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tofacitinib (Xeljanz)

Advice

Following a full submission:

tofacitinib citrate (Xeljanz®) is accepted for restricted use within NHS Scotland.

Indication under review: In combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.

SMC restriction: In patients with severe disease (a disease activity score [DAS28] greater than 5.1) that has not responded to intensive therapy with a combination of conventional DMARDs. In patients with severe disease inadequately controlled by a tumour necrosis factor (TNF) antagonist, it may be used in patients ineligible to receive rituximab.

In a phase III / IV study in patients with rheumatoid arthritis with an inadequate response to conventional DMARDs, non-inferiority of tofacitinib was demonstrated when compared with a tumour necrosis factor alpha (TNF) inhibitor (both in combination with methotrexate) in relation to proportion of patients achieving an American College of Rheumatology response of at least 50% (ACR50). A phase III study in patients with rheumatoid arthritis with an inadequate response to TNF inhibitors demonstrated that tofacitinib plus methotrexate significantly improved signs and symptoms of RA when compared with placebo plus methotrexate.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of tofacitinib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

Drug Details

Drug Name: tofacitinib (Xeljanz)
SMC Drug ID: 1298/18
Manufacturer: Pfizer Ltd
Indication: In combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.
BNF Category:
Submission Type: Full submission
Status: Restricted
Date Advice Published: 12 February 2018

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