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Commissioning policy template Treatment (brand name, manufacturer if applicable) For the treatment of

Adalimumab (Humira, Abbott) Ankylosing spondylitis (AS)

Background Adalimumab is an inhibitor of tumour necrosis factor (TNF). It is given by subcutaneous injection. This treatment is excluded from PbR tariff. Nice recommends it is used for:: The treatment of severe active ankylosing spondylitis where: o there has been inadequate response to conventional therapy (sequential use of 2 NSAIDs at maximum tolerated doses, and o have a VAS and BASDAI score of at least 4 on 2 occasions 12 weeks apart without any change of treatment. Commissioning position

Based on NICE guidance TA 143: Adalimumab will be routinely commissioned by NHSK in accordance with NICE TA 143 for ankylosing spondilitis. NHSK will routinely fund etanercept as a second line option should a patient suffer adverse effects or is intolerant to adalimumab within the first 12 weeks of therapy only. NHSK will not fund sequential use of anti-TNFs in AS when treatment with the recommended anti-TNF/s as identified in NICE TAG 143 have failed to work, or there has been an inadequate response or loss of efficacy. Treatment will cease to be funded if there is inadequate response at 12 weeks assessment following initiation of therapy. An adequate response to treatment is defined as a: Reduction of the BASDAI score to 50% of the pre-treatment value or by 2 or more units and Reduction of the spinal pain VAS by 2 cm or more. An equivalent method of assessment may be used if BASDAI and VAS systems cannot be used. In patients where an initial adequate response has been achieved, NHSK will cease funding If the continued response to treatment, as defined above , is not maintained (assessment of continued efficacy should be undertaken every 12 weeks). In this situation a repeat assessment should be made after a further 6 weeks. If at this 6-week assessment the response to therapy has not been maintained, funding / treatment will be discontinued This policy must be read in conjunction with the following policies: Etanercept for ankylosing spondilitis Infliximab for ankylosing spondilitis


Effective from Summary of evidence/rationale Date

November 2010 NICE Guidance: TA 143

Policy to be reviewed by Contact for this policy

November 2012 Neill McDonald: neill.mcdonald@kirklees.nhs.uk

November 2010


/Adalimumab_Ankylosing