PembrolizumabKeytruda
Treatment of unresectable advanced and metastatic cancers, excluding adjuvant, neoadjuvant, or perioperative settings, and excluding tumours known to be unresponsive to PD-1 inhibitors.
Decisions on record
- Meeting Mar 2026 Noted Gastroesophageal cancers no PSD
- Meeting Dec 2025 Recommended Advanced and metastatic cancers
- Meeting Nov 2025 Recommended Head and neck squamous cell carcinoma – neoadjuvant and adjuvant treatment of resectable locally advanced HNSCC
- Meeting Jul 2025 Not recommended Primary advanced or recurrent dMMR endometrial cancer
- Meeting Jul 2025 Not recommended Unresectable advanced and metastatic cancer (broad listing proposal)
- Meeting Mar 2025 Recommended High-risk locally advanced cervical cancer (LACC)
- Meeting Nov 2024 Recommended Renal cell carcinoma at intermediate-high or high risk of recurrence
- Meeting Jul 2024 Noted Advanced or metastatic gastro-oesophageal cancers no PSD
48 earlier decisions
- Dec 2023 Deferred Multiple indications with current or future TGA registration no PSD
- Nov 2023 Recommended Metastatic or locally advanced cutaneous squamous cell carcinoma (not curable by surgery/radiation)
- Jul 2023 Recommended Early stage triple negative breast cancer (eTNBC)
- May 2023 Recommended Adjuvant treatment of resected Stage IIIB, IIIC or IIID melanoma no PSD
- Mar 2023 Recommended Breast cancer; locally recurrent unresectable or metastatic triple negative breast cancer
- Mar 2023 Noted Endometrial cancer; advanced endometrial cancer
- Mar 2023 Not recommended Breast cancer; early stage triple negative breast cancer
- Nov 2022 Recommended Persistent, recurrent or metastatic (Stage IVB) cervical cancer
- Nov 2022 Not recommended Locally advanced or metastatic (Stage III or IV) urothelial cancer
- Jul 2022 Recommended Urothelial cancer, colorectal cancer, primary mediastinal B-cell lymphoma, classical Hodgkin lymphoma
- May 2022 Recommended Gastro-oesophageal cancers, advanced or metastatic, first line with chemotherapy no PSD
- Mar 2022 Recommended Squamous cell carcinoma of the head and neck
- Mar 2022 Recommended Endometrial cancer
- Mar 2022 Recommended Renal cell carcinoma
- Mar 2022 Deferred Oesophageal carcinoma or HER-2-negative gastroesophageal junction adenocarcinoma
- Nov 2021 Deferred Squamous cell carcinoma of the head and neck (SCCHN)
- Nov 2021 Not recommended Oesophageal/gastro-oesophageal junction cancer
- Mar 2021 Recommended First-line metastatic dMMR colorectal cancer
- Nov 2020 Not recommended Squamous cell carcinoma of the head and neck (SCCHN)
- Mar 2020 Recommended Melanoma
- Mar 2020 Recommended Melanoma Non-small cell lung cancer (NSCLC)
- Mar 2020 Recommended Primary mediastinal B- cell lymphoma (PMBCL)
- Mar 2020 Recommended Melanoma
- Nov 2019 Deferred Melanoma
- Aug 2019 Noted Non-small cell lung cancer (NSCLC)
- Jul 2019 Recommended Non-small cell lung cancer (NSCLC)
- Jul 2019 Not recommended PEMBROLIZUMAB is indicated for use in Melanoma:
- Mar 2019 Not recommended Metastatic colorectal carcinoma (CRC)
- Mar 2019 Noted First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) expressing PD-L1 TPS>50%.
- Nov 2018 Recommended Melanoma
- Nov 2018 Not recommended Melanoma
- Nov 2018 Not recommended Non-small cell lung cancer (NSCLC)
- Nov 2018 Not recommended Primary mediastinal B- cell lymphoma (PMBCL)
- Jul 2018 Recommended First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC)
- Jul 2018 Recommended Locally advanced or metastatic urothelial cancer (LA or mUC)
- Jul 2018 Not recommended Squamous cell carcinoma for the head and neck (SCCHN)
- Mar 2018 Recommended Melanoma
- Mar 2018 Deferred First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC)
- Nov 2017 Not recommended Locally advanced or metastatic urothelial cancer (LA or mUC)
- Nov 2017 Deferred First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC)
- Aug 2017 Recommended Classical Hodgkin's lymphoma
- Jul 2017 Deferred Classical Hodgkin's lymphoma
- Mar 2017 Not recommended Non-small cell lung cancer
- Nov 2016 Recommended Melanoma
- Nov 2016 Not recommended Non-small cell lung cancer (NSCLC)
- Nov 2016 Not recommended Pembrolizumab is indicated for the treatment of unresectable or metastatic melanoma in adults.
