| Formulary Chapter 10: Musculoskeletal and joint diseases - Full Chapter
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| Notes: |
Where a formulary entry does not detail a medicine’s indications for use, the medicine can be assumed to be approved for all licensed indications.
Formulary approved "off-label" use is detailed separately. |
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| Details... |
| 10.01.03 |
Drugs which suppress the rheumatic disease process |
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Tacrolimus caps (Behcet's disease)
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 Restricted
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USE UNDER SPECIALIST SUPERVISION ONLY
Approved for use in the management of less complex Behcet's disease
 Dose = up to 4mg BD (based on plasma trough concentration)
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| 10.01.03 |
Gold |
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Auranofin tablets
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Formulary
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 USE UNDER SPECIALIST SUPERVISION ONLY
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Soldium aurothomalate imjection
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Formulary
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 USE UNDER SPECIALIST SUPERVISION ONLY
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| 10.01.03 |
Penicillamine |
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Penicillamine tabs (rheumatoid athritis)
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Formulary
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USE UNDER SPECIALIST SUPERVISION ONLY
Approved for:
Severe rheumatoid arthritis
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| 10.01.03 |
Antimalarials |
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Chloroquine sulphate tabs
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Formulary
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 USE UNDER SPECIALIST SUPERVISION ONLY
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Hydroxychloroquine tabs (rheumatology indications - including off-label use)
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Formulary
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Refer to SE London immunomodulatory shared care guidance for list of indications (link above at start of BNF section)
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| 10.01.03 |
Drugs affecting the immune response |
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Azathioprine tabs (rheumatology indications - including off-label use)
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Formulary
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Refer to SE London immunomodulatory shared care guidance for list of indications (link above at start of BNF section)
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Ciclosporin caps, oral solution (rheumatology indications, including off-label use)
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Formulary
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Refer to SE London immunomodulatory shared care guidance for list of indications (link above at start of BNF section)
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Leflunomide tabs (rheumatology indications - including off-label use)
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Formulary
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Refer to SE London immunomodulatory shared care guidance for list of indications (link above at start of BNF section)
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Methotrexate tablets, subcutaneous injection (rheumatology indications - including off-label use)
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Formulary
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Refer to SE London immunomodulatory shared care guidance for list of indications (link above at start of BNF section)
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Mycophenolate mofetil caps, tabs, suspension (rheumatology indications - including off-label use)
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Formulary
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Refer to SE London immunomodulatory shared care guidance for list of indications (link above at start of BNF section)
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Mycophenolate sodium tabs (rheumatology indications - including off-label use)
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Formulary
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Refer to SE London immunomodulatory shared care guidance for list of indications (link below)
- Restricted to use where there is intolerance to mycophenolate mofetil.
- Refer to APC recommendation (link below)
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 SE London APC recommendation: Mycophenolate sodium (mycophenolic acid) 360mg tablets for autoimmune rheumatic and dermatological conditions in patients unable to tolerate mycophenolate mofetil
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Tacrolimus immediate release capsules (off-label rheumatological indications)
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Formulary
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Approved off-label indications:
- Moderate to severe systemic lupus erythematosus as a steroid sparing agent
- Polymyositis and dermatomyositis, including secondary ILD from these conditions
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| 10.01.03 |
Cytokine modulators - USE UNDER SPECIALIST SUPERVISION ONLY |
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Abatacept injection
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Formulary
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Approved as per NICE technology appraisal guidance
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 NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis (NHSE)
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
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Adalimumab injection (rheumatology indications)
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Formulary
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Approved as per NICE technology appraisal guidance
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NICE TA195: Rheumatoid arthritis - drugs for treatment after 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 (CCG)
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
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Anakinra injection (Adult-Onset Still's Disease )
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Formulary
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Approved for use as per NHSE policy criteria (see link below)
Note: Anakinra and Tocilizumab cannot be used concurrently
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Clinical Commissioning Policy: Anakinra/tocilizumab for the treatment of Adult-Onset Still’s Disease refractory to second-line therapy (adults) (170056P)
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Baricitinib tabs
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Formulary
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Approved as per NICE technology appraisal guidance
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MHRA Mar 20: Baricitinib (Olumiant▼): risk of venous thromboembolism
NICE TA466: Baricitinib for moderate to severe rheumatoid arthritis
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Belimumab injection
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Restricted
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Approved as per NICE technology appraisal guidance
Lupus Consultants only
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MHRA Apr 19: Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials
NICE TA397: Belimumab for treating active autoantibody-positive systemic lupus erythematosus
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Certolizumab pegol injection
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Formulary
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Approved for use as per NICE technology appraisal guidance
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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 injection (rheumatology indications)
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Formulary
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Approved as per NICE technology appraisal guidance
Biosimilar products available, to be prescribed by brand name.
Contact pharmacy department for advice on brand for routine prescribing if unsure
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NICE TA195: Rheumatoid arthritis - drugs for treatment after failure of a TNF inhibitor
NICE TA199: Psoriatic arthritis - etanercept, infliximab and adalimumab
NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis (NHSE)
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
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Golimumab injection (rheumatology indications)
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Formulary
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Approved as per NICE technology appraisal guidance
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NICE TA220: Psoriatic arthritis - golimumab
NICE TA225: Rheumatoid arthritis - golimumab
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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Infliximab injection (licensed rheumatology indications)
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Formulary
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Approved as per NICE technology appraisal guidance
Biosimilar products available, to be prescribed by brand name.
Contact pharmacy department for advice on brand for routine prescribing if unsure
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NICE TA195: Rheumatoid arthritis - drugs for treatment after failure of a TNF inhibitor
NICE TA199: Psoriatic arthritis - etanercept, infliximab and adalimumab
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
SE London APC position statement: Biosimilar infliximab
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Rituximab injection (ANCA vasculitis)
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Formulary
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Approved as per NICE technology appraisal and NHSE policy guidance below
Biosimilar products available, to be prescribed by brand name.
