Beclometasone with formoterol (Fostair) for asthma

• Beclometasone + formoterol (eformoterol) FDC is now PBS-listed for maintenance treatment of asthma in adults
  It is not PBS-listed for maintenance and reliever therapy or as an anti-inflammatory reliever.
• The addition of another ICS + LABA FDC to the PBS provides more treatment choices for patients and prescribers.
  Beclometasone + formoterol FDC is a treatment option at steps 3 and 4 of the Australian Asthma Handbook treatment algorithm
• The choice of maintenance treatment for asthma should include individual patient factors and preferences
  Differences in device (ie, MDI or DPI) may influence selection of maintenance treatment.

On 1 December 2020, beclometasone 100 micrograms + formoterol 6 micrograms (Fostair) fixed-dose combination (FDC) metered dose inhaler (MDI) was listed on the PBS General Schedule (Section 85) as Authority Required (Streamlined) for people with asthma who are aged 18 years and over.¹

The clinical criteria states that patients must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids (ICS).

Beclometasone + formoterol FDC is not indicated for the initiation of treatment for people with asthma. The FDC is also not PBS-listed for use as maintenance and reliever therapy, or anti-inflammatory reliever therapy for people with mild asthma.¹

See the PBS website for complete details for each item.

At the July 2020 PBAC meeting, the PBAC recommended the listing of beclometasone + formoterol FDC as maintenance treatment for adults with asthma.²

Before Fostair was listed, no ICS + LABA FDC inhalers containing beclometasone + formoterol were available on the PBS.² (Note that various strengths of budesonide + formoterol FDC are available on the PBS.)

The recommendation to list was informed by comments from the National Asthma Council Australia and Asthma Australia which described a range of benefits of maintenance treatment with beclometasone + formoterol FDC. Both groups also supported the addition of another PBS-listed ICS + LABA FDC to allow greater choice for patients and prescribers.²

Evidence from clinical studies found beclometasone 100 micrograms + formoterol 6 micrograms FDC at a dose of two inhalations twice daily to be non-inferior in terms of effectiveness and safety compared to nominated comparators for patients requiring maintenance therapy with medium dose ICS (step 4 of the Australian Asthma Handbook treatment algorithm).² The PBAC considered the evidence was reasonable for maintenance treatment for adults with asthma.

Evidence for effectiveness and safety in patients requiring low-dose ICS maintenance treatment (step 3) was not presented in the submission. However the PBAC agreed it was reasonable to anticipate that low-dose beclometasone + formoterol FDC (one inhalation twice daily) would be similar to other low-dose ICS + LABA FDCs, based on established equipotent ICS doses.²

Pharmacological treatment of asthma involves a stepwise approach. The Australian Asthma Handbook (developed by National Asthma Council Australia) treatment algorithm recommendations for step 3 and step 4 are listed below. Patients requiring treatment at either of these steps experience frequent symptoms, or their symptoms are uncontrolled with regular maintenance ICS. The aim of treatment is to reduce the frequency and severity of asthma symptoms.³

Table 1: Steps 3 and 4 of the treatment algorithm for adults and adolescents with asthma³

^{*Definitions of low, medium and high doses for each ICS can be found in the Australian Asthma Handbook}

For maintenance treatment of asthma, beclometasone + formoterol FDC is a substitute for all available ICS + LABA FDCs on the PBS at comparable doses, including both MDI and dry powder inhaler (DPI) formulations. It is an alternative low-dose ICS + LABA FDC at step 3 at a dose of one inhalation twice daily. It is an alternative medium dose ICS + LABA FDC at step 4, when taken at a dose of two inhalations twice daily.²

Beclometasone 100 micrograms + formoterol 6 micrograms FDC (Fostair) is an MDI, while budesonide 100 micrograms + formoterol 6 micrograms (Symbicort Turbuhaler) is a DPI. Both of these inhalers (at this dose) will have similar efficacy. As different devices require different techniques, the choice of maintenance treatment is related to the type of inhaler that is suitable for the individual patient and their age.⁴

TGA indications cover asthma and COPD

Beclometasone + formoterol FDC was approved in January 2020 for use by adults (18 years and older) for the regular treatment of asthma where use of a combination product with ICS + LABA is appropriate. These are:⁶

• patients whose symptoms are not adequately controlled with ICS and 'as needed' SABA or
• patients whose symptoms are already adequately controlled on both ICS and LABA.

In addition to asthma, beclometasone + formoterol FDC is also indicated for symptomatic treatment of adults with severe COPD (FEV₁ < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.⁶

Health professionals should note that this FDC product is not TGA-approved or PBS-listed as anti-inflammatory reliever therapy for patients with mild asthma.⁶

Handbook recommendations are broader than PBS listing

Beclometasone + formoterol FDC is recommended in the Australian Asthma Handbook as an option for maintenance and reliever treatment (step 3)³ and is also TGA-approved for this use. However, health professionals should note the FDC product is not PBS-listed for this treatment approach.¹

The PBAC noted that the clinical evidence showed that patients receiving maintenance and as-needed beclometasone + formoterol FDC reduced the time to the first severe exacerbation when compared to maintenance beclometasone + formoterol FDC plus as-needed salbutamol, but also resulted in more treatment-related adverse effects.^2,7

Additional considerations against PBS listing for maintenance and reliever therapy included high potential for patient confusion and inappropriate use as reliever therapy.²

With only one strength of beclometasone + formoterol FDC listed on the PBS, patients who need higher doses of ICS will have to switch to an alternative ICS + LABA FDC. The need to switch may also increase patient confusion and risk of inappropriate use.²

Adherence to current asthma treatment and inhaler technique should be reviewed at each clinical visit before health professionals consider ‘stepping up’ a patient’s treatment regimen.^1,3

Ensure all patients with asthma have an individualised written asthma action plan that is appropriate for their treatment regimen, asthma severity, culture, language, literacy level, and ability to self-manage.³ The National Asthma Council has developed a specific action plan that may be used for patients receiving treatment with Fostair.

Patients should have a clear understanding of how to use their device before starting treatment with beclometasone + formoterol FDC. If they are having difficulty, using a spacer may be beneficial with an MDI and can also reduce local adverse effects related to ICS.⁴ They should also be aware that beclometasone + formoterol FDC is not intended to be used as a reliever for people with mild asthma⁸, and they should carry their prescribed reliever with them at all times.³

During the COVID-19 pandemic, it may be difficult to try out inhalers before filling out a prescription, if a new sample or dummy inhaler isn’t available for each patient. It may be helpful once a device has been chosen, for the prescriber to add a note to the pharmacist to check technique when the inhaler is dispensed.

NPS MedicineWise has information for patients about asthma, asthma medicines and inhaler devices.

If preferred, patients can also get information over the phone by calling NPS MedicineWise’s Medicines Line at 1300 MEDICINE (1300 633 424).