BenralizumabFasenra
Treatment of uncontrolled severe eosinophilic asthma. New presentation (pre-filled pen/auto-injector form) as a treatment option.
Decisions on record
- Meeting Mar 2020 Recommended Eosinophilic asthma
- Meeting Mar 2018 Recommended Uncontrolled severe eosinophilic asthma
- Meeting Mar 2018 Recommended Uncontrolled severe eosinophilic asthma
Access path
- TGA registered · Fasenra
TGA label equal than the PBS population
- Mar 2018Recommended
Evidence: Other → RCT
- Mar 2018Recommended · restricted
Evidence: Other → RCT
- Mar 2020Recommended · restricted
Comparator changed: mepolizumab → benralizumab pre-filled syringe (Fasenra PFS)
- PBS listing · Restricted
From the public summary
5.1 The PBAC recommended the listing of a new form of benralizumab (pre-filled pen/auto-injector form; Fasenra Pen), on the basis that it should be available only under special arrangements under Section 100 (Highly Specialised Drugs Program) for the treatment of uncontrolled severe eosinophilic asthma.PSD · Mar 2020
5.2 The PBAC recommended the listing of Fasenra Pen on a cost-minimisation basis to benralizumab (pre-filled syringe; Fasenra PFS), with equi-effective doses being one benralizumab 30 mg in 1 mL Pen equivalent to one benralizumab 30 mg in 1 mL PFS.PSD · Mar 2020
4.10 The minor submission presented a cost-minimisation analysis of Fasenra Pen compared with Fasenra PFS. The proposed equi-effective doses were one benralizumab 30 mg in 1 mL pen is equivalent to one benralizumab 30 mg in 1 mL PFS.PSD · Mar 2020
4.11 The submission proposed that the Special Pricing Arrangement for Fasenra PFS should apply for Fasenra Pen. For more detail on PBAC’s view, see section 5 PBAC outcome.PSD · Mar 2020
4.8 The minor submission claimed that Fasenra Pen and PFS contain the same formulation and are therefore equivalent.PSD · Mar 2020
4.9 The PBAC considered that the claim of equivalent comparative effectiveness and comparative safety was reasonable. For more detail on PBAC’s view, see section 5 PBAC outcome.PSD · Mar 2020
4.2 The PBAC noted and welcomed the input from 1 organisation via the Consumer Comments facility on the PBS website. Asthma Australia provided comments, which described a range of benefits of having the new pen form available including increasing patient choice between delivery device, and the ease of use of an injection pen compared to the PFS form.PSD · Mar 2020
6.68 The submission anticipated that there was a Risk Sharing Arrangement in place for mepolizumab and omalizumab, and expected that benralizumab would be added to this agreement, including any existing price-volume caps.PSD · Mar 2018
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as the submission compared two presentations of the same drug with equi-effective doses and equal pricing.
The PBAC considered that there should be no financial implications with the listing of the pen form of benralizumab as the new form would not grow the overall biologics market in severe asthma, but rather substitute for use of the PFS. PBAC · 2020
Decision context
PopulationPatients with uncontrolled severe eosinophilic asthma (same population as the pre-filled syringe form already listed on PBS)
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2020 | Recommended · restricted | benralizumab pre-filled syringe (Fasenra PFS) | — | Single-arm · Surrogate |
| Mar 2018 | Recommended | mepolizumab | — | Other |
| Mar 2018 | Recommended · restricted | mepolizumab | — | RCT · ARR |
Consumer voice
Asthma Australia provided consumer input highlighting benefits of the new pen form, including increased patient choice between delivery devices and improved ease of use compared to the pre-filled syringe form.
increasing patient choice between delivery device, and the ease of use of an injection pen compared to the PFS form Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC recommendation cover identical population: patients with uncontrolled severe eosinophilic asthma, with no additional restrictions applied.