Timely access to quality colonoscopy | Access to surgery | Access to radiotherapy | Access to cancer medicines | Cancer medicine status 2004-2024 timeline
Bowel Cancer Australia has long advocated for referral to colonoscopy within 30 days for people with a positive screen or bowel cancer symptoms to minimise stress and anxiety, as recommended in the Optimal Care Pathway.
Newly released medical guidelines, however are now recommending patients be referred to colonoscopy within a 120-day threshold.
Research shows diagnostic intervals exceeding 120 days are associated with poorer outcomes.
Bowel Cancer Australia is calling on Federal, State and Territory Governments to commit to a national Colonoscopy Wait-time and Performance Guarantee – with recording, reporting and resourcing - to address delays in diagnosing Australia’s second biggest cancer killer.
Visit our Colonoscopy Wait-time and Performance Guarantee webpage to learn more about Bowel Cancer Australia's proposal.
Train-the-colonoscopy-trainer project
Bowel Cancer Australia representatives are working towards improving the quality of colonoscopy in Australia.
They have been instrumental in establishing and implementing the Train-the-Colonoscopy-Trainer Project under the umbrella of the National Endoscopy Training Initiative. This comprises a series of practical workshops aimed at registrars and fellows who are in the process of learning colonoscopy.
Bowel Cancer Australia specialists are also contributing to the federal Colonoscopy Quality Working Group.
Both initiatives are important to the long-term success of the National Bowel Cancer Screening Program, since safe accurate colonoscopy is vital if the benefits of the program are to be realised and maximised.
The adequacy of training of endoscopists has a direct bearing on the quality of endoscopic care.
| Access to surgery
According to the AIHW, in 2018-19 the time within which 50% of patients with a principal diagnosis of bowel cancer were admitted for surgery was 15 days, with 90% of patients admitted for surgery within 34 days.
Without timely surgery, bowel cancer may progress and people with early-stage disease may face a reduced opportunity for cure.
Delays in cancer surgery can also result in distress for patients and their carers.
Waiting times for surgery for bowel cancer are a measure of access to potentially life-saving treatment.
In Australia there are no maximum acceptable waiting time benchmarks for planned cancer surgery. Surgeries are prioritised using the same waiting list system as other planned surgeries.
Patients are assigned to planned surgery waiting lists by surgeons as urgent or semi-urgent or non-urgent cases.
Most patients waiting for bowel cancer surgery are listed as urgent (surgery within 30 days is clinically recommended) and a lesser number are listed as semi-urgent (surgery within 90 days is clinically recommended).
According to the National Health Performance Authority 2011-12 report, there were 11,729 patients admitted to hospital for surgery for malignant bowel cancer. Nearly four in 10 (37%) of these patients (4,345) received planned surgery at one of the 127 public hospitals covered in the report; most of these 4,345 patients (69%) received their care in major metropolitan hospitals.
In 2011-12, across Australia a total of 55 of the 85 peered hospitals provided surgery for at least 90% of patients within 30 days. Of these, 14 peered hospitals provided surgery for 100% of patients within 30 days.
The hospitals with the lowest percentage of patients that received their surgery within 30 days were:
Major metropolitan hospitals
- Princess Alexandra, QLD - 39%
- Fremantle, WA - 52%
Major regional hospitals
- Royal Hobart, TAS - 61%
- Coffs Harbour, NSW - 65%
Large hospitals
- Calvary Mater (Newcastle) - 47%
- Repatriation General, SA - 83%
By 45 days, a total of 76 peered hospitals had provided surgery for at least 90% of patients. Of these, 36 hospitals provided surgery for 100% of patients.
In 2011-12, of the 4,345 patients who had surgery for bowel cancer at the 127 hospitals in the report, 87% received their surgery within 30 days. This means that 576 patients waited longer.
Nearly all patients (94%) had received their surgery by 45 days. This means that 243 patients waited longer.
| Access to radiotherapy (radiation therapy)
In 2018-19, according to the AIHW, 90% of male and female bowel cancer patients received radiotherapy treatment within 25 and 24 days of being assessed as ready for care, respectively.
A course of radiotherapy is a series of one or more external beam radiotherapy treatments prescribed by a radiation oncologist. A patient can receive more than one course of radiotherapy at the same time (courses that are simultaneous or overlap).
The waiting time is the number of days from when a patient is ready to be treated with radiotherapy in the opinion of the treating specialist (‘ready for care’) until the day the patient first receives radiotherapy treatment - that is, the number of days between the ready-for-care date and the radiotherapy start date.
