Lancashire and South Cumbria
Formulary
 
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10 Musculoskeletal and joint diseases

This chapter of the formulary is under continual development, please let the team know if you have any comments about the contents: mlcsu.lscformulary@nhs.net

For more information about the formulary development process, please see: https://www.lancsmmg.nhs.uk/lancashire-and-south-cumbria-icb-formulary-development/

10-01-03 Cytokine modulators

Consultant Rheumatologist initiation only.
Only to be prescribed in accordance with NICE Guidelines.

Commissioned by NHS England for paediatric indications where an adult NICE TA is in place.


Abatacept Orencia®
Formulary

Solution for infusion 250mg
solution for injection pre-filled syringes 125mg/1ml
Solution for injection pre-filled pens 125mg/1ml

Commissioned in accordance with LSCMMG biologics pathways.
NHSE NHSE commissioned for some indications.
Consult chapter links for more details.

Link  NICE TA195: Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor
Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
Link  NICE TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed

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Adalimumab
Formulary

S/C injection 40mg prefilled syringe and pen

Commissioned in accordance with LSCMMG biologics pathways.
NHSE NHSE commissioned for some indications.
Consult chapter links for more details.

Link  MHRA: Tumour necrosis factor alpha inhibitors
Link  NHSE: Clinical commissioning policy: Etanercept and adalimumab for the treatment of deficiency of adenosine deaminase type 2 (aged 5 years and older) [2319]
Link  NICE TA195:Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor
Link  NICE TA199: Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis
Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
Link  NICE TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
Link  NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed

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Anakinra Kineret®
Formulary

Solution for injection pre-filled syringes  100mg/0.67mL

NICE does not recommend Anakinra for the treatment of rheumatoid arthritis.

Link  NICE TA685: Anakinra for treating Stills disease

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Apremilast Otezla®
Formulary

Tablets 10mg, 20mg, 30mg

Commissioned in accordance with LSCMMG biologics pathways.

Link  MHRA: Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour
Link  NICE TA433: Apremilast for treating active psoriatic arthritis

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Baricitinib
Formulary

Tablets 2mg, 4mg

Commissioned in accordance with LSCMMG biologics pathways.

Link  Baricitinib (Olumiant▼): risk of venous thromboembolism
Link  MHRA: Baricitinib (Olumiant▼): increased risk of diverticulitis, particularly in patients with risk factors
Link  MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
Link  NICE TA466: Baricitinib for moderate to severe rheumatoid arthritis
Link  NICE TA982: Baricitinib for treating juvenile idiopathic arthritis in people 2 years and over (terminated appraisal)

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Belimumab Benlysta®
Formulary

Concentrate for solution for infusion 120mg, 400mg

Solution for injection pre-filled pen 200mg

Do Not Prescribe TA806 Belimumab for treating lupus nephritis (terminated appraisal)

Link  MHRA: Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials
Link  NICE TA752:Belimumab for treating active autoantibody-positive systemic lupus erythematosus
Link  NICE TA806: Belimumab for treating lupus nephritis (terminated appraisal)

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Bimekizumab Bimzelx®
Formulary

Pre-filled syringe/pen 160mg/ml, 320mg/2ml

 

Link  NICE TA916: Bimekizumab for treating active psoriatic arthritis
Link  NICE TA918: Bimekizumab for treating axial spondyloarthritis

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Certolizumab Pegol Cimzia®
Formulary

Solution for injection pre-filled pens 200mg/1ml
Solution for injection pre-filled syringes 200mg/1ml
Solution for injection in a dose-dispenser cartridge 200mg/1ml

Commissioned in accordance with LSCMMG biologics pathways.

Consult chapter links for more details.

Link  MHRA: Tumour necrosis factor alpha inhibitors
Link  NICE TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
Link  NICE TA415: Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor
Link  NICE TA445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs

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Etanercept
Formulary

Solution for injection pre-filled syringe 25mg, 50mg
Solution for injection pre-filled pen 25mg, 50mg
Powder and solvent for solution for injection 10mg, 25mg

Commissioned in accordance with LSCMMG biologics pathways.
NHSE NHSE commissioned for some indications.
Consult chapter links for more details.

Link  MHRA: Tumour necrosis factor alpha inhibitors
Link  NHSE: Clinical commissioning policy: Etanercept and adalimumab for the treatment of deficiency of adenosine deaminase type 2 (aged 5 years and older) [2319]
Link  NICE TA195:Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor
Link  NICE TA199: Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis
Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
Link  NICE TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
Link  NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed

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Filgotinib  Jyseleca®
Formulary

Tablets 100mg, 200mg

Commissioned in accordance with LSCMMG biologics pathways.

Link  MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
Link  NICE TA676: Filgotinib for treating moderate to severe rheumatoid arthritis

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Golimumab Simponi®
Formulary

Solution for injection pre-filled pen 50mg, 100mg
Solution for injection pre-filled syringe 50mg

Commissioned in accordance with LSCMMG biologics pathways.

Consult chapter links for more details.

