1708.1 – Hepatitis delta virus (HDV) RNA PCR testing to determine eligibility for PBS-subsidised bulevirtide (HEPCLUDEX) for treatment of HDV

New MBS item (MSAC–PBAC co-dependent submission).

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.

Type: Investigative technology

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.

The following consultation deadlines apply:

• Pre-PASC consultation deadline: Bypassing PASC
• Pre-MSAC consultation deadline: Friday 14 February 2025 11:59 pm AEDT

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This application will be considered at the following meetings:

• PASC meeting: Bypassing PASC
• ESC meeting: 13 to 14 February 2025
• MSAC meeting: 3 to 4 April 2025

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The outcome of this application is pending.

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