Reported waiting times include non-working days (such as weekends or public holidays) and other days on which a service was not able to provide services (such as when key staff are unavailable or where there has been equipment failure).
Other waiting periods—such as the time between when a person contacts their GP and their first appointment with a medical oncologist, and the time between receipt of the patient’s first referral to a radiation oncologist to the date of that patient’s first consultation with a radiation oncologist are not included in calculating the radiotherapy waiting times.
The ready-for-care date is set by the treating specialist and takes into account things such as the need for prior treatment or post-operative healing. If a patient is not ready for care on this date for personal reasons, the ready-for-care date will be set at a later time, when a patient states they are ready.
Treatment may be delayed due to waiting times in pre-treatment imaging or testing, treatment service availability, staff shortages, equipment breakdown, or even a lack of available accommodation for a patient travelling for treatment.
| Access to medicines
Timely access. Affordable treatment options. Better outcomes.
While screening is important for the prevention and early detection of bowel cancer, it is also important for health policy to recognise that bowel cancer patients require improved access to affordable treatment options.
Bowel Cancer Australia welcomed the 2013 Coalition Government's commitment to restore transparency, certainty and confidence to the process by which medicines are listed on the Pharmaceutical Benefits Scheme (PBS) – ensuring medicines are listed on the basis of advice from the independent Pharmaceutical Benefits Advisory Committee.
The Health Minister will have the authority to list medicines recommended by the PBAC that do not cost more than $20 million in any of the first four years of listing.
The previous Labor Government changed PBS approvals (previously approved after a positive Pharmaceutical Benefits Advisory Committee (PBAC) recommendation) by requiring Cabinet approval. Following pressure from industry groups and consumer organisations the Government began to automatically allow PBAC-approved treatments onto the PBS if they cost less than $10 million a year.
Fewer than 50% of bowel cancers are currently detected early, which underscores the need for improved access to affordable treatment options.
Patients with metastatic bowel cancer want to live as full a life as possible, for as long as possible, and will actively seek out new treatments.
Australians with metastatic bowel cancer say they still have more they want to do with their lives and want access to new treatments to enable them to live as full a life as possible according to Bowel Cancer Australia's My Cancer My Voice Patient Survey.1
More than three quarters (77 per cent) said more life-extending treatments were needed for metastatic bowel cancer; If a new treatment was available overseas (but not in Australia), more than 40 per cent would travel overseas and a similar number (45 per cent) would write to the Government seeking access;
More than two thirds (68 per cent) would ask their doctor to try and get access to the treatment and about three in five (59 per cent) would try to get included in a clinical trial to access the treatment.
There are limited treatment options currently available to extend life for those with metastatic bowel cancer.
A limited number of treatment options which have been shown to deliver modest incremental life-extending benefits are currently available in Australia for people with metastatic bowel cancer.
Bowel cancer patients have had the longest wait for treatment funding, with one life-extending medication taking more than six years and a record eight submission before being subsidised.2
Despite this, median overall survival rates for people with metastatic bowel cancer have increased over the last three decades from 5 months to 24 months,3 and in a select group of people (patients with KRAS wild type tumours) up to 33 months.
| Cancer Medicines Status - 2004 to 2024 timeline
Enhertu
Not currently TGA-approved for treatment of patients with metastatic bowel cancer.
- April 2024 - the US Food and Drug Administration (FDA) granted accelerated approval to Enhertu (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
Avzivi (biosimilar)
Not currently TGA-approved for treatment of patients with metastatic bowel cancer.
- December 2023 - the US Food and Drug Administration (FDA) granted approval of Avzivi (bevacizumab-tnjn), a biosimilar brand of Avastin, in combination with IV fluorouracil-based chemotherapy for first- or second-line treatment of metastatic bowel cancer, and in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment of metastatic bowel cancer that has progressed on a first-line regimen containing bevacizumab.
Fruzaqla
Not currently TGA-approved for treatment of patients with metastatic bowel cancer.
- November 2023 - the US Food and Drug Administration (FDA) granted approval to Fruzaqla (fruquintinib) for the treatment of adult patients with metastatic bowel cancer who received prior fluoropyrimidine -, oxaliplatin -, and irinotecan-based chemotherapy, an anti-VEGF therapy, and if RAS wild-type and medically appropriate, an anti-EGFR therapy.
Tukysa + Trastuzumab
Provisionally TGA-approved and ARTG-registered for treatment of patients with metastatic bowel cancer, but not currently listed as a subsidised treatment on the PBS.
