North East and North Cumbria Formulary


	North East and North Cumbria ICS Formulary

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Formulary Chapter 5: Infections - Full Chapter

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COVID-19 Therapeutic Alert

Interim Clinical Commissioning Policy: Antivirals or neutralising monoclonal antibodies in the treatment of COVID-19 in hospitalised patients (Version 5 - effective from 10th February 2022)

NENC ICB - Cellulitis Diagnosis and Management in Ambulatory Adults in primary care; Supporting Information

NICE NG15: Antimicrobial stewardship: systems and processes for effective antimicrobial medicine use

NICE NG63: Antimicrobial stewardship: changing risk-related behaviours in the general population

North of Tyne, Gateshead and North Cumbria - Antibiotic and Diagnostic quick reference tools

Primary Care Antimicrobial Guidelines

TEWV: Antibiotic Prescribing Procedure

UK Interim Clinical Commissioning Police - Therapies for patients with symptomatic hospital-onset COVID-19

Details...

05.03.03.02

Chronic hepatitis C & hepatitis D

Daclatasvir

Formulary

Approved for the treatment of chronic hepatitis C in line with NICE and NHS England Commissioning Policy.

Elbasvir & grazoprevir (Zepatier^®)

Formulary

Approved for the treatment of chronic hepatitis C in line with NICE and NHS England Commissioning Policy.

NICE TA413: Elbasvir–grazoprevir for treating chronic hepatitis C

Glecaprevir & Pibrentasvir (Maviret^®)

Formulary

Approved for the treatment of chronic hepatitis C in line with NICE and NHS England Commissioning Policy.

NICE TA499: Glecaprevir–pibrentasvir for treating chronic hepatitis C

Peginterferon Alfa (Pegasys®, ViraferonPeg®)

Formulary

Approved for hepatitis B and C in accordance with NICE guidelines and NHS England Commissioning Policies.

See Section 08.02.04

Ribavirin

Formulary

NICE TA106: Hepatitis C - peginterferon alfa and ribavirin

NICE TA200: Hepatitis C - peginterferon alfa and ribavirin

NICE TA75: Hepatitis C - pegylated interferons, ribavirin and alfa interferon

Sofosbuvir

(Sovaldi^®)

Formulary

Approved for the treatment of chronic hepatitis C in line with NICE and NHS England Commissioning Policy.

NICE TA330: Sofosbuvir for treating chronic hepatitis C

Sofosbuvir & Ledipasvir (Harvoni^®)

Formulary

To be used in accordance with NHS England Commissiong Policy

NICE TAG63: Ledipasvir–sofosbuvir for treating chronic hepatitis C

Sofosbuvir & velpatasvir ( Epclusa^®)

Formulary

Approved for the treatment of chronic hepatitis C in line with NICE and NHS England Commissioning Policy.

NICE TA430: Sofosbuvir–velpatasvir for treating chronic hepatitis C

Sofosbuvir, Velpatasvir & Voxilaprevir (Vosevi^®)

Formulary

Approved for the treatment of chronic hepatitis C in line with NICE and NHS England Commissioning Policy.

NICE TA507: Sofosbuvir–velpatasvir–voxilaprevir for treating chronic hepatitis C

Bulevirtide (Hepcludex^®)

Formulary

2mg powder for solution for injection
Approved as an option for treating chronic hepatitis D in adults with compensated liver disease in line with NICE and NHSE Specialised Commissioning Policy only if:
- there is evidence of significant fibrosis (METAVIR stage F2 or above or Ishak stage 3 or above) and
- their hepatitis has not responded to peginterferon alfa‑2a (PEG‑IFN) or they cannot have interferon-based therapy
Only available from:
- The Newcastle Upon Tyne Hospitals NHS Foundation trust

NICE TA896: Bulevirtide for treating chronic hepatitis D

MHRA Drug Safety Update (Dec 2018): Direct-acting antivirals for chronic hepatitis C: risk of hypoglycaemia in patients with diabetes

MHRA Drug Safety Update (Jan 2017): Direct-acting antiviral interferon-free regimens to treat chronic hepatitis C: risk of hepatitis B reactivation

MHRA Drug Safety Update (Jan 2017): Direct-acting antivirals to treat chronic hepatitis C: risk of interaction with vitamin K antagonists and changes in INR

MHRA Drug Safety Updates: Sofosbuvir and combinations - risk of severe bradycardia and heart block when taken with amiodarone

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Key

	Notes
	Section Title (top level)
	Section Title (sub level)
	First Choice item
	Non Formulary section
	Restricted Drug
	Unlicensed
	Display tracking information
	Link to adult BNF
	Link to children's BNF
	Link to SPCs

	Cytotoxic Drug
	Controlled Drug
	High Cost Medicine
	NHS England
	Homecare
	CCG

Traffic Light Status Information

Status	Description
	Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.
	Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.
	Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.
	Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.
	NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.
	UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.
	NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.