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NICE wants more info on Bayer's anticoagulant Xarelto

UK body wants more clinical and cost-effectiveness data on the DVT drug

The UK's National Institute for Health and Clinical Excellence (NICE) has asked for additional information before it can complete its appraisal of Bayer's Xarelto for the treatment of venous thromboembolism.

Draft guidance issued by the agency today asks Bayer to supply additional data on the drug's clinical and cost effectiveness in deep vein thrombosis (DVT) and pulmonary embolism (PE) "in the context of UK clinical practice", according to Meindert Boysen, NICE's programme director for technology appraisals.

The guidance now goes out for public comment in advanced of an expected review completion in July 2012.

This is the second time NICE has taken issue with Bayer's dossier for Xarelto, which is a new type of drug called a Factor Xa inhibitor.

The agency also asked for more data on Xarelto (rivaroxaban) in January as part of its consultation process on the drug's use to prevent stroke and systemic embolism in people with atrial fibrillation (AF), saying that the single trial submitted to support this use was insufficient.

In the latest draft guidance, Boysen said NICE's Independent Appraisal Committee is particularly concerned that Bayer had not provided an analysis for patients who needed treatment beyond 12 months, given that "some people with DVT need to continue on anticoagulant therapy permanently".

In addition, the Committee says there seem to be differences in the effectiveness of Xarelto among patient groups assigned to 3, 6 and 12 months of therapy that need further exploration. It is scheduled to meet next on 17 April.

The provisional cost of Xarelto to the NHS would be £2.10 per day, or £766.50 annually, but costs could vary in different settings because of negotiated procurement discounts.

That is significantly more expensive than warfarin - the most widely-used anticoagulant at present - but warfarin has a number of limitations which are acknowledged by NICE.

"Many patients find taking warfarin to be a source of stress, because it requires regular monitoring with blood tests, dosing adjustments, and patients must be careful about their diet because of warfarin's interaction with certain foods," said Boysen.

"Rivaroxaban may be a useful alternative," he added.

The assessment in DVT and PE is somewhat more positive than NICE's earlier comments on the AF indication, in which it said it was "minded not to recommend" the drug based on the available evidence.

Another new anticoagulant - Boehringer Ingelheim's direct thrombin inhibitor Pradaxa (dabigatran etexilate)- has struggled to make it past the Independent Appraisal Committee but was eventually backed by NICE in its final appraisal.

That however prompted an appeal by NHS Salford, which argued that NICE had dramatically underestimated the take-up of Pradaxa and that approval would require a complete redesign of anticoagulant services at the primary care trust. As yet the outcome of that appeal has not been published.

13th March 2012

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