Although in 2013 France was the first European country to allow biosimilars substitution (albeit under certain conditions), in the absence of an implementing decree detailing the conditions for substitution and what information should be delivered to physicians, the new rules have not had their expected effect.
Given the difficulty of drafting and passing the decree, the government is increasing alternative routes to foster the use of biosimilars. The issue has become a priority following the recent launch of a new generation of biosimilars. Whereas, over the last couple of years, biosimilars were used in hospitals only, they have now reached therapeutic areas where treatments are prescribed in hospitals but dispensed by community pharmacies. This significantly increases the volumes concerned and raises the question of substitution in community pharmacies, whereas dispensation in hospitals focusses on interchangeability, in the hands of physicians prescribing the drug.
I. Uncertainties around enforceability of substitution
Article L. 5125-23-3 of the public health code lists four conditions under which “the pharmacist can dispense, by substitution to the biological medicine prescribed, a similar biological medicine”: (i) substitution has not been excluded by the prescriber, (ii) the medicine substituted is registered in the repertoire listing similar biologic groups, (iii) it is available for initiation of treatment or for consistency purposes and (iv) finally it should not create additional costs for the social security system. Nevertheless, the article also refers to a decree to further detail the conditions for the substitution and the information delivered to physicians.
The decree was expected by June 2015. Some stakeholders argue that after four years, biosimilar substitution should be directly applicable as the main conditions are already known. However, the Legislator has since twice amended article L. 5125-23-3, in 2016 and in 2018, without removing the reference to the decree.
Moreover, several public health authorities, including the National Agency for Medicines and Health Products Safety (l’Agence nationale de sécurité du médicament et des produits de santé or ANSM) and the French Health Authority (HAS) have positioned themselves against substitution without a decree: “the substitution by the pharmacist, in the context of the supply of a biological medicine by another mentioned on the list of biosimilar medicines elaborated by the ANSM, is not possible at this stage, in the absence of an implementing decree.”
II. Promotion of biosimilars by incentive schemes
Pending a decree for the effective implementation of substitution, and to address situations where substitution would in any case not apply because the products were dispensed only in hospitals, the French government has nonetheless found ways to foster the use of biosimilars with the view to reduce public spending.
Firstly, every hospital must enter into a contract with its local health authority (ARS) that sets forth several goals (CAQES), notably to purchase and prescribe biosimilars. The template agreement also provides for a commitment to reach a minimum level of prescription for biosimilars prescribed in hospital but delivered in community pharmacies. An instruction by the Minister of Health and the Minister of Budget dated 3 August 2017 fixes this rate at 70%.
Furthermore, within the parameters of experimentation allowed by the Social Security Financing Bill for 2018, a guideline dated 19 February 2018 and an order of 3 August 2018 put in place two types of financial incentives for hospitals which reach a certain level of prescription of biosimilars dispensed within their district. Each hospital which has entered into a CAQES will receive a markup corresponding to 20% of the price difference between the originator and the biosimilar for the proportion of its total prescription using biosimilars (whether in hospitals or in community pharmacies). The same mechanism also applies at the level of therapeutic units for 45 selected hospitals, in order to assess whether this has an influence on the level of prescription of biosimilars. For the moment, this only concerns etanercept and insulin glargine, but the scope may be broadened at any time.
Finally, Article 66 of the Social Security Financing Bill for 2019 provides for a new scheme granting hospitals financial incentives for the prescription of biosimilars dispensed in community pharmacies.
In the context of cost reduction and a focus on financing innovation, the Government’s decision to encourage the use of biosimilars is not contestable as such. However, implementation through multiple orders and guidelines makes the scheme opaque and difficult to understand.
Moreover, the mechanisms put in place foster the use of biosimilars solely because they pertain to this category of products, regardless of their price and rebates. As such, it might lead to distortion of competition with regards to originators who are also able to grant rebates.
This results in a real pressure on hospitals and physicians to prescribe biosimilars, which conflicts with the freedom to prescribe inherent to the art of medicine, and the financial independence that physicians must have, especially in regards to prescriptions.
It is evident that when it comes to biosimilars, physicians are at the heart of the system. Whereas substitution has proven efficient for generics, biosimilars might not go beyond interchangeability.