SMC accepts Sanofi’s Dupixent® (dupilumab) and Sarclisa® (isatuximab) for use within NHS Scotland

SMC accepts Sanofi’s Dupixent^®  (dupilumab) and  Sarclisa^®  (isatuximab) for use within NHS Scotland

·         People living with severe asthma and those with relapsed and refractory multiple myeloma (RRMM) now have access to new treatment options

·         Severe asthma is the most serious and life threatening form of asthma[9]

·         Multiple myeloma is the second most common type of blood cancer[10]

READING, UK – 12 April 2021 – The Scottish Medicines Consortium (SMC) has accepted both Dupixent^® (dupilumab) and Sarclisa^® (isatuximab) for use within NHS Scotland.

Dupilumab will be available for use as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe asthma,[11] providing a much needed treatment option for people living with severe asthma in Scotland.[12]^,[13]

There are many medicines available that treat the symptoms of asthma, but dupilumab is different as it acts on a specific and different underlying cause of the disease – type 2 inflammation. Dupilumab dampens down two key drivers of the type 2 inflammatory process (IL-4 and IL-13), reducing asthma attacks and cutting down the number of people needing urgent hospital care compared to the current standard of care.[14]^,[15],[16]

“Severe asthma can be life-limiting. Difficulties breathing, frequent hospital visits and the fear of an asthma attack are everyday occurrences for people living with this condition,” said Dr Brian Lipworth, Professor of Allergy and Pulmonology, University of Dundee. “There remains a big unmet need despite currently available treatments for severe asthma. For patients whose asthma remains uncontrolled with current treatments, access to dupilumab provides them with a new option that specifically targets the underlying cause of the disease, reducing inflammation and narrowing of the airways, which in turn improves the functioning of the lungs and reduces the risk of asthma attacks.”

In clinical trials, dupilumab also improved lung function, reduced or eliminated the need to use oral corticosteroids (OCS) in patients who were OCS-dependent and improved health-related quality of life measures compared to placebo.6^,7

Isatuximab, in combination with pomalidomide and dexamethasone (pom-dex) will also be available for use within NHS Scotland. Isatuximab has been accepted as a fourth-line therapy in combination with pom-dex, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior therapies including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.9

This decision is based on the ICARIA-MM trial which demonstrated that isatuximab in combination with pom-dex showed a reduction in risk of disease progression or death in adults by 40%, potentially extending the length of time a patient can live without their cancer progressing by 5 months compared to treatment with pom-dex alone.[17]

“This is a very positive day for people living with severe asthma and those with multiple myeloma; as these decisions by the SMC provide access to two new treatments which have been shown to improve patient lives,” said Nicole Farmer, General Manager, UK & Ireland, Sanofi Genzyme. “Severe asthma can be debilitating, so access to dupilumab means that people with this condition may have greater hope of staying out of hospital and continuing to live their lives. For people living with multiple myeloma who have run out of options, isatuximab may offer them precious additional time without their disease progressing to spend with their loved ones.”

About dupilumab

Dupilumab is a human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in asthma.[18]^,[19] 

The SMC has accepted dupilumab for use as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe asthma who have:³

• Type 2 inflammation characterised by blood eosinophils greater than 150 cells/microlitre and fractional exhaled nitric oxide (FeNO) greater than 25 parts per billion, and 4 or more exacerbations (asthma attacks) in the preceding year, and
• Previously received biologic treatment with anti-immunoglobulin E (IgE) or anti-IL-5 therapies

About LIBERTY ASTHMA clinical programme and type 2 inflammation

The SMC decision is based on a subset of patients taking part in the LIBERTY ASTHMA clinical programme that evaluated 2,888 adults and adolescents (12 years of age and older). All trials enrolled eligible asthma patients irrespective of minimum baseline type 2 inflammatory biomarkers, such as eosinophils or FeNO levels.6^,7,8

The type 2 immune response is believed to be a major driver in severe asthma. Uncontrolled severe asthma is mainly driven by type 2 inflammatory IL-4, IL-13 and IL-5, which contribute to common asthma phenotypes including eosinophilic, allergic and mixed.[20]^,[21],[22]

About isatuximab

Isatuximab is a monoclonal antibody (also known as a mAb) that binds to a specific site on a protein called CD38, a high amount of which is present on the surface of multiple myeloma cells. By binding to the CD38 protein, isatuximab helps the body’s immune system target and destroy the cancerous cell.⁹

About ICARIA-MM

The SMC decision is based on a cohort of patients from the pivotal ICARIA-MM trial who received three prior lines of anti-myeloma treatment, including lenalidomide and a proteasome inhibitor.⁹ ICARIA-MM was the first randomised Phase 3 trial to report results evaluating an anti-CD38/pomalidomide/dexamethasone combination. It was an open-label, multi-centre trial evaluating isatuximab in combination with pom-dex versus pom-dex alone in patients with RRMM.⁹ The study enrolled 307 patients with RRMM across 102 hospitals spanning 24 countries, including sites in the UK.⁹