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 Formulary Chapter 10: Musculoskeletal and joint diseases - Full Chapter
10.01.03  Expand sub section  Drugs which suppress the rheumatic disease process
10.01.03  Expand sub section  Gold
10.01.03  Expand sub section  Penicillamine
10.01.03  Expand sub section  Antimalarials
10.01.03  Expand sub section  Drugs affecting the immune response to top
10.01.03  Expand sub section  Cytokine modulators
Abatacept (Orencia®)
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Formulary
Red
  • Abatacept 250mg injection is approved for:
    • Juvenile idiopathic arthritis in patients aged six years and above (licensed) and under six years. It should only be prescribed with informed consent.
    • People aged 6 years and older to treat polyarticular juvenile idiopathic arthritis (JIA) whose diease has responded inadequately to other DMARDs, including at least one tumour necrosis factor (TNF) inhibitor in accordance with NICE.
    • Rheumatoid arthritis after the failure of a TNF inhibitor in line with NICE.
    • Treatment in adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed in accordance with NICE.
    • Treatment of severe treatment-resistant morphoea in line with NHS England Clinical Commissioning Policy
    • Treating modertae rheumatoid arthritis after conventional DMARDs have failed in line with NICE
    • Treating idiopathic inflammatory myopathies in adults and children aged 2 and over in line with NHS England Commissioning Policy
  • Abatacept 125mg SC injection (prefilled syringe) is approved for moderate to severe rheumatoid arthritis in accordance with NICE.
 
Link  Clinical Commissioning Policy (210505P) Statement: Abatacept for treatment of severe treatment-resistant morphoea (localised scleroderma)
Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
Link  NICE TA375: 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
 
Adalimumab
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Red
  • Adalimumab is approved for:
    • The treatment of adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed in accordance with NICE 
    • Rheumatoid arthritis after the failure of a TNF inhibitor in accordance with NICE.
    • Treatment of severe active ankylosing spondylitis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs in accordance with NICE.
    • Psoriatic arthritis in accordance with NICE.
    • As a second-line anti-TNF therapy in children with juvenile idiopathic arthritis and uveitis.
    • Children and adults aged 2 years and older to treat polyarticular juvenile idiopathic arthritis (JIA) whose disease has responded inadequately to 1 or more DMARD in accordance with NICE.
    • Treating moderate rheumatoid arhritis after conventional DMARDs have failed in line with NICE

 

 
Link  NICE TA195: Rheumatoid arthritis - after failure of a TNF inhibitor
Link  NICE TA199: Psoriatic arthritis
Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
Link  NICE TA375: 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
 
Anakinra (Kineret®)
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Formulary
Red
  • Approved for:
    • Juvenile Idiopathic Arthritis (JIA) in line with NICE and NHS England Clinical Commissioning Policy: E03/P/d
    • Periodic Fevers and Autoinflammatory conditions in line with NHS England Clinical Commissioning Policy: 170062P
    • Adult‑onset Still’s disease and systemic juvenile idiopathic arthritis in people 8 months and older in line with NICE
    • Cryopyrin Associated Periodic Syndrome in line with NHSE Service Specification
    • The treatment of severe gout in patients who have not responded to other treatment and for patients with pseudogout who have failed to respond to conventional treatment or unable to tolerate conventional treatment.
    • Chronic Infantile Neurocutaneous Arthritis (CINCA) and Muckle-Wells Syndrome (unlicensedunlicensed indications).
    • Islet cell transplantation as part of a protocol including alemtuzumab and etanercept to improve outcomes (i.e. insulin dependance)
    • Haemophagocytic Lymphohistiocytosis (HLH) for adults and children in all ages

 

 
Link  NICE TA685: Anakinra for treating Still’s disease
 
Apremilast (Otezla®)
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Formulary
Red
High Cost Medicine
  • Approved for the treatment of psoriatic arthritis in line with NICE
 
Link  MHRA Drug Safety Update (Jan 2017): Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour
Link  NICE TA433: Apremilast for treating active psoriatic arthritis
 
Belimumab (Benlysta®)
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Red

  • Approved for treating active autoantibody-positive systemic lupus erythematosus in line with NICE

 
Link  MHRA Drug Safety Update (April 2019): Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials
Link  NICE TA752: Belimumab for treating active autoantibody-positive systemic lupus erythematosus
 
Bimekizumab  (Bimzelx®)
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Red
High Cost Medicine
CCG
  • Approved for the treatment of active psoriatic arthritis in line with NICE



 
Link  NICE TA916: Bimekizumab for treating active psoriatic arthritis
 
Certolizumab Pegol (Cimzia®)
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Formulary
Red
  • Approved for:
    • Adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed in accordance with NICE.
    • Rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor in accordance with NICE.
    • Severe active ankylosing spondylitis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs in accordance with NICE.
    • Psoriatic arthritis in accordance with NICE.

