may occur within the first year of diagnosis.
` With regard to
`biologic therapies, the ACR further subdivides “early disease” by
`disease duration of <3 months or 3 to 6 months, to accommodate the
`needs for early advancement of the patient to biologic therapies when
`7
`disease activity is high.
`
`Despite positive clinical outcomes from treatment advances, healthcare
`costs associated with the treatment of a prevalent and lifelong disease
`such as RA are a considerable issue for health plans. The ACR
`estimates that per-patient treatment with biologic therapies is typically in
`10
`excess of $12,000 annually.
` The Agency for Healthcare Research
`and Quality estimates the annual costs for RA medications from as low
`as a few hundred dollars for oral, nonbiologic DMARDs to a high of
`11
`more than $16,000 for injectable biologic DMARDs.
` As new
`therapeutic options for RA become available, provider practices and
`payer strategies to support evidence-based care within the confines of
`cost management demand close examination.
`
`This study was conducted to identify provider and payer practices and
`perceptions regarding therapeutic options and reimbursement for RA.
`To this end, Reimbursement Intelligence, a healthcare research
`company, conducted parallel online surveys with health plan payers
`and rheumatologists. Payers were asked to also consider market trends
`and potential for formulary coverage of RA therapies currently in
`development.
`
`Methods
`
`Online parallel-structure surveys were conducted in November 2011
`and were completed by 2 groups: 100 rheumatologists and 50 payers
`identified as advisors to Pharmacy & Therapeutics Committees who are
`formulary decision makers for RA coverage. The payer group survey
`respondents included 50 pharmacy and medical directors from national
`and regional health plans who had held their positions for more than 2
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`Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers
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`years. The payer group of health plans represented 80 million covered
`lives.
`
`The distribution of plan types among payer respondents included
`Medicare Part D, commercial plans, Medicare Advantage, freestanding
`prescription drug plans, Managed Medicaid, and dual-eligible
`populations. More than two thirds (69%) of payers represented
`commercial plans with 3- or 4-tier formularies.
`
`Table 1
`
`The rheumatologist group represented providers from large and small
`group practices, and ones with and without in-office infusion
`capabilities. Rheumatologists were screened as to whether their
`practice offered in-office biologic infusions, the practice volume of in-
`office infusions weekly, and the number of rheumatologists in the
`practice. The sample was weighted toward rheumatology and
`multispecialty group practices seeing more than 80 patients with RA
`monthly.
`
`The parallel-structure payer and rheumatologist surveys were
`comprised of approximately 150 questions, and the survey instrument
`required answers to all questions. Survey questions included specific
`probes about 8 biologic therapies currently indicated for RA (Table 1);
`existing medications that may receive an RA indication; and new, small-
`molecule oral agents still in development. All respondents received an
`honorarium for their participation.
`
`Results
`
`Tier Placement
`
`Figure 1
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`Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers
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`Tiered cost-sharing is a common strategy for therapies covered under a
`pharmacy benefit. Payers reported that none of the current 8 biologic
`medications (Table 1) covered under the pharmacy benefit is placed on
`tier 1. Tier 2 stat us was given most frequently to etanercept (Enbrel;
`36%) and adalimumab (Humira; 34%), whereas the remaining products
`were distributed across tiers 3 and 4 (Figure 1).
`
`Prior Authorizations and Step Edits
`
`Figure 2
`
`To target medications to appropriate patients, health plans may require
`patients to meet predetermined clinical criteria and receive prior
`authorization before reimbursement is approved. Similarly, health plans
`may use step edits, or a “fail-first” requirement, where payment for a
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`Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers
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`therapy will be made only after certain therapies have been used first. If
`the patient does not respond appropriately (ie, considered a “step” or
`“failure”), then the provider will likely recommend a second-line
`12
`therapy.
`
`Payers were asked about approval rates when prior authorizations or
`step edits are required. Survey results show that most health plans use
`prior authorizations to manage utilization of RA therapies; 80% to 88%
`reported they require prior authorizations for the 8 biologic options
`presented in the survey. More than half (55%) of the providers reported
`approval rates between 81% and 100% of the time, whereas 29%
`reported approval rates from 61% to 80% of the time (Figure 2).
`
`Distribution Strategy and Use of Specialty Pharmacies
`
`Most (80%) payers in the survey reported they use specialty
`pharmacies for distribution of biologic therapies for RA. Among those
`who use specialty pharmacies, 65% reported using closed networks,
`whereas 83% reported they do not mandate the use of specialty
`pharmacies for distribution of office-infused biologic agents. Specialty
`pharmacy services often offer services beyond product dispensing.
`Payers reported that the most valuable add-on services are patient
`education (60%), compliance programs (54%), compliance/adherence
`data reported back to payers (46%), and reimbursement assistance
`(28%).
