AMCP Partnership Forum: Biosimilars—Ready, Set, Launch

SUMMARY: Through 2020, reference biologic products will lose patent protection that will be worth $54 billion to the U.S. economy. Consequently, interest in biosimilars is intensifying across the health care industry. Managed care organizations (MCOs) are depending on the savings opportunity that biosimilars promise. After the first FDA approval of a biosimilar in March 2015, the Academy of Managed Care Pharmacy (AMCP) convened a biosimilar Partnership Forum on June 10-11, 2015. The goal of this forum was to address current readiness of MCOs to optimize biosimilars; identify gaps, challenges, and opportunities with regard to biosimilars; and recommend education and training content to help AMCP best meet the needs of its members and stakeholders. The forum brought together multiple stakeholders from MCOs, pharmacy benefit managers, specialty pharmacies, integrated delivery networks, federal government and standards setting organizations, consumer advocacy groups, and the pharmaceutical industry. Through a series of 4 one-hour webinars and a 1.5-day live workgroup session, participants identified current challenges and readiness issues in addressing biosimilars. These challenges included lack of a consolidated educational strategy for incorporating biosimilars into the clinical decision-making process; deficiencies in current levels of federal (e.g., the FDA) or state (e.g., departments of insurance) guidance; limited intelligence on pricing strategies and consideration of stakeholder contracting alignment and risk sharing; and operational implementation issues. Participants identified necessary tactics for executing a successful biosimilar strategy. These tactics included creating a broad multiple stakeholder coalition to support educational efforts to gain public, provider, and other stakeholder acceptance; aligning utilization incentives through reimbursement policies and programs; encouraging benefit design and stakeholder collaboration; advancing the coding and technology infrastructure to support operations, contracting, billing, reimbursement, and reporting needs; and having appropriate active surveillance mechanisms to enable assessment of the clinical performance of biosimilars and their innovator products. Participants recommended guidance for AMCP to optimally support its membership and stakeholders with educational and training programs at multiple venues; a platform for regular communications and updates; and advocacy, community promotion, and education.

I nterest in biosimilars is intensifying across the health care industry because from now through 2020, reference biologic products will lose patent protection that will be worth $54 billion to the U.S. economy. 1 This has significant ramifications for managed care organizations (MCOs) administratively and economically.
The use of biosimilars will allow patients in the United States access to safe and effective alternatives to innovator biologic products. The U.S. Food and Drug Administration (FDA) will approve biosimilars as safe and effective using a "totality of evidence" approach by sponsors. This approach requires sponsors to demonstrate that biosimilars are physicochemically, pharmacokinetically, pharmacodynamically, biologically, and clinically similar to a biologic and that there are no clinically meaningful differences between the biosimilar and the reference biologic product. Biosimilars are not exact copies of the approved branded medical product, and the FDA will allow minor differences between the products.
The introduction of biosimilars may help blunt the impact of ever-increasing pharmaceutical prices on pharmacy and medical budgets. A 2014 analysis by RAND found that the introduction of biosimilars could save the U.S. health system $13-$66 billion between 2014-2024. 2 Biosimilars have already been in use in the European Union (EU). Since 2006, the EU has had access to approximately 22 biosimilars. 3 Through the European Medicines Agency, the EU has centralized approval for biosimilars. However, each country may approve laws related to substitution. This is similar to the United States where the FDA has central authority to approve biosmilars but states have authority to determine substitution requirements. The different approaches used by EU countries on substitution issues have resulted in road blocks to biosimilar development. 4 Therefore, the federal and state legislative and regulatory infrastructure adopted early in the United States will likely be critical for ensuring adoption.
The FDA issued the first U.S. approval of a biosimilar in March 2015, for the biosimilar Zarxio (filgrastim-sndz), 5 using the new 351(k) pathway provided through the Biologics Price Competition and Innovation Act (BPCIA) of 2009. Biosimilarity to a reference biologic, as defined by section 351(k) of the BPCIA and FDA guidance, includes the following: • The biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components" and "there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product." • Biosimilarity to a reference biologic includes 2 distinct levels of approval for a biosimilar: those that are "highly similar"

