For COPD patients the PBS is to remove the clinical criteria restricting access to patients with a FEV1 <50% of predicted for triple therapy Trelegy (fluticasone furoate with umeclidinium and vilanterol) from 1 March 2020.
The move is expected to allow more than 16,000 patients per year to access triple therapy. It follows a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) in March 2019, which concluded that triple therapy provided a significant improvement in efficacy over dual therapy (LAMA/LABA) for some patients with COPD.
The PBAC said the removal of the FEV1 threshold from the clinical criteria would be consistent with recent amendments to the GOLD guidelines, and “reflect current evidence indicating that FEV1 lacks precision to be used clinically as a predictor of exacerbations or mortality in patients with COPD.”
It also noted that history of previous exacerbations is regarded as the best predictor of future COPD episodes.
And in other PBS changes, more patients with lung cancer will gain access to immunotherapy from 1 March 2020 via listings for durvalumab and atezolizumab
Durvalumab (Imfinzi, AstraZeneca) will be listed for the first time for treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
More than 1,300 patients per year are expected to benefit from the listing of the anti PD-L1 immune checkpoint inhibitor therapy, which would cost more $100,000 per course of treatment without a subsidy.
Atezolizumab (Tecentriq, Roche) will be have its PBS listing expanded to include first-line treatment of patients with extensive-stage small cell lung cancer (SCLC) in combination with a platinum-based chemotherapy and etoposide.
Around 1,000 patients per year are expected to benefit from this listing. Without PBS subsidy, patients might otherwise pay more than $50,900 per course of treatment.
The listing follow recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) in November 2019.