France is already known as a challenging market for industry with its strict SMR/ASMR ratings system that can penalize specific therapies. Now, the country is looking at changing its funding system for expensive drugs, drawing opposition from oncologists who believe access to needed therapies may be at stake.
In this debate, 30 French oncologists have signed a letter addressed to health minister Marisol Touraine denouncing an expected loss of funding for certain expensive cancer drugs. At the forefront of the debate is the balance between what oncologists claim to be callous cost containment and cancer-stricken French citizens’ quality of life.
For public hospitals and private hospitals working in the public sector, medicines are funded through groupes homogènes de séjour (GHSs; uniform hospitalization groups), a DRG-based system. However, the French government recognizes that certain drugs and technologies are too expensive to fit within the GHSs; therefore, these products—known as médicaments facturés en sus des GHS (drugs invoiced on top of the GHS), or the list “en sus”—are funded separately. The list is updated every March by The Ministry of Health and the Agence Technique de l’Information sur l’Hospitalisation (ATIH; Technical Agency for Information on Hospitalization) in order to add new products while simultaneously removing products that are considered less innovative.
The oncologists’ outcry stems from the possibility that expensive cancer drugs could be removed from the list “en sus,” thus wreaking havoc on hospitals’ standard budgets and preventing patient access. The efficacy of cancer drugs is at the crux of the matter—these drugs are notoriously expensive but sometimes only extend life by a few months and regularly receive lower ASMR ratings in France. Such ratings measure the degree of improvement on a five-point scale—from I (major improvement) to V (no improvement)—and are an important influence on a drug’s price.
Previously, inclusion on the list “en sus” was made on the basis of a single price, even if the product was awarded different ASMR ratings for various indications. Now, however, the ATIH will work by product and indication. Consequently, a drug could be included on the list within one indication and not in another, thus limiting funding opportunities. France has typically used SMR ratings to measure a drug’s medical benefit, followed by ASMR ratings to assess a therapy’s improvement in medical benefit vs. a chosen comparator with unfavorable ratings limiting a drug’s ability to obtain a price premium. Upon the pending approval of a new decree, the list “en sus” will include only products with commendable ASMR ratings (I, II, III). Products that provide only a minor improvement (ASMR IV) will be included if there is no alternative treatment or if they are less expensive. Among cancer drugs on the market since 2012, only 27 percent received an ASMR of I, II, or III—a statistic that has caused oncologists to fear imminent loss of funding.
The French government has been moving toward more cost-containment strategies regarding healthcare spending in recent years, notably proposing strategies in the 2016 Social Security Finance Bill that would reduce costs at a targeted €3.4 billion (US $3.9 billion), with the ATIH specifically hoping to save €205 million ($226 billion). From the French government’s perspective, it is logical to prune expensive, less effective drugs from the list “en sus” to make room for more innovative products. Oncologists, however, argue that patients’ quality of life is more important than cost-containment, citing the circuitous nature of cancer treatment and the often unpredictable timeline of the disease. From pharma’s point-of-view, the proposed elimination of cancer treatments and consequent strain on hospitals’ standard budgets could lead to a push for price reductions that could cost pharma millions, as few citizens would be able to afford the expensive drugs without supplemental government funding.
Taken together, this plan would make an already challenging market in France even more difficult and could ultimately affect patients’ access to some therapies.