Overcoming barriers to biosimilar adoption: real-world perspectives from a national payer and provider initiative.

In response to a published national payer survey indicating striking needs for multistakeholder initiatives to increase biosimilar adoption, a focus workgroup meeting joining payers and providers was conducted in December 2019 in Boston, MA. Before the focus group meeting, a survey was sent to health care providers to collect perceptions about barriers to biosimilar adoption and gather input on best potential strategies for addressing these barriers. The focus group panel consisted of 5 managed care pharmacists and 3 physician experts in rheumatology, dermatology, and gastroenterology, representing large managed care organizations and health care systems in the Boston area. A clinical moderator facilitated discussions between the payers and providers regarding challenges to biosimilar adoption and potential collaborative strategies to overcome these barriers. The focus group participants identified hurdles to biosimilar adoption in 3 major areas: (1) the lack of confidence in biosimilar interchangeability and a need for education about biosimilars, (2) the lack of financial incentives to switch to biosimilars from the reference biologic product, and (3) administrative burdens that impair the prescription of biologics. Learning from their mutual experiences, the focus group participants formulated action plans to address these barriers. The top strategies recommended by the participants included advancing biosimilar education, facilitating administrative processes related to biosimilar prescriptions, and increasing provider reimbursement while reducing cost sharing to patients receiving biosimilars. DISCLOSURES: The study reported on in this article was part of a continuing education program funded by an independent educational grant that was awarded by Sandoz Inc., a Novartis Division, to PRIME Education, LLC. The grantor had no role in the study design, execution, analysis, or reporting. The Academy of Managed Care Pharmacy (AMCP) received grant funding from PRIME to assist with participant recruitment and content review for the continuing education program. Bandekar, Cheifetz, Edgar, Helfgott, Hoye-Simek, Liu, and Smith received an honorarium from PRIME for serving as faculty for the continuing education program. Cheifetz has received research grants from Inform Diagnostics and consulting fees from AbbVie, Bacainn, BMS, Grifols, Janssen, Pfizer, Prometheus, Samsung, and Takeda unrelated to this work. Smith has received consulting fees from Boehringer-Ingelheim, has served as an investigator on industry-initiated trials for AbbVie and Pfizer, and has served as an investigator on investigator-initiated trials for Novartis and Regeneron. Carter, Fajardo, and Simone have nothing to disclose.

A regional analysis of payer and provider views on cholesterol management: PCSK9 inhibitors as an illustrative alignment model.

BACKGROUND: Multiple barriers exist for appropriate use of the proprotein convertase subtilisin/kexin type 9 enzyme inhibitors (PCSK9i) in patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) with inadequately controlled hypercholesterolemia despite standard therapies. Among these barriers, high payer rejection rates and inadequate prior authorization (PA) documentation by providers hinder optimal use of PCSK9i. OBJECTIVES: To (a) identify and discuss provider and payer discordances on barriers to authorization and use of PCSK9i based on clinical and real-world evidence and (b) align understanding and application of clinical, cost, safety, and efficacy data of PCSK9i. METHODS: Local groups of 3 payers and 3 providers met in 6 separate locations across the United States through a collaborative project of AMCP and PRIME Education. Responses to selected pre- and postmeeting survey questions measured changes in attitudes and beliefs regarding treatment barriers, lipid thresholds for considering PCSK9i therapy, and tactics for improving PA processes. Statistical analysis of inter- and intragroup changes in attitudes were performed by Cox proportional hazards test and Fisher's exact test for < 5 variables. RESULTS: The majority of providers and payers (67%-78%) agreed that high patient copayments and inadequate PA documentation were significant barriers to PCSK9i usage. However, payers and providers differed on beliefs that current evidence does not support PCSK9i cost-effectiveness (6% providers, 56% payers; P = 0.003) and that PA presents excessive administrative burden (72% providers, 44% payers; P = 0.09) Average increases pre- to postmeeting were noted in provider beliefs that properly documented PA forms expedite access to PCSK9i (22%-50% increase) and current authorization criteria accurately distinguish patients who benefit most from PCSK9i (6%-22%). Payers decreased in their belief that current authorization criteria accurately distinguish benefiting patients (72%-50%). Providers and payers increased in their belief that PCSK9i are cost-effective (44%-61% and 28%-50%, respectively) and were more willing to consider PCSK9i at the low-density lipoprotein cholesterol threshold of > 70 mg/dL for patients with ASCVD (78%-83% and 44%-67%, respectively) or FH (22%-39% and 22%-33%). Payers were more agreeable to less stringent PA requirements for patients with FH (33%-72%, P = 0.019) and need for standardized PA requirements (50%-83%, P = 0.034); these considerations remained high (89%) among providers after the meeting. Most participants supported educational programs for patient treatment adherence (83%) and physician/staff PA processes (83%-94%). CONCLUSIONS: Provider and payer representatives in 6 distinct geographic locations provided recommendations to improve quality of care in patients eligible for PCSK9i. Participants also provided tactical recommendations for streamlining PA documentation processes and improving awareness of PCSK9i cost-effectiveness and clinical efficacy. The majority of participants supported development of universal, standardized patient eligibility criteria and PA forms. DISCLOSURES: The study reported in this article was part of a continuing education program funded by an independent educational grant awarded by Sanofi US and Regeneron Pharmaceuticals to PRIME Education. The grantor had no role in the study design, execution, analysis, or reporting. AMCP received grant funding from PRIME to assist in the study, as well as in writing the manuscript. McCormick, Bhatt, Bays, Taub, Caldwell, Guerin, Steinhoff, and Ahmad received an honorarium from PRIME for serving as faculty for the continuing education program. McCormick, Bhatt, Bays, Taub, Caldwell, Guerin, Steinhoff, and Ahmad were involved as participants in the study. Bhatt discloses the following relationships: Advisory board: Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Level Ex, Medscape Cardiology, PhaseBio, PLx Pharma, Regado Biosciences; Board of directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data monitoring committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research funding: Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); Site co-investigator: Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded research: FlowCo, Merck, Novo Nordisk, Takeda. Bays' research site has received research grants from 89Bio, Acasti, Akcea, Allergan, Alon Medtech/Epitomee, Amarin, Amgen, AstraZeneca, Axsome, Boehringer Ingelheim, Civi, Eli Lilly, Esperion, Evidera, Gan and Lee, Home Access, Janssen, Johnson and Johnson, Lexicon, Matinas, Merck, Metavant, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi, Selecta, TIMI, and Urovant. Bays has served as a consultant/advisor for 89Bio, Amarin, Esperion, Matinas, and Gelesis, and speaker for Esperion. McCormick, Caldwell, Guerin, Ahmad, Singh, Moreo, Carter, Heggen, and Sapir have nothing to disclose.

