On 17 August 2018, an order concerning a national experiment to incentivise hospital prescription of similar biological drugs (biosimilars) was published. The experiment is part of the health innovation programme provided for in Article L.162-31-1 of the Social Security Code and results from the 2018 Social Security Financing Bill, which allows the experimentation of novel methods of remuneration to: (i) sustain the efficiency of and access to the healthcare system; and (ii) encourage healthcare professionals to favour the prescription of biosimilars.
Given the current low penetration rate of biosimilars in France (less than 10%) and the pricing gap between biologics and biosimilars, the experiment seeks to find new ways of remuneration to favour the prescription of biosimilars in healthcare institutions that will be delivered at city pharmacies. Savings will be redistributed to fund expensive new treatments.
The project is led by the Healthcare Ministry and the National Health Insurance Fund (Cnam), which will select up to 40 projects on the basis of, in particular, the quality of the proposed incentivising scheme and the potential number of prescriptions. To participate in the project, healthcare institutions must comply with the specifications set out in the annex of the order, which require, for example:
- A description of the objective and purpose: the experiment is restricted to specific groups of medicines for which the biosimilars benefit from reimbursement and are delivered at city pharmacies (anti-TNT alpha etanercept and/or glargine insulin);
- The intended results and impact in terms of improvement of patient service, purchasing power vis-à-vis pharmaceutical companies, and efficiency of healthcare expenses;
- The project duration: a three-year-maximum period from the launch of the experiment (not before 1 October 2018), with evaluation taking place by the beginning of 2022;
- The territorial scope;
- Project participants: data on the leading healthcare institutions and/or services concerned, partners and the nature of collaboration;
- Test categories: novel financing, organisation or efficiency schemes;
- Rationale of the economic model and sustainability of the proposed financing scheme: number of patients, inclusion/exclusion criteria, financial estimate of the model;
- Financing mechanism of the project, including possible need for financial aid;
- Evaluation mechanisms to determine whether the novel financing scheme increases the penetration rate of biosimilars;
- Information gathered from patients concerned by the project (and modalities thereof).
Interested institutions must submit their proposals by 15 September 2018.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, August 2018 Issue (Thomson Reuters).