`
`Perceptions of Management Approach
`
`Payer respondents characterized their general approach to RA
`management in terms of level of stringency of drug approval
`requirements for providers. Specifically, payers were asked, “How
`would you characterize your plan’s general approach toward the
`management of rheumatoid arthritis?” Respondents were asked to
`choose from 5 categories—“open access,” “somewhat regimented,”
`“regimented approach,” and “other.”
`
`Regimented was defined as “patients must have documented failure on
`a DMARD and a preferred biologic.” Open access was defined as
`“physician decides patient therapy and no documentation needed.”
`
`Overall, 40% of payers characterized their plan’s approach as
`regimented. In contrast, only 33% of providers characterized their plans
`as regimented. A little more than one third (36%) of payers
`characterized their management approach as somewhat regimented, in
`which patients must have a documented failure while using a DMARD
`before a biologic drug will be approved.
`
`Conversely, 57% of providers characterized their health plans as
`somewhat regimented. Of the payers, 10% reported that they offer
`open access, in which the physician decides on the patient’s therapy
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`Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers
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`and no documentation is needed for treatment initiation or changes.
`More payers (16%) than providers (10%) reported open access in this
`survey.
`
`Impact of Reimbursement Process on Access to Biologics
`
`Figure 3
`
`Providers reported that oral methotrexate (Trexall, Rheumatrex) is
`initiated within the first 3 months of RA diagnosis: 74% reported
`immediate initiation of the drug; 22% reported initiating methotrexate
`within 1 to 3 months. In addition, 21% of providers also reported
`initiating biologics within 1 to 3 months after initiation of methotrexate;
`61% reported initiating biologics between 3 to 6 months; and 8%
`reported initiation of biologics between 6 months and 1 year. With
`regard to the number of biologics used for each patient, only 7% of
`providers reported that patients remained using the first biologic
`throughout the duration of their disease; 48% and 43% of providers
`indicated that patients typically cycle through 2 or 3 biologics,
`respectively, in the course of the disease (Figure 3).
`
`Figure 4
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`Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers
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`Payers and providers were asked to rank, in order of importance (from
`highest to lowest), the reasons for choice of preferred biologic (Figure
`4). For both respondent groups, efficacy ranked the highest in influence
`on choice of biologics. Payers ranked etanercept, adalimumab, and
`infliximab (Remicade)—the 3 most established of the 8 biologics
`studied—as the most frequent first- and second-line drug choices.
`Payers reported that contracting/rebating is the second most frequent
`influence in determining a preferred biologic for patients with
`commercial coverage. For the Medicare population, payers ranked
`safety as more important than contracting/rebating.
`
`Payers and providers were asked about the main reason for low
`utilization of newer tumor necrosis factor (TNF) inhibitors, such as
`certolizumab (Cimzia) and golimumab (Simponi), and asked to rank in
`order from highest to lowest the reason for low utilization. Although
`contracting/price had some impact on product choice, ranking third,
`provider comfort with older agents was the first-ranked reason given by
`both providers and payers. More than three fourths (79%) of providers
`reported that some documentation of medical need for a biologic is
`always required. However, providers, like payers, stated that approval
`is granted more than two thirds of the time (Figure 2).
`
`Only 15% of providers reported that plans require quantitative
`measurements (ie, x-ray) of active disease to allow the initiation or
`change of biologics. One third (34%) of providers and 40% of payers
`reported ACR 20% criteria for improvement (ACR20) achievement as a
`requirement for approval of a biologic therapy, and 42% of providers
`and 44% of payers reported that demonstrated safety and tolerability
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`Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers
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`are required to initiate biologic drug therapy.
`
`Figure 5
`
`Providers were asked, “Under what circumstances would you be willing
`to take steps to dispute a payer decision?” More than two thirds (68%)
`agreed with the statement, “To appeal a denied prior authorization of
`one autoimmune biologic because payer requires failure of a different
`autoimmune biologic agent (eg, step edit).” Similarly, 60% chose the
`statement, “To counter onerous administrative or documentation
`requirements (eg, to eliminate burdens some request for additional
`documentation beyond reasonable medical notes),” with 68% choosing
`the statement, “to secure reimbursement following a claim denial for an
`on-label diagnosis.” In a follow-up question, providers were asked how
`many times they would dispute a denial before accepting the denial as
`a defined payer policy. Nearly one third (32%) of providers reported 1
`time, 38% reported 2 times, and 17% reported 3 times. In this survey,
`providers reported that their support staff was generally successful at
`overcoming prior authorization and stepedit requirements (Figure 5).
