Government funds medicine for approximately 10,000 eligible Australians with certain advanced or metastatic cancers

Ethical Strategies on behalf of MSD Australia & New Zealand

Cancer patients, advocates, and doctors are joining MSD in welcoming a milestone decision by the Federal Government to provide subsidised access to KEYTRUDA® (pembrolizumab) for over 10,000 newly eligible Australians over the next four years, with certain advanced and metastatic cancers.¹

From 1 September 2026, the cost of KEYTRUDA will be subsidised through the Pharmaceutical Benefits Scheme (PBS) for eligible Australians whose cancer cannot be surgically removed and is known to be sensitive to immunotherapy.¹This means eligible patients, including those with rare or less common cancers with limited treatment options, will pay just $7.70 (concession) or $25.00 (general patients) for each infusion of KEYTRUDA treatment.²

Immunotherapies like KEYTRUDA harness the body’s immune system to tackle cancer cells.³ KEYTRUDA is registered on the Australian Register of Therapeutic Goods (ARTG 263932) for 29 advanced and metastatic indications,⁴ across different cancer types, only 13 were previously PBS-funded.⁵

Until now, access to KEYTRUDA through the PBS has depended on separate assessments for each cancer indication. Under this new listing, the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that clinicians use their clinical judgement, guided by the best available clinical evidence, to determine whether KEYTRUDA treatment is suitable for a person living with immunotherapy-sensitive advanced or metastatic cancer.⁶

This PBS listing coincides with the registration for KEYTRUDA in certain patients with chemotherapy-resistant ovarian cancer.⁴This will allow immediate funded access for approximately 80 eligible women¹ with advanced or metastatic ovarian cancer – without the typical delay for medicines between a ARTG registration and PBS listing of 466 days.⁷

Associate Professor Sumitra Ananda, Medical Oncologist at the Peter MacCallum Cancer Centre and Epworth HealthCare, says oncologists and patients have advocated for a new approach to immunotherapy funding for many years.

“This is an important moment that may expand immunotherapy access for thousands of Australians and give doctors the discretion to make appropriate evidence-based treatment decisions,” says Associate Professor Ananda.

“Today’s announcement will help make this immunotherapy treatment option more affordable and potentially remove the financial burden that patients with advanced or metastatic cancer may face.”

Chifumi Umeda, Managing Director, MSD Australia & New Zealand, commended the Federal Government on its support of cancer treatment funding reform.

“MSD has spent a decade working with the cancer community to arrive at this important day. It has been a long and winding road, but the result is affordable and equitable access to this immunotherapy for eligible Australians. We are thankful to Minister Butler for his support and stewardship in this funding in Australia,” says Chifumi Umeda.

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About advanced and metastatic cancer. Advanced cancer is a term used to describe cancer that has spread, or returned after treatment, and is unlikely to be cured.⁸

About rare and less common cancer. Rare cancers is a term which encompasses both rare and less common cancers.⁹ A rare cancer is defined as an incidence of less than six per 100,000 Australians per annum.⁹ A less common cancer is defined as one that has between 6 and 12 incidences per year per 100,000 population.⁹ It is estimated that 42,000 people are diagnosed with a form of rare or less common cancer in Australia every year.⁹

The new PBS listing applies to KEYTRUDA component of the following registered indications:¹^,⁴

KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of unresectable or metastatic melanoma in adults.
KEYTRUDA® (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumour aberrations.
KEYTRUDA® (pembrolizumab), in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the first-line treatment of patients with NSCLC expressing PD-L1 [tumour proportion score (TPS) ≥1%] as determined 1 by a validated test, with no EGFR or ALK genomic tumour aberrations, and is: stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of patients with advanced NSCLC whose tumours express PD-L1 with a ≥1% TPS as determined by a validated test and who have received platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have received prior therapy for these aberrations prior to receiving KEYTRUDA.
KEYTRUDA® (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
KEYTRUDA® (pembrolizumab), as monotherapy or in combination with platinum and 5 fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of patients with metastatic or unresectable recurrent HNSCC, and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.
KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of patients with metastatic or unresectable recurrent HNSCC with disease progression on or after platinum containing chemotherapy and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.
KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of adult and paediatric patients with relapsed or refractory classical Hodgkin Lymphoma (cHL):
1. following autologous stem cell transplant (ASCT) or
2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.
KEYTRUDA® (pembrolizumab) is indicated for the treatment of adult and paediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.
KEYTRUDA® (pembrolizumab), in combination with enfortumab vedotin, is indicated for the first-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC).
KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum containing chemotherapy.
KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemotherapy.
KEYTRUDA® (pembrolizumab) is indicated for the treatment of adult and paediatric patients with unresectable or metastatic solid tumours that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer, as determined by a validated test, that have progressed following prior treatment and when there are no satisfactory alternative treatment options.
KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic colorectal cancer (CRC) that is MSI-H or dMMR as determined by a validated test.
KEYTRUDA® (pembrolizumab), in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC).
KEYTRUDA® (pembrolizumab), in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
KEYTRUDA® (pembrolizumab), in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
KEYTRUDA® (pembrolizumab), as monotherapy, is indicated for the treatment of adult and adolescent (12 years and older) patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
KEYTRUDA® (pembrolizumab), in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
KEYTRUDA® in combination with (lenvatinib) is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
KEYTRUDA® (pembrolizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GOJ) adenocarcinoma that is not HER2-positive.
KEYTRUDA® (pembrolizumab), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GOJ) adenocarcinoma, whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.
KEYTRUDA® (pembrolizumab), in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced or metastatic carcinoma of the oesophagus or HER2-negative gastroesophageal junction (GOJ) adenocarcinoma (tumour centre 1 to 5 centimetres above the GOJ) that is not amenable to surgical resection or definitive chemoradiation.
KEYTRUDA® (pembrolizumab) is indicated for the treatment of adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication was approved via the provisional approval pathway, based on the pooling of data on objective response rate and response duration across multiple different tissue types in a single-arm trial. The assumption that TMB-H status is predictive of the treatment effect of KEYTRUDA for every tissue type has not been verified. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.
KEYTRUDA® (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (CPS ≥10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease.
KEYTRUDA® (pembrolizumab), in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express PD-L1 (CPS≥1) as determined by a validated test, and who have received one or two prior systemic treatment regimens.

