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Bedfordshire and Luton Joint Formulary
Bedfordshire Hospitals NHS Foundation Trust
Bedfordshire, Luton and Milton Keynes ICB
Formulary Chapter: 5 - Infections 
Notes:

For full details on UKHSA guidance for managing common infections with local amendments please see:

BLMK Primary Care Antimicrobial Guidelines hosted via: https://blmkantibioticspubliclive.azurewebsites.net/

Secondary care antimicrobial guidelines:

Bedfordshire Hospitals Foundation Trust: Antimicrobial guidelines are hosted on:  EOLAS Medical App. 
05.03.03.02 Chronic hepatitis C
NHSE Clinical Commissioning Policy Statement for treatment of chronic Hepatitis C in patients with cirrhosis

Dasabuvir 250mg (Exviera®)
(Tablets)

RED
Restricted Drug Restricted
FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Restricted - to be initiated only by a Consultant Gastroenterologist/Hepatologist in accordance with NICE TA365.

BNF BNFc SPC
NICE TA365: Ombitasvir–paritaprevir–ritonavir with or without dasabuvir for treating chronic hepatitis C

Elbasvir & grazoprevir 50mg/ 100mg (Zepatier®)

RED
Restricted Drug Restricted
FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.
Restricted - to be prescribed by a Consultant Gastroenterologist/Hepatologist in accordance with NICE TA413
Elbasvir 50 mg/ grazoprevir 100 mg tablets.
BNF BNFc SPC
NICE TA413: Elbasvir–grazoprevir for treating chronic hepatitis C

Glecaprevir & Pibrentasvir 100mg/ 40mg (Maviret®)
(Tablets)

RED
Restricted Drug Restricted
FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.
Restricted - to be initiated only by a Consultant Gastroenterologist/Hepatologist in accordance with NHS England funding requirements.
BNF BNFc SPC
NICE TA499: Glecaprevir–pibrentasvir for treating chronic hepatitis C

Ledipasvir and Sofosbuvir 400mg/ 90mg (Harvoni®)
(Tablets)

RED
Restricted Drug Restricted
FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Restricted - to be initiated only by a Consultant Gastroenterologist/Hepatologist in accordance with NICE TA363 for the treatment of chronic hepatitis C.

BNF BNFc SPC
MHRA Drug Safety Update (May 2015) - Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone NICE TA363: Ledipasvir–sofosbuvir for treating chronic hepatitis C

Ombitasvir/ paritaprevir/ ritonavir (Viekirax®)
(Tablets)

RED
Restricted Drug Restricted
FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Restricted - to be initiated only by a Consultant Gastroenterologist/Hepatologist in accordance with NICE TA365 for the treatment of adults with chronic hepatitis C.

Ritonovir 12.5mg/Paritaprevir 50mg/Ombitasvir 75mg
BNF BNFc SPC
NICE TA365: Ombitasvir–paritaprevir–ritonavir with or without dasabuvir for treating chronic hepatitis C

Simeprevir 150mg (Olysio®)
(Capsules)

RED
Restricted Drug Restricted
FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Recommended in combination with peginterferon alfa and rivavirin as an option for treatment of chronic hepatitis C infection of genotype 1 and 4 in adults, in accordance with NICE TA331.

Restricted - to be prescribed only by a Consultant Gastroenterologist/Hepatologist

BNF BNFc SPC
MHRA Drug Safety Update (August 2015) - Simeprevir with sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone NICE TA331: Simeprevir in combination with peginterferon alfa and ribavirin for treating genotypes 1 and 4 chronic hepatitis C

Sofosbuvir / velpatasvir 400mg/100mg (Epclusa®)
(Tablets)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Restricted - to be initiated only by a Consultant Hepatologist in accordance with NICE TA430  for the treatment of chronic hepatitis C.

BNF BNFc SPC
NICE TA430: Sofosbuvir-velpatasvir for treating chronic hepatitis C

Sofosbuvir 400mg (Sovaldi®)
(Tablets)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Indicated in combination with ribavirin, with or without peginterferon alfa for chronic hepatitis C infection of genotypes 1, 3, 4, 5 or 6 in patients with compensated liver disease.

Restricted - to be initiated only by a Consultant Gastroenterologist/Hepatologist

BNF BNFc SPC BlueTeq
MHRA Drug Safety Update (August 2015) - Simeprevir with sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone NICE TA330: Sofosbuvir for treating chronic hepatitis C

Sofosbuvir 400mg/ Velpatasvir 100mg/ Voxilaprevir 100mg (Vosevi®)
(Tablets)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Restricted - to be initiated only by a Consultant Hepatologist in accordance with NICE TA507 for the treatment of chronic hepatitis C.

BNF BNFc SPC BlueTeq
NICE TA507: Sofosbuvir–velpatasvir–voxilaprevir for treating chronic hepatitis C
Classifications
GREEN
May be initiated in any care setting
Amber SPA
Specialist to advise therapy and provide first 28 days supply, continuation in Primary Care
Amber SPIS
Specialist to initiate and stabilise medicine prior to continuation in Primary Care
SCG
To be prescribed as per Shared Care Guidance. If no SCG in place status reverts to red.
RED
Red medicines are designated as specialist only medicines which should only be prescribed by a specialist, usually within secondary care (either due to the requirement for specialist knowledge, long-term monitoring requirements, or restrictions that mean medicine supplies are only available to hospitals).
DNP
A decision has been made either locally and/or nationally not to routinely commission this preparation. Do not prescribe.
SELF
To be purchased over the counter. May be prescribed for chronic, long term conditions or on admission to hospital if essential.