Three new hepatitis C treatments will be listed on the PBS from 1 March 2016. If you are a health professional managing clients with hepatitis C, what do you need to know?
The PBS has published a list of detailed answers to questions commonly raised by prescribers. The document addresses queries like which medicines are being listed on 1 March, how they will be presented and whether the medicines can be prescribed for children.
The new medicines, Harvoni ®, Sovaldi ® and Daklinza ® and Sovaldi ® and Ibavyr ® will be available through both the PBS General Schedule (‘Section 85’) and the Section 100 (S100) Highly Specialised Drugs (HSD) Program. PBS patient and prescriber eligibility will be the same whether the medicines are being prescribed under the PBS General Schedule or the HSD program.
The medicines are being made available through the PBS for all adult patients with chronic hepatitis C infection. The factors considered in determining suitability of treatment regimens and durations only include:
a) the patient’s disease genotype
b) their cirrhotic status, and
c) whether they have previously had treatment for their hepatitis C.
They cost no more than a regular prescription.
Where state or territory requirements allow, gastroenterologists, hepatologists, or infectious disease physicians experienced in the treatment of chronic hepatitis C infection will be eligible to prescribe the new medicines. All other medical practitioners, including general practitioners (GPs), will also be eligible to prescribe under the PBS, provided that is done in consultation with a gastroenterologist, hepatologist, or infectious disease physician experienced in the treatment of chronic hepatitis C infection.
The PBS document also provides clarification on what "in consultation with" means in this context.
The document points out the need for PBS Authority for these drugs and details the information needed when seeking authority to prescribe. Also discussed are number of prescriptions allowed at one time, repeats and prescribing different courses.
Approved community pharmacies will be allowed to fill prescriptions issued under the S85 General Schedule, but if issued by by an eligible prescriber under the S100 HSD arrangements in a public hospital, the presciptions may only be filled by a section 94 approved hospital authority.
The document also includes attachments detailing treatment regimes and appropriate dispensing locations.
More information
More information on the listing is available from the PBS on their website.