New PBS listings and changes for hepatitis C medicines

From 1 March 2016 several new antiviral agents became available on the PBS for use in patients with chronic hepatitis C. They include daclatasvir (Daklinza), sofosbuvir (Sovaldi), ribavirin (Ibavyr) and the fixed-dose combination ledipasvir with sofosbuvir (Harvoni).1

Read more about the PBS listing for daclatasvir.

Read more about the PBS listing for sofosbuvir.

Read more about the PBS listing for ledispasvir with sofosbuvir.

Read more about the PBS listing for ribavirin.

Hepatitis C medicines now available on the PBS General Schedule

This listing of these medicines is a significant change from previous listings for hepatitis C virus (HCV) treatments, which were under the Section 100 (S100) highly specialised drugs program (HSD) only.

The new listings are now included in both the PBS General Schedule (‘Section 85’) and the S100 HSD Program. The S100 listing provides prisoner access through arrangements under the HSD Program.1

Who can prescribe these medicines?

PBS patient and prescriber eligibility will be the same whether the medicine is prescribed on the PBS General Schedule or the HSD program.

The listing on the general schedule removes the requirement for GPs to be accredited to meet prescriber eligibility. Under the new listing, gastroenterologists, hepatologists, or infectious-disease physicians experienced in treating chronic hepatitis C infection will be eligible to prescribe.

All other medical professionals, including GPs, will also be eligible to prescribe under the PBS provided that it is done in consultation with a specialist. ‘In consultation with’ means that the prescribing GP must consult with a specified specialist by phone, mail, email or videoconference before authority is given.1

Prescribers will require a PBS Authority before prescribing these medicines, using either written or telephone channels to seek approval.1

No change to dispensing rules for new hepatitis C listings

These medicines will not be available under the new S100 HSD Community Access arrangements introduced on 1 July 2015. Approved pharmacists in the community will be able to dispense when a prescription is issued under the General Schedule. However, if the prescription has been written under S100 HSD arrangements in a public hospital, approved pharmacists in the community will not be able to dispense.1

Find out more about new hepatitis C treatments listed on the PBS.

Read more about the July 2015 S100 supply arrangements.

Introduction of direct-acting antivirals a major advance

The introduction of new direct-acting antiviral (DAA) treatment regimens has been described as a major advance for HCV therapy.2 Most people will now be suitable for treatment and most people who start treatment will be cured, which is defined as HCV RNA below the level of detection at least 12 weeks after the end of treatment.3

Eradicating the virus reduces the risk of liver fibrosis or progression of existing liver disease in patients with HCV.4 All patients with HCV should be considered for antiviral therapy.

The DAA agents are now the treatment of choice for HCV in Australia, and the agent used will depend on the presence or absence of liver cirrhosis, the HCV genotype and whether the person has had therapy previously.3

The new S85 provision for community dispensing of DAA therapy by GPs is intended to increase capacity for treatment and reduce the burden of HCV and secondary liver disease.3

At the same time these advancements necessitate the development of new models of care for HCV treatment, which have been outlined in the newly released Australian recommendations for the management of hepatitis C virus infection: a consensus statement 2016.

Treatment in primary care is appropriate for most people with HCV. However, people with complications arising from infection, such as severe fibrosis, cirrhosis, complex comorbidities or other types of liver disease, or those who have failed previous DAA treatment, should be referred for specialist care.3

Follow the prescribing matrix outlined by the PBAC

The Pharmaceutical Benefits Advisory Committee has outlined a prescribing matrix based on treatment history and HCV genotype for antiviral treatment regimens that are supported by evidence and available for PBS rebate.

See the prescribing matrix in the General Statement for Drugs for the Treatment of Hepatitis C for information on how these new PBS listed medicines fit into management of patients with chronic hepatitis C.

More information

For more information regarding diagnosis and management of HCV in primary care see the CPD-accredited online learning module Managing hepatitis C in primary care. This is a collaboration between NPS MedicineWise and the Gastroenterological Society of Australia.