With significant input from members and advocates, Lung Foundation Australia made a number of submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) for the considerations at the March meeting.
We are pleased by the positive recommendations to list new medicines and increase access to current medicines. This helps Australians living with lung cancer access the right medicines at the right time, and at low cost; greatly improving quality of life and health outcomes.
The outcomes from the March meeting are below.
Entrectinib has now been approved for listing on the Pharmaceutical Benefits Scheme (PBS) following considerations at the March PBAC meeting. A request was made for the listing of entrectinib for the treatment of locally advanced (Stage IIIB) or metastatic (Stage IV) c-ros proto-oncogene 1 (ROS1)-positive non-squamous or not otherwise specified (NOS) non-small cell lung cancer (NSCLC).
Lung Foundation Australia, with its members and supporters, supported the listing of entrectinib on the PBS for patients with ROS1-positive NSCLC, highlighting the benefits of targeted treatment with entrectinib, including prolonged survival, improved quality of life, reduced hospital visits due to more tolerable side effects compared to chemotherapy, potential activity against central nervous system metastases. Lung Foundation Australia supported the listing of entrectinib on the PBS, as an alternative treatment option for patients with ROS1-positive NSCLC, particularly for patients who are unsuitable or intolerant to crizotinib. Lung Foundation patient advocates contributed detailed and persuasive evidence to the submission.
The PBAC recommended the Authority Required listing of entrectinib as monotherapy for the treatment of patients with locally advanced (Stage IIIB) or metastatic (Stage IV) c-ros proto-oncogene 1 (ROS1)-positive non-squamous or not otherwise specified (NOS) non-small cell lung cancer (NSCLC). The PBAC’s recommendation for listing was based on, among other matters, its assessment, that the cost-effectiveness of entrectinib would be acceptable if it were cost-minimised against crizotinib.
The PBAC considered there was a clinical need for alternative treatment options for patients with ROS1-positive NSCLC, particularly for patients who are unsuitable or intolerant to crizotinib.
The PBAC considered it would be appropriate to restrict entrectinib to ROS1 inhibitor naïve patients and patients who have developed intolerance to a ROS1-inhibitor given the evidence indicating a lack of response in patients who received previous treatment with a ROS1 inhibitor (see paragraph 3.3). The PBAC noted there would also need to be flow-on restriction changes to the current listing for crizotinib to restrict use to patients who have not received treatment with a ROS1 inhibitor or patients who have experienced intolerance to previous treatment with a ROS1 inhibitor.
Updates to existing or recommended listings:
A minor submission has been made requesting the addition of a 400 mg every six weeks (Q6W) flat dosing regimen to the current 200 mg every three weeks (Q3W) flat dosing regimen.
Lung Foundation Australia supported the submission on the basis that the less frequent dosing option would provide greater flexibility and reduced burden for patient.
The PBAC recommended the addition of the 400 mg Q6W flat dosing regimen to the existing 200 mg Q3W flat dosing regimen for all existing and recommended pembrolizumab PBS listings for melanoma and non-small cell lung cancer (NSCLC) indications where pembrolizumab monotherapy is used.
The PBAC also considered it would be appropriate to restrict initial treatment for NSCLC with the 400 mg Q6W dosing regimen to a maximum of 4 doses to restrict treatment to a maximum of 24 weeks, noting the existing listing for Stage IV (metastatic) NSCLC allows for a maximum of 21 weeks treatment under the initial treatment restriction.
The PBAC advised that continuing treatment for Stage IV (metastatic) NSCLC and grandfathering treatment for Stage IV (metastatic) NSCLC with the 400 mg Q6W dosing regimen should be restricted to a total of 18 cycles or up to 24 months.
A minor submission was made requesting extending the November 2019 PBAC recommendation for a new form of atezolizumab (840 mg/14 mL injection) and additional 1680 mg every 4 weeks (Q4W) dosing regimen to include the treatment of previously untreated patients with extensive stage small cell lung cancer (1L ES-SCLC) when atezolizumab monotherapy is used for continuing treatment.
Lung Foundation Australia supported the submission as the less frequent dosing option would provide greater flexibility and reduce any burden on patients associated with treatment, especially for patients in rural and remote areas.
The PBAC recommended extending its November 2019 recommendation for the 840 mg in 14 mL injection of atezolizumab and the addition of the 1680 mg Q4W flat dosing regimen to include the treatment of previously untreated patients with extensive stage small cell lung cancer (1L ES-SCLC) where atezolizumab monotherapy is used for continuing treatment.
The PBAC considered that 3 repeats for continuing treatment, which would provide 16 weeks of therapy under a Q4W dosing regimen, would be appropriate.
The PBAC considered that additional grandfathering provisions for the 1680 mg Q4W dosing regimen would not be required as any 1L ES-SCLC grandfathered patients could be prescribed the 1680 mg Q4W dosing regimen under the continuing treatment restriction following PBS subsidised treatment under the existing grandfather restriction for 1L ES-SCLC.
We look forward to updating you on the timelines of new listings as further details come to light.