DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC)

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1 DERBYSHIRE JOINT AREA PRERIBING COMMITTEE (JAPC) Derbyshire commissioning guidance on biologic drugs f the treatment of Rheumatoid arthritis with methotrexate This algithm is a tool to aid the implementation of NICE guidance on biologic drugs f the treatment of rheumatoid arthritis. It includes all of the biologic drugs approved by NICE f treatment local variations f the commissioning algithm. Use stard DMARD treatment(s) f Rheumatoid arthritis Is DAS28 sce 5.1? Has the disease responded to intensive with a combination of DMARDS? If rituximab is not contra-indicated Rituximab + MTX (as per TA195) OR Abatacept + MTX (TA195) (local agreement) Baricitinib + MTX (local agreement) Tofacitinib + MTX (local agreement) maintain same treatment monit patient every 6 months If me than 1 treatment is suitable, the least expensive should be chosen. Choices are listed in most cost effective der. First line biologic agent: Etanercept biosimilar + MTX (TA375) Alternative biologic can be considered if first line biologic is clinically inappropriate: Infliximab biosimilar + MTX (TA375) Certolizumab pegol + MTX (TA375) Sarilumab + MTX (TA485) Golimumab + MTX (TA225, TA375) Adalimumab + MTX (TA375) Abatacept +MTX (TA375) Tocilizumab + MTX (TA247, TA375) (as ) Baricitinib + MTX (TA466) Tofacitinib + MTX (TA480) consider alternative biologic agent Etanercept biosimilar + MTX (TA375) Infliximab biosimilar + MTX (TA375) Certolizumab pegol + MTX (TA375) Sarilumab + MTX (TA485) Golimumab + MTX (TA225, TA375) Adalimumab + MTX (TA375) Tocilizumab + MTX (TA247, TA375) (as ) maintain same treatment monit patient every 6 months Has the biologic drug been withdrawn because of an adverse event? Local variation to NICE NICE approved treatments Etanercept biosimilar + MTX (TA375) Infliximab biosimilar + MTX (TA375) Certolizumab pegol + MTX (TA375) Sarilumab + MTX (TA485) Golimumab + MTX (TA225, TA375) Adalimumab + MTX (TA375) Abatacept +MTX (TA375) Tocilizumab + MTX (TA247, TA375) (as ) Baricitinib + MTX (local agreement) Tofacitinib + MTX (local agreement) Has the biologic drug been withdrawn because of an adverse event? maintain same treatment monit months Stop treatment The CCG s will only commission 6 treatment options (5 switches) per patient - this includes 2 treatment failures 1 intolerance

2 Derbyshire commissioning guidance on biologic drugs f the treatment of Rheumatoid arthritis without methotrexate This algithm is a tool to aid the implementation of NICE guidance on biologic drugs f the treatment of rheumatoid arthritis. It includes all of the biologic drugs approved by NICE f treatment local variations f the commissioning algithm. Use stard DMARD treatment(s) f Rheumatoid arthritis Is DAS28 sce 5.1? * Patients who have had a proven malignancy in the last 10 years those with significant pulmonary fibrosis may be offered rituximab instead of TNF inhibit If me than 1 treatment is suitable, the least expensive should be chosen. Choices are listed in most cost effective der f mono. First line biologic agent: Etanercept biosimilar (TA375) Use RA pathway with methotrexate Has the disease responded to intensive with a combination of DMARDS? Is the patient intolerant to MTX, is treatment with MTX considered to be inappropriate? Alternative biologic can be considered if first line biologic is clinically inappropriate: Certolizumab pegol (TA375) Sarilumab (TA485) Adalimumab (TA375) Tocilizumab (TA247, TA375) (as ) Baricitinib (TA466) Tofacitinib (TA480) If rituximab* as mono is not contra-indicated Rituximab (local agreement) Baricitinib (local agreement) Tofacitinib (local agreement) Etanercept biosimilar (TA195) Certolizumab (NICE TA415) Sarilumab (TA485) Adalimumab (TA195) - maintain monit months Tocilizumab (as ) (local agreement) Has the biologic drug been withdrawn because of an adverse event? Mono options: Etanercept biosimilar (TA375) Certolizumab (NICE TA415) Sarilumab (TA485) Adalimumab (TA375) maintain monit Tocilizumab (as ) (local agreement) Baricitinib (local agreement) Tofacitinib (local agreement) Has the biologic drug been withdrawn because of an adverse event? - maintain monit months Stop treatment consider an alternative biologic agent The CCG s will only commission 6 treatment options (5 switches) per patient - this includes 2 treatment failures 1 intolerance

3 Drug NICE TA TA details Route Dose Intravenous therapies Abatacept Selective T-cell stimulation modulat conventional DMARDS 1 st line 125mg once weekly Adalimumab Monoclonal antibody that specifically binds to TNF f pts: <60kg 500mg dose kg - 750mg dose >100kg mg dose Given initially at week 0, 2, 4 then every 4 weeks thereafter. 40mg every other week F mono dose may increase to 40mg per week, if patient experiences a decrease in response. Certolizumab Recombinant humanised antibody Fab' fragment against TNF alpha NICE TA415 to TNF inhibit Initially 400mg given at Week 0, 2 4 then 200mg every 2 weeks thereafter Or 400mg every 4 weeks, once clinical response confirmed. Etanercept Biosimilar Recombinant human TNF recept fusion protein. to TNF inhibit 50mg every week Or 25mg twice weekly to TNF inhibit

4 Golimumab Monoclonal antibody that prevents the binding of TNF to its recepts. NICE TA225 F pts < 100kg - 50mg every month F pts >100kg - 100mg every month, if inadequate clinical response after 3-4 doses.) Infliximab biosimilar Rituximab Biosimilar Sarilumab Chimeric monoclonal antibody, with high affinity to TNF. Chimeric monoclonal antibody depletes B- cell population. Human monoclonal antibody selective f the IL-6 recept NICE TA485 to TNF inhibit If pt has had an inadequate response intolerant of DMARDS at least one TNF DMARDs / 1 biological DMARD, only if they cannot have rituximab 3mg/kg dose, given at week 0, 2, 6 then every 8 weeks thereafter. If there is an inadequate response loss of response after 12 weeks of treatment, consider increasing dose step-wise by approximately 1.5mg/kg up to a maximum of 7.5mg/kg every 8 weeks 3mg/kg every 4 weeks 2x 1000mg given 2 weeks apart, repeated no less than 16 weeks. 200mg once every 2 weeks. Reduce the dose to 150mg once every 2 weeks f patients with neutropenia, thrombocytopenia increased LFTS. And Tocilizumab Monoclonal antibody inhibits interleukin-6 (IL-6) recept NICE TA247 Disease responded inadequately to rituximab at least 1 biological DMARD And - 162mg once weekly (as per SPC) - 8mg/kg every 4 weeks

5 Oral therapies Baricitinib Tofacitinib Selective JAK1 JAK2 inhibit Inhibit of JAK1 JAK3. NICE TA466 NICE TA480 inhibit the pt cannot receive rituximab because of CI adverse event to rituximab DMARDs / 1 biological DMARD (only if they cannot have rituximab) DMARDs / 1 biological DMARD (if they cannot have rituximab) PO PO F patients >100kg, doses exceeding 800mg are not recommended 4mg once daily. 2mg once daily is appropriate f pts 75 years over 5mg taken twice daily