With the Trump Administration’s recent withdrawal of their proposal to modify the rebate safe harbor, what do manufacturers need to know in preparing for the future? Todd Edgar reviews the history of the proposal and offers some advice.
The CMS has announced that individual markets, small and large group, and self-insured group health plans will be allowed to implement copay accumulator programs starting in 2020. What does this mean for market access? Kellie Rademacher provides an overview.
In May 2019, the FDA released guidance to clarify the level of evidence required from manufacturers to support interchangeability between a biosimilar and the reference product. Erin Lopata explains how this may impact stakeholders, and how price and utilization could be influenced by increased competition in the biologics market.
The HHS final rule requiring inclusion of price into all televised DTC for pharmaceuticals reimbursable under Medicare/Medicaid that have a cost greater than $35 per month was to begin this July, but manufacturers may have won a reprieve with an initial court ruling that HHS overstepped its bounds. Jeremy Schafer takes a look at the implications of this ruling, the proposed new policy, and how manufacturers can mitigate some of the risks.