Be the change you want to see!
Bowel Cancer Australia empowers people living with or beyond bowel cancer with tools and knowledge to be advocates for their own health.
We advocate for robust and meaningful inclusion of the lived-experience perspective in all decisions affecting patients, including access, affordability, and healthcare delivery of new medicines, tests, or services.
New treatment approaches bring promise and hope to people living with bowel cancer, but only if access is timely, affordable and provides choice.
How decisions regarding access and affordability are made in Australia
Health technology assessment (HTA)
Before any new pharmaceutical drug, diagnostic test, medical device, surgically implanted prostheses, medical procedure, or public health intervention becomes available in Australia, it must undergo health technology assessment (HTA).
HTA is used to work out the benefits and comparative value of health technologies and procedures.
The Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC), Medical Services Advisory Committee (MSAC), and the Prostheses List Advisory Committee (PLAC) each perform HTA processes and advise the Department of Health and the Minister for Health of their findings.
The key questions HTA aims to answer for each new health technology, in comparison to alternative interventions, are:
Is it safe?
Does it improve health outcomes?
Is it cost effective?
This information is then used to guide policy, funding, and clinical decisions, and assist with patient decision-making.
Assessing safety, quality, and efficiency
Therapeutic Goods Administration (TGA)
The TGA is the national body responsible for assessing the safety, quality, and efficiency of any health technology defined as a ‘therapeutic good’, before it can be entered on the Australian Register of Therapeutic Goods (ARTG).
Therapeutic goods can include a broad range of things, from bandages, bowel cancer screening test kits, and herbal remedies, to tissue grafts and paracetamol. They generally fall under three main categories:
Medicines - including prescription, over-the-counter and complementary medicines
Biologicals - something made from or containing human cells or tissues, such as human stem cells
Medical devices - including instruments, implants and appliances, such as bowel screening testing kits
The TGA also regulates what are known as ‘other therapeutic goods’, which include items such as tampons and disinfectants.
Recommended
If a therapeutic is approved by the TGA, it is entered on the Australian Register of Therapeutic Goods (ARTG) and can be supplied within Australia.
Further assessment, referred to as post market surveillance, continues by the TGA, and includes reports of any adverse events.
Deferred
The TGA may determine more information or evidence is required before a decision can be made. If so, they will defer entering the therapeutic on the ARTG until further assessment can be conducted.
Not recommended
If the TGA decides against entering the therapeutic on the ARTG, there are still ways patients can access therapeutic goods not approved for use in Australia.
Authorised prescribers
The Authorised Prescriber Scheme allows authorised medical practitioners to supply therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the ARTG, to a class of patients with a particular medical condition.
Clinical trials
Clinical trials provide early access to innovative treatments and interventions for patients and improve the overall standard of medical care provided in Australian hospitals through the uptake of evidence into practice.
The following avenues provide for the importation into and/or supply in Australia of 'unapproved' therapeutic goods for use in a clinical trial:
Clinical Trial Notification (CTN) scheme; and
Clinical Trial Approval (CTA) scheme.
Expanded Access Programs (EAP)
Offered by pharmaceutical companies, EAP provide an investigational product cost-free when associated with participation in a clinical trial and usually involve patients with serious or life-threatening conditions.
An EAP may include patients who do not meet the enrolment criteria for a clinical trial in progress, or those who have been participating in a clinical trial and require continued supply of an investigational product after its conclusion.
To find out more about EAP, speak with your oncologist.
Medical Treatment Overseas Program (MTOP)
For Australians with a life-threatening medical condition, where effective treatment is not available in Australia, the Medical Treatment Overseas Program (MTOP) provides financial assistance to receive proven lifesaving medical treatment overseas.
To be eligible, you must be an Australian citizen or resident, and reside in Australia. You will need to provide evidence addressing mandatory medical eligibility criteria, and will require the assistance of the specialist(s) from whom you are receiving treatment in Australia to complete the application.
Personal importation scheme
Under the Personal Importation Scheme, you may legally import a three-month supply into Australia of unapproved therapeutic goods for personal use (at the maximum dose recommended by the manufacturer) at one time under certain circumstances without any approval required by the TGA.
Special Access Scheme (SAS)
The Scheme allows certain health practitioners to access therapeutic goods for a single patient that are not included in the ARTG, on a case-by-case basis.
An application or notification form must be completed by an appropriate health practitioner, as they must be able to justify on medical grounds why their patient requires the unapproved therapeutic good.
Assessing value for money
Innovative treatments deliver meaningful health outcome advances, but they can come at a high cost.
Following TGA approval, the manufacturer or sponsor can apply for public or private subsidy for the therapeutic under an Australian Government funding program, to reduce the financial burden on patients.