■■ Biosimilar Challenges and Solutions
To engage national stakeholders in a discussion of the challenges and opportunities presented by biosimilars, the Academy of Managed Care Pharmacy (AMCP) convened a Partnership Forum entitled "Biosimilars-Ready, Set, Launch" on June 10-11, 2015. Stakeholder participants came together to consider the current readiness of MCOs to optimize biosimilars; identify gaps, challenges, and opportunities with regard to biosimilars; and to recommend education and training content to help AMCP best meet the needs of its members and stakeholders. Participants included individuals from MCOs, pharmacy benefit managers (PBMs), IDNs, specialty pharmacies, federal government and standards setting organizations, consumer advocacy groups, and the pharmaceutical industry. This biosimilars forum explored how managed care pharmacy can work with key stakeholders to ensure a smooth launch of biosimilars for patients, providers, and payers. The goal of the forum was to develop a list of launch issues and strategies and define the role of AMCP in coordinating training on these strategies across the broad group of stakeholders.
There were 2 components to the forum: (1) a series of 4 one-hour preparatory webinar sessions and (2) a 1.5-day workgroup session.

Webinar Sessions
Between mid-May and early June 2015, invited forum participants were encouraged to participate in a series of 4 webinars. These webinars were designed to provide appropriate background information on biosimilars so that the discussion at the Partnership Forum focused solely on the substantive issues. The 4 webinar topics were as follows: Prescriber communication and notification, out-of-pocket spending limits, implications for retail pharmacy operations, and formulary issues.

Implications for Biosimilars Administered in the Physician Office.
Federal reimbursement rules (rebates, bundling, payments, and copays), clinical pathways, contracting, prior authorization and ePA, tracking, adverse event reporting, and patient support services. and those that are "highly similar AND interchangeable." • The biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components" and "there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product." • The biosimilar approval pathway includes an application to the FDA that must include information showing biosimilarity to the reference product based on analytical studies ("highly similar"); animal studies (including toxicity assessment); and a clinical study or studies (immunogenicity, pharmacokinetics [PK], and pharmacodynamics [PD]). • Additionally, the biosimilar uses the same mechanism(s) of action (if known); condition(s) for use, route, dosage form, and strength which were previously approved for the reference product; and production facilities meets standards "to be safe, pure, and potent." 6 For a biosimilar to be also considered interchangeable, it must meet the following additional requirements: • The biological product is biosimilar to the reference product.
• The biological product can be expected to produce the same clinical result as the reference product in any given patient. • For a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alteration or switch. 6 The introduction of biosimilars in the United States will focus on products typically infused or injected in a physician's office, outpatient clinics, and home infusion. Coverage and reimbursement for nonpharmacy dispensed products and products that are administered in a physician's office or outpatient clinic generally fall under the medical benefit and their respective reimbursement systems. Medical benefit drug selection and management become more complex because of such varied factors as the following: • Physician, facility, accountable care organizations (ACO), or integrated delivery networks (IDN) contracts and incentives. • Government and private payer reimbursement rules (e.g., Part B Medicare). • MCO and payer medical claims systems that often do not support the level of management that is now standard in the pharmacy drug claim adjudication systems.
Biosimilars represent an additional competitive force in the market that, with optimal management, may help mitigate specialty drug trends and provide greater access to critical therapies through improved affordability.

Workgroup Session
The forum workgroup session was a live session held June 10-11, 2015. For this part of the forum, participants were divided into 2 discussion groups: one group had a formulary and clinical focus, and the other group focused on operations. The workgroup topics are listed as follows and the outcomes of the discussions are summarized in the sections below: 1. Biosimilars: formulary and operational differentiators challenging stakeholders 2. Stakeholder clinical data and product labeling: identification requirements and issues 3. Medical benefit biosimilars (physician/outpatient administration): stakeholder opportunities and challenges 4. Pharmacy benefit biosimilars (self-administered): strategic preparation and management 5. Implementing and executing a successful biosimilar strategy 6. Building biosimilar impact training and education programs for managed care and other stakeholders: recommendations for AMCP action