`
`Overall, payers and providers were consistent in their responses in
`regard to changes in the way RA will be managed over the next 2 to 4
`years, with 54% of rheumatologists and 68% of payers reporting no
`change. Payers were asked if changes in reimbursement for office-
`infused products influenced the treatment selection rheumatologists
`currently make. More than 6 of 10 (62%) payers said that these
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`Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers
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`changes would not influence treatment selection.
`
`Regarding sites of care, 82% of the rheumatologists reported providing
`in-office infusion, although 62% of these providers also reported using
`an alternate site of care at least part of the time. When asked does “site
`of care affect your choice of therapy,” 72% of providers agreed with the
`statement, “It does not affect my choice of biologic.”
`
`Potential Impact of Expanding Therapeutic Options for RA
`
`Table 2
`
`Payers and providers were asked to assess the potential impact of
`several emerging trends in RA therapies, including new, small-molecule
`oral disease-modifying agents (Table 2). Respondents were asked,
`“Once FDA [US Food and Drug Administration] approved, how will they
`change your treatment strategy? Assume efficacy and safety are similar
`to current TNF inhibitors. Assume price parity to current biologics.” One
`third (36%) of providers and one fifth (20%) of payers reported these
`agents will be used after methotrexate but before TNF inhibitors. One
`third (33%) of providers and 16% of payers reported these agents will
`be used after TNF inhibitor failure. Smaller numbers, 15% of providers
`and 18% of payers, reported these agents will be used after TNF
`inhibitors fail. Only 11% of providers and 34% of payers say they are
`not sure.
`
`If small-molecule drugs are priced at a 15% to 20% discount to
`biologics, a little more than half (52%) of payers reported they would
`position them before TNF inhibitors. However, if small-molecule drugs
`were priced at a 15% to 20% premium to biologics in product costs,
`they would position them after TNF inhibitors. If the price of these
`compounds were discounted relative to TNF inhibitors, an expedited
`review would be expected by 46% of payer respondents.
`
`Most payers (88%) and more than half (57%) of providers reported they
`believe small-molecule therapies to be in the same therapeutic class as
`biologics. More than two thirds (68%) of payers noted that approval of
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`Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers
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`the first small-molecule therapy would likely trigger a class review of the
`biologics. Regarding compliance potential of orals, which will be dosed
`13,14
`2 or 3 times daily,
` 58% of payers and 44% of providers reported
`that oral dosing would improve patient compliance; 25% of providers
`and 8% of payers reported they believe it will reduce compliance as a
`result of the 2- or 3-times daily dosing regimen, and 29% of providers
`and 28% of payers reported that compliance will not be an issue.
`
`Consideration of adoption of new therapies at launch was reported by
`only 27% of providers. However, 46% of providers reported they would
`require <1 year of experience with a new therapy to regularly prescribe
`it, with the balance of respondents (27%) reporting a 1- to 3-year time
`frame to adoption. In addition, payers and providers were asked if they
`were aware of any ongoing head-to-head trials in RA; affirmative
`responses were given by 12% of payers and 26% of providers. Payers
`and providers were then asked, “How significant would the results of a
`head-to-head trial be in selecting your preferred biologic, if the trial
`design is for superiority?” On a scale of 1 to 7, with 1 representing “not
`significant at all” and 7 representing “most significant,” 40% of both
`payers and providers selected 6, whereas 34% and 33%, respectively,
`selected 7.
`
`Figure 6
`
`Payers and providers in this survey were asked if there would be an
`impact on prescribing patterns if an early RA indication was approved
`by the FDA. Among rheumatologists, 46% reported they would not
`change prescribing of biologics, with 23% reporting they will add a
`biologic within 1 year of initiating methotrexate. Nearly one third (31%)
`of rheumatologists reported they would prescribe a biologic at the time
`methotrexate or another DMARD is initiated (Figure 6).
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`Discussion
`
`Cost Burden
`
`RA represents a significant burden to payers and is positioned as the
`15
`highest priority therapeutic category for most health plans.
` Specialty
`pharmacy costs for RA therapies account for more than 25% of total
`16
`spending for specialty drugs.
` Although nonspecialty drug costs in
`many categories are expected to grow more slowly over the next 3
`years (because of increased availability of generics), costs for specialty
`16
`therapies are expected to grow between 15% and 17% annually.
`
`Between 2011 and 2013, the costs for RA biologics are expected to be
`the single largest contributor to increases in specialty drug spending
`and are predicted to represent approximately one fifth (21%) of all
`16
`health plan drug spending by 2014.
`
`Payers continue to implement and refine a variety of reimbursement
`strategies to balance quality of care in light of the economic burden of
`RA biologics, with varying effects.
`
`Payer Reimbursement Management
`
`The high costs associated with RA therapies have led payers to look for
`strategies to manage immediate costs, while weighing the potential for
`long-term costs of delayed treatment (eg, disability). Health plans have
`historically covered biologic therapies with subcutaneous delivery under
`a pharmacy benefit, because patients can self-administer these
`15
`therapies.