The amount of tax funding available for treatments is limited, so a rigorous assessment of ‘value’ is conducted by at least one HTA expert advisory committee, such as the:
Medical Services Advisory Committee (MSAC) for medical services involving new procedures or health technologies (i.e., biomarker testing) to be funded under the Medicare Benefits Schedule (MBS)
Pharmaceutical Benefits Advisory Committee (PBAC) for pharmaceuticals to be funded under the Pharmaceutical Benefits Scheme (PBS).
Medical Devices and Human Tissue Advisory Committee (MDHTAC) for medical devices and human tissue products for listing on the Prescribed List of Benefits for Medical Devices and Human Tissue Products (Prescribed List or PL) and the benefits payable by private health insurers (if the patient is covered).
The Australian government considers advice from these committees regarding safety, effectiveness and quality, and uses the assessment to inform decisions about which therapeutics provide the best value for money for the Australian taxpayer.
Patients are also invited to express their views.
This provides an important opportunity for bowel cancer patients, families, and carers to share their unique insights and experience with decision makers about what it’s like to live with bowel cancer and give a real-life view of the ‘value’ and potential of a new medicine, device, test, or treatment.
On completion of the assessment, the HTA committee advises the Minister for Health with regards to rejecting, deferring or recommending the listing.
Medical Service Advisory Committee (MSAC)
To be covered by Medicare, medical services and devices need a Medicare Benefits Schedule (MBS) item number. This requires assessment by the Medical Services Advisory Committee (MSAC).
The MBS is a list of the medical services for which the Australian Government will pay a Medicare rebate, to provide patients with financial assistance towards the costs of their medical services, including professional services.
The types of items on the MBS include consultation (e.g., GP and specialist appointments) and procedural/therapeutic (including surgery) services, as well as diagnostic services (e.g., biomarker testing and colonoscopy).
Public consultation is held at the start of the application process.
This provides an important opportunity for bowel cancer patients, families, and carers to share their unique perspective and experience with decision makers about what it’s like to live with bowel cancer and give a real-life view of the ‘value’ and potential of a new medical service or device.
To stay up to date regarding upcoming submissions affecting bowel cancer patients and how you can have your say, sign up to be an advocate.
Pharmaceutical Benefits Advisory Committee (PBAC)
For a medicine to be listed on the Pharmaceutical Benefits Scheme (PBS) it requires assessment by the Pharmaceutical Benefits Advisory Committee (PBAC).
The PBS is a list of medicines the Australian Government subsidises, making treatments more affordable for patients. The types of items on the PBS include chemotherapy, targeted therapies and immunotherapies.
The primary role of the PBAC is to recommend new medicines for listing on the PBS. Committee members include doctors, health professionals, health economists and consumer representatives.
No new medicine can be listed unless the committee makes a positive recommendation.
When recommending a medicine for listing, the PBAC is tasked with determining if a medicine is safe and clinically and cost effective (‘value for money’).
The Economics Subcommittee considers the price for the medicine in relation to the expected outcomes, in comparison to comparable medicines on the PBS.
The Drug Utilisation Committee looks at how much of the medicine will be used by Australians, to determine the cost to the health system to fund the medicine.
In addition, a formal targeted public consultation is held at the start of the application process, so that it is available to the PBAC consumer representatives to collate and summarise for the PBAC meeting.
The submission process enables bowel cancer patients, families, and carers to share their unique perspective and experience with decision makers about what it’s like to live with bowel cancer
The PBAC needs your insights into how periods of increased survival and reduced toxicity impact experience and quality of life.
Your input gives a real-life view of the ‘value’ and potential of a new medicine and will be presented to the PBAC by a consumer representative on the committee.
To stay up to date regarding upcoming submissions affecting bowel cancer patients and how you can have your say, sign up to be an advocate.
MSAC meeting outcome
Based on the evidence submitted, MSAC determines whether to reject, defer, or recommend listing the medical service or device on the MBS.
Not Recommended
If MSAC determines the service or device is not clinically and cost-effective when considered against a comparator or it is not deemed as safe after a full HTA, they will advise the Minister of Health not to include it on the MBS.
Deferred
MSAC may determine more information or evidence is required before a decision can be made. If so, they will advise the Minister of Health to defer listing on the MBS until further assessment can be conducted.
Recommended
If MSAC determines the service or device to be clinically and cost-effective and safe after a full HTA, they will advise the Minister of Health to include it on the MBS.
The Hon Mark Butler MP | Minister for Health & Aged Care
The Minister for Health decides
Based on advice from MSAC and the department, the Minister will decide whether public funding should be granted for the listing of the recommended medical service on the MBS.
Once approved by the Minister, the department will implement the decision of Government through amendment to regulations and/or other instruments, generally in line with the most appropriate budget cycle.