 
Link  NICE TA 415 - Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor
Link  NICE TA375: 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 TA445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs
Link  NICE TA574: Certolizumab pegol for treating moderate to severe plaque psoriasis
 
Etanercept
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Formulary
Red
High Cost Medicine

Prescribe by brand name.

  • Approved formulations include 10mg (Enbrel®) 25mg injection (Enbrel®, Benepali® & Erelzi®), 50mg injection (Enbrel®, Benepali® & Erelzi®). 
  • Approved for:
    • Treatment in adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed in line with NICE.
    • Rheumatoid arthritis after the failure of a TNF inhibitor in line with NICE.
    • Psoriatic arthritis in accordance with NICE.
    • Treatment of severe active ankylosing spondylitis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs in accordance with NICE.
    • The treatment of juvenile idiopathic arthritis (JIA) in people 2 years or older whose disease has responded inadequately to, or who are intolerant of methotrexate in line with NICE.
    • Treatment of Juvenile Scleroderma (Its use will be subject to informed consent and specialists using etanercept in this indication should collect data on patient outcomes. If after a six month trial, treatment were found to be beneficial, it would be continued for two years. If unsuccessful after six months, treatment should be discontinued).
    • People aged 2 years and older to treat polyarticular juvenile idiopathic arthritis (JIA) whose diease has responded inadequately to, or who are intolerant of methotrexate in line with NICE.
    • Treating moderate rheumatoid arthritis after conventional DMARDs have failed in line with NICE


 
Link  NICE TA35: Adult psoriasis
Link  NICE TA195: Rheumatoid arthritis after the failure of a TNF inhibitor
Link  NICE TA199: Psoriatic arthritis
Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for JIA
Link  NICE TA375: 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
 
Golimumab (Simponi®)
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Formulary
Red
High Cost Medicine
CCG
  • Approved for:
    • Rheumatoid arthritis in accordance with NICE.
    • Psoriatic arthritis in accordance with NICE.
    • The treatment of severe active ankylosing spondylitis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs in accordance with NICE.
    • Treatment in adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed in accordance with NICE.
    • The treatment of non-radiographic axial spondyloarthritis in accordance with NICE

 

 
Link  NICE TA220: psoriatic arthritis
Link  NICE TA497: Golimumab for treating non-radiographic axial spondyloarthritis
Link  NICE TA375: 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
 
Guselkumab  (Tremfya)
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Red
  • 100 mg/1 mL as a pre-filled syringe
  • Approved (alone or with methotrexate) for treating active psoriatic arthritis after inadequate response to DMARDs in line with NICE

Overview | Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs | Guidance | NICE

 
Link  NICE TA815: Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs
 
Infliximab (Remsima®, Inflectra®, Remicade® )
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Formulary
Red
  • Approved for:
    • Treatment in adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs have failed in accordance with NICE.
    • Rheumatoid arthritis after the failure of a TNF inhibitor in line with NICE.
    • Psoriatic arthritis in accordance with NICE.
    • JIA in patients who have not responded to etanercept.
    • Juvenile dermatomyositis and paediatric onset Behcet’s disease where there has been intolerance or lack of response to 1st and 2nd line therapies.
    • The treatment of severe active ankylosing spondylitis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs in accordance with NICE.
    • Treating moderate rheumatoid arthritis after conventional DMARDs have failed in line with NICE


  • Prescribe by brand name; Remsima®, Inflectra®, Remicade®. 

