Background: How medicines become available in Australia
For a medicine to be supplied and subsidised to treat a medical condition in Australia, two key processes, both at a Federal Government level, are required:
Step 1: Registration – Listing on the Australian Register of Therapeutic Goods (ARTG)
- To achieve medicines approval in Australia, the sponsor (usually a pharmaceutical company) must first apply to the TGA. The TGA is responsible for assessing the package of evidence collected after several years of research, to verify the claimed quality, safety and efficacy of the medicine. This process takes about one year and includes specialist evaluation and analysis of all data collected during the several years of investigation of the new treatment.
- Once the TGA approves a medicine, it is listed on the ARTG. At this point, the medicine is considered to have “TGA registration” or “Marketing Authorisation” and can legally be sold in Australia, however, it will cost patients the full price set by the sponsor until Step 2 is completed.
- The medicine is then subject to ongoing, continuous monitoring, known as pharmacovigilance, by the TGA and the manufacturer to ensure the continued quality, safety and efficacy of the medicine.
Step 2: Reimbursement – Listing on the Pharmaceutical Benefits Scheme (PBS)
- To list on the PBS, the manufacturer of the medicine needs to submit a package of clinical and economic evidence to the Pharmaceutical Benefits Advisory Committee (PBAC), to demonstrate the medicines relative safety and efficacy and cost effectiveness compared to alternative treatments. The PBAC consists of doctors, specialists, health professionals, health economists and consumer representatives, and is responsible for recommending to the Minister for Health which medicines are value for money and should be subsidised through the PBS at a cost-effective price.
- Once a medicine receives a positive recommendation from the PBAC, the Department of Health commences negotiations with the medicine manufacturer regarding public price and volume. This is formalised in a contract between the Commonwealth Government and the manufacturer.
- Once the medicine is listed on the PBS there are further rules governing how the reimbursed, cost-effective price can change, with statutory price reductions mandated at specific intervals and other reference comparisons made to the prices of similar listed medicines to reduce prices over time.
- On average, time to reimbursement from registration takes 391 days1.
- To see where a medicine is at within the reimbursement process, you can search the Government’s Medicines Status website, https://www.pbs.gov.au/medicinestatus/home.html
- Consumer comments are welcomed by the PBAC. For further details visit: http://www.pbs.gov.au/info/industry/ listing/elements/pbac-meetings/pbac-consumer-comments
First point of contact
To determine the status of a medicine in the registration and reimbursement processes, contact the sponsor company’s Medical Information team. Contact details will be clearly displayed on the Australian website of the company.
If a medicine is not expected to be registered or reimbursed in Australia in a suitable timeframe, other avenues for access should be investigated. These include clinical trial participation; compassionate use programs; the Special Access Scheme, overseas importation or the local private market following registration. The sponsor company and clinicians can assist with this information.
It is important to know where in the registration and reimbursement processes a medicine is before commencing advocacy activity. Additionally, the specific condition (indication) for which a medicine is being evaluated should be understood. This is because separate submissions are required for each different indication. Information that will assist in advocacy preparations:
- Medicine name (the active compound and the BRAND name);
- Indication (what condition or disease does the medicine treat);
- Sponsor company (this should be readily available on the internet);
- Registration and/or reimbursement status of medicine in Australia
As well as medicine specific advocacy, other advocacy opportunities exist. Often the Government is undertaking reviews of medicines access processes. Two such reviews currently underway are reviews of the National Medicines Policy and Health Technology Assessment (HTA). There are advocacy opportunities for these 2 reviews.
Federal Member of Parliament (MP)
Access to medicines is managed by the Federal Government Department of Health.
Writing to and meeting with your local MP or State Senator is a good first step in your advocacy.
You can find the contact details of your local MP by visiting www.aph.gov.au/Senators_and_Members and entering your postcode, electorate or the name of the MP or Senator.
To help with your advocacy, an example of an advocacy letter and glossary of terms can be found here.
The Hon Mark Butler MP
Telephone: (02) 6277 7220
Postal Address: PO Box 6022, House of Representatives, Parliament House, Canberra ACT 2600
Shadow Minister for Health
Senator The Hon Anne Ruston
Telephone: (02) 6277 4822 or (02) 9604 0710
Postal Address: The Senate, PO Box 6100 Parliament House, Canberra ACT 2600
Pharmaceutical Benefits Advisory Committee (PBAC)
Patient support groups
There are numerous patient support groups at a local community, state and national levels that may already be active in seeking access to the same medicine that you are. Asking the Sponsor company, a medical practitioner or conducting research online (‘disease name’ patient group Australia) will be useful in identifying the most relevant group/s to contact.
Sponsor companies & industry
The company may also be seeking patient input to a reimbursement submission. Patient stories and experiences help to better understand the patient perspective. To provide input to a possible reimbursement submission, you should contact the Sponsor company directly.
Medicines Australia is the representative association of the research-based pharmaceutical companies (Sponsors) who invent, develop, manufacture and supply innovative medicines, treatments and vaccines to the Australian community. A list of member companies is available at https://medicinesaustralia.com.au/about-us/ our-members/ and includes links to company webpages and contact details.