A new report from business management consultancy, Numerof & Associates has found that pharma executives are increasingly rethinking the launch of high-priced, speciality products outside of the US amid a rapidly shifting global policy and regulatory landscape.
In order to uncover the longer-term challenges manufacturers are observing across the pharma market – primarily focusing on changing US policies such as the Most Favored Nation (MFN) provision, the Inflation Reduction Act (IRA), and more – Numerof surveyed 175 pharma executives from 67 small, medium and large-cap companies.
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From interview-led conversations with these high-ranking individuals, Numerof uncovered that they unanimously viewed the current era of policy change as “unlike anything” they have previously experienced, and that the new policy environment will cause an industry-wide reconsideration of how to approach the commercial environment.
They also identified increasing scrutiny around a drug’s clinical and economic value, which both play key factors in justifying pricing and reimbursement decisions. This evolving approach, they say, is increasingly placing market access at the forefront of executive considerations.
Because of policies like MFN and the IRA, as well as Europe-wide schemes like the Joint Clinical Assessment (JCA) and the EU Pharmaceutical Package, executives are now considering how pricing access and launch decisions in one market will influence other geographies – marking a notable change from prior models under which decisions were confined to specific regions.
With global pricing decisions in sharper focus, companies are also thinking more about whether, and when, they should launch their drugs in individual countries due to the potential downstream impacts on pricing negotiations a drug’s debut may have in subsequent locations. For example, if a company launched in a lower-price market first, this could impact the price they could set the drug at in other markets.
In some cases, executives are even opting not to launch their high-priced, speciality products at all in certain markets – potentially restricting access to more profitable regions and worsening patient outcomes in certain areas.
Clinical trials also see shift amid policy changes
Alongside the impacts on commercial strategy post-approval, Numerof’s survey also uncovered newfound approaches in clinical research triggered by the shifting global policy landscape.
As launch sequencing considerations become increasingly commonplace, companies are now asking whether the markets they plan to enter should influence the endpoint they use in their studies, as well as how early they generate that evidence.
The considerations don’t just extend to endpoints, however, as key players in market access such as health systems and payers want to see robust data packages for a drug – including real-world data (RWE), cost-effectiveness and comparative efficacy research that highlights a therapy’s differentiated potential versus the current standard of care (SoC). This means companies are viewing evidence generation as increasingly crucial in the post-marketing setting due to its potential to confirm a drug’s economic, clinical and patient-centric value past findings in a controlled trial environment.
For ‘pipeline-in-a-product’ assets, they also believe that indication sequencing is becoming more deliberate, with the order of clinical activity prioritisation depending on policy changes in the focal market, as well as its downstream impact on commercial value. For example, an indication that could bring in a higher price tag outside of the US could be more favourable to target, even if the population is smaller, over a broader indication with more available therapies.
However, some are now questioning the sustainability of the multi-indication blockbuster model, as they note that smaller patient populations could offer stronger differential value – potentially paving the way to justify more premium pricing.
With the pharma sector undergoing a period of rapid evolution, Numerof concludes that pharma companies must adapt their approach to account for these changes, with organisational efficiency and agility, as well as effective decision-making, at the heart of the approach.
