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17 March 2010
NICE has published guidance (TA 186) recommending certolizumab pegol▼ as an option for the treatment of adults with rheumatoid arthritis (RA) only if:
- the drug is used in the same way as defined in the NICE TA 130 for adalimumab, etanercept and infliximab, and
- the manufacturer provides the first 12 weeks of certolizumab pegol free of charge to all patients starting treatment.
Action:
Healthcare professionals involved in the care and treatment of people with rheumatoid arthritis should familiarise themselves with this technology appraisal (TA 186). When a NICE technology appraisal recommends use of a drug or treatment, or other technology, the NHS must provide funding and resources for it within 3 months of the guidance being published.
A patient access scheme (PAS) has been agreed. Certolizumab pegol is comparatively priced with other tumour necrosis factor (TNF) inhibitors and no increase in the number of eligible patients is anticipated. Therefore, implementation of this TA is not anticipated to make a significant change to NHS resources. NICE has provided an audit support tool.
NICE TA 186 should be considered in the context of the clinical guideline on RA in adults which was published in 2009 and is discussed in an NPC stop press blog with educational materials available on the rheumatoid arthritis section of NPC
What does this guidance say?
Certolizumab pegol is recommended as an option for adults with active RA when used as described for the other tumour necrosis factor (TNF) inhibitors, adalimumab, etanercept and infliximab in NICE TA130. This includes patient’s with a disease activity score (DAS 28) >5.1 on at least two occasions, one month apart. The patient should also have undergone trials of two disease modifying drugs (DMARDs), including methotrexate (unless contraindicated) for a period of time normally six months in length.
When using the DAS28, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect a person’s responses to this scoring tool. Adjustments should be made as appropriate.
Certolizumab pegol, in combination with methotrexate, is indicated for adults with moderate-to-severe, active RA who have failed on DMARDs, including methotrexate. Certolizumab pegol can be given as monotherapy if methotrexate is not tolerated or continued treatment is inappropriate.
The Summary of Product Characteristics for certolizumab pegol recommends a starting dose of 400mg subcutaneously at weeks 0, 2 and 4, followed by maintenance doses of 200mg every two weeks. Response is usually achieved within 12 weeks of treatment. Continued treatment should be carefully reconsidered if no evidence of benefit has been seen within this period.
The manufacturer and the Department of Health have agreed a patient access scheme (PAS). Patients will receive the first 12 weeks of therapy (10 pre-filled syringes of 200mg each) free of charge via a homecare provider. The PAS will be available at least until this TA is reviewed by NICE in September 2010, when the guidance for adalimumab, etanercept and infliximab is also to be reconsidered.
More information on other aspects of rheumatoid arthritis can be found on the rheumatoid arthritis section of NPC
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