French Govt Calls For 70% Biosimilar Prescribing Rate; Substitution Groups Published
Executive Summary
Moves are under way in France to give the biosimilars market a shot in the arm by setting a 70% target for initial prescribing rates and encouraging pharmacist substitution through the creation of similar biological medicine groups.
The French authorities are making a concerted push to encourage the wider use of biosimilar medicines as a way of achieving savings on the drugs bill. The health ministry has asked doctors to aim for a biosimilar prescribing rate of at least 70%, and has created 11 biological medicine groups to make it easier for pharmacists to substitute a biosimilar for a prescribed reference drug.
The ministry said that increasing the use of biosimilars has numerous advantages, including widening the availability of biological medicines for a given disease, reducing the risk of supply chain interruptions, and increasing competition among similar products, for example through hospital tendering. The draft social security financing law for 2018, which was published in September, provides for expected savings of €40m next year from the wider use of biosimilars.
Achieving “rapid growth” in the rate of biosimilar prescribing is an important way of allowing the most recent therapeutic products to be reimbursed “while guaranteeing a level of efficacy and safety strictly comparable to that of reference biological products already on the market,” the ministry said in a circular issued last month.
The overall aim is to encourage the “systematic prescribing” of a biosimilar medicine, with the objective of starting 70% of new biological treatments with a biosimilar rather than with the reference biological medicine, according to the government. It also said that changing from a prescribed reference product to one of its biosimilars during treatment should be encouraged, and that when two equivalent therapeutic strategies are available, there should be a preference for “the most efficient from the medico-economic point of view, particularly when one of those strategies involves a biosimilar medicine.”
In hospitals, the aim is to encourage competition among drugs belonging to the same similar biological medicine group, with health establishments and purchasing groups taking steps to encourage competition as soon as biosimilars are available. Hospital doctors should preferably prescribe a biosimilar, again with a target minimum prescribing rate of 70%, and the biosimilar should continue to be given if treatment then continues under a general practitioner.
The health ministry has asked the country’s regional health agencies to take steps to reach these objectives, and to inform it of the actions they are planning for 2018. Examples of actions that can be taken, it says, are information brochures for health professionals, discussing biosimilars as part of continuing medical education, information campaigns by health insurance bodies, and giving hospitals the tools to allow them to calculate the savings achieved by using biosimilars.
New Biosimilar Substitution Groups
Meanwhile, pharmacists now have the benefit of a new register of 11 “similar biological medicine” groups containing the reference product and all its biosimilars. The groups, which have been created by the medicines regulator ANSM, cover the following substances (originator drug in parentheses): adalimumab (AbbVie’s Humira), enoxaparin (Sanofi’s Lovenox), epoetin (Janssen’s Eprex), etanercept (Amgen’s Enbrel), filgrastim (Amgen’s Neupogen), follitropin alfa (Merck KGaA’s Gonal-F), infliximab (Janssen’s Remicade), insulin glargine (Sanofi’s Lantus), rituximab (Roche’s MabThera), somatropin (Sandoz’ Genotonorm), and teriparatide (Lilly’s Forsteo). The groups contain a total of 39 products (the 11 originators and 28 biosimilars).
The rules on substitution have been in place for some time, having been enshrined in the 2017 social security financing Act that was adopted in December 2016.
That law stated that substitution of a reference product with a biosimilar can only take place within a product group and provided the doctor had not written “not substitutable”, and could happen either at the initiation of treatment or during treatment. Before that change, pharmacists could only substitute at the start of treatment. If a biosimilar product is substituted for a reference drug, treatment must then continue with that biosimilar – i.e., there should be no switching back and forth.
The change to the legislation was preceded by ANSM’s May 2016 decision to relax its stance on biosimilar interchangeability, which stated that while in principle patients should preferably not be switched between a reference drug and a biosimilar during treatment, this could be done provided the patient agrees and treatment is closely monitored. ANSM said at the time that in light of the growing body of experience and knowledge of the efficacy and safety of biosimilar medicines in the EU, "a position that formally excludes all interchangeability during a course of treatment no longer seems justified.” (Also see "France Relaxes Stance On Biosimilar Switching" - Pink Sheet, 6 May, 2016.)
The Question Of Excipients
The product group register also has links to a database of excipients with known effects (such as allergens). In order to guarantee “the highest level of safety it is useful to take into account the excipients with known effects when making a substitution,” bearing in mind that the reference product might contain excipients that are not present in the similar biological products (and vice versa), it says.
The database includes a range of products like aprotinine, aspartame, benzalkonium chloride, ethanol, lactose, mannitol, sesame oil, starch and so on.
Where the reference product does not contain one of the substances on the list, a biosimilar that also lacks that excipient should be chosen where possible, the government says. However, if a biosimilar contains one or more such excipients where the reference product does not, it can still be prescribed as long as it can be established there is no risk of the patient experiencing any adverse reactions.
From the editors of Scrip Regulatory Affairs.