The French Ministry of Health, in their role as implementers of France’s national policies for medical care, public health and more, wanted to determine the challenges with their current process for health technology assessments (HTA). Their plan was to develop alternative solutions for reimbursement and pricing of medicines by leveraging economic evaluations. They commissioned the “Rapport Polton”1 (Polton Report) from Dominique Polton, advisor to the director-general of the French National Health Insurance Fund (CNAMTS). One of the main areas of focus for the Rapport Polton was the challenges associated with the evaluation of patient medical benefits2 (SMR) and the evaluation of the improvement of those medical benefits3 (ASMR) by the HTA agency, HAS4. Through the Rapport Polton, five reasons surfaced that clearly outline why there needs to be a change in French health technology assessments.
Here are five key findings of the report:
1. The SMR was found to mimic the marketing authorization evaluation
SMRs are supposed to be an accurate reflection of:
- a medicine’s efficacy and safety
- its place in the therapeutic strategy
- the severity of the disease targeted
- the type of action (preventive, curative, symptomatic)
- its public health benefits2
The Rapport Polton published the results of an HAS audit of assessments from 2014. It showed that the main drivers for receiving a “good” SMR were the same as for being granted marketing authorization. In both cases, the emphasis is on efficacy, safety and place in the therapeutic strategy.
2. A lower SMR may mean physicians simply choose a more fully reimbursed, newer, more expensive medicine for their patients
Routine SMR re-evaluations of older medicines by HAS have provided lower SMR levels and thus lower reimbursement rates. This is true even if the older medicines still offer benefits in a particular subpopulation of patients. This phenomenon is leading physicians to prefer the latest (and more expensive), well-reimbursed medicines for their patients.
Example: anti-H2 vs. proton pump inhibitor (PPI)
Anti-H2 and PPI are used to treat gastroesophageal reflux disease (GERD). Anti-H2s were marketed at the end of the 1980s, and PPIs were launched during the 1990s with both being awarded SMRs of “substantial” for the treatment of GERD. In 2005, the SMR for anti-H2s was downgraded from “substantial” to “low”, with reimbursement falling from 65% to 15%. Moreover, HAS does not consider that anti-H2s have a place in the therapeutic strategy; “the anti-H2s have a rapid and short action on GERD and should be reserved for the patients who have infrequent reflux, while PPIs should be the first-line treatment of patients who suffer from typical and frequent reflux”. If physicians were to follow HAS recommendations, their patients with infrequent symptoms would bear a higher co-payment than patients with frequent symptoms. In reality, physicians are more inclined to prescribe PPIs to all patients (incurring higher healthcare system costs).
3. The ASMRs are not being routinely reviewed
SMRs for community-setting products are reviewed every five years. ASMRs, measuring the improvement in medical benefits, are therefore more likely to be dynamic over time. Even though ASMR scores are given to every new medicine reaching the French market, they are not being reviewed on a regular basis.
4. It is difficult to evaluate the ASMR in the absence of a comparator, providing manufacturers with the opportunity to try to negotiate a higher price
In the absence of a direct comparator and when the medical benefits are unclear to the HAS, medicines usually receive an ASMR IV5, together with a low or moderate SMR. However, an ASMR IV allows pharmaceutical manufacturers to negotiate on the price, associating some new types of treatment with a higher price.
5. ASMRs are ignored by physicians who are not obliged to follow the HAS reports
HAS recommendations are not enforceable, and French physicians are not required nor expected to follow the HAS guidelines.
The gliptins are one of the latest therapeutic classes of medicines intended for treating diabetes. Gliptins are meant to be used third-line and are reimbursed; however, for certain subpopulations, they have received an SMR rating of “insufficient” meaning that HAS believes they should not be used (or reimbursed) for these particular subpopulations. Despite this, 8% of gliptin prescriptions have actually been reimbursed for patients from subpopulations where they were not recommended for reimbursement. This is an indication that physicians ignore HAS recommendations and prescribe the gliptins as they see fit, regardless of subpopulation and HAS recommendation. Ultimately, there is no mechanism to prevent reimbursement of a prescription for a patient from an “insufficient” subpopulation.
It is unclear yet how these Rapport Polton criticisms will contribute to the development of a revised evaluation in France, but they have clearly demonstrated the limits of the current SMR/ASMR evaluations and the adverse effects of these, incentivizing physicians to prescribe more innovative medicines than required.
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1. Rapport de Dominique POLTON sur la réforme des modalités d’évaluation des médicaments, Decembre 2015, last accessed February 2016.
2. Service Médical Rendu (SMR)
3. Amélioration du Service Médical Rendu (ASMR)
4. Haute Autorité de Santé (HAS)
5. ASMRs range from I to V, I being the best achievable, and V meaning that the medicine does not offer any improvement of medical benefits.
6. Décret n°99-915 du 27 octobre 1999.