PegfilgrastimPelgraz
Chemotherapy-induced neutropenia in patients receiving chemotherapy with intention of achieving cure or substantial remission, who are at greater than 20% risk of developing febrile neutropenia or at substantial risk of prolonged severe neutropenia for ≥7 days.
Decisions on record
- Meeting Mar 2020 Recommended Chemotherapy- induced neutropenia
- Meeting Nov 2019 Recommended Chemotherapy-induced neutropenia
- Meeting Nov 2018 Recommended Chemotherapy-induced neutropenia no PSD
- Meeting Jul 2018 Deferred Chemotherapy-induced neutropenia
- Meeting Mar 2018 Recommended Prophylaxis of chemotherapy induced neutropenia
- Meeting Jul 2017 Deferred Prophylaxis of chemotherapy induced neutropenia
- Meeting Mar 2011 Recommended Bone marrow cell stimulator no PSD
- Meeting Jul 2009 Recommended Neutropenia no PSD
5 earlier decisions
- Nov 2008 Recommended Immunostimulant
- Mar 2008 Not recommended Prevention of neutropenia.
- Nov 2007 Recommended Neutropenia no PSD
- Jul 2007 Recommended Prevention of neutropenia
- Sep 2002 Recommended Stimulates production of white blood cells. no PSD
Access path
- TGA registered · Pelgraz
TGA label narrower than the PBS population
- Nov 2006Recommended
Listing: Private hospital authority required → Restricted
- Nov 2006Recommended · restricted
Listing: Private hospital authority required → Restricted
- Jul 2007Recommended
Comparator changed: placebo plus secondary prophylactic use of pegfilgrastim → no…
- Jul 2007Recommended · restricted
Comparator changed: placebo plus secondary prophylactic use of pegfilgrastim → no…
- Mar 2008Not recommended
Uncertain clinical benefit (no survival benefit demonstrated as chemotherapy dose intensity was maintained in both…
- ↻ resubmittedNov 2008Recommended · restricted
Comparator changed: No G-CSF (advanced breast cancer); pegfilgrastim secondary…
- Jul 2017Deferred
Comparator changed: filgrastim → secondary prophylaxis
- Mar 2018Recommended · restricted
Comparator changed: secondary prophylaxis → no treatment (placebo) for primary…
- Jul 2018Recommended · restricted
Comparator changed: no treatment (placebo) for primary prophylaxis; secondary prophylaxis…
- Nov 2019Recommended · restricted
Listing: Authority Required → Restricted
- Mar 2020Recommended · restricted
Comparator changed: Neulasta (pegfilgrastim reference brand) → Neulasta
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of the biosimilar brand of pegfilgrastim, Pelgraz, on the basis that it should only be available under special arrangements under Section 100 (Highly Specialised Drugs program) for all indications for which the reference brand (Neulasta) is currently PBS-listed.PSD · Mar 2020
6.2 The PBAC recommended listing Pelgraz on a cost-minimisation basis to the Neulasta brand of pegfilgrastim, and noted that this would result in no net cost to the Government because the listing of Pelgraz is not expected to grow the market. 5PSD · Mar 2020
5.12 The minor submission presented a cost-minimisation analysis of Pelgraz compared with Neulasta. The equi-effective doses were estimated as 6 mg of Pelgraz is equal to 6 mg of Neulasta for the same frequency and duration of therapy.PSD · Mar 2020
5.13 The Sponsor noted the price reductions applied to pegfilgrastim in 2017 following listing of the Ristempa brand, and in 2018 following the broadening of the restriction as recommended by the PBAC in March 2018 with a price reduction to ensure a cost- effective listing in the expanded population. The minor submission requested an ex- manufacturer price for Pelgraz equivalent to that of Neulasta at the time of listing.PSD · Mar 2020
5.9 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of Pelgraz compared with Neulasta. The TGA Delegate was satisfied that the data for Pelgraz demonstrated an equivalent level of efficacy and safety for the desired indication as the comparator drug. 4PSD · Mar 2020
5.10 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonably supported by the data.PSD · Mar 2020
6.2 The PBAC noted and welcomed the input from health care professionals (1) and organisations (1) via the Consumer Comments facility on the PBS website. The comments indicated that treatment with pegfilgrastim as primary prophylaxis for febrile neutropenia could improve outcomes by enabling more aggressive treatment.PSD · Jul 2017
6.3 The PBAC also noted the advice received from the Medical Oncology Group of Australia (MOGA), which indicated that there were additional patient groups, such as those undergoing dose dense chemotherapy with anthracycline and cyclophosphamide, or treatment with paclitaxel, who would also benefit from this therapy.PSD · Jul 2017
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design. Submission assumed Pelgraz would be listed at same price as Neulasta with no net cost to Government.
The PBAC recommended listing Pelgraz on a cost-minimisation basis to the Neulasta brand of pegfilgrastim, and noted that this would result in no net cost to the Government because the listing of Pelgraz is not expected to grow the market. PBAC · 2020
Decision context
PopulationCancer patients receiving chemotherapy with intention of achieving cure or substantial remission who are at greater than 20% risk of developing febrile neutropenia or substantial risk of prolonged severe neutropenia for ≥7 days.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2020 | Recommended · restricted | Neulasta | — | RCT · Other |
| Nov 2019 | Recommended · restricted | Neulasta (pegfilgrastim reference brand) | — | RCT · Other |
| Jul 2018 | Recommended · restricted | Neulasta (pegfilgrastim reference brand) | — | RCT · Duration of severe neutropenia (DSN) in Cycle 1 |
| Mar 2018 | Recommended · restricted | no treatment (placebo) for primary prophylaxis; secondary prophylaxis for primary vs secondary comparison | $15k–45k | Cost-minimisation · Cost-minimisation |
| Jul 2017 | Deferred | secondary prophylaxis | $15k–45k | Meta-analysis · Febrile neutropenia rate |
| Nov 2008 | Recommended · restricted | filgrastim | — | RCT · Febrile neutropenia prevention |
| Mar 2008 | Not recommended | No G-CSF (advanced breast cancer); pegfilgrastim secondary prophylaxis (early breast cancer) | $15k–45k | RCT · Febrile neutropenia |
| Jul 2007 | Recommended | no prophylaxis | — | RCT · febrile neutropenia event avoided |
| Jul 2007 | Recommended · restricted | no prophylaxis | — | RCT · FN |
| Nov 2006 | Recommended | placebo plus secondary prophylactic use of pegfilgrastim | $30k | RCT · Other |
| Nov 2006 | Recommended · restricted | placebo plus secondary prophylactic use of pegfilgrastim | $30k | RCT |
Consumer voice
Health care professionals and organisations indicated that pegfilgrastim as primary prophylaxis for febrile neutropenia could improve outcomes by enabling more aggressive treatment. The Medical Oncology Group of Australia advised that additional patient groups undergoing dose dense chemotherapy or paclitaxel treatment would also benefit from this therapy.
treatment with pegfilgrastim as primary prophylaxis for febrile neutropenia could improve outcomes by enabling more aggressive treatment Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to curative-intent chemotherapy and specific febrile neutropenia risk thresholds; TGA label covers all post-chemotherapy neutropenia.