Biosimilars: Formulary and Operational Differentiators Challenging Stakeholders.
Participants were asked to contrast biosimilars to other pharmaceuticals, identifying the differences for formulary decision making and pharmacy operations. The discussion focused on identifying significant contributors and differentiators that would pose challenges to biosimilar uptake in the United States. The key issues and considerations included the following: • Geographic variations at the state and regional levels may require application of different strategies to promote adoption. Participants identified the following factors that must be considered on state and regional levels for strategies to promote adoption of biosimilars: a. Regulations and requirements among state boards of pharmacy requirements for interchangeability and notification. b. State insurance requirements for benefit design, including coverage requirements, prior authorization, and copayment provisions. c. Geographic insurance market dynamics, such as whether a state or region is heavily managed or contracted or whether fee-for-service dominates. Stakeholders must be sure to understand the current legislative and regulatory infrastructure in their market or region when developing a biosimilars strategy. • Stakeholder receptivity and collaboration will depend on a number of variables with solutions needing to be tailored accordingly.
The more critical stakeholder factors impacting potential receptivity and collaboration identified were as follows: a. Pharmacy stakeholders: independent versus chain pharmacy and their incentives for facilitating biosimilar use. b. Physician practice stakeholders: private practice versus large health system or employee physician and their tolerance for risk contracts or pay-for-performance programs.
c. Employers: insurance type (e.g., self-insured vs. insured) and degree of influence over the biologics drug benefit offered. d. Members/patients: out-of-pocket copay or coinsurance differences between the biosimilar and reference product. • Different lines of business may require unique approaches to optimizing biosimilars. Participants identified the following challenges: a. Medicaid rules are applied differently by state and by feefor-service versus managed Medicaid programs, which represent a significant challenge to payers and providers working across multiple states and program types. b. Medicare Part D rules provide disincentives for biosimilars when members are in the coverage gap. c. Commercially insured businesses traditionally have had more latitude in benefit design and use of management controls (e.g., policies to address copay subsidy programs). Some legislatures are limiting this flexibility (e.g., oral parity laws).

Stakeholder Clinical Data and Product Labeling and Identification Requirements.
In this session, participants were asked to identify key biosimilar requirements, issues, and opportunities in the clinical area and in the product labeling and identification areas. The key issues and considerations identified included the following: • Education on the new approval process and clinical/data requirements will be critical to gaining stakeholder acceptance of biosimilars. Multiple stakeholder educational initiatives are prerequisites for success. Education should include an understanding of the biosimilar approval process (e.g., PK/PD data and clinical study requirements) and the data and clinical information needs for formulary decision making (e.g., PK/PD process, immunogenicity, and clinical trials). Using the 10-year global biosimilar experience and clinical data that is being generated internationally will be important to biosimilar acceptance in the United States. Educational programs explaining European clinical data should be developed for pharmacy and therapeutics committees (P&T) and physician decision makers. • Tracking and documentation of biosimilars administered in the physician office is problematic. Operationally, electronic exchange of biosimilar specifications (e.g., for tiers, copays, and naming) and reporting difficulties were highlighted. Lack of regulatory guidance clarity with regard to naming and standardized coding (e.g., J codes) creates a climate that could impede biosimilar acceptance. Pharmacovigilance tracking and documentation are similarly challenged by biosimilar naming and coding gaps. • Stakeholder notification, education, and alignment are key to gaining biosimilar acceptance. MCOs will need to be transparent in addressing and collaborating with their providers on key issues of product preference (e.g., formulary positioning), incentivized reimbursement, contracting and risk structures, and provision of ongoing clinical surveillance information.

Medical Benefit Biosimilars (Physician/Outpatient Administration): Stakeholder Opportunities and Challenges.
During this session, participants were asked to identify the process risks and mitigation strategies needed to enhance the value and potential for biosimilars administered in the physician office and other outpatient care settings. The key concerns and considerations identified included the following: • An effective office-administered biosimilar strategy needs to account for physician practice differences in drug purchasing/ acquisition as well as sensitivity to cost and margin. Practice differences in acquisition costs, purchasing arrangements, and reimbursement mechanisms impact the likelihood of biosimilar uptake. Successful collaboration and agreement may be dependent on factors specific to large versus small group practices, hospital-owned practices, and the existing use or reliance on wholesalers and other purchasing groups. Larger groups and those in health systems may have their own product selection, contracting, and use that may exclude MCOs. Alignment of reimbursement strategies for physician offices and groups who use the buy-and-bill practice will be an important part of the strategy. • Physician practice information technology systems and electronic medical records (EMR) documentation processes may be inadequate to effectively incorporate biosimilars. EMRs will need to have timely updating of their drug libraries to include the new biosimilars and adapt for National Drug Code (NDC)level documentation in order to more readily identify specific product utilization and to facilitate appropriate billing and reimbursement. Product-specific prior authorization (PA) websites are commonly used by physician offices for ordering biologic drugs, posing a distinct disadvantage for biosimilars. Encouraging the adoption of the National Council for Prescription Drug Program electronic PA standard (part of the e-prescribing standard) could help supplant these product-specific PA websites. • Physician and office staff education will be critical. This includes clinical and operational/process eduction and training; addressing and removing safety, efficacy, indication, and other potential clinical acceptance barriers; as well as education on any changes in the claims submission process. Peer-to-peer discussion support will be needed. For large practices who accept risk, MCOs can provide reporting and pay-for-performance support in order to identify and address practice outliers. • MCOs need to address organizational readiness to effectively manage office-administered biosimilars. MCO organizational responsiveness (e.g., developing an integrated approach to specialty drug management) is imperative. Addressing the strategic and operational needs for a more integrated approach to managing the medical-pharmacy specialty drug benefit is a critical step for biosimilar success. This may include updating claims and reimbursement systems capabilities and renew focus on provider and health system contracting, incentives, and risk structures. Provider and internal education and training on medical systems, contracting, and reimbursement should be augmented. Aligning member medical and pharmacy specialty drug benefits need to be considered.

