The patchwork of state regulations regarding Medicaid coverage for new, innovative treatments can create barriers for patients seeking access to the most advanced therapies, including treatments for rare diseases, according to an analysis published by Avalere Monday.
The background: Avalere’s study looks at how 10 states handle decisions on Medicaid coverage for two “medical benefit” drugs, which are typically specialty drugs administered by health care providers instead of pharmacies, Bio.News reports.
Medical benefit drugs include many innovative cell and gene therapies, which offer major improvements in care but also face special regulatory barriers, as regulators seek to keep up with the science. Many treatments for rare diseases also fall within this category.
The key finding: “Currently, patient and caregiver experience and access to innovative therapies may vary considerably by state,” the report says.
Potential problems that could limit patient access to new therapies include:
- In some states, there is limited sharing of public information, limited information on public meetings and/or limited opportunities for the public to provide There are also limits on information provided by manufacturers in some states.
- Some states have not published their coverage policies on the drugs under review, and other states “had policies that were more restrictive than the FDA label for at least 1 of the innovative therapies.”
- Some states “Make coverage determinations on a case-by-case basis rather than implementing formal coverage policies.”
Why it matters: Given that 61.1% of enrollees in Medicaid identify as a minority the variations in state policy would seem likely to exacerbate health care disparities. This could also have a disproportionate effect on access for rare disease patients.
Room to improve: By identifying potential problematic policies, the report highlights “opportunities for increased consistency and transparency.”
Read more on Bio.News.
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