Here’s a breakdown of the process that ensures equitable access for all Australians:
Understanding the Process
Australia, like many other countries, has a system with two key steps:
- TGA approval: First, the manufacturer (sponsor) applies to the Therapeutic Goods Administration (TGA) for the drug to be commercially available. While this allows doctors to prescribe it, these treatments can be very expensive, often costing thousands of dollars per month.
- PBAC subsidy: The next crucial step is getting the drug listed on the Pharmaceutical Benefits Scheme (PBS). The PBAC (Pharmaceutical Benefits Advisory Committee) reviews the drug’s effectiveness and cost-effectiveness to determine if the government will subsidise it. This is why most PBS prescriptions in Australia have a manageable cost (under $50). Only after PBAC approval and the Federal Minister for Health’s go-ahead can a new treatment become the standard of care in Australia.
Equity vs. Speed
This system promotes equity. Once listed on the PBS, every Australian has access to the treatment at the same affordable price.
However, compared to the US system, it can seem slow. In the US, the FDA has a single approval process, making new drugs available faster. This comes at a cost – the US relies on a “user-pays” healthcare system, where insurance determines access. This is a disadvantage to Americans who do not have insurance or whose insurance plan does not cover such treatments.
The Role of PBAC Submissions
The PBAC submission process is comprehensive. Medical associations, healthcare professionals, even individuals, and their representatives can submit information.
However, for new listings, the sponsor usually holds the most relevant data, particularly from clinical trials. Public input is sought after an initial submission. If you are a patient, carer, member of the public, health professional or member of a consumer interest group you are welcome to provide input.
Here are tips on submitting consumer comments to ensure they are constructive to the overall process.
Accessing Treatments Not Yet on the PBS
If a promising treatment hasn’t reached the PBS yet, but is TGA-approved, you might consider self-funding it. This can be costly, fortunately, there are alternatives:
- Clinical Trials: Participating in a clinical trial offers access to the new treatment while contributing valuable research data.
- Compassionate Access Programs: These programs allow access to unregistered drugs for patients with serious or life-threatening illnesses.
- Co-Payment Schemes: Some manufacturers offer co-payment programs to help patients afford their medications.
Talk to Your Doctor
The best way to explore your options for accessing a new cancer treatment is to talk openly with your treating clinician. They can advise you on the specific situation and help you navigate the process.
