NICE recommends AZ’s Forxiga in triple therapy

It’s been a mixed week for AstraZeneca: lung cancer drug Tagrisso became the first product to be funded via the new Cancer Drugs Fund in England- a dubious honour – then sales expectations for heart drug Brilinta were hit by a trial failure.

Today comes some straightforwardly good news – NICE has recommended National Health Service funding for its Forxiga (dapagliflozin) as part of a “triple therapy” regime in type 2 diabetes.

NICE rushed the decision through to final draft, meaning Forxiga is likely to soon compete with rival SGLT-2 inhibitors Jardiance (empagliflozin) from Boehringer and Eli Lilly, and Janssen’s Invokana (canagliflozin), which are also recommended for this use. Like Tagrisso, Forxiga is one of a group of newer products that AZ is hoping will help fill a revenue hole caused by the US patent expiry of cholesterol drug, Crestor (rosuvastatin) – and sales are already picking up.

In Q2 sales were $211 million, 64% higher than in the same period last year. NICE said Forxiga can be added to metformin and sulfonylurea if diabetes patients are not controlling their blood sugar with the double therapy. Forxiga, Jardiance and Invokana are already recommended for use on their own if a person cannot use metformin or other drugs, or in combination with metformin as dual therapy.

In its guidance, NICE said the cost per QALY based on available data was almost £38,000, above its usual threshold of £20,000-£30,000. But NICE noted estimates from AZ suggesting weight loss would only be maintained for a year were probably pessimistic. NICE noted in its guidance that it is likely that this class of drugs can reduce heart failure, saying the high cost-effectiveness estimate did not reflect these quality of life benefits.

Professor Carole Longson, director of NICE’s centre for health technology evaluation said: “We’ve been able to speed up this appraisal, going straight to final draft stage because we plan to recommend dapagliflozin. This should help final guidance to be published sooner, and so benefit people more quickly.” NICE has launched its usual consultation into the final draft, and England’s National Health Service must make sure the drug is available within three months of publication of final guidance

In a separate announcement, AZ has continued with its process of outlicensing drugs which are not part of its core portfolio. The company announced today that it will sell ex-US rights to its Rhinocourt Aqua for allergic and non-allergic rhinitis to Johnson & Johnson affiliate Cilag GmbH for $330 million.

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