LipegfilgrastimLonquex
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy.
Decision on record
- Meeting Mar 2016 Recommended Neutropenia
Access path
- TGA registered · Lonquex
TGA label narrower than the PBS population
- Mar 2016Recommended · restricted
vs pegfilgrastim
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended an Authority Required listing of lipegfilgrastim under Section 100 (Highly Specialised Drugs Program) for prophylaxis of chemotherapy induced neutropenia. The recommendation was made on a cost-minimisation basis with filgrastim where the equi-effective doses are lipegfilgrastim 6 mg once per chemotherapy cycle, pegfilgrastim 6 mg once per chemotherapy cycle and filgrastim injection 5 microgram/kg/day for 11.25 days.PSD · Mar 2016
7.2 The PBAC noted that the submission’s nominated comparator, pegfilgrastim, would be the agent most likely to be substituted. However, the PBAC considered that there would also be some substitution for filgrastim, and that filgrastim is therefore also a relevant comparator. The PBAC recalled that pegfilgrastim was listed on a cost- minimisation basis with filgrastim.PSD · Mar 2016
6.18 The equi-effective doses are estimated as lipegfilgrastim 6 mg once per chemotherapy cycle and pegfilgrastim 6 mg once per chemotherapy cycle. There is uncertainty regarding the efficacy of lipegfilgrastim in those weighing >80 kg: the TGA-approved PI for lipegfilgrastim indicates that “[a] statistically significant difference in lipegfilgrastim exposure was observed between the heaviest (>80 kg) and the lightest (<60 kg) subjects studied.PSD · Mar 2016
Should a decrease in efficacy be observed among heavier patients, the assumption that a single syringe of lipegfilgrastim would substitute for a single syringe of pegfilgrastim may not hold.PSD · Mar 2016
6.14 The submission describes lipegfilgrastim as non-inferior in terms of comparative effectiveness and non-inferior in terms of comparative safety over pegfilgrastim. This claim was adequately supported (if the PBAC accepts that a non-inferiority criterion of less than one day for the duration of severe neutropenia is reasonable and that the PBS population is not significantly heavier than those enrolled in the trials as there is uncertainty regarding …PSD · Mar 2016
6.15 The ESC considered that the submission’s clinical claim of non-inferior comparative effectiveness and non-inferior comparative safety over pegfilgrastim was reasonable.PSD · Mar 2016
6.2 The PBAC noted and welcomed the input from a health professional (1) via the consumer comments facility on the PBS website. The comment described how lipegfilgrastim would be used to prevent neutropenia and lessen the risk of septic infection in patients receiving chemotherapy.PSD · Mar 2016
Cost-effectiveness
Cost-minimisation analysis; numeric pricing and cost comparisons are redacted (commercial-in-confidence). The PBAC did not proceed to recommend based on ICER.
Decision context
PopulationAdult patients treated with cytotoxic chemotherapy for malignancy, specifically breast cancer patients receiving doxorubicin 60 mg/m² and docetaxel 75 mg/m² every 3 weeks in the pivotal trials.
Why it was knocked back
- Uncertainty regarding efficacy in patients weighing >80 kg; clinical evidence limited to breast cancer only, while requested listing was for multiple indications; lack of head-to-head trial evidence versus filgrastim (a relevant comparator); unclear whether flow-on approval to other indications is justified when efficacy established only in breast cancer; no recommendation made by PBAC.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2016 | Recommended · restricted | pegfilgrastim | — | RCT · Duration of severe neutropenia |
Consumer voice
A health professional provided input describing how lipegfilgrastim would be used to prevent neutropenia and lessen the risk of septic infection in patients receiving chemotherapy.
The comment described how lipegfilgrastim would be used to prevent neutropenia and lessen the risk of septic infection in patients receiving chemotherapy. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to breast cancer patients receiving specific chemotherapy regimens (doxorubicin/docetaxel), whereas TGA label covers all malignancies except CML and MDS.