On May 10, the House Ways and Means Committee held a hearing on “Examining Policies that Inhibit Innovation and Patient Access“. You can view the testimony here. I summarized submitted Congressional Testimony with the help of ChatGPT below. Actual testimony submitted is also referenced below as well.
Mr. Tony Gonzales, National Early-Stage Advisor, Alzheimer’s Association. The individual sharing their story discusses their experience living with mild cognitive impairment (MCI) and their frustration with the lack of access to FDA-approved Alzheimer’s treatments for Medicare beneficiaries. They recount the initial signs of their condition, difficulties with obtaining an accurate diagnosis, and the impact on their daily life. They emphasize the need for more awareness and support for individuals under the age of 65 who are affected by Alzheimer’s. The individual highlights the progress in Alzheimer’s research and the availability of treatments approved by the FDA, but criticizes Medicare’s refusal to cover them, creating barriers to care. They call for CMS (Centers for Medicare & Medicaid Services) to reconsider their coverage policies and provide Medicare beneficiaries with the opportunity to access these treatments. The individual shares their personal hopes and aspirations for more time to spend with loved ones and live their life to the fullest despite their condition. They conclude by urging policymakers to advocate for fair treatment and access to Alzheimer’s treatments. (Actual testimony)
Mr. Ted Okon Executive Director, Community Oncology Alliance. The Congressional testimony highlights concerns regarding the proposed drug pricing reforms and their potential impact on cancer care. The testimony emphasizes the complexity of pricing negotiations for drugs with multiple indications and the potential negative consequences, such as increased launch prices and limited research for new indications. It raises concerns about the operational challenges and payment cuts associated with Medicare Part B drugs, as well as the potential impact on independent cancer care providers and access to care. The testimony also discusses the importance of maintaining innovation in cancer therapies and the challenges posed by generic drug shortages. It calls for a careful consideration of policy changes to avoid unintended consequences and ensure access to affordable and innovative treatments. (Actual testimony)
Dr. Darius Lakdawalla Professor of Pharmaceutical Economics and Public Policy, USC Leonard D. Schaeffer Center for Health Policy & Economics. Darius N. Lakdawalla, an economist and professor at the University of Southern California, testified before the U.S. House Ways & Means Subcommittee on Health on the impact of federal policy on medical innovation. He highlighted the importance of medical innovation in improving patient outcomes and emphasized the tradeoff between innovation and patient access. While Medicare price negotiation may lower prices in the short term, Lakdawalla argued that it poses risks to both innovation and patient health in the long term. He proposed a balanced policy approach that includes generous prescription drug coverage, drug prices aligned with the value delivered to patients, and robust competition within the pharmaceutical supply chain. Lakdawalla also discussed the need for evidence-based methods to measure the value of new medicines and suggested a three-part pricing framework that considers the drug’s value over its lifecycle. (Actual testimony)
Dr. Joshua Makower, M.D. Director, Stanford Byers Center for Biodesign, Stanford University.
Josh Makower, a physician-inventor, entrepreneur, and professor at Stanford University, testifies about the challenges faced by medical technology innovators in accessing timely reimbursement for their breakthrough medical technologies. He highlights the “valley of death” where FDA-authorized technologies often lack Medicare or insurance coverage, resulting in delayed or limited access for patients. Makower presents survey results indicating that Medicare coverage for such products takes an average of 4.7 years, and only 44% achieve nominal Medicare coverage within 5.7 years. He emphasizes the need for a swift and predictable pathway for reimbursement to encourage innovation and investment in critical areas of patient care. The survey indicates that an accelerated reimbursement pathway would significantly influence innovators and investors’ decision-making. Makower urges the creation of a well-designed program that enables coverage while collecting evidence, benefiting patients and promoting invention, innovation, and investment in unmet clinical needs. He calls on CMS and Congress to address this issue with proposed rules and legislation, respectively, to accelerate patient access to critical medical technologies. Makower concludes by emphasizing the importance of bridging the gap and ending the “valley of death” to ensure that innovations can benefit patients and providers. (Actual testimony)
Dr. Aaron S. Kesselheim MD, JD, MPH Professor of Medicine, Harvard Medical School. Aaron Kesselheim, a primary care doctor and professor of medicine at Harvard Medical School, provides testimony on meaningful drug innovation and the need for distinguishing between innovations that provide added therapeutic benefits and those that do not. He emphasizes the crucial role of public funding, such as NIH investments, in facilitating transformative drugs. Kesselheim highlights the high costs of brand-name drugs in the US and the prevalence of low-value drugs that contribute to substantial healthcare spending. He discusses the FDA approval of atacanumab for Alzheimer’s disease without clear evidence of efficacy, prompting the need for CMS to restrict payment to clinical trials. Kesselheim also mentions CMS’s project to pay less for accelerated approval drugs and the need for evidence of clinical benefits. He suggests doubling the NIH budget, granting the government authority to reduce spending on drugs without meaningful benefits, and establishing an expert organization to evaluate new drugs’ value and pricing. Kesselheim emphasizes that these steps will incentivize meaningful innovation and protect patients from financial burden and low-value treatments. (Actual testimony)
Do watch the whole testimony when you have a chance.