- Mar 2016 Not recommended Melanoma
- Mar 2015 Recommended Melanoma
Access path
- TGA registered · Keytruda
- Mar 2015Recommended · restricted
vs ipilimumab
- Mar 2016Not recommended
- ↻ resubmittedNov 2016Recommended
Evidence: RCT → Cost-minimisation
- Nov 2016Not recommended
Evidence: RCT → Cost-minimisation
- Nov 2016Not recommended
Evidence: RCT → Cost-minimisation
- Mar 2017Not recommended
Comparator changed: docetaxel (squamous NSCLC) and pemetrexed (non-squamous NSCLC) →…
- ↻ resubmittedJul 2017Recommended · restricted
Comparator changed: platinum-based doublet chemotherapy → brentuximab vedotin
- Aug 2017Recommended · restricted
- Nov 2017Deferred
Comparator changed: brentuximab vedotin → platinum-based doublet chemotherapy
- Nov 2017Not recommended
Comparator changed: brentuximab vedotin → platinum-based doublet chemotherapy
- ↻ resubmittedMar 2018Recommended
Evidence: RCT → Other
- Mar 2018Deferred
Evidence: RCT → Other
- Jul 2018Recommended · restricted
Listing: Restricted → Authority Required
- Jul 2018Not recommended
Listing: Restricted → Authority Required
- ↻ resubmittedJul 2018Recommended · restricted
Listing: Restricted → Authority Required
- Nov 2018Not recommended
Comparator changed: standard of care (paclitaxel or docetaxel) → observation (placebo)
- Nov 2018Not recommended
Comparator changed: standard of care (paclitaxel or docetaxel) → observation (placebo)
- Nov 2018Not recommended
Comparator changed: standard of care (paclitaxel or docetaxel) → observation (placebo)
- ↻ resubmittedNov 2018Recommended · restricted
Comparator changed: standard of care (paclitaxel or docetaxel) → observation (placebo)
- Mar 2019Noted
Evidence: Other → Single-arm
- Mar 2019Noted
Evidence: Other → Single-arm
- Jul 2019Not recommended
Comparator changed: platinum-based chemotherapy → placebo
- ↻ resubmittedJul 2019Recommended · restricted
Comparator changed: platinum-based chemotherapy → placebo
- Aug 2019Recommended · restricted
Listing: Authority Required → Restricted
- Nov 2019Deferred
Listing: Restricted → Authority Required
- Mar 2020Recommended
Comparator changed: nivolumab and dabrafenib + trametinib → 200 mg every three weeks flat…
- Mar 2020Recommended · restricted
Comparator changed: nivolumab and dabrafenib + trametinib → 200 mg every three weeks flat…
- Mar 2020Recommended
Comparator changed: nivolumab and dabrafenib + trametinib → 200 mg every three weeks flat…
- Mar 2020Recommended
Comparator changed: nivolumab and dabrafenib + trametinib → 200 mg every three weeks flat…
- Nov 2020Recommended · restricted
Comparator changed: Chemotherapy regimens such as ICE, GDP or DHAP with or without…
- Mar 2021Recommended · restricted
Comparator changed: first-line platinum + 5-FU chemotherapy followed by second-line…
- Nov 2021Not recommended
Comparator changed: Standard of care (FOLFOX, cetuximab + FOLFOX, bevacizumab + FOLFOX) →…
- Nov 2021Deferred
Comparator changed: Standard of care (FOLFOX, cetuximab + FOLFOX, bevacizumab + FOLFOX) →…
- Mar 2022Recommended
Comparator changed: platinum-based chemotherapy (carboplatin or cisplatin) and…
- Mar 2022Recommended · restricted
Comparator changed: platinum-based chemotherapy (carboplatin or cisplatin) and…
- Mar 2022Not recommended
High and moderately uncertain ICER at the proposed price, despite demonstrated clinically meaningful improvement in…
- ↻ resubmittedMay 2022Recommended
Comparator changed: cisplatin + 5-FU → cisplatin + 5-fluorouracil (5-FU)
- Jul 2022Recommended
Comparator changed: cisplatin + 5-fluorouracil (5-FU) → pembrolizumab 200 mg every 3 weeks
- Nov 2022Recommended · restricted
Comparator changed: pembrolizumab 200 mg every 3 weeks → chemotherapy (paclitaxel and…
- Nov 2022Noted
Comparator changed: pembrolizumab 200 mg every 3 weeks → chemotherapy (paclitaxel and…
- Mar 2023Not recommended
