Homeopathy in France: what are the challenges and prospects?
In the debate between traditional and alternative medicine, the French Minister for Solidarity and Health, Agnès Buzyn has asked the HAS, the French Health Agency (Haute autorité de santé), to reassess the reimbursement of homeopathic medicines. Not surprisingly, on June 28, the French Health Agency issued a negative opinion on the reimbursement of homeopathic medicines by Social Security. As a consequence, the French government announced that homeopathy will no longer be covered. France, which was an exception on this matter in Europe, is therefore preparing to follow the path taken by the majority of its European colleagues.
Homeopathy and the debate on its effectiveness
Homeopathy consists in administering an infinitesimal dose of an active substance to a patient, which, at a higher dose, would cause symptoms similar to those of the sick patient in a healthy subject. The active substance, derived from plants, minerals or animals, is however so diluted that its effectiveness is debated among healthcare professionals. This therapeutic method, based on the principle of similarity, was initially proposed by Hippocrates.
As the efficacy of homeopathic medicines had not been scientifically evaluated in France, they have so far been reimbursed at 30% under a special health insurance scheme. Following the debate that emerged on their effectiveness, the HAS carried out an analysis of the available scientific literature, which led to the assessment that the effectiveness of homeopathy is not sufficient for it to qualify for reimbursement. However, beyond the efficacy of the active substance, there is the placebo effect which has been proven effective time and again on patients’ subjective symptoms such as pain, fatigue and anxiety. Still, the effect of a drug must be greater than what can be induced by a placebo effect – which is used as a reference in clinical trials – in order to be eligible for reimbursement.
The impact of the reimbursement change
The very likely adjustment of cost coverage in the near future will have several consequences. First of all, there will be a direct economic impact – the French Health Insurance will save around 130 million euros per year. This figure represents roughly 0.7% of the French drug reimbursements. The removal of cost coverage for homeopathy will therefore only be a limited contribution to the budgetary balance that the Social Security system is so keen to achieve.
In terms of the manufacturers, three major players will be impacted: Boiron, Lehning and Weleda. The announcement by Boiron, the global leader in the field, that such a change in reimbursement would lead to a loss of 1,300 jobs in France (which corresponds to half of the local workforce) does not seem to have had the intended effect on HAS.
For patients, in addition to the direct financial impact caused by the change in reimbursement, there is a risk that the current cost of granulates – about two euros per tube – could increase by a factor of two or three. The value-added tax for homeopathic medicines will increase from 2.1% for reimbursed drugs to 10% for non-reimbursed drugs. Moreover, the price regulations for covered pharmaceutical products will no longer apply. To limit these effects, the government could have opted for a reduction of reimbursement instead of a total removal of reimbursement.
New perspectives for therapeutic strategies
Even when considering the most conservative scenario in which homeopathy only acts as a placebo, it has recently been shown by several studies that the effect of an “openly” administered placebo – the patient knows that he or she is taking a placebo – combined with an active drug is greater than the benefit of an active drug alone[1]. A combination with “open” placebos would therefore allow for a reduced dose of the active drug. Moreover, the use of a “blind” placebo also allows a reduction of the dose of the active drug, in particular by using the human learning capacity. After repeated effective treatments, a placebo treatment with similar visual, gustatory, and olfactory characteristics can generate a response similar to that of the active treatment.
“This approach is particularly interesting in the context of the opioid crisis for pain management” adds Delphine Bertrem, head of the Health Business Unit at Alcimed. Clinical studies in the United States and Italy have shown a reduction in the use of opioids, corticosteroids, benzodiazepines and amphetamines in patients with pain, psoriasis, insomnia and attention deficit or hyperactivity disorder via placebos[2]. In case of such a use, the cost of placebos for insurance providers would be offset by the decrease in the volume of active drugs prescribed. Could homeopathy be a good placebo candidate for such therapeutic strategies?
[1] Kaptchuk TJ & al. Open label placebo: can honestly prescribed placebos evoke meaningful therapeutic benefits? BMJ. 2018.
[2] Colloca L, Enck P et al. Relieving Pain using Dose-Extending Placebos: A Scoping Review. Pain. 2016 Aug; 157(8): 1590–1598.
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