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 Formulary Chapter 10: Musculoskeletal and joint diseases - Full Chapter
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10.01.03  Expand sub section  Drugs which suppress the rheumatic disease process
10.01.03  Expand sub section  Gold
10.01.03  Expand sub section  Penicillamine
10.01.03  Expand sub section  Antimalarials
10.01.03  Expand sub section  Drugs affecting the immune response to top
10.01.03  Expand sub section  Cytokine modulators
Abatacept 125mg (Orencia®)
(sub-cutaneous injection)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not yet available.

Restricted - to prescribing by Consultant Rheumatologists only for the treatment of rheumatoid arthritis, as the preferred choice when abatacept IV is recommended in accordance with Biologics for Rheumatoid Arthritis guideline (BHTCG 749FM) and NICE TA 375.

NOTE If patients fail to respond to one route they may NOT try the alternative route.

Red Specialist Centre For treatment of JIA in accordance with NHS England Clinical Commissioning Policy Biologic Therapies for the treatment of Juvenile Idiopathic Arthritis (JIA) (July 2015) E03X04. Prescribing by consultant paediatric rheumatologist under 'shared care' with a Specialized Service Paediatric Rheumatology consultant in accordance with requirements defined in Policy E03X04. 
Link  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
Link  Rheumatoid Arthritis Biologics treatment - Secondary Care guideline (BHTCG 749FM)
   
Abatacept 250mg (Orencia®)
(intravenous infusion)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage

Restricted - to Rheumatology consultant prescribing only, in accordance with Biologics for Rheumatoid Arthritis guideline (BHTCG 749FM) and NICE TA 195 and NICE TA 375.

NOTE If patients fail to respond to one route they may NOT try the alternative route.

Red Specialist Centre For treatment of JIA in accordance with NHS England Clinical Commissioning Policy Biologic Therapies for the treatment of Juvenile Idiopathic Arthritis (JIA) (July 2015) E03X04. Prescribing by consultant paediatric rheumatologist under 'shared care' with a Specialized Service Paediatric Rheumatology consultant in accordance with requirements defined in Policy E03X04. 
Link  NICE TA195 - Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor
Link  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
Link  Rheumatoid Arthritis Biologics treatment - Secondary Care guideline (BHTCG 749FM)
   
Adalimumab 40mg (Imraldi®, Amgevita®, Humira®)
(injection, prefilled pen or syringe (Rheumatology))
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
CCG
BlueTeq

FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage.


Note: ALL prescribing of adalimumab must include generic and brand name. Imraldi® is first choice preperation. Amgevita® is second choice preparation in those intolerent to citrate element (switch application via Blueteq).


Red Traffic Light 


1. Restricted - to Rheumatology consultant prescribing only, in accordance with Biologics for Rheumatoid Arthritis guideline (BHTCG 749FM) and NICE TA 375 and TA 195.
2. Restricted - to Rheumatology consultant prescribing only, in accordance with Biologics for Ankylosing Spondylitis guideline (BHTCG 737FM) and NICE TA 143.
3. Restricted - to prescribing by Rheumatology or Dermatology consultants only, in accordance with Biologics for Psoriatic arthritis guideline (BHTCG 740FM) and NICE TA 199

Red Specialist Centre 


4. Restricted - prescribing by consultant opthalmologists following initiation by Specialist Centre.
For treatment continuation for non-infectious uveitis in adult patients in accordance with NICE TA460, NHSE Clinical Commissioning Policy D12/P/b, July 15 and NHSE Interim Clinical Commissioning Policy Statement 170010/PS. BHT Opthalmology consultants will prescribe as outreach to the Specialist Centre delivered as part of a provider network. Name of Specialist centre and clinician involved in MDT to be communicated to Formulary Team prior to initiating treatment at BHT. If treatment is continued at BHT, the biologic will be administered by Rheumatology
5. Restricted - For treatment of JIA in accordance with NHS England Clinical Commissioning Policy Biologic Therapies for the treatment of Juvenile Idiopathic Arthritis (JIA) (July 2015) E03X04. Prescribing by consultant paediatric rheumatologist under 'shared care' with a Specialized Service Paediatric Rheumatology consultant in accordance with requirements defined in Policy E03X04.

