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Published November 15, 2023
The following statement was made today by Michael Ward, MS, Alliance Vice President of Public Policy and Government Affairs, during the public comment portion of the Centers for Medicare & Medicaid Services (CMS) virtual patient-focused Listening Session on Xarelto. This session was the last of several listening sessions planned on the Medicare Drug Price Negotiation Program which began on October 30, at which Alliance President Sue Peschin offered testimony on Eliquis.
Good afternoon. My name is Michael, and I work at the Alliance for Aging Research. On behalf of the older adults we advocate for, we thank CMS for hosting these forums.
While some stakeholders have been pointing to warfarin as an alternative to direct oral anticoagulants, known as DOACs, this isn’t an apples-to-apples situation and the costs are not directly comparable. DOACs can easily be taken at home and have fewer harmful drug interactions or do not require dietary restrictions. In contrast, warfarin requires vigilant monitoring via a prothrombin time blood test and the drug interacts with many common OTC medications such as acetaminophen and ibuprofen, and some dietary supplements. For individuals that are unable to self-administer the test, they may incur additional clinic costs and effort to have INR monitoring done at a lab, testing center, or medical office.
These costs are not nominal and illustrate how vital it is to consider outcomes that are important to patients – in the Medicare population, beneficiaries are older and have a greater level of disability compared to other insured populations which may limit their ability to both self-administer as well as travel for testing. It is important to not only include the sticker price, but to consider the ancillary costs AND outcomes that patients find important and improve their quality of life.
It is also vital that care providers maintain autonomy over determining the therapy that is best for their patients. In a previous listening session, one participant noted their insurer had used step therapy when they started DOAC therapy, when their doctor felt another DOAC would have been more appropriate for them. While there are more protections in Medicare than in private plans, it is vital that CMS establish additional protections to prevent inappropriate utilization management, such as non-medical switching, given the financial dynamics of Part D redesign.
CMS should use head-to-head studies whenever possible in comparing outcomes and negotiating prices and avoid using metrics such as the equal value of life years methodology which may discriminate against older adults and people with disabilities – the very populations that Medicare serves. Pricing should also acknowledge that ambiguity exists – for example, some studies show that Eliquis may have fewer side effects than Xarelto, while a 2018 study indicated Xarelto had fewer serious side effects when used in medically frail populations for non-valvular Afib.
Pricing should support and incentivize the use of the drug that is best for specific patient populations. In addition to afib, Xarelto is indicated for the treatment of deep vein thrombosis and in the pediatric population.
In short, CMS must consider relevant pricing and outcomes for secondary indications in establishing prices, given the agency’s moiety policy.
Today represents the final listening session for the ten drugs subject to price negotiation in 2026. In the future, we want to ensure CMS receives feedback during these sessions that are directly applicable in price negotiation discussions. We’ve heard a number of participants speak about the need for concrete guardrails to prevent UM abuse. Just as importantly, CMS needs to not only know about the outcomes, data and endpoints that matter to patients but also be able to ask clarifying questions and open dialogue. The Alliance and other patient organizations look forward to working with the agency to create a two-way conversation.
Thank you again.