Bayer has persuaded the UK's National Institute of Health and Clinical Excellence (NICE) to back Xarelto after supplying new clinical and cost effectiveness evidence for the oral anticoagulant.
NICE's positive recommendation in its final draft guidance follows its January call for more evidence on the drug's use and sets Xarelto up for a direct marketing battle with Boehringer Ingelheim's Pradaxa (dabigatran etexilate) once it is finalised.
The drugs are part of a new generation of oral anticoagulants looking to replace warfarin, which is almost 60 years old, but Xarelto (a Factor Xa inhibitor) and Pradaxa (a direct thrombin inhibitor) work in different ways.
Boehringer yesterday took the surprising step of cutting Pradaxa's UK price by 13 per cent from £2.52 to £2.20 a day, bringing it much closer to Xarelto's provisional cost of £2.10.
Boehringer said it did this to make its drug, approved by NICE in this indication earlier this month, “as affordable as possible in this tough financial climate" and allow doctors to prescribe the drug "based on clinical need, not cost".
NICE's final draft guidance for Xarelto (rivaroxaban) recommends the drug as a treatment option for the prevention of stroke and systemic embolism in atrial fibrillation (AF) patients.
Professor Carole Longson, NICE Health Technology Evaluation Centre director, said: “We know that people taking warfarin can find it difficult to maintain their blood clotting at a proper level and are often not within the target therapeutic range. For example, older people with atrial fibrillation and comorbidities are more likely to have poorly controlled clotting and may be at an increased risk of stroke or bleeding.
“Rivaroxaban, like dabigatran etexilate, which NICE recently approved as an option for this indication, can benefit people with AF in these circumstances because it doesn't require such regular monitoring and dose adjustments.”
It is estimated as many as 700,000 people could suffer from AF in England and Wales and patient group the Atrial Fibrillation Association welcomed the decision.
Its founder Trudie Lobban said: “These are exciting times, with 45 per cent of all embolic strokes caused by AF; the approval of this new oral anticoagulant is a fantastic leap forward in anticoagulation therapy. The decision by NICE at last provides doctors and AF patients with a new option to prevent a potentially fatal or debilitating AF related stroke.”
NICE final draft guidance says the decision about whether to start treatment with Xarelto should be made after an informed discussion between the clinician and the person about the risks and benefits of the drug compared with warfarin.
It also recommended that for people who are taking warfarin, the potential risks and benefits of switching to Xarelto should be considered in light of their level of international normalised ratio (INR) control.
Bayer Healthcare UK said NICE could publish its Final Appraisal Determination (FAD) on Xaralto as early as April.
Medical director Luis-Felipe Graterol said: “Xarelto has the potential to make a positive difference to NHS anticoagulation services by helping simplify clot prevention, particularly for the one third of patients who are not currently achieving an adequate level of stroke protection with warfarin.
“Bayer Healthcare UK is committed to ensuring that Xarelto is available as an option for these patients, and we look forward to continuing our work with local NHS fundholders to help evolve services with this once-daily therapy.”
The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies will still have to make decisions locally on whether to fund it or not.
Meanwhile, NICE has ongoing appraisals of Xarelto for the treatment of deep vein thrombosis (DVT) and the prevention of recurrent DVT and pulmonary embolism following an acute DVT in adults, and for the prevention of VTE in people hospitalised for acute medical conditions.
The Institute has already recommended Bayer's drug for the prevention of VTE in adults who have elective total hip replacement surgery or total knee replacement surgery.