netFormulary
Data extracted : 24/11/2017
 Formulary Section 10: Musculoskeletal and joint diseases
 Details...
10.01 Drugs used in rheumatic diseases and gout
10.01 Osteoarthritis and soft-tissue disorders
Hyaluronic acid is not supported in NICE Clinical Guidelines for use in osteoarthritis of the knee.

At UHL it has been supported for pain relief in osteoarthritis of shoulder only. (Red traffic light status)
Clinical support has been given for use in specific patients with painful osteoarthritis who have exhausted other therapies, surgery is not appropriate and who have previously responded to treatment  but funding is still outstanding so not available for use in this group yet.
Link   Leicestershire Evaluations: Synvisc® in Osteoarthritis in Shoulder
10.01.01 Non-steroidal anti-inflammatory drugs

  • Use the lowest effective dose for the shortest period to control symptoms and review the need for long-term treatment periodically. Pain relief should start soon after taking the first dose but an anti-inflammatory effect may take up to 3 weeks.

  • NSAIDS are associated with an increased cardiovascular (CV) risk. Low-dose ibuprofen (≤ 1200mg daily) or naproxen ≤1000mg daily have the lowest CV risk.

  • Low dose ibuprofen is associated with the lowest risk of GI toxicity. However all NSAIDs are associated with serious GI toxicity and they should be used cautiously in patients who are at high risk including patients >65 years and those on long term therapy. Use of a proton-pump inhibitor (PPI) reduces the risk, and should routinely be co-prescribed for anyone with osteoarthritis or rheumatoid arthritis and those ≥ 45 years with chronic low back pain PLUS anyone else at high risk of GI toxicity.

  • Renal failure may be provoked by NSAIDs. Avoid in patients with pre-existing or risk factors for renal impairment.

  • Topical NSAIDs and/or paracetamol should be considered first for hand and knee OA
Link   MHRA Advice: Diclofenac: new contraindications and warnings after a Europe-wide review of cardiovascular safety
Link   MHRA Advice: Etoricoxib: revised dose recommendation for rheumatoid arthritis and ankylosing spondylitis
Link   MHRA Advice: Non-steroidal anti-inflammatory drugs (NSAIDs): further evidence that the cardiovascular risk with diclofenac is higher than other non-selective NSAIDs and similar to the selective COX-2 inhibitors.
Link   NICE CG 177: Osteoarthritis (This guidance updates and replaces NICE CG59)
Link   NICE CG 79: Rheumatoid Arthritis: The management of rheumatoid arthritis in adults
Link   NICE CG 88: Low Back Pain
Link   Q&A: Can breastfeeding mothers take ibuprofen
Link   QIPP Detail Aid: NSAIDs - ibuprofen or naproxen preferred
Link   QIPP Detail Aid: Reduce Diclofenac prescribing in Leicestershire
First Choice:
Ibuprofen 
Doses of 400mg only have marginal therapeutic benefit over 200mg doses and are associated with more adverse effects.
The suspension is significantly more expensive than tablets.
Ibuprofen is also suitable for women who are breast feeding.
Second Choice:
Naproxen 
Naproxen tablets/EC tablets
Restricted Drug  Diclofenac Preparations 
Restricted except for short term pre or peri-operative or post-natal use.
Recent trial data has shown an increased risk of cardiovascular events in patients treated with diclofenac. One of the Better Care Better Value targets is to reduce the amount of diclofenac prescribed as a percentage of all NSAID prescriptions. Leicestershire primary care has one of the worst ratios in the UK.
  • Contraindicated in patients with established cardiovascular disease. Avoid in patients with risk factors for cardiovascular disease.
  • For patients already taking diclofenac, consider changing to ibuprofen (1200mg per day or less) or naproxen (1000mg per day) if continued use is necessary.
  • Restricted Drug  Sulindac 
    For patients on lithium therapy if an NSAID is considered essential. Other NSAIDs may raise lithium levels and precipitate toxicity.
    10.01.03 Drugs which suppress the rheumatic disease process

    • Generally, when used alone immunosuppressants are not more effective than corticosteroids, but provide an alternative in selected cases. Immunosuppressants may be more effective in combination with steroids than treatment with a single drug and may allow a reduction in steroid dosage.

    • Methotrexate is suitable for moderate to severe active rheumatoid arthritis. Prescribers should be familiar with advice issued by the National Patient Safety Authority (NPSA) to reduce risk in prescribing of methotrexate.

    • The BNF recommends that only one strength of methotrexate tablet (usually 2.5 mg) is prescribed and dispensed.

