Medicare High-Value Drug List Plan
The first model is the Medicare $2 Drug List or Medicare High-Value Drug List Plan. This model was designed to address the concern of both patients and healthcare providers that uncertainty and a lack of transparency regarding the cost of prescription make it challenging to establish and maintain care. As a result, the first model was designed to ascertain whether offering roughly 150 high-value generic drugs at reasonable costs and with dependable cost sharing will improve health and equity results, boost adherence to treatment plans, and lower costs.
To test this model, however, Medicare Part D plans will be urged to offer specific prescription drugs from a "standardized drug list" for a maximum co-pay of $2 per monthly supply. The idea has already been tested in a limited way: big retail pharmacy companies frequently provide standardized drug lists. This approach's impact is measured in healthcare spending, patient outcomes, and medication adherence. The HHS proposed that the model will make beneficiaries' healthcare costs more predictable. It also argues that this model is consistent with the $2,000 Part D out-of-pocket spending cap imposed by the Inflation Reduction Act, which takes effect in 2025.
Cell and Gene Therapy Access Model
The second model is the Cell and Gene Therapy Access model. The model focuses on Medicaid recipients. It uses outcome-based payment models, enabling multistate agreements with cell and gene therapy manufacturers. The model will enhance collective bargaining, which might result in reduced costs. The Center for Medicare & Medicaid Services (CMS) will begin the development of this model in 2023 with a test launch in 2026, and it will target cell and gene therapies used for conditions like sickle cell disease and cancer.
Accelerating Clinical Evidence Model
The FDA created the Accelerated Approval Pathway (AAP) in 1992 to enable earlier approval of drugs that treat severe conditions and meet unmet medical needs. The FDA typically requires a manufacturer to conduct sufficient and well-controlled post-marketing confirmatory clinical trials with due diligence to confirm the drug's expected clinical benefit as a requirement for accelerated approval. Confirmatory trials must be completed because incomplete clinical data and delayed confirmatory trials may force beneficiaries to take ineffective drugs, incur additional costs, and impede a patient's advancement toward alternative therapies or treatments.
The third model, the Accelerating Clinical Evidence Model, aims to resolve this problem by encouraging manufacturers to keep creating novel treatments, apply for expedited approval, and finish timely confirmatory trials to demonstrate the clinical advantage of these treatments. The model will first focus on Medicare Part B fee-for-service providers. However, it may later be expanded to cover other programs as well. CMS will consult the FDA to explore the model in 2023, and if suitable, CMS plans to launch the model as soon as it is practical.
According to HHS, this approach would alleviate payer worries about covering medications with incomplete or delayed confirmatory trials. Additionally, it would align manufacturer motivations and encourage them to accelerate drug release.
While these models and proposals have the potential to significantly lower prescription drug spending, they have also faced criticism from some pharmaceutical companies and industry groups. They argue that these models could lead to reduced innovation and access to new medications, as well as harm patient care.
Despite these concerns, it’s clear that action is needed to address the rising cost of prescription drugs in the U.S. The HHS models and proposals are important steps towards this goal, and it will be important to continue evaluating their effectiveness and making adjustments as needed to ensure that patients can access the medications they need at a price they can afford.
