by Guillaume Bietry
PARIS, 28 Dec (APM) - Gilead France is to charge €350,000 per patient receiving its CAR-T therapy Yescarta (axicabtagene ciloleucel) during the post-early access scheme (ATU) period, the head of its French operations Michel Joly has told APM.
Along with Novartis’ Kymriah (tisagenlecleucel),Yescarta is part of a new drug class that seems promising in haemato-oncology but which is very expensive with data still in the early stages.
Gilead’s drug was approved in Europe at the end of August for adults with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy (APMHE 59444
It was made available at an early stage in France under a cohort ATU which started at the end of July for patients with large B-cell lymphoma (APMHE 59088
The drug still has ATU status, but as it has been approved in Europe, its status will change to post-ATU in 2019, Joly said in a recent interview with APM. Discussions with France’s drugs regulator, ANSM, are ongoing to prolong the ATU for several months.
Joly said Gilead had provided Yescarta for free since the beginning of the cohort ATU five months ago. “In 2019, we will move to a paying model for the post-ATU" period, with a price of €350,000 per patient, he said.
Novartis set a cohort ATU price of €320,000 per patient, APM learnt from corroborative sources.
Pharma companies have to pay back retroactive discounts if the final price obtained by France’s healthcare products pricing committee (CEPS) once the product is approved is less than the price charged by the pharma when the product is in the ATU/post-ATU period.
Price negotiations in 2019
Yescarta and Kymriah have already been evaluated by France’s Transparency Commission (CT), the body which makes reimbursement recommendations and gives therapeutic value ratings, ahead of the drugs being reimbursed in France. The first was found to have moderate additional therapeutic value (ASMR III) (APMHE 60995
) and the second was found to have ASMR III and minor additional therapeutic value (ASMR IV) (APMHE 61117
Now opinions from France’s economic and public health evaluation committee (Ceesp) are expected. Joly said that the opinion for Yescarta is likely to be published “in the upcoming weeks”, which will mean price negotiations with CEPS can start in 2019.
Joly noted that the €350,000 price was a “starting price” for discussions with CEPS, which notably reflects the positive 24-month follow-up data from the ZUMA-1 trial, presented at the beginning of December at the American Society of Haematology (ASH) congress (APMHE 60862
). “Half of patients were still alive, compared to a life expectancy of six months [for patients] at a therapeutic dead end,” Joly said.
“Yescarta concerns a number of quite weak patients. So, the budgetary impact is minimal, less than 0.5% of the cost of managing cancers,” he added.
Five qualified prescribing centres
The first patient (49 years old) was subject to the ATU in July and treated at the beginning of September at the Saint-Louis hospital in Paris (part of the AP-HP Paris hospital group), according to a synthesis report published online by ANSM. About 30 patients are now subject to it, said the head of Gilead France.
CAR-T drugs are ‘one-off’ drugs created using patients' own blood cells, which means they have to be harvested (through apheresis), sent to a production centre then infused back into patients in a healthcare centre, after the patient has received lymphodepletive chemotherapy.
These centres must be certified by the European Medicines Agency. They must have an intensive care department, because of the serious adverse events that arise after infusion.
Saint-Louis hospital was the first site to be certified by Gilead, followed by the Nantes, Lille and Montpellier university hospitals and by the Paoli-Calmettes Institute (IPC) in Marseille. “We hope to finish the year with a new centre,” said Joly. “Our aim is to cover the whole territory,” he added, emphasising the aim of having 15 to 20 certified centres in 2019.
He pointed out that France's national cancer institute INCa and France’s care management body DGOS are working on their own approval criteria healthcare centres need to meet to prescribe CAR-Ts (APMHE 60011
Given the numerous stages in the drug’s manufacturing process and the often critical state of patients, the CAR-T manufacturing process needs to be as short as possible.
Under the ATU, the process took 28 days between apheresis and the healthcare centre getting Yescarta. In the U.S., where production takes place, the process requires 17 days.
To reduce the length of time the process takes in Europe, a production site is being built in the Netherlands, and should be operational in 2020. Joly said that Gilead wants to shorten the recorded month-long production time by a week. “It’s possible and it’s a crucial element for patients,” he said.