PARIS, Dec 22 (APM) - A French report on drug monitoring in real life calls on the authorities to “build an overall strategy” for this, including by strengthening public-private partnerships and setting up a “strategic coordination body” for public institutions.
The report by Dominique Polton, president of the national health data institute (INDS); pharmacology professor Bernard Bégaud; and Franck von Lennep, former head of the Department of research, evaluation and statistics (Drees) and currently advisor to prime minister Edouard Philippe, was commissioned by former health minister Marisol Touraine.
On Tuesday, it was made public by current health minister Agnès Buzyn, who also announced the launch of a working group to implement its proposals (APMHE A56146).
The authors’ observations on the French situation are not particularly positive. “We should not idealise what is happening elsewhere in this area, but it is a fact that France is depriving itself of a tool that would at very least allow us to verify whether recommendations for use are complied with, and which, beyond this objective, represents a source of knowledge on diseases and care practices which is also useful for practitioners,” they said.
“France has its strong points but is not fully aware of what is at stake” concerning data sources, real life follow-up or use of data. The country was however “visionary” in its building of the database covering the various health insurance schemes (Sniiram), a “powerful” medico-administrative database that “still gives our country an advantage”.
However, there are “few important projects for establishing more extensive databases particularly databases including clinical data,” and any initiatives are all too often local and dispersed. This leaves the construction of databases linking information from patient files and collected by the various professionals “at the draft stage”.
Concerning real-life monitoring of treatment and use of these data for regulatory purposes, France “seems to remain outside of the movement developing in a growing number of countries” where reimbursement of certain drugs is accompanied on a compulsory basis by the collection and transmission of information by prescribers. The authors say the idea of recording prescription information is “uncommon among clinicians” in France.
“In fact, all these people are effectively carrying out or commissioning real life studies,” the authors emphasise. They list the organisations which use this kind of data - including health technology assessment body HAS - to draw up correct use and therapeutic strategy guidelines, and the French economic committee for health products CEPS, which may use it for setting prices with pharmaceutical companies, depending on contractual clauses.
’Limited value’ of current databases
An overview of French real-life studies and data sources shows their “great wealth of initiatives and achievement,” but the report goes on to talk about “a certain fragmentation and dispersion of effort”. Consequently, none of the stakeholders - the authorities, users, pharmaceutical companies or health professionals - has visibility over everything that currently exists in terms of data sources and real life studies, it says.
“In their current state, most of these databases are of limited value” the report says. While there are so many of them that a comprehensive inventory cannot be made, “their quality is uneven, many of them have not been evaluated, and the collection methods are heterogeneous, making it difficult to compile the data at national level”.
The number of cohorts and registers that can be exploited on a routine basis for real-life studies of drugs, which “are sufficiently substantial and include variables which are relevant for this objective”, is “currently limited” as a result.
The authors also diagnose a lack of oversight, making it difficult to ensure a shared vision of the available resources, of the deficiencies that need dealing with on a priority basis, synergies to be set up or guidance to issue for building these tools.
They say the French health ministry and HAS remain distanced from the wave of interest in observational studies. “The mission considers it is essential for HAS to join the movement and also invest in exploiting the SNDS [the national health data system], which can already provide relevant usage data,” the writers say.
A final weakness found is the fact that the culture of evaluation has not been “adequately” instilled in doctors in the field. Clinical research is respected, but observational research is not, the report emphasises: there is no financing, little remuneration for time spent on it, and its value is not highlighted.
Proposals for ‘new momentum’
The three authors use this overview as a basis for proposals to create "new momentum". They say the foundation stone of their “strategy” will be to determine the use of the data, as “collecting and processing real life data is not an end in itself”.
They say “there is room for improvement in the use made of real life data for a number of purposes,” - monitoring the safety of marketed drugs, the field that has benefited most from the data recently; monitoring the correct use of medicines; or checking they comply with the guidelines and reimbursement conditions - where there is “plenty of room for progress”.
The “overall strategy” proposed should rely on three main approaches: thorough exploitation of existing data sources (SNDS) and definition of the priority areas requiring further data collection tools; development of these on the basis of obligations and incentives; and the reconciliation of pragmatism - to improve the existing body of data - with ambition, since visionary projects drive progress.
To improve coordination and sharing between public regulators, they propose:
- setting up a body for strategic coordination of public institutions, which would aim to agree on priorities and a work programme as well as defining areas for progress
- boosting public institutions’ internal skills and using joint financing to share the two pharmaco-epidemiological research platforms set up by France’s drug regulator ANSM in 2014.
New methodological guidelines
To “guarantee the quality of and boost confidence in observational studies,” the recommendations involve:
- disseminating the recommendations of the European network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), promoting registration of studies on the EU-PASS register and involving INDS in study transparency
- finalising an educational document, which could be distributed independently and become the reference for methodology.
The “federating energies to improve existing tools and develop new ones” component involves:
- strengthening financial or symbolic ining it compulsory to set up and maintain registries for various sensitive treatments
- planning public-private partnerships to develop new information databases
- for INDS, maintaining an easily accessible registry recording requests to use the database.
A few cross-sectional proposals are also included, including recommendations to:
- analyse SNDS users’ needs
- reinforce the strategic management of registries and cohorts through improved governance
- use a large, representative sample of volunteer doctors to set up a compendium of diagnoses and other information currently lacking in medico-administrative data.