| Formulary Chapter 10: Musculoskeletal and joint diseases - Full Chapter
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| Notes: |
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.
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| Chapter Links... |
 LSCMMG: Axial Spondyloarthritis: High Cost Drugs Commissioning Pathway |
| LSCMMG: Gout Management Summary Guidelines |
| LSCMMG: Juvenile Idiopathic Arthritis in adult patients: Position statement for biological agents |
| LSCMMG: Psoriatic Arthritis: High Cost Drugs Commissioning Pathway |
| LSCMMG: Rheumatoid Arthritis: High Cost Drugs Commissioning Pathway |
| NHS England high cost drugs commissioning list |
| NICE CG124: Hip fracture: management |
| NICE NG100: Rheumatoid arthritis in adults: management |
| NICE NG193: Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain |
| NICE NG219: Gout: diagnosis and management |
| NICE NG226: Osteoarthritis in over 16s: diagnosis and management |
| NICE NG38: Fractures (non-complex): assessment and management |
| NICE NG59: Low back pain and sciatica in over 16s: assessment and management |
| NICE NG65: Spondyloarthritis in over 16s: diagnosis and management |
| Details... |
| 10.01.03 |
Drugs which suppress the rheumatic disease process |
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Gold |
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Penicillamine |
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Antimalarials |
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Drugs affecting the immune response |
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Cytokine modulators |
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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. |
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Abatacept (Orencia®)
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Formulary
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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 commissioned for some indications.
Consult chapter links for more details.
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 NICE TA195: Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor
NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
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
NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed
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Adalimumab
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Formulary
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S/C injection 40mg prefilled syringe and pen
Commissioned in accordance with LSCMMG biologics pathways.
NHSE commissioned for some indications.
Consult chapter links for more details.
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MHRA: Tumour necrosis factor alpha inhibitors
NHSE: Clinical commissioning policy: Etanercept and adalimumab for the treatment of deficiency of adenosine deaminase type 2 (aged 5 years and older) [2319]
NICE TA195:Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor
NICE TA199: Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis
NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
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
NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed
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Anakinra (Kineret®)
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Formulary
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Solution for injection pre-filled syringes 100mg/0.67mL
NICE does not recommend Anakinra for the treatment of rheumatoid arthritis.
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NICE TA685: Anakinra for treating Still’s disease
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Apremilast (Otezla®)
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Formulary
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Tablets 10mg, 20mg, 30mg
Commissioned in accordance with LSCMMG biologics pathways.
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MHRA: Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour
NICE TA433: Apremilast for treating active psoriatic arthritis
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Baricitinib
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Formulary
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Tablets 2mg, 4mg
Commissioned in accordance with LSCMMG biologics pathways.
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Baricitinib (Olumiant▼): risk of venous thromboembolism
MHRA: Baricitinib (Olumiant▼): increased risk of diverticulitis, particularly in patients with risk factors
MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
NICE TA466: Baricitinib for moderate to severe rheumatoid arthritis
NICE TA982: Baricitinib for treating juvenile idiopathic arthritis in people 2 years and over (terminated appraisal)
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Belimumab (Benlysta® )
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Formulary
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Concentrate for solution for infusion 120mg, 400mg
Solution for injection pre-filled pen 200mg
 TA806 Belimumab for treating lupus nephritis (terminated appraisal)
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MHRA: Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials
NICE TA752:Belimumab for treating active autoantibody-positive systemic lupus erythematosus
NICE TA806: Belimumab for treating lupus nephritis (terminated appraisal)
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Bimekizumab (Bimzelx®)
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Formulary
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Pre-filled syringe/pen 160mg/ml, 320mg/2ml
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NICE TA916: Bimekizumab for treating active psoriatic arthritis
NICE TA918: Bimekizumab for treating axial spondyloarthritis
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Certolizumab Pegol (Cimzia®)
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Formulary
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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.
