Gilead has revealed that the National Institute for Health and Care Excellence (NICE) has recommended Hepcludex for use across the NHS.

The therapy – also known as bulevirtide – has been developed to treat chronic hepatitis delta virus (HDV) infection.

The drug is recommended as an option for treating chronic hepatitis D among adults with compensated liver disease, provided there is evidence of significant fibrosis. It also requires that the patients’ hepatitis has either not responded to peginterferon alfa-2a (PEG-IFN) or they cannot have interferon-based therapy.

Bulevirtide remains the only therapy to be conditionally licensed for this specific patient population across Great Britain. In spite of being the most aggressive form of viral hepatitis, the options for patients living with the condition have been severely limited.

Consequently, NICE’s decision will result in hundreds of eligible patients being granted the option of a treatment that slows or halts aspects of the illness.

The NICE recommendation applies to the NHS in England, however, it is expected that the NHS in Wales will follow the verdict over the coming days. Furthermore, Gilead is working with the health authorities in Northern Ireland to make bulevirtide available as quickly as possible.

Bulevirtide was accepted by the Scottish Medicines Consortium earlier this year.
Paul Desmond, from the Hepatitis B Foundation, reflected: “Despite the exceptional progress that has been made in treating other forms of viral hepatitis over recent years, chronic HDV infection has remained a real challenge.”

Dr Ahmed Elsharkawy, consultant transplant hepatologist and honorary senior clinical lecturer at the University of Birmingham, concluded: “While many people have heard of hepatitis C and hepatitis B, today chronic hepatitis D infection is arguably the most aggressive and difficult-to-treat form of viral hepatitis.

The Scottish Medicines Consortium (SMC) has accepted Pfizer’s Vydura for treating acute migraine with or without aura under specific circumstances.

It involves patients who have had insufficient symptom relief after using at least two triptans or among people for whom triptans are not tolerated. Patients who have not had adequate pain relief with non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol can also qualify.

Vydura – also known as Rimegepant – is an oral lyophilisate and is the first calcitonin gene-related peptide (CGRP) receptor antagonist migraine therapy to be accepted by the SMC.

Migraine can be a severe and painful long-term health condition, with a wide variety of symptoms, often including head pain, vomiting, nausea, disturbed vision, fatigue, severe pain and sensitivity to light, sound and smells.

Dr David Watson, from Hamilton Medical Group, explained: “Migraines can have a significant impact on the daily lives of people who suffer with them. Today’s decision, to recommend an orally dissolvable wafer and expand migraine treatment options, is a positive step towards helping to improve care for eligible patients in Scotland.”

Toby Cousens, head of hospital and internal medicine at Pfizer, believes the decision will positively effect many lives: “There is an unmet medical need to support people living with migraine and today’s decision is good news for eligible patients in Scotland.”

He added: “As well as the physical impact of symptoms, migraine can have a negative impact on the professional and personal lives of those living with it. We’re committed to supporting people living with migraine and will continue to work with the SMC and other health bodies in the UK to help further improve access and care.”

Up to 43 million workdays are lost across the UK every year to migraine-related episodes. Furthermore, migraine may cost the UK economy between £6bn and £10bn every year.