- November 2023 - the Therapeutic Goods Administration (TGA), via the provisional approval pathway, registered Tukysa (tucatinib) in combination with trastuzumab on the Australian Register of Therapeutic Goods (ARTG), for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic bowel cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
- January 2023 - the US Food and Drug Administration (FDA) granted accelerated approval to Tukysa (tucatinib) in combination with Herzuma (trastuzumab), a biosimilar brand of Herceptin, for RAS wild-type HER2-positive unresectable or metastatic bowel cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Bevaciptin (biosimilar)
A biosimilar brand of Avastin, for first- and second-line treatment of patients with metastatic bowel cancer, but not currently listed as a subsidised treatment on the PBS.
November 2022 - Bevaciptin, a biosimilar brand of Avastin was listed on the Pharmaceutical Benefits Scheme (PBS) as a subsidised first- and second-line treatment option for patients with metastatic bowel cancer.
- March 2022 - the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of Bevaciptin, as a biosimilar brand of Avastin, for the first- or second-line treatment of patients with metastatic bowel cancer on the Pharmaceutical Benefits Scheme (PBS) as a subsidised treatment option.
- November 2021 - the Therapeutic Goods Administration (TGA) evaluated and registered Bevaciptin, as a biosimilar brand of Avastin, on the Australian Register of Therapeutic Goods (ARTG), for the first- or second-line treatment of patients with metastatic bowel cancer.
Bevacip (biosimilar)
TGA-approved and ARTG registered, as a biosimilar brand of Avastin, for first- and second-line treatment of patients with metastatic bowel cancer, but not currently listed as a subsidised treatment on the PBS.
- November 2021 - the Therapeutic Goods Administration (TGA) evaluated and registered Bevacip, as a biosimilar brand of Avastin, on the Australian Register of Therapeutic Goods (ARTG), for the first- or second-line treatment of patients with metastatic bowel cancer.
Abevmy (biosimilar)TGA-approved and ARTG registered, as a biosimilar brand of Avastin, for first- and second-line treatment of patients with metastatic bowel cancer, but not currently listed as a subsidised treatment on the PBS.
- November 2021 - the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of Abevmy, as a biosimilar brand of Avastin, for the first- or second-line treatment of patients with metastatic bowel cancer on the Pharmaceutical Benefits Scheme (PBS) as a subsidised treatment option.
- September 2021 - the Therapeutic Goods Administration (TGA) evaluated and registered Abevmy, as a biosimilar brand of Avastin, on the Australian Register of Therapeutic Goods (ARTG), for the first- or second-line treatment of patients with metastatic bowel cancer.
Braftovi
Currently listed on the PBS in combination with Erbitux for patients with BRAF V600E-variant metastatic bowel cancer who have not responded to a prior systemic therapy.
January 2022 - Braftovi was listed on the Pharmaceutical Benefits Scheme (PBS) as a subsidised treatment option in combination with Erbitux for patients with BRAF V600E-variant metastatic bowel cancer who have not responded to a prior systemic therapy.
- May 2021 - the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of Braftovi in combination with Erbitux for the targeted treatment of patients with BRAF V600E-variant metastatic bowel cancer who have received prior systemic therapy. This followed MSAC's support at its 31 March - 1 April 2021 meeting to amend the descriptor for MBS item 73338 to include BRAF V600 testing.
- May 2021 - the Therapeutic Goods Administration (TGA) registered Braftovi in combination with Erbitux on the Australia Register of Therapeutic Goods (ARTG), for the treatment of adult patients who have metastatic bowel cancer with a BRAF V600E mutation as detected by a validated test, and who have received prior systemic therapy.
- March 2021 - the Pharmaceutical Benefits Advisory Committee (PBAC) deferred the listing of Braftovi (encorafinib) until the Medical Services Advisory Committee (MSAC) decides to list the BRAF V600 biomarker test on the Medical Benefits Schedule (MBS). If MSAC decides to list the biomarker test, the PBAC would support an expedited process for reconsideration to align any PBAC recommendation for listing Braftovi with the circumstances supported by MSAC.
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April 2020 - the US Food and Drug Administration (FDA) approved Braftovi in combination with Erbitux for the treatment of adult patients with metastatic bowel cancer with BRAF V600E mutation after prior therapy.
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December 2019 - the US Food and Drug Administration (FDA) accepted and granted priority review for Braftovi in combination with Erbitux with or without Mektovi, for the treatment of patients with metastatic bowel cancer with BRAF V600E mutation following one or two lines of therapy.
