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 Formulary Chapter 16: Off-label use / Unlicensed / Non-BNF - Full Chapter
16.01  Expand sub section  Other items
Anal Irrigation Systems
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Formulary
Amber Continuation

Suitable for prescribing in primary care following specialist recommendation in line with Clinical Commissioning Policy 248.

 
   
Aquadeks
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Restricted Drug Restricted
Brown

For cystic fibrosis in children.

APCO March 2012.

 
   
Botulinum Toxin A (Xeomin®)
(Sialorrhoea (Severe Drooling))
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Formulary
Red

For treating chronic sialorrhoea in line with NICE TA605.

Also see Clinical Commissioning Policy 254A.

APCO November 2019.

 
Link  NICE TA605: Xeomin (botulinum neurotoxin type A) for treating chronic sialorrhoea
   
Cerliponase alpha (Brineura®)
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Formulary
Red
NHS England

For treating neuronal ceroid lipofuscinosis type 2. Funded by specialised commissioning.

APCO January 2020.

 
Link  NICE HST12: Cerliponase alfa for treating neuronal ceroid lipofuscinosis type 2
   
Dibotermin alfa (InductOs®)
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Formulary
Red
NHS England

For primary and revision spinal fusion.

Funded by specialised commissioning.

APCO May 2018.

 
   
Gastrografin
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Formulary
Red

For short bile obstruction.

APCO May 2018.

 
   
Holoclar
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Formulary
Red

For treating limbal stem cell deficiency after eye burns as per NICE TA467.

NB. The responsible commissioning body is still to be confirmed for this treatment.

APCO September 2017. 

 
Link  NICE TA467: Holoclar for treating limbal stem cell deficiency after eye burns
   
Intratympanic methylprednisolone  (Sodium Succinate)
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Formulary
Red

For sensorineural hearing loss. Agreed at May MMTC.

APCO July 2019.

 
   
Lanadelumab (Takhzyro®)
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Formulary
Red
NHS England

For preventing recurrent attacks of hereditary angioedema as per NICE TA606.

Funded by specialised commissioning.

APCO November 2019.

 

 
Link  NICE TA606: Lanadelumab for preventing recurrent attacks of hereditary angioedema
   
Mydrane
(Cataract surgery)
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Formulary
Red
Secondary care use only.

APCO September 2017. 

 
   
Strimvelis
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Formulary
Red
NHS England

Strimvelis for treating adenosine deaminase deficiency–severe combined immunodeficiency as per NICE HST7.

APCO March 2018.

 
Link  NICE HST7: Strimvelis for treating adenosine deaminase deficiency–severe combined immunodeficiency
   
Sulphur Hexafluoride (Sonovue)
(Contrast Media)
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Restricted Drug Restricted
Red

For enhancement of tissues/ blood vessels/ fluid on an ultrasound scan for children. Restricted to radiology.

 
   
Tacrolimus suppositories
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Formulary
Red

Specialist prescribing only approved at MMTC May 2019.

APCO July 2019.

 

 
   
Voretigene Neparvovec  (Luxturna®)
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Formulary
Red
NHS England

For treating inherited retinal dystrophies caused by RPE65 gene mutations in line with HST11.

Funded by specialised commissioning.

APCO November 2019.

 
Link  HST11: Voretigene neparvovec for treating inherited retinal dystrophies caused by RPE65 gene mutations
   
 ....
 Non Formulary Items
Abnoba-viscum (Mistletoe extract)

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Non Formulary
Black

For the treatment of malignant melanoma. See Clinical Commissioning Policy 2C.

Priorities Committee March 2009.

 
Actipatch®
(Electromagnetic pulse therapy patches)

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Non Formulary
Black

Lack of good evidence for effectiveness.

APCO September 2018.

 
Dehydroepiandrosterone  (DHEAS)

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Non Formulary
Black

Not recommended following the removal of the adrenal gland.

APCO July 2004.

 
Depigmenting  (Pigmanorm®)
(cream)

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Non Formulary
Black

Unlicensed. Not recommended in line with Policy No 6i (TVPC16)  Aesthetic treatments for adults and children.

APCO May 2019.

 
Gamolenic acid

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Non Formulary
Black

For mastalgia and atopic eczema. 

NB. Product licence withdrawn October 2002.

 
Naltrexone
(Multiple sclerosis)

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Non Formulary
Black

Not recommended for multiple sclerosis (low dose naltrexone).

APCO March 2005.

 
Pentosan Polysulphate Capsules 50 mg  (Elmiron®)

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Non Formulary
Black

Not recommended as no cost-efficacy data.

APCO July 2010.

 
RESPeRATE® device

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Non Formulary
Black

For hypertension, routine provision of relaxation therapies by primary care teams is not currently recommended within NICE CG127.

APCO March 2012.

Link  NICE CG127: Hypertension in adults: diagnosis and management
 
Sodium Hyaluronate 800mg/50mL (1.6%), Sodium Chondroitin Sulfate 1g/50mL (2%)  (Ialuril®)

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Non Formulary
Black

Medical device for urinary tract conditions.

APCO May 2014.

 
Souvenaid®

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Non Formulary
Black

Some evidence of improved memory but limited to very early disease only and no improvement in cognition demonstrated. Can be purchased OTC as per Clinical Commissioning Policy 88D.

APCO January 2013.

 
Timolol  (Topical)
(Infantile haemangioma)

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Non Formulary
Black

Not recommended for use as limited evidence and may be more cosmetic or superficial in majority of cases.

APCO January 2016.

 
Virulite Cold Sore Machine

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Non Formulary
Black

Not recommended for use. Can be purchased OTC.

APCO March 2008.

 
  
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

Red

Red: Medicines which should only be prescribed in secondary care by a specialist.  

Amber Continuation

Amber Continuation: Medicines which should be initiated or recommended by a specialist for continuation in primary care. The specialist must notify the GP that the prescribing responsibility has been transferred.   

Amber Shared Care Protocol

Amber Shared Care Protocol: Medicines which are appropriate to be initiated and stabilised by a specialist, once stabilised the medicine may be appropriate for responsibility to be transferred from secondary to primary care with the agreement of a GP and a formal ‘shared care’ agreement. The shared care protocol must be approved by the Area Prescribing Committee Oxfordshire (APCO).   

Green

Green: Medicines which are suitable for initiation and ongoing prescribing within primary care.   

Brown

Brown: Medicines which should only be prescribed in restricted circumstances.  

Black

Black: Medicines which are not recommended for use because of lack of evidence of clinical effectiveness, cost effectiveness or safety.  

OCCG Green

not used  

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