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News & Trends - Pharmaceuticals

Clinical society champions Sanofi and GSK therapies to curb corticosteroid dependency

Health Industry Hub | January 29, 2024 |

Pharma News: Ahead of the upcoming March Pharmaceutical Benefits Advisory Committee (PBAC) meeting, the Australasian Society of Clinical Immunology and Allergy (ASCIA) has submitted two submission in support of Sanofi and GSK therapies in asthma management.

Asthma, affecting a staggering 2.8 million Australians, with 5–10% experiencing severe cases, has prompted ASCIA to advocate for changes in the approach to treatment. While oral corticosteroids (OCS) can be life-saving in emergency situations, prolonged usage poses significant risks, including adverse outcomes and heightened mortality risks. Astonishingly, research indicates that 40–60% of severe asthma patients are subjected to long-term OCS treatment despite global guidelines recommending limitations on its use.

ASCIA’s PBAC submission extends to Sanofi’s Dupixent (dupilumab), approved for use and listed on the Pharmaceutical Benefits Scheme (PBS) for severe asthma patients aged 12 and above. ASCIA advocates for its funding to be extended to children aged 6 to 11 years with uncontrolled severe asthma.

“It is important to have biologicals such as dupilumab, with a very strong evidence base, as a treatment option to help manage severe, uncontrolled asthma, which can greatly impact health and quality of life, particularly in patients with other atopic diseases and/or comorbidities. Whilst dupilumab does not replace the need for oral corticosteroids (OCS), it can potentially bring the use of OCS into more acceptable risk-benefit doses for patients with severe asthma. This is important regarding growth and development in patients aged from 6 to 11 years,” the society said.

Medicines Australia CEO voices policy and advocacy focus for 2024

The European Academy of Allergy and Clinical Immunology (EAACI) supports this sentiment, noting Dupixent’s ability to reduce “the daily dose of oral corticosteroids (OCS) with high certainty of evidence.”

Additionally, ASCIA is backing GSK’s application for changes to the PBS listing of Nucala (mepolizumab) for the treatment of uncontrolled severe asthma. Nucala, approved and listed on the PBS since 2017, has shown benefits in phase II (Dream) and phase III (Mensa) studies. GSK’s request to alter the current PBS requirement for OCS in the initial treatment of uncontrolled severe asthma aligns with ASCIA’s goal of improving health outcomes for patients.

In its submission to the PBAC, ASCIA highlighted “Effective and targeted biologic therapies such as mepolizumab for treatment of uncontrolled severe asthma can have a significant impact on health outcomes and quality of life, particularly in patients with other atopic diseases and/or comorbidities. Proposed changes to the requirement for oral corticosteroid (OCS) treatment prior to treatment with mepolizumab should improve health outcomes for patients by potentially reducing the use of OCS into more acceptable risk-benefit doses for patients with severe asthma.”

A concerted effort is necessary to tackle the issue of reliance on OCS. As with worldwide efforts to reform the overuse of antibiotics, changing national and local policies is crucial to ensure that the use of OCS becomes limited.

The seemingly cost-effective nature of oral corticosteroid masks the substantial health impairments and increased healthcare resource utilisation associated with prolonged use. To combat this, a global reduction in the reliance on OCS may be achieved by establishing a threshold of 500 mg/year and implementing campaigns to raise awareness of the appropriate use of OCS.

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