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Published October 30, 2023
The following statement was made today by Alliance President and CEO Sue Peschin during the public comment portion of the Centers for Medicare & Medicaid Services (CMS) virtual patient-focused Listening Session on Eliquis. This session was the first of several listening sessions planned on the Medicare Drug Price Negotiation Program to take place through November 15.
My name is Sue Peschin and I serve as President and CEO of the Alliance for Aging Research. Thank you for the opportunity to comment.
Since 2019, the Alliance has consistently opposed Medicare drug price negotiation policies because they all rely on significant cuts to beneficiary access in order to reach projected CBO savings. While political messaging claims price negotiation will help to reign in high drug prices, the process instead captures drugs that serve millions of Medicare beneficiaries at comparatively modest cost—such as Eliquis—rather than drugs that induce sticker shock.
So, what will cutting access look like in practical terms? Well, while the IRA guarantees formulary inclusion for all 10 selected drugs being discussed in these listening sessions, it does not guarantee formulary placement for any of them.
Starting in 2026, Medicare beneficiaries and family caregivers will need to check their plan formularies. If their plan has switched formulary tier placement for a selected drug, beneficiaries may either need to pay more out-of-pocket to stay on it, switch to a preferred drug in the same class, or switch to a new plan. Insurance plans are also likely to restrict access to selected drugs through utilization management practices, such as prior authorization and step therapy. Unfortunately, CMS only pledges to ‘monitor’ utilization management by Part D plans, not develop guardrails to protect patient access.
Switching stable patients off an anticoagulant therapy such as Eliquis is alarming for patients reliant on blood thinners to manage clot risk. An August 2022 survey from the American Society of Preventive Cardiology found that—of respondents taking anticoagulants who were non-medically switched by payors—70% of Health plans’ explanations for the switches were financial, but many led to serious health consequences. A reported 28% of patients experienced side effects; 7% had heart attacks, 4% had strokes, and 20% actually stopped taking their blood thinners. These are patients at very high risk for deep vein thrombosis, pulmonary embolism, stroke, and heart attack. It is vital that Medicare create actual safeguards to prevent these potentially dangerous impacts.
The government’s lack of transparency about its price-setting methodology is also concerning. We may or may not hear today from the Institute for Clinical and Economic Review, or ICER—about their “special report” on Eliquis.
ICER reports are indeed special in that they are payer-centric, not patient-centric. Arnold Ventures is the largest funder of ICER, and we think Arnold funding should be reported as a conflict by groups speaking here today, such as PORTAL and DFA.
ICER uses its own equal value of life years—known as the evLY or the evLYG—metric in its report. However, claims by ICER that the evLY fixes the biases of the QALY and complies with the law as described in the IRA, are misleading. A report from the Disability Rights Education and Defense Fund (DREDF) states that “Adding the evLY is not a solution; it merely forces payers to choose between one measure that undervalues life extension (the QALY) and one that affords no value to quality-of-life improvements (the evLY). Neither account for both the full value of life-extension and the value of quality-of-life improvement.” Hundreds of patient advocacy organizations agree with DREDF that the evLY metric is discriminatory—including the Alliance.
While CMS mentions health equity as one of its strategic pillars, the adoption of such methodology in Part D price-setting will hit underserved people with disabilities, and those in rural communities and communities of color the hardest. ICER also does not follow best practices on patient engagement. If CMS truly intends to be patient-focused, it should reject ICER’s methodology and any of the reports they present on selected drugs.