Zirabev (biosimilar)
TGA-approved and ARTG registered, as a biosimilar brand of Avastin, for first- and second-line treatment of patients with metastatic bowel cancer, but not currently listed as a subsidised treatment on the PBS.
- July 2020 - the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of Zirabev, as a biosimilar brand of Avastin, for the first- or second-line treatment of patients with metastatic bowel cancer on the Pharmaceutical Benefits Scheme (PBS) as a subsidised treatment option.
- November 2019 - the Therapeutic Goods Administration (TGA) evaluated and registered Zirabev, as a biosimilar brand to Avastin, on the Australian Register of Therapeutic Goods (ARTG), for the first- or second-line treatment of patients with metastatic bowel cancer.
- June 2019 - the US Food and Drug Administration (FDA) approved Zirabev, as a biosimilar to Avastin, for the first- or second-line treatment of patients with metastatic bowel cancer.
Mvasi (biosimilar)
A biosimilar brand of Avastin, currently listed on the PBS as a subsidised first- and second-line treatment for patients with metastatic bowel cancer.
June 2021 - Mvasi, a biosimilar brand of Avastin was listed on the Pharmaceutical Benefits Scheme (PBS) as a subsidised first- and second-line treatment option for patients with metastatic bowel cancer.
- December 2020 - the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of Mvasi, as a biosimilar brand of Avastin, for the first- or second-line treatment of patients with metastatic bowel cancer on the Pharmaceutical Benefits Scheme (PBS) as a subsidised treatment option.
- June 2020 - the Therapeutic Goods Administration (TGA) registered Mvasi, as a biosimilar brand of Avastin, on the Australian Register of Therapeutic Goods (ARTG), for the first- or second-line treatment of patients with metastatic bowel cancer.
- September 2017 - the US Food and Drug Administration (FDA) approved Mvasi, as a biosimilar brand of Avastin, for the first- or second-line treatment of patients with metastatic bowel cancer.
Opdivo + Yervoy
Not currently TGA-approved for treatment of patients with metastatic bowel cancer.
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July 2018 - the US Food and Drug Administration (FDA) granted accelerated approval to Yervoy for use in combination with Opdivo for the treatment of patients 12 years of age and older, with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic bowel cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
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July 2017 - the US Food and Drug Administration (FDA) granted accelerated approval to Opdivo for the treatment of patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic bowel cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
Keytruda
Currently listed on the PBS as a first-line treatment for previously untreated unresectable or metastatic deficient mismatch repair (dMMR) bowel cancer.
August 2021- Keytruda was listed on the Pharmaceutical Benefits Scheme (PBS) as a subsidised first-line treatment option in adults with previously untreated unresectable or metastatic deficient mismatch repair (dMMR) bowel cancer.
- March 2021 - the the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of Keytruda on the Pharmaceutical Benefits Scheme (PBS) as a first-line treatment option in adults with previously untreated unresectable or metastatic deficient mismatch repair (dMMR) bowel cancer (mCRC).
- December 2020 - the Therapeutic Goods Administration (TGA) registered Keytruda on the Australia Register of Therapeutic Goods (ARTG), for the first-line treatment of previously untreated patients with unresectable or metastatic bowel cancer that is microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).
- June 2020 - the US Food and Drug Administration (FDA) approved Keytruda as a monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) bowel cancer.
- July 2019 - the Therapeutic Goods Administration (TGA), via the provisional approval pathway, registered Keytruda on the Australian Register of Therapeutic Goods (ARTG), for the treatment of adult and paediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) bowel cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin , and irinotecan.
- March 2019 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Keytruda on the Pharmaceutical Benefits Scheme (PBS) as a second-line treatment option for locally advanced (unresectable) or Stage IV (metastatic) bowel cancer with deficient mismatch repair (dMMR).
The PBAC considered that insufficient evidence was provided in the submission to evaluate the efficacy and safety of Keytruda in the second-line setting.
In addition, the PBAC considered that the economic evaluation was unreliable and therefore, the cost-effectiveness estimates were highly uncertain.
The PBAC considered that the nominated place in therapy, as a second-line treatment, was incorrect as the majority of patients in the key study had failed at least two prior lines of treatment.
The PBAC considered that it would have been more appropriate to position Keytruda as a last-line treatment option. The PBAC therefore also considered that the nominated comparators were incorrect.
