PARIS, Feb 9 (APM) - The therapeutic value of a drug (SMR) - which equates to how much it is reimbursed - will not be featured on drug labels in France until July 1, according to the latest version of the draft law.
The proposal, which is criticised by pharma and pharmacists, was initially postponed to January 1; the latest version of the text now features the date July 1, with an adaptation period running until January 1 2016.
The draft decree also reviews the technical and graphic terms and conditions related to the change.
Since autumn 2013, the government has been planning to feature the SMR ranking of a particular drug on its box. In December 2013, APM revealed that a first draft decree planned implementation as of July 1 2014, at the same time that the vignette was deleted from drug boxes. The vignette is a small adhesive label featuring the price of the product and the rate at which social security reimburses it.
The new draft decree concerns drugs reimbursed by the health insurance organisations and the objective is that it should indicate the SMR ranking “taken into account for fixing, by the director general of the national union of health insurance offices (UNCAM), the participation level of the insured person in the costs of acquiring the drug”.
The SMR ranking is the opinion by the French Transparency Commission (CT) of the therapeutic value of a drug by assessing: if it is a preventative treatment or a cure, the severity of the condition, how well the drug works, whether or not it has a public health interest, and its deemed absolute value.
The CT, part of the French national authority for health (HAS), awards an SMR of either: important, moderate, weak or insufficient, which equates to reimbursements levels of 65%, 30%, 15% and 0% respectively.
UNCAM later fixes the participation level of the insured person on the basis of this SMR.
The box was also due to comprise an SMR ranking for each of the therapeutic indications, but this is no longer mentioned. According to the February issue of Pharmacien de France, the monthly journal published by the Federation of French Pharmacists Unions (FSPF), where a drug has several SMR rankings, it is planned to feature only the highest one.
The latest draft decree says the SMR ranking shall be featured and, subsequently where necessary, updated at the latest six months after publication of the UNCAM decision.
On the drug box, the SMR shall feature in the form of a pictogram comprising a black circle against a coloured background, according to a draft decree of which APM has also received a copy.
An orange background shall correspond to insufficient SMR (previously black), a blue background to low SMR (previously red), a red background to moderate SMR (previously blue) and green to important SMR (unchanged).
It was previously planned for the pictogram to comprise one or several colours, depending on whether the drug has one or several indications with different SMR rankings.
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