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10.0 Musculoskeletal and joint diseases

10.0 Musculoskeletal and joint diseases

10.1.1 Non-steroidal anti-inflammatory drugs (NSAIDs)

First line treatment
GREEN      Ibuprofen   
                   tablets 200mg, 400mg, 600mg
                   syrup 100mg/5mL  
GREEN      Naproxen
                   tablets  250mg, 500mg
 
Gastrointestinal toxicity and cardiovascular toxicity are the two most important safety concerns for
non-steroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors (coxibs). Clinical trial and 
epidemiological data have given important information on the level of risk with individual
medicines. However, these data are complex and there are no robust comparisons for many 
NSAIDs. Most evidence relates to the coxibs, naproxen, ibuprofen, and diclofenac.  The National 
Prescribing Centre (NPC) has summarised up-to-date prescribing advice and information in relation
to NSAIDs, which is available through their website (www.npc.nhs.uk).
 
Thrombotic risks
In October 2006, the Commission on Human Medicines (CHM) gave advice on the latest evidence for 
cardiovascular thrombotic risks: 
 
          >     Diclofenac 150 mg daily has a thrombotic risk profile similar to that of at least one coxib 
                 (etoricoxib) and possibly others
          >     Naproxen 1000 mg daily has a lower thrombotic risk than coxibs and, overall, epidemiological 
                 data do not suggest an increased risk of myocardial infarction
          >     For ibuprofen at high doses (eg, 2400 mg daily) there may be a small thrombotic risk, but at 
                 lower doses (eg, 1200 mg daily or less) epidemiological data do not suggest an increased risk 
                 of myocardial infarction
 
Less evidence is available for other NSAIDs, but they may be associated with a small risk of thrombotic 
events, especially with long duration of treatment and high doses.
 
Cardiovascular risks
Results of two recently published epidemiological studies lend support to the view that some increase in
thrombotic cardiovascular risk may apply to all NSAID users, irrespective of their baseline risk, and not 
only to chronic users. The absolute increase in risk for 'healthy' users is very low. Current advice 
remains that patients should use the lowest effective dose and the shortest duration of treatment 
necessary to control symptoms. Overall evidence continues to indicate that naproxen is associated with
a lower thrombotic risk than coxibs. For ibuprofen, no significant increase in risk has been identified 
for doses of up to 1200mg daily.
 
Reference: Drug Safety Update, Volume 2 Issue 7, February 2009.
 
Gastrointestinal risks
The Committee on Safety of Medicines (now the Commission on Human Medicines) has reviewed the 
relative gastrointestinal risks of NSAIDs on several occasions.  Recently, we have highlighted the high 
gastrointestinal risks with piroxicam, ketoprofen, and ketorolac.  Of the traditional NSAIDs, low-dose
ibuprofen offers the lowest risk. Coxibs are associated with reduced gastrointestinal risk relative to 
most NSAIDs at equivalent doses. However, coxibs (like NSAIDs) may vary in their effects, and evidence
for a reduction in the most clinically important gastrointestinal risks for etoricoxib is weak.  Proton 
pump inhibitors reduce the gastrointestinal risks associated with NSAIDs, and may reduce the risks to a
similar level as use of a coxib alone.
 
Other NSAIDs
GREEN       Diclofenac
                    injection 25mg/mL
                    suppositories 12.5mg, 25mg, 50mg, 100mg
GREEN       Mefenamic acid
                    capsules 250mg
                    tablets 500mg         
 
Indometacin is usually recommended only for ankylosing spondylitis and gout.
GREEN       Indometacin
                    capsules 25mg, 50mg       
                    suppositories 100mg
 
Patients over 65 years who are in high risk groups for developing ulcers (history of peptic ulcer or 
bleeding, cardiovascular disease) should be given protection for the stomach when prescribed NSAIDs.
NSAIDs and PPIs (Section 1.3.5) are often used together for these at risk patients.
 