- July 2017 - the US Food and Drug Administration (FDA) granted accelerated approval to Keytruda for the treatment of adult and paediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) bowel cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
Lonsurf
Currently listed on a the PBS as a subsidised third-line treatment for patients with metastatic bowel cancer.
December 2018 - Lonsurf was listed on the Pharmaceutical Benefits Scheme (PBS) as a subsidised third-line treatment option for patients with metastatic bowel cancer.
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July 2018 - the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of Lonsurf on the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients with metastatic bowel cancer who were treated previously or were not considered suitable for current available therapies.
The PBAC considered that in the context of limited treatment options in this disease setting, the small treatment benefit of Lonsurf may be meaningful for some patients.
The PBAC considered that the reduced price proposed, in conjunction with the proposed Risk Share Agreement, were adequate to address the residual uncertainty around cost-effectiveness and budget impact.
- March 2018 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Lonsurf on the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients with metastatic bowel cancer who were previously treated with, or were not considered candidates for, available therapies including fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, anti-VEGF therapy and anti-EGFR therapy.
- November 2017 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Lonsurf on the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients with metastatic bowel cancer who were previously treated with, or were not considered suitable for current available therapies, on the basis of a modest clinical benefit, moderate toxicity and an unacceptably high and uncertain incremental cost-effectiveness ratio, since the extent of benefit observed in the trial setting may not be realised in clinical practice.
The PBAC was concerned that the financial impact of listing was substantial with a total net cost to the PBS.
- July 2017 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Lonsurf on the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients with metastatic bowel cancer who were previously treated with, or were not considered suitable for, current available therapies on the basis of a modest clinical benefit, moderate toxicity and an unacceptably high and uncertain incremental cost-effectiveness ratio, since the extent of benefit observed in the trial setting may not be realised in clinical practice.
- May 2017 - the Therapeutic Goods Administration (TGA) registered Lonsurf on the Australian Register of Therapeutic Goods (ARTG), for the treatment of adult patients with metastatic bowel cancer who were previously treated with, or were not considered candidates for, fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
- March 2017 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Lonsurf on the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients with metastatic bowel cancer who were previously treated with, or were not considered suitable for, current available therapies, based on modest clinical benefit, moderate toxicity and an unacceptably high and uncertain incremental cost-effectiveness ratio, since the extent of benefit observed in the trial setting may not be realised in clinical practice.
- November 2016 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Lonsurf on the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients with metastatic bowel cancer who were previously treated with, or were not considered suitable for, current available therapies.
The decision was made on the basis of a modest clinical benefit, high and uncertain incremental cost-effectiveness ratio, and concern that the extent of benefit as observed in the clinical trial would not be released in clinical practice.
- September 2015 - the US Food and Drug Administration (FDA) approved Lonsurf for patients with metastatic bowel cancer who are no longer responding to other therapies.
Stivarga
TGA-approved and ARTG-registered as a third-line treatment for patients with metastatic bowel cancer, but not currently listed as a subsidised treatment on the PBS.
- November 2021 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Stivarga on the Pharmaceutical Benefits Scheme (PBS), on the basis that the evidence presented indicated Stivarga is toxic and would adversely impact patients' overall quality of life, whilst having a limited impact on prognosis.
- July 2014 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Stivarga on the Pharmaceutical Benefits Scheme (PBS), on the basis that the observed improvement in comparative effectiveness associated with Stivarga was small and of uncertain clinical significance, especially in the context of the increase in serious adverse effects associated with treatment.
- November 2013 - the Therapeutic Goods Administration (TGA) registered Stivarga on the Australian Register of Therapeutic Goods (ARTG), for the treatment of patients with metastatic bowel cancer who were previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, anti-VEGF therapy, and if KRAS wild type, an anti-EGFR therapy.
- September 2012 - the US Food and Drug Administration (FDA) approved Stivarga for treatment of patients with metastatic bowel cancer who were previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
Zaltrap
Zaltrap has been removed from the Australian Register of Therapeutic Goods (ARTG).
February 2018 - Zaltrap was discontinued as a treatment option for patients with metastatic bowel cancer ‘due to cost effectiveness and other treatment options being more available’.
The manufacturer no longer supplies Zaltrap in Australia and it was removed from the Australian Register of Therapeutic Goods (ARTG). The ARTG is the register for all therapeutic goods that can be lawfully supplied in Australia. Sometimes a special provision is made to make available some medicines that are not listed in response to the needs of patients. To find out more visit access to therapeutic goods on the ARTG website.
