DabrafenibTafinlar
Recommended OncologyAuthority RequiredFirst-line line
Treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.
2
Submissions
1 resub
2013–13
On the record
$45k–105k
ICER range
2 sourced ICERs · 2013
ICER stated
Cost basis
risk sharing
Decisions on record
- Meeting Jul 2019 Recommended Melanoma
- Meeting Mar 2019 Deferred Melanoma
- Meeting Nov 2015 Recommended Melanoma
- Meeting Jul 2013 Recommended Melanoma
Access path
- TGA registered · Tafinlar
TGA label narrower than the PBS population
- Mar 2013Recommended
vs dacarbazine (DTIC)
- Jul 2013Recommended
ICER dropped $105,000 → $75,000 (-29%)
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
The resulting new incremental cost per QALY gained was between $45,000 to $75,000, which the PBAC considered to be acceptable. PBAC · 2013
ICER uncertainEconomic model disputedCost-effectiveness accepted
Decision context
PopulationPatients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma who are previously untreated.
Risk sharingA risk-sharing arrangement was proposed to deal with the financial risk of use of dabrafenib beyond progression through a cap.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Recommended | — | $45k–75k | RCT |
| Mar 2013 | Recommended | dacarbazine (DTIC) | $75k–105k | RCT · PFS |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| BRAF V600 mutation testing in melanoma | BRAF V600 mutation status | deferred | 2013 |
| BRAF V600 testing in Stage III melanoma | BRAF V600 mutation | supported | 2019 |
| BRAF mutation test for metastatic melanoma | BRAF V600 mutation | supported | 2018 |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to previously untreated patients (first-line), while TGA label permits any BRAF V600 positive unresectable Stage IIIC or metastatic melanoma regardless of prior treatment.