Utility of the ISPOR Presentations Database to Support the Centers for Medicare and Medicaid Services (CMS) Drug Price Negotiation (DPN): An Apixaban and Rivaroxaban Case Study

Author(s)

Lee LY1, Valliant S2, Willke R3, Higashi M3, Pizzi L4
1Center for Health Outcomes, Policy & Economics, Ernest Mario School of Pharmacy, School of Public Health, Rutgers University, Piscataway, NJ, USA, 2Center for Health Outcomes, Policy & Economics, Ernest Mario School of Pharmacy, School of Public Health, Rutgers University, Perkasie, PA, USA, 3The International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville, NJ, USA, 4ISPOR, Lawrenceville, NJ, USA

OBJECTIVES: To review ISPOR Presentations Database (IPD) to assess the feasibility of extracting clinical, humanistic, and economic data for Centers for Medicare & Medicaid Services (CMS) public call for evidence on Medicare Drug Price Negotiation (DPN).

METHODS: IPD, a searchable archive of more than 60,000 citable research abstracts of podium and poster presentations from ISPOR conferences, was used to extract evidence on apixaban and rivaroxaban, top two cardiovascular medications selected for CMS DPN in 2023. Abstracts were published in ISPOR's flagship journal, Value in Health, and session presentations from ISPOR's conferences were also included. Apixaban and rivaroxaban were searched exclusively as keywords. Outcomes of interest were study methods, QALY reporting, population, and CMS-specified considerations. Non-English abstracts were excluded. Two independent reviewers conducted extraction and cross-verification.

RESULTS: Of 298 total IPD entries, 43% had either a poster or presentation content attached. In the database, 80% of apixaban and 74% of rivaroxaban assessed comparative effectiveness. The most captured study methods were cost-effectiveness analyses (44% for apixaban; 42% for rivaroxaban). 44% of apixaban and 45% of rivaroxaban reported QALYs. 24% for apixaban and 23% for rivaroxaban were in US perspective. CMS's interests such as unmet needs, special populations, risks/harms, and unique scenarios related to benefit, safety, patient experience, and health equity were inadequately captured, partly due to ambiguity in CMS criteria. 12% of apixaban IPD entries and 7% for rivaroxaban specified Medicare or elderly population.

CONCLUSIONS: The ISPOR Presentations Database provides grey literature that can add HEOR evidence to CMS’ decision-making process. Its contents may have reduced publication bias compared to published papers. Further clarification of CMS’ definition of special populations, health equity, and unique considerations related to drug efficacy and safety is needed. Limitations such as potential duplications and preliminary, non-peer-reviewed posters should be considered when leveraging this database.

Conference/Value in Health Info

2024-05, ISPOR 2024, Atlanta, GA, USA

Value in Health, Volume 27, Issue 6, S1 (June 2024)

Code

PT10

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

Cardiovascular Disorders (including MI, Stroke, Circulatory), No Additional Disease & Conditions/Specialized Treatment Areas

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