Pharmacy Benefit Biosimilars (Self-Administered): Strategic Preparation and Management.
In this workgroup session, participants were asked to identify payer and provider solutions for optimally supporting contracting, incentives, risk, copay, and rebate structures. These elements are pivotal to the biosimilar formulary process and to facilitating access and affordability in the specialty drug benefit. The top elements and considerations pinpointed included the following: • Program barriers need to be addressed and managed. Regulatory barriers (e.g., copay caps being enacted by various states, parity laws, and interchangeability rules that vary by state) were some of the key challenges identified. System upgrades are needed to provide flexible biosimilar benefit designparticipants reported systems that are hampered by too few tiers to differentiate multiple biosimilars products for the same innovator. Processes that reduce member product choice incentives (e.g., out-of-pocket maximums) need to be considered. Strategically, updating of benefit designs needs to take place now for impact in the 2017 benefit cycle. Retail pharmacy product selection and promotion was also mentioned as a potential barrier if they are not part of the MCO's discussion and planning. • Lessons learned from previous biosimilar-like product management opportunities may be helpful in facilitating success. This session discussion centered around lessons learned from biosimilar-like product introductions and MCO best practices. Using growth hormones as an example, alternative product positioning (e.g., generics and alternative brands) may have been a difficult sell to physicians because of provider or patient preferences and, in some cases, to PBMs because of existing contracts. Ultimately, a lack of savings flow back to MCOs was a critical limiter of uptake. Biosimilars will require MCOs to "take it up a notch," using as a reference successful public awareness campaigns for generics over the past decades. • A successful biosimilar management program will track along the usual brand drug management spectrum to include use of the key components of contracting and rebates, preferential positioning, formulary lock-out, and utilization management (e.g., PA and step therapy), even in the face of noninterchangeability at the pharmacy. • Timing and urgency in planning is key. MCOs are starting to work on 2017 programs, including Medicare Part D, public exchanges, and even commercial benefits. Therefore, new benefit designs, financial modeling amendments, and filings to insurance departments or CMS that may be needed to strategically prepare for biosimilars are needed now, given that these programs are already starting to take shape in mid-2015.

Implementing and Executing Successful Biosimilar
Strategies. During the fifth workgroup session, participants were asked to rank the top 5 formulary, clinical, and operational elements for a successful biosimilar strategy launch. Those top 5 elements are listed as follows: • Educational initiatives and strategy are critical (the 3 Cs: consistent, constant, and collaborative). Patient and provider clinical and safety questions need to be addressed with broad educational efforts. Forum participants concluded that education will need to be consistent and persistent with a multichannel public relations communication and marketing plan that includes collaboration across multiple stakeholders. • Collaboration is key to stakeholder acceptance. Examples include collaborations with retail networks to ensure that state notification requirements do not constrain biosimilar fulfillment and collaboration between the MCOs, health systems, and pharmaceutical manufacturers to provide consistent education and relevant clinical data for stakeholders. • Incentives need to be aligned. P&T biosimilar decisions need to be translated into actionable contracting and benefit design strategies. Using appropriate and stakeholder incentivized contracting and reimbursement approaches will drive biosimilar utilization and lower out-of-pocket costs for members. Market influences of ACOs, IDNs, specialty carve outs, GPOs, wholesalers, and physician-office fee schedules need to be studied carefully by each MCO. The pharmaceutical industry needs to engage with MCOs early, provide clinical and approval process information and updates, and support the MCO engagement/education with physicians and health care systems. MCOs, employers, and state Medicaid agencies need to be encouraged to take a longer view instead of a shortterm market-share view that might limit biosimilar uptake. • Upgrading coding infrastructure is foundational. For reimbursement and contracting (including pharmaceutical company contracting and provider contracting), it is imperative that the innovator product and each biosimilar be distinguishable. Forum participants recommended that NDC numbers be included on all billing, as is currently required in some states for Medicaid physician office-administered injectable drugs. Participants recommended that AMCP advance this strategy to CMS for Medicare claims and that MCOs work to update commercial provider contracts to require NDC numbers and to update data warehouses and reporting tools to include the new NDC information. Until NDC numbers are required for billing, participants noted that distinct J-codes are needed for each biosimilar and innovator product. Capturing this level of detail is also necessary for benefit adjudication, reporting adverse events, and other utilization and performance metrics. The removal of regulatory and market barriers and hurdles, including establishing an appropriate naming convention and path for more efficient interchangeability were noted as important fundamentals for optimizing an effective strategy. • Reporting and performance monitoring are critical. Systems that do not allow integrated reporting of medical and pharmacy specialty drugs are problematic. As a key component of physician or health system contracting, MCOs and PBMs will need to provide performance and financial level reporting and support on utilization and opportunities. Identifying outliers within a practice with actionable education and intervention tools will need to be a part of this collaboration. Pharmacovigilance and comparative effectiveness research such as that being pursued by AMCP's Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) will be instrumental in validating comparative safety and efficacy between biosimilars and their reference products.

