The FDA approved Apretude (cabotegravir extended-release injectable suspension) for pre-exposure prophylaxis (PrEP) for HIV in December. Administered as an injection every other month, Apretude gives people at risk of contracting HIV a PrEP alternative to taking daily pills.
The Biden Administration is retaining a Trump-era policy allowing private insurers to prevent the value of manufacturer cost sharing assistance from being counted toward deductibles or out-of-pocket maximums in a recently-issued proposed rule governing health care plans. The decision not to revise or rescind the policy in the Centers for Medicare and Medicaid Services proposed rule on the Patient Protection and Affordable Care Act benefit and payment parameters for 2023 is a disappointment for manufacturers and patient groups, which have argued for change since the policy was proposed in 2020 for implementation in 2021. The deadline for comments on the latest proposed rule is 27 January.
The COVID-19 pandemic has caused a significant loss of resources for HIV research, services, treatment, and more, as the focus went to pushing through a vaccine for the novel coronavirus. However, some of the technology developed in response to the pandemic may be the key to developing better treatments for HIV—and even a vaccine against it.
Every issuer participating in a federal exchange — or a state marketplace using the federal platform — must offer at least one standardized plan option starting in 2023 and those plans will receive differential display on healthcare.gov, CMS proposes in its draft exchange rule unveiled this week. The 2023 proposed Notice of Benefit and Payment Parameters was released Tuesday and CMS will accept comments for 30 days. The agency also plans to conduct network adequacy reviews in all states.
The US Food and Drug Administration (FDA) has approved a bi-monthly injectable form of PrEP to prevent HIV infection, adding yet another tool in the fight against HIV/AIDS nine years after the agency first authorized daily PrEP pills. The injectable PrEP regimen—intended to prevent HIV transmission through sex, not injection drug use—begins with one shot in back-to-back months before shifting to bi-monthly jabs. Patients also have the option of testing their body’s tolerance of the injectable drug, known as Apretude, by taking it orally for four weeks before moving to the shots.