By Priyanka Kiritharan, Analyst
Email: [email protected]
Last month, France’s HTA body; Haute Autorite De Sante (HAS) changed its criteria that triggers the cost-effectiveness evaluation of products claiming ASMR levels I, II or III, which will come into effect from 1st January 2023 . The changes have been made to articles 1-4 of the current criteria; defined by the HAS board, in 2013 , which will become redundant once the new criteria are implemented.
The first change to article 1, states that HAS will consider the figure of estimated or recorded business, ’in the indication concerned’ by the request, rather than ‘all indications together’, thus a breakdown in projected sales for each indication is required. In addition, the HAS board will also consider drug’s forecast based on pre-tax sales as opposed to non-tax inclusive sales in the indication of interest.
Changes to the second article lists all the new information required to be submitted to HAS when filing for a reimbursement request. These are as follows:
- its claims concerning the impact on the organisation of care, professional practices or the conditions of care the conditions of care for patients;
- an estimate of the forecast sales per year over 3 years, in the case of a first registration, or the sales observed, in the case of renewal of registration;
- an estimate of the projected population per year over three years, , in the case of initial registration, or the population reached per year over three years, in the case of registration renewal.
Pharma companies must pay close attention to points (2) and (3). While the estimated forecast sales and projected population over 3 years will provide HAS a better understanding of the long-term budget impact, the new criterion highlights that information ‘transmitted to HAS, in particular that relating to turnover and the population reach, must correspond to the information transmitted to CEPS’ . With this new change in place, pharma companies are expected to be more transparent with regards to their budget impact model to ensure that there is an alignment between the positioning strategy and the budget impact, for the target population that pharma companies are seeking reimbursement for. Regarding point (1), there will need to be further clarification on how these impacts will be captured and to what degree these will have on the final decision.
Additionally, health economic evaluation will be required, per article 3 as follows:
- if the product concerned is an advanced therapy medicinal product (ATMP), professional practices or the conditions of patient care, OR
- if the sales are ≥ €20 million per year excluding tax, OR
- if the company claims an impact on the organisation of care, professional practices or the conditions of patient care.
Ultimately, changes to article 3 means that HAS have expanded the number of drugs that will require a cost-effective model to be submitted, particularly high budget impact drugs such as ATMPs.
ASMR (added clinical benefit) ratings are the ultimate driver and the deciding factor of HTA outcomes in France. Nevertheless, the Economic and Public Health Commission Committee (CEESP) are responsible for cost-effectiveness evaluations and can influence pricing decisions, and therefore the price potential of ATMPs. With the new clauses in place, pharma companies will be expected to submit a cost-effectiveness model for high budget impact ATMPs that do not display an added clinical benefit.
Finally, the changes made to article 4 are as follows:
As an exception, health economic evaluation is not required:
- where the medicinal product is not protected by any patent or supplementary protection certificate; OR
- where the application concerns an extension of the paediatric indication for which the indication in adults is already reimbursed; OR
- when the application concerns an extension of the indication that leads to an increase in the treated population of less than 5% over 2 years.
The implementation of the exemption criterion within the cost-effectiveness criteria is good news for pharma companies who are seeking to expand their label from adult to paediatric populations. Typically, data to show cost-effectiveness for paediatric orphan drugs may be limited. Therefore, this new exemption criteria can potentially facilitate accelerated reimbursement decisions for paediatric extensions, as no cost-effectiveness model is required – a win-win for both patients and pharma companies.
Overall, the new clauses to the pharmacoeconomic evaluation criteria expands the budget impact modelling horizon and the number of drugs that will be subjected to cost-effectiveness evaluation. P4A will be closely monitoring the status of the cost-effectiveness criteria and the implications that these changes may have on orphan drugs or ATMPs once these changes come into effect.
- Microsoft Word – DC_2022_0212_SED_SEM_Décision_éligilibilité_médico_économique_CD_20220623_VD (has-sante.fr)
- High Authority of Health – Decision n ° 2013.0111/DC/ SEESP of 18 September 2013 of the college of the HAS relating to the significant impact on the expenses of the health insurance triggering the medico-economic evaluation of the products claiming an ASMR or an ASA of levels I, II or III (has-sante.fr)