PARIS, Feb 19 (APM) - Celgene reached an innovative pricing agreement with the French economic committee for health products (CEPS) for Imnovid (polamidomide) capsules for multiple myeloma based on the creation of a real-world data collection registry, managing director Franck Auvray told APM.

In an interview on Wednesday, Auvray said: “If the product proves to be beneficial for the patient, it is covered by health insurance. If not, we will reimburse the health insurance.”

The deal was reached between Celgene and CEPS during pricing negotiations last July and gives an insight into the apparently flexible agreements that are discussed behind closed doors.

Imnovid was approved in Europe in August 2013 for the treatment of relapsed or refractory multiple myeloma in adults who have previously received at least two treatments including Celgene’s Revlimid (lenalidomide) and Janssen’s Velcade (bortezomib), and have progressed since the last treatment.

In France, the drug has been available in hospitals under a group temporary authorisation since July 2012. The Transparency Commission granted it a ‘moderate’ clinical benefit rank (ASMR III) in January with an estimated target population of 1,600 to 1,700 patients par year. The sales price was set at 425 euros per capsule, net of tax, to be included in the list of products being administered in hospitals only.

“With the different stakeholders, we have created a system that allows managing the efficacy and the safety of the drug,” Auvray said.

Since December 2013, with the involvement of concerned physicians and chemists, Celgene has implemented a registry of the patients receiving Imnovid (1,000 people to-date). It is using this to collect acceptance, proper use and efficacy data for the French drug regulator (ANSM), the French national authority for health (HAS) and CEPS.

Criteria for efficient response to treatment have been established with HAS and CEPS on the basis of those established by the International Myeloma Working Group (IMWG). However, detailed criteria remain “confidential to preserve physicians’ freedom to prescribe”.

The results are shared with CEPS on an annual basis and help determine how much Celgene will have to pay to the French central agency for social security funds (ACOSS).

“At the beginning of treatment, we use forms that allow a simple comprehensive follow-up,” Celgene’s managing director said. “As treatment progresses we have to make sure that the follow up and final forms are properly filled in. There are ongoing discussions on this point. I am confident that we will get there”.

“It has been difficult to convince the physicians and the authorities,” Auvray said. For him, giving up the traditional price negotiation procedures is a responsible stakeholder approach, willing to contribute to new market access modes and ensure that the health insurance system be sustainable.

Celgene stressed the innovative nature of this agreement for a drug with a ‘moderate’ clinical benefit (ASMR III) and therefore with a European guaranteed price. To-date two comparable agreements have been disclosed regarding drugs with no clinical benefit (ASMR V): for GlaxoSmithKline’s anti-epileptic (retigabine) and UCB’s Cimzia (certolizumab ) for rheumatoid arthritis.

Auvray stressed that Celgene asked for the lowest price in the European corridor (including Germany, UK, Italy and Spain) and that the new implemented system - costing health industries several hundreds of thousands euros - has delayed discussions with the French economic committee for health products (CEPS).

But he hopes that the discussion conducted for Imnovid can apply to other drugs, i.e. Revlimid, expecting an extension of indication as a first-line treatment of multiple myeloma. Celgene also might follow the patients under Abraxane (nab-paclitaxel) when indicated for pancreatic cancer.

Auvray said Celgene also hopes to work together with the health authorities and other firms on drugs with similar indications. “We must avoid creating more registries or observatories. We do not need four registries for four drugs. We need to think together on how to collect real-life data in a given pathology,” he said.

eh/ab/sf/hlc