The Minister of Health will allow, by a decree to appear in the coming days, the reimbursement of baclofen in the indication for treatment of alcohol dependence.
The Ministry of Health confirms the information, baclofen will very soon be part of the reimbursed treatments. An order must appear “in the coming days” to record the reimbursement of this treatment of alcohol dependence. According to Philippe Jaury, national coordinator of the Bacloville clinical trial, the box of 30 tablets of 10mg, which costs 5 to 7 euros, would be covered at 30% by Social Security. The ministry emphasizes that “the reimbursement of baclofen as part of its temporary recommendation for use (RTU) constitutes an unprecedented decision to respond to a major public health concern: the fight against alcoholism.”
Solicited by 50,000 patients
Since March 14, baclofen has in fact benefited from a temporary recommendation for use (RTU), granted by the Medicines Safety Agency (ANSM). This muscle relaxant, which cuts the urge to drink, has been used since 2008 by more than 50,000 alcohol-dependent patients. “Baclofen may be prescribed after failure of other treatments available in alcohol-dependent patients for the following two indications: helping to maintain abstinence after withdrawal in alcohol-dependent patients and major reduction in alcohol consumption down to the low level of consumption in high-risk alcohol-dependent patients ”, then specified the ANSM.
Monitoring of efficacy data
However, baclofen is not a miracle treatment: specialists speak of a real revolution, but stress that baclofen has no effect in one in two patients. In addition, this RTU is temporary; the drug situation will have to be reviewed in 3 years, in the light of the results of clinical trials currently underway and the monitoring of tens of thousands of patients treated under this RTU. By then, a system for monitoring drug efficacy and safety data has been set up. The electronic portal https://www.rtubaclofene.org should make it possible to guide patients and prescribers in the use of this new treatment for alcoholism and to detect pharmacovigilance signals.
Baclofen RTU also comes with a long list of contraindications: for all people with severe neurological or psychiatric disorders (uncontrolled epilepsy, schizophrenia, bipolar disorder, severe depression) or severe renal or hepatic impairment.
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