Draft guidance consultation

1 Recommendations

1.1 Bulevirtide is not recommended, within its marketing authorisation, for treating chronic hepatitis D with compensated liver disease in adults.

1.2 This recommendation is not intended to affect treatment with bulevirtide that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

People with hepatitis D also have hepatitis B. There are no licensed treatments specifically for hepatitis D but standard care usually involves treating symptoms and the hepatitis B. People with significant fibrosis (scarring) in their liver can be offered peginterferon alfa-2a (PEG‑IFN) off label.

The company positioned bulevirtide for people with chronic hepatitis D who have tried PEG‑IFN and the condition did not respond, or for people who cannot have it. It also positioned it only for people with a METAVIR stage of F2 or over (which means they have significant fibrosis). Testing for METAVIR stage involves a biopsy, which is invasive and may have side effects, and many people refuse it.

Clinical trial evidence shows bulevirtide is effective compared with standard care. But there are uncertainties around how long it works for. There are also uncertainties because some people in the trial did not have a METAVIR stage and some had a stage of F1 or F0. Because of the uncertainties in the clinical-effectiveness evidence and in the economic model, the cost-effectiveness estimates are also uncertain. They are also above what NICE normally considers an acceptable use of NHS resources, even if the severity of the condition and its effect on quality and length of life are taken into account.

So bulevirtide is not recommended.