by Helen Collis at the TOPRA meeting

BRUSSELS, Oct 15 (APM) - Companies opting for an adaptive licensing scheme in Europe are likely to see greater revenues over the product’s life cycle, despite initial access to a narrower patient population, than following the standard access pathway, a conference heard.

Speaking at the TOPRA regulatory affairs conference in Brussels on Tuesday, James Anderson, director of European partnerships, government affairs, public policy and patient advocacy at GlaxoSmithKline, said using a model to predict net estimated profit value (NPV) for a range of treatments showed that due to earlier revenue generation, most products would deliver greater returns via an adaptive route, or at least close to the same amount, compared with the traditional route.

“Looking at different scenarios - in most cases as we move from the structured approach to the more adaptive approach, the net estimate profit value (NPV) goes up,” he said.

Anderson explained that the model was developed by a multi-stakeholder group under the New Drug Development Paradigms (NEWDIGS) research programme, brought together by Massachusetts Institute of Technology (MIT).

Invited stakeholder include regulators, payers, health technology assessment (HTA) bodies and patient groups and tested different market access scenarios for different products, looking at various early or adaptive access possibilities.

The type of drugs that were considered using this approach was very broad from vaccines to cancer drugs, he said. Although most of them were early phase, some were also in Phase II or slightly later.

“We looked at the continuous learning nature of a proposal under early access that can be delivered in various ways and a proposal to collect real world data.

He added: “We have seen from NEWDIGS that early access can predict a better NPV due to the earlier revenues coming in.”

The conference heard that once a treatment is made available to patients under an early access scheme, often for a smaller patient population than filing under the normal route to market, the idea would be to gradually expand the indication, giving access to larger patient populations.

He cautioned, however, that early access programmes were no guarantee that this would happen.

During a panel discussion on the pros and cons of Europe’s adaptive licensing programmes, an audience member asked what other incentives there were for pharma to follow this pathway.

Anderson said companies could have greater predictability of revenues. “You can have the same NPV with a de-risked investment profile,” he said.

However, he said for some assets, the NPV was greater when the product entered the market via the traditional route, such as for some vaccines. “That’s an area we need to look at since companies are rational and they go down the route with the most profit,” he said.

Tomas Salmonson, chair of Europe’s CHMP and of Sweden’s Medicinal Products Agency (MPA) agreed that predictability was a great incentive for pharma.

“If regulators set a certain type of criteria for a specific situation, i.e. a targeting a treatment to certain patients, payers will create money to stimulate it and prescribers will adopt the products. It’s for society to tell us where they want us to focus development and we put some kind of predictability in that.”

/hlc/rs