MBS listed
If approved, the medical service will be included in the Medical Benefits Scheme (MBS). When an item number already exists, it is expanded to include the recommendation.
Medicare rebates do not, and were never intended to, cover the full cost of medical services.
The Australian Government sets a Medicare Schedule Fee to determine the amount of the rebate that patients receive from the Government.
Rebates are paid as a percentage of the Medicare Schedule Fee as follows:
100% for consultations provided by a GP;
85% for all other services provided by a medical practitioner in the community; and
75% for all services that are provided by a medical practitioner during an episode of hospital treatment when the patient is admitted as a private patient.
Medical practitioners set their own fees for their services. If these are higher than the Medicare Schedule Fee, the difference is known as an out-of-pocket cost paid by the patient.
PBAC meeting outcome
The PBAC decides whether to reject, defer or recommend listing a medicine on the PBS based on the evidence, which can include submissions from patients and their families about how affordable access to the medicine would benefit them.
Not Recommended
If PBAC determines the medicine is not clinically and cost-effective when considered against a comparator or it is not deemed as safe after a full HTA, they will advise the Minister of Health not to include it on the PBS. In those instances, independent review is available.
Resubmit
If a medicine is rejected, the manufacturer or sponsor can resubmit their application at a later stage. In some instances, medicines have been resubmitted multiple times before finally being listed on the PBS.
Deferred
The PBAC may determine more information or evidence is required before a decision can be made. If so, they will defer listing the medicine on the PBS until further assessment can be conducted.
Alternative access pathways for TGA approved treatments not listed on the PBS
In instances where the drug has been TGA approved and registered on the ARTG, but the submission for listing on the PBS is in progress or has been rejected or deferred, alternative options to help finance the treatment may be available. Speak with your specialist for more details.
Clinical trials
Clinical trials provide early access to innovative treatments and interventions for patients and improve the overall standard of medical care provided in Australian hospitals through the uptake of evidence into practice.
Compassionate Use
Compassionate use is a program offered by pharmaceutical companies to provide a medicine free of charge for indications that are not already included in a funded scheme.
Speak with your specialist for more details.
Cost-Share Programs (CSP)
CSP are programs offered by pharmaceutical companies that offer a medicine commercially at a reduced price. Use of the product either individually or as a part of a program should be considered as if the drug was simply being marketed at that reduced price. Treatment costs are shared between a pharmaceutical company and the hospital or health service organisation and/or the patient. Cost-share arrangements may include deferred cost, subsidised supply of a medicine (e.g., half price) or arrangements in which supply of a medicine at a reduced price is provided after the purchase of a specified (threshold) amount.
Speak with your specialist for more details.
Life Saving Drugs Program (LSDP)
The LSDP pays for specific essential medicines to treat patients with rare and life-threatening diseases.
Funding for medicines on the LSDP is separate to the PBS.
The LSDP covers medicines if:
they are clinically effective, but not cost effective enough to list on the PBS;
they treat life threatening and rare conditions (defined as 1 case per 50,000 people or fewer in the Australian population); and
the pharmaceutical company (sponsor) applies for an LSDP listing.
There are currently 16 medicines available through the program, which treat 10 rare conditions.
Speak with your specialist for more details.
Product Familiarisation Programs (PFP)
PFP are programs offered by pharmaceutical companies that are designed to allow the prescriber to evaluate and become familiar with a product while PBS listing is being sought. Products offered under a PFP must be in accordance with the TGA approved indications and the indication for which PBS listing is being sought.
Speak with your specialist for more details.
Recommended
If the PBAC decides to recommend the medicine for listing following rigorous assessment regarding the medicine’s safety and clinical and cost effectiveness, a process of price negotiations are undertaken with the medicine sponsor (usually a pharmaceutical company).
Price negotiations
If negotiations are successful, the PBAC will recommend to the Minister of Health that the medicine be included in the Pharmaceutical Benefits Scheme (PBS) or if already included, its indication expanded to include other chronic illnesses or diseases.
The medicine will only be recommended for listing by PBAC if a price agreement can be reached.
The Minister for Health decides
Based on advice from PBAC and the department, the Minister will decide whether public funding should be granted for the listing of the recommended medicine on the PBS.
Once approved by the Minister, the department will implement the decision of Government through amendment to regulations and/or other instruments, generally in line with the most appropriate budget cycle.
PBS listed
If approved, the medicine will be included in the Pharmaceutical Benefits Scheme (PBS) or if already included, its indication expanded to include other chronic illnesses or diseases.
Medicines listed on the PBS are sold to patients at a significantly reduced (government-subsidised) price – currently $41.30 per script or $6.60 per script for concession card holders.
Without the PBS, many medications would be financially out of reach to patients who need them.
For example, the listing of one medicine to treat bowel cancer means patients no longer pay as much as $150,000 per course of treatment.
