OmalizumabOMLYCLO
Treatment of uncontrolled severe asthma (USA), uncontrolled severe allergic asthma (USAA), and severe chronic spontaneous urticaria (CSU) in eligible patients. The PFP presentation is requested under the same circumstances as the currently PBS-listed PFS presentation.
Decisions on record
- Meeting Mar 2026 Recommended Uncontrolled severe asthma, severe chronic spontaneous urticaria
- Meeting May 2025 Recommended Chronic rhinosinusitis with nasal polyps
- Meeting Mar 2025 Recommended Uncontrolled severe asthma, uncontrolled severe allergic asthma, severe chronic spontaneous urticaria
- Meeting Mar 2025 Recommended Uncontrolled severe asthma, uncontrolled severe allergic asthma, severe chronic spontaneous urticaria
- Meeting Nov 2021 Not recommended Uncontrolled severe asthma; Severe chronic spontaneous urticaria; Uncontrolled severe allergic asthma
- Meeting Mar 2018 Recommended Severe chronic spontaneous urticaria
- Meeting Nov 2016 Recommended Severe chronic idiopathic urticaria
- Meeting Jul 2016 Recommended Paediatric severe allergic asthma
6 earlier decisions
- Nov 2015 Recommended Severe chronic idiopathic urticaria
- Nov 2015 Recommended Severe allergic asthma
- Nov 2014 Recommended 75 mg/0.5 mL injection, 1 x 0.5 mL syringe; 150 mg/mL injection, 1 x 1 mL syringe; 150 mg injection [1 x 150 mg vial] (&) inert substance diluent [1 x 1.2 mL ampoule], 1 pack Xolair® Novartis Pharmaceuticals Australia Pty Ltd (Minor submission) Severe allergic asthma To propose revision of PBS restr
- Mar 2014 Recommended Xolair® Novartis Pharmaceuticals Australia Pty Ltd Severe allergic asthma To request listing as a Section 100 (Highly Specialised Drugs Program) +/- STREAMLINED benefit, a new presentation of omalizumab, for the existing indication of uncontrolled severe allergic asthma. no PSD
- Nov 2010 Recommended Severe allergic asthma
- Nov 2009 Not recommended Anti-asthma drug
Access path
- TGA registered · OMLYCLO
TGA label narrower than the PBS population
- Nov 2009Recommended · restricted
vs placebo and oral corticosteroids (depending on patient…
- Nov 2010Recommended
Comparator changed: placebo and oral corticosteroids (depending on patient subgroup) →…
- Nov 2014Recommended
Evidence: RCT | Single-arm → Cost-minimisation
- Nov 2015Recommended · restricted
Evidence: Cost-minimisation → RCT
- Nov 2015Recommended · restricted
Evidence: Cost-minimisation → RCT
- Jul 2016Recommended · restricted
Comparator changed: cyclosporin and standard of care (placebo) → placebo plus optimised…
- Nov 2016Recommended
Comparator changed: placebo plus optimised asthma therapy → cyclosporin
- Mar 2018Recommended · restricted
Evidence: RCT → Cost-minimisation
- Nov 2021Not recommended
PBAC considered that a solution requires the sponsor to seek ARTG registration of a co-pack or combination product…
- ↻ resubmittedMar 2025Recommended · restricted
- Mar 2025Recommended · restricted
- May 2025Recommended · restricted
Comparator changed: existing 150 mg/mL pre-filled syringe of omalizumab → mepolizumab
- Mar 2026Recommended · restricted
Comparator changed: mepolizumab → Xolair (originator omalizumab) PFP and PFS presentations
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required listing of omalizumab for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), on the basis that it should be available only under special arrangements under Section 100 Highly Specialised Drug Program (HSD).PSD · May 2025
• omalizumab 346.67 mg every 4 weeks is equivalent to mepolizumab 100 mg every 4 weeks.PSD · May 2025
6.61 The submission presented a CMA of omalizumab versus mepolizumab based on the claim of non-inferiority efficacy and safety.PSD · May 2025
6.62 The CMA presented in the submission was based on the published price for mepolizumab.PSD · May 2025
6.14 The eligibility criteria of the four studies were broadly consistent with the proposed PBS listing, however, there were some key differences in study design, inclusion/exclusion criteria and baseline characteristics between studies, which impact the transitivity assumption:PSD · May 2025