See section 01.05.03 (Gastroenterology) and 13.05.03 (Dermatology)

 
Link  Biologics for Ankylosing Spondylitis (AS) and non-Radiographic Axial Spondyloarthritis (AxS) - Secondary Care guideline (BHTCG 737FM)
Link  Biologics for Psoriatic Arthritis - Secondary Care guideline (BHTCG 740)
Link  NHS England Clinical Commisioning Policy D12/P/b: Infliximab (Remicade) and Adalimumab (Humira) As Anti-TNF Treatment Options For Adult Patients with Severe Refractory Uveitis
Link  Rheumatoid Arthritis Biologics treatment - Secondary Care guideline (BHTCG 749FM)
Link  NICE TA 143 Adalimumab, etanercept and infliximab for ankylosing spondylitis
Link  NICE TA 195 Treatment of rheumatoid arthritis after the failure of a TNF inhibitor
Link  NICE TA199 Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis
Link  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
Link  NICE TA 460: Adalimumab and dexamethasone for treating non-infectious uveitis
   
Belimumab 120mg, 400mg
(powder for concentrate for solution for infusion)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red Specialist Centre
High Cost Medicine
FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Rheumatologists, under shared care with a Specialist Centre. In BHT this is generally OUH. Prescribing is in accordance with NICE TA 397 and NHSE SSC 1705. 
Link  MHRA Drug Safety Update - April 2019: Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials
Link  NICE TA 397: Belimumab for treating active autoantibody-positive systemic lupus erythematosus
   
Certolizumab Pegol 200mg (Cimzia®)
(injection, prefilled syringe)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine

FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not yet available.

NOTE: use restricted in BHT to patients with a low number of co-morbidities and low risk of infection and is subject to further audit.

Restricted - prescribing by Consultant Rheumatologists,
1. in accordance with Biologics for Rheumatoid Arthritis guideline (BHTCG 749FM), NICE TA 375 and NICE TA 415.
2. in accordance with Biologics for Ankylosing Spondylitis (AS) and non-radiographic axial spondyloarthritis (AxS) (BHTCG 737FM) and NICE TA 383.


Restricted - prescribing by Consultant Rheumatologists and Consultant Dermatologists,
3. in accordance with Biologics for Psoriatic Arthritis (BHTCG 740FM) and NICE TA 445

 
Link  Biologics and Apremilast in Psoriatic Arthritis - Secondary Care guideline (BHTCG 740FM)
Link  Biologics for Ankylosing Spondylitis (AS) and non-Radiographic Axial Spondyloarthritis (AxS) - Secondary Care guideline (BHTCG 737FM)
Link  NICE TA 415: Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor
Link  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
Link  Rheumatoid Arthritis Biologics treatment - Secondary Care guideline (BHTCG 749FM)
Link  NICE TA 445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs
   
Etanercept 25mg, 50mg (Enbrel®, Benepali®)
(injection (Rheumatology))
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage.

NOTE:
ALL prescribing of etanercept must include generic and brand name.
Benepali® is first choice etanercept preparation.

1. Restricted - to Rheumatology consultant prescribing only in accordance with NICE TA 35.
2. Restricted - to Rheumatology consultant prescribing only in accordance with Biologics for Ankylosing Spondylitis guideline (BHTCG 737FM) and NICE TA 143.
3. Restricted - to prescribing by Rheumatology or Dermatology consultants only, in accordance Biologics for Psoriatic arthritis guideline (BHTCG 740FM) and NICE TA 199.
4. Restricted - to Rheumatology consultant prescribing only, in accordance with Biologics for Rheumatoid Arthritis guideline (BHTCG 749FM) and NICE TA 375 and NICE TA 195.

Red Specialist Centre 5. For treatment of JIA in accordance with NHS England Clinical Commissioning Policy Biologic Therapies for the treatment of Juvenile Idiopathic Arthritis (JIA) (July 2015) E03X04. Prescribing by consultant paediatric rheumatologist under 'shared care' with a Specialized Service Paediatric Rheumatology consultant in accordance with requirements defined in Policy E03X04.