Comparator changed: Standard of care (chemotherapy) → standard chemotherapy (neoadjuvant…
- ↻ resubmittedMar 2023Recommended · restricted
Comparator changed: Standard of care (chemotherapy) → standard chemotherapy (neoadjuvant…
- Mar 2023Recommended · restricted
Comparator changed: Standard of care (chemotherapy) → standard chemotherapy (neoadjuvant…
- Jul 2023Recommended · restricted
Comparator changed: current standard chemotherapy regimens (taxane-based monotherapy or…
- Nov 2023Recommended · restricted
Comparator changed: Standard chemotherapy guided by physician for the neoadjuvant phase…
- Nov 2024Recommended
Comparator changed: cemiplimab → surveillance
- Mar 2025Recommended · restricted
Comparator changed: surveillance → concurrent chemoradiotherapy (CCRT) alone
- Jul 2025Not recommended
- Jul 2025Not recommended
- ↻ resubmittedNov 2025Recommended · restricted
Comparator changed: dostarlimab (dMMR population); platinum-based chemotherapy alone…
- Dec 2025Recommended
Evidence: RCT → Cost-minimisation
- PBS listing · Authority Required
From the public summary
9.1 The PBAC recommended under section 101(3) of the Act, a change to the circumstances under which pembrolizumab is made available as a pharmaceutical benefit under Part VII of the Act to expand its use for advanced and metastatic cancers. The PBAC is satisfied that the extended listing will provide, for some patients, a significant improvement in efficacy over alternate therapies (or watchful waiting).PSD · Dec 2025
9.2 The PBAC welcomed the revised approach to the restriction criteria and noted this had largely addressed its concerns from the July 2025 submission, particularly regarding access for patients with rare cancers. The PBAC recalled it had recommended nivolumab ± ipilimumab for a broad listing for advanced and metastatic cancers in September 2025.PSD · Dec 2025
6.40 The submission presented a stepped economic evaluation for the use of PEM+SoC for the treatment of LA HNSCC based on the direct, randomised KN689 trial that compared PEM+SoC to SoC alone.PSD · Nov 2025
6.41 The key components of the economic evaluation are summarised in Table 9. 19 OFFICIALPSD · Nov 2025
6.35 The submission described PEM+SoC as superior in terms of efficacy and inferior but manageable in terms of safety compared to SoC alone.PSD · Nov 2025
6.36 The ESC considered that the claim of superior efficacy of PEM+SoC compared with SoC was partially supported by the evidence presented in the submission and considered that the magnitude of clinical benefit had been overestimated for the following reasons:PSD · Nov 2025
6.3 The PBAC noted the advice received from Head and Neck Cancer Australia and Rare Cancers Australia supporting the PBS listing of pembrolizumab for the perioperative treatment of patients with resectable LA HNSCC.PSD · Nov 2025
Rare Cancers Australia noted that further treatment options may help to reduce the invasiveness of current procedures, ultimately enhancing patients' quality of life.PSD · Nov 2025
Cost-effectiveness
No ICER calculated; this is a broad multi-indication listing proposal with risk-sharing arrangement rather than a traditional cost-effectiveness analysis.
the PBAC considered the model provided did not provide sufficient clarity as to the inputs and underlying assumptions driving the outputs and that this difficulty in verifying the outputs of the financial model meant it was not reliable for decision making. PBAC · 2025
Decision context
PopulationAdults with unresectable advanced or metastatic cancers (across multiple cancer types including NSCLC, melanoma, urothelial cancer, colorectal cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, Hodgkin lymphoma, and others), excluding adjuvant, neoadjuvant, or perioperative settings and tumours known to be unresponsive to PD-1 inhibitors.
