PARIS, Feb 17 (APM) - Pharmacists in France will be able to substitute an initial Remicade (infliximab) prescription for the newly-launched biosimilar, although debate continues around which pharmacists will have the right to do so.
According to Jean-Etienne Allain, head of Hospira France’s biologicals, this will be able to be done by community pharmacists - despite IV-administered Remicade only being available in hospitals.
Speaking to APM on Monday, he also said there should be calls in French hospitals not only for treatment-naive patients, but also pre-treated patients to receive a biosimilar of the anti-TNF. However, this is not written into the new substitution law and studies are ongoing into the risks and benefits of switching to biosimilar treatment. (APMMA 40770)
Under Article 47 in France's 2014 social security funding law (LFSS), pharmacists have been granted substitution rights for biosimilars at start of treatment, but there continues to be debate on how and where this can be implemented.
According to Allain, this provision essentially concerns pharmacy-level substitution in “the community” but said it can also be done in hospital “via a market change” - something that has yet to be clarified by the law.
Since midnight on Friday, Hospira’s Inflectra and Servier group-member Biogaran’s Remsima, both developed and produced by Korean company Celltrion, can be marketed in France following European approval in September 2013.
These are the first biosimilars of a monoclonal antibody to be approved in Europe and have both been launched this week priced at around 30% less than Johnson & Johnson/Merck & Co’ Remicade. (APMMA 41482) (APMMA 41485)
During an afternoon debate on biosimilars organised at the end of January by the parliamentary office for the evaluation of scientific and technical choices (OPECST), François Chast, head of the clinical pharmacy department at the Cochin hospital (a member of the Paris group of hospitals, AP-HP) reported on a study at AP-HP on the interchangeability between Remicade and its biosimilars.
“Forty-eight hours ago, I was at a gastroenterology, rheumatology and oncology specialists’ meeting within the Paris hospitals,” he said, on January 29. “At the moment, we are heading towards an interchangeability decision within the Paris hospitals on this first drug, infliximab that will be available. I think it is appropriate to speak of a wide substitution right,” he had continued.
Nevertheless, his point of view stood out as very much in the minority among the speakers at the meeting.
“Pretty generally, we are heading towards a situation where (in the calls for patients) there will be a those who are treatment naïve and those who are pre-treated patients,” Allain told APM on Monday.
He added that treatment-naïve patients - the only group that will be the subject of true competition among the biosimilars companies - might account for between 20% and 25% of the patients, in infliximab indications in gastroenterology (Crohn’s disease and ulcerative colitis).
In its rheumatology indications (rheumatoid arthritis, ankylosing spondylitis, etc.), Remicade already has strong competition from other drugs that reached the market more recently and are easier to administer.
“Initially, prescribers will want to get their hand in,” with biosimilars, to “get an idea” of their efficacy, the head of Hospira said.
Allain declined to comment on rebate levels Hospira is preparing to grant in the hospital tenders, pointing out that “according to the literature” the discount range is between 20% and 30%.
At the end of January, the French economic committee for health products (CEPS) set the selling price to hospitals (the price at which it is reimbursed to hospitals) at 434.40 euros for a 20 ml vial (APMMA 41242).
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