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Adaptive licensing and early access to innovation: The views from ISPOR Europe annual meeting

03 December 2014 Milena Izmirlieva

The issue of early access to innovation in pharma was the focus of the second plenary session at the ISPOR 17th Annual European Congress earlier this month. During the second plenary session there were interesting presentations on this topic from Adrian Towse (UK's Office of Health Economics; OHE), Hans-Georg Eichler (European Medicines Agency; EMA), Richard Bergström (European Federation of Pharmaceutical Industries and Associations; EFPIA), Alric Rüther (Institute for Quality and Efficiency in Health Care; IQWiG), and Carole Longson (National Institute for Health and Care Excellence; NICE). The prominence of this topic in this and other ISPOR sessions was not unexpected given how high early access is on the agenda of pharmaceutical companies, payers and patients.

For pharma manufacturers early access to innovation should generally translate into early patient access and earlier revenues than if a company waits for the full marketing authorisation and standard pricing and reimbursement review. But some serious concerns remain. A report by the Escher Foundation, entitled "Improving the EU system for the marketing authorisation of medicines," which was referred to in the second ISPOR plenary session, found that conditional marketing authorisation continues to have some negative connotations for pharmaceutical companies. It has too long been perceived as a "rescue option" when evidence is insufficient and not a "prospectively planned pathway to provide early access," according to Towse's presentation.

Meanwhile Eichler discussed in his presentation the adaptive licensing pathway introduced by the EMA. Adaptive licensing, previously explored in the IHS blog, allows companies to get rolling approval for medicines whereby approval is initially granted in a limited indication and as more data become available approval is expanded to additional indications. Adaptive licensing on its own is not enough to allow early market entry, however. A product approved under adaptive licensing, in Eichler's view, needs reimbursement so "a managed entry or adaptive entry" is needed. It is essential to understand payer preference for risk tolerance, he further indicated, as this will determine how to segment correctly the subpopulation of patients for which the benefits of the new product may outweigh the risks. A similar view was echoed in Bergström's presentation: adaptive licensing is not sufficient, what patients and pharmaceutical companies need is an adaptive pathway for market access.

The issue of creating a pathway for innovative pharmaceuticals approved under adaptive licensing was also highlighted in Longson's presentation. She focused on the need to consider another level - the clinician who needs to support an innovation after the marketing authorisation agency and the HTA agency have issued a positive recommendation. "This is where the real barrier to access can occur," Longson stated. Clinicians, represented by clinical implementation groups in England, are also needed to fill in feedback forms and help generate the post-marketing evidence for new medicines. She also mentioned another issue - and one that the pharmaceutical industry and the regulator would ideally not want to face - namely, the creation of an exit strategy for products that fail to meet expectations in the market place.

Whether these expectations are safety and efficacy related or cost-effectiveness related one thing is certain based on the ISPOR Europe second plenary session: adaptive licensing is a step in the right direction, but there are still lots of issues to work out in terms of adaptive reimbursement pathways and even exits if outcomes don't pan out as planned.

Milena Izmirlieva is head of the research team at IHS Life Sciences

Posted December 3 2014



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