by Natalie Morrison
LONDON, June 8 (APM) - The European Medicines Agency (EMA) has "not been as successful" as it hoped in getting 'payer buy-in' on drugs authorised under early approval schemes, the regulator's senior medical officer Dr. Hans-Georg Eichler has told APM.
However, the regulator is keen to change this with more early engagement, he said in a phone interview.
With already strained healthcare budgets, payers are by in large "not fond of early access schemes" which bring expensive drugs out earlier, he said in the interview on Tuesday.
"They [payers] say 'if there is a drug with even higher uncertainty and these companies come in at a premium price, we're paying a lot of money for little information'," he said, conceding that this is a rational argument.
"I guess what we are trying to do is get more of a buy-in from those downstream decision-makers. We have not been as successful as we wanted originally to have more HTA bodies from across Europe on board," he added.
The EMA is only now starting to engage with payers - which in some countries are distinct from HTA bodies - on the "frontier of knowledge generation post-licensing", Eichler said. This kind of knowledge generation is particularly important for drugs approved on early and more limited data.
The regulator's ambitions include getting more registries up and running, "in one way or another", to generate more real world data on approved drugs, Eichler said.
More early joint discussions with companies, payers and regulators would also help firm up the concepts of post-marketing knowledge generation, and would enable companies to meet both regulatory and payer needs in trial designs.
Regulators, payers and patients alike must be willing to accept more uncertainty for drugs approved under early access schemes such as PRIME, since these products address high unmet medical needs where it is urgent to get promising treatments out quickly, Eichler said (APMMA 53397).
Payers know they must accept more flexible pathways based on increasing levels of post- rather than pre-marketing data, as regulators have become more flexible in approvals, Eichler said. Still, payers are "struggling to transform the concept into reality, and some are more willing to explore than others," he added.
The EMA is now trying to convince payers that although it cannot influence how companies price their drugs - under EU law, pricing cannot figure in EMA decisions - in theory, an early access scheme for a small number of patients costs less than running a late-stage clinical trial.
So also in theory, if companies were willing to lower their prices as they were making a lower investment it could bring down cost, he said, though stressing "that's not for us [at the EMA] to judge".
In any case, "we are not the last decision-maker in the chain", he said, noting that the goal of timely access - particularly important for drugs approved under expedited pathways - will not be realised if if there are reimbursement delays. In Europe, delays can last years, and in some areas might even mean no access at all.
"If we [the EMA] did a stellar job getting the right drug out for the right patients, but the payer says no, no-one is helped," said Eichler, "therefore we also need to enrol these post-regulatory decision-makers in the whole process much earlier on."
Eichler also said he would be keen to avoid situations where regulators and health technology assessment (HTA) bodies disagree too often, noting: "If too many public bodies contradict each other, the public will lose trust in us.
"We all have a vested interest in not contradicting each other too often."
In general, the number of parallel scientific advice meetings held at the EMA "growths month on month", Eichler said. "I would argue this is almost routine procedure."
Yet "all of that needs refining", he continued, adding that EMA is in constant contact with the European HTA umbrella organisation EUnetHTA.
On recent industry calls for more harmonised HTA processes in Europe (APMMA 51928), with even the potential of one unified HTA body for the Union, he said: "it's not on me to say whether there will be one body".
"The question is, is it important, or could we have HTA bodies that collaborate and try to share work and come out with a more or less harmonised assessment of the data?", Eichler said, adding this is how the regulatory community operates.
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