2.3 Budesonide + formoterol

2. Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #32, November 2020)

2.3 Interim decision in relation to budesonide + formoterol

Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to budesonide and formoterol.

Materials considered

In making this interim decision, the Delegate considered the following material:

• The application to amend the current Poisons Standard with respect to budesonide + formoterol;
• The 138 public submissions, including 12 written submissions, received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
• The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #32);
• Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of the substance; (b) the purposes for which a substance is to be used and the extent of use of the substance; (c) the toxicity of the substance; (d) the dosage, formulation, labelling, packaging and presentation of the substance; (e) the potential for abuse of the substance; and (f) any other matters considered necessary to protect public health;
• The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018);
• The Scheduling handbook: Guidance for amending the Poisons Standard; and
• The Australian Asthma Handbook (AAH) (pdf,148kb).

Summary of ACMS advice to the Delegate

The Committee recommended that the current scheduling of budesonide and formoterol remains appropriate.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (a) the risks and benefits of the use of the substance; (b) the purposes for which a substance is to be used and the extent of use of the substance; (c) the toxicity of the substance; (d) the dosage, formulation, labelling, packaging and presentation of the substance; (e) the potential for abuse of the substance; and (f) any other matters considered necessary to protect public health.

The reasons for the advice included:

1. the risks and benefits of the use of a substance
   • Benefit:
     • Some benefit if patients at level 2, as defined by the Australian Asthma Handbook (AAH) (pdf,148kb) have easier access to combination therapy.
     • 'As-needed' low dose budesonide/formoterol reduces the risk of severe exacerbations by about two-thirds compared with SABA-only treatment and is non-inferior to daily low dose ICS for severe exacerbations
   • Risk:
     • Risk of inappropriate use (e.g. use for conditions other than asthma) and inadequate monitoring by non-asthmatics, AAH step 1 or step 3-4.
     • Generally safe.
     • Possible risk of adrenal suppression if ICS overused but not at usual therapeutic doses with regular medical review.
2. the purposes for which a substance is to be used and the extent of use of a substance
   • Primary purpose is the relief of the symptoms of asthma but with a secondary benefit of reducing the risk of severe asthma exacerbations.
   • This is a new indication and a significant change from previous guidance. Prescribers, dispensers and patients are all adapting to change. More evidence is needed on how the change in indication will affect usage in Australia.
   • Potential for extensive use in population of patients who currently rely on SABA-only treatments, leading to improved asthma management.
3. the toxicity of a substance
   • Established safety profile although there is a possible risk of adrenal suppression if ICS overused but not at usual therapeutic doses with regular medical review.
4. the dosage, formulation, labelling, packaging and presentation of a substance
   • Multiple dosages available for the same conditions with different scheduling proposed - may be confusing to consumer.
5. the potential for abuse of a substance
   • Potential for overuse
6. any other matters that the Secretary considers necessary to protect public health
   • 'As-needed' low dose budesonide/formoterol without concomitant use of an inhaled corticosteroid (ICS)-based preventer is a recent change to asthma management in Australia and a period of adjustment/familiarisation may be required.
   • Over-reliance on SABA, frequently in the context of poor compliance with prescribed ICS, is common.
   • Patients are at risk of asthma-related death and urgent asthma-related healthcare if they are treated with SABA alone.

Reasons for the interim decision (including findings on material questions of fact)

I have made an interim decision not to amend the current Poisons Standard in relation budesonide and formoterol. My view is that the current scheduling of budesonide and formoterol is appropriate. The detailed reasons for my decision follow.

I acknowledge that recent updated clinical guidance has recommended the use of low dose beta agonist (LABA)/low dose inhaled corticosteroid (ICS) combined reliever medicines, as the primary medication in all but very mild asthma. However, the use of budesonide-formoterol fixed dose combination (FDC) as a PRN medication is very new to Australia and marks a significant change to asthma management. I am of the view that this proposal is premature and further evidence is required to support the use of this medicine in an over the counter (OTC) setting. Having considered the Scheduling Policy Framework 2018 (SPF 2018), I find that budesonide-formoterol FDC does not meet the Scheduling Factors under a Schedule 3 classification, as the limited clinical experience under the new guidelines, mean that the medicine would not be substantially safe with pharmacist intervention to ensure quality use.

I have considered the views expressed by the applicant and agree that there are potential benefits to OTC availability of budesonide-formoterol FDC as a PRN and that this may be a safer option than OTC use of short acting beta agonist (SABA). However, on balance, I find there is currently insufficient evidence of a net public health benefit from the wider availability of budesonide-formoterol FDC. In my opinion, there is a risk of inappropriate use for conditions outside of asthma and I am not confident that consumers could identify the ailments or symptoms that may be treated by this medicine.

I am of the view that increased availability could compromise medical management of asthma. Asthma is a serious chronic disease and good asthma management relies on accurate diagnosis, regular review and tailoring of treatment. Overlapping conditions and complex management decisions are common. I am concerned that these protections, in particular the provision of patient review and follow-up, would not be adequately in place under the care of a pharmacist. I find that the potential for harm in the absence of medical practitioner oversight carries more weight than the benefit of increased patient access.

I have considered the proposed risk mitigation strategies outlined in the Appendix M entry put forward by the applicant. I am concerned with the process, monitoring and audit of compliance with schedule M, including the feasibility for an asthma action plan to be uploaded to My Health Record (MyHR) for example, and for current, signed asthma management plans from a medical practitioner to be mandated as evidence. I note that previous prescriptions alone are inadequate as the same medications are used for a variety of respiratory conditions. I find that under the proposed Appendix M entry, it would be difficult to determine medically diagnosed asthma.

I have considered the public submissions received in response to the pre-meeting notice and note that the majority of submissions were in opposition to the proposal, including a number of asthma peak representative bodies (Asthma Australia and National Asthma Council). Furthermore, I note, that budesonide-formoterol FDC is currently a prescription only medicine in all other comparable international jurisdictions including the USA, UK, Canada and NZ.

Having considered the need for medical practitioner oversight and the risks to consumers with the lack of patient review and follow up in a pharmacy setting, I am of the view that the current scheduling of budesonide and formoterol under Schedule 4 is appropriate.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) the risks and benefits of the use of the substance; (b) the purposes for which a substance is to be used and the extent of use of the substance; (c) the toxicity of the substance; (d) the dosage, formulation, labelling, packaging and presentation of the substance; (e) the potential for abuse of the substance; and (f) any other matters considered necessary to protect public health.