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DORSET MEDICINES ADVISORY GROUP

COMMISSIONING STATEMENT ON THE USE OF AND SECUKINUMAB FOR TREATING ACTIVE AFTER INADEQUATE RESPONSE TO DMARDS

SUMMARY  NHS Dorset Clinical Commissioning Group and NICE recommends the use of certolizumab pegol or secukinumab, in accordance with NICE TA 445. NICE TA 445 states:

Certolizumab pegol alone, or in combination with , is recommended as an option for treating active psoriatic arthritis in adults only if:  It is used as described in the NICE technology appraisal guidance on , and for the treatment of psoriatic arthritis (recommendations 1.1 and 1.2) or  The person has had a tumour necrosis factor (TNF)-alpha inhibitor but their disease has stopped responding after the first 12 weeks.

Certolizumab pegol is only recommended if the company provides it as agreed in the patient access scheme.

Secukinumab alone, or in combination with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults only if:  It is used as described in the NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis (recommendations 1.1 and 1.2) or BACKGROUND  The person has had a TNF alpha inhibitor but their disease has not responded within the first 12 weeks or has stopped responding after 12 weeks or  TNF alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis).

Secukinumab is only recommended if the company provides it as agreed in the patient access scheme.

Assess the response to certolizumab pegol and secukinumab after 12 weeks and 16 weeks of treatment respectively. Only continue treatment if there is clear evidence of response, defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria. People whose disease has a Area and Severity Index (PASI) 75 response but whose PsARC response does not justify continuing treatment should be assessed by a dermatologist, to determine whether continuing treatment is appropriate based on skin response (as described in the NICE technology appraisal guidance on

etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis, recommendation 1.3).

RELEVANT NICE https://www.nice.org.uk/guidance/ta445 GUIDANCE

FORMULARY STATUS Red

PBR STATUS Drug costs excluded from PbR tariff

COMMISSIONING These treatments would be used within the local guideline agreed for the IMPLICATIONS management of psoriatic arthritis with biologic agents.

RELEVANT CLINICAL Commissioned within MSK Right Care programme. WORKING GROUP The local pathway for the management of psoriatic arthritis with biologics suggests that certolizumab or secukinumab may be considered as a first PATIENT PATHWAY line option. Where clinically appropriate the most cost effective agent IMPLICATIONS should be selected.

SUMMARY OF EVIDENCE TO SUPPORT https://www.nice.org.uk/guidance/ta445 FORMULARY STATUS NICE states:

“Certolizumab pegol and secukinumab are further options for the treatment of active psoriatic arthritis after inadequate response to disease-modifying anti-rheumatic drugs (DMARDs). Therefore, no significant change in resource impact is anticipated. ASSESSMENT OF COST There are patient access schemes for certolizumab pegol and IMPLICATIONS secukinumab which provide discounts to the list price. The discount for secukinumab is commercial in confidence. Certolizumab pegol and secukinumab are commissioned by clinical commissioning groups. Providers are secondary care and community care.”

REFERENCES http://www.nice.org.uk/guidance/ta369

Date July 2017

Review date May 2019 or before in the light of new information

Contact for this Policy Michelle Trevett, Senior Pharmacist, NHS Dorset CCG