Olmesartan French Delisting Delayed, But Still Big Hit For Daiichi Sankyo

The antihypertensive olmesartan is to lose its reimbursement status in France next year, on the grounds that its efficacy had been shown to be less convincing that that of other angiotensin receptor blockers.

The French health authorities have announced that Daiichi Sankyo Co. Ltd.'s angiotensin II receptor blocker, olmesartan, is to lose its reimbursement status after its medical benefit rating was deemed "insufficient" by the health technology body, Haute Autorité de Santé (HAS).

The move is likely to hit Daiichi Sankyo's French sales hard: it said that the olmesartan franchise was "the major part of the revenues for our French affiliate with up to 85% of French sales." There was some consolation for the company, though, as the delisting has been postponed from July this year to January 2017.

Olmesartan is marketed in France as a monotherapy for essential arterial hypertension by Daiichi Sankyo as Olmetec and by its co-marketing partner Menarini Group as Alteis, and in combination with HCTZ (Co-Olmetec and Alteisduo respectively) or amlodipine (Sevikar and Axeler).

The decision to delist products containing the drug was taken in April last year by the transparency committee of the French health technology assessment body, the HAS, on the grounds that its efficacy had been shown to be "less convincing" that that of other ARBs. Although olmesartan reduced arterial pressure, its efficacy in terms of reducing the number of cardiovascular events and deaths had not been demonstrated, "unlike the majority of the other ARBs that are available and reimbursed."

Moreover, the HAS said that unlike other available angiotensin II antagonists, olmesartan had been shown in pharmacovigilance enquiries and published studies to carry an increased, albeit very rare, risk of serious enteropathies, unlike other products in the class.

These illnesses took the form of severe chronic diarrhea with significant weight loss and renal insufficiency that could require hospitalization for intestinal malabsorption, and the symptoms could appear several months or even years after initiation of treatment, ANSM said in its letter to doctors. "Diagnosis is difficult and often delayed and is therefore the cause of numerous serious complications," the agency added.

It said that the results of research by the national health insurance agency CNAMTs, together with an analysis of data from spontaneous reporting in France and from the medical literature, did not flag up any signs of enteropathies with the other ARBs.

"It was on the basis of all these elements that products containing olmesartan were re-evaluated by the transparency committee of the HAS, which judged their medical benefit to be insufficient and recommended their removal from the list of reimbursed products."

Delisting Delayed

A decree published on April 3 this year announced that olmesartan products would no longer be reimbursed as of July 3, thereby giving patients three months to consult their doctor and discuss their treatment options. However, Daiichi Sankyo told Scrip that a French court decided that the delisting should be postponed, and this will now be effective from Jan. 3, 2017.

ANSM said that delay would give patients additional time to consult their doctor and have their treatment re-evaluated.

Daiichi Sankyo said it was "pleased with the postponement of the reimbursement decision in France because it is in the best interest of patients. Before the court order was issued, patients who are treated in France with medication based on olmesartan were facing a time period of only three months in which their prescribing physician had to change the treatment before loss of reimbursement."

Olmesartan-containing products have accumulated more than 60 million patient-years of experience, the company said, noting that the EU marketing authorization was reconfirmed this year – "an important validation for the safety and efficacy of this product."

ANSM said that patients on olmesartan should not suddenly stop taking the product but should consult their doctor to have their treatment re-assessed, noting that there were "several effective, better tolerated and reimbursed alternatives available." Both ANSM and the HAS will be posting more information for patients and health professionals on their websites.