KEYTRUDA® (pembrolizumab) Minimum Consumer Medicine Information.³

KEYTRUDA contains the active ingredient pembrolizumab. KEYTRUDA is a medicine that may treat certain cancers by working with the immune system. KEYTRUDA may be given in combination with other anticancer medicines. Not everybody is suitable to have KEYTRUDA as a treatment for their cancer. If you have any questions about these specific medicines, please ask your doctor. Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them. KEYTRUDA can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. Sometimes these problems can become severe or life-threatening and can lead to death. More than one side effect can occur at the same time, and side effects can arise at any time during treatment and even after the treatment has ended. These can include immune system problems affecting: the lungs; intestines; liver, kidneys; skin, hormone glands (especially thyroid, pituitary, and adrenal glands) and blood sugar levels. Infusion reactions can sometimes be severe and life-threatening. Rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic) can occur. Very common side effects include diarrhoea, hair loss, vomiting, decreased appetite, swelling of the lining of the digestive system (for example mouth, intestines), mouth sores, constipation, elevated liver enzymes, decrease in red blood cell count and decrease in platelets, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain, decreased sodium levels in the blood, fever, infections of the upper respiratory tract, low levels of thyroid hormone, a decreased number of white blood cells (which are important in fighting infection) in patients with primary mediastinal B-cell lymphoma. These are not the only side effects that occur with KEYTRUDA. Before using KEYTRUDA, a doctor will check if a person with cancer has an autoimmune disease (a condition where the body attacks its own cells) like Crohn's, ulcerative colitis, or lupus; had an organ transplant (like a kidney transplant) or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of the lungs (called pneumonitis); have liver damage. If you already have an autoimmune disease, the risk of side effects may be higher. If you are pregnant or plan to become pregnant, tell your health care provider as KEYTRUDA can cause harm or death to your unborn baby. Effective birth control must be used during treatment and for at least 4 months after the last dose of KEYTRUDA. Tell your health care provider if you are breastfeeding or intend to breastfeed. Do not breastfeed while taking KEYTRUDA. Tell your doctor or pharmacist if you are taking any other medicines, vitamins, or supplements, particularly medicines that can make your immune system weak such as steroids.

For further information read the KEYTRUDA Consumer Medicine Information available at https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-CMI- 01513-1&d=20231101172310101. Patients should discuss their treatment options with their doctor.

PBS Indications: KEYTRUDA^® (pembrolizumab) is listed on the Pharmaceutical Benefits Scheme for certain types of cancer. Further criteria apply. Consult the Pharmaceutical Benefits Scheme at www.pbs.gov.au for full information.

‒ENDS‒

Merck Sharp & Dohme (Australia) Pty Limited. Level 1, Building A, 26 Talavera Road, Macquarie Park NSW 2113. AU-KEY-01664v1 Issued September 2026

References:

[1] Australian Government. Department of Health, Disability, and Ageing. Schedule of Pharmaceutical Benefits. https://www.pbs.gov.au/pbs/ Accessed September 2026

[2] Australian Government. Department of Health, Disability, and Ageing. Schedule of Pharmaceutical Benefits. https://www.health.gov.au/cheaper-medicines/pbs-co-payments?language=en.%20Accessed%20March%202026

[3] KEYTRUDA (pembrolizumab). Consumer medicine information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-CMI- 01513-1&d=20231101172310101 Accessed July 2026

[4] KEYTRUDA (pembrolizumab). Product information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-PI-01512-1&d=20260323172310101 Accessed September 2026

[5] Department of Health, Disability, and Ageing. Department of Health, Disability and Ageing. Pharmaceutical Benefits Scheme. Pembrolizumab, Code & Prescriber item numbers https://www.pbs.gov.au/medicine/item/10424p-10436g-10475h-10493g-11330h-11352l- 11492w-11494y-11632f-11646y-12119w-12120x-12121y-12122b-12123c-12124d-12125e-12126f-12127g- 12128h-12129j-12130k Accessed August 2025

[6] Department of Health, Disability and Ageing. Pharmaceutical Benefits Advisory Committee Meeting December 2025 Outcomes. https://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac- outcomes 30 January 2026

[7] Medicines Matter 2022 Australia’s Access to Medicines 2016-2021 https://www.medicinesaustralia.com.au/wp-content/uploads/sites/65/2023/04/Medicines-Matter-2022-FINAL.pdf Accessed August 2026

[8] Cancer Council. Advanced Cancer Treatment. https://www.cancer.org.au/cancer-information/screening-tests-and-treatments/treatment/advanced-cancer-treatment#what-is-advanced-cancer Accessed August 2026

[9] Rare Cancers Australia. What is a rare cancer. https://www.rarecancers.org.au/the-reality-of-rare/what-is-a-rare-cancer/ Accessed August 2026

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