Independent Drug Value Assessment Act of 2024
This bill reflects a significant shift towards enhancing transparency and accountability in drug pricing. By requiring independent value assessments, the legislation seeks to provide a clearer understanding of the economic benefits of drugs to patients and the healthcare system. The independent evaluations will analyze the benefits of drugs on both an individual and a societal level, which includes direct benefits to patients and indirect benefits to families and the healthcare system. Advocates believe this will help ensure that the costs associated with new drugs are justified and that healthcare resources are utilized more effectively.
House Bill 6977, known as the Independent Drug Value Assessment Act of 2024, aims to amend the Public Health Service Act to establish a demonstration project for developing and publishing independent value assessments for newly approved drugs. The bill mandates that the Secretary of Health and Human Services, through the Assistant Secretary for Planning and Evaluation, contract for independent evaluations of drug approvals, ensuring these assessments are completed within 90 days of drug approval. Furthermore, the legislation will also require evaluations of previously approved drugs by the end of fiscal year 2028, focusing particularly on high-expenditure drugs and those designated as breakthrough therapies.
Notably, there are provisions within the bill that may be contentious. For instance, the prohibition of using quality-adjusted life years (QALYs) in assessments has drawn attention. Critics argue that removing such metrics could undermine the ability to measure a drug’s cost-effectiveness effectively. Additionally, the requirement for public participation in the assessment process, which includes soliciting information from various stakeholders like manufacturers and patient organizations, may raise concerns regarding potential conflicts of interest and the objectivity of the evaluations.