    • Azathioprine, ciclosporin and cyclophosphamide are considered more toxic than methotrexate and are used in cases that have not responded to other disease modifying drugs. Ciclosporin is licensed for severe active rheumatoid arthritis when conventional second-line therapy is inappropriate or ineffective.

    • Disease-modifying drugs such as sulfasalazine, penicillamine, leflunomide, hydroxychloroquine and sodium aurothiomalate (’gold’) may be used as alternatives to immunosuppressants in the management of rheumatoid arthritis.

    • Early treatment and control of inflammatory joint disease is essential to minimise joint damage and eventual disability. Prompt referral to a specialist is important. Patients with active rheumatoid disease should not be managed on non-steroidal anti-inflammatory drugs and/or corticosteroids in the long-term.

    • Response to all disease-modifying agents may be delayed for several months. Patients who fail to respond to one agent or suffer serious side effects may respond to another.
    Link   NPSA Safety Alert: Oral methotrexate
    Link   SCA: Disease Modifying Anti-Rheumatic Drugs (DMARDs)
    Restricted Drug  Gold  (sodium aurothiomalate )
    ’Red  New patients Rheumatology use only


    ’Amber  Existing patients to continue injections in primary care under SCA
    Restricted Drug  Methotrexate   (Subcutaneous)
    Specialist Rheumatology use only
    Restricted Drug  Apremilast  
    Supported in line with NICE TA 433

    Date of entry of decision to formulary: May 2017
    10.01.03 Cytokine modulators
    Link   Leicestershire Guidelines: Rheumatology Biological Therapy
    Link   NICE CG 79: Rheumatoid Arthritis
    Link   NICE TA 195: RA - Adalimumab, etanercept, infliximab, rituximab, abatacept after failure of a TNF
    Link   NICE TA 199: Psoriatic arthritis: Etanercept, infliximab and adalimumab
    Link   NICE TA 373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
    Link   NICE TA 375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (Replaced TA130 Jan 2016)
    Link   NICE TA 383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis (Replaced TA 143 Feb 2016)
    Restricted Drug  Secukinumab 
    Specialist Rheumatology Use
    For use in line with NICE TA 407
    First line choice for ankylosing spondylitis on cost grounds

    Date of entry of decision to formulary: December 2016

    For use in line with NICE TA 445 for psoriatic arthritis.
    Date of entry of decision to formulary July 17
    First line choice for patients without concomitant moderate to severe plaque psoriasis on cost grounds(maintenance dose 150mg monthly)
    Restricted Drug  Abatacept  
    Specialist Rheumatology use only
    High cost drug excluded to tariff

    Date of entry of decision to Formulary: July 13 (TA 280)
    Restricted Drug  Adalimumab  (Rheumatology)
    Specialist Rheumatology use only.
    High cost drug excluded to tariff
    For use only in line with NICE TA 130 (RA), TA 383 (AS and non-radiographic axial spondyloarthritis), TA 199 (PSA) and TA 195 (Following failure of a TNF) See links below
    Restricted Drug  Certolizumab pegol 
    Specialist Rheumatology use only
    High cost drug excluded to tariff.
    Use in line with NICE TA 383 (AS and non-radiographic axial spondyloarthritis), NICE TA 375 and NICE TA 415(Rheumatoid Arthritis) Latter added January 2017
    Use in line with NICE TA 445 for psoriatic arthritis. Date of entry to formulary July 17
    Restricted Drug  Etanercept   (Rheumatology )
    Specialist Rheumatology use only
    High cost drug excluded to tariff
    For use only in line with NICE TA 130 (RA), TA 383 (AS and non-radiographic axial spondyloarthritis), TA 199 (PSA) and TA 195 (Following failure of a TNF) See links below
    Restricted Drug  Golimumab  
    Specialist Rheumatology use only
    High cost drug excluded to tariff
    Restricted Drug  Infliximab (Inflectra®)  (Rheumatology)
    Specialist Rheumatology use only
    High cost drug excluded to tariff
    For use only in line with NICE TA 130 (RA), TA 383 (AS), TA 199 (PSA) and TA 195 (Following failure of a TNF) See links below

    Prescribe by brand. Biosimilar infliximab (Inflectra) to be used for new patients
    Restricted Drug  Rituximab (Truxima®)  (Rheumatology)
    Specialist Rheumatology use only
    High cost drug excluded to tariff, CCG commissioned. In Rheumatology indications the biosimilar Truxima should be used for all new treatment courses

    Use in SLE commissioned by NHSE in line with policy below only
    Restricted Drug  Tocilizumab  
    IV: Specialist Rheumatology use only in line with NICE TA 247
    High cost drug excluded to tariff
    Subcutaneous preparation also supported
    Restricted Drug  Ustekinumab (Rheumatology) 
    Specialist Rheumatology use in line with NICE TA 340

    Date of entry of decision to formulary: September 2015
    10.01.04 Gout and cytotoxic-induced hyperuricaemia
    10.01.04 Acute attacks of gout

    • Treat acute attacks of gout with a non-steroidal anti-inflammatory drug (NSAID) for about a week. High doses are necessary, at least for the first day or two or until the pain is controlled. Avoid aspirin in gout.

