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Alectinib, Crizotinib, Ceritinib

Recommended · restricted OncologyAuthority Required

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) positive for ALK gene rearrangement (alectinib, crizotinib, ceritinib) or ROS1-positive (crizotinib).

1
Submissions
1 resub
2019–19
On the record
ICER range
Not modelled
Cost basis

Access path

1 submission · public record
  1. Nov 2019
    Recommended · restricted
  2. PBS listing · Authority Required
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
4.1 The PBAC recommended an increase in the number of repeats for the Authority Required listings for alectinib and crizotinib for Stage IIIB (locally advanced) or Stage IV (metastatic) NSCLC from 1 to 3. The PBAC noted that this change would be consistent with the current listing for erlotinib.PSD · Nov 2019
4.2 The PBAC also considered that the change should apply to all ALK inhibitors including ceritinib for Stage IIIB (locally advanced) or Stage IV (metastatic) NSCLC.PSD · Nov 2019

Cost-effectiveness

Not a clinical or economic evaluation submission. This is a procedural request to amend the number of repeats for already-listed medicines; no ICER calculated or applicable.

Decision context

PopulationPatients with Stage IIIB (locally advanced) or Stage IV (metastatic) NSCLC with ALK gene rearrangement (alectinib, crizotinib, ceritinib) or ROS1-positive disease (crizotinib).

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Nov 2019 Recommended · restricted Other

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