Nivolumab for the treatment of renal cell carcinoma: 24 month predicted versus actual analysis

Page last updated: 13 November 2020

Drug utilisation sub-committee (DUSC)

June 2020

Abstract

Purpose

To compare the predicted and actual utilisation of nivolumab for the second line treatment of renal cell carcinoma (RCC) in the first 24 months of Pharmaceutical Benefits Scheme (PBS) listing.

Date of listing on the Pharmaceutical Benefits Scheme (PBS)

Nivolumab was PBS listed on 1 August 2017 for the 2nd line treatment of Stage IV clear cell variant renal cell carcinoma.

Data Source / methodology

Data were extracted from the Services Australia Supplied Prescription database for all PBS items that have an RCC restriction. The Services Australia Authority Approvals database was used to determine the treatment indication when the PBS item code was not indication specific.

Key Findings

  • Second line nivolumab is the most common PBS treatment for RCC. In 2019 Q4 there were 1,493 patients receiving PBS treatment for RCC, of these 463 received 2nd line nivolumab.
  • In both Year 1 and 2 after listing there was approximately 50% more patients than predicted. However there were less prescriptions than predicted because the prescriptions per patient were approximately half that predicted.
  • 18.4% of patients appear to have not used a TKI before initiation of 2nd line nivolumab. This is outside the PBS restriction which requires a patient to fail prior TKI treatment.
  • The most common treatment switch for patients who had 2nd line RCC treatment is from nivolumab to cabozantinib.
  • The median and mean length of treatment (including breaks and date of death (DoD) adjustment) with 2nd line nivolumab was 5.6 and 9.9 months respectively. This is consistent with predicted mean and median of 5.54 and 9.52 months respectively.
  • The date of death analysis revealed that 42.0% of patients that had 2nd line nivolumab treatment had died by the end of the analysis period (31/12/2019).  71.8% of patients were deemed to have stopped treatment by the end of the analysis period, of these 9.9% had died on treatment, 48.6% had stopped treatment before death and 41.4% had stopped treatment and were still alive.
  • The majority of patients (55%) that died had their last nivolumab prescription within the last 3 fortnights (infusions are generally fortnightly) before death. This may indicate that some patients were treated beyond disease progression, which is outside the PBS restriction.
  • The median overall survival from the start of 2nd line nivolumab treatment was 1.69 years (20.3 months) and the mean was 1.47 years (17.6 months).

Full Report