North East and North Cumbria Formulary


	North East and North Cumbria ICS Formulary

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Formulary Chapter 10: Musculoskeletal and joint diseases - Full Chapter

10.01.03

Drugs which suppress the rheumatic disease process

Durham and Darlington Shared Care Guidance

NICE NG100: Rheumatoid arthritis in adults: management

NICE NG226: Osteoarthritis in over 16s: diagnosis and management

North Cumbria Shared Care Guidelines

South Tyneside & Sunderland APC Shared Care Guidelines

Tees Shared Care Guidance

Newcastle, North Tyneside, Northumberland & Gateshead - Guidelines for Monitoring of Immune Modifying Drugs (IMDs) in Stable Adult Patients (excluding post transplantation) in Primary and Secondary Care

10.01.03

Gold

10.01.03

Penicillamine

10.01.03

Antimalarials

10.01.03

Drugs affecting the immune response

10.01.03

Cytokine modulators

Abatacept (Orencia®)

Formulary

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.

Clinical Commissioning Policy (210505P) Statement: Abatacept for treatment of severe treatment-resistant morphoea (localised scleroderma)

NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis

NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed

NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed

Adalimumab

Formulary

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

NICE TA195: Rheumatoid arthritis - after failure of a TNF inhibitor

NICE TA199: Psoriatic arthritis

NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis

NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed

NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis

NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed

Anakinra (Kineret®)

Formulary

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 (unlicensed 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

NICE TA685: Anakinra for treating Still’s disease

Apremilast (Otezla^®)

Formulary

Approved for the treatment of psoriatic arthritis in line with NICE

MHRA Drug Safety Update (Jan 2017): Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour

NICE TA433: Apremilast for treating active psoriatic arthritis

Belimumab (Benlysta®)

Formulary

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

MHRA Drug Safety Update (April 2019): Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials

NICE TA752: Belimumab for treating active autoantibody-positive systemic lupus erythematosus

Bimekizumab (Bimzelx^®)

Formulary

160mg/1ml solution for injection - pre-filled pen and syringes
Approved for the treatment of active psoriatic arthritis in line with NICE
Approved fofr the treatment of axial spondyloartritis in line with NICE

NICE TA916: Bimekizumab for treating active psoriatic arthritis

NICE TA918: Bimekizumab for treating axial spondyloarthritis

Certolizumab Pegol (Cimzia®)

Formulary

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.

NICE TA 415 - Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor

NICE TA375: 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 TA445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs

NICE TA574: Certolizumab pegol for treating moderate to severe plaque psoriasis

Etanercept

Formulary

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

NICE TA35: Adult psoriasis

NICE TA195: Rheumatoid arthritis after the failure of a TNF inhibitor

NICE TA199: Psoriatic arthritis

NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for JIA

NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed

NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis

NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed

Golimumab (Simponi^®)

Formulary

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

NICE TA220: psoriatic arthritis

NICE TA497: Golimumab for treating non-radiographic axial spondyloarthritis

NICE TA375: 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

Guselkumab (Tremfya)

Formulary

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

NICE TA815: Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs

Infliximab (Remsima^®, Inflectra^®, Remicade^® )

Formulary

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
- Refractory sarcoidosis (excluding neurosarcoidosis) in adults in line with NHSE Specialised Commissioing Policy
Prescribe by brand name; Remsima®, Inflectra®, Remicade®.

NHSE Specialised Commissioning Policy: Infliximab for refractory sarcoidosis (excluding neurosarcoidosis) (adults)

NICE TA195: Rheumatoid arthritis (after failure of a TNF inhibitor)

NICE TA199: Psoriatic arthritis

NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed

NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis

NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed

Ixekizumab (Taltz^®)

Formulary

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

NICE TA537: Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs

NICE TA718: Ixekizumab for treating axial spondyloarthritis

Rituximab

Formulary

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

NHS England Commissioning Policies (Specialised Rheumatology)

NICE TA195: Rheumatoid arthritis - after failure of a TNF inhibitor

NTAG - Treatment Appraisal Decision Summary - Rituximab Biosimilars

MHRA Drug Safety Update (Dec 2013): Rituximab: screen for hepatitis B virus before treatment.

