The Trump Administration announced a savings of $12 billion to the federal Medicare program from the second round of IRA drug price negotiations. Included in the 15 prescription drugs negotiated was acalabrutinib (Calquence), a CLL drug. Alongside the savings to the federal government, some sources have cited savings in related patient out-of-pocket costs of $685 million across the 15 drugs.
CLL Society actively participated in the negotiations surrounding acalabrutinib, making sure the federal government negotiators understood the benefits of treatment with acalabrutinib and with any therapeutic alternatives the Centers for Medicare & Medicaid Services (CMS) was or should be considering. We worked closely with some patients and our Medical Advisory Board to both learn their perspectives through this process and help them participate with us at relevant meetings.
With respect to reports of reductions in patient out-of-pocket costs, we note that most cancer patients are not expected to save anything in out-of-pocket costs given the cap on prescription drugs that went into effect last year. Beneficiaries on far cheaper treatments or with sporadic medication needs may be more likely to see such savings. By contrast, the reduction in prices to most cancer drugs is likely to only produce savings for the federal government, not the patients in our community.
At the same time, we expect significant changes in Medicare Advantage plans’ coverage of negotiated medications. So, it will be critical for our patients, doctors and broader community to report in and let us know whether and how these negotiations – ibrutinib (Imbruvica) in Round 1 and acalabrutinib in Round 2 – have affected their ability to prescribe or get the CLL medications best suited to them.
As the negotiated prices go into effect January 1, 2026 (for Round 1) and 2027 (for Round 2), CLL Society will ask for patient experience in accessing all CLL drugs, beyond just ibrutinib and acalabrutinib. Sharing our community’s difficulties or ease of insurance coverage and access to treatment options throughout this year will be critically important. CLL Society has repeatedly advocated for CMS to be open to hearing from all groups like ours about problems and addressing them in real-time.
Since these negotiations were paired with other Part D changes, it is widely expected that traditional Part D plans and Medicare Advantage plans will be far more aggressive in delaying or denying access to prescription drugs. Real time feedback to the government will hopefully allow CMS to address any inappropriate barriers.
Please watch this space for opportunities to provide CLL Society with details of your experience this year and how it differs from previous years.