 

 
Link  Infliximab subcutaneous injection (Remsima SC ®) - interim COVID-19 guidance
Link  NICE TA195: Rheumatoid arthritis (after failure of a TNF inhibitor)
Link  NICE TA199: Psoriatic arthritis
Link  NICE TA375: 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
 
Ixekizumab (Taltz®)
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Formulary
Red
High Cost Medicine
CCG
  • 80mg/ml pre-filled syringe or pen
  • Approved for the treatment of axial spondyloarthritis in line with NICE
  • Approved for the treatment of active psoriatic arthritis after inadequate response to DMARDS

 
Link  NICE TA537: Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs
Link  NICE TA718: Ixekizumab for treating axial spondyloarthritis
 
Rituximab
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Formulary
Red
  • Approved for:
    • Adults with severe systemic lupus erythematosus who have failed conventional therapies.
    • Rheumatoid arthritis after the failure of a TNF inhibitor in line with NICE.
    • Combination with methotrexate as first-line biological therapy in cases where there is an absolute contraindication to tumour necrosis factor inhibitors (NETAG approval).
    • Combination with other (non-methotrexate) disease modifying antirheumatic drugs and as monotherapy in cases in which conventional treatment with tumour necrosis factor inhibitors or methotrexate is deemed unsafe (NETAG approval).
    • For immunoglobulin G4-related disease (IgG4-RD) in accordance with NHS England Commissioning Criteria
    • Myositis in accordance with NHS England Commissioning Criteria
    • Juvenile Idiopathic Arthritis (JIA) in accordance with NHS England Commissioning Criteria

 

 
Link  NHS England Commissioning Policies (Specialised Rheumatology)
Link  NICE TA195: Rheumatoid arthritis - after failure of a TNF inhibitor
Link  NTAG - Treatment Appraisal Decision Summary - Rituximab Biosimilars
Link  MHRA Drug Safety Update (Dec 2013): Rituximab: screen for hepatitis B virus before treatment.
Link  MHRA Drug Safety Update (Dec 2014): Rituximab: progressive multifocal leukoencephalopathy in a patient
 
Sarilumab  (Kevzara®)
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Formulary
Red
High Cost Medicine

  • 150mg/1.14mL & 200mg/1.14mL injection

  • Approved as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs) in line with NICE

 
Link  NICE TA485: Sarilumab for moderate to severe rheumatoid arthritis
 
Secukinumab (Cosentyx®)
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Formulary
Red
  • Approved for active ankylosing spondylitis in line with NICE.
  • Approved for psoriatic arthritis in line with NICE.
  • Approved for the treatment of non-radiographic axial spondyloarthritis in line with NICE
 
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
 
Tocilizumab (RoActemra®)
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Formulary
Red
NHS England
CCG
BlueTeq
  • IV preparations approved for:
    • Systemic JIA in children and young people aged 2 years and older in line with NICE.
    • People aged 2 years and older to treat polyarticular juvenile idiopathic arthritis (JIA) whose diease has responded inadequately to previous therapy with methotrexate in line with NICE.
    • An alternative treatment to anakinra for patients with systemic onset JIA who have already received treatment with etanercept and adalimumab (NETAG approval). Not recommended for polyarticular JIA.
    • Rheumatoid arthritis in accordance with NICE.
    • Treatment in adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed in accordance with NICE.
  • 162mg SC injection is approved for:
    • Rheumatoid arthritis in accordance with NICE.
    • Giant cell arteritis in adults only if:
      • they have relapsing or refractory disease
      • they have not already had tocilizumab
      • tocilizumab is stopped after 1 year of uninterrupted treatment at most.
  • Monitoring: monitoring of tocilizumab in adult patients can be undertaken by GPs under a shared care arrangement Amber

 

 
Link  MHRA Drug Safety Update (July 2019): 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: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA518: Tocilizumab for treating giant cell arteritis
Link  North of Tyne, Gateshead and North Cumbria - Tocilizumab monitoring Shared Care Guideline 2023
 
Upadacitinib (Rinvoq®)
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Formulary
Red
High Cost Medicine
CCG
  • Approved for the treatment of severe active rheumatoid arthritis in adults in line with NICE.
  • Approved for the treatment of moderate rheumatoid arthritis in line with NICE.
  • Approved for the treatment of active psoriatic arthritis after inadeqaute response to DMARDs in line with NICE.



 
Link  MHRA Drug Safety Update (April 2023): 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 TA814: Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis
Link  NICE TA829: Upadacitinib for treating active ankylosing spondylitis
Link  NICE TA861: Upadacitinib for treating active non-radiographic axial spondyloarthritis
 
Ustekinumab (Stelara®)
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Formulary
Red
  • Approved for psoriatic arthritis in accordance with NICE.
 
Link  MHRA Drug Safety Update (Jan 2015): Ustekinumab (Stelara): risk of exfoliative dermatitis
Link  NICE TA340: Ustekinumab for treating active psoriatic arthritis (Updated March 2017)
 
10.01.03  Expand sub section  Sulfasalazine
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.  

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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