MHRA Drug Safety Update (Dec 2014): Rituximab: progressive multifocal leukoencephalopathy in a patient

Sarilumab (Kevzara^®)

Formulary

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

NICE TA485: Sarilumab for moderate to severe rheumatoid arthritis

Secukinumab (Cosentyx®)

Formulary

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

NICE TA407: Secukinumab for active ankylosing spondylitis after treatment with non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors

NICE TA445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs

NICE TA719: Secukinumab for treating non-radiographic axial spondyloarthritis

Tocilizumab (RoActemra^®)

Formulary

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.

MHRA Drug Safety Update (July 2019): Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation

NICE TA247: Tocilizumab for the treatment of rheumatoid arthritis

NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis

NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed

NICE TA518: Tocilizumab for treating giant cell arteritis

Upadacitinib (Rinvoq^®)

Formulary

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.

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

NICE TA665: Upadacitinib for treating severe rheumatoid arthritis

NICE TA744: Upadacitinib for treating moderate rheumatoid arthritis

NICE TA768: Upadacitinib for treating active psoriatic arthritis after inadequate response to DMARDs

NICE TA814: Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis

NICE TA829: Upadacitinib for treating active ankylosing spondylitis

NICE TA861: Upadacitinib for treating active non-radiographic axial spondyloarthritis

Ustekinumab (Stelara®)

Formulary

Approved for psoriatic arthritis in accordance with NICE.

MHRA Drug Safety Update (Jan 2015): Ustekinumab (Stelara): risk of exfoliative dermatitis

NICE TA340: Ustekinumab for treating active psoriatic arthritis (Updated March 2017)

MHRA Drug Safety Update (April 2014): Tumour necrosis factor alpha inhibitors: risk of tuberculosis - screen all patients before starting treatment and monitor them closely

10.01.03

Sulfasalazine

....

Key

	Restricted Drug
	Unlicensed
	Link to adult BNF
	Link to children's BNF
	Link to SPCs
	Cytotoxic Drug
	Controlled Drug

	High Cost Medicine
	NHS England
	Homecare
	ICB
	Low carbon footprint
	Medium carbon footprint
	High carbon footprint

Status	Description
	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.
	Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. These medicines are considered suitable for primary care prescribing following specialist initiation of therapy and stabilisation, with ongoing communication between the primary care prescriber and specialist as set out in the associated shared care guideline (SCG). Shared care should be initiated by the specialist, which includes consultant, suitably trained specialist non-medical prescriber or GPwER within a secondary, tertiary, or primary care clinic. The specialist should send the primary care prescriber a copy of the NENC Clinical Effectiveness and Governance (CEG) Subcommittee approved SCG to sign. The primary care prescriber should sign the SCG or indicate reasons why they are unable to accept the agreement and return a copy back to the specialist, as soon as possible. SCGs are available or are being developed for most of the drugs listed as AMBER.
	Drugs normally recommended or initiated by a hospital specialist who is a prescriber, a GP with an extended role [GPwER], or a specialist within primary care which can be safely maintained in primary care and monitored in primary care. In some cases, a further restriction for use may be defined. The primary care prescriber must be familiar with the drug to take on prescribing responsibility or must obtain the required information from the specialist. Therefore, provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by primary care prescriber or provide information re stopping criteria. These are considered suitable for primary care prescribing following specialist assessment and recommendation of therapy, with ongoing communication between the primary care prescriber and specialist, if necessary. In some case these drugs require specialist initiation and short to medium term monitoring of efficacy or toxicity until the patient’s dose is stable. Following specialist review the patient may be transferred to primary care for ongoing prescribing. Ongoing prescribing by primary care can include, if required, additional dose titrations and assessment of efficacy, with ongoing communication between the primary care prescriber and specialist, if necessary. If the drug requires urgent initiation, it is expected that the specialist undertakes the initial prescribing responsibility for an appropriate period of time, usually a minimum of 28 days. A GREEN+ drug can only be recommended to primary care for initiation if does not need to be initiated within 28 days.
	Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible.
	UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.
	Drugs that have been considered by the NENC Clinical Effectiveness and Governance (CEG) Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria ICS. These may also include all medicines with a “not NHS” or “DLCV” classification in the BNF, those agents as included within the NICE “Do not do” list, and those agents included with the NHS England: Items which should not routinely be prescribed in primary care.