Lung Cancer Advocacy: Bridging the Gap Between Clinical Trials and Real-World Patient Care
Research advances in lung cancer only improve outcomes when they are translated into evidence-based treatments accessible to all patients, regardless of where they live or whether a clinical trial is available. At Thoracic Oncology Group Australasia (TOGA), we drive change in lung cancer care by advocating through targeted stakeholder submissions. Guided by our mission to prevent, treat and cure thoracic cancers through research, clinical trials, education and advocacy, TOGA ensures that every Australian can benefit from new thoracic cancer therapies, identifying where
- clinical evidence is strong,
- patient need is high,
- policy change can make the greatest difference.
This is the purpose of TOGA’s submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), which directly influence access to new lung cancer therapies in Australia.
TOGA’s Role in Translating Research
At TOGA, our lung cancer advocacy focuses on turning research breakthroughs from clinical trials into tangible improvements in patient care. This requires ongoing engagement with regulatory and reimbursement processes.
TOGA monitors emerging clinical evidence and identifies gaps where patient access is limited.
Submissions to the PBAC are guided by both patient need and robust research evidence.
By translating research into actionable policy, access to new treatments, and offering quality education events, TOGA helps ensure clinicians have the latest evidence at their fingertips to guide decision-making.
Through evidence-based advocacy, TOGA supports clinicians in offering the best possible outcomes for all Australians living with lung cancer.
How PBAC Submissions Provide Access to Equitable Lung Cancer Care
Reimbursement through the Pharmaceutical Benefits Scheme (PBS) is the essential final step that turns research discoveries into accessible patient care. TOGA contributes by supporting PBAC submissions where the evidence shows clear clinical value and an unmet need. These submissions represent targeted, evidence-based advocacy in lung cancer — designed to bridge the gap between discovery, approval, and equitable access.
The PBAC meets three times a year, usually in March, July and November. In a submission for PBS listing the sponsor of the medicines provides the PBAC with detailed clinical and economic information in support of their submission. PBAC publishes its main meeting agenda 15 weeks before each meeting, which includes the list of submissions it will consider. Consultation on these submissions is open for 8 weeks.
Anybody can make a submission to support a PBAC application. View current PBAC consultations for new lung cancer treatments.
Supported Applications to Improve Access to New Lung Cancer Treatments in Australia
In 2025, TOGA made submissions for the following PBAC applications, guided by independent review of high-quality evidence and the critical role that access would fulfil in continued provision of quality and equitable lung cancer care.
Treatment | Indication | Clinical Need | Outcome | Evidence | |
|---|---|---|---|---|---|
Ipilimumab / Nivolumab | Metastatic & unresectable NSCLC | Overcame the “once-in-a-lifetime” PBS restriction, enabling flexible delivery of the full 35-cycle course and supporting real-world evidence generation. | Approved | Checkmate 9LA
Checkmate 227
| |
Osimertinib | Locally advanced EGFR+ NSCLC (post-CRT) | No effective maintenance therapy; EGFR+ NSCLC does not benefit from checkpoint inhibitors. | Approved | LAURA | |
Encorafenib + Binimetinib | BRAF V600E metastatic NSCLC | No targeted therapy previously available; poor outcomes with chemotherapy. | Approved | PHAROS | |
Lurbinectedin | Extensive-stage SCLC | IMforte study showed addition to maintenance atezolizumab improved PFS & OS. | Approved | IMforte | |
Repotrectinib | ROS1+ NSCLC (including G2032R mutation) | Addresses acquired resistance, offers an additional option for 1L treatment and offers intracranial activity. | Approved | TRIDENT-1 | |
Osimertinib with chemotherapy | Metastatic EGFR+ NSCLC | Combination with chemotherapy led to significantly longer EFS and OS compared to treatment with osimertinib monotherapy | Approved | FLAURA-2 |
Evidence-Based Advocacy Lifts Immunotherapy Restrictions for Metastatic NSCLC
TOGA’s evidence-based advocacy to overcome once in a lifetime immunotherapy restriction included conducting a summit of all stakeholders in 2023, direct letters to PBAC, and support of the eventual ipilimumab/nivolumab submission to PBAC.
The recent approval of PBS-reimbursed ipilimumab/nivolumab for all metastatic and unresectable cancers, according to clinician judgement of best available clinical evidence, enables rechallenge with immunotherapy beyond two years of commencement of treatment. This allows the option to cease and resume immunotherapy treatment, which may be appropriate with some side effects of treatment. A future similar expansion in PBS reimbursement criteria for pembroluzimab will allow patients to receive the full evidence-based course of up to 35 cycles, even if treatment extends beyond 2 years due to temporary interruptions or toxicity management.
You can learn more about this expanded access to immunotherapy treatment in the announcement by Minister for Health and Ageing, The Hon Mark Butler MP. Hear from TOGA clinicians in two podcasts;
Key benefits of the change:
Patients can safely receive the full therapeutic benefit from extended treatment while maintaining tolerability.
Patients who have received immunotherapy for treatment of early-stage NSCLC and subsequently relapsed can be treated with ipilimumab/nivolumab if the treating clinician is comfortable with available evidence
Clinicians will be able to manage temporary treatment holds and rechallenge strategies without compromising therapy duration.
Supports real-world evidence generation to inform optimal dosing, scheduling, and clinical guidelines.
PBS policy alignment with international lung cancer clinical guidelines
For more information on the relevant clinical trials, review CHECKMATE 9LA and CHECKMATE 227
To understand more about the different mechanisms of action of ipilimumab, compared to pembroluzimab and nivolumab, read our news post on Lung Cancer Immunotherapy: Why It Doesn’t Always Work and What’s Next in Clinical Trials
Adjuvant Alectinib
ALK+ NSCLC is a type of lung cancer that has benefitted from genomic testing and precision medicine, with identification of molecular and newer therapies enabling people with ALK+ metastatic NSCLC to live for many years. TOGA welcomes the addition of PBS-reimbursed alectinib as a treatment after surgery for people with ALK+ NSCLC, based on the highly successful ALINA clinical trial.
For more information on the relevant clinical trials, hear TOGA’s Prof Ben Solomon describe the ALINA clinical trial at the ESMO 2023 congress, and the CROWN clinical trial at the ESMO 2020 congress.
We are also pleased that after advocacy by various stakeholders, patients are able to access up to 3 years of adjuvant alectinib in early-stage NSCLC, with no effect on ALK TKI access should they relapse to metastatic disease.
Advocacy ensures that advances in research translate into real-world improvements in care. By engaging with processes like PBAC submissions, TOGA helps ensure new therapies reach the people who need them most.
How do I Find Out if the PBAC Submission was Successful?
Outcomes from PBAC meetings are listed 6 weeks after the meeting. Public summary documents can provide you with more details about the submission and the decision made by PBAC. It is not uncommon for further questions to be clarified before approval.
The new medicine is not immediately available on the PBS after the PBAC approval. A commonly cited statistic is that in 2018, it took on average 420 days until the medicine was available on the PBS.
In response to feedback from stakeholders, the Health Technology Assessment (HTA) system, which is the system to approve new medicines on the PBS and Medicare in Australia, has undergone a review. See the outcomes and recommendations of the HTA review.