Risk sharingTwo-tier risk-sharing arrangement (RSA) with tiered subsidisation caps. Tier 1 covers current PBS-listed indications and two PBAC-recommended but not yet implemented indications at effective price. Tier 2 applies a consolidated rebate for expanded use including future indications, retreatment, use beyond 2 years, and rare cancers.
Why it was knocked back
- Not recommended at July 2025 meeting; proposal did not establish reliable basis for financial estimates. The PBAC considered the financial model lacked sufficient clarity on inputs and underlying assumptions, and outputs could not be adequately verified. Model did not include required elements such as offset medicines, patient copayments, Services Australia impacts, and MBS administration costs impacts.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Dec 2025 | Recommended | — | — | Cost-minimisation |
| Nov 2025 | Recommended · restricted | standard of care (adjuvant radiotherapy with or without chemotherapy) | — | RCT · EFS |
| Jul 2025 | Not recommended | — | — | RCT |
| Jul 2025 | Not recommended | dostarlimab (dMMR population); platinum-based chemotherapy alone followed by pembrolizumab + lenvatinib (pMMR population | — | RCT · PFS |
| Mar 2025 | Recommended · restricted | concurrent chemoradiotherapy (CCRT) alone | — | RCT · PFS |
| Nov 2024 | Recommended | surveillance | — | RCT · DFS |
| Nov 2023 | Recommended · restricted | cemiplimab | — | Single-arm · ORR |
| Jul 2023 | Recommended · restricted | Standard chemotherapy guided by physician for the neoadjuvant phase, and placebo in the adjuvant phase | $35k–45k | RCT · Pathological complete response (pCR), event-free survival (EFS), overall survival (OS) |
| Mar 2023 | Not recommended | standard chemotherapy (neoadjuvant phase) and placebo (adjuvant phase) | — | RCT · pCR, EFS, OS |
| Mar 2023 | Recommended · restricted | chemotherapy (doxorubicin or paclitaxel); dostarlimab in dMMR subgroup | — | RCT · OS |
| Mar 2023 | Recommended · restricted | current standard chemotherapy regimens (taxane-based monotherapy or carboplatin + gemcitabine) | — | RCT · OS |
| Nov 2022 | Recommended · restricted | chemotherapy (paclitaxel and platinum compound [cisplatin or carboplatin]) with or without bevacizumab | — | RCT · OS |
| Nov 2022 | Noted | Standard of care (chemotherapy) | — | RCT · OS |
| Jul 2022 | Recommended | pembrolizumab 200 mg every 3 weeks | — | Other · Other |
| May 2022 | Recommended | cisplatin + 5-fluorouracil (5-FU) | — | RCT · OS |
| Mar 2022 | Recommended | First-line platinum-based chemotherapy (carboplatin or cisplatin with 5-fluorouracil), followed by second-line nivolumab | — | RCT · OS |
| Mar 2022 | Recommended · restricted | nivolumab in combination with ipilimumab (NIVO+IPI) | — | RCT · OS |
| Mar 2022 | Not recommended | cisplatin + 5-FU | — | RCT · PFS, OS |
| Nov 2021 | Not recommended | Cisplatin plus 5-fluorouracil (5-FU) | — | RCT · OS |
| Nov 2021 | Deferred | platinum-based chemotherapy (carboplatin or cisplatin) and 5-fluorouracil followed by second-line nivolumab in 50% of pa | — | RCT · OS |
| Mar 2021 | Recommended · restricted | Standard of care (FOLFOX, cetuximab + FOLFOX, bevacizumab + FOLFOX) | — | RCT · OS |
| Nov 2020 | Recommended · restricted | first-line platinum + 5-FU chemotherapy followed by second-line nivolumab in 66.7% of patients | — | RCT · OS |
| Mar 2020 | Recommended | 200 mg every three weeks flat dosing regimen | — | Other · Other |
| Mar 2020 | Recommended · restricted | nivolumab monotherapy | — | RCT · OS |
| Mar 2020 | Recommended | nivolumab | — | RCT · Surrogate |
| Mar 2020 | Recommended | Chemotherapy regimens such as ICE, GDP or DHAP with or without rituximab | — | RCT · ORR |
| Nov 2019 | Deferred | nivolumab and dabrafenib + trametinib | — | RCT · RFS |