See section 13.05.03 (for Dermatology) 
Link  Biologics and Apremilast in Psoriatic Arthritis - Secondary Care guideline (BHTCG 740FM)
Link  Biologics for Ankylosing Spondylitis (AS) and non-Radiographic Axial Spondyloarthritis (AxS) - Secondary Care guideline (BHTCG 737FM)
Link  NICE TA35: Arthritis (juvenile idiopathic) - etanercept
Link  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
Link  Rheumatoid Arthritis Biologics treatment - Secondary Care guideline (BHTCG 749FM)
Link  NICE TA143: Adalimumab, Etanercept and Infliximab for Ankylosing Spondylitis
Link  NICE TA195: Rheumatoid arthritis - drugs for treatment after failure of a TNF inhibitor
   
Golimumab 50mg (Simponi®)
(injection, prefilled pen or syringe)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine

FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not yet available.

1. Restricted - to prescribing by Rheumatology or Dermatology consultants only, in accordance with Biologics for Psoriatic arthritis guideline (BHTCG 740FM) and NICE TA 220.
2. Restricted - to Rheumatology consultant prescribing only, in accordance with Biologics for Rheumatoid Arthritis guideline (BHTCG 749FM) and NICE TA 375.
3. Restricted - to Rheumatology consultant prescribing only in accordance with Biologics for Ankylosing Spondylitis (AS) and non-Radiographic Axial Spondyloarthritis (AxS) guideline (BHTCG 737FM), NICE TA 233 and NICE TA 497.

 
Link  Biologics and Apremilast in Psoriatic Arthritis - Secondary Care guideline (BHTCG 740FM)
Link  Biologics for Ankylosing Spondylitis (AS) and non-Radiographic Axial Spondyloarthritis (AxS) - Secondary Care guideline (BHTCG 737FM)
Link  NICE TA220: Psoriatic arthritis - golimumab
Link  NICE TA225: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA233: Ankylosing spondylitis - golimumab
Link  Rheumatoid Arthritis Biologics treatment - Secondary Care guideline (BHTCG 749FM)
Link  NICE TA 497: Golimumab for treating non-radiographic axial spondyloarthritis
   
Infliximab 100mg (Inflectra, Remsima, Remicade®)
(intravenous infusion)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine

NOTE:
ALL prescribing of infliximab must include generic and brand name.
Inflectra® is first choice infliximab biosimilar for all new patients, with Remsima® second choice only when first choice is more expensive or not available.
Infliximab biosimilars may be prescribed for patients currently receiving Remicade® brand when considered clinically appropriate by the relevant consultant and with consent of the patient.
Red Traffic Light  FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage.
1. Restricted - to Rheumatology consultant prescribing only, in accordance with Biologics for Rheumatoid Arthritis guideline (BHTCG 749FM) and NICE TA 375 and 195.
2. Restricted - to prescribing by Rheumatology or Dermatology consultants only, in accordance with Biologics for Psoriatic arthritis guideline (BHTCG 740) and NICE TA 199.
3. Restricted - to prescribing by Rheumatology consultants only, in accordance with Biologics for Ankylosing Spondylitis (AS) and non-radiographic axial spondyloarthritis (AxS) guideline (BHTCG 737FM) and NICE TA 383.

Red Specialist Centre 4. Restricted - prescribing by consultant opthalmologists following initiation by Specialist Centre. For treatment continuation for severe refractory uveitis in adult patients in accordance with NHSE Clinical Commissioning Policy D12/P/b, July 15. BHT Opthamology consultants will prescribe as outreach to the Specialist Centre delivered as part of a provider network. Name of Specialist centre and clinician involved in MDT to be communicated to Formulary Team prior to initiating treatment at BHT. If treatment is continued at BHT, the biologic will be administered by Rheumatology.
5. For treatment of JIA in accordance with NHS England Clinical Commissioning Policy Biologic Therapies for the treatment of Juvenile Idiopathic Arthritis (JIA) (July 2015) E03X04. Prescribing by consultant paediatric rheumatologist under 'shared care' with a Specialized Service Paediatric Rheumatology consultant in accordance with requirements defined in Policy E03X04.

see Section 1.5.3 (for Gastroenterology) and 13.5.3 (for Dermatology)

