SYMBICORT (budesonide/formoterol) TURBOHALER 200/6® ACCEPTED FOR USE IN SCOTLAND AS RELIEVER THERAPY FOR PATIENTS WITH MILD ASTHMA AGED 12 YEARS AND OLDER

• Symbicort Turbohaler 200/6^® has been approved by the Scottish Medicines Consortium (SMC) as dual-combination, inhaled corticosteroid + long-acting beta2-agonist (ICS/LABA) reliever therapy to be taken as needed, in response to symptoms in patients with mild asthma aged 12 years and older.^[1]
• Symbicort Turbohaler (budesonide/formoterol) 200/6^® is the first inhaler in mild asthma with a marketing authorisation containing both an ICS and a beta-2 adrenoceptor agonist with rapid and long-lasting effects.¹
• All patients with asthma are at risk of asthma attacks, including patients with mild asthma.^[2] In the UK, more than 12,000 lives have been lost to asthma in the last ten years and the UK has one of the worst death rates for asthma in Western Europe.^[3]
• It is widely accepted that an over-reliance on short-acting beta2-agonist (SABA) reliever inhalers (blue inhalers) is associated with an increased risk of asthma attacks and mortality, and is a key driver of poor asthma outcomes in the UK.^[4],[5]

London, UK, Monday 13 May 2024 – Today, AstraZeneca announced that the Scottish Medicines Consortium (SMC) has accepted Symbicort Turbohaler (budesonide/formoterol) 200/6^® as reliever therapy for use within NHS Scotland for patients with mild asthma aged 12 years and older.¹ AstraZeneca estimates that approximately 210,000 patients in Scotland who live with mild asthma may be eligible for this treatment as a result of this decision.^[6]

Asthma affects 2 out of 10 people in Scotland and this chronic, variable, inflammatory disease is characterised by asthma attacks and symptoms including breathlessness and wheezing.^[7] 'Mild' asthma imposes a substantial burden on patients, and if treated sub-optimally can increase the risk for disease progression, exacerbations, morbidity, and mortality, as well as reducing quality of life and the ability to perform daily activities.^[8]

Dr Brian Lipworth, Scottish Centre for Respiratory Research Ninewells Hospital, University of Dundee, said: “The SMC’s decision is based on robust data from four different clinical trials demonstrating that Symbicort Turbohaler 200/6^® effectively targets airway inflammation and also delivers rapid, long-acting relaxation of the airway. Even people with mild asthma are at risk of a severe asthma attack, which can be life-threatening. By providing patients in Scotland with an innovative new treatment option for mild asthma, we can alleviate the disease burden by reducing patients' risk of having a severe asthma attack and reduce the environmental impact, given that a patient whose asthma is well-controlled has a lower carbon footprint, thereby optimising best practice in asthma care.”

Anti-inflammatory treatment with inhaled corticosteroids (ICS) is the mainstay of asthma management with short-acting beta2-agonist (SABA) only inhalers used to provide immediate relief of symptoms.^[9] SABAs do not possess any anti-inflammatory properties and do not protect against asthma attacks.^[10] Evidence shows that over-reliance on SABAs and concurrent poor adherence to ICS in clinical practice can have serious consequences for patients.^[11]

Budesonide/formoterol Turbohaler 200/6 addresses this issue by delivering an ICS dose combined with a long acting beta2-agonist (LABA) with each as needed inhalation.¹ This offers a potential solution to the risks associated with SABA over-reliance and/or poor ICS adherence at the same time as relieving symptoms and treating airway inflammation in patients with mild asthma.^[12] This optimised approach to asthma management also supports NHS Scotland’s Realistic Medicine strategy ambitions by reducing over use of SABA-only inhalers thereby avoiding the harm that they can cause when used in excess.^[13]

Dr Ed Piper, Medical & Scientific Affairs Director, AstraZeneca UK, said: “We are delighted that SMC has accepted Symbicort Turbohaler 200/6 for use as a reliever in patients with mild asthma across NHS Scotland. This is another important step in our mission to eliminate asthma attacks and revolutionise the management of asthma for millions of people living with the disease. We're committed to collaborating with NHS Scotland to swiftly deliver access to this new treatment option for eligible patients in routine clinical care.