Cox IIs (cyclo-oxygenase II selective inhibitors)
The MHRA has issued the following general advice concerning all selective COX-2 inhibitors (Feb-05):
 
          >     Patients with established ischaemic heart disease, cerebrovascular disease or peripheral 
                 arterial disease should be switched to alternative treatment 
          >     For all patients the balance of gastrointestinal and cardiovascular risk should be 
                 considered before prescribing a COX-2 inhibitor, particularly for those with risk
                 factors for heart disease and those taking low dose aspirin, for whom gastrointestinal benefit 
                 has not been clearly demonstrated.
          >     The lowest effective dose of COX-2 inhibitor should be used for the shortest necessary
                 period.  Periodic re-evaluation is recommended, especially for osteoarthritis patients who may
                 only require intermittent treatment.
          >     Gastro-protective agents should be considered for patients switched to non-selective 
                 NSAIDs   
 
GREEN       Celecoxib
                   capsules 100mg, 200mg    
GREEN      Meloxicam
                   tablets 7.5mg, 15mg     
AMBER     Etoricoxib (Rheumatology initiation only)
                   tablets 60mg, 90mg, 120mg
 
RED           Parecoxib 40mg powder and solvent for solution for injection - for use in prevention of post-
                   operative pain  (administration in theatres) and pain management for patients with poor 
                   absorption or nil by mouth as an alternativeto IV diclofenac.
 
Osteoarthritis - NICE Clinical Guideline 177 February 2014
Treatment and management
Core treatment:
There are three core interventions which should be considered for every person with osteoarthritis:
           >     access to appropriate patient information sources,
           >     activity and exercise,
           >     interventions to achieve weight loss if person is overweight or obese.    
 
If further treatment is required then adjunctive treatments should be considered; 
 
Pharmacological:
          >     Paracetamol (regular dosing may be required). AND/OR
          >     Topical non steroidal anti-inflammatory drugs (NSAIDs) or topical capsaicin for knee or hand 
                 osteoarthritis
 
If above agent/s are ineffective or insufficient then consider;
          >     Substitution or addition of an oral NSAID or COX-2 inhibitor (but NOT eterocoxib) OR
          >     Opioid analgesics
Consider intra-articular corticosteroid injections if pain is moderate to severe.
 
Treatment with oral NSAIDs/COX-2 inhibitors:
All oral NSAIDs/COX-2 inhibitors have similar analgesic effects but vary in their gastrointestinal, liver and
cardio-renal toxicity. This should be taken into account when choosing the drug and dose for an 
individual patient.
 
Treatment with oral NSAIDs/COX-2 inhibitors:
          >     Prescribe the lowest effective dose for the shortest possible period of time,
          >     ALWAYS co-prescribe a proton pump inhibitor (PPI) - choose one with the lowest cost.
          >     Assess patient risk factors for gastrointestinal, liver and cardio-renal toxicity,
          >     Consider ongoing monitoring of patient risk factors,
          >     Use an alternative analgesic if patient is taking low-dose aspirin. 
 
Treatment with opioids: 
          >     Consider the risks and benefits particularly in elderly people.
          >     Adverse effects: constipation, nausea, itchiness, drowsiness and confusion
 
Non-pharmacological: 
          >     Application of heat or cold to the site of pain.
          >     Transcutaneous electrical nerve stimulation (TENS).
          >     Manipulation and stretching, particularly for hip osteoarthritis.
          >     Assessment for bracing/joint supports/insoles for people with biomechanical joint pain or 
                 instability.
          >     Assistive devices (for example, walking sticks and tap turners) for people with specific 
                 problems with daily activities. Expert advice may be required.
 
Treatments not recommended 
          >     rubefacients
          >     intra-articular hyaluronan injections
          >     electro-acupuncture
          >     chondroitin or glucosamine products
 
 
 
 


                   

 

 

10.1.2 Corticosteroids

10.1.2.2 Local corticosteroid injections
These are given by intra-articular injection or by injection into soft tissue or the tendon sheath and
should be considered as an adjunct to core treatments for the relief of moderate to severe pain 
 in people with osteoarthritis.
 
GREEN      Hydrocortisone acetate injection 25mg/mL
GREEN      Methylprednisolone injection 40mg/mL 
GREEN      Triamcinolone acetonide injection 40mg/mL 
RED           Triamcinolone acetonide injection 10mg/mL    
RED           Triamcinolone hexacetanide 20mg/mL (Lederspan®) – unlicensed import for use in chronic
                   juvenile arthritis only.
 
