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NICE recommends earlier use of Roche’s RoActemra for rheumatoid arthritis

Cost-effectiveness watchdog also backs Lilly's diabetes drug Bydureon and ALK-Abelló’s bee and wasp allergy treatment Pharmalgen

Roche's RoActemra has been recommended for use on the NHS in England and Wales as a second-line treatment for patients with rheumatoid arthritis (RA).

The National Institute for Health and Clinical Excellence (NICE) deemed the drug, in combination with methotrexate, a cost-effective use of resources to treat patients with RA for whom treatment with disease-modifying anti-rheumatic drugs (DMARDs) has been ineffective.

Previously, RoActemra had only been available for people with RA as a third-line treatment option if DMARDs had been ineffective, and if patients had also both demonstrated an inadequate response to one or more TNF inhibitors and could not take another Roche drug, MabThera (rituximab).

The recommendation is based on a patient access scheme agreed between Roche and the UK's Department of Health, offering RoActemra at a discounted rate.

Details of the access scheme are confidential, although the usual annual acquisition cost of the drug per year for an average-sized patient would be £9,295.

A similar scheme was agreed between Roche and the DH regarding RoActemra's use as a treatment for systemic juvenile idiopathic arthritis. In that setting the drug is available on the NHS with a discount provided by Roche, but only if other treatments have not produced an adequate response.

According to NICE, the number of people that might be able to use RoActemra will be just 10 per cent of the 400,000 people in the England and Wales who are thought to have the condition.

Ailsa Bosworth, chief executive of the National Rheumatoid Arthritis Society, said: “This decision is most welcome as it is vital that patients have effective options available as soon as one treatment approach fails.”

Additional recommendations for Lilly's Bydureon and ALK-Abelló's Pharmalgen

In separate decisions NICE has also approved Eli Lilly's Bydureon (exenatide)

Bydureon was backed as part of a triple therapy regimen in combination with two other treatments for people with type 2 diabetes.

The drug can be used with metformin and a sulphonylurea, or metformin and a thiazolidinedione, to help control blood sugar levels in individuals who have a high BMI or for whom therapy with insulin would have significant occupational implications.

Bydureon can also be used as a dual therapy (in combination with metformin or a sulphonylurea) if a patient cannot use either metformin or a sulphonylurea, or cannot use thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors.

The treatment is a once-weekly form of Byetta, co-developed with Amylin. However, Amylin is in the process of buying back full rights to the drug following Lilly's diabetes partnership with Boehringer Ingelheim. Amylin is expected to have full European rights for Bydureon by the end of 2013.

NICE also gave the go-ahead to ALK-Abelló's Pharmalgen for use on the NHS as a treatment option for bee and wasp allergy.

The medicine can be used in people who have a severe systemic reaction to bee or wasp venom, or a moderate systemic reaction and who have raised baseline serum tryptase, as well as those who are at a high risk of future stings or are anxious about future stings.

22nd February 2012

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