USA —President Joe Biden has on March 9, unveiled his 2024 budget proposal, which outlines a comprehensive set of ambitious goals.
However, it is worth noting that these proposals may never come to fruition as Congress ultimately controls the federal purse strings and Republicans currently have control of the House.
One significant aspect of the budget proposal is the plan to rapidly increase the number of drugs that will be subject to negotiation, building on the Inflation Reduction Act.
The proposed changes would decrease the amount of time that small and large molecule drugs go without negotiations, from 10 years for small molecules and 13 years for biologics to just five years for both.
This shift is expected to have a much more substantial impact on biopharmaceutical research and development than the original IRA.
While the original IRA was projected by the Congressional Budget Office to cut only about 10 drugs over the span of 30 years, the proposed changes would drastically expand the number of drugs that would be subject to negotiation.
In addition, the Biden administration is targeting the eradication of hepatitis C, a significant public health concern in the United States.
The proposed budget includes measures to address the issue by allocating resources to improve screening and treatment, which would help curb the spread of the disease.
Overall, while the proposed budget is ambitious, its success is heavily dependent on the outcome of the upcoming congressional elections, as the Republicans currently control the House.
However, the proposed changes could have a significant impact on the pharmaceutical industry and public health if implemented.
According to Endpoints, the US Department of Health and Human Services (HHS) chose not to comment on the updated negotiation numbers, but subsequently leaked them to Bloomberg and Politico reporters.
The leaked information reveals that the number of drugs subject to negotiation will increase from 140 to 300 drugs between 2024 and 2033, resulting in a projected savings of US$160 billion over the next decade.
CMS did not provide any comment in response to the leaked information.
US$11 billion to eradicate Hepatitis C
In addition to the proposed changes to drug negotiations, President Biden has also included a US$11 billion plan over the next decade to eradicate hepatitis C nationwide within five years.
Former NIH Director Francis Collins and Rachael Fleurence, a member of the White House, outlined the program in a JAMA Viewpoint, stating that it aims to expand screening, testing, treatment, prevention, and monitoring of hepatitis C infections in the US, with a focus on high-risk populations.
Although the program carries a significant price tag, the potential savings from preventing expensive cases of liver failure and liver cancer could be substantial in the future.
Recent data also suggests that treating hepatitis C can lead to benefits beyond liver disease, such as improved outcomes for diabetes and kidney disease.
Biden’s budget proposal includes several notable funding increases and provisions. These include allocating US$1.4 billion over 10 years to cap insulin cost-sharing at US$35 in commercial plans, building on the Inflation Reduction Act’s out-of-pocket cap for Medicare beneficiaries.
Additionally, US$670 million will be allocated over five years to expand and modernize regulatory capacity and infrastructure to respond to future pandemics or biological threats.
The budget also includes US$521 million in additional funding for the FDA and US$50 million for the FDA to advance the President’s Cancer Moonshot goals.
The Cancer Moonshot initiative will expand resources and collaborations around diagnostic and therapeutic products to treat rare cancers, and other efforts to address cancer morbidity and mortality.
Furthermore, US$10 million will be allocated to support a range of medical product safety activities.
Finally, the proposal also expands drug shortage notification requirements to include situations when a manufacturer is unlikely to be able to meet increased demand.
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