 
Link  Biologics and Apremilast in Psoriatic Arthritis - Secondary Care guideline (BHTCG 740)
Link  Biologics for Ankylosing Spondylitis (AS) and non-Radiographic Axial Spondyloarthritis (AxS) - Secondary Care guideline (BHTCG 737FM)
Link  NHS England Clinical Commissioning Policy D12/P/b: Infliximab (Remicade) and Adalimumab (Humira) As Anti-TNF Treatment Options For Adult Patients with Severe Refractory Uveitis
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
Link  NICE TA195: Rheumatoid arthritis - drugs for treatment after failure of a TNF inhibitor
Link  NICE TA199: Psoriatic arthritis - etanercept, infliximab and adalimumab
Link  Patient Information Leaflet: Infliximab and Biosimilars
Link  Rheumatoid Arthritis Biologics treatment - Secondary Care guideline (BHTCG 749FM)
   
Rituximab 100mg/10mL, 500mg/50mL (MabThera®, Truxima®)
(intravenous infusion)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine

FOR ALL PRESCRIBING - HIGH COST DRUGS compliance form required - see link from Formulary homepage.

NOTE:
ALL prescribing of RItuximab must include generic and brand name.
Truxima® is first choice rituximab biosimilar for all new patients, with MabThera® second choice only when first choice is more expensive or not available.
Rituximab biosimilars may be prescribed for patients currently receiving MabThera® brand when considered clinically appropriate by the relevant consultant and with consent of the patient.

Red 1. Restricted - to Rheumatology consultant prescribing only, in accordance with Biologics for Rheumatoid Arthritis guideline (BHTCG 749FM), NICE TA 195 and TVPC Biologics in RA Policy 51.
 
Red Specialist Centre  2. Restricted - to consultant Rheumatologists prescribing following approval by Thames Valley Specialised Rheumatology Network MDT for:
a. treatment of ANCA-associated vasculitis in adults, NHSE Clinical Commissioning policy A13/P, Jan 15.
b. treatment of dermatomyositis and polymyositis (adults), NHSE SSC Policy 1636/P, July 16.
c. immunoglobulin G4-related disease (IgG4-RD) in accordance with NHSE SSC 1685 and NHSE Clinical Commissioning Policy 16057/P.
BHT Rheumatology consultants will prescribe as outreach to the Specialist Centre delivered as part of a provider network. Name of Specialist centre and clinician involved in MDT to be communicated to Formulary Team prior to initiating treatment at BHT.
3. For treatment of JIA in accordance with NHS England Clinical Commissioning Policy Biologic Therapies for the treatment of Juvenile Idiopathic Arthritis (JIA) (July 2015) E03X04. Prescribing by consultant paediatric rheumatologist under 'shared care' with a Specialized Service Paediatric Rheumatology consultant in accordance with requirements defined in Policy E03X04.

See section 08.02.03 (Haematology)

 
Link  Rheumatoid Arthritis Biologics treatment - Secondary Care guideline (BHTCG 749FM)
Link  Rituximab Intravenous Infusion for Rheumatoid Arthritis and Vasculitis - Secondary Care Guideline (BHTCG 792FM)
Link  NHS England Clinical Commissioning Policy 16057/P: Rituximab for immunoglobulin G4- related disease (IgG4-RD)
Link  NHSE Clinical Commissioning Policy: Rituximab for the treatment of dermatomyositis and polymyositis in adults (16036/P)
Link  NICE TA195: Rheumatoid arthritis - drugs for treatment after failure of a TNF inhibitor
Link  NHSE Clinical Commissioning Policy: Rituximab for the treatment of ANCA-associated vasculitis in adults (A13/P, January 2015)
   
Sarilumab 150mg, 200mg
(solution for injection in pre-filled syringe/pen )
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine

FOR ALL PRESCRIBING, prior approval via a completed Blueteq form is required. 


Red Traffic Light 1. Restricted - to Rheumatology consultant prescribing only, in accordance with Rheumatoid Arthritis Biologics treatment guideline (BHTCG 749FM) and NICE TA 485.


Link  Rheumatoid Arthritis Biologics treatment - Secondary Care guideline (BHTCG 749FM)



Link  NICE TA 485: Sarilumab for moderate to severe rheumatoid arthritis


 
Red Traffic Light 2. Restricted -  to initiation on the advice of a Respiratory and  ICU consultant for use in accordance with guideline 17FM Tocilzumab and Sarilumab for patients with COVID-19 pneumonia (adults).


