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Immune system
Immune system / Immune system disorders and transplantation
  anakinra NICE TA685
Adult Onset Stills Disease

Approved for Adult Onset Stills Disease.  Prior approval required.  Application to be submitted via Blueteq

Anakinra for the Management of Acute Gout

Approved by JPG in 2013 for patients admitted with acute gout where the use of colchicine, NSAIDs and steroids was ineffective or contra-indicated.

The decision to initiate and prescribe Anakinra must be made by a consultant rheumatologist. Patients will receive one dose of 100mg by subcutaneous injection. If the symptoms are not sufficiently reduced after 24 hours the dose maybe repeated. No more than 2 doses should be administered for an attack.

Anakinra is not licensed for the management of gout. Patients should therefore be informed of this and educated about the use of Anakinra. Informed consent from the patient must be documented in the medical record.

Anakinra for Haemophagocytic Lymphohistiocytosis (HLH)

Approved in April 2022 DTC as per NHSE commissioning policy SSC2301.

  Solution for injection
Kineret (Swedish Orphan Biovitrum Ltd)
  antithymocyte immunoglobulin (rabbit) Hospital Only NICE TA481
Renal Transplant including ATG guidance

Renal Transplant - HOSPITAL ONLY

  Solution for infusion
Antithymocyte immunoglobulin (rabbit) (Non-proprietary) Hospital Only
  Powder and solvent for solution for infusion
Thymoglobulin (Sanofi) Hospital Only
  avacopan Hospital Only NICE TA825
Avacopan-Severe active granulomatosis with polyangiitis or microscopic polyangiitis in adults - December 2022 (NICE TA 825)

Approved NEL FPG in line with NICE TA 825.

Avacopan with a cyclophosphamide or rituximab regimen is recommended, within its marketing authorisation, as an option for treating severe active granulomatosis with polyangiitis or microscopic polyangiitis in adults.

  Oral capsule
Tavneos (Vifor Fresenius Medical Care Renal Pharma UK Ltd)
  azathioprine Hospital Only
IBD Shared Care Guidelines 2019

IBD Shared Care Guidelines

  Oral suspension
Jayempi (Nova Laboratories Ltd)
  Oral tablet
Azathioprine (Non-proprietary)
Imuran (Aspen Pharma Trading Ltd)
  basiliximab Hospital Only NICE TA481
Renal Transplant including ATG guidance

Renal Transplant - HOSPITAL ONLY

Immunosuppression post renal transplant, September 2009

Basiliximab was the only suitable alternative and so the Renal Unit planned to swap to this.  Daclizumab had been available at a reduced cost and so the change would result in a significant cost pressure for PCTs as these drugs were PbR exclusions. The Group ratified the change to basiliximab.

HOSPITAL ONLY

  Powder and solvent for solution for injection
Simulect (Novartis Pharmaceuticals UK Ltd) On Formulary
Immunosuppression post renal transplant

HOSPITAL ONLY

Renal Transplant including ATG guidance

  belatacept Off Formulary NICE TA481
NICE TA481

Immunosuppressive therapy for kidney transplant in adults (October 2017)

Belatacept is not recommended as an initial treatment to prevent organ rejection in adults having a kidney transplant. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop

  Powder for solution for infusion
Nulojix (Bristol-Myers Squibb Pharmaceuticals Ltd)
  belimumab Hospital Only NICE TA752
Belimumab NICE TA 752 for the management of systemic lupus erythematosus (SLE), (March 2022)

HOSPITAL ONLY

 

120 mg vial IV

400 mg vial IV

Dose

10 mg/kg every 2 weeks for 3 doses then 10mg/kg every 4 weeks

 

200 mg prefilled pen / prefilled syringe

 

Dose

200 mg once weekly, administered subcutaneously.

 

Approved in line with NICE TA 752

  Solution for injection
Benlysta (GlaxoSmithKline UK Ltd)
  Powder for solution for infusion
Benlysta (GlaxoSmithKline UK Ltd)
  belumosudil NICE TA949
  Oral tablet
Rezurock (Sanofi)
  budesonide NICE TA708
NICE TA937
  Orodispersible tablet
Jorveza (Dr. Falk Pharma UK Ltd)
  Modified-release tablet
Cortiment (Ferring Pharmaceuticals Ltd)
  Modified-release capsule
Budesonide (Non-proprietary)
Kinpeygo (Genus Pharmaceuticals Holdings Ltd)
  Gastro-resistant capsule
Budenofalk (Dr. Falk Pharma UK Ltd)
  Gastro-resistant granules
Budenofalk (Dr. Falk Pharma UK Ltd)
  Inhalation powder
Budelin Novolizer (Viatris UK Healthcare Ltd)
Easyhaler (Orion Pharma (UK) Ltd)
Pulmicort Turbohaler (AstraZeneca UK Ltd)
  Nebuliser liquid
Budesonide (Non-proprietary)
Pulmicort Respules (AstraZeneca UK Ltd)
  Enema
Entocort (Tillotts Pharma UK Ltd)
  Spray
Budesonide (Non-proprietary)
  Rectal foam
Budenofalk (Dr. Falk Pharma UK Ltd)
  canakinumab
  Solution for injection
Ilaris (Novartis Pharmaceuticals UK Ltd)
  chloroquine On Formulary
Malaria treatment and prophylaxis

Refer to Parasitology section of MicroGuide.

