by Edouard Hubert

PARIS, Mar 9 (APM) - The Equipment and Health Products Agency of the AP-HP Paris Hospital group has decided not to make a distinction between Merck Sharp & Dohme’s Remicade (infliximab) and its biosimilar versions in the calls for tenders it launches, APM has learned from corroborating sources.

The Agence générale des équipements et produits de santé (AGEPS) made the decision after Remicade faced competition from biosimilars such as Servier-group member Biogaran’s Remsima and Hospira’s Inflectra.

The biosimilars have obtained indications identical to those of the reference drug, in rheumatology (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) gastroenterology (Crohn’s disease, ulcerative colitis) and in dermatology (psoriasis).

A debate emerged in France on interchangeability between Remicade and its biosimilar versions. The social security funding law (LFSS) for 2014 set up a substitution right for pharmacists - though without specifying whether this refers only to the community pharmacist or to any pharmacist dispensing drugs - in favour of biosimilars, but only in treatment initiation. The application decree has not been published yet.

A care management body circular that could ask hospital pharmacies to stand ready to dispense a reference drug and its biosimilars has also been mentioned, but has not yet been published, either.

For a drug only dispensed in hospitals such as Remicade, for which the patent fell into the public domain in mid-February, there was the issue of knowing what attitude purchasing bodies would adopt: whether they would purchase a single infliximab or whether they would purchase two - Remicade for patients already under treatment, and Remicade or one of its biosimilars to use in case of treatment initiation (APMMA 41502).

APM research has found the two main hospital procurement agencies, AGEPS (for AP-HP) and the Union des hôpitaux pour les achats - UniHA - Hospital procurement union groupement de cooperation sanitaire - GCS - health co-operation grouping made opposite choices.

In an e-mail to APM, AP-HP said it “published a consultation on February 12 on competitive bidding for the infliximab proprietary medicine (Remicade) with the two biosimilars (Remsima and Inflectra) and retained a single drug”.

“This consultation follows on from the experts’ consensus on the three relevant AP-HP medical disciplines validated by the central drug commission. The consensus concluded on the therapeutic equivalence of Remicade with the biosimilar versions arriving on the market,” AP-HP added.

It said this therapeutic equivalence “complies with the law and the indications in the marketing authorisation” and considers it is important to “clearly distinguish between the ban concerning community pharmacists’ substitution terms and conditions (essentially in cases of initial prescription, namely treatment initiation) and hospital prescription to which these various provisions do not apply”.

Nevertheless, in an inventory of biosimilars published in September 2013, France’s drug regulator ANSM recommended “treating, as far as possible, a particular patient with the same drug without making changes within a particular biosimilar family,” (APMMA 35712).

Whereas AP-HP acknowledges its consultation “relies on the principle of interchangeability between the proprietary medicine and biosimilars for already-treated patients,” it says it “plans, however, in medically justified exceptional clinical settings, the possibility of maintaining the initial treatment, in view of the fact that Remicade prescription is seldom an emergency situation”.

It does not provide details on these “exceptional clinical settings” nor does it specify the proportion of patients likely to be concerned (by them).

AP-HP has a supply of Remicade to last through to the end of the year, within the framework of the end of a previous tender.

Finally, AP-HP says its decision is part of its “consistent strategy” aiming to “privilege the notion of therapeutic equivalence on the basis of expert groups’ opinions in each discipline wherever possible”.

It was not able to specify AGEPS annual expenditure on Remicade.

AP-HP is part of UniHA, which does not wish to participate in the joint call for tender for infliximab and is the largest central purchasing body in France.

Contary to AP-HP, UniHA decided to launch a call for tender with two batches, one for already-treated patients (approximately 75% of the volume) and another for treatment-naïve patients (approximately 25%), its deputy director general Julie Bourgueil told APM on Friday.

Already treated patients will receive Remicade with no discount, while treatment naive patients will receive the biosimilar, with a large but undisclosed discount.

“Our strategy has been to work closely with the prescribers and we have chosen to proceed progressively,” she reported. The calls for tender, due to end on May 31, are for one year, renewable.

The strategy covers 50 hospitals, including almost all the University hospitals, said Bourgeuil.

“We could not allow ourselves to launch a call for tender with a single batch for so many hospitals, knowing that the members’ reflection process on (infliximab) prescription is more or less mature. In a trial run, we cannot run this risk”.

Bourgeuil added that the strategy allowed for a high volume of infliximab at a favourable price, but gave no further details.

But Hospira mentioned price reductions in comparison with the reference price, already reduced by 10% at end 2014 by the French economic committee for health products - CEPS, that can reach up to 30%.

UniHA foresees the infliximab biosimilar market will progress owing to renewal in patients who have been started off on biosimilar treatment, and if prescribers accept interchangeability among infliximabs.

In its monthly newsletter of October 2014, UniHA provided an estimate of its savings objectives, while warning these are difficult to put into accurate figures, particularly owing to the level of adherence of prescribers.

Based on a “treatable perimeter” of 70 million euros per year, gain for the first year was estimated at one million, with substitution limited to new patients in rheumatology (7.7 million euros taking into account the price reduction that came into force on November 1 2014).

“Next, as clinical data build up, including results of clinical trials performed in gastroenterology and of the ‘switches’ in rheumatology, it is likely the substitution perimeter will be extended first to all of rheumatology (gain increased by 6.3 million euros), then to gastroenterology (gains increased by 21 million euros),” UniHA said.

eh/aki/rs