572 09 ustekinumab (Stelara)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:
- ustekinumab (Stelara) for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA) (restricted)
Further Details:
USTEKINUMAB (STELARA)
- Ustekinumab (Stelara) is accepted for restricted for use within NHS Scotland for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA).
- Significantly more patients treated with ustekinumab achieved at least 75% improvement in their Psoriasis Area and Severity Index (PASI) score at week 12, compared with those treated with a tumour necrosis factor alpha antagonist.
- Continued treatment should be restricted to patients who achieve a PASI 75 response within 16 weeks.
- This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ustekinumab. This SMC advice is dependent upon the continuing availability of the patient access scheme in NHS Scotland.
- The net budget impact for the NHS in Scotland was estimated by the manufacturer to be £2k in year 1 rising to £14k by year 5. Note that these figures are based on implementation of the patient access scheme. The manufacturer assumed 9 patients in year 1 and 173 in year 5. The manufacturer assumed a market share of 1.6% in year 1 rising to 24.8% in year 5. This may be an underestimate.
Notes for editors – Glossary:
- Plaque psoriasis – Psoriasis is a chronic skin disease which causes red, raised skin patches that produce dead, flaky skin cells. Plaque psoriasis is the most common type of this skin condition and can affect any part of the body.
Notes for editors – About SMC:
1. The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) in Scotland about the use of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. It does this after new medicines have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) / European Medicines Evaluation Agency (EMEA).
2. The SMC process encourages pharmaceutical manufacturers to make a submission before a product is launched. The aim is to issue advice as soon as possible after the launch of a product.
3. Membership of the SMC has been derived from NHS Boards across Scotland. Membership is wide ranging across multi-disciplines of NHS Scotland and also includes members of the Association of British Pharmaceutical Industry (ABPI), and patient and voluntary group representatives.
4. This advice represents the views of the Scottish Medicines Consortium and was arrived at after careful consideration of the available evidence. Health professionals are expected to take due account of this recommendation when exercising their clinical judgement. This recommendation does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
For further information, contact Stephen Ferguson on 07779 329 689.