Recent Articles

Market access is easy, there are only 5 steps

As we welcome our 6th director to Access Infinity and take our collective market access experience to well over a century, we have been thinking about what sets us apart as a market access consultancy. Our digital solutions are an obvious answer with many thousands of expert hours going into their design and development (1), allowing us as consultants to work faster, smarter, and more rigorously than we have ever been able before. (…)

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The ups and downs of CIPM price revisions

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.

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GETTING MORE OUT OF YOUR ANALOGUE ASSESSMENTS WITH NURO

‘What pricing opportunities do I have when launching in a highly genericised landscape?’

‘What does differentiation look like in a crowded market place?’

‘If my clinical comparator is off label, how do I support a trial design that is acceptable to payers?’

These can be difficult questions to tackle. Often, the first place to look for answers are analogues, i.e. what other products faced a similar situation and what can we learn from them? Finding good analogues (or even no analogues!) can go a long way in better informing your market access strategy and in developing stronger business cases internally.

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BALANCING A FASTER TIME TO LAUNCH VS OPTIMAL ACCESS: CONDITIONAL MARKETING AUTHORISATION AND HTA BODIES

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?

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HOW GARDASIL RESHAPED THE VACCINES MARKET

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.

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