Australians with a rare form of bowel cancer will have access to KEYTRUDA® (pembrolizumab) on the PBS from 1 August 2021
July 20, 2021 10:29 am Australia/Sydney
Approximately 300 Australians diagnosed with a specific type of bowel cancer each year[1] will have access to immuno-oncology therapy KEYTRUDA on the Pharmaceutical Benefits Scheme (PBS) from 1 August 2021.
MSD announced today that its cancer treatment KEYTRUDA will be listed on the PBS for the first-line monotherapy treatment of patients with a type of bowel cancer – unresectable (a tumour that cannot be removed by surgery[2]) or metastatic (cancer that has spread to an area outside the colon/rectum[3]) colorectal cancer that have a specific alteration (known as a biomarker) called deficient mismatch repair (dMMR), as determined by a validated test[4]. The presence of a biomarker can help clinicians select patients that are suitable for treatment, rather than apply a “one size fits all” approach to treatment.[5]
KEYTRUDA is a cancer immunotherapy that works to reactivate the immune system to attack tumour cells by blocking a cancer cell protein (known as programmed death receptor 1 or PD-1) which, if left unchecked, allows cancer cells to pass undetected by the body’s natural defences[6].
An estimated 15,000 Australian patients will be diagnosed with bowel cancer each year[7] – the fourth most commonly diagnosed cancer in Australia6; and in 2020, there were an estimated 5300 deaths from bowel cancer in Australia6 – making bowel cancer the second leading cause of cancer death in Australia6. Risk factors may include age (over 50), diet, obesity, family history, smoking, alcohol, inflammatory bowel disease and polyps[8].
A small number of bowel cancers have a biomarker, deficient mismatch repair (dMMR), which helps in identifying patients that may be suitable for treatment with immuno-oncology therapies such as KEYTRUDA[9]. This biomarker may also provide information on the likely course of disease in an untreated patient with bowel cancer. Testing for this biomarker in bowel cancer is already standard practice in Australia but there were previously no PBS funded treatment options that matched this specific biomarker for metastatic colorectal cancer patients, until now.[10][4]
Julien Wiggins, CEO Bowel Cancer Australia, welcomed the availability of KEYTRUDA on the PBS for this subset of bowel cancer patients:
“This PBS listing of KEYTRUDA is the first immunotherapy to be subsidised for bowel cancer patients living with this rare subtype of bowel cancer. No longer will patients and their families be faced with the decision of whether to go into debt to fund this treatment, or to decline it.”
Julien Wiggins, CEO Bowel Cancer Australia
Professor Peter Gibbs, from Western Health in Melbourne, specialises in treating patients with bowel cancer and welcomed today’s news:
“Approximately 300 Australians diagnosed with this type of bowel cancer per year will be eligible to receive this immuno-oncology treatment on the PBS.”
“This is the first subsidised immuno-oncology treatment option for patients with this type of bowel cancer. As a clinician, it is often challenging to present treatment options to patients that may be financially out of reach, therefore it is important news for patients and clinicians alike that this treatment is now on the PBS,”
Professor Peter Gibbs, Medical Oncologist & Clinical Researcher
Ms Anna Morris, 34 years old from Melbourne, was diagnosed with metastatic bowel cancer at the age of 28: “My cancer diagnosis came as a shock as I had no relevant clinical history. I was only diagnosed with bowel cancer after being treated for a blood clot in my arm, which was due to the cancer already spreading to another part of my body.
“After biomarker testing, the results showed that immuno-oncology therapy was a treatment option for me. With the financial support of my family, I was able to access KEYTRUDA but I know that isn’t always an option for some patients. I am excited to hear that certain metastatic bowel cancer patients now have subsidised access to this immuno-oncology treatment.”
Ms Glenys Seymour, 70 years old from Sale in Victoria, received KEYTRUDA for dMMR metastatic bowel cancer through a clinical trial run by Professor Peter Gibbs at Western Health. “I was diagnosed with Stage 4 bowel cancer just six weeks after my husband passed away from mesothelioma. After exploring a variety of different treatment options with the clinicians looking after me, it was determined that for my type of bowel cancer, chemotherapy was not going to work. My son then asked if I was eligible to go on a clinical trial for any new treatment options.
“My son asked the right question at the right time and I was lucky enough to be able to join a clinical trial. Now that KEYTRUDA is on the PBS, patients facing this diagnosis in the future don’t have to rely on luck, like I did, to access this treatment option.”
MSD Managing Director for Australia and New Zealand, Mr Michael Azrak, said this latest PBS listing for KEYTRUDA is important news for eligible Australian bowel cancer patients, their loved ones, their carers, and their treating clinicians.
“This PBS listing of KEYTRUDA is the therapy’s 10th subsidy in Australia[4]. I continue to be humbled by the impact PBS listings have on the lives of Australians. MSD will continue to work hard to ensure eligible Australian patients with cancer have subsidised access to an immuno-oncology treatment option.
