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 Formulary Chapter 5: Infections - Full Chapter
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05.03.03  Expand sub section  Viral hepatitis
Adefovir Dipivoxil 10mg
(tablet)
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Restricted Drug Restricted
Red
High Cost Medicine
Restricted - not routinely commissioned. An Individual Funding Request is required before commencing treatment. 
   
Entecavir 500micrograms, 1mg
(tablet)
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 on Formulary homepage.

Restricted - to prescribing by Consultant Gastroenterologists or Associate Specialists of Gastorenterology in conjunction with Hepatitis B clinic and in accordance with NICE TA 153 and BHT Clinical Guideline on Hepatitis B. 
Link  Hepatitis B (chronic): diagnosis and management
Link  NICE TA153: Hepatitis B - entecavir
   
05.03.03.01  Expand sub section  Chronic hepatitis B
05.03.03.02  Expand sub section  Chronic hepatitis C
Boceprevir 200mg
(capsule)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Gastroenterologists and Associate Specialist Gastroenterology in accordance with NICE TA 252 (see link below for Telaprevir) and NICE TA 253.

 
Link  NICE TA 253: Boceprevir for the treatment of Genotype 1 Chronic Hepatitis C
   
Daclatasvir 30mg, 60mg (Daklinza®)
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Gastroenterologists/Hepatologists and Associate Specialist (Gastroenterology), as part of Thames Valley ODN in accordance with NICE TA 364 or NHSE Commissioning Policy statement 1524, June 2015 - Hepatitis C with cirrhosis and NHSE SSC 1615. All patients will be discussed in the ODN MDT.

 
Link  NHSE Clinical Commissioning Policy Statement for treatment of chronic Hepatitis C in patients with cirrhosis
Link  NICE TA364 - Daclatasvir for treating chronic hepatitis C
   
Dasabuvir 250mg (Exviera® )
(tablet)
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Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Gastroenterologists/Hepatologists and Associate Specialist (Gastroenterology), as part of ODN in accordance with NHSE Commissioning Policy statement 1524, June 2015 - Hepatitis C with cirrhosis.

 
Link  NHSE Clinical Commissioning Policy Statement for treatment of chronic Hepatitis C in patients with cirrhosis
   
Elbasvir/Grazoprevir 50mg/100mg (Zepatier®)
(film-coated tablets)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Gastroenterologists/Hepatologists and Associate Specialists (Gastroenterology), as part of Thames Valley ODN in accordance with NICE TA 413.

 
Link  NICE TA 413: Elbasvir–grazoprevir for treating chronic hepatitis C
   
Glecaprevir/ pibrentasvir 100mg/40mg (Maviret®)
(tablets)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Gastroenterologists/Hepatologists and Associate Specialist (Gastroenterology), as part of Thames Valley ODN and in accordance with NICE TA 499.

 
Link  NICE TA 499: Glecaprevir-pibrentasvir for treating chronic hepatitis C
   
Simeprevir 150mg
(capsule)
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Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Gastroenterologists and Associate Specialist Gastroenterology in accordance with NICE TA331 and within the framework of an Operational Delivery Network in accordance with NHSE Specialized Commissioning.

 
Link  NICE TA 331: Simeprevir in combination with peginterferon and ribavirin for treating genotypes 1 and 4 chronic hepatitis C
   
Sofosbuvir 400mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted to:
1. Prescribing by Consultant Gastroenterologists and Associate Specialist Gastroenterology in accordance with NICE TA330 and within the framework of an Operational Delivery Network in accordance with NHSE Specialized Commissioning.
2. Prescribing by Consultant Gastroenterologists/Hepatologists and Associate Specialist (Gastroenterology), as part of ODN in accordance with NHSE Commissioning Policy statement 1524, June 2015 - Hepatitis C with cirrhosis.

 
Link  NHSE Clinical Commissioning Policy Statement for treatment of chronic Hepatitis C in patients with cirrhosis
Link  NICE TA 330: Sofosbuvir for treating chronic hepatitis C
   
Sofosbuvir/ Velpatasvir 400mg/100mg (Epclusa® )
(film-coated tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red Specialist Centre
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Gastroenterologists/Hepatologists and Associate Specialist (Gastroenterology), as part of Thames Valley ODN in accordance with NICE TA 430.

 
Link  NICE TA 430: Sofosbuvir–velpatasvir for treating chronic hepatitis C
   
Sofosbuvir/ velpatasvir/ voxilprevir 400mg/100mg/100mg (Vosevi®)
(tablets)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Gastroenterologists/Hepatologists and Associate Specialist (Gastroenterology), as part of Thames Valley ODN and in accordance with NICE TA 507.

 
Link  NICE TA 507: Sofosbuvir-velpatasvir-votilaprevir for treating chronic hepatitis C
   
Sofosbuvir/Ledipasvir 400mg/90mg (Harvoni® )
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Gastroenterologists/Hepatologists and Associate Specialist (Gastroenterology), as part of Thames Valley ODN in accordance with NICE TA 363 or NHSE Commissioning Policy statement 1524, June 2015 - Hepatitis C with cirrhosis and NHSE SSC 1615. All patients will be discussed in the ODN MDT.

 
Link  NHSE Clinical Commissioning Policy Statement for treatment of chronic Hepatitis C in patients with cirrhosis
Link  NICE TA363 - Ledipasvir-sofosbuvir for treating chronic hepatitis C
   
Telaprevir 375mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Gastroenterologists and Associate Specialist Gastroenterology in accordance with NICE TA 252 and NICE TA 253 (see link above in Boceprevir).

 
Link  NICE TA 252: Telaprevir for the treatment of Genotype 1 Chronis Hepatitis C
   
Viekirax 12.5mg/75mg/50mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

Contains: Ombitasvir/Paritaprevir/Ritonavir

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Gastroenterologists/Hepatologists and Associate Specialist (Gastroenterology), as part of Thames Valley ODN in accordance with NICE TA 365 or NHSE Commissioning Policy statement 1524, June 2015 - Hepatitis C with cirrhosis and NHSE SSC 1615. All patients will be discussed in the ODN MDT.

 
Link  NHSE Clinical Commissioning Policy Statement for treatment of chronic Hepatitis C in patients with cirrhosis
Link  NICE TA365 - Ombitasvir-paritaprevir-ritonavir with or without dasabuvir for treating chronic hepatitis C
   
 ....
 Non Formulary Items
test Chronic hepatitis C

View adult BNF View SPC online View childrens BNF
Non Formulary
 
  
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.  

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