Final draft guidance recommending tocilizumab (RoActemra) as an additional option for treatment of moderate to severe rheumatoid arthritis is published by NICE today (Friday 2 July). This follows a request from the independent appraisal committee to the manufacturer of tocilizumab for further information on the use of the drug at specific stages of the treatment pathway. Earlier draft guidance published for consultation in March 2010 was minded not to recommend the use of the drug, and so the committee asked for the additional information to be made available.
This final draft guidance is now with stakeholders who have the opportunity to appeal against it; NICE has not yet issued final guidance to the NHS.
Tocilizumab is a modern 'biologic' (made from living material) and is used to reduce inflammation in the joints, to help prevent long term damage. Other drugs, which act in a similar way are already available, but patients do not always respond or respond well to them.
The final draft recommendations include:
- Tocilizumab, in combination with methotrexate, is recommended for the treatment of moderate to severe active rheumatoid arthritis in people whose rheumatoid arthritis has responded inadequately to one or more tumour necrosis factor alpha (TNF-?±) inhibitors and:
- whose rheumatoid arthritis has responded inadequately to rituximab
or
- in whom rituximab is contraindicated or when rituximab is withdrawn because of an adverse effect.
Dr Carole Longson, Director of the Centre for Health Technology at NICE, said: "Having received the extra data we requested from the manufacturer, we're pleased to be able to make positive draft recommendations on tocilizumab for people who cannot have rituximab to treat their rheumatoid arthritis. These provisional recommendations say that tocilizumab is an option if there has been an inadequate response to one or moretumour necrosis factor alpha (TNF-?±) inhibitors and where rituximab has also produced an inadequate response or where it is contraindicated or has produced undesirable side effects. The use of tocilizumab after rituximab was raised as a potentially important place for this drug in the treatment pathway during consultation on previous draft guidance. The additional information provided by the manufacturer on use in these circumstances has enabled the appraisal committee to now produce positive recommendations - which we hope will be good news for people with rheumatoid arthritis."
Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.
About the guidance
1. Information on the NICE appraisal of tocilizumab for the treatment of moderate to severe active rheumatoid arthritis is available here.
2. This is final draft guidance - also called the final appraisal determination document. Three previous sets of draft consultation guidance were issued on the use of tocilizumab for the treatment of moderate to severe active rheumatoid arthritis in March 2010, December 2009 and October 2009.
3. Tocilizumab (RoActemra, Roche) is administered as an intravenous infusion, given over 1 hour. The recommended dosage is 8 mg/kg, but no lower than 480 mg, given once every 4 weeks. The cost for tocilizumab as reported by the manufacturer is ??9295/year for a patient weighing approximately 70 kg. Tocilizumab is available in three vial sizes, which are priced at ??102.40 for an 80-mg vial, ??256 for a 200-mg vial and ??512 for a 400-mg vial. Costs may vary in different settings because of negotiated procurement discounts.
4. Where tocilizumab is used as an option for people after rituximab in line with the recommendations, the cost per quality adjusted life year (QALY) gained was ??27,100. Where tocilizumab is used as an option for people who are contraindicated to rituximab or who have rituximab withdrawn due to adverse events, the cost per QALY gained was ??27,900.
Source:
NICE
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