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MHRA: Tumour necrosis factor alpha inhibitors
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
NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
NICE TA415: Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor
NICE TA445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs
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Etanercept
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Formulary
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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 commissioned for some indications.
Consult chapter links for more details.
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MHRA: Tumour necrosis factor alpha inhibitors
NHSE: Clinical commissioning policy: Etanercept and adalimumab for the treatment of deficiency of adenosine deaminase type 2 (aged 5 years and older) [2319]
NICE TA195:Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor
NICE TA199: Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis
NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
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
NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed
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Filgotinib (Jyseleca®)
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Formulary
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Tablets 100mg, 200mg
Commissioned in accordance with LSCMMG biologics pathways.
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MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
NICE TA676: Filgotinib for treating moderate to severe rheumatoid arthritis
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Golimumab (Simponi®)
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Formulary
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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.
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MHRA: Tumour necrosis factor alpha inhibitors
NICE TA220: Golimumab for the treatment of psoriatic arthritis
NICE TA225: Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying anti-rheumatic drugs
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
NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
NICE TA497: Golimumab for treating non-radiographic axial spondyloarthritis
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Guselkumab (Tremfya®)
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Formulary
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Solution for injection in pre-filled pen 100mg/1ml
Commissioned in accordance with LSCMMG biologics pathways.
Consult chapter links for more details.
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NICE TA815: Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs
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Infliximab
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Formulary
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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 commissioned for some indications.
Consult chapter links for more details.
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MHRA: Tumour necrosis factor alpha inhibitors
NICE TA195:Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor
NICE TA199: Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis
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
NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed
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Ixekizumab (Taltz®)
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Formulary
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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.
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NICE TA537: Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs
NICE TA718: Ixekizumab for treating axial spondyloarthritis
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Risankizumab (Skyrizi®)
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Formulary
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Solution for injection pre-filled pen 150mg/1ml
Solution for injection pre-filled syringe 150mg/1ml
Commissioned in accordance with LSCMMG biologics pathways.
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NICE TA803: Risankizumab for treating active psoriatic arthritis after inadequate response to DMARDs
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Rituximab (Biosimilars avaliable)
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Formulary
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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 commissioned for some indications.
Consult chapter links for more details.
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MHRA: Rituximab: screen for hepatitis B virus before treatment
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®)
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Formulary
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Solution for injection pre-filled pen 150mg, 200mg
Solution for injection syringe 200mg
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NICE TA485: Sarilumab for moderate to severe rheumatoid arthritis
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Secukinumab (Cosentyx®)
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Formulary
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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.
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NICE TA407: Secukinumab for active ankylosing spondylitis after treatment with non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors
NICE TA445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs
NICE TA719: Secukinumab for treating non-radiographic axial spondyloarthritis
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Tocilizumab (Biosimilars avaliable)
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Formulary
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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 commissioned for some indications.
Consult chapter links for more details.
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MHRA: Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation
NICE TA247: Tocilizumab for the treatment of rheumatoid arthritis
NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
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
NICE TA518: Tocilizumab for treating giant cell arteritis
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Tofacitinib (Xeljanz®)
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Formulary
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Tablets 5mg, 10mg
Modified-release tablets 11mg
Commissioned in accordance with LSCMMG biologics pathways.
NHSE commissioned for some indications.
Consult chapter links for more details.
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MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
MHRA: Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies
MHRA: Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections
MHRA: Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing
NICE TA480: Tofacitinib for moderate to severe rheumatoid arthritis
NICE TA543: Tofacitinib for treating active psoriatic arthritis after inadequate response to DMARDs
NICE TA735: Tofacitinib for treating juvenile idiopathic arthritis
NICE TA920: Tofacitinib for treating active ankylosing spondylitis
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Upadacitinib (Rinvoq ®)
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Formulary
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Modified-release tablets 15mg, 30mg, 45mg
Commissioned in accordance with LSCMMG biologics pathways.
