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PanitumumabVectibix

Recommended OncologyRestrictedFirst-line line

First-line treatment of RAS wild-type metastatic colorectal cancer in combination with oxaliplatin-based chemotherapy.

5
Submissions
4 resub
2008–15
On the record
$45k–75k
ICER range
2 sourced ICERs · 2008–2014
Cost-min
Cost basis
risk sharing

Decisions on record

4 decisions
  • 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

5 submissions · public record
  1. TGA registered · Vectibix

    TGA label narrower than the PBS population

  2. Nov 2008
    Recommended

    vs best supportive care

  3. Mar 2013
    Recommended

    Comparator changed: best supportive care → Cetuximab (later-line setting); FOLFOX alone…

  4. Nov 2013
    Recommended · restricted

    Comparator changed: Cetuximab (later-line setting); FOLFOX alone (first-line setting) →…

  5. Jul 2014
    Recommended

    Comparator changed: cetuximab → FOLFOX chemotherapy alone and bevacizumab + FOLFOX

  6. Mar 2015
    Recommended

    Comparator changed: FOLFOX chemotherapy alone and bevacizumab + FOLFOX → cetuximab

  7. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
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
Economic analysis
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
Clinical claim
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

2 sourced ICERs · 2008–2014

Cost-minimisation analysis; no ICER calculated

The PBAC noted that, as a result, this listing would be cost neutral to the Commonwealth. PBAC · 2015
ICER uncertain ×2ICER / price too highEconomic model disputedImmature survival dataSurrogate endpointCost-effectiveness accepted ×2

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

5 entries
DecidedOutcomeComparatorICEREvidence
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

MSAC
ServiceBiomarkerMSAC outcomeYear
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

By decision profile

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.