News Alert: France PLFSS 2022 Widens Scope for Drug Reimbursement, Increases Temporary Access Options

PRICENTRIC BRIEF: 

  • The French Government has unveiled the social security financing bill (PLFSS) for 2022, containing plans regarding expenditureS linked to COVID-19, a continuation of the Ségur de la santé, and the forecast of a social deficit of more than EUR 21 billion.
  • Presented to the Council of Ministers on October 7, 2021, the PLFSS is once again heavily impacted by the ongoing effects of COVID-19. According to the document, COVID-19 is expected to cost nearly EUR 5 billion in 2022, a substantially lower figure than 15 billion in 2021 and 18 billion in 2020.
  • Going forward, the French government is proposing a new system of access to transitional reimbursement and temporary one-year access to guarantee rapid access to innovation while requiring companies to provide the data necessary to further assess reimbursement of the drug. This is in addition to the already existing Authorized Temporary Use (ATU) schemes in place in France.

THE DETAILS : 

PARIS, France— The French Government has unveiled the social security financing bill (PLFSS) for 2022, containing plans regarding expenditure linked to COVID-19, a continuation of the Ségur de la santé and the forecast of a social deficit of more than EUR 21 billion.

Presented to the Council of Ministers on October 7, 2021, the PLFSS is once again heavily impacted by the ongoing effects of COVID.

According to the document, COVID-19 is expected to cost nearly EUR 5 billion in 2022, a substantially lower figure than 15 billion in 2021 and 18 billion in 2020.

However, the government noted on the release of the bill how this provision, due to the purchase of tests, vaccines et cetera, would likely change in the event of a resumption of the pandemic, as was the case for the 2021 PLFSS.

The full text can be found here.

Healthcare Expenditure

The continuation of the Ségur de la santé is expected to add EUR 2.7 billion in the PLFSS, in order to fund essentially the upgrading of nursing staff and the medico-social sector.

The national health insurance expenditure target (ONDAM) is, for the first time in its history, on a negative trend (-0.6%), headed to 236.3 billion euros in 2022. However, excluding related expenditure to COVID-19 and to the health sector, the ONDAM will be up +2.6%, increasing by 2.7% for the hospital sector. No savings will be required of hospitals.

This means that in 2022 health insurance spending will increase by EUR 8.4 billion compared to 2021, which represents an additional 28.8 billion compared to 2019 – excluding COVID-19 related expenses.

In 2022, the plan states that more than EUR 2 billion will be devoted to national support investment in health within the ONDAM:

  • EUR 500 M for the financing of investments, in particular the day-to-day health facilities.
  • EUR 384 M in financing excluding Ségur (mainly corresponding to last installments of funding dedicated to supporting projects of structuring investments within the framework of the Grand Investment Plan and of the remainder of the credits of the ex-COPERMO)
  • EUR 119 M for the development of the use of digital technology in hospitals;
  • EUR 440 M for the financing of investments in the medico-social field, to which are added EUR 100 M  for medico-social digital and EUR 30 M for the annual investment program (PAI) of the CNSA outside Ségur;
  • EUR 515 M for the financing of digital healthcare (excluding medico-social and hospital), including € 251 M for the city care sector in the form of an incentive financial support for the use of digital tools

On the release of the document, the government outlined key proposals of the bill going forward:

  • Free contraception for all women up to 25 years (today this support stops at 18);
  • Automatic allocation of complementary health insurance to beneficiaries of RSA and its facilitation for beneficiaries of minimum old age;
  • Easier access to visual care: orthoptists will be able to perform simple visual assessments without a prescription and prescribe glasses or contact lenses for weak corrections;
  • Generalize several experiments, such as those on the prevention of childhood obesity or HIV testing without a prescription;
  • Expand the scope of drugs fully reimbursed by Social Security and better financing of expensive drugs in hospitals;
  • Health insurance coverage of medical telemonitoring for chronic diseases;
  • 400 million euros for the elderly, after the creation of the 5th “autonomy” branch in 2020. The aim is to secure the funding of home help services. From January 1, 2022, a minimum rate of 22 euros per hour of service will be introduced for the personalized autonomy allowance (APA) at home;
  • Nearly EUR 145 million for the installation of reception solutions (financing of new places) and support for people with disabilities;
  • Real-time payments for individuals of the tax credit and social assistance related to personal services (home help, childcare, etc.).

Pricing & Reimbursement of Drugs

According to the PLFSS release, health insurance expenditure relating to health products such as drugs is expected to increase by EUR 1 bn in 2022, under the strategic council of health industries’ (CSIS) goal to make France the first European nation “innovative and sovereign in health.”

Going forward, the French government is proposing a new system of access to transitional reimbursement and temporary one-year access to guarantee rapid access to innovation while requiring companies to provide the data necessary to further assess reimbursement of the drug.

This is in addition to the already existing Authorized Temporary Use (ATU) schemes in place in France.

As noted by the PLFSS, the system will be reserved, after validation of technical criteria, for digital solutions presumed innovative telemonitoring as well as digital therapies also known as “digital therapeutics.”

Additionally, in order to improve the distribution of products with an actual benefit (SMR) or service expected (SA) rating that bring clinical improvement recognized by the Haute Health authority (HAS) – and which are not currently fully reimbursed –  there are plans to widen the scope of reimbursement by the 1st January 2022 to all health products that hold significant AB/SA/improvement of actual benefit/minor improvement of expected service.

Re-localizing Supply 

The PLFSS highlights how the government wishes to strengthen the consideration of the footprint industry in setting the prices of health products, in order to encourage increased production capacities locally.

Increasing local production of materials could help limit the risks of shortages and increase the security of supply of drugs to France’s market.

Earlier this year France backed domestic production following COVID-19, after its president, Emmanuel Macron, and Sanofi announced plans to bolster domestic production of medicines, as countries “scramble to strengthen their healthcare industries to counter the coronavirus pandemic.”

France is the latest in a line of countries to throw its weight behind local manufacturing, with Poland’s domestic drug manufacturers also recently emphasizing the need for production support mechanisms in Poland, in order to be able to compete with other European countries for a significant role in the new European “roadmap” strategy launched earlier this year.

G5 Sante

Parallel to the release of the PLFSS, the G5 Santé held a meeting calling for a “moratorium on the fall in the prices of drugs with a strong stake in health independence.”

The industry group, which is made up of bioMérieux, Guerbet, Ipsen, LFB, Pierre Fabre, Sanofi, Servier, and Théa, rejected the PLFSS’ proposals on drug pricing cuts, to enable France to be sovereign in terms of health.

The group noted that the cuts would entail laboratories to contribute EUR 825 million; “far from the stability of the amount of price reductions promised by the President of the Republic.”

In 2021, the government asked laboratories for funding of EUR 640 million – less than the EUR 920 million asked in 2020.

The extended scope of fully reimbursed drugs, as mentioned above, does however represent an additional cost of EUR 370 million for Social Security.

The G5 Santé welcomed a PLFSS proposal in which an industrial criterion in setting the price of medicines will now allow the geographical location of production sites to be taken into account. The group also called for European production to be favored during hospital tenders.

Finally, in terms of market access, manufacturers expressed at the meeting that they want to allow direct access to pharmaceutical innovations as soon as they obtain marketing authorization in Europe, as is currently the case in Germany.

 

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