1708 – Hepatitis Delta Virus (HDV) RNA PCR testing to determine eligibility for PBS-subsidised bulevirtide (HEPCLUDEX) for treatment of HDV

Page last updated: 17 October 2023

Application Detail

Description of Medical Service

Polymerase chain reaction (PCR) testing is a method used to rapidly make copies of a small DNA sample and amplify it to a large enough amount to study in detail. PCR tests work by taking a sample of blood, saliva, mucus, or tissue. An enzyme called polymerase is added to the sample. This causes the sample to produce copies, which is repeated multiple times. If a virus or pathogen is present, it will be indicated on the testing machine.

Description of Medical Condition

Hepatitis delta virus (HDV) is a rare blood-borne virus that occurs in people infected with the hepatitis B virus. The liver disease associated with HDV runs a more progressive course than chronic hepatitis B, and may lead to cirrhosis within 2 years in 10–15% of patients.

Reason for Application

New MBS item

Medical Service Type

Investigative technology

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1164 KB)
Application Form (Word 670 KB)

Consultation Survey

Consultation Survey (PDF 691 KB)
Consultation Survey (Word 72 KB)

PASC Consultation
Consultation closed

MSAC Consultation
MSAC consultation input must be received by no later than Friday, 16 February 2024 for it to be considered by MSAC at its April 2024 meeting.

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process

PICO Confirmation

PICO Confirmation (PDF 636 KB)
PICO Confirmation (Word 358 KB)

Assessment Report


Public Summary Document


Meetings for this Application


13-14 April 2022


15-16 February 2024


4-5 April 2024