The manufacturer no longer supplies Zaltrap in Australia and it was removed from the Australian Register of Therapeutic Goods (ARTG). The ARTG is the register for all therapeutic goods that can be lawfully supplied in Australia. Sometimes a special provision is made to make available some medicines that are not listed in response to the needs of patients. To find out more visit access to therapeutic goods on the ARTG website.
- July 2013 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Zaltrap on the Pharmaceutical Benefits Scheme (PBS), on the basis of inadequate comparative efficacy and potentially worse safety resulting in an unacceptably high incremental cost-effectiveness ratio (ICER), a lack of clarity regarding the clinical place in therapy of Zaltrap, an absence of comparative data against other relevant chemotherapy regimens, and, on the basis that non-inferiority against Erbitux had not been adequately established.
- April 2013 - the Therapeutic Goods Administration (TGA) registered Zaltrap on the Australian Register of Therapeutic Goods (ARTG), in combination with irinotecan-fluoropyrimidine-based chemotherapy for the treatment of patients with metastatic bowel cancer who were previously treated with an oxaliplatin-containing regimen.
- August 2012 - the US Food and Drug Administration (FDA) approved Zaltrap in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy for treatment of patients with metastatic bowel cancer that is resistant to or has progressed following an oxaliplatin-containing regimen.
Vectibix
Currently listed on the PBS as a subsidised first- and second-line treatment for patients with metastatic bowel cancer.
- Mar 2018 - the Pharmaceutical Benefits Advisory Committee (PBAC) considered the report of the Drug Utilisation Sub-Committee which considered the predicted and actual use of targeted therapies for metastatic bowel cancer. The PBAC considered that the targeted therapies, including Vectibix, were being used largely as expected and recommended no further action.
- June 2017 - The US Food and Drug Administration (FDA) approved Vectibix for the treatment of patients with RAS wild type metastatic bowel cancer as first-line treatment, in combination with FOLFOX and as monotherapy, following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
October 2015 - Vectibix, in combination with first-line chemotherapy, was listed on the Pharmaceutical Benefits Scheme (PBS) as a subsidised treatment option for patients with RAS wild type metastatic bowel cancer.
- March 2015 - the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of Vectibix on the Pharmaceutical Benefits Scheme (PBS), for the first-line treatment of patients with RAS wild type metastatic bowel cancer on a cost- minimisation basis compared with Erbitux.
- January 2015 - he Pharmaceutical Benefits Scheme (PBS) restrictions were amended for Vectibix to include only patients with RAS wild type status rather than KRAS wild type status.
- July 2014 - to align with its TGA-approved indications, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended that the current PBS restrictions for Vectibix be amended urgently to include only patients with RAS wild type metastatic bowel cancer, in coordination with corresponding amends to the related MBS item description to extend mutation testing to cover all RAS mutations.
The Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Vectibix on the Pharmaceutical Benefits Scheme (PBS) as a first-line treatment option for patients with RAS wild type metastatic bowel cancer due to uncertain extent of incremental clinical benefit overs its comparators.
April 2014 - Vectibix as monotherapy or in combination with an irinotecan-based therapy, was listed on the Pharmaceutical Benefits Scheme (PBS) as a subsidised treatment option for patients with KRAS wild type metastatic bowel cancer after failure of first-line chemotherapy.
- March 2014 - the US Food and Drug Administration (FDA) approved Vectibix for use in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, as first-line treatment in patients with KRAS wild type metastatic bowel cancer.
- November 2013 - the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of Vectibix on the Pharmaceutical Benefits Scheme (PBS), for the later-line treatment of patients with KRAS wild type metastatic bowel cancer.
The PBAC considered that the restrictions for Vectibix should be consistent with the current restrictions for Erbitux, and include wording so that simultaneous use of Vectibix and Erbitux or switching from one agent to the other following disease progression would not be allowed, except where patients experienced intolerance necessitating permanent treatment withdrawal.
- March 2013 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Vectibix on the Pharmaceutical Benefits Scheme (PBS) as a first-line treatment option for patients with KRAS wild type metastatic bowel cancer.
- December 2011 - the Therapeutic Goods Administration (TGA) registered Vectibix on the Australian Register of Therapeutic Goods (ARTG) for the treatment of patients with epidermal growth factor receptor (EGFR) expressing KRAS wild type metastatic bowel cancer as first-line therapy in combination with FOLFOX; as second-line therapy in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan); as a monotherapy in patients after the failure of standard chemotherapy.
