Keep pulling the thread on Steve Mather.
The Inflation Reduction Act (IRA) in the United States is compressing revenue horizons for pharmaceutical companies.
The Joint Clinical Assessment (JCA) is a new, active policy in Europe that redefines the standard for acceptable evidence of a drug's value.
The Inflation Reduction Act (IRA) establishes a 9-year window for small molecule drugs before they are subject to price negotiations with Medicare and Medicaid in the US.
The Inflation Reduction Act (IRA) establishes a 13-year window for biologic drugs before they are subject to price negotiations in the US.
A top 25 pharmaceutical company has pivoted its portfolio strategy in response to the Inflation Reduction Act, shifting investment from small molecules to complex therapies to leverage the longer 13-year negotiation window.
At a recent ISPOR meeting, Roche stated that for two of its oncology assets approaching the Joint Clinical Assessment (JCA), it anticipated needing to provide evidence for 25 and 36 different PICO scenarios, respectively.
Rare disease assets will become subject to the Joint Clinical Assessment (JCA) in Europe starting in 2028.
The Most Favored Nation (MFN) pricing policy, introduced during the Trump administration, links drug pricing decisions across international borders, restricting pricing opportunities for pharmaceutical companies.
The Joint Clinical Assessment (JCA) in Europe requires that clinical trials for new drugs must simultaneously serve the needs of both regulators and health technology assessment (HTA) bodies.
Steve Mather asserts that under the new regulatory landscape, a drug's clinical trial protocol design has effectively become its global market access strategy.
Steve Mather believes that commercial excellence at launch cannot recover value for a pharmaceutical asset if that value was not designed into the asset during its early development stages.
Pharmaceutical companies are developing modular clinical trial designs to be more flexible in accommodating the divergent evidence requirements from different European countries under the Joint Clinical Assessment (JCA).