France’s Health Innovation 2030 Plan Proposes to Adopt a Market Access Pathway Like the German System to Accelerate Patient Access to Innovative Medicines – What Changes Can Be Expected?

The average time to patient access in France can exceed 500 days which is comparatively longer than other key EU markets (Figure 1)³. Over the years, the pricing and reimbursement processes have lengthened which has meant that hospitals may need several years to find funding for certain treatments and in some cases some hospitals do not get access to expensive therapies at all¹. This affects patient benefit which can cause loss of years of life and quality of life.

Identifying the current access framework as a root cause for delays in patient access to innovative treatments, on June 29 the French government announced a new plan which will aim to radically reform the current framework, following the German system as an example¹.

In its initiative which forms part of France’s €7B Health Innovation 2030 plan¹, the French government has proposed to establish a system which will provide immediate market access to all products that receive an “Improvement in Actual Medical Benefit” (IAMB / ASMR) rating of I to IV from the French National Health Authority (HAS), with a 2-years test period for the new medicines¹.

We discuss below what changes can be expected to the access landscape in France, comparing this with the current framework in Germany.

The Current Market Access Framework in France

After receiving marketing authorization, the reimbursement procedure for including innovative medicines on a positive list of reimbursed products would involve the steps below, with the launch delayed until after the pricing negotiation processes have completed (Figure 2)^4-6:

• HTA Evaluation: The Transparency Commission (TC) of HAS conducts a health technology assessment to determine if a drug should be reimbursed and provides ratings based on medical benefit (Service Médical Rendu: SMR) and therapeutic improvement compared to the standard of care (Amélioration du Service Médical Rendu: ASMR). While the SMR rating determines the level of reimbursement, the ASMR rating is the basis for pricing negotiations.

The consequences of ASMR rating are as follows:

• • ASMR I, II or III (Major/Significant/Moderate improvement): Faster access (price notification instead of negotiation) and price consistent with European ones. However, ASMR I – III ratings are rarely given out.
  • ASMR IV (Minor improvement): Price at comparator price, unless the drug is more effective in a restricted population
  • ASMR V (No improvement) – Price less than comparator

• Pharmaco-economic evaluation: If the manufacturer claims an ASMR rating of I-III for the drug in the TC dossier and the drug’s cost is expected to have a significant impact on the healthcare budget (more than €20M annual sales) then a cost-effectiveness dossier must be submitted to HAS’s Economic and Public Health Committee (CEESP) which will provide an economic opinion to the pricing committee⁸.

• Pricing: The prices of reimbursable medicines are negotiated with the Economic Committee of Health Products (CEPS) based on the level of added benefit (ASMR) and CEESP’s opinion. The reimbursement rate is then fixed by a decision from Nationale des Caisses d’Assurance Maladie (UNCAM) health insurance agency primarily based on SMR. The final price is approved by the Ministry of Health.

Factors Contributing to Delayed Launch of Innovative Medicines in France

While EU’s Transparency Directive (89/105/EEC)⁷ requires pricing and reimbursement (P&R) decisions to be made within a specific timeframe (90-180 days), the processes involved usually take longer consequently delaying the launch of innovative drugs.

According to HAS’s 2020 annual report, the TC committee have been meeting close to their target timeline of 90 days, with the evaluations requiring an average of 105.5 days from the validation of the file submitted by the manufacturer until the delivery of the final opinion¹⁰.

However, CEESP’s pharmacoeconomic evaluation process could be a source of delay, with the average time taken for an evaluation in 2020 reported to be 161 days¹¹. For innovative drugs, usually associated with high costs and hence can have a significant effect on the healthcare budget, CEESP’s opinion has become an additional consideration for the price-setting.

Following this, innovative medicines can be subjected to extended price negotiations with CEPS, which is a key source of delay. With manufacturers facing increased pressure to prove cost-effectiveness against comparators and more price scrutiny because of it – and manufacturers themselves aiming to achieve value they deem right – this process in some cases can extend to years.

Expected Changes to France’s Market Access Framework, Adapting One Like the German System

With the new plan, the following changes can be expected to the reimbursement procedure, dependent on the ASMR rating awarded by HAS:

ASMR I to IV: Drugs getting a rating of I to IV can be expected to receive direct reimbursement with further evaluation of the value-based price proceeding in the background (Figure 3a). This can significantly shorten the time to patient access.