10.1.2.3 Other local injections
Hyaluronan injections for osteoarthritis- Updated Feb 2014 CG177
NICE states ‘ Do not offer intra-articular hyaluronan injections for the management of osteoarthritis'
 
BLACK - Hyaluronan injections.
 
 
 
                   




10.1.3. Drugs which suppress the rheumatic disease process

These are sometimes called disease modifying anti-rheumatic drugs (DMARDs). They are used when
NSAIDs alone are not sufficient and they should only be initiated by a specialist. They require 4-6
months of treatment for a full response. If there is no benefit after 6 months they should be
discontinued on specialist advice.
 
AMBER SHARED CARE     Azathioprine tablets 25mg, 50mg
AMBER SHARED CARE     Ciclosporin (Neoral®)
                                             capsules 25mg, 100mg
                                             oral solution 100mg/mL
RED                                     Cyclophosphamide injection 500mg, 1g
AMBER                               Hydroxychloroquine tablets 200mg - see Prescriber Information Sheet    
AMBER SHARED CARE     Leflunomide tablets 10mg, 20mg
RED                                     Leflunomide tablets 100mg (used for initial loading doses only)
 
Secondary care will prescribe and supply leflunomide for the first three months, the primary care prescriber
may then take over prescribing and the associated monitoring.
 
Methotrexate    
All new patients started on methotrexate will be supplied with 2.5mg tablets only. Prescribers are
reminded to follow the monitoring guidance outlined in the shared care protocol available here .
 
AMBER SHARED CARE     Methotrexate tablets 2.5mg only
RED                                     Methotrexate injection, for s/c or i/m use (Metoject®, Ebetrex®)
 
  Methotrexate should be prescribed once weekly as a single dose on the same day each week.
 Folic acid 5mg should normally be taken the day after methotrexate dosing. 
 
AMBER SHARED CARE     Penicillamine tablets 125mg, 250mg 
AMBER SHARED CARE     Sodium aurothiomalate injection 10mg, 20mg, 50mg
AMBER SHARED CARE     Sulfasalazine tablets e/c 500mg
 
Cytokine modulators   
These drugs should be prescribed by specialists only, and in line with any relevant NICE guidance. 
 
Certolizumab, rituximab and tocilizumab (inc. Abatacept, Adalimumab, Etanercept, Golimumab and
Infliximab) - NICE guidance for rheumatoid arthritis (TAG 130, 186, 195, 198, & 225).
Treatment pathways for highly active rheumatoid arthritis in adults who have failed to respond to at 
least two standard disease modifying anti-rheumatic drugs (DMARDs) including methotrexate. These 
drugs should be prescribed according to the guidelines of the British Society for Rheumatology under 
the supervision of consultant rheumatologist.            
 
Please refer to the full guidelines for further information.
 
Etanercept - NICE guidance for juvenile idiopathic rheumatoid arthritis (TAG 35) 
For children aged 4 to 17 years who have active JIA in at least five joints and whose condition has not 
responded adequately to or have been unable to tolerate treatment with methotrexate. Only a 
consultant who regularly sees children and young adults with JIA and who runs specialised paediatric
rheumatology clinics should prescribe etanercept.      
 
 Please refer to full guidelines for further information.  
 
Secukinumab is recommended, within its marketing authorisation, as an option for treating active
ankylosing spondylitis in adults whose disease has responded inadequately to conventional therapy
(non-steroidal anti-inflammatory drugs or TNF‑alpha inhibitors) as per NICE TA407 
 
RED       Secukinumab solution for injection 150mg/1mL
 
Adalimumab, Certolizumab pegol , Etanercept, Golimumab and Infliximab - in line with NICE Guidance 
for Ankylosing spondylitis and non-radiographic axial spondyloarthritis (NICE TA383).      
(Replaces NICE technology appraisal guidance on adalimumab, etanercept and infliximab for ankylosing
spondylitis (TA143) and golimumab for the treatment of ankylosing spondylitis (TA233). 
 
