Epoetin LambdaNovicrit
Recommended HaematologyRestrictedNot applicable line
Anaemia associated with intrinsic renal disease (chronic renal failure) during correction and maintenance therapy phases.
3
Submissions
1 resub
2010–17
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2017 Recommended Anaemia associated with intrinsic renal disease
- Meeting Jul 2010 Recommended Anaemia
Access path
- TGA registered · Novicrit
TGA label equal than the PBS population
- Jul 2010Recommended · restricted
Listing: Restricted | Authority Required → Authority Required
- Jul 2010Recommended · restricted
Listing: Restricted | Authority Required → Authority Required
- Jul 2017Recommended
Comparator changed: epoetin alfa → epoetin alpha (cost-minimisation basis)
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended the amendment of the existing restriction of epoetin lambda to remove the note ‘Epoetin lambda should only be administered by the intravenous route’ to allow for subcutaneous administration for the treatment of anaemia associated with intrinsic renal disease.PSD · Jul 2017
5.2 The PBAC recalled that the note was previously based on information in the TGA approved Product Information, at the time of listing, which has since been updated to indicate that epoetin lambda can be administered subcutaneously where intravenous access is not readily available.PSD · Jul 2017
Economic analysis
4.3 As a minor submission requesting a restriction change, an economic comparison was not relevant.PSD · Jul 2017
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as this was a minor submission requesting a restriction change only.
As a minor submission requesting a restriction change, an economic comparison was not relevant. PBAC · 2017
Decision context
PopulationPatients with symptomatic or transfusion-requiring anaemia associated with chronic renal failure.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Recommended | epoetin alpha (cost-minimisation basis) | — | Cost-minimisation · Cost-minimisation |
| Jul 2010 | Recommended · restricted | epoetin alfa | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
| Jul 2010 | Recommended · restricted | epoetin alfa | — | RCT · Hb_change |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify symptomatic or transfusion-requiring anaemia in chronic renal failure during correction and maintenance phases.