Contact pharmacy department for advice on brand for routine prescribing if unsure
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NHSE Policy A13/P/a: Rituximab for the treatment of ANCA-associated vasculitis in adults
NICE TA308: Rituximab in combination with glucocorticoids for treating anti-neutrophil cytoplasmic antibody-associated vasculitis
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Rituximab injection (rheumatology - licensed indications)
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Formulary
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Approved as per NICE technology appraisal guidance below
Biosimilar products available, to be prescribed by brand name.
Contact pharmacy department for advice on brand for routine prescribing if unsure
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NICE TA195: Rheumatoid arthritis - drugs for treatment after failure of a TNF inhibitor
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Sarilumab pre-filled pen or syringe
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Formulary
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Approved as per NICE Technology Appraisal guidance
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NICE TA485: Sarilumab for moderate to severe rheumatoid arthritis
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Secukinumab injection (ankylosing spondylitis & psoriatic arthritis)
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Formulary
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Approved as per NICE technology appraisal guidance
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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
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Tocilizumab (cytokine relsease syndrome following CAR T-cell therapy)
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Formulary
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Refer to SPC for management of cytokine release syndrome (including dosing) following CAR T-cell therapy
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MHRA Jul 2019: rare risk of serious liver injury including cases requiring transplantation
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Tocilizumab injection (Adult-Onset Still's Disease )
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Formulary
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Approved for use as per NHSE policy criteria (see link below)
Note: Anakinra and Tocilizumab cannot be used concurrently
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Clinical Commissioning Policy: Anakinra/tocilizumab for the treatment of Adult-Onset Still’s Disease refractory to second-line therapy (adults) (170056P)
MHRA Jul 2019: rare risk of serious liver injury including cases requiring transplantation
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Tocilizumab injection (arthritis)
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Formulary
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Approved as per NICE technology appraisal guidance
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MHRA Jul 2019: rare risk of serious liver injury including cases requiring transplantation
NICE TA238: Arthritis (juvenile idiopathic, systemic) - tocilizumab (NHSE)
NICE TA247: Rheumatoid arthritis - tocilizumab (rapid review TA198)
NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis (NHSE)
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
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Tocilizumab subcutaneous injection (giant cell arteritis)
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Formulary
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Approved as per NICE technology appraisal guidance
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MHRA Jul 2019: rare risk of serious liver injury including cases requiring transplantation
NICE TA518: Tocilizumab for treating giant cell arteritis
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Tofacitinib tabs (rheumatology indications)
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Formulary
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Approved as per NICE technology appraisal guidance
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MHRA Mar 20: Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections
MHRA May 19: 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
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Ustekinumab injection (psoriatic arthritis)
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Formulary
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Approved as per NICE technology appraisal guidance
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NICE TA340: Ustekinumab for treating active psoriatic arthritis
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Infliximab injection (rheumatology off-label indications)
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Restricted
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Approved off-label indication:
Severe refractory Behcet's disease including Behcet's Eye disease, pulmonary and peripheral arterial aneurysms
To be prescribed as per the Barts Health Satellite Unit Biologic Referal Pathway. Contact formulary team for further info.
Note: Biosimilar products available, to be prescribed by brand name. Contact pharmacy department if unsure of brands.
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SE London APC position statement: Biosimilar infliximab
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Rituximab injection (rheumatology - off-label indications)
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Restricted
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Approved off-label indications:
Treatment of resistant acute autoimmune connective tissue disorders (CTDs) such as:
- Systemic lupus erythematosus (SLE) - Blueteq application required
- Inflammatory myopathies
- Sjogren’s syndrome
- Systemic vasculitides
- IgG4-related disease (as per NHSE Policy 16057/P)
- Behcet's Disease; including Behcet's Eye disease (as per Barts Health Satellite Unit Biological Referal Process)
Reserved for patients with severe active autoimmune diseases that have failed to respond to or are intolerant of at least two immunosuppressants (azathioprine, methotrexate, mycophenolate or cyclophosphamide), each having been taken for at least three months
Biosimilar products available, to be prescribed by brand name.
Contact pharmacy department for advice on brand for routine prescribing if unsure
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NHSE 16057/P: Rituximab for IgG4-related disease
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Tocilizumab injection (Takayasu arteritis -off-label)
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Formulary
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Approved off-label indication:
For Takayasu arteritis, as per criteria in NHSE commissioning policy 16056/P
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NHSE 16056/P: Tocilizumab for Takayasu arteritis (adults)
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| 10.01.03 |
Sulfasalazine |
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Sulfasalazine e/c tablets (rheumatology indications - including off-label use)
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Formulary
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Refer to SE London immunomodulatory shared care guidance for list of indications (link above at start of BNF section)
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Key |
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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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CCG |
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Traffic Light Status Information
| Status |
Description |
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Specialist or hospital prescribing only.
The responsibility for prescribing, monitoring, dose adjustment and review should remain with the specialist or hospital.
In very exceptional circumstances a specialist may discuss individual patient need for a RED drug to be prescribed by a GP and the GP should consider informing the Medicines Management team before a decision is made to prescribe for individual patients.
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Treatment can be initiated in primary care after a recommendation from an appropriate specialist |
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Specialist initiation followed by maintenance prescribing in primary care |
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Specialist initiation with ongoing monitoring required. After dose stabilisation GPs can be requested to take over prescribing responsibilities using the approved APC shared care documentation |
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Specialist and non-specialist initiation |
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Not recommended for prescribing |
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