Nivolumab plus Ipilimumab for first-line Stage IV clear cell variant renal cell carcinoma, October 2021
Page last updated: 24 March 2022
Drug utilisation sub-committee (DUSC)
October 2021
Abstract
Purpose
To compare the predicted and actual utilisation of nivolumab + ipilimumab for the first-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 + Ipilimumab was PBS listed on 1 March 2019 for the first-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 2021 Q2 there were 1,579 patients receiving PBS treatment for RCC, of these 472 received 2nd line nivolumab. The second most common treatment is first-line nivolumab, with 312 patients being treated in 2021 Q2.
- For ipilimumab, in both Years 1 and 2 after listing there were slightly more patients than predicted. However there were slightly less prescriptions than predicted because the prescriptions per patient were less than predicted. This can be explained by the estimates assuming that all patients will complete the induction phase (i.e. 4 prescriptions). Figure 9 shows that 38% of patients received less than the full course of 4 ipilimumab scripts.
- For nivolumab in the first line setting, there were 32% and 67% more patients than expected in Years 1 and 2 respectively. In Year 1 there were more nivolumab patients (442) than ipilimumab patients (395). This can be explained by the results of the drug initiation sequence analysis (Table 4) which shows that over the period from the listing of first-line nivolumab (1 March 2019) to the end of June 2021 there were 91 patients that were supplied only first-line nivolumab (maintenance phase) prescriptions. This pattern of use was outside the PBS restrictions. Some of these may have been grandfathering patients who failed to be allocated the specific PBS item code for such patients. In Year 2 an additional factor that could explain the more than expected number of patients was the presence of continuing patients from Year 1. These had not been factored into the estimates.
- For nivolumab, there were 75% and 76% less scripts per patient than expected in Years 1 and 2 respectively. This is mainly due to the overestimation of the average length of treatment in the submissions and final agreed estimates. A second factor is the shift from 2 to 4 weekly dosing after the 1 September 2019 restriction change. A third factor was the incorrect use of PBS item codes where some patients who initiate first-line nivolumab + ipilimumab treatment used 2nd line nivolumab treatment items for their first-line maintenance treatment (see Table 4).
