RipretinibQINLOCK
Recommended OncologyAuthority RequiredLater-line line 💬 consumer voice
Advanced gastrointestinal stromal tumour (GIST) after failure of or intolerance to imatinib and sunitinib.
2
Submissions
1 resub
2021–21
On the record
$95k–115k
ICER range
1 sourced ICER · 2021
ICER stated
Cost basis
Decisions on record
- Meeting Jul 2021 Recommended Gastrointestinal stromal tumour
- Meeting Mar 2021 Not recommended Advanced gastrointestinal stromal tumour
Access path
- TGA registered · QINLOCK
TGA label narrower than the PBS population
- Mar 2021Not recommended
vs best supportive care
- ↻ resubmittedJul 2021Recommended · restricted
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended the Authority Required (immediate/real-time assessment) listing of ripretinib for treatment of advanced gastrointestinal stromal tumour (GIST).PSD · Jul 2021
The resubmission provided a revised price and financial estimates in response to previous concerns raised by the PBAC. In addition, the resubmission included updated survival data from the key clinical trial.PSD · Jul 2021
Economic analysis
4.7 In the key trial (INVICTUS), 65.9% (29/44) of patients in the BSC arm crossed over to receive ripretinib after progression. At the March 2021 meeting the PBAC noted the cost-utility analysis presented assumed that these patients would receive treatment with ripretinib post progression. The PBAC agreed with the ESC that the assumption that patients in the BSC arm would receive post progression ripretinib was incorrect and strongly favoured ripretinib.PSD · Jul 2021
4.8 The March 2021 pre-PBAC response indicated a willingness to reduce the price of ripretinib with the extent of the reduction considered acceptable to the sponsor not quantified. At that time the PBAC acknowledged the sensitivity analysis as presented in paragraph 4.7 potentially underestimated the benefit of ripretinib due to use of the ITT OS results without adjustment for the 65.9% (29/44) of patients in the BSC arm receiving ripretinib.PSD · Jul 2021
Clinical claim
responses compared with placebo/BSC, along with significant improvements in PFS and prolongation of OS. Ripretinib offers an acceptable safety profile and maintains HRQoL.PSD · Jul 2021
Source: Table 1.1, p6 of the resubmission. BSC: best supportive care; GIST: gastrointestinal stromal tumours; HRQoL: health-related quality of life; ORR: objective response rate; OS: overall survival; PFS: progression-free survival; TTP: time to progression. For more detail on PBAC’s view, see section 5 PBAC outcome.PSD · Jul 2021
Consumer comments
4.2 The PBAC noted and welcomed the input from individuals (3), health care professionals (4) and organisations (2) via the Consumer Comments facility on the PBS website. The comments from individuals as well as those from the GIST Community Patient Submission described the fear and anxiety associated with not having additional GIST treatment options once progression occurs.PSD · Jul 2021
4.3 The Medical Oncology Group of Australia (MOGA) also expressed its strong support for the ripretinib submission, categorising it as one of the therapies of “high priority for PBS listing” on the basis of the INVICTUS trial.PSD · Jul 2021
Cost-effectiveness
ICER is stated in redacted form; the ranges are provided in footnotes to Table 4 and Table 1.
In the base case analysis, ripretinib generates 0.86 incremental QALYs and $75,000 to < $95,000 incremental costs over a seven year time horizon compared with BSC, resulting in an ICER of $95,000 to < $115,000/QALY gained. PSD · 2021
Decision context
PopulationPatients with advanced unresectable or metastatic GIST who have progressed or are intolerant to imatinib and sunitinib.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2021 | Recommended · restricted | Best Supportive Care | $95k–115k | RCT · PFS |
| Mar 2021 | Not recommended | best supportive care | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| INVICTUS | Ph 3 | 129 | Progression-Free Survival (PFS) | completed |
| NCT02571036 | Ph 1 | 282 | Safety/tolerability of oral DCC-2618: incidence of adverse events | completed |
Consumer voice
Consumer input from 3 individuals, 4 health care professionals, and 2 organisations described fear and anxiety about lacking additional GIST treatment options after disease progression, highlighted the impact on typically younger patients and their families, and noted benefits of ripretinib including disease control and maintenance of quality of life.
The comments from individuals as well as those from the GIST Community Patient Submission described the fear and anxiety associated with not having additional GIST treatment options once progression occurs. Consumer comments · PSD
unmet needanxiety and fearquality of lifetreatment burden on familydisease progression
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to 2+ prior kinase inhibitors (imatinib and sunitinib); TGA label permits 3+ prior kinase inhibitors.