Chloroquine

Update of malaria prevention guidelines for travellers from the UK

  Oral solution
Malarivon (Wallace Manufacturing Chemists Ltd) On Formulary
  Oral tablet
Avloclor (Alliance Pharmaceuticals Ltd)
  ciclosporin Hospital Only NICE TA369
Renal Transplant including ATG guidance

Renal Transplant - HOSPITAL ONLY

June-2024 - Verkazia® (ciclosporin) 1 mg/mL eye drops

Verkazia® (ciclosporin) 1 mg/mL eye drops approved at NEL FPG for  

  • Severe Vernal Keratoconjunctivitis (VKC)  

Off-label indications:  

  • Severe Atopic Keratoconjunctivitis (AKC),  
  • Blepharo-keratoconjunctivitis (BKC) / Ocular Rosacea, 
  • Thygeson’s keratitis & Chronic GvHD 
  • Dry Eye Disease (DED)/ Keratoconjunctivitis Sicca (KCS) 

 

Formulary Status: Amber - Specialist initiated 

  Oral solution
Neoral (Novartis Pharmaceuticals UK Ltd) On Formulary
Sandimmun (Novartis Pharmaceuticals UK Ltd)
  Solution for infusion
Sandimmun (Novartis Pharmaceuticals UK Ltd) Hospital Only
  Eye drops
Ikervis (Santen UK Ltd)
Verkazia (Santen UK Ltd)
  Oral capsule
Ciclosporin (Non-proprietary)
Capimune (Viatris UK Healthcare Ltd)
Capsorin (Morningside Healthcare Ltd)
Deximune (Dexcel-Pharma Ltd)
Neoral (Novartis Pharmaceuticals UK Ltd)
Sandimmun (Novartis Pharmaceuticals UK Ltd)
Vanquoral (Teva UK Ltd)
  eculizumab NICE HST1
  Solution for infusion
Bekemv (Amgen Ltd)
Epysqli (Samsung Bioepis NL B.V. Ltd)
Soliris (Alexion Pharma UK Ltd)
  everolimus Hospital Only NICE TA421
NICE TA432
NICE TA449
Afinitor® NICE TA498
Certican® NICE TA348
Certican® NICE TA481
  Dispersible tablet
Votubia (Novartis Pharmaceuticals UK Ltd)
  Oral tablet
Everolimus (Non-proprietary)
Afinitor (Novartis Pharmaceuticals UK Ltd)
Certican (Novartis Pharmaceuticals UK Ltd)
Votubia (Novartis Pharmaceuticals UK Ltd)
  hydroxychloroquine sulfate On Formulary
Alopecia Pathway

DMARD monitoring for dermatology

HYDROXYCHLOROQUINE SULFATE

To suppress the rheumatic process and in Systemic or Cutaneous Lupus Erythemetous

  Oral tablet
Hydroxychloroquine sulfate (Non-proprietary)
Quinoric (Bristol Laboratories Ltd)
  mycophenolate mofetil On Formulary NICE TA481
NICE TA481
DMARD monitoring for dermatology

Mycophenolate in pregnancy - new MHRA advice


Renal Transplant including ATG guidance

Renal Transplant - HOSPITAL ONLY

MYCOPHENOLATE MOFETIL

HOSPITAL ONLY FOR USE POST ORGAN TRANSPLANT

 

Treatment pathway for non-pregnant adult patients with immune thrombocytopenia (ITP

https://weshare.bartshealth.nhs.uk/immunology-immuno-haematology-and-general-haematology?media_item=18159&media_type=10#file-viewer

  Gastro-resistant tablet
Mycophenolate mofetil (Non-proprietary) On Formulary
Mycophenolate Paediatric Nephritis Shared Care Guideline

see attached

Alopecia Pathway

see attached

Ceptava (Sandoz Ltd)
Myfortic (Novartis Pharmaceuticals UK Ltd)
Mycophenolate Paediatric Nephritis Shared Care Guideline

