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

Page last updated: 19 July 2024

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 closed Friday, 16 February 2024.

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

Public Summary Document (PDF 744 KB)
Public Summary Document (Word 167 KB)

Meetings for this Application

PASC

13-14 April 2022

ESC

15-16 February 2024

MSAC

4-5 April 2024