1708.1 - Hepatitis Delta Virus (HDV) RNA PCR testing to determine eligibility for PBS-subsidised bulevirtide (HEPCLUDEX) for treatment of HDV

Page last updated: 21 October 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 (MSAC-PBAC co-dependent submission)

Medical Service Type

Investigative technology

Previous Application Number/s

1708

Associated Documentation

Application Summary and PICO Set

Application Summary (PDF 187 KB)
Application Summary (Word 29 KB)

PICO Set (PDF 455 KB)
PICO Set (Word 112 KB)

Consultation Survey

Consultation Survey

PASC Consultation
Bypassing PASC

MSAC Consultation
MSAC consultation closes Friday 14 February 2025

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

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Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

Bypassing PASC

ESC

13-14 February 2025

MSAC

3-4 April 2025