Inflation Reduction Act Impacts Drug Research and Development
The recently passed Inflation Reduction Act aims to alleviate the burden on patients and the government when it comes to expensive drugs. However, certain provisions within the legislation unintentionally hinder the development of medications for rare diseases. This has raised concerns about the future of research into potential treatments for these conditions.
One example of the unintended consequences of the law is the suspension of research by Alnylam into its treatment for Stargardt disease, a rare eye disorder. The company cited the need to evaluate the impact of the Inflation Reduction Act as the reason for halting their research efforts. This decision was influenced by a provision in the law that exempts drug companies from price-setting negotiations for drugs that only treat one rare disease. If Alnylam were to continue researching treatments for Stargardt, they would lose this exemption, making the clinical development program too costly to pursue.
While the Inflation Reduction Act has positive aspects for patients, such as a $2,000 cap on out-of-pocket prescription drug costs for Medicare patients and a $35 per-month cap on insulin payments, it is already affecting the discovery and development of new drugs for rare diseases. The law’s impact extends to small molecule medicines, which are crucial for treating neurological disorders, cancers, and other diseases.
One particular issue is the discrepancy in negotiating prices between small molecule drugs and biologics. The act allows Medicare to negotiate prices for small molecules after seven years, compared to the 11 years afforded to biologic treatments. This creates an imbalance that disadvantages developers of small molecule drugs, which are more challenging to discover and manufacture. As a result, the range of targeted treatment options may be reduced, impacting patient care and potentially leading to unintended healthcare spending consequences.
The unintended consequences of the Inflation Reduction Act can be addressed by implementing changes to incentivize drug development. Firstly, there should be a focus on incentivizing the development of drugs for more than one rare disease indication. Additionally, the penalty for small molecule drug development should be removed. These adjustments can be made without affecting the overall budget implications of the bill, and they would encourage the development of treatments that address urgent, unmet patient needs.
Considering the broad impact of the Inflation Reduction Act on all US payers and patients, it is crucial to assess its full consequences. By fixing provisions that hinder drug development and investment decisions, there is an opportunity to incentivize research that will benefit patients waiting for cures. As politics and government policies are constantly changing, it is essential to address these unintended impacts promptly and ensure that patients with rare diseases are not further disadvantaged by the legislation.
Original Story at medcitynews.com – 2023-08-30 13:01:25
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