Alopecia Pathway

Mycophenolate in pregnancy - new MHRA advice


  Oral suspension
Mycophenolate mofetil (Non-proprietary)
Mycophenolate Paediatric Nephritis Shared Care Guideline

see attached

Alopecia Pathway

see attached

CellCept (Roche Products Ltd) On Formulary
Mycophenolate Paediatric Nephritis Shared Care Guideline

see attached

Alopecia Pathway

see attached

Mycophenolate shared care dermatology

see attached

  Powder for solution for infusion
CellCept (Roche Products Ltd)
  Oral tablet
Mycophenolate mofetil (Non-proprietary)
CellCept (Roche Products Ltd)
Myfenax (Teva UK Ltd)
  Oral capsule
Mycophenolate mofetil (Non-proprietary)
CellCept (Roche Products Ltd)
Myfenax (Teva UK Ltd)
  rituximab Hospital Only NICE TA308
NICE TA195
NICE TA243
NICE TA137
NICE TA193
NICE TA226
NICE TA174
NICE TA359
NICE TA561
Rituximab-Connective Tissue Disease and Hypersensitivity Pneumonitis - Interstitial Lung Disease (CTD-ILD and HP-ILD) (November-2022)

NEL FPG Approved for use in Connective Tissue Disease- Interstitial Lung Disease (CTD-ILD) and Hypersensitivity Pneumonitis- Interstitial Lung Disease (HP-ILD)

Treatment of Interstitial Lung Disease (ILD) in patients with severe active disease that has failed to respond to, or patient is intolerant to at least 2 immunosuppressants (tacrolimus, methotrexate, mycophenolate or cyclophosphamide), each having been taken for at least 3 months.

Rituximab IV 1g on day 1 and day 15, then repeated 6 monthly if the patient responds.

Hospital Only

RENAL SERVICE

On Formulary for Idiopathic Membraneous Glomerulonephritis,

biopsy-proven, steroid-sensitive minimal change nephropathy or primary focal segmental glomerulosclerosis (non-commissioned).

 

Renal Transplant Patients

For vasculitis in renal transplant 
As immunuppression for ABO incompatible transplants

 

Rituximab use in clinical haematology indications

Truxima brand is used in clinical haematology indications. 

Rituximab for the treatment of IgM paraproteinaemic demyelinating peripheral neuropathy in adult

Rituximab for the treatment of IgM paraproteinaemic demyelinating peripheral neuropathy in adults approved for use in May 2022 DTC as per Clinical Commissioning policy SSC2319

  Solution for injection
MabThera (Roche Products Ltd)
  Solution for infusion
MabThera (Roche Products Ltd) Hospital Only
Renal transplant patients

For vasculitis in renal transplant patients 
As immunuppression for ABO incompatible transplants

Rixathon (Sandoz Ltd)
Ruxience (Pfizer Ltd)
Truxima (Celltrion Healthcare UK Ltd)
  satralizumab
  Solution for injection
Enspryng (Roche Products Ltd)
  sirolimus Hospital Only NICE TA481
Sirolimus 0.1% topical (Unlicensed Special)

Topical is Sirolimus is available to use in patients with Tuberous Sclerosis Manifesting with Facial Angiofibromata.

  Oral solution
Rapamune (Pfizer Ltd) Hospital Only
  Oral tablet
Rapamune (Pfizer Ltd)
  tacrolimus Hospital Only NICE TA82
NICE TA481
NICE TA481
DMARD monitoring for dermatology

Renal Transplant including ATG guidance

Renal Transplant - HOSPITAL ONLY

  Modified-release tablet
Envarsus (Chiesi Ltd) Hospital Only
  Modified-release capsule
Advagraf (Astellas Pharma Ltd) On Formulary
Dailiport (Sandoz Ltd)
  Granules for oral suspension
Modigraf (Astellas Pharma Ltd)
  Solution for infusion
Prograf (Astellas Pharma Ltd) On Formulary
  Cutaneous ointment
Tacrolimus (Non-proprietary)
Protopic (LEO Pharma)
  Oral capsule
Adoport (Sandoz Ltd)
Prograf (Astellas Pharma Ltd)
  tocilizumab NICE TA375
NICE TA247
NICE TA518
NICE TA878
  Solution for injection
RoActemra (Roche Products Ltd)
Tyenne (Fresenius Kabi Ltd)
  Solution for infusion
RoActemra (Roche Products Ltd)
Tyenne (Fresenius Kabi Ltd)
  voclosporin NICE TA882
TA 882 – July 2023, Voclosporin with mycophenolate mofetil for treating lupus nephritis

 Voclosporin with mycophenolate mofetil approved at NEL FPG for treating  lupus nephritis in line with NICE TA.

