Update on PBS listing for new hepatitis C medicines – October 2015

Following our letter to the Minister, we have received a response which in brief states that:

  • A medicine cannot be listed on the PBS without a recommendation from the PBAC and neither the Government nor my Department interferes in the independent process of the PBAC.’ 
  • My Department is progressing the listing of these medicines as swiftly as possible in line with PBAC recommendations. The listing date will depend on the successful negotiations with the sponsors of these medicines.’

We have been informed that generally a period of seven weeks is required from the date of the announcement to list a medicine and the date that the medicine becomes available on the PBS to ensure all the medicines and administrative processes are in place. Consequently, a December listing for the new all oral hepatitis medicines is now highly unlikely, and we are now hoping that a February listing date will be announced by the Minister prior to the end of 2015, however, some roadblocks remain and nothing is certain.

The basis for the negotiations between the government and the Pharmaceutical companies is the Pharmaceutical Benefits Advisory Committee (PBAC) recommendations. From a community perspective, this means:

  • Only interferon-free hepatitis C treatment options are being considered.
  • Interferon-free options can be achieved for all common Australian genotypes if all of the recommended medicines are subsidised.
  • There is no intent to restrict treatment access by stage of liver disease.
  • Appropriately trained GPs will be able to prescribe the treatments.

The Minister has been advised by the PBAC of the high clinical need and a total cost to the government has been estimated. Currently the Pharmaceutical companies and the Department are in negotiations to finalise the pricing arrangements.  

Once these price negotiations have been completed, the approval of the PBS listing requires the Turnbull Government (Cabinet) to sign off on the expenditure. Minister Ley will need to identify equivalent savings to allow the PBS listing to proceed. While this may seem a daunting task, it is important to remember that the Pharmaceutical Benefits Scheme has been undergoing significant reforms in recent times, including mandatory price reductions and price disclosures. These measures were specifically designed to create the headroom for new innovative medicines such as the hepatitis C all oral treatments to be listed on the PBS and significant savings have already been made.

We are obviously hoping that a swift approval by Cabinet will be forthcoming once the price negotiations with the Pharmaceutical companies have been concluded in line with the PBAC recommendations. The detrimental impact of delays for people living with hepatitis C is well understood by all parties.

Helen Tyrrell
CEO, Hepatitis Australia

 

Page updated 22 October 2015