In Germany, new products are launched right after marketing authorization with the manufacturer allowed to set the price in the first 12 months (Figure 3b). During this period, the drug undergoes a benefit assessment by the G-BA and then the manufacturer proceeds with price negotiation with the National Association of Statutory Health Insurance Funds (GKV). Based on this framework, the average time to patient access has been reported to be around 120 days (Figure 1).

Adopting such a system will mean patients do not have to wait for potentially lifesaving therapies which can otherwise be delayed if there are delays in pharmaco-economic evaluation and price negotiations.

ASMR of V: Drugs receiving a ASMR of V (no therapeutic improvement) can be expected to go through the current route where the manufacturer will proceed to negotiating price with CEPS after receiving a decision from HAS (Figure 3a).

For those drugs which HAS judge to show no therapeutic improvement over comparators, manufacturers will need to negotiate price with CEPS as drugs can be listed only if their price is less than the comparators.

HAS’s ASMR scoring encapsulates both the existence of a medical benefit and then quantifies the extent of it, which indicates this process is less agile overall. With the reform focusing on accelerating the time to access, a full revamp of the ASMR process or reimbursement based on the SMR could have been considered.

There is currently no clarity as to how the incremental benefit could be linked with pricing. It remains to be seen whether pharmaco-economic evaluation will continue to be a requirement for price negotiations, or the French may opt for a system more like the German system where the manufacturer is able to enter price negotiations with the GKV-Spitzenverband (government health insurance system) as soon receiving a positive verdict from the G-BA. In Germany, pharmaco-economics is not used in the early benefit assessment process. It is reserved for situations where no agreement can be reached between the manufacturer and the GKV after price negotiations and the intervention of an arbitration board has not helped resolve the dispute. At this point a cost-benefit assessment can be requested by the manufacturer or the GKV to be conducted by IQWiG⁵. However, no such request has been made to date⁵.

Given the current struggle to comply with EU’s Transparency Directive, it remains to be seen whether the French government will be able to deliver on its plan. If the plan is implemented, faster market access can provide increased commercial success to manufacturers of innovative medicines.

References

1. https://www.gouvernement.fr/sites/default/files/contenu/piece-jointe/2021/06/sante_innov30_a4_07_vdefdp.pdf
2. https://www.elysee.fr/admin/upload/default/0001/10/878189f8b95f7905f5b4ecf540701a425e615cdf.pdf
3. https://www.efpia.eu/media/602652/efpia-patient-wait-indicator-final-250521.pdf
4. https://www.has-sante.fr/upload/docs/application/pdf/2014-03/pricing_reimbursement_of_drugs_and_hta_policies_in_france.pdf
5. https://ihsmarkit.com/index.html
6. https://www.has-sante.fr/jcms/c_1647592/fr/decision-n2013-0111/dc/seesp-du-18-septembre-2013-du-college-de-la-has-relatif-a-l-impact-significatif-sur-les-depenses-de-l-assurance-maladie-declenchant-l-evaluation-medico-economique-des-produits-revendiquant-une-asmr-ou-une-asa-de-niveaux-i-ii-ou-iii
7. https://uk.practicallaw.thomsonreuters.com/PLCCoreDocument/ViewDocument.html?DocumentGuid=I4cdf80b0eeb711e698dc8b09b4f043e0&ViewType=FullText&HasDraftingNotes=False&ResearchReportViewMode=False&SessionScopeIsValid=True&IsCourtWireDocument=False&IsSuperPrivateDocument=False&IsPrivateDocument=False&ClientMatter=Cobalt.Website.Platform.Web.UserData.ClientMatter&AuthenticationStrength=0&IsMedLitStubDocument=False&IsOutOfPlanDocumentViewClicked=False&TransitionType=Default&ContextData=(sc.Default)&BillingContextData=(sc.Default)&firstPage=true
8. https://europepmc.org/article/med/27123173
9. High Authority of Health – Medicines: processing times for access to reimbursement files (has-sante.fr)
10. https://www.has-sante.fr/upload/docs/application/pdf/2021-06/ra_2020_ct_vdef.pdf
11. https://www.has-sante.fr/upload/docs/application/pdf/2021-06/ra_2020_ceesp-vdef.pdf