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Tocilizumab + MTX (TA247, TA375) (as ) maintain same treatment monit patient every 6 months Has the biologic drug been withdrawn because of an adverse event?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(TA247, TA375) (as ) Baricitinib + MTX (local agreement) Tofacitinib + MTX (local agreement) Has the biologic drug been withdrawn because of an adverse event?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
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
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 60-100kg - 750mg dose >100kg - 1000mg 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
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
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