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New HTA Decisions in England
October 2021
Drug name
XELJANZ® (tofacitinib)
Company
Pfizer
Decision date
09/09/2021
Therapeutic area
Musculoskeletal conditions
Therapeutic sub area
Arthritis
Decision
Recommended with restrictions
Indication
Tofacitinib is indicated for treating active polyarticular juvenile idiopathic arthritis (JIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis in people 2 years and older.
Decision Detail
1.1 It is recommended only if the patient's condition has responded inadequately to previous treatment with disease-modifying antirheumatic drugs (DMARDs), and only if: • a tumour necrosis factor (TNF) alpha inhibitor is not suitable or does not control the condition well enough, and • the company provides tofacitinib according to the commercial arrangement (simple discount patient access scheme). 1.2 Tofacitinib can be used with methotrexate, or as monotherapy when methotrexate is not tolerated or if continued treatment with methotrexate is inappropriate. 1.3 If tofacitinib is one of a range of treatments considered suitable by patients, or their parents or carers, and their clinicians, choose the least expensive (taking into account administration costs and commercial arrangements). 1.4 This recommendation is not intended to affect treatment with tofacitinib that was started in the NHS before this guidance was published. Children and young people having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. This decision should be made jointly by the clinician, the child or young person, and their parents or carers.
Summary
Tofacitinib has been compared with placebo in a phase 3, randomised, double-blind trial, study A3921104. This showed that tofacitinib was superior to placebo for a range of outcomes at 44 weeks. As there are no trials directly comparing tofacitinib with current treatments, the company carried out indirect comparisons to compare tofacitinib with adalimumab and tocilizumab. These suggested that, for the outcomes of disease flare, disease activity (measured by the American College of Rheumatology [ACR] 30, 50 and 70), tofacitinib is similar to the comparators (the exact results are considered confidential by the company and cannot be reported here). The committee concluded that tofacitinib is likely to have similar clinical effectiveness to adalimumab and tocilizumab, although the long-term effectiveness is uncertain. The company did not present any clinical evidence comparing tofacitinib with etanercept. The committee appreciated that this would have been difficult to do, and any analysis would have been very uncertain. Adalimumab biosimilars are available in the NHS at a considerable discount to the list price of the originator product (exact prices are confidential and cannot be reported here). There is also a confidential discount for tocilizumab. When this is applied, tofacitinib has similar overall costs to tocilizumab but costs more than adalimumab and is likely to cost more than etanercept. (the exact results are confidential and cannot be reported here). The company did not provide a cost-comparison analysis comparing tofacitinib with etanercept. However, the committee was aware that etanercept biosimilars are available in the NHS at a considerable discount to the list price of the originator (exact prices are confidential and cannot be reported here). This means tofacitinib is likely to have higher costs than etanercept. So the committee concluded that it could recommend tofacitinib for both polyarticular JIA and juvenile psoriatic arthritis, but only if a tumour necrosis factor (TNF) alpha inhibitor (such as adalimumab and etanercept) is not suitable or does not control the condition well enough.