The Spanish healthcare system is notorious for being cost-conscious. With COVID-19 acting as a major setback in terms of budget allocation and public debt (1), this could have consequential knock-on effects on Spain’s willingness to pay for drugs. One mechanism that allows them to exercise their predisposition to implement budget control is drug pricing.
Generating comprehensive data in rare diseases or chronic progressive conditions, can be challenging often requiring lengthy study durations and very high investment. The European Medicines Agency (EMA) therefore considers granting early market authorisation of a product for seriously debilitating, life-threatening, or rare diseases. Given the current global climate from challenges. posed by COVID-19, even more interest has been directed towards fast-tracking market authorisation. Conditional Marketing Authorisation (CMA) is a regulatory pathway for such diseases that enables timely access to therapies. Our question is: what are the HTA implications of launching with a CMA?
COVID-19 has enhanced interest in infectious diseases, such that vaccine rollout is seen as the light at the end of the pandemic tunnel. For decades, the vaccine segment of the pharmaceutical industry had been regarded as a market with limited revenue opportunities. However, these myths have been dispelled by novel, high-price products such as Prevnar and Gardasil, illustrating that vaccines have commercial potential with the right strategies in place.