These drugs are for people with severe active ankylosing spondylitis or severe non‑radiographic axial
spondyloarthritis who have tried non‑steroidal anti‑inflammatory drugs (NSAIDs), but they have not 
worked.
 
RED           Adalimumab pre-filled pen/syringe 40mg
RED           Certolizumab pegol pre-filled syringe 200mg
RED           Etanercept vial for injection 25mg    
                   pre-filled pen/syringe 25mg, 50mg
RED           Golimumab pre-filled pen/syringe 50mg,100mg
RED           Infliximab vial for infusion 100mg
 
Golimumab for severe non-radiographic axial spondyloarthritis.
This drug is for adults who have tried nonsteroidal anti-inflammatory  drugs (NSAIDs), 
but they have not worked. Recommended as an option, within its marketing authorisation, as an
option in NICE TA497
 
RED        Golimumab 50 mg solution for injection in pre-filled pen    (Simponi®)
                                                                                                                             CCG Commissioned - BlueTeq Form 
 
Adalimumab, Etanercept, Infliximab, Certolizumab pegol, Golimumab, tocilizumab and abatacept - 
 
NICE Guidance for Rheumatoid arthritis not previously treated with DMARDS or after conventional 
DMARDS only have failed are recommended as an option by NICE. NICE TA375.  
                                    Please refer to full guidelines for further information. 
  
 
Belimumab NICE TA752 -updates and replaces NICE TA397 
Recommended as an option as add-on treatment for active autoantibody-positive systemic lupus 
erythematosus in people with high disease activity despite standard treatment, only if:
    > high disease activity is defined as at least 1 serological biomarker (positive abti-double0strabded 
       DNA or low complement) and a SELENA-SLEDAI score of greater than or equal to 10
    > treatment is continued beyond 24 weeks only if the SELENA-SLEDAI score has improved by 4 points 
       or more
    > the company [provides belimumab according to the commercial arrangement.
 
RED     Belimumab ( Benlysta®)
            powder for concentrate for solution for infusion 120mg, 400mg 
                                                                                                                             NHS England Commissioned
 
Adalimumab, Etanercept, Golimumab and Infliximab - NICE guidance for psoriatic 
arthritis (NICE TAG199 & 220)
 
Treatment options for adults with severe active psoriatic arthritis who: 
 
          >     have peripheral arthritis with three or more tender joints, and
          >     three or more swollen joints, and
          >     other disease modifying anti-rheumatic drugs (DMARDs) administered individually or in 
                 combination have not worked.
                                          Please refer to the full guidelines for further information.
 
  
Abatacept (Orencia), adalimumab (Humira), etanercept (Enbrel) and tocilizumab (RoActemra) are 
recommended as possible treatments for people with polyarticular juvenile idiopathic arthritis. Full
 guidance - NICE TA373
          >     Adalimumab and etanercept are recommended as possible treatments for people with 
                 enthesitis-related juvenile idiopathic arthritis.
          >     Etanercept is recommended as a possible treatment for people with psoriatic juvenile 
                 idiopathic arthritis 
 
Abatacept   
Abatacept may be considered as a second line option for rheumatoid arthritis if either rituximab or 
methotrexate is contraindicated or an adverse reaction has been experienced (see NICE guidance). 
Infusion to be administered in hospital. (NICE TA195)
 
Abatacept for treating Rheumatoid Arthritis after failure of conventional disease modifying anti-
rheumatic drugs (NICE TAG280) (rapid review of TAG234) - recommended as an option by NICE in adults
whose disease has responded inadequately to two conventional DMARD's including methotrexate if 
used in accordance with recommendations for other biologicals (TAG130) and PAS is provided
 
RED           Abatacept vial for infusion 250mg
RED           Abatacept pre-filled pen/syringe 125mcg
 
Adalimumab    
Adalimumab is recommended either alone or in combination for the treatment of psoriatic arthritis
and ankylosing spondylitis. It is also a treatment option for rheumatoid arthritis (see NICE guidance). 
Patients should be trained to self administer the injection.
 
