What is the future of innovative biomarker testing in France


In 2015, France had come up with a solution to enable fast adoption of innovative biomarker testing: the RHIN and Complementary lists of Innovative Acts outside Nomenclature, eligible to the MERRI03 fund, managed by DGOS (Direction Générale de l'Offre de Soin). Innovative biomarker tests included in these could be funded for up to three years with the possibility to extend the period for further two years.

In principle, RHIN would enable faster adoption while waiting for HAS (Haute Autorité de Santé) evaluation and the 3-years period would be used for collecting clinical data and outcomes to enable inclusion of a given test into the classical reimbursement via the statutory insurance as part of the National Insurance "NABM" list (Nomenclature for Acts in Medical Biology). The extra 2 years were for tests that still needed to collect further health economic information. The MERRI would be a fix envelop of 380M € and would cover 100% of the test.

In reality, as no molecular test were available at NABM, all of them were included at RHIN. The increasing number of biomarkers, the use of novel technologies and further tests that can guide treatment decision have put a big pressure on the MERRI fixed envelope, as new tests were constantly entering but no tests were exiting. As a result of an ever-increasing list, the fix envelope led to laboratories receiving less funding per test performed. Transferring tests from RHIN to the NABM could have released the pressure, yet, so far just BCR-ABL amplification test has made the transition and only in April 2021.

In 2018, this pressure led to the decision from DGOS to reduce critically the funding rate for innovative tests via the RIHN, which became just 50% of the tariff and reflect that the costs are almost the double of the fixed funding, which cannot increase.  Moreover, instead of providing funding directly to laboratories, fund start to be provided to the prescribing centers. The idea behind of this is that hospitals would then cover the remainder of the costs. This has a deep impact in the French testing landscape, leading to an increase of single gene testing and decrease of the use of NGS as a way for some hospitals to reduce the impact to their funds, which translated to a worse perspective for patients.

To address the decrease on funding, several labs in France have performed micro-costing studies to determine the real cost of NGS, taking into consideration all related aspects such as personnel, reagents, instruments, electricity, etc. The aim was to support the implementation by comparing the real cost of NGS over single gene approaches and also showing that NGS real cost can still be aligned to some extent with current funding.

As patient access inequalities have appeared across the country due to this closed envelope, several groups of experts (including GFCO, SFMPP, GGC and led by Unicancer and La Ligue Contre Le Cancer) have started to raise their voice to alert the government and the Ministry of Health of the current situation and call for the reform and improved coverage for biomarker testing, specially the molecular ones. Their recommendations, which are part of IGAS and IGES reports (two French inspection agencies), submitted recently to the Ministry of Health, have been also reiterated and reinforced during SFMPP2021 congress, showing the pressing and urgent need to implement the proposed changes, including:

·      the transfer as soon as possible of common test from RIHN list to NABM;

·      an increase of the RIHN fund;

·      a list of test to be evaluated by HAS;

·      the implementation of an ATU-like system for innovative acts;

·      a new RIHN process with a fixed period and HAS in charge of establishing real world evidences;

·      the support of NGS approaches integrating several acts;

·      the creation of a RIHN working group;

·      to draft the idea of a specific CDx fund;

·      to define new modalities for coding acts and link the act to the patient.

Some initial changes have been implemented including:

·      the creation of new Nomenclature Counsel "HCN" (Haut Conseil de Nomenclature) responsible for reviewing and updating the French code system (timeframe 2021-26)

·      the launch of a study by the INCa to uncover the innovative acts outside nomenclature in oncology and identify ways to improve funding, which will constitute the base for the reform of the RHIN.

·      the announcement of a new Healthcare Innovation 2030 plan. This 7-billion euro plan aims at creating a more innovative model, closer to the German one and review of RHIN, reimbursement and HTA are part of the plan.

Despite recent announcements, French pathologists have indicated that uncertainty towards the incorporation of new or innovative tests into RIHN funding will remain for a while, as well as the path for NABM is currently unclear. This is a challenge for different tests, including comprehensive NGS panels, liquid biopsy and others. Additionally, even if the plan started being reinforced, the next presidential election also cast a doubt on how much of the reform will/can be implemented. In the end, although ongoing changes in the French Healthcare system point toward expanding coverage and access to innovative biomarker tests, the near future of reimbursement for new tests has still many open questions.  It is important for both pharma and Dx companies to start navigating these new waters and understand how these changes can impact their strategy and the access of patients to testing.

Contact us to better understand how IPBA can help your precision medicine strategy and find alternatives to mitigate risks on market access and test availability.

Camille Garnier, PhD - cgarnier@ipbadvisors.com - Inflection Point Biomedical Advisors