Strategies for Overcoming Barriers to Adopting Biosimilars and Achieving Goals of the Biologics Price Competition and Innovation Act: A Survey of Managed Care and Specialty Pharmacy Professionals.

BACKGROUND: The Biologics Price Competition and Innovation Act (BPCIA) of 2009, which included pathways for FDA approval of biosimilar products, was designed to promote more affordable, expanded patient access to biologic therapies. Achieving these BPCIA goals depends on overcoming formidable barriers to biosimilar adoption. Managed care and specialty pharmacy professionals are uniquely qualified to inform initiatives to address these barriers. OBJECTIVE: To assess perceptions regarding strategies for overcoming barriers to biosimilar adoption among managed care and specialty pharmacy professionals by conducting a survey study. METHODS: Invitations to complete the online survey were emailed by the Academy of Managed Care Pharmacy (AMCP) to members and customers and to contacts sourced from a commercial database. In addition to questions on respondent demographics and perceptions of biosimilars, the survey listed 16 strategies for overcoming key barriers to biosimilar adoption. On a 5-point scale, participants rated their opinion on the likelihood that each strategy would have the potential to assist in achieving BPCIA goals. The survey also listed 6 barriers to biosimilar adoption. On a 5-point scale, participants rated their perceived difficulty in overcoming each barrier. The survey concluded with an open-text item that asked participants to list 3 additional strategies for overcoming biosimilar adoption barriers. Response frequencies were calculated to describe participants' ratings of the strategies and barriers. Statistical analyses were conducted to assess whether the ratings differed among respondents grouped by work organization. For the open-text item, we conducted qualitative content analyses to categorize strategies by stakeholder groups that might take primary implementation roles. RESULTS: A total of 300 managed care and specialty pharmacy professionals completed the survey. There was considerable variation in the preferences, policies, and practices regarding biosimilar adoption among respondents' work organizations. Responses to several survey items reflected positive attitudes about the safety and efficacy of biosimilars; for example, 84% agreed or strongly agreed that FDA-approved biosimilars are safe and effective for patients who switch from a reference biologic. Based on pooled percentages for ratings of likely and extremely likely to overcome barriers to biosimilar adoption, the highest-rated strategies were for prescriber education about evidence from switching studies (91%) and FDA guidance on pharmacy-level substitution of reference biologics with biosimilars (90%). The lowest-rated strategies were for requiring therapeutic drug monitoring for patients who switch to biosimilars (39%) and using quotas to incentivize providers to prescribe biosimilars (40%). For the qualitative analysis, the highest numbers of respondents' suggested strategies indicated primary implementation roles of biosimilar manufacturers (40%), the federal government (26%), and managed care organizations (15%). CONCLUSIONS: Reflecting the unique knowledge, perspectives, and practices of managed care and specialty pharmacy professionals, the study findings are relevant to informing and advancing initiatives for achieving BPCIA goals. DISCLOSURES: The survey study reported in this article was part of a continuing education program funded by an independent educational grant, which was awarded by Sandoz, a Novartis Division, to PRIME Education. The Academy of Managed Care Pharmacy (AMCP) received grant funding from PRIME to assist in developing the survey and writing the manuscript. The grantor had no role in the study design, execution, analysis, or reporting. Greene and Pardo are employed by PRIME. Singh and Carden are employed by AMCP. Greene, Singh, Carden, and Pardo have no other disclosures. Lichtenstein received an honorarium from PRIME for serving as faculty for the continuing education program and has been a consultant for Pfizer, Cellceutix, and Merck.

Findings from a National Survey of Medicare Beneficiary Perspectives on the Medicare Part D Medication Therapy Management Standardized Format.