I would like to thank the Minister for Health and Aged Care, the Honourable Greg Hunt MP for listing this treatment option on the PBS for eligible bowel cancer patients. Providing patients with timely and affordable access to medicines through the PBS is what motivates me and each of my colleagues at MSD.
This PBS listing was announced approximately 230 days after KEYTRUDA was registered for this indication by the Therapeutic Goods Administration (TGA). Some new medicines in Australia can take up to 410 days from registration to be listed on the PBS[11], however this listing indicates that registration to reimbursement timelines for new medicines in Australia can be accelerated. We are committed to working with the Australian Government to continue to get medicines to patients sooner through the PBS”
Michael Azrak, MSD Managing Director, Australia & New Zealand
KEYTRUDA Selected Safety Information
Immune-mediated adverse reactions, including severe and fatal cases have occurred in patients receiving KEYTRUDA. These have included but are not limited to: pneumonitis, colitis, hepatitis, nephritis, adrenal insufficiency, hypophysitis, type 1 diabetes mellitus including diabetic ketoacidosis, thyroid disorders including hyperthyroidism, hypothyroidism and thyroiditis, uveitis, myositis, Guillain-Barre syndrome, pancreatitis, encephalitis, sarcoidosis, myasthenic syndrome/myasthenia gravis (including exacerbation), myelitis, vasculitis, myocarditis, pericarditis, pericardial effusion, peripheral neuropathy, sclerosing cholangitis, severe skin reactions (SJS, TEN and bullous pemphigoid), solid organ transplant rejection and severe infusion reactions (hypersensitivity, anaphylaxis). Refer to PI for full list.
Immune mediated AEs have occurred after discontinuation of KEYTRUDA, may affect more than one body system and can occur simultaneously.
The safety of KEYTRUDA was evaluated in 2799 patients with unresectable or metastatic melanoma or metastatic NSCLC in controlled and uncontrolled studies. The most common treatment-related SAEs were: pneumonitis, colitis, diarrhoea, and pyrexia. The most common treatment-related adverse reactions (reported in >10% of patients) were: fatigue, pruritus, rash, diarrhoea, and nausea.
Adverse events occurring in patients with MSI-H/dMMR cancer including previously untreated CRC, were generally similar to those occurring in patients with melanoma or NSCLC.
For further information, refer to the Product Information
Based on PI approved May 2021.
Refer to the Consumer Medical Information leaflet, or your doctor or pharmacist for further information about KEYTRUDA.
PBS Information: Authority required (STREAMLINED) or Authority required. This product is not listed on the PBS for certain indications. Refer to the PBS Schedule for full authority information
Note to Editor: Professor Peter Gibbs has been involved in clinical trials sponsored by MSD. He has received honoraria as a member of advisory boards for MSD. In relation to this media announcement, no compensation was provided to Professor Peter Gibbs and the opinions expressed is his own. Professor Peter Gibbs has been briefed by MSD on the approved use of this product.
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References
[1] MSD data on file.
[2] https://www.merriam-webster.com/dictionary/unresectable Accessed 29.04.21
[3] https://www.cancer.gov/publications/dictionaries/cancer-terms/def/late-stage-cancer Accessed 8.06.21
[4] Pharmaceutical Benefits Advisory Committee (PBAC) Meeting Outcomes, March 2021 PBAC meeting, Published 23.4.21
[5] Cancer Biomarkers in Australia, Forward, Prof Ian Olver, Prof Doug Brooks, Prof Adrian Esterman, Sansom Institute for Health Research University of South Australia 2019
[6] MSD Australia. Approved KEYTRUDA Product Information. May 2021
[7] AIHW https://ncci.canceraustralia.gov.au/diagnosis/cancer-incidence/cancer-incidence Accessed 22.10.2020
[8] Cancer Council Australia Understanding Bowel Cancer 2019 https://www.cancer.org.au/assets/pdf/understanding-bowel-cancer-booklet Accessed 7.12.2020
[9] Lee V, Murphy A, Le DT, Diaz LA Jr. Mismatch Repair Deficiency and Response to Immune Checkpoint Blockade. Oncologist. 2016 Oct;21(10):1200-1211. doi: 10.1634/theoncologist.2016-0046. Epub 2016 Jul 13. PMID: 27412392; PMCID: PMC5061538.
[10] A review of the current testing methodologies for the detection of mismatch repair deficiency in tumours. Dr P Scott August2019 http://www.msac.gov.au/internet/msac/publishing.nsf/Content/9C7DCF1C2DD56CB ECA25801000123C32/$File/Review%20paper%202020-01-13.pdf
[11] Medicines Australia. 2018. Comparison of Access and Reimbursement Environments: A report benchmarking Australia’s access to new medicines: Edition 4.