- November 2008 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Vectibix on the Pharmaceutical Benefits Scheme (PBS), due to uncertain clinical benefit and the resultant high and highly uncertain cost-effectiveness.
- May 2008 - the Therapeutic Goods Administration (TGA) registered Vectibix on the Australian Register of Therapeutic Goods (ARTG) for the treatment of patients with epidermal growth factor receptor (EGFR) expressing metastatic bowel cancer whose disease progressed following treatment with a fluoropyrimidine, oxaliplatin- and irinotecan-based chemotherapy.
- September 2006 - the US Food and Drug Administration (FDA) approved Vectibix following priority review for the treatment of patients with epidermal growth factor receptor (EGFR) expressing metastatic bowel cancer after disease progression on, or following treatment with chemotherapy regimens containing fluoropyrimidine-, oxaliplatin-, and irinotecan.
Erbitux
Currently listed on the PBS as a subsidised first- and second-line treatment for patients with metastatic bowel cancer.
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March 2018 - the Pharmaceutical Benefits Advisory Committee (PBAC) considered the report of the Drug Utilisation Sub-Committee which considered the predicted and actual use of targeted therapies for metastatic bowel cancer. The PBAC considered that the targeted therapies, including Erbitux, were being used largely as expected and recommended no further action.
June 2015 - Erbitux in combination with first-line chemotherapy was listed on the Pharmaceutical Benefits Scheme (PBS) as a subsidised treatment option for patients with RAS wild type metastatic bowel cancer.
- January 2015 - the Pharmaceutical Benefits Scheme (PBS) restrictions were amended for Erbitux to include only patients with RAS wild type status rather than KRAS wild type status.
- November 2014 - the Pharmaceutical Benefits Advisory Committee (PBAC) recommended extending Erbitux’s existing listing to include first-line treatment for patients with metastatic bowel cancer on a cost-minimisation basis compared with Avastin.
The PBAC considered that requested restrictions for Erbitux should include wording so that simultaneous use of Erbitux and Vectibix or switching from one agent to the other following disease progression would not be allowed,, except where patients experienced intolerance necessitating permanent treatment withdrawal.
- July 2014 - to align with its TGA-approved indications, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended that the current PBS restrictions for Erbitux be amended urgently to include only patients with RAS wild type metastatic bowel cancer, in coordination with corresponding amends to the related MBS item description to extend mutation testing to cover all RAS mutations
- May 2013 - the Therapeutic Goods Administration (TGA) registered Erbitux on the Australian Register of Therapeutic Goods (ARTG) for the treatment of patients with epidermal growth factor receptor (EGFR) expressing KRAS wild type metastatic bowel cancer, in combination with infusional 5-fluorouracil/folinic acid plus irinotecan; in combination with irinotecan in patients who are refractory to first-line chemotherapy; in first-line combination with FOLFOX; and as a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and irinotecan-based therapy.
- June 2012 - the US Food and Drug Administration (FDA) approved Erbitux in combination with FOLFIRI (irinotecan, 5-Fluorouracil, leucovorin) for the first-line treatment of patients with KRAS wild type, epidermal growth factor receptor (EGFR) expressing metastatic bowel cancer.
September 2011 - Erbitux was listed on the Pharmaceutical Benefits Scheme (PBS) as a subsidised treatment option as monotherapy, or in combination with an irinotecan-based therapy, for patients with KRAS wild type metastatic bowel cancer after failure of first-line chemotherapy.
- July 2010 - the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of Erbitux on the Pharmaceutical Benefits Scheme (PBS), for the treatment of metastatic bowel cancer in patients who meet certain criteria, on the basis of high but acceptable cost-effectiveness compared with best supportive care.
- March 2010 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Erbitux on the Pharmaceutical Benefits Scheme (PBS), due to uncertain clinical benefit and uncertain cost-effectiveness.
- July 2009 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Erbitux on the Pharmaceutical Benefits Scheme (PBS), due to high and uncertain cost-effectiveness.
- March 2009 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Erbitux on the Pharmaceutical Benefits Scheme (PBS), because of high and uncertain cost-effectiveness.
- November 2008 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Erbitux on the Pharmaceutical Benefits Scheme (PBS), because of uncertainty about the extent of clinical benefit and the resultant high and uncertain cost-effectiveness.
- October 2007 - the US Food and Drug Administration (FDA) approved Erbitux as a monotherapy for the treatment of patients with epidermal growth factor receptor (EGFR) expressing metastatic bowel cancer after failure of both irinotecan- and oxaliplatin-based chemotherapy.
