In the context of the pandemic, Decree No. 2020-1090 of 25 August 2020 on various measures relating to the reimbursement of health products (the “Decree”) could have been overseen as merely being a technical document.
Although it is far from groundbreaking, the Decree nonetheless marks a new shift in the paradigm of market access proceedings. Through the harmonization and simplification of the procedures for the reimbursement of health products (both pharmaceutical products and medical devices), it mainly offers health authorities more flexibility on the timing of assessments, and on the criteria for reassessments.
More flexible timing: the end of the five-year renewal requirement
The Decree reduces the scope and timeframe of the adversarial procedure that may be initiated whenever a price decrease, mandatory discount, or delisting is being contemplated. The entire procedure now has to take place within 45 days. Within this timeframe, the company is entitled to provide its written observations within 20 days and is only allowed 8 days following the notification of the contemplated decision to request a hearing. In addition, the company may no longer request a hearing if a decision to de-list a product or to further restrict the conditions of reimbursement is contemplated. The legality of this reduced timeframe for the adversarial procedure will certainly be challenged sooner or later at the administrative courts.
However, the biggest change probably lies in the removal of the emblematic five-year period for which medicinal products reimbursed are listed before needing to apply for the renewal of their listing.
Until the adoption of the Decree, registration on the list of medicinal products which are reimbursed (contrary to the registration on the list of medicinal products which are reimbursed and prescribed at hospitals), expired after five years. As a consequence, pharmaceutical establishments marketing products had to file an application for renewal no later than 180 days before the registration’s validity was due to expire.
Products can now remain on the list for an undetermined period.
But the Ministry may also delist any product which has not been marketed for one year.
In addition, it is also possible for the Ministry of Health, as well as for the Transparency Commission, to periodically reassess the reimbursement conditions at any time, and even potentially prior to a five-year period.
A reassessment may occur under various circumstances, an indicative (but not exhaustive) list of which is included in the Decree: (i) upon the listing of a competing product, (ii) following the update of the therapeutic strategy in light of new efficacy data, or (iii) in light of the financial burden of the product (either by itself or as part of an anticipated total cost of treatment).
In addition, the reassessment may not just concern (i) the therapeutic value of the product (SMR/ASMR) but may also encompass (ii) the listing criteria and conditions, as well as (iii) the target population.
In contrast with the increased demand for stability and foreseeability, the Decree instead paves the way for increased flexibility on the period when pricing and reimbursement measures can be reassessed, which allows the authorities to adapt more quickly to changing financial priorities.
Cementing the transparency commission’s current practices within the regulation
The Decree also increases the Transparency Commission’s leeway in the benchmarking of products’ therapeutic value.
The list of clinically relevant comparators extends to healthcare products and therapies beyond the scope of pharmaceutical products, as well as non-listed products, hence encompassing off-label use.
This aims at strengthening the legal ground of the Transparency Commission’s current practice, as stated in its doctrine of September 20181.
In the same way, the Decree introduces the long-awaited option for a conditional opinion from the Transparency Commission, alongside the Commission’s doctrine and HAS action plan for the assessment of innovative medicinal products dated 27 January 2020.
The Decree provides the Transparency Commission with the possibility of issuing conditional opinions, subject to the provision of additional data necessary for the subsequent reassessment of a medicinal product within a short timeframe. The Transparency Commission’s final opinion shall be issued within a maximum period of six months from the end of the conditional period.
However, there is a significant caveat: the Transparency Commission is entitled to de-list the product if additional data are not provided or deemed insufficient.
And in any case, the absence of conditional data has been added to the list of the price fixing criteria.
The French health authorities are now equipped with a pretty comprehensive arsenal to adapt market access conditions to a changing financial environment. It remains to be seen how these measures will play out, with the CEPS and the LEEM being expected to enter into a new framework agreement. The question remains whether this new regulation will significantly reduce the conventional approach, prominent in health products reimbursement.
1 HAS, Evaluation des médicaments – Doctrine de la commission de la transparence – Principes d’évaluations de la CT relatifs aux médicaments en vue de leur accès au remboursement, September 2018, p. 8: “a clinically ‘relevant’ comparator may be a medicinal product (active or placebo, with or without marketing authorization), medical device, procedure or any other non-drug therapy (or diagnostic method). It is at the same level of the therapeutic strategy as the new drug and is intended for the same patients”