    • Recommended choices are below. Etoricoxib is also licensed for acute gouty arthritis but an MHRA alert advises that it may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses. Therefore, special attention should be paid to blood pressure monitoring during treatment. If blood pressure rises significantly, alternative treatment should be considered.

    • A short course of prednisolone is sometimes used.
    Link   MHRA Advice: Diclofenac: new contraindications and warnings after a Europe-wide review of cardiovascular safety
    Link   MHRA Advice: Etoricoxib: revised dose recommendation for rheumatoid arthritis and ankylosing spondylitis
    First Choice:
    Naproxen 
    Second Choice:
    Diclofenac 
    Short term use
    Second Choice:
    Indometacin 
    Less commonly prescribed.
    Restricted Drug  Colchicine 
    Acute gout, where NSAIDs are not suitable e.g. those with heart failure, renal impairment or taking anticoagulants. Adverse effects frequently limit its use. In difficult or resistant cases seek specialist advice.
    10.01.04 Long-term control of gout
    Prophylaxis with allopurinol is necessary for recurrent acute attacks, chronic gout and symptomatic hyperuricaemia (with urate nephropathy). It may increase the incidence of acute attacks during the first few months of treatment therefore a NSAID e.g. ibuprofen 400mg three times daily should be given for 1-2 months (colchicine 500micrograms twice daily is suitable for patients that cannot take NSAIDs). Prophylactic drugs should never be commenced until an acute attack has fully resolved, as symptoms are likely to be worsened. 

    First Choice:
    Allopurinol 
    Allopurinol and its metabolites are renally excreted and may accumulate if kidney function is impaired. In severe renal insufficiency, it may be advisable to use less than 100 mg per day or to use single doses of 100mg at longer intervals than one day.
    Restricted Drug  Febuxostat 
    For use only in line with NICE TA 164 for patients who are intolerant of allopurinol or where allopurinol is contra-indicated.
    10.01.04 Hyperuricaemia associated with cytotoxic drugs
    Restricted Drug  Rasburicase 
    Specialist prescribing only
    High cost drug excluded to tariff commissioned by NHSE
    10.01.05 Other drugs for rheumatic diseases
    10.02 Drugs used in neuromuscular disorders

    Restricted Drug  Ataluren  (Translarna)
    Duchenne muscular dystrophy in line with NICE HST3
    10.02.01 Drugs which enhance neuromuscular transmission
    10.02.01 Acetylcholine-release enhancers
    10.02.02 Skeletal muscle relaxants
    Quinine Sulphate 300mg  
    For leg cramps.
    Review benefits regularly.
    10.03.01 Enzymes
    Restricted Drug  Collagenase  
    Specialist use only in line with NICE TA 459

    Date of entry of decision to formulary: October 2017
    10.03.02 Rubefacients, topical NSAIDs, capsaicin, and poultices
    10.03.02 Topical NSAIDs and counter-irritants
    • NICE CG 59 osteoarthritis recommends that consideration be given to offering topical NSAIDs for pain relief in addition to core treatment for people with knee or hand osteoarthritis.

    • Topical capsaicin 0.025% should be considered as an adjunct to core treatment for knee or hand osteoarthritis.

    • Rubefacients are not recommended for the treatment of osteoarthritis.

    Link   NICE CG 177: Osteoarthritis (This guidance updates and replaces NICE CG59)
    First Choice:
    Ibuprofen 5% Gel 
    Restricted Drug  Capsacin cream 
  • ’Green For use in line with NICE CG173 for management of neuropathic pain
  • ’Green For use in line with NICE CG17 for management of Osteoarthritis
  • Restricted Drug  Capsaicin Patch  (Qutenza®)
    Supported for use by the pain clinic only. For use only in patients with peripheral neuropathic pain (non-diabetic) who have tried and not responded to other pain relief - amitriptyline, gabapentin, pregabalin, duloxetine, oxycodone, tramadol and lidocaine patch

    CCG agreement for pass through payment agreed locally

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