BACKGROUND: The Medication Therapy Management (MTM) Program Standardized Format (SF) is a written summary of a comprehensive medication review (CMR) that must be provided to Medicare Part D beneficiaries. Concerns have been raised regarding the number of pages of the SF, mailing costs, the static nature of the document, and the lack of integration into beneficiaries' electronic health records. To date, limited research exists on beneficiaries' perceptions of the SF. OBJECTIVE: To evaluate the perspectives of beneficiaries regarding the utility of the SF to inform potential modifications for optimal use. METHODS: An online survey, designed based on the standard approach to measuring patient satisfaction with health service attributes and previous qualitative research, was distributed through Medicare Part D plans to beneficiaries who had received a CMR in the past year. Survey distribution began July 1, 2018, and data collection ended on October 31, 2018. Descriptive statistics are reported for demographic information; health status; perceived value and helpfulness of the SF and its 3 components (cover letter, medication action plan [MAP], personal medication list [PML]); updates to the SF; alternate formatting; and integration of the SF into health records. RESULTS: A total of 9,975 surveys were sent electronically by 4 Medicare Part D plans to beneficiaries who had received a CMR in the past year. Of the 434 unduplicated survey respondents (response rate of 4.3%), 58.5% were aged 65 to 84 years; 60% identified themselves as white; and 49.1% had at least a college education. The most commonly reported comorbidities were diabetes (50.5%) and high cholesterol (43.1%), with 10.7% of respondents rating their health as "very good" or "excellent" and 27.4% choosing "poor" or "fair." Beneficiaries rated how well the SF helped improve different aspects of their medication management (e.g., solving medication-related problems, keeping track of medications, correctly using medications, and understanding why medications are being taken), with 40.8%-44.9% choosing "very good" to "excellent" for each aspect. Helpful sections included "What we talked about" and "What I need to do"for the MAP, and medication name, strength, dosage form, and "How and why I use the medication" for the PML. Less helpful were the fill-in sections of the MAP, with 48.6% reporting that they did not write in any information. In contrast, 44.7% of the participants noted that they updated their PML. A wallet card version of the PML, if available, would be used by 54.6% of participants. About one third of Medicare beneficiaries shared the SF with their doctor, and 26% of the participants gave copies of their medication summary to their relatives. CONCLUSIONS: Fewer than half of the respondents perceived the SF as very good or excellent in helping them to manage their medications. This national survey provides Medicare beneficiary-focused evidence that more work is needed to improve the usability and portability of the SF. This can be achieved by allowing flexibility in the design of the SF, while including essential elements. DISCLOSURES: This study was funded by the Academy of Managed Care Pharmacy (AMCP), which provided a grant to the University of Maryland School of Pharmacy to conduct this study. Carden and Kumbera are AMCP employees. Brandt reports a grant from IMPAQ and consulting fees from Rand, outside of this study. Pellegrin is a member of the AMCP MTM Advisory Board. The other authors have nothing to disclose.

Utilizing data consortia to monitor safety and effectiveness of biosimilars and their innovator products.

BACKGROUND: The Biologics Price Competition and Innovation Act, introduced as part of the Affordable Care Act, directed the FDA to create an approval pathway for biologic products shown to be biosimilar or interchangeable with an FDA-approved innovator drug. These biosimilars will not be chemically identical to the reference agent. Investigational studies conducted with biosimilar agents will likely provide limited real-world evidence of their effectiveness and safety. How do we best monitor effectiveness and safety of biosimilar products once approved by the FDA and used more extensively by patients? OBJECTIVE: To determine the feasibility of developing a distributed research network that will use health insurance plan and health delivery system data to detect biosimilar safety and effectiveness signals early and be able to answer important managed care pharmacy questions from both the government and managed care organizations. METHODS: Twenty-one members of the AMCP Task Force on Biosimilar Collective Intelligence Systems met November 12, 2013, to discuss issues involved in designing this consortium and to explore next steps. RESULTS: The task force concluded that a managed care biosimilars research consortium would be of significant value. Task force members agreed that it is best to use a distributed research network structurally similar to existing DARTNet, HMO Research Network, and Mini-Sentinel consortia. However, for some surveillance projects that it undertakes, the task force recognizes it may need supplemental data from managed care and other sources (i.e., a "hybrid" structure model). CONCLUSIONS: The task force believes that AMCP is well positioned to lead the biosimilar-monitoring effort and that the next step to developing a biosimilar-innovator collective intelligence system is to convene an advisory council to address organizational governance.