Link  Tocilizumab and Sarilumab for COVID-19 pneumonia (adults) - Secondary Care guideline (BHTCG 17FM)


Link  NHSE Interim Clinical Commissioning Policy: Sarilumab for critically ill patients with COVID-19 pneumonia (adults)


Link  NHSE interim Clinical Commissioning Policy: Tocilizumab for critically ill patients with COVID-19 pneumonia (adults)

 
   
Tocilizumab 162mg
(sub-cutaneous injection, pre-filled syringe)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine

FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. (NICE compliance to be verified if NICE compliance form not yet available)

Red Traffic Light
1. Restricted - to Rheumatology consultant prescribing only, for the treatment of rheumatoid arthritis, as an alternative to tocilizumab IV recommendations in NICE TA 247, NICE TA 375 and in accordance with Rheumatoid Arthritis Biologics treatment guideline (BHTCG 749FM)


 NICE TA 247: Tocilizumab for the treatment of rheumatoid arthritis (rapid review of TA 198)


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


Rheumatoid Arthritis Biologics treatment - Secondary Care guideline (BHTCG 749FM)




Red Specialist Centre
2. Restricted - to consultant Rheumatologists following approval by Thames Valley Specialised Rheumatology Network MDT. For treatment of Takayasu Arteritis (TAK) in adults accordance to criteria defined in NHS England Clinical Commissioning Policy 16056/P. BHT Rheumatology consultants will prescribe as outreach to the Specialist Centre delivered as part of a provider network. Name of Specialist centre and clinician involved in MDT to be communicated to Formulary team prior to initiating treatment at BHT.


NHS England 16056/P Clinical Commissioning Policy: Tocilizumab for Takayasu arteritis (adults)



3. Restricted to prescribing by Oxford University Hospital Consultant Rheumatologists for the treatment of giant cell arteritis in accordance with NICE TA 518 and NHSE Spec Comm Letter 1894, August 2018.


NICE TA 518: Tocilizumab for treating giant cell arteritis




NOTE: Patients should use either IV or SC tocilizumab. If they fail on either of the routes, they may not use the alternative route.

 
   
Tocilizumab 80mg/4mL, 200mg/10mL, 400mg/20mL (RoActemra®)
(concentrate for intravenous infusion)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine

FOR ALL PRESCRIBING, prior approval via a completed Blueteq form is required. 

Red Traffic Light 1. Restricted - to Rheumatology consultant prescribing only, as an alternative to subcutaneous tocilizumab in accordance with Rheumatoid Arthritis Biologics treatment guideline (BHTCG 749FM) and NICE TA 247.


Rheumatoid Arthritis Biologics treatment - Secondary Care guideline (BHTCG 749FM)


NICE TA 247: Tocilizumab for the treatment of rheumatoid arthritis (rapid review of TA 198)


Tocilizumab IV in Rheumatology - Secondary Care guideline (BHTCG 690FM)




Red Specialist Centre2. Restricted - consultant Rheumatologists following approval by Thames Valley Specialised Rheumatology Network MDT. For treatment for Takayasu Arteritis (TAK) in adult in accordance to criteria defined in NHS England Clinical Commissioning Policy 16056/P. BHT Rheumatology consultants will prescribe as outreach to the Specialist Centre delivered as part of a provider network. Name of Specialist centre and clinician involved in MDT to be communicated to Formulary Team prior to initiating treatment at BHT


NHSE CC Policy 16056/P :Tocilizumab for Takayasu arteritis (adults)

NOTE: For above indications 1 and 2, patients should use either IV or SC tocilizumab. If they fail on either of the routes, they may not use the alternative route.


 


Red Traffic Light3. Restricted: to initiation on the advice of a Respiratory or ICU consultant for use in accordance with guideline 17FM Tocilzumab and Sarilumab for patients with COVID-19 pneumonia (adults).


Tocilizumab and Sarilumab for COVID-19 pneumonia (adults) - Secondary Care guideline (BHTCG 17FM)


BHT PIL: Tocilizumab and Sarilumab Treatment for COVID-19


NHSE interim Clinical Commissioning Policy: Tocilizumab for critically ill patients with COVID-19 pneumonia (adults)


NHSE Interim Clinical Commissioning Policy: Sarilumab for critically ill patients with COVID-19 pneumonia (adults)

 
   
Tofacitinib 5mg
(film-coated tablets )
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
CCG
BlueTeq

FOR ALL PRESCRIBING - NICE compliance form via BLUETEQ required - see link from Formulary homepage. NICE compliance to be verified if form not available.