• The SYNAPSE study was limited to patients who had undergone prior surgery for NPs (100%), while the POLYP 1/2 and MERIT trials were not restricted to nasal surgery in the previous 6 months, and included 60% and 64% of patients with previous surgery, respectively. The submission presented an ITC including available data for post-surgical populations from the POLYP 1/2 and MERIT trials.PSD · May 2025
6.2 The PBAC noted and welcomed the input from one individual and one health care professional, as well as, one medical and one consumer organisation via the Consumer Comments facility on the PBS website. The comments described how the symptoms of CRSwNP make those affected feel like they have a flu or acute upper respiratory tract infection every day and leads to impaired sleep, poor concentration and fatigue.PSD · May 2025
The input stated that omalizumab reduces nasal blockage thereby improving sleep, concentration and energy levels enabling fuller contribution to their family, work and society. The input noted the initial inconvenience of administration by a general practitioner and that omalizumab must be refrigerated and is not held in stock at pharmacies. Access through self-administration at home was described as much improved.PSD · May 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design. Submission proposed listing at the same approved ex-manufacturer price (AEMP) as equivalent PFS presentations.
The submission estimated nil net financial implications to the PBS/RPBS for listing Omlyclo. PSD · 2025
Decision context
PopulationAdults and adolescents ≥12 years of age with uncontrolled severe asthma or uncontrolled severe allergic asthma; adults and adolescents ≥12 years of age with severe chronic spontaneous urticaria; children 6 to <12 years of age with allergic asthma (per TGA registration).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | Xolair (originator omalizumab) PFP and PFS presentations | — | Cost-minimisation |
| May 2025 | Recommended · restricted | mepolizumab | — | Single-arm · Surrogate |
| Mar 2025 | Recommended · restricted | Xolair (reference biologic omalizumab) | — | Cost-minimisation · Cost-minimisation |
| Mar 2025 | Recommended · restricted | existing 150 mg/mL pre-filled syringe of omalizumab | — | Cost-minimisation · Cost-minimisation |
| Nov 2021 | Not recommended | — | — | Cost-minimisation |
| Mar 2018 | Recommended · restricted | cyclosporin | — | Cost-minimisation · Cost-minimisation |
| Nov 2016 | Recommended | cyclosporin | — | RCT · Itch severity (Urticaria Activity Score over 7 days [UAS7]) |
| Jul 2016 | Recommended · restricted | placebo plus optimised asthma therapy | — | RCT · Clinically significant exacerbation rate |
| Nov 2015 | Recommended · restricted | — | $15k–45k | RCT · Asthma exacerbation rate |
| Nov 2015 | Recommended · restricted | cyclosporin and standard of care (placebo) | — | RCT · UAS7 |
| Nov 2014 | Recommended | — | — | Cost-minimisation |
| Nov 2010 | Recommended | placebo in addition to Optimal Asthma Therapy (OAT) | $45k–75k | RCT | Single-arm · Asthma Control Questionnaire (ACQ) score, Asthma Quality of Life Questionnaire (AQLQ), emergency visits, hospital admissions |
| Nov 2009 | Recommended · restricted | placebo and oral corticosteroids (depending on patient subgroup) | — | RCT |
Consumer voice
Consumer input described how CRSwNP symptoms severely impact daily functioning, with omalizumab improving nasal blockage, sleep, concentration and energy levels. Professional and organisational input highlighted omalizumab's safety profile, steroid-sparing potential, and value as an alternative treatment option for patients who have undergone multiple prior treatments including surgery.
The comments described how the symptoms of CRSwNP make those affected feel like they have a flu or acute upper respiratory tract infection every day and leads to impaired sleep, poor concentration and fatigue. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to serum IgE ≥30 IU/mL and prior surgery or unsuitability for surgery; TGA label has no biomarker or surgery requirements.