RED           Adalimumab pre-filled pen/syringe 40mg
 
Apremilast - NICE TA433 (relaces TA372)                                                                    CCG Commissioned
Apremilast, alone or in combination with disease-modifying antirheumatic drugs (DMARDs), is 
recommended as an option for treating active psoriatic arthritis in adults only if:
        ¤     they have peripheral arthritis with 3 or more tender joints and 3 or more swollen joints and
        ¤     their disease has not responded to adequate trials of at least 2 standard DMARDs, given either  
               alone or in combination and
        ¤     the company provides apremilast with the discount agreed in the patient access scheme
 
RED        Apremilast tablets 10mg, 20mg, 30mg (Otezla®)
 
Certolizumab  
Certolizumab pegol in combination with methotrexate is indicated for the treatment of moderate
to severe, active rheumatoid arthritisin adult patients when the response to conventional disease
modifying anti-rheumatic drugs (DMARDs) including methotrexate, has been inadequate (see NICE 
guidance). Patients should be trained to self administer the injection.
 
RED           Certolizumab pre-filled syringe 200mg
 
Certolizumab  and Secukinumab as per NICE TA445                                              CCG Commissioned 
The response to certolizumab pegol and secukinumab should be assessed  after 12 weeks and 16 weeks of 
treatment respectively and should only be continued if there is clear evidence of response as in NICE TA445.
 
Certolizumab pegol alone, or in combination with methotrexate, is recommended as an option for
treating active psoriatic arthritis in adults only if:
 
          >     it  is used as described in the NICE technology appraisal guidance on on etanercept, infliximab
                 and adalimumab for the treatment of psoriatic arthritis  (recommendations 1.1 and 1.2) or
          >     the person has had a tumour necrosis factor (TNF)-alpha inhibitor but their disease has
                 stopped responding after the first 12 weeks.
 Certolizumab pegol is only recommended if the company provides it as agreed in the patient access
 
Secukinumab alone, or in combination with methotrexate, is recommended as an option for treating 
active psoriatic arthritis in adults only if:
          >     it is used as described in the NICE technology appraisal guidance on etanercept, infliximab 
                 and adalimumab for the treatment of psoriatic arthritis (recommendations 1.2 and 1.2) or 
          >     the person has had a TNF‑alpha inhibitor but their disease has not responded within the first   
                 12 weeks or has stopped responding after 12 weeks or
          >     TNF‑alpha inhibitors are contraindicated but would otherwise be considered (as described in 
                 NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the 
                 treatment of psoriatic arthritis). 
Secukinumab is only recommended if the company provides it as agreed in the patient access 
scheme.
 
RED            Certolizumab pre-filled syringe 200mg
RED            Secukinumab pre-filled syringe 150mg/1mL
 
Certolizumab
Certolizumab is recommended for the treatment of adults withactive and progressive psoriatic arthritis
in line with NICE TA199, that is when the person has peripheral arthritis with three or more  tender 
joints and three or more swollen joints and their psoriatic arthritis has not responded to adequate trials
of at least two standard disease-modifying antirheumatic drugs, administered either individually or in 
combination.
Certolizumab should be used in combination with methotrexate where possible, however can be given
as monotherapy in the case of intolerance to methotrexate or when continued treatment with 
methotrexate is inappropriate
 
RED            Certolizumab pre-filled syringe 200mg
 
Certolizumab
An option as  as a second line anti-TNF (tumour necrosis factor) in psoriatic arthritis (PsA) following 
discontinuation of first anti-TNF due to an adverse event or primary or secondary inefficacy.
 
RED             Certolizumab pre-filled syringe 200mg
 
Certolizumab 
Certolizumab pegol is licensed for the treatment of adults with severe active ankylosing spondylitis 
who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory 
drugs (NSAIDs)  (in line with NICE TA143)
 
RED            Certolizumab pre-filled syringe 200mg
 
Certolizumab
Certolizumab pegol  is recommended as an option for treating rheumatoid arthritis after inadequate
response to a TNF-alpha inhibitor -  NICE TA415
 
RED            Certolizumab pre-filled syringe 200mg                                                  CCG commissioned   
 
Etanercept                                                                                                                                     
Etanercept is recommended either alone or in combination with methotrexate for the treatment of 
active polyarticular juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis. It is also a
treatment option for rheumatoid arthritis (see NICE guidance). Patients should be trained to self 
administer the injection.
 