` Intravenous and infusion therapies have been covered
`largely under a medical benefit, because drug administration needs to
`15
`be delivered by a healthcare professional.
`
`Drugs covered under the medical benefit lack the scrutiny of drug
`utilization review and coverage management protocols used in
`pharmacy benefit structures. The entry of new oral and self-injectable
`products will generate greater scrutiny, which may result in an impact
`16
`on cost.
` As new biologics enter the market, health plans will need to
`consider how coverage channels, including rebates or other discounts
`offered under a pharmacy benefit structure, will impact future costs.
`
`Currently, there is no biologic therapy on the market that is specifically
`indicated for “early” RA. Because early stages of RA are diagnosed by
`clinical presentation rather than a definitive test, diagnostic parameters
`1
`of early RA remain unclear.
`
`The survey findings highlight emerging trends in RA cost-management
`strategies, including payers’ efforts to follow evidence-based guidelines
`for use of RA biologics, and the trend toward shifting a greater
`proportion of the cost to patients; the resulting framework can inform the
`coordination of cost and clinical management of RA. Results from this
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`survey also show that payers and providers were generally aligned in
`terms of perceptions of current and future treatments for RA. Because
`provider experience and satisfaction with older RA agents were
`reported as the underlying driver for using current therapies, uptake of
`newer agents may also follow a similar pattern. Of note were responses
`that having an indication for early RA would not influence prescribing
`patterns, because biologics generally are already being used within 1
`year of diagnosis, which is still considered early in the course of the
`disease.
`
`Limitations
`
`The limitations of this study include those inherent to all surveys.
`Survey questions must be developed broadly to be appropriate to as
`many respondents as possible. Surveys in general are inflexible to
`adaptation to individuals or subsets of respondents, so captured data
`may not reveal the richer context of the questions posed.
`
`In addition, this survey was administered online and was formatted with
`forced-answer questions. Although there is a benefit to capturing
`responses for all questions and all respondents, question saliency may
`not be uniform for all respondents, thereby impacting the weight of each
`question in relation to others.
`
`Furthermore, the sample size of the provider group was twice that of the
`payer group, which could skew intergroup comparisons.
`
`Conclusion
`
`Although the availability of highly effective biologic therapies for RA has
`greatly improved patient care, the cost of these therapies remains a
`priority concern for patients, providers, and payers alike. Provider and
`payer satisfaction with older RA agents, and skepticism about the
`incremental value of new therapies, will continue to raise the hurdles for
`new RA therapies coming to market.
`
`Author Disclosure Statement
`Ms Greenapple reported no conflicts of interest.
`
`References
`
`1. Rindfleisch JA, Muller D. Diagnosis and management of rheumatoid
`arthritis. Am Fam Physician. 2005;72:1037-1047.
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`2. Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001;358:903-
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`3. Myasoedova E, Crowson CS, Kremers HM, et al. Is the incidence of
`rheumatoid arthritis rising? Results from Olmsted County, Minnesota,
`1955-2007. Arthritis Rheum. 2010;62:1576-1582.
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`4. Sokka T. Work disability in early rheumatoid arthritis. Clin Exp
`Rheumatol. 2003;21(5 suppl 31):S71-S74.
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`Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers
`
`(CP- 690,550), an oral Janus kinase inhibitor, or adalimumab versus
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`
`Stakeholder Perspective
`Biologic Therapies for Rheumatoid Arthritis: It's All about
`Value
`Albert Tzeel, MD, MHSA, FACPE
`Regional Medical Director
`Medicare Operations
`North Florida, Humana
`Jacksonville, FL
`
`Value has been defined as the relationship between benefits and costs.
`Using mathematical concepts, value has been described as “value =
`benefits/cost” or the units of benefit derived from a given number of
`units of costs. Applying this definition, if we wish to maximize the value
`of a therapy, there are only 2 ways to achieve it: either by increasing
`the benefits obtained from the therapy, or by decreasing the cost paid
`for that therapy.
`
`Value in healthcare is also a function of perspective. What may be
`considered valuable to an individual patient undergoing treatment or to
`a physician prescribing that treatment to a similar group of patients may
`not necessarily be considered valuable to the same extent by a payer,
`who must not only pay for that individual’s treatment but who also has
`to manage the needs of multiple groups of patients and/or members
`with equally compelling medical conditions and priorities. Optimizing
`value within the healthcare system means that physicians and payers
`must be aligned in the way they view the various benefits and costs of
`a given treatment.
`
`Achieving such optimization is where the article by Ms Greenapple in
`this issue of American Health & Drug Benefits fit