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Sanofi responds to draft NICE guidance for its innovative atopic dermatitis drug Dupixent® (dupilumab)1

• NICE issues draft guidance not recommending Dupixent® (dupilumab) and opens consultation period, ending 24 April, 20181
• NICE Appraisal Committee agreed that dupilumab is innovative and a step change in managing atopic dermatitis1
• This draft NICE recommendation will not affect those people who have been receiving treatment with dupilumab that was started in the NHS before this guidance was published1
• Dupilumab is the first and only targeted biologic in the European Union with marketing authorisation for use in atopic dermatitis2

 

GUILDFORD, UK – APRIL 3rd, 2018 – The National Institute for Health and Care Excellence (NICE) has issued draft guidance that does not recommend Dupixent® (dupilumab), within its marketing authorisation, for the treatment of moderate-to-severe atopic dermatitis in adults when systemic therapy is suitable.1 This appraisal consultation document (ACD) is not NICE’s final decision on dupilumab.

“Whilst this is disappointing news, it is only the first step in the NICE appraisal process and we are currently reviewing NICE’s recommendations and the details that led to this initial assessment,” said Jessamy Baird, Director of Patient Access UK & Ireland at Sanofi. “Dupilumab is an innovative medicine that represents a step change in the management of atopic dermatitis, which the Appraisal Committee itself acknowledged. We appreciate there will be complexities when assessing the cost-effectiveness of such a new treatment approach and will be submitting a formal response to the draft NICE guidance in the next few weeks.”

The ACD contains the Appraisal Committee’s preliminary recommendation, which may change after comments received during the consultation period, ending 24 April, 2018.

High unmet need in atopic dermatitis

In December 2015, a Promising Innovative Medicine (PIM) status was granted to dupilumab by the Medicines and Healthcare Products Regulatory Agency (MHRA) and an Early Access to Medicines (EAMS) positive Scientific Opinion for its use in severe atopic dermatitis was received in March 2017. The inclusion of dupilumab as the first chronic medicine within EAMS by the MHRA recognises both the innovative nature of dupilumab and also that severe atopic dermatitis represents an area of high unmet need.

Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme, added: “We are fully committed to achieving a positive final outcome to ensure that dupilumab can be made available on the NHS for appropriate atopic dermatitis patients in England. We encourage the atopic dermatitis and eczema community to review and comment on the guidance so that the real-life impact of atopic dermatitis and treatment with dupilumab can be fully understood and assessed.”

Draft guidance acknowledges dupilumab’s efficacy

The draft guidance noted that the clinical evidence shows that dupilumab is effective at treating moderate-to-severe atopic dermatitis following failure (or contraindication) of topical therapies and systemic immunosuppressant agents. However, NICE felt there was uncertainty about cost-effectiveness estimates for dupilumab, which were higher than those NICE normally considers an acceptable use of NHS resources.

About Atopic Dermatitis

AD (also known as atopic eczema) is the most common form of eczema.3 In the United Kingdom, approximately 1.5 million (3%) adults have atopic dermatitis.4,5 Within the general UK population, it is estimated that there are 14 adults per 100,000 with moderate AD and 6 adults per 100,000 with severe AD who may be eligible for treatment with dupilumab.6 Moderate-to-severe AD is characterised by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.7,8 Itch is one of the most burdensome symptoms for patients and can be debilitating.In addition, people with moderate-to-severe AD experience impaired quality of life, including disrupted sleep, and increased anxiety and depression symptoms along with their disease.7

About Dupilumab

Dupilumab is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD, and certain other allergic or atopic diseases. Dupilumab was granted a marketing authorisation in the European Union on 28 September 2017.2,9

Dupixent is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

Full summary of product characteristics for dupilumab can be accessed at: https://www.medicines.org.uk/emc/product/8553/smpc

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

For more information please visit www.sanofi.co.uk.


References

[1] NICE. Dupilumab for treating moderate to severe atopic dermatitis after topical treatments [ID1048]. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta10218/documents. (Accessed April 2018).

[2] The electronic Medicines Compendium (eMC). Dupilumab. Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc (Accessed April 2018)

[3] NHS Choices. Atopic Eczema (Atopic Dermatitis). Available at: http://www.nhs.uk/conditions/Eczema(atopic)/Pages/Introduction.aspx (Accessed April 2018).

[4] Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66 (suppl 1): 8–16.

[5] Office for National Statistics. 2014 UK mid-year population estimate. Available at: http://www.ons.gov.uk/generator?uri=/peoplepopulationandcommunity/populationandmigration/populationesti mates/articles/overviewoftheukpopulation/february2016/ff1144ea&format=xls (Accessed April 2018).

[6] Sanofi. Data on File. August 2016.

[7] Simpson et al. Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults. Am Acad Dermatol, pp. 74(3):491-498, 2016.

[8] Mount Sinai. Patient Care Atopic Dermatitis. Available at: http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/atopic-dermatitis#risk. (Accessed April 2018).

[9] Simpson et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. NEJM, vol. 375, pp. 2335-2348, 2016. SOLO 1: Available at: https://clinicaltrials.gov/ct2/show?term=solo&cond=Atopic+Dermatitis&rank=3. (Accessed April 2018). SOLO 2: https://clinicaltrials.gov/ct2/show?term=solo&cond=Atopic+Dermatitis&rank=2. (Accessed April 2018).

Date of preparation: April 2018 - Job bag number:SAGB.IMM.18.03.0404

Updated: April 03, 2018

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