Policy Shifts, Price Talks Hinder Cancer Innovation: R. Haumschild
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New policies are challenging oncology innovation and shifting clinical trial focus towards rare diseases, says Ryan Haumschild, vice president of ambulatory pharmacy at Emory University and Winship Cancer Institute. He states that policies such as the Inflation Reduction Act and changes in manufacturer-negotiated pricing are affecting how stakeholders think about value, pricing, and access. Haumschild also asserts that the policy infrastructure needs to keep pace with the rapid advancements in precision medicine, and that payers need to expand their coverage to include more broad panels, not just for first-line therapy, but for subsequent lines as well.
Oncology Innovation and Clinical Trials Face Challenges Due to New Policies
Novel regulations are impacting oncology innovation and influencing the direction of clinical trials, especially towards rare diseases. This is according to Ryan Haumschild, PharmD, MS, MBA, CPEL, who is the vice president of ambulatory pharmacy at Emory University and Winship Cancer Institute.
Haumschild conducted a panel discussion on the continually changing sphere of oncology innovation at the Patient-Centered Oncology Care® (PCOC) conference in Nashville, Tennessee. The discussion was titled “Innovations in Industry: Looking at the Next Decade.”
Policy Challenges to Innovation
When asked about the most significant challenges to innovation posed by new policies, Haumschild pointed out several emerging regulations. These include the Inflation Reduction Act, manufacturer-negotiated pricing, the Most Favored Nation, and changes in the Enhancing Oncology Model network. The impacts of these new policies are felt in the way stakeholders evaluate value, price, and access to oncology innovations.
However, Haumschild emphasized the importance of remaining competitive while still promoting innovative products, despite these policy changes. He also suggested leveraging the Inflation Reduction Act to ensure that patients continue to have access to their treatments.
Impact on Clinical Trials
Regarding the effects of policy and funding changes on clinical trials, Haumschild stressed their importance, especially for patients without a good standard-of-care therapy. He further suggested that price-negotiated medications could prompt a shift towards funding trials for more rare diseases. This change could be beneficial for patients with high unmet needs and offers pharmaceutical companies an opportunity to invest in areas protected from price negotiations.
The Need for Policy to Keep Pace with Innovation
With a significant focus on precision medicine in oncology innovation, Haumschild questioned whether the current policy infrastructure could keep up with the pace of scientific advancement. He believes that payers are expanding, but there is a need for more rapid expansion.
According to Haumschild, there is a need for broader policy coverage not only for initial, first-line therapy but also for subsequent lines of progression. He believes if the best therapies are provided to patients, it will not only prolong their efficacy but also reduce the total cost of care.
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