  Oral capsule
Lupkynis (Otsuka Pharmaceuticals (U.K.) Ltd)
Immune system / Multiple sclerosis
  alemtuzumab On Formulary NICE TA312
ALEMTUZUMAB

HOSPITAL ONLY

Alemtuzumab for Multiple Sclerosis

See attached

  Solution for infusion
Lemtrada (Sanofi)
  cladribine Hospital Only NICE TA616
  Solution for injection
Litak (Lipomed GmbH)
  Solution for infusion
Leustat (Atnahs Pharma UK Ltd)
  Oral tablet
Mavenclad (Merck Serono Ltd)
  dimethyl fumarate Hospital Only
Moderate to Severe Plaque Psoriasis

Approved to treat moderate to severe plaque psoriasis in line with NICE TA475.  Prior approval required via Blueteq

Skilarence® NICE TA475
Tecfidera® NICE TA320
  Gastro-resistant tablet
Skilarence (Almirall Ltd) Hospital Only
  Gastro-resistant capsule
Dimethyl fumarate (Non-proprietary)
Tecfidera (Biogen Idec Ltd) On Formulary
  diroximel fumarate Hospital Only NICE TA794
Diroximel Fumarate-For treating relapsing remitting multiple sclerosis (NICE TA 794)

Approved at DTC July 2022 for for treating relapsing remitting multiple sclerosis as per NICE TA 794

  Gastro-resistant capsule
Vumerity (Biogen Idec Ltd)
  fampridine Hospital Only
  Modified-release tablet
Fampyra (Biogen Idec Ltd)
  fingolimod Hospital Only NICE TA254
Fingolimod for MS

HOSPITAL ONLY

FINGOLIMOD

Multiple Sclerosis

  Oral capsule
Fingolimod (Non-proprietary)
Gilenya (Novartis Pharmaceuticals UK Ltd)
  glatiramer acetate Hospital Only NICE TA527
GLATIRAMER ACETATE

Multiple Sclerosis

Beta Interferon & Glatiramer Acetate For Treatment Of Multiple Sclerosis

NICE TA32

  Solution for injection
Brabio (Viatris UK Healthcare Ltd)
Copaxone (Teva UK Ltd) Hospital Only
Beta Interferon & Glatiramer Acetate For Treatment Of Multiple Sclerosis

NICE TA32

  interferon beta Hospital Only NICE TA527
NICE TA527
INTERFERON BETA

HOSPITAL ONLY

Beta Interferon & Glatiramer Acetate For Treatment Of Multiple Sclerosis

NICE TA32

  Solution for injection
Avonex (Biogen Idec Ltd)
Rebif (Merck Serono Ltd)
  Powder and solvent for solution for injection
Betaferon (Bayer Plc)
Extavia (Novartis Pharmaceuticals UK Ltd)
  natalizumab Hospital Only NICE TA127
NATALIZUMAB

HOSPITAL ONLY

  Solution for infusion
Tyruko (Sandoz Ltd)
Tysabri (Biogen Idec Ltd) On Formulary
Natalizumab

HOSPITAL ONLY

  ocrelizumab Hospital Only NICE TA533
NICE TA585
Primary Progressive Multiple Sclerosis

On Formulary Hospital Only

  Solution for infusion
Ocrevus (Roche Products Ltd) Hospital Only
  ofatumumab Hospital Only NICE TA699
  Solution for injection
Kesimpta Sensoready (Novartis Pharmaceuticals UK Ltd)
  ozanimod Off Formulary NICE TA706
NICE TA828
Ozanimod - Treating moderately to severely active ulcerative colitis - December 2022 - (NICE TA 828)

Ozanimod Approved at NEL FPG in line with NICE TA 828.

Ozanimod is recommended as an option for treating moderately to severely active ulcerative colitis in adults, only if:

  • conventional treatment cannot be tolerated or is not working well enough and infliximab is not suitable, or

biological treatment cannot be tolerated or is not working well enough

  Oral capsule
Zeposia (Bristol-Myers Squibb Pharmaceuticals Ltd)
  peginterferon beta-1a NICE TA624
  Solution for injection
Plegridy (Biogen Idec Ltd)
  ponesimod Hospital Only NICE TA767
  Oral tablet
Ponvory (Janssen-Cilag Ltd)
  siponimod Hospital Only NICE TA656
  Oral tablet
Mayzent (Novartis Pharmaceuticals UK Ltd)
  teriflunomide Hospital Only NICE TA303
  Oral tablet
Teriflunomide (Non-proprietary)
Aubagio (Sanofi)
Immune system / Autoimmune hepatitis
  penicillamine Hospital Only
PENICILLAMINE

FOR HOSPITAL USE ONLY

  Oral tablet
Penicillamine (Non-proprietary)