PanitumumabVectibix
First-line treatment of RAS wild-type metastatic colorectal cancer in combination with oxaliplatin-based chemotherapy.
Decisions on record
- Meeting Mar 2015 Recommended Metastatic colorectal cancer
- Meeting Jul 2014 Recommended 100 mg/5 mL injection, 1 x 5 mL vial 400 mg/20 mL injection, 1 x 20 mL vial Vectibix® Amgen Australia Pty Ltd Change to listing (Major submission) Metastatic colorectal cancer (mCRC) 1. Request to modify the existing later-line metastatic colorectal cancer (mCRC) panitumumab listing from eligibility
- Meeting Nov 2013 Recommended Vectibix® Amgen Australia Pty Ltd Major submission Metastatic colorectal cancer Resubmission to request Section 100 (Efficient Funding of Chemotherapy) Authority Required (STREAMLINED) listings for the treatment of KRAS wild-type metastatic colorectal cancer in patients who have failed first-line ch
- Meeting Nov 2008 Not recommended Monoclonal antibody
Access path
- TGA registered · Vectibix
TGA label narrower than the PBS population
- Nov 2008Recommended
vs best supportive care
- Mar 2013Recommended
Comparator changed: best supportive care → Cetuximab (later-line setting); FOLFOX alone…
- Nov 2013Recommended · restricted
Comparator changed: Cetuximab (later-line setting); FOLFOX alone (first-line setting) →…
- Jul 2014Recommended
Comparator changed: cetuximab → FOLFOX chemotherapy alone and bevacizumab + FOLFOX
- Mar 2015Recommended
Comparator changed: FOLFOX chemotherapy alone and bevacizumab + FOLFOX → cetuximab
- PBS listing · Restricted
From the public summary
The PBAC recommended the first-line listing of panitumumab, for the treatment of RAS wild-type metastatic colorectal cancer, on the basis of cost minimisation with cetuximab. The equi-effective doses are panitumumab 6 mg/kg every two weeks and cetuximab 250 mg/m2 weekly, following an initial loading dose of 400 mg/m2. 3PSD · Mar 2015
The PBAC noted that, as a result, this listing would be cost neutral to the Commonwealth.PSD · Mar 2015
6.21 The re-submission presents modelled cost-utility analyses in RAS WT mCRC for comparisons of first-line panitumumab + FOLFOX with (1) bevacizumab + FOLFOX, (2) FOLFOX alone, and (3) a weighted combination of these comparators. This is consistent with the claims of superiority presented in the clinical evidence.PSD · Jul 2014
6.22 The re-submission did not present an economic evaluation of the other request in the re-submission to change the PBS eligibility criteria for panitumumab from KRAS WT to RAS WT. The ESC advised that such an evaluation would result in dominance for RAS WT because this would reduce the proportion of existing patients receiving additional panitumumab resulting in inferior health outcomes, and the increased costs of RAS testing would be outweighed by the …PSD · Jul 2014
6.19 For the first-line RAS WT mCRC population, the re-submission describes panitumumab + FOLFOX as: superior in terms of comparative effectiveness and with “a different safety profile” compared to bevacizumab + FOLFOX; and superior in terms of comparative effectiveness and which “adds a manageable level of toxicity” (or otherwise inferior in terms of comparative safety) over FOLFOX alone. 11PSD · Jul 2014
6.20 Each description about comparative effectiveness is supported by the respective randomised trial, however the addition of panitumumab to FOLFOX appears to have an inferior safety profile compared with the addition of bevacizumab to FOLFOX or compared with FOLFOX alone.PSD · Jul 2014
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
The PBAC noted that, as a result, this listing would be cost neutral to the Commonwealth. PBAC · 2015
Decision context
PopulationAdults with RAS wild-type metastatic colorectal cancer, WHO performance status 2 or less, previously untreated, receiving first-line oxaliplatin-based chemotherapy
Risk sharingPanitumumab to join the same risk share arrangement as cetuximab and bevacizumab in the first-line setting
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2015 | Recommended | cetuximab | — | Cost-minimisation · Cost-minimisation |
| Jul 2014 | Recommended | FOLFOX chemotherapy alone and bevacizumab + FOLFOX | $94k | RCT · PFS |
| Nov 2013 | Recommended · restricted | cetuximab | — | RCT · OS |
| Mar 2013 | Recommended | Cetuximab (later-line setting); FOLFOX alone (first-line setting) | — | RCT · PFS | OS |
| Nov 2008 | Recommended | best supportive care | $45k–75k | RCT · PFS |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| KRAS mutation testing for panitumumab | KRAS mutation status | supported | 2013 |
| RAS (KRAS and NRAS) mutation testing | RAS (KRAS and NRAS) mutations | supported | 2014 |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to first-line only and specifies WHO performance status ≤2; TGA label includes both first-line and second-line indications.