Link  MHRA: Tumour necrosis factor alpha inhibitors
Link  NICE TA220: Golimumab for the treatment of psoriatic arthritis
Link  NICE TA225: Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying anti-rheumatic drugs
Link  NICE TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
Link  NICE TA497: Golimumab for treating non-radiographic axial spondyloarthritis

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Guselkumab Tremfya®
Formulary

Solution for injection in pre-filled pen 100mg/1ml

Commissioned in accordance with LSCMMG biologics pathways.

Consult chapter links for more details.

Link  NICE TA815: Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs

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Infliximab
Formulary

Solution for injection pre-filled pen 120mg/1ml
Powder for concentrate for solution for infusion 100mg

Adequate resuscitation facilities must be available when infliximab is used.

Commissioned in accordance with LSCMMG biologics pathways.
NHSE NHSE commissioned for some indications.
Consult chapter links for more details.

Link  MHRA: Tumour necrosis factor alpha inhibitors
Link  NICE TA195:Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor
Link  NICE TA199: Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis
Link  NICE TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
Link  NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed

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Ixekizumab Taltz®
Formulary

Solution for injection pre-filled pen 80mg/1ml
Solution for injection pre-filled syringe 80mg/1ml

Commissioned in accordance with LSCMMG biologics pathways.

Consult chapter links for more details.

Link  NICE TA537: Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs
Link  NICE TA718: Ixekizumab for treating axial spondyloarthritis

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Risankizumab Skyrizi®
Formulary

Solution for injection pre-filled pen 150mg/1ml
Solution for injection pre-filled syringe 150mg/1ml

Commissioned in accordance with LSCMMG biologics pathways.

Link  NICE TA803: Risankizumab for treating active psoriatic arthritis after inadequate response to DMARDs

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Rituximab Biosimilars avaliable
Formulary

Concentrate for intravenous infusion 500mg/50mL

All anti-lymphocyte monoclonal antibodies should be given under the supervision of an experienced specialist, in an environment where full resuscitation facilities are immediately available.

Commissioned in accordance with LSCMMG biologics pathways.
NHSE NHSE commissioned for some indications.

Consult chapter links for more details.

Link  MHRA: Rituximab: screen for hepatitis B virus before treatment
Link  NICE TA195:Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor

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Sarilumab Kevzara®
Formulary

Solution for injection pre-filled pen 150mg, 200mg
Solution for injection syringe 200mg

Link  NICE TA485: Sarilumab for moderate to severe rheumatoid arthritis

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Secukinumab Cosentyx®
Formulary

Solution for injection pre-filled pen 150mg/1ml, 300mg/2ml
Solution for injection pre-filled syringe 75mg/0.5ml, 150mg/1ml

Commissioned in accordance with LSCMMG biologics pathways.

Link  NICE TA407: Secukinumab for active ankylosing spondylitis after treatment with non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors
Link  NICE TA445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs
Link  NICE TA719: Secukinumab for treating non-radiographic axial spondyloarthritis

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Tocilizumab Biosimilars avaliable
Formulary

Solution for injection pre-filled pen 162mg/0.9ml
Solution for injection pre-filled syringe 162mg/0.9ml
Concentrate for solution for infusion 80mg, 200mg, 400mg

Commissioned in accordance with LSCMMG biologics pathways.
NHSE NHSE commissioned for some indications.

Consult chapter links for more details.

Link  MHRA: Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation
Link  NICE TA247: Tocilizumab for the treatment of rheumatoid arthritis
Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
Link  NICE TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA518: Tocilizumab for treating giant cell arteritis

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Tofacitinib Xeljanz®
Formulary

Tablets 5mg, 10mg
Modified-release tablets 11mg

Commissioned in accordance with LSCMMG biologics pathways.
NHSE NHSE commissioned for some indications.
Consult chapter links for more details.

Link  MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
Link  MHRA: Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies
Link  MHRA: Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections
Link  MHRA: Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing
Link  NICE TA480: Tofacitinib for moderate to severe rheumatoid arthritis
Link  NICE TA543: Tofacitinib for treating active psoriatic arthritis after inadequate response to DMARDs
Link  NICE TA735: Tofacitinib for treating juvenile idiopathic arthritis
Link  NICE TA920: Tofacitinib for treating active ankylosing spondylitis

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Upadacitinib  Rinvoq®
Formulary

Modified-release tablets 15mg, 30mg, 45mg

Commissioned in accordance with LSCMMG biologics pathways.

Link  MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
Link  NICE TA665: Upadacitinib for treating severe rheumatoid arthritis
Link  NICE TA744: Upadacitinib for treating moderate rheumatoid arthritis
Link  NICE TA768: Upadacitinib for treating active psoriatic arthritis after inadequate response to DMARDs
Link  NICE TA829: Upadacitinib for treating active ankylosing spondylitis
Link  NICE TA861: Upadacitinib for treating active non-radiographic axial spondyloarthritis

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Ustekinumab
Formulary

Solution for injection pre-filled syringe 45mg/0.5ml, 90mg/1ml
Solution for injection pre-filled pen 45mg/0.5ml, 90mg/1ml
Solution for injection vial 45mg/0.5ml

Commissioned in accordance with LSCMMG biologics pathways.

Link  MHRA: Ustekinumab (Stelara): risk of exfoliative dermatitis
Link  NICE TA340: Ustekinumab for treating active psoriatic arthritis

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