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.

Pain management content in curricula of U.S. schools of pharmacy.

OBJECTIVES: To identify individuals in schools of pharmacy in the United States who are responsible for covering the topic of pain management in courses for doctor of pharmacy students and to describe how and at what depth pain management is covered in pharmacy school curricula. DESIGN: One-time qualitative assessment. SETTING: Schools of pharmacy in the United States. PARTICIPANTS Twenty-eight faculty members with the rank of professor, associate professor, or assistant professor who had been employed in their current positions for at least 2 years and who were directly involved in preparing and teaching didactic courses that address pain management. INTERVENTION: In-depth telephone interviews. MAIN OUTCOME MEASURES: Qualitative responses to open-ended interview questions. RESULTS: While pain management was included in the curricula of all 28 schools of pharmacy, it was generally covered in a fragmented way, usually as part of presentations on diseases with pain as a prominent feature (e.g., cancer pain addressed during oncology lectures) or as part of discussions of analgesics. Only two schools offered stand-alone courses in pain management, and both of those courses were electives that were taken by an average of 15 students per year. Three-fourths of respondents believed that pain was being given too little emphasis in their schools' curricula. Palliative care and the use of medications in the treatment of cancer pain was not presented in a standardized manner, and respondents were unsure of how the subject was covered in pharmacy law classes. Instruction about the diagnosis of pain, patient assessment, and physical examination was reported as "minimal" by most respondents. Respondents perceived a need for a single, complete reference and teaching resource that would address the entire spectrum of pain management as it applies to pharmacy. CONCLUSION: The topic of pain management is poorly presented and inadequately developed in the curricula of many U.S. schools of pharmacy.

Pain management content in curricula of u.s. Schools of pharmacy.

OBJECTIVES To identify individuals in schools of pharmacy in the United States who are responsible for covering the topic of pain management in courses for doctor of pharmacy students and to describe how and at what depth pain management is covered in pharmacy school curricula. DESIGN One-time qualitative assessment. SETTING Schools of pharmacy in the United States. PARTICIPANTS Twenty-eight faculty members with the rank of professor, associate professor, or assistant professor who had been employed in their current positions for at least 2 years and who were directly involved in preparing and teaching didactic courses that address pain management. INTERVENTION In-depth telephone interviews. MAIN OUTCOME MEASURES Qualitative responses to open-ended interview questions. RESULTS While pain management was included in the curricula of all 28 schools of pharmacy, it was generally covered in a fragmented way, usually as part of presentations on diseases with pain as a prominent feature (e.g., cancer pain addressed during oncology lectures) or as part of discussions of analgesics. Only two schools offered stand-alone courses in pain management, and both of those courses were electives that were taken by an average of 15 students per year. Three-fourths of respondents believed that pain was being given too little emphasis in their schools' curricula. Palliative care and the use of medications in the treatment of cancer pain was not presented in a standardized manner, and respondents were unsure of how the subject was covered in pharmacy law classes. Instruction about the diagnosis of pain, patient assessment, and physical examination was reported as "minimal" by most respondents. Respondents perceived a need for a single, complete reference and teaching resource that would address the entire spectrum of pain management as it applies to pharmacy. CONCLUSION The topic of pain management is poorly presented and inadequately developed in the curricula of many U.S. schools of pharmacy.