- Two direct-acting antiviral (DAA) medicines for chronic hepatitis C infection will be delisted from the PBS
Daclatasvir was removed from the PBS on 1 October 2020 and sofosbuvir on 1 November 2020.
- Daclatasvir and sofosbuvir were first listed on the PBS in 2016 to improve access to treatment options for hepatitis C infection
Daclatasvir was prescribed in combination with sofosbuvir as separate tablets, and sofosbuvir was prescribed alone.
- Since these medicines were listed, newer fixed-dose combination (FDC) DAA options for hepatitis C infection have become available
The newer treatment options have fewer pills and shorter courses and are recommended as first-line treatment.
- The delisting of daclatasvir and sofosbuvir is not expected to have much impact on current prescribing
Prescriptions for sofosbuvir plus daclatasvir decreased dramatically after the introduction of new DAA regimens.
On 1 October 2020, daclatasvir 30 mg and 60 mg (Daklinza) tablets were delisted from the PBS.1
Sofosbuvir 400 mg (Sovaldi) tablets were delisted from the PBS on 1 November 2020, however sofosbuvir will remain available on the PBS as a component of other combinations (eg, sofosbuvir 400 mg + ledipasvir 90 mg). The status of sofosbuvir is now ‘Supply Only’. Supply Only items are available on the PBS Schedule for dispensing, but not for prescribing, usually for a period of up to 12 months after they are deleted.2
These delistings are from both the PBS General Schedule (S85) and Highly Specialised Drugs Program (S100).1,2
See the PBS website for complete details for each item.
Why were the changes made?
On 1 October 2020, the Therapeutic Goods Administration (TGA) acknowledged the removal of daclatasvir 30 and 60 mg tablets from the Australian market, with a notification of medicine supply shortage.3
The sponsor has stated that daclatasvir is being discontinued in countries where it is no longer routinely prescribed or other therapeutic options are available.4
Daclatasvir and sofosbuvir were some of the first DAA medicines made available through the PBS when they were listed in March 2016.5
Since these medicines were listed, newer treatment options for chronic hepatitis C have become available. They have fewer pills and may have shorter courses of treatment. Additionally, daclatasvir and sofosbuvir are only indicated for treatment of specific genotypes of hepatitis C.5,6
The newer DAA regimens are pan-genotypic, meaning they are able to be used with all genotypes of the hepatitis C virus. Pan-genotypic regimens are now recommended as first-line treatment for chronic hepatitis C infection.6
Both daclatasvir and sofosbuvir as single agents have been removed from Australian treatment guidelines.7
Will the changes affect current prescribing?
Delisting of daclatasvir and sofosbuvir is expected to have little impact on current prescribing. Prescriptions for sofosbuvir plus daclatasvir decreased dramatically after the introduction of the FDC sofosbuvir + velpatasvir (Epclusa), a single-tablet regimen. This FDC, which was PBS-listed in August 2017,8 is first-line for treatment-naïve patients.6
The TGA has stated that the deletion of daclatasvir from the market is likely to have only a small impact on patients.3
Daclatasvir and sofosbuvir were listed on the PBS as part of the Australian Government’s National Hepatitis C strategy. Changes to the prescribing rules were made in 2016 to allow the broadest possible access to DAA medicines. PBS listing of DAA medicines allows GPs to initiate treatment in primary care, with the goal of substantially increasing the hepatitis C treatment workforce.6 From the time of listing up to mid-2017, approximately 19% of people living with hepatitis C started treatment with a DAA medicine. Prior to this, when interferon with ribavirin was used as treatment, annual subsidised treatment uptake did not exceed 2% of the prevalent population per year.9
The proportion of people living with hepatitis C who were prescribed DAA treatment by GPs increased from 8% in March 2016 to 39% in June 2017.9 GPs were the main prescribers of DAA treatment in all states except NSW and Victoria.6 With this trend, we can assume that prescribing of DAAs by GPs would further continue to increase.
From 1 April 2020, authorised nurse practitioners can prescribe hepatitis C treatments under the Highly Specialised Drugs program. Under previous arrangements, they were only able to prescribe under the PBS General Schedule.6 This improves availability of hepatitis C treatment for vulnerable populations, such as people living in remote and regional areas, those experiencing homelessness and those in custodial settings.10
What else should health professionals know?
Changes to prescribing information and processes
Active ingredient prescribing
On 31 October 2019, active ingredient prescribing regulations were introduced by the PBS under the National Health Act 1953. Active ingredient prescribing is part of a wider government strategy to ensure consistent and standardised medicines information.11
Active ingredient prescribing aims to:11
- ensure the identification of active ingredient names on all PBS prescriptions
- increase patient understanding of the medicines they are taking
- promote the uptake of generic and biosimilar medicines.
Under the regulations, prescribers:11
- are required to include the active ingredient on all PBS prescriptions (excluding handwritten prescriptions, paper-based medication charts in residential aged care settings, and medicines with four or more active ingredients).
- can include a brand after the active ingredient on a prescription, if the medicine prescribed is likely to pose a patient safety risk if the brand is not specified or to ensure medicine continuance where a patient is familiar with a particular brand of their regular medicine.