RED           Etanercept vial for injection 25mg
                   pre-filled pen/syringe 25mg, 50mg
 
Golimumab 
Treatment option for adults with severe active psoriatic arthritis only if used as described for other
tumour necrosis factor (TNF) inhibitors and the manufacturer provides the 100mg dose of  Golimumab
at the same cost as the 50mg dose.  
                         Please refer to the full guidelines for further information.
 
RED         Golimumab pre-filled pen/syringe 50mg,100mg 
 
Infliximab  
Infliximab may be considered as an option to treat rheumatoid arthritis where:
          >     certolizumab, adalimumab and etanercept are contraindicated, or
          >     methotrexate is contraindicated or not tolerated, or
          >     the patient cannot self inject (see NICE guidance). 
 
It is also a treatment option for psoriatic arthritis. Infusion to be administered in hospital.
 
RED           Infliximab vial for infusion 100mg
 
Rituximab  
Rituximab in combination with methotrexate is recommended as a second line option for the treatment
of adults with severe active rheumatoid arthritis who have had an inadequate  response to, or are 
intolerant of, other disease modifying anti-rheumatic drugs (DMARDs), including at least  one tumour
necrosis factor (TNF) inhibitor. Treatment with rituximab should be given no more frequently than
every 6 months (see NICE guidance). Infusion to be administered in hospital.
 
Pre-medication 30-60 minutes before hand with methylprednisolone is necessary to reduce infusion-
related reactions. Rituximab should be prepared by a pharmacist or healthcare professional observing
aseptic techniques. As per BSR guidelines for anti-TNFs, treatment should be withdrawn following
adverse events or where there is an inadequate response at 3 months following initiation of treatment.
Rituximab should be funded via 'pass through funding' under payment by results, booked out to
individual patients in pharmacy and recharged directly to the PCTs. A New Drug review for rituximab
in rheumatoid arthritis is available - click here.
 
RED           Rituximab vial for infusion 100mg, 500mg
 
Sarilumab - NICE guidance for moderate to severe rheumatoid arthritis (TA485)
Sarilumab with methotrexate , is recommended 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) - as per NICE TA485
                                                                                                             CCG Commissioned (Blue Tec form required)
 
Tocilizumab      
Tocilizumab in combination with methotrexate is recommended third line for the treatment of 
moderate to severe active rheumatoid arthritis in people whose condition (NICE TA198):
          >     has responded inadequately to one or more tumour necrosis factor alpha (TNFα) 
                 inhibitors; and 
          >     has responded inadequately or are contraindicated to rituximab, or when rituximab is 
                 withdrawn because of an adverse effect as per NICE guidance. 
 
Tocilizumab in combination with methotrexate is recommended for some children with juvenile 
idiopathic arthritis where all other treatments have failed (NICE TA238).
 
Infusion to be administered in hospital.
RED           Tocilizumab vial for infusion 80mg, 200mg, 400mg
 
Subcutaneous Tocilizumab is recommended for use as an alternative to intravenous Tocilizumab
providing the patient meets the prescribing criteria as set out in NICE technology appraisals for
1st, 2nd and 3rd  line use to treat active rheumatoid arthritis (RA) and the agreed Lancashire 
Rheumatology Alliance flex for use as monotherapy. CLICK here to link to the recommendation.
 
RED      Tocilizumab injection 162mg pre-filled syringe
 
Tocilizumab is recommended as an option in treating Giant Cell Arteritis by NICE TA518, when used with
a tapering course of glucocoticoids (and when used alone after glucocorticoids) only if:
 
          >      they have relapsing or refractory disease
          >      they have not already had
          >      tocilizumab is stopped after 1 year of uninterrupted treatment at most and
          >      the company provides it with the discount agreed in the patient access scheme
 
RED         Tocilizumab concentration for solution for infusion (RoActemra®)
                                                                                                                              (NHS England Commissioned)
 
Tofacitinib - Moderate to severe rheumatoid arthritis NICE TA480 
Tofacitinib, with methotrexate, is recommended 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 anti-rheumatic drugs (DMARDs), only if:
 
