Position statement on the appropriate usage of biologic therapies for asthma in South Africa.

Biologic therapies such as monoclonal antibodies are highly effective in reducing disease burden (exacerbations/corticosteroid usage/ hospitalisation) in patients with severe asthma. These medications are currently prohibitively expensive for widespread use compared with standard inhaled and oral therapy. They are indicated for patients with predominantly type 2-high inflammation. Judicious use of biologic therapies in the South African context is imperative given the country's limited healthcare resources. The prescription and clinical use of these therapies within the scope of the South African Health Products Regulatory Authority registered indications therefore require clear guidance and appropriate preparatory optimisation to ensure that the appropriate patients receive the correct medication within an acceptable time frame. Not all patients with difficult-to-treat, or nominally designated as severe, asthma require a biologic therapy in order to be optimally controlled. Simple attention to basic asthma therapeutic principles and treatment of comorbid disease by a clinician with a special interest in asthma may be all that is required. This position statement, written by senior clinicians from the South African Thoracic Society (SATS), is intended to supplement the SATS asthma treatment recommendation of 2021. It provides clear guidance on the appropriate assessment of patients being considered for biologic therapy and clarifies which background medication is required to initiate a biologic therapy in an evidence-based manner. A balanced consideration of side-effects, scientific evidence and cost is essential to prevent unjustified harm to patients by delaying or denying access to biologic therapy. A process to endorse biologic therapy has been created in parallel, and forms are available from SATS, along with registration in the severe asthma registry to support clinicians in appropriate assessment and justification for prescription.