PARIS, 28 Sep (APM) - Drug reimbursement in France may in future be conditional on real world data, the government says in the 2019 social security funding bill (PLFSS), a copy of which APM has received.

The outlines of the PLFSS were presented on Tuesday and include 58 articles.

Article 42, which is expected to come into effect on 1 March 2019, features several measures on drugs, including the extension of early access schemes (ATUs) to cover indication extensions and changes to the reimbursement of homeopathic products.

It also includes several changes relating to how healthcare products are priced and reimbursed.

“The reform of early access and the recent increased momentum in the drug spend, which is greater than in previous years, will also mean that new ways of negotiating reimbursement of healthcare products need to be found, and also new ways of monitoring them to ensure that they are used correctly in real world situations,” said the government in the article’s explanatory statement.

Article 42 stipulates that under a decree from the health and social security ministries, drug reimbursement and other potentially related services would be conditional on the transmission of information relating to patients treated, in the context of the prescription; on the indications that the drug or service is prescribed for; and on the results or effects of these treatments.

This information can be sent to the health insurance’s medical control services, to the French database covering the various health insurance schemes Sniiram and to the French medicalised information system programme PMSI.

Not respecting these obligations will lead to a procedure to claw back any undue payments.

It notes that adding a product to the list of drugs to be reimbursed in the community may involve “particular prescribing, dispensing or usage conditions, notably for the duration of reimbursement”.

Obligatory discounts for treatment combinations

In the explanatory statement for article 42, the government says that “the rise of immunotherapies and the use of treatment combinations, which are very promising in offering better treatment for certain complex and progressive diseases, mean that the tools and mechanisms CEPS [the French economic committee for health products] uses for negotiations need to be reviewed so as to allow it to better guarantee the sustainability of our reimbursement system.

“In fact, these combination treatments could lead to the health insurance doubling or tripling the cost of some reimbursements, and CEPS lacks leverage when combination drugs are marketed by different pharmaceutical companies.”

As a consequence of this, article 42 extends a measure under which CEPS sets obligatory discounts - which is currently applied to medical devices - to combination drugs, so as to facilitate the search for an agreement-based arrangement with all parties.

This measure will only apply if an agreement-based solution is not found with all parties, and it will respect the price-setting rules, if applicable under the scope of the drug framework-agreement (which expires at the end of December).

This means that under article 42, drug reimbursement may be conditional on pharma companies applying obligatory discounts. These discounts could concern a drug, or if applicable, a group of comparable drugs with similar therapeutic aims. The discounts would be able to take into account at least one of the criteria set out in article L162-16-4 of the social security code (the additional therapeutic benefit rating ASMR, medico-economic evaluation, sales volumes, conditions of use, how long a drug has been available), applied to net prices.

“These discounts are set under an agreement by the company marketing the drug and CEPS, or, by default, through a ruling, when the drug concerned or certain comparable drugs are likely to be used, at least in part, together with or after other drugs,” the article says.

CEPS’s latest mission statement, which will soon be sent to its chair, asks the body to look for “ambitious agreement-based solutions” with the aim of implementing a new pricing system for treatment combinations (APMMA 59842).

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