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MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
NICE TA665: Upadacitinib for treating severe rheumatoid arthritis
NICE TA744: Upadacitinib for treating moderate rheumatoid arthritis
NICE TA768: Upadacitinib for treating active psoriatic arthritis after inadequate response to DMARDs
NICE TA829: Upadacitinib for treating active ankylosing spondylitis
NICE TA861: Upadacitinib for treating active non-radiographic axial spondyloarthritis
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Ustekinumab
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Formulary
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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.
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MHRA: Ustekinumab (Stelara): risk of exfoliative dermatitis
NICE TA340: Ustekinumab for treating active psoriatic arthritis
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| 10.01.03 |
Sulfasalazine |
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Key |
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Restricted Drug |
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Unlicensed |
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
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Scottish Medicines Consortium |
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Cytotoxic Drug |
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Controlled Drug |
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High Cost Medicine |
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Cancer Drugs Fund |
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NHS England |
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Homecare |
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ICB |
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Low carbon footprint |
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Medium carbon footprint |
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High carbon footprint |
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| Status |
Description |
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Green:
Appropriate for initiation and ongoing prescribing in both primary and secondary care.
Generally, little or no routine drug monitoring is required. |
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Green (Restricted):
Appropriate for initiation and ongoing prescribing in both primary and secondary care provided:
Additional criteria specific to the medicine or device are met, or
The medicine or device is used following the failure of other therapies as defined by the relevant LSCMMG pathway.
Generally, little or no routine drug monitoring is required.
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Red medicines:
Medicine is supplied by the hospital for the duration of the treatment course.
Primary care initiation or continuation of treatment is not recommended unless exceptional circumstances such as specialist GP.
Red medicines are those where primary care prescribing is not recommended. These treatments should be initiated by specialists only and prescribing retained within secondary care. They require specialist knowledge, intensive monitoring, specific dose adjustments or further evaluation in use. If however, a primary care prescriber has particular specialist knowledge or experience of prescribing a particular drug for a particular patient it would not always be appropriate for them to expect to transfer that prescribing responsibility back to secondary care. There should be a specific reason and a specific risk agreement, protocol and service set up to support this.
Primary care prescribers may prescribe RED medicines in exceptional circumstances to patients to ensure continuity of supply while arrangements are made to obtain ongoing supplies from secondary care. |
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Amber level 0:
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Little or no specific monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Brief prescribing document or information sheet may be required.
Primary care prescribers must be familiar with the drug to take on prescribing responsibility or must get the required information.
When recommending or handing over care, specialists should ask primary care prescribers to take over prescribing responsibility, and should give enough information about the indication, dose, monitoring requirements, use outside product licence and any necessary dose adjustments to allow them to confidently prescribe. |
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Amber level 1 (with shared care):
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Minimal monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Primary care prescribers are advised not to take on prescribing of these medicines unless they have been adequately informed by letter of their responsibilities with regards monitoring, side effects and interactions and are happy to take on the prescribing responsibility. A copy of locally approved shared care guidelines should accompany this letter which outlines these responsibilities. Primary care prescribers should then tell secondary care of their intentions as soon as possible by letter so that arrangements can be made for the transfer of care. |
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Amber level 2 (with shared care and enhanced service):
Initiated by specialist and transferred to primary care following a successful initiation period.
Significant monitoring required on an on-going basis.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Suitable for enhanced service.
These medicines are considered suitable for GP prescribing following specialist initiation of therapy, as per shared care document which will be sent out with the request to prescribe, with on-going communication between the primary care prescriber and specialist. Amber Level 2 medicines require significant monitoring for which an enhanced service may be suitable. (Subject to local commissioning agreements). |
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Do not prescribe: NOT recommended for use by the NHS in Lancashire and South Cumbria.
Includes medicines that NICE has not recommended for use and terminated technology appraisals, unless there is a local need. |
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Grey medicines:
Medicines which have not yet been reviewed or are under the review process.
GPs and specialists are recommended not to prescribe these drugs.
This category includes drugs where funding has not yet been agreed.
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Refer to local guidance. |
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