NICE's independent appraisal committee has asked Roche, the manufacturer of tocilizumab (RoActemra), a new treatment for moderate to severe active rheumatoid arthritis, for further additional information on its product.
The committee is minded not to recommend the use of the drug but the additional information it has asked for today (4 March) could result in the final guidance being positive at specific stages of the treatment pathway. This draft guidance has been issued for consultation: NICE has not yet issued final guidance to the NHS.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 NICE appraisal is trying to establish in what circumstances using tocilizumab might be a good use of NHS funds, for patients for whom other similar treatments aren't working.
The further information requested includes:
- cost-effectiveness analyses from the manufacturer of tocilizumab on its use in people whose rheumatoid arthritis has responded inadequately to previous tumour necrosis factor-?± inhibitors and who are intolerant to, or unsuitable for, treatment with rituximab
- cost-effectiveness analyses from the manufacturer of tocilizumab on its use in people whose rheumatoid arthritis has responded inadequately to previous treatment with rituximab.
This third draft guidance includes the new request for further information on using tocilizumab for people who cannot have rituximab, if rituximab is contraindicated or unsuitable for them (point 1 above). This possible use was raised in the consultation on the previous draft guidance as a potentially important place for tocilizumab in the treatment pathway. Further data is sought as evidence was not previously provided by the manufacturer on this particular use.
The minded no for giving tocilizumab after rituximab remains (point 2 above), as the committee heard from patients and experts that this is a logical place in the pathway for tocilizumab to be considered as an option. The committee accepted the view that trying three biological treatments could be better than two, so re-iterated this minded no from the previous draft to encourage further data to be submitted on this point.
Andrew Dillon, Chief Executive of NICE, said: "With no cure, finding ways to relieve pain, improve mobility and reduce long term damage are the goals in treating rheumatoid arthritis. We want to know how tocilizumab can help, but we need to be sure that it offers real additional benefits for patients - and we need to be confident that those benefits justify the cost.
"We don't think that using it before trying other, existing biologics, (such as etanercept or rituximab) is the right approach, but the additional information may be important in deciding whether - and how - tocilizumab can work effectively and cost effectively for patients when these treatments aren't working.
"We don't all respond to drugs in the same way, so having a range of treatment options is important. We're looking forward to hearing Roche's further response to help us decide whether tocilizumab should be added to the options already available to patients living with this very disabling disease."
NICE's preliminary recommendations are available for public consultation from 4 March 2010 until 25 March 2010. Comments received during this consultation will be considered by the committee and following this meeting the next draft guidance will be issued.
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.
Source
NICE
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