Building Biosimilar Impact Training and Education Programs for Managed Care and Other Stakeholders:
Recommendations for AMCP Action. In this session, forum participants created an action plan for AMCP based on the key issues and considerations discussed during the forum.
Recommendations included the following: • AMCP needs to foster partnerships and collaboration across a wide spectrum of professional associations, organizations, and agencies. This coalition's mission should be to facilitate national preparedness for optimizing biosimilars and needs to embrace a wide spectrum of professional associations journal articles, e-Dossiers), new training should be developed to address biosimilars as follows: a. Equipping P&T committees with a facile understanding of biosimilar PK/PD, extrapolation, and clinical evidentiary requirements. b. Understanding A-Z of immunogenicity. • Understanding coding, acquisition, billing, reimbursement (e.g., Wholesale Acquisition Cost, Average Wholesale Price, and average sales price), and tracking issues. a. Aligning incentives and understanding biosimilar contracting (e.g., rebating, risk, pay for performance) strategies. For example, with pricing and contracting strategies, understanding why a biosimilar's medical versus pharmacy specialty mix matters (e.g., notification and interchangeability are unimportant for physician-office injectables). b. Developing tools to assess knowledge gaps in organizations and among outside stakeholders.
Other recommendations included adding standards in residency programs, including biosimilars in the AMCP Student P&T Competition; creating a webinar topic series; and creating a biosimilar "app."

■■ Conclusions
Participants agreed that a strong market for biosimilars in the United States is important for ensuring that consumers have access to safe and effective medications at lower costs. To ensure robust implementation, the regulatory pathway must be conducive to the adoption of biosimilars and not a hindrance. Public and private stakeholders may also help adoption of biosimilars by providing educational efforts to ensure that health care providers and consumers understand biosimilars through educational efforts that focus on scientific, clinical, regulatory, and reimbursement issues associated with biosimilars. and organizations as well as government, industry, and advocacy groups (e.g., AHIP, PCMA, AACP, APhA, and physician specialty groups). Partnering on national and regional advocacy for topics such as drug nomenclature and coding, contracting and IT system enhancements, and removing barriers should be contemplated. The strength of MCO messaging platforms needs to be engaged to help members understand their total cost of health care and to forecast future cost to members. Nonbranded toolkits should be developed for use by prescribers and patients.
• AMCP should create a Biosimilar Operations Learning Center.
The function of this learning center would be to create and distribute tools and web-based educational and training material that facilitate a national biosimilars message and consumer education effort and promote and highlight best practices. This center could monitor and report alerts on the regulatory environment, benchmark biosimilar utilization, and update international clinical experience and publications. Funding to support this broad stakeholder education and training mission should be sought from participating organizations. • AMCP programs should drive the discussion nationally. AMCP educational programs should be constructed to drive the broad range of discussions that needs to take place nationally. AMCP should sponsor forums for the reporting of best practices for tailoring tactics to the setting (e.g., MCOs, IDNs, ACOs, practice management groups; physicianbuying groups, GPOs, and wholesalers; retail and specialty pharmacy; and Medicare and Medicaid). Programming that elucidates market conflicts and their resolution will provide forward momentum. • Education and training programs for AMCP members need to be comprehensive and flexible. In addition to its traditional educational methods (e.g., policy statements, white papers,