Budesonide With Eformoterol Fumarate DihydrateSymbicort Turbuhaler
Treatment of asthma in adults with frequent asthma episodes or symptoms despite oral corticosteroids, inhaled corticosteroids, or combination ICS/LABA therapy; and treatment of COPD in adults with FEV1 <50% predicted and repeated exacerbations despite beta-2 agonist therapy.
Decisions on record
- Meeting Aug 2018 Recommended Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dehydrate 12 micrograms per dose, 2 x 60 doses DuoResp® Spiromax®, Teva Pharma Australia Pty Ltd Symbicort Turbuhaler®, AstraZeneca Pty Ltd Asthma no PSD
- Meeting Mar 2018 Noted Asthma and chronic obstructive pulmonary disease (COPD) no PSD
- Meeting Nov 2017 Recommended Asthma and chronic obstructive pulmonary disease (COPD)
- Meeting Jul 2013 Recommended Asthma
- Meeting Nov 2012 Not recommended Asthma: treatment of asthma where use of a combination (inhaled corticosteroid and long acting beta 2-agonist) is appropriate in adults and adolescents. This includes patients who are symptomatic on inhaled corticosteroid therapy; patients who are established on regular long acting beta 2-agonist an no PSD
- Meeting Nov 2011 Not recommended Symptomatic treatment of moderate to severe COPD (FEV1 < 50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbation. Symbicort is not indicated for the initiation of bronchodilator therapy in COPD. no PSD
- Meeting Nov 2010 Recommended Asthma and chronic obstructive pulmonary disease (COPD)
- Meeting Nov 2010 Not recommended Asthma and chronic obstructive pulmonary disease (COPD)
1 earlier decision
- Mar 2007 Recommended Asthma drug
Access path
- TGA registered · Symbicort Turbuhaler
TGA label narrower than the PBS population
- Mar 2007Recommended · restricted
Comparator changed: Seretide (fluticasone and salmeterol) plus as needed short acting…
- Mar 2007Recommended · restricted
Comparator changed: Seretide (fluticasone and salmeterol) plus as needed short acting…
- Nov 2010Recommended · restricted
Comparator changed: Seretide (fluticasone and salmeterol) plus short-acting beta agonist…
- Jul 2013Recommended
Comparator changed: fluticasone with salmeterol (Seretide®) → budesonide/eformoterol…
- Jul 2017Not recommended
inability to back titrate the dose with a similar device, limited ability of prescribers to avoid possible adverse…
- ↻ resubmittedNov 2017Recommended
Evidence: Other → Cost-minimisation
- Aug 2018Recommended
Listing: Authority Required → Restricted
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended the listing of a new brand of budesonide with eformoterol fumarate dehydrate, DuoResp® 200/6 and 400/12 Spiromax® as an alternative brand to the currently listed Symbicort brand.PSD · Nov 2017
6.2 The PBAC noted that the DuoResp® Spiromax® is available in two strengths (200/6 and 400/12), whereas Symbicort® Turbuhaler® is available and PBS listed in 100/6, 200/6 and 400/12 strengths. The PBAC noted that a DuroResp® 100/6 Spiromax® formulation meeting bioequivalence criteria for the purposes of a regulatory submission had not yet been developed.PSD · Nov 2017
5.6 The resubmission requested a cost minimisation to the currently listed Symbicort® Turbuhaler® formulations. The Secretariat notes that, while not a matter for the PBAC, a recommendation to list DuoResp® Spiromax® would result in a 16% statutory price reduction under section 99ACC of the National Health Act 1953.PSD · Nov 2017
5.7 Following the pre-PBAC response, the sponsor submitted a revised pricing proposal to deliver a ''''''% reduction on the current ex-manufacturer price for DuoResp® Spiromax®.PSD · Nov 2017
5.2 The PBAC noted and welcomed the input from organisations (2) via the Consumer Comments facility on the PBS website. The comments described a range of issues in regards to the treatment of asthma and COPD with budesonide with eformoterol including the ability to back titrate dosages and the need to correctly educate 4PSD · Jul 2017
Cost-effectiveness
Cost minimisation analysis — no ICER calculated. Pricing redacted in document.
The Secretariat notes that, while not a matter for the PBAC, a recommendation to list DuoResp® Spiromax® would result in a 16% statutory price reduction under section 99ACC of the National Health Act 1953. PSD · 2018
Decision context
PopulationAdults aged 18 years and over with asthma requiring maintenance therapy after oral corticosteroids, optimal inhaled corticosteroids, or ICS/LABA combination; adults aged 18 years and over with COPD with FEV1 <50% predicted and repeated exacerbations despite beta-2 agonist therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Aug 2018 | Recommended | Symbicort Turbuhaler | — | Cost-minimisation · Cost-minimisation |
| Nov 2017 | Recommended | Symbicort Turbuhaler | — | Cost-minimisation · Cost-minimisation |
| Jul 2017 | Not recommended | Symbicort Turbuhaler | — | Other |
| Jul 2013 | Recommended | budesonide/eformoterol fixed dose combination DPI (Symbicort Turbuhaler) | — | RCT · mPEF |
| Nov 2010 | Recommended · restricted | fluticasone with salmeterol (Seretide®) | — | RCT · Other |
| Mar 2007 | Recommended · restricted | Seretide (fluticasone and salmeterol) plus as needed short acting beta agonist | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
| Mar 2007 | Recommended · restricted | Seretide (fluticasone and salmeterol) plus short-acting beta agonist; Symbicort maintenance plus short-acting beta agoni | — | RCT · time to first severe exacerbation |
Consumer voice
Two consumer organisations provided input on budesonide with eformoterol treatment for asthma and COPD, emphasising the importance of dose titration, patient education on inhaler devices, and restrictions on pharmacy-level substitution for new delivery devices.
The comments described a range of issues in regards to the treatment of asthma and COPD with budesonide with eformoterol including the ability to back titrate dosages and the need to correctly educate patients on the correct use of new inhaler devices, with particular emphasis on the need to restrict pharmacy level substitution ("a" flagging) for new delivery devices of existing medications. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with frequent episodes/symptoms despite prior therapy and COPD with FEV1 <50% and exacerbations; TGA label covers asthma and COPD broadly.