        >     disease is severe (a disease activity score [DAS28] of more than 5.1) and
        >     the company provides tofacitinib with the discoiunt agreed in the patient access scheme
 
Tofacitinib with methotrexate, is recommended as an option for treating active rheumatoid arthritis in
adults whose disease has responded inadequately to, or who cannot have, other DMARDs, including at
least 1 biological DMARD, only if:
 
      >     disease  is severe (a DAS28 of more than 5.1) and
      >     they cannot have rituximab
      >     the company provides tofacitinib with the discount agreed in the patient access scheme
 
Tofacitinib can be used as monotherapy for adults who cannot take methotrexate because it is 
contraindicated or because of intolerance, when the criteria in sections 1.1 and 1.2 are met.
 
RED       Tofacitinib 
               tablets 5mg (Xeljanz®)                                              (CCG Commissioned - Blue Teq form required)
 

 

 


10.1.4 Gout and cytotoxic-induced hyperuricaemia

Acute attacks of gout     
High doses of NSAIDs are usually used.
Colchicine is an alternative. The BNF dose of colchicine is known to cause gastrointestinal side effects,
particularly in patients with impaired renal function. Local rheumatologists recommend colchicine be given at
a dose of 500micrograms twice daily for acute gout.
 
GREEN      Colchicine tablets 500 micrograms
 
Long term control of gout  
Long term control to reduce formation of uric acid can be achieved with allopurinol. It should not be started 
during an acute attack. For approximately the first 6 weeks of therapy NSAIDs or colchicine should also be 
given.
 
GREEN      Allopurinol tablets 100mg, 300mg
 
Febuxostat 
NICE TA164 advises febuxostat, within its marketing authorisation, as an option for the management
of chronic hyperuricaemia in gout only for people who are intolerant of allopurinol or for whom allopurinol
is contraindicated. 
Intolerance of allopurinol is defined as adverse effects that are sufficiently severe to warrant its discontinuation, or to prevent full dose escalation for optimal effectiveness as appropriate within its marketing 
authorisation.  Annual treatment costs for febuxostat are approximately £318 while for allopurinol they are approximately £16.
 
Drug Safety Update July 2019 advises avoiding treatment with febuxostat in patients with pre-existing major
cardiovascular disease (for example,  myocardial infarction, stroke or unstable angina), unless no other 
therapy options are appropriate.
 
AMBER     Febuxostat tablets 40mg, 80mg
 
Hyperuricaemia associated with cytotoxic drugs
 
RED           Rasburicase 1.5mg (Consultant Haematologist use only)
 
 

10.2.1 Drugs which enhance neuromuscular transmission

The anticholinesterases are used as first line treatment in myasthenia gravis. Edrophonium has brief action and is used
in diagnosis.
RED           Edrophonium injection 10mg/mL
AMBER     Pyridostigmine tablets 60mg
 
Acetylcholine-release enhancer, 3, 4 diaminopyridine (an orphan drug) has been approved for use in the treatment of 
Lambert-Eaton myasthenic syndrome (LEMS), a rare disorder of neuromusculsr transmission.
 
RED          3, 4 Diaminopyridine tablets 10mg
 
RED     Nusinersen:  solution for injection 2.4 mg per 1 ml (Spinraza®)                            NHS England commissioned
NICE TA588   Nusinersen is recommended as an option for treating 5q spinal muscular atrophy (SMA) only if:
                           > people have pre-symptomatic SMA, or SMA types 1,2 or 3 and
                           > the condition is in the managed access agreement are followed.
 
RED    Risdiplam oral solution 0.75mg/ml [Evrysdi]                                                               NHS England commissioned
NICE TA755  Risdiplam is recommended as an option for treating 5q spinal muscular atrophy in people 2 months and 
                     older with a clinical diagnosis of SMA types 1,2 or 3 or with pre-symptomatic SMA and 1 to 4 SMN2 copies. 
                      It is recommended only if the conditions of the managed access agreement are followed.
                      
