by Edouard Hubert

PARIS, Feb 22 (APM) - The chairman of the French economic committee for health products (CEPS) has said it is "challenging" to price innovative cancer drugs used in combination.

Maurice-Pierre Planel was speaking on Tuesday at an event organised by pharmaceutical executives association ACIP, ESSEC business school and the specialist newspaper le Quotidien du médecin.

At the end of a brief presentation on the framework for setting drug prices in France, Planel discussed "the new mechanisms" the committee is faced with, essentially for cancer drugs. He mentioned longer treatment periods for effective drugs, leading them to be administered on a "chronic" basis; rapid securing of indication extensions that can multiply the target population by 10; along with drugs intended for use in combination.

"Where the drugs come from the same pharma, [pricing] is doable," he said. The combinations used in some melanomas, Roche's Cotellic (cobimetinib)+Zelboraf (vemurafenib), and Novartis' Mekinist (trametinib)+Tafinlar (dabrafenib), are examples of this.

"However, we very rapidly find ourselves talking about three or even - as the board chair of France's health technology assessment body HAS Agnès Buzyn pointed out - 'n' products in the combination," Planel continued.

"How do we go about pricing? That's a good question … and what do we do when several different pharmas are involved?" he asked, without offering any answers.

"The idea is not to pay the double of a fixed combination," he added. "The sum of the costs of just one of the elements doesn't interest us," he added later, wondering about the valuation of each drug. "Is it 50/50, 70/30? The answer is not clear."

He said the subject had been broached with the French pharma industry body LEEM during a meeting of the joint policy steering committee at the end of January, and that another meeting with representatives of the trade body on the criteria for determining the prices of drug combinations is scheduled for next week.

During his 90 minute-speech to a full auditorium, Planel discussed the draft framework agreement due to be signed with patients' associations (APMMA 51901) and criticism of CEPS' lack of transparency.

He said he is frequently asked to transmit agreements signed with pharmas, but that he complies with the administrative document access commission (Cada) case law that protects trade secrets. He added that if he were to publish the summaries of the committee's meetings, it would mean "blacking out half or three-quarters" of the text, which would make the "cure worse than the disease".

Asked about communications in the debate on drug price levels, the CEPS chair said that he has no dedicated staff member for this activity and qualified his own efforts as "inaudible".

"On an institutional level our discourse is merely technical," he said.

He evoked his participation in a meeting organised by the G5 Health Association (G5 santé) in October 2016. "A pharma representative said: 'We have a poor image but it doesn't really matter'. But it does matter. CEPS has the same image... we're all in the same boat," he said.

Planel reiterated his suspicion of performance contracts. He mentioned the contracts (no more than five) that were under way when he was appointed at the end of 2015, adding that they "are not working out in the expected way". He said that, in each case, the end of the contract benefited the authorities but that pharmas are "unwilling" to accept the consequences.

"I'm not going all out for performace contracts," he said, calling for "robust contracts" to "avoid ambiguity". He also criticised pharmas' slowness to carry out contractual commitments such as post-marketing studies.

"Practically speaking, the contracts I have on my desk don't make me want to sign more," he declared.

Asked about the criteria used to select the classes of drugs whose prices are to be cut, he cited "classes that are big enough enough to allow savings" and that have not been affected by cuts for a number of years. For 2017, he mentioned the examples of blood-derived products and imaging products.

He also mentioned drug classes that are the subject of re-evaluation by HAS, such as the opinion on hepatitis C (HCV) drugs issued at the end of 2016 (APMMA 50888) and another on direct oral anticoagulants (DOACs) due in spring.

Planel also said that within the context of the biosimilar monitoring committee, he wants to publish an annex to the framework contract that would set out policy concerning the prices of these drugs, like the one that already exists for generics.

/eh/aki/clg