A transition period has been arranged to ensure prescribers have sufficient time to update prescribing software to versions which meet the new active ingredient prescribing requirements.
Community level electronic prescriptions
On 31 October 2019, Commonwealth legislation changed to recognise electronic prescriptions as a legal prescription for the purpose of PBS-listed medicine supply. Electronic prescribing is part of a wider government strategy to support safer medicine management and improve the efficiency of the PBS. It will not be mandatory, but provides prescribers and their patients with a safe and secure alternative choice to paper prescriptions.
Electronic prescribing aims to:
- improve efficiency in prescribing and dispensing medications
- remove the need for handling and storing a physical paper prescription
- support digital health services such as telehealth services to ensure continuity of patient care
To support the legislative changes, technical upgrades are currently underway to ensure safe, secure and seamless transmission of information of electronic prescriptions between prescribing and dispensing clinical software and to PBS payment systems.
Once in place, two models will be available to support electronic prescription; Token and Active Script List.
More information about electronic prescriptions is available:
Pan-genotypic regimens are recommended as first-line treatment for chronic hepatitis C. Virtually all patients are suitable for DAA therapy, including those who were previously intolerant of or not eligible for interferon therapy. Several interferon-free regimens combining DAAs are PBS-listed and there are three pan-genotypic FDC DAA regimens listed on the PBS including:6
- sofosbuvir 400 mg + velpatasvir 100 mg (Epclusa)
- sofosbuvir 400 mg + velpatasvir 100 mg + voxilaprevir 100 mg (Vosevi)
- glecaprevir 100 mg + pibrentasvir 40 mg (Maviret).
There are still several genotype-specific regimens are listed on the PBS. The hepatitis C genotype should be determined before prescribing these regimens. They are well tolerated and have 95% efficacy in people with or without cirrhosis. They are:6
- elbasvir 50 mg + grazoprevir 100 mg (Zepatier), specific for genotypes 1 or 4.12
- ledipasvir 90 mg + sofosbuvir 400 mg (Harvoni), specific for genotypes 1, 4, 5 or 6.12
The Therapeutic Guidelines have stated that as a result of the significant changes in the management of hepatitis C, the topic is expected to be updated later in 2020.13
What should people living with hepatitis C know?
Changes to the available treatment options may result in some confusion for people living with hepatitis C. They should contact their health professional for review in case any changes to their treatment regimen are required.
Intense monitoring for people receiving treatment with DAAs is usually not required (compared to interferon regimens), due to the high efficacy of these medicines, the lack of a role for response-guided therapy and an improved side effect profile. A review at 12 weeks after completing therapy will be required to document sustained virologic response.6
Patients can use the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) website to find a practitioner trained or experienced in hepatitis C.
- Pharmaceutical Benefits Scheme. PBS Schedule: Summary of changes (October 2020). Canberra: Australia Government Department of Health, 2020 (accessed 8 October 2020).
- Pharmaceutical Benefits Scheme. PBS Schedule: Summary of changes (November 2020). Canberra: Australian Government Department of Health, 2020 (accessed 2 November 2020).
- Therapeutic Goods Administration. Daclatasvir dihydrochloride - medicine shortage information. Canberra: Australian Government Department of Health, 2020 (accessed 8 October 2020).
- Bristol Myers Squibb. Important information about the discontinuation of Daklinza. New York, USA: Bristol Myers Squibb, 2020 (accessed 8 October 2020).
- BioPharmaDispatch. PBS update confirms the impact of innovation. Deakin, ACT: Daily Dispatch, 2020 (accessed 8 October 2020).
- Gastroenterological Society of Australia. Australian recommendations for the management of hepatitis C virus infection: a consensus statement (June 2020). Sydney: ASHM, 2020 (accessed 8 October 2020).
- Pharmaceutical Benefits Scheme. General Statement for Drugs for the Treatment of Hepatitis C. Canberra: Australian Government Department of Health, 2020 (accessed 14 October 2020).
- Pharmaceutical Benefits Scheme. Schedule of Pharmaceutical Benefits (August 2017). Canberra: Australian Government Department of Health, 2017 (accessed 14 October 2020).
- Australian Government Department of Health. Fifth national hepatitis C strategy 2018-2022. Canberra: Australian Government Department of Health, 2018 (accessed 8 October 2020).
- Pharmaceutical Benefits Scheme. Authorised Nurse Practitioners now eligible to prescribe certain Highly Specialised Drugs. Canberra: Australian Government Department of Health, 2020 (accessed 8 October 2020).
- Australian Government Minister for Health. Explanatory Statement - National health (Pharmaceuticals Benefit) Amendment (Active Ingredient Prescribing) Regulations 2019. Canberra: Australian Government Department of Health, 2019 (accessed 1 October 2020)
- Australian Medicines Handbook. Oral antivirals in chronic hepatitis C. Adelaide: AMH Pty Ltd, 2020 (accessed 9 October 2020).
- Gastrointestinal Expert Group. Therapeutic Guidelines: Viral hepatitis. West Melbourne: Therapeutic Guidelines Pty Ltd, 2017 (accessed 9 October 2020).