| Aug 2019 | Recommended · restricted | — | — | RCT · OS |
| Jul 2019 | Not recommended | placebo | — | RCT · PFS |
| Jul 2019 | Recommended · restricted | For PD-L1 TPS <50%: platinum doublet chemotherapy followed by PD-(L)1 inhibitors. For PD-L1 TPS ≥50%: pembrolizumab mono | — | RCT · OS |
| Mar 2019 | Noted | FOLFIRI, cetuximab + FOLFIRI, bevacizumab + FOLFIRI | — | Single-arm · ORR |
| Mar 2019 | Noted | platinum-based chemotherapy | $45k–75k | RCT · OS |
| Nov 2018 | Not recommended | observation (placebo) | — | RCT · PFS |
| Nov 2018 | Not recommended | For PD-L1 TPS <50%: platinum doublet chemotherapy followed by PD-(L)1 inhibitor. For PD-L1 TPS ≥50%: pembrolizumab monot | — | RCT · OS |
| Nov 2018 | Not recommended | standard of care (SOC) chemotherapy regimens (ICE, GDP, DHAP) | — | Single-arm · ORR |
| Nov 2018 | Recommended · restricted | — | — | Other |
| Jul 2018 | Recommended · restricted | platinum-based doublet chemotherapy | — | RCT · OS |
| Jul 2018 | Not recommended | nivolumab | — | RCT · OS |
| Jul 2018 | Recommended · restricted | standard of care (paclitaxel or docetaxel) | — | RCT · OS |
| Mar 2018 | Recommended | — | — | Other |
| Mar 2018 | Deferred | platinum-based doublet chemotherapy | — | RCT · OS |
| Nov 2017 | Deferred | platinum-based doublet chemotherapy | — | RCT · PFS |
| Nov 2017 | Not recommended | standard of care (SOC): paclitaxel and docetaxel | — | RCT · OS |
| Aug 2017 | Recommended · restricted | brentuximab vedotin | — | Single-arm · ORR |
| Jul 2017 | Recommended · restricted | brentuximab vedotin | — | Single-arm · OS |
| Mar 2017 | Not recommended | platinum-based doublet chemotherapy | — | RCT · OS |
| Nov 2016 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Nov 2016 | Not recommended | ipilimumab | — | RCT · OS | PFS |
| Nov 2016 | Not recommended | docetaxel (squamous NSCLC) and pemetrexed (non-squamous NSCLC) | — | RCT · OS |
| Mar 2016 | Not recommended | ipilimumab | $45k–75k | RCT · OS | PFS |
| Mar 2015 | Recommended · restricted | ipilimumab | — | RCT · ORR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| KN-407 | Ph 3 | 559 | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumor… | completed |
| KEYNOTE-826 | Ph 3 | 617 | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1… | completed |
| KN-006 | Ph 3 | 834 | Progression-free Survival (PFS) According to Response Evaluation Criteria In Solid Tumors … | completed |
| KN-522 | Ph 3 | 1,174 | Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no … | completed |
| KN775 | Ph 3 | 827 | Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1… | completed |
| KN158 | Ph 2 | 1,609 | Objective Response Rate (ORR) | active not recruiting |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| PD-L1 immunohistochemistry testing for NSCLC | PD-L1 expression (tumour proportion score ≥50%) | not supported | 2017 |
| PD-L1 immunohistochemistry testing (22C3 antibody) for head and neck squamous cell carcinoma | PD-L1 expression (combined positive score ≥1) | not supported | 2020 |
| PD-L1 immunohistochemistry testing for triple negative breast cancer | PD-L1 Combined Positive Score (CPS) ≥10 | supported | 2023 |
Consumer voice
Consumer input from individuals, healthcare professionals, and organisations supported PBS listing of pembrolizumab for resectable LA HNSCC, highlighting the serious complications of current surgical and radiation treatments and the clinical need for additional treatment options to improve quality of life and reduce recurrence.
surgical resection and radiation can often lead to serious complications, including severe disfigurement, loss of vision, and impairments in the ability to swallow, speak, eat, or drink, profoundly affecting both the physical and mental wellbeing of patients. Consumer comments · PSD