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Approving Medicines in Australia

There are two important regulatory bodies in Australia involved in the approval and use of medicines called the Therapeutic Goods Administration and the Pharmaceutical Benefits Scheme and we will take a look at how they both work to approve new medicines.

Therapeutic Goods Administration (TGA) of Australia

The TGA is Australia’s regulatory authority for therapeutic goods such as medicines. TGA carry out a range of assessment and monitoring activities to ensure medicines available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access within a reasonable time frame to these medicines and is a requirement by Australian law. The TGA must approve a medicine for a certain indication before it can be listed on the Pharmaceutical Benefits Scheme. You can go online to the TGA website to search for a medicine by name to see if it is approved for use in Australia.

https://www.tga.gov.au/

Pharmaceutical Benefits Scheme (PBS) of Australia

The PBS is part of the Australian Government’s National Health Policy and they provide timely, reliable and affordable access to medicines for Australians. Under the PBS, the government subsidises the cost of a medicine for most medical conditions so that Australians do not have to afford the entire cost of the medicine and instead pays a smaller fraction of the cost which makes medicines more affordable to the Australian public. You can go online to the PBS website listed below to search for a medicine by name to see if it is currently covered by the PBS.

http://www.pbs.gov.au/pbs/home

How do medicines get approved by the PBS?

The PBS have an advisory committee of independent expert individuals called the Pharmaceutical Benefits Advisory Committee (PBAC). PBAC have a process they follow by which medicines are reviewed for listing on the PBS. PBAC make recommendations to the government about whether to subsidise new medicines or not and then the government makes the decision of whether to subsidise the new medicine on the PBS.

What is the application process for getting a new medicine approved by the PBS?

  • PBAC meet three times a year in March, July and November to review submissions for listing on the PBS and the key steps to submission of a medicine are as follows;
  • The sponsor of the medicine (normally the pharmaceutical company) makes a submission for a medicine to the PBAC four months prior to the PBAC meeting date
  • The PBAC agenda listing all submissions is published 10 weeks prior to the meeting
  • Members of the public and health professionals can submit comments about the submissions to the PBAC from the date of the agenda is published up until 4 weeks prior to the meeting
  • PBAC recommendations are published 6 weeks after the meeting
  • If the PBAC rejects a submission it will explain why and the sponsor of the medicine can resubmit if they can address the PBAC’s concerns
  • Under special circumstances, the government may agree to subsidise the cost of a medicine on a provisional basis. This process is known as the ‘Managed Access Program’ and PBAC may agree to this access program under the following circumstances;
  • Where patients have an urgent clinical need for a medicine
  • There is enough clinical evidence to show the benefit of the medicine but not enough to demonstrate cost-effectiveness
  • Where the sponsor of the medicine will be able to provide more clinical evidence in a reasonable time period so that the PBAC can undertake a full assessment of the medicines value
  • The ‘Managed Access Program’ does not guarantee that a medicine will be approved for listing on the PBS indefinitely either as PBAC may recommend delisting of the medicine based on the further clinical evidence provided about the efficacy and safety of the medicine

How can patients have a say in the PBAC review process for PBS?

Anyone is the Australian public who has an interest in a certain medicine and the decision on whether it should be subsidised on the PBS is able to have their voice heard. This includes those people living with the disease, a loved one who has been impacted by the disease, members of the public, carers, family members, friends, health care professionals and patient consumer groups.

Consumer involvement from patients allows the submission for a certain medicine to demonstrate how the availability of that particular medicine on the PBS would impact an individual’s quality of life and most importantly how not being able to access the medicine would disadvantage an individual.

  • Where patients have an urgent clinical need for a medicine
  • There is enough clinical evidence to show the benefit of the medicine but not enough to demonstrate cost-effectiveness
  • Where the sponsor of the medicine will be able to provide more clinical evidence in a reasonable time period so that the PBAC can undertake a full assessment of the medicines value
  • The ‘Managed Access Program’ does not guarantee that a medicine will be approved for listing on the PBS indefinitely either as PBAC may recommend delisting of the medicine based on the further clinical evidence provided about the efficacy and safety of the medicine

How can patients have a say in the PBAC review process for PBS?

Anyone is the Australian public who has an interest in a certain medicine and the decision on whether it should be subsidised on the PBS is able to have their voice heard. This includes those people living with the disease, a loved one who has been impacted by the disease, members of the public, carers, family members, friends, health care professionals and patient consumer groups.

Consumer involvement from patients allows the submission for a certain medicine to demonstrate how the availability of that particular medicine on the PBS would impact an individual’s quality of life and most importantly how not being able to access the medicine would disadvantage an individual.

The PBAC meeting agenda with the list of medicines for submission can be found on the PBS website and you can make comments on a form on the following website link;

http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/agenda

You can also access the consumer comments form through the Department of Health website using the following website link;

http://www.health.gov.au/internet/main/publishing.nsf/Content/PBAC_online_submission_form

What happens after the PBAC make a recommendation for medicines to be listed on the PBS?

The Health Minister (or delegate) considers the PBAC’s recommendations and the Health Department’s advice on the cost of the medicine to the PBS which is developed through the negotiations with the medicine’s sponsor.

The decision to subsidise a medicine goes to the cabinet if the cost of the medicine is expected to be in excess of 20 million dollars a year to the PBS. If the cabinet approves the subsidy the decision on the timing to add the medicine to the PBS is decided by the Health Minister. The timing of these reviews by cabinet can vary but may take up to 6 months from the PBAC’s recommendations.

How can a patient gain access to a medicine prior to registration or subsidy on the PBS?

Patients may be able to access a medicine prior to it being approved by the TGA on a clinicl trial or by a ‘Special Access Scheme’. The ‘Special Access Scheme’ enables doctors to apply for a medicine for their patient when they have exhausted all other approved treatment options and more information on this scheme can be found on the TGA website by following this website link;

http://www.tga.gov.au/form/special-access-scheme

Some pharmaceutical companies also offer ‘Patient Access Programs’ for medicines approved by the TGA but awaiting PBS listing. Doctors can apply for a patient to receive a medicine on these programs and the patient eligibility is determined by the pharmaceutical company and there may be a cost of the medicine incurred by the patient. Pharmaceutical companies in Australia are guided by the Code of Conduct and are therefore limited with the information that they can provide directly to patients. If you are wondering if there is are any other medicines out there that may help you in the treatment of your lymphoma do not be afraid to ask your doctor or nurse for further information.