RED   Mexiletine capsules 167mg [Namuscla®]                                                                      NHS England commissioned 
NICE TA748  Mexiletine is recommended, within its marketing authorisation, as an option for treating the 
                      symptoms of myotonic disorders. It is recommended only if the company provides mexiletine 
                      according to the commercial arrangement.
                  
 

10.2.2 Skeletal muscle relaxants

Used for the relief of chronic muscle spasm or spasticity acting principally on the CNS.
 
GREEN      Baclofen     
                   tablets 10mg, 
                   liquid 5mg/5mL
GREEN      Diazepam      
                   tablets 2mg, 5mg, 10mg,
                   syrup 2mg/5mL
GREEN      Tizanidine
                   tablets 2mg, 4mg
 
     Cannabis extract – Delta-9-Tetrahydrocannabinol (THC) 27mg and Cannabidiol (CBD) 25mg (Sativex®) 
     oromucosal spray
     For symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) 
     who have not responded adequately to other anti-spasticity medication.
     This recommendation only covers the use of Delta-9-Tetrahydrocannabinol (THC) 27mg and Cannabidiol (CBD) 25mg 
     (Sativex) oromucosal spray for the indication of moderate to severe spasticity due to multiple sclerosis (MS) who have 
     not responded adequately to other anti-spasticity medication.
 
     SEE Cannabis-based medicinal products NG144
 
     AMBER     Cannabis extract – Delta-9-Tetrahydrocannabinol (THC) 27mg and Cannabidiol (CBD) 25mg (Sativex®) 
                       oromucosal spray. Specialist recommendation/initiation
                       INFORMATION FOR PRESCRIBERS: click here

       BLACK Traffic Light for all other indications





                                      

10.3.1 Enzymes

[Collagenase clostridium hystolyticum  Discontinued by manufacturer]
Collagenase Clostridium histolyticum 900mcg (Xiapex®) *
* Xiapex® - Sobi has discontinued commercialisation of this product at the end of 2019 - see attached information
 
Hyaluronidase  
Used to render tissues more easily permeable to injected fluids i.e. in hypodermoclysis.
 
AMBER     Hyaluronidase injection 1500 unit
 

10.3.2 Rubefacients and other topical anti-rheumatics

Topical non-steroidal anti-inflammatory drugs (NSAIDs) are recommended by NICE as a first line treatment with or 
without regular paracetamol for the management of osteoarthritis.
 
GREEN      Ibuprofen gel 5%
GREEN      Ketoprofen gel 2.5% (licensed for up to 7 days use only)
 
Prescribers are reminded that photosensitivity reactions are an important side effect of Ketoprofen gel. Before
prescribing
          >     Verify that the patient does not have any phototoxicity- or photoallergy-related contraindications.
          >     explain to patients the steps they need to take to minimise the risk of photosensitivity reactions
          >     check that patients understand the risk of photosensitivity and the steps they need to take to minimise this
                 risk. A prescriber checklist is available here 
 
Capsaicin
If above agent/s are ineffective or insufficient then alongside other options (such as oral NSAIDs, oral opioids or 
intra-articular injections) consider substitution or addition of topical capsaicin for hand/knee osteoarthritis.
 
Cautions 
Avoid contact with eyes, and inflamed or broken skin. Hands should be washed immediately after use. Not for use
under tight bandages. Avoid taking a hot shower or bath just before or after applying capsaicin - burning sensation 
enhanced.
 
Side-effects   
Transient burning sensation can occur during initial treatment, particularly if too much cream is used, or if the
frequency of administration is less than 3–4 times daily.
 
GREEN      Capsaicin cream 0.025% [Zacin®] (for osteoarthritis of the hand and knee only- NOT for back pain)  
                   For general musculoskeletal pain advise to purchase a rubefacient product]  [Consider OTC/Self care]  
AMBER     Capsaicin cream 0.075% [Axsain®] (for post herpetic neuralgia & painful diabetic neuropathy)
 
For the use in specialist services, Transvasin® cream has been approved for off-licence use to improve the blood 
flow of the ear lobe prior to measuring capillary ear lobe blood gases.
 
RED            Transvasin® cream
 
Information about changes to medicines or treatments on the NHS: Changes to rubefacients prescribing: Patient Information Leaflet