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Short Report
10 October 2023

Availability of comparative real-world evidence research in Medicare patients: implications for Centers for Medicare and Medicaid Services drug price negotiations

Authors: Ashley Jaksa https://orcid.org/0000-0003-3571-3345 [email protected], Patrick J Arena https://orcid.org/0000-0003-3024-771X, and Nicolle Gatto https://orcid.org/0000-0002-9659-7811Author Info & Affiliations
Volume 12, Number 11
https://doi.org/10.57264/cer-2023-0125
PDFFormats

Abstract

Aim: To evaluate the availability of published comparative real-world evidence (RWE) studies in Medicare patients for the ten drugs set to undergo Centers for Medicare and Medicaid Services (CMS) price negotiations in 2026. Materials & methods: A scoping review was completed in MEDLINE/PubMed to evaluate the availability of comparative RWE investigations conducted among Medicare-eligible patient populations in the US for the following drugs: apixaban, rivaroxaban, sitagliptin, ibrutinib, empagliflozin, etanercept, dapagliflozin, sacubitril/valsartan, ustekinumab and insulin aspart. Results: Of the 170 real-world comparative studies identified, 55 (32.4%) used Medicare real-world data (RWD) while 34 (20.0%) used commercial claims data in conjunction with either Medicare Advantage or Medicare Supplementary databases. The number of studies varied considerably by drug with apixaban and rivaroxaban studies accounting for the majority (i.e., 67.1%) of comparative RWE studies. Approximately a third or less of the comparative RWE studies were conducted in CMS RWD per drug. Conclusion: Our results demonstrate there is a considerable amount of comparative RWE for apixaban, rivaroxaban, and etanercept but limited comparative RWE for the other drugs set to undergo CMS price negotiations in 2026; additionally, our findings set up a number of next steps (e.g., risk of bias assessments) for further exploration of the available evidence base. Overall, CMS and manufacturers should consider proactively generating high-quality comparative RWE studies in the Medicare population to ensure that future price negotiations are based on robust evidence.

Tweetable abstract

A scoping review suggests there is limited comparative #RWE for the first drugs that will be subject to #CMS price negotiations under the #IRA #realworldevidence #Medicare #CER.

Plain language summary

Following the passage of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services (CMS) will be able to negotiate the price of certain drugs with pharmaceutical companies.

What is this article about?

The US government recently selected the first ten drugs that will be subject to the CMS price negotiations. Here, we investigated the availability of comparative real-world evidence (RWE; evidence from real-world data sources such as electronic health records), which is one component of the clinical evidence that CMS will consider, for the first ten drugs subject to the price negotiations.

What were the results?

Of the 170 comparative RWE studies that we identified in the literature, only about a third (32.4%) were conducted using Medicare data. Additionally, the number of studies varied considerably by drug with apixaban and rivaroxaban studies accounting for the majority (67.1%). We also found that the identified studies examined a wide range of indications, outcomes, and drug comparators.

What do the results mean?

Our findings imply that there is limited comparative RWE on the first ten drugs that will be subject to CMS price negotiations; these results therefore highlight the need for more comparative RWE studies for these drugs in order to ensure that the evidence base for them is as complete as possible.

Supplementary Material

File (supplementary data.docx)

References

Papers of special note have been highlighted as: • of interest; •• of considerable interest
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