1. Restricted - to Rheumatology consultant prescribing only, in accordance with Rheumatoid Arthritis Biologics treatment guideline (BHTCG 749FM) and NICE TA 480


 


2. Restricted - prescribing by Rheumatology and Dermatology Consultants in accordance with Biologics in Psoriatic Arthritis Algorithm (BHTCG 740FM) and NICE TA 543.


 


See section 01.05.03 (for Gastroenterology) 

 
Link  MHRA Drug Safety Update - May 2019: Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing
Link  Rheumatoid Arthritis Biologics treatment - Secondary Care guideline (BHTCG 749FM)
Link  NICE TA 480: Tofacitinib for moderate to severe rheumatoid arthritis
Link  NICE TA 543: Tofacitinib for treating active psoriatic arthritis after inadequate response to DMARDs
   
Ustekinumab 45mg/0.5mL (Stelara®)
(injection, prefilled syringe (Rheumatology))
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage
Restricted to:
1. Prescribing by Consultant Dermatologists and Rheumatologists, in accordance with Biologics for Psoriatic Arthritis guideline (BHTCG 740FM) and NICE TA 340.  
Link  Biologics and Apremilast in Psoriatic Arthritis - Secondary Care guideline (BHTCG 740FM)
   
10.01.03  Expand sub section  Sulfasalazine
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
SMC
Scottish Medicines Consortium
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Black

Not recommended for use because of lack of evidence of clinical effectiveness, cost effectiveness or safety.
Drugs which have been evaluated and rejected by the Medicines Value Group (MVG)
Drugs defined as ‘Low Priority’ by the South Central Priorities Committee
New drugs which have not as yet been evaluated by the MVG
Any drug not listed in the Buckinghamshire Formulary  

Red

Drugs which should only be prescribed in secondary care by a specialist.
Require specialist knowledge and/or equipment for patient selection and initiation
Require long term on-going monitoring and dose adjustment to ensure efficacy and minimise toxicity by a specialist
Designated as “hospital only“ by product licence, NICE, DoH or BNF
May need further evaluation by a specialist
Are hospital initiated clinical trial materials  

Red Specialist Centre

As for ‘red’ (above) with the addition of the following:
Designated by NHS England to require initiation by or in prior agreement with a Specialist Centre. Continuation where appropriate by BHT (or other secondary care provider)
Detailed requirements for Specialist Centre initiation to be described in the wording of the formulary restriction  

Amber Protocol

Drugs which should be initiated in secondary care by the specialist with follow-on prescription and monitoring according to a drug specific Shared Care Protocol(SCP). Prescribing may be continued in primary care following the SCP
Require specialist knowledge and/or equipment for patient selection and initiation
Require short or medium term (eg. 3 to 6 months) specialist monitoring of efficacy or toxicity. The need for stabilisation will vary with different drugs and patients, but is usually a minimum of 2 months (see principles for shared care)
Require significant long term monitoring
Require ongoing communication between the GP and the specialist
Have clearly defined consultant, GP and patient responsibilities documented in a shared care protocol (see responsibilities for amber protocol drugs)  

Amber Initiation

Drugs suitable for primary care prescribing following specialist initiation
Require specialist knowledge and/or equipment for patient selection
Monitoring does not require specialist knowledge or equipment
If the drug is one with which the primary care prescriber is unfamiliar the specialist is expected to provide sufficient information on the drug indication, dose, duration , monitoring and any further necessary dose adjustments
Require the first prescription to be written by the specialist  

Amber Recommended

Drugs suitable for primary care prescribing following specialist recommendation
As for amber initiation except that:- The first prescription may be written by the GP after specialist recommendation.  

Green

Drugs for which primary care prescribers would normally take full responsibility for prescribing and monitoring
Drugs not included in the Traffic Light list but included on joint formulary.
New drugs classified as red or amber but as greater experience regarding their safety and efficacy is established may move to Green after re-consideration by the MVG and APC.  

netFormulary