PARIS, Oct 23 (APM) - CISS, a collaboration comprising around 30 French healthcare associations, has urged its members to pull together to plan “necessary changes” it believes are needed in drug policy in France, in an open letter to the health minister Marisol Touraine.

The health bill, adopted in a Cabinet meeting last week and due to be examined in parliament early in 2015, “should be the occasion to adjust the existing French structure” it said in the letter, dated Wednesday, while regretting that many conclusions of the 2011 drug conference have not been acted upon.

Among the changes, CISS wants new pricing agreements, in view of the discussions on the high cost for health insurance of the new direct-acting antivirals (DAAs) in the treatment of hepatitis C, including Gilead’s Sovaldi (sofosbuvir), due to come onto the market in France shortly.

Sovaldi is currently available at the price applied in the framework of the temporary authorisation (ATU), namely 56,000 euros for a 12-week course (APMMA 39507).

Its impact on health insurance expenditure is estimated at 1 billion euros in 2015, and the government wants to attenuate this via a new regulating mechanism voted in the national assembly on Wednesday under the proposed Social Security Budget bill (PLFSS) for 2015 (APMMA 40190).

CISS said that “safeguarding” health insurance requires “more than one measure, and for now, it is difficult to evaluate the benefits this measure will bring".

In the opinion of the health collective, the process, methods and criteria used to determine the prices of drugs and medical devices should be “less opaque,” particularly concerning R&D and production costs. It emphasises that although it is currently HCV drugs that are causing concern, the problem will happen again in future with other pathologies, in oncology in particular.

CISS demands an overhaul of health product evaluation and re-evaluation processes. There is also a need to review the “too tenuous link” between evaluation and price, “with the aim of achieving a more rational policy for placing products on the market, maintaining them on the market or withdrawing them from the market, as well as concerning reimbursement”.

Finally, the health collective wants “significant efforts” to be made concerning transparency, in order to have civil society participate in the work of the Transparency Commission (CT), the national committee evaluating medical devices and health technologies (CNEDIMTS), the board of the French national authority for health (HAS), the French economic committee for health products (CEPS) and the Strategic Council of Health Industries (CSIS).

“It is no longer acceptable for matters relating to drugs and medical devices to continue to be dealt with under opaque conditions. How should we interpret the fact that your health bill … resolutely sets aside appointing user representatives within the authorities that deal with these matters whereas it approves it in all other subjects?” CISS questioned the minister Touraine.

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