The Directorate of Health Care Supply (DGOS), the Directorate of Social Security (DSS), the Directorate General for Health (DGS) and the National Union of Health Insurance Funds (Uncam) published an order 12 October 2017 to require the Regional Health Agencies (ARSs) to promote the use of biosimilar drugs (the “Order”).
Like generic pharmaceuticals, biosimilars are cheaper than the breakthrough biologic and have therefore been quickly embraced by governments seeking to reduce costs to their healthcare systems. But the use of a ministerial order that would clearly promote the prescription of biosimilars appears rather unusual.
I. The last piece of a progressive update of the French health system in favor of biosimilar drugs
Biosimilar drugs have been defined in the Public health code through the Law No 2007-248 dated 26 February 2007 relating to the adaptation to the EU legislation with regard to medicinal products.
The substitutability of biosimilars is addressed in article 47 of the Law No 2013-1203 relating to the Social Security funding for 2014 (at articles L. 5125-23-2 and L. 5125-23-3). Pursuant to this law, pharmacists were authorized to substitute a biosimilar only at the initiation phase of the treatment, to ensure continuity of treatment. While the law provided for the adoption of a decree that would detail the conditions under which substitution would be permitted, such a decree was never adopted.
The new Law No 2016-1827 relating to the Social Security funding for 2017 went one step further. Following the ANSM’s position on biosimilars, strict continuity of treatment was no longer sustainable, and the new law softens the approach by allowing substitution even after treatment had begun with another product.
However, despite these new changes, biosimilars’penetration rate was still insufficient to significantly reduce Social Security expenditures, representing only 10.6% of all biological drugs as of March 2017. It was in this context, and with the intent to increase substitution and market penetration of biosimilars within the French health system, that the Order was adopted.
II. An explicit fostering of biosimilars use
The Order begins from the premise that the efficacy and safety of biosimilars is equivalent to biologics and allow substitution of biosimilars at any time during a patient’s course of therapy.
The Order also notes that the law requires that both biologics and biosimilars be prescribed the same way, physicians be provided with similar types of information for both, and the efficacy and safety of both are equally traceable. The Order demonstrates that there is no additional burden in prescribing a biosimilar.
The local health agencies (ARS) are asked to disseminate this message on a local level, through informational and promotional campaigns. As such, the ARS are invited to take various actions to promote the use of biosimilars, such as providing patients with information brochures on biosimilars, harmonizing prescribers’ practices in favor of biosimilars, providing assistance to hospitals in the organization of tenders, developing financial tools to enable the hospitals to calculate the savings inherent in prescribing biosimilars. The Order also encourages hospitals to launch competitive public tenders as soon as a biosimilar is available, which means that ongoing markets might be terminated early.
More importantly, hospitals are also asked to draw an action plan and assign quantitative targets by 1st March 2018, the aim being to reach 70% of all prescriptions for biologics are biosimilars, through renegotiation of the quality and efficiency contracts entered into with each hospital.
The Order, which strongly favors prescription of biosimilars, overlooks both the pioneering efforts of firms that develop innovative biologics as well as the practical matter that these firms may, in fact, reduce the cost of these biologics upon the introduction of biosimilars through significant price cuts and commercial rebates.
The way this instruction will be implemented will be even more crucial in a context where contracts entered into between ARS and hospitals might lead to financial sanctions imposed on hospitals by the Social security such as decrease in reimbursement rates, if they do not meet the targets for the prescription of biosimilars.