- July 2006 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Erbitux on the Pharmaceutical Benefits Scheme (PBS), due to uncertain clinical benefit and unacceptable and uncertain cost-effectiveness.
- November 2005 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Erbitux on the Pharmaceutical Benefits Scheme (PBS), due to uncertain clinical benefit and unacceptable and uncertain cost-effectiveness.
- March 2005 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Erbitux on the Pharmaceutical Benefits Scheme (PBS), due to the uncertain extent of clinical benefit and the uncertain, but unfavourable, cost-effectiveness.
- February 2005 - the Therapeutic Goods Administration (TGA) registered Erbitux on the Australian Register of Therapeutic Goods (ARTG) in combination with irinotecan, or as a single agent, for the second-line treatment of patients with epidermal growth factor receptor (EGFR) expressing metastatic bowel cancer whose disease had progressed or was refractory to irinotecan based therapy.
- Febraury 2004 - the US Food and Drug Administration (FDA) approved Erbitux in combination with irinotecan, or alone, for the treatment of patients with epidermal growth factor receptor (EGFR) expressing metastatic bowel cancer.
Avastin
Avastin has been removed from the Australian Register of Therapeutic Goods (ARTG).
December 2021 - Avastin was discontinued as a treatment option for patients with metastatic bowel cancer ‘due to the lack of demand for private purchase since removal from the Pharmaceutical Benefits Scheme (PBS)' in June.
The manufacturer no longer supplies Avastin in Australia and it was removed from the Australian Register of Therapeutic Goods (ARTG). The ARTG is the register for all therapeutic goods that can be lawfully supplied in Australia. Sometimes a special provision is made to make available some medicines that are not listed in response to the needs of patients. To find out more visit access to therapeutic goods on the ARTG website.
The manufacturer no longer supplies Avastin in Australia and it was removed from the Australian Register of Therapeutic Goods (ARTG). The ARTG is the register for all therapeutic goods that can be lawfully supplied in Australia. Sometimes a special provision is made to make available some medicines that are not listed in response to the needs of patients. To find out more visit access to therapeutic goods on the ARTG website.
June 2021 - Avastin was removed from the the Pharmaceutical Benefits Scheme (PBS) by the manufacturer as a 'result of local price reductions that make the availability of Avastin unsustainable in the market' and introduction of a biosimilar brand of bevacizumab. The 'decision to withdraw has no correlation to the safety or efficacy of Avastin'.
- March 2018 - the Pharmaceutical Benefits Advisory Committee (PBAC) considered the report of the Drug Utilisation Sub-Committee which considered the predicted and actual use of targeted therapies for metastatic bowel cancer. The PBAC considered that the targeted therapies, including Avastin, were being used largely as expected and recommended no further action.
June 2015 - Avastin’s listing on the Pharmaceutical Benefits Scheme (PBS) was amended to include treatment in combination with second-line chemotherapy for patients with RAS wild type metastatic bowel cancer after failure of first-line anti-EGFR antibodies.
- November 2014 - the Pharmaceutical Benefits Advisory Committee (PBAC) recommended amending Avastin’s existing listing to include second-line treatment for patients with RAS wild type metastatic bowel cancer after failure of first-line anti-EGFR antibodies.
July 2009 - Avastin was listed on the Pharmaceutical Benefits Scheme (PBS) as a subsidised treatment option, in combination with first-line chemotherapy, for patients with previously untreated metastatic bowel cancer. Avastin was also listed as a continuing PBS-subsidised treatment, in combination with first-line chemotherapy, for patients who previously received PBS-subsidised treatment with Avastin and did not have progressive disease.
- July 2008 - the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of Avastin on the Pharmaceutical Benefits Scheme (PBS), on the basis of high, but acceptable cost-effectiveness.
- March 2008 - the Pharmaceutical Benefits Advisory Committee (PBAC) rejected the listing of Avastin on the Pharmaceutical Benefits Scheme (PBS), on the grounds of a high cost effectiveness ratio in the first-line population and high and uncertain cost-effectiveness in the second-line population.
- February 2005 - the Therapeutic Goods Administration (TGA) registered Avastin on the Australian Register of Therapeutic Goods (ARTG), in combination with fluoropyrimidine-based chemotherapy, for the treatment of patients with metastatic bowel cancer.
- February 2004 - the US Food and Drug Administration (FDA) approved Avastin, in combination with intravenous 5-fluorouracil-based chemotherapy, for the first- and second-line treatment of patients with metastatic bowel cancer.
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