SABA overuse is both a clinical and environmental challenge.^[14],[15] 70% of the total carbon footprint of asthma care in the UK and almost two-thirds of NHS Scotland’s carbon emissions originating from metered dose inhalers (MDIs) are represented by SABAs.^[16],[17] NHS Scotland’s Climate Emergency & Sustainability Strategy highlights that through improvements in the way asthma is managed there is an opportunity to reduce SABA overuse.¹⁸ This SMC acceptance creates a window to support NHS Scotland’s ambitious target to reduce emissions from inhalers by 70% by 2028.^[18]

The safety and tolerability data for budesonide/formoterol 200/6 as needed, were consistent with the known profile of the medicine.¹⁹ The common drug related adverse reactions are headache, tremor, palpitations and mild throat irritation.¹⁹

AstraZeneca is committed to improving asthma care for patients in the UK. We are working towards a zero-tolerance approach to asthma attacks in the UK and to reduce asthma-related exacerbations in a way that benefits both the patient community and the environment alike. We will continue to work with NHS Scotland at all levels to ensure that eligible patients have access to this medicine as soon as possible. 

[1] Scottish Medicines Consortium. Budesonide/formoterol (Symbicort® Turbohaler^®) 200 micrograms/6 micrograms/inhalation, inhalation powder. Detailed advice document. SMC2622 – published 13 May 2024.

[2] Asthma + Lung UK. What is Asthma. Available at: https://www.asthma.org.uk/conditions/asthma/what-asthma. Last accessed: May 2024.

[3] Asthma + Lung UK. Asthma care is in crisis – charity sounds the siren as asthma death toll rises. Available at: https://www.asthmaandlung.org.uk/media/press-releases/asthma-care-crisis-charity-sounds-siren-asthma-death-toll-rises. Last accessed: May 2024.

[4] Kaplan A, Mitchell PD, Cave AJ, Gagnon R, Foran V, Ellis AK. Effective Asthma Management: Is It Time to Let the AIR out of SABA?.J Clin Med. 2020;9(4):921.

[5] Bloom CI, Cabrera C, Arnetorp S, Coulton K, Nan C, J.P. van der Valk J, Quint JK. Asthma-Related Health Outcomes Associated with Short-Acting β2-Agonist Inhaler Use: An Observational UK Study as Part of the SABINA Global Program. Adv Ther. 2020;37:4190-4208.

[6] AstraZeneca UK Ltd. Data on File. ID: REF-229267. 2024.

[7] Asthma – Chest Heart & Stroke Scotland. Asthma. Available at: Asthma - Chest Heart & Stroke Scotland (chss.org.uk). Last accessed: May 2024.

[8] Respiratory Medicine. A review of the burden and management of mild asthma in adults-Implications for clinical practice. Available at: A review of the burden and management of mild asthma in adults — Implications for clinical practice - Respiratory Medicine (resmedjournal.com). Last accessed: May 2024.

[9] Domingo C, Singh D/ The Changing Asthma Management Landscape and Need for Appropriate SABA Prescription. Adv Ther. 2023; 40: 1301-1316.

[10] Kuna P, et al. Effect of budesonide /formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract. 2007 May; 61(5):725–736.

[11] Caminati M, Vaia R, Furci F, Guarnieri G, Senna G. Uncontrolled Asthma: Unmet Needs in the Management of Patients. J Asthma Allergy. 2021;14: 457-466

[12] O'Bryne PMO et al. The paradoxes of asthma management: time for a new approach? Eu Respir J. 2017 50: 1701103.

[13] Scottish Government. Value based health and care: action plan. Available at: Value based health and care: action plan - gov.scot (www.gov.scot). Last accessed: May 2024.

[14] Nwaru BI, Ekström M, Hasvold P, Wiklund F, Telg G, Janson C. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J. 2020;55(4):1901872.

[15] Alzaabi A, Bell J, Montero-Arias F, Jackson PD, Wang H, Budgen N, Farouk H, Maslova E. Carbon Footprint of inhalers in respiratory treatment: SABA CARBON International. 2022; 60: 2901.

[16] Wilkinson, AJK et al. BTS Oral Abstract No: S26. Available at: http://dx.doi.org/10.1136/thorax-2020-BTSabstracts.32. Last accessed: May 2024.

[17] Scottish Government. Quality prescribing for respiratory illness 2024 to 2027 - draft guidance: consultation. Available at: 10. Environmental impact of inhalers - Quality prescribing for respiratory illness 2024 to 2027 - draft guidance: consultation - gov.scot (www.gov.scot). Last accessed: May 2024.

[18] Scottish Government. NHS Scotland climate emergency and sustainability strategy: 2022-2026. Available at: NHS Scotland climate emergency and sustainability strategy: 2022-2026 - gov.scot (www.gov.scot). Last accessed: May 2024.