A U.K. National Institute for Health and Clinical Excellence (NICE) panel has denied an appeal from Cordis, a division of Johnson & Johnson (J &J), regarding reimbursements for drug-eluting stents (DES) used to treat coronary artery disease.
NICE issued a guidance in February recommending DES as a “possible treatment” for coronary artery disease patients if two conditions are met:
- The artery to be treated is less than 3 mm in diameter or the affected section of the artery is longer than 15 mm — conditions that indicate a patient is at high risk of requiring further interventions if a conventional bare-metal stent is used; and
- The additional cost of a DES over a bare-metal stent is no more than $600.
Cordis appealed the guidance, arguing that NICE was seeking to control the price of the stents or to establish procurement policy for the U.K. National Health Service, according to FDANews. The Miami Lakes, Fla.-based Cordis cited evidence that DES are cost-effective at price premiums up to roughly $800–$900 over the cost of bare-metal stents, saying the evidence should be reflected in the guidance.
When the appeal was denied in late July, NICE re-released its final guidance, confirming the criteria it set forth in February.
“We’re disappointed that NICE’s appeal panel did not uphold our appeal, and we’re in the process of evaluating our options regarding the appeal panel’s ruling,” said Christopher Allman, J &J spokesman.
According to NICE, J &J could challenge the decision by applying to the High Court for permission to apply for judicial review, FDA News reported.