(Uxbridge, Middlesex 6^th September 2023) – Bristol Myers Squibb (BMS) today announced that the National Institute for Health and Care Excellence (NICE) has published its Final Guidance recommending mavacamten for reimbursement and use across the National Health Service (NHS) in England and Wales.¹ Mavacamten is a first-in-class treatment option for adult patients with symptomatic (New York Heart Association, NYHA, class 2 to 3) obstructive hypertrophic cardiomyopathy (oHCM).¹

The Final Guidance recommends mavacamten to be used in eligible patients as an add-on to individually optimised standard care, including beta-blockers, non-dihydropyridine calcium-channel blockers or disopyramide, unless these are contraindicated.¹

Sunil Nair, Consultant Cardiologist & lead for inherited and acquired heart muscle diseases at Norfolk and Norwich University Hospitals NHS Foundation Trust commented: "Despite its prevalence, those diagnosed with HCM have been faced with limited treatment choices to manage their condition. This NICE recommendation introduces a new treatment option for eligible patients, that specifically targets the underlying cause of obstructive HCM (oHCM), offering the possibility of better symptom management and improved overall quality of life for patients with this condition." *

Hypertrophic cardiomyopathy (HCM) is the most common inherited heart condition, estimated to affect around 1 in 500 people in the UK.² A common form of HCM is oHCM, which affects approximately 70% of patients.³ In oHCM, the heart muscle wall becomes thickened and stiff, making it harder for the heart to pump blood around the body,^2,[iii] resulting in symptoms which can be restrictive and even debilitating. There is also an increased risk of sudden cardiac death in patients.[iv]^,[v]

Joel Rose, Chief Executive Officer at Cardiomyopathy UK commented: “Obstructive hypertrophic cardiomyopathy (oHCM) can have a serious impact on people’s quality of life. The recommendation of a new therapy, such as mavacamten, may provide a treatment option for eligible patients. Cardiomyopathy UK is committed to sharing the latest clinical information and to providing support to the oHCM and wider cardiomyopathy community. We welcome this new advancement in oHCM disease management.” **

The most common symptoms of HCM include heart palpitations, chest pain, dizziness, fainting, shortness of breath, and tiredness.² Most people who have HCM have few or no symptoms and can live a normal life,[vi] with some only feeling symptoms when they exercise or exert themselves.[vii] Those who do experience symptoms may be greatly impacted in terms of their quality of life, with patients often making changes to their lifestyle, such as limiting their physical activity, to accommodate their condition.^[viii] For many, this means they are unable to work, have difficulty being active, and find it challenging to perform everyday tasks.⁸

----------

Notes to editors

* Sunil Nair acted as a clinical expert on the recent NICE appraisal committee for mavacamten evaluation and approval. Commentary has been provided independently within this media release without compensation from Bristol Myers Squibb.

** Joel Rose represented Cardiomyopathy UK on the recent NICE appraisal committee for mavacamten evaluation and approval.  Commentary has been provided independently within this media release without compensation from Bristol Myers Squibb.

About mavacamten

Mavacamten (pronounced mah-vah-cam-ten) is a first-in-class selective, allosteric and reversible cardiac myosin inhibitor. In oHCM patients, cardiac myosin inhibition with mavacamten normalises contractility, reduces dynamic left ventricular outflow tract (LVOT) obstruction, and improves cardiac filling pressures.[ix] This results in a reduction of actin-myosin cross-bridge formation, thereby reducing excessive heart contractions and improving the efficiency of the heart.[x] Mavacamten is a once-daily oral capsule, that should be used as an add-on to individually optimised standard care that includes beta-blockers, non-dihydropyridine calcium-channel blockers or disopyramide, unless these are contraindicated.¹

About access to mavacamten

The National Institute for Health and Care Excellence (NICE) published final draft guidance following its appraisal of mavacamten for routine NHS access to mavacamten in England and Wales on 2^nd June 2023.⁵ The Northern Ireland Department of Health will align to NICE guidance and implement their own advice in due course. A separate submission has been made to the Scottish Medicines Consortium (SMC) and to the National Centre for Pharmacoeconomics (NCPE) in the Republic of Ireland.

Mavacamten received Marketing Authorisation in Great Britain on 28^th July 2023 from the Medicines and Healthcare products Regulatory Agency (MHRA), and its marketing authorisation for Northern Ireland and the Republic of Ireland, from the European Commission (EC) on 26^th June 2023.9

Bristol Myers Squibb is committed to ensuring eligible patients can access this treatment as quickly as possible via UK health services and will continue to work in collaboration with all relevant authorities to help achieve this.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at bms.com/gb.

References

[i] National Institute for Health and Care Excellence. Mavacamten for treating symptomatic obstructive hypertrophic cardiomyopathy. [TA913]. Available at: https://www.nice.org.uk/guidance/TA913. Accessed September 2023.

[ii] Cardiomyopathy UK. Hypertrophic cardiomyopathy factsheet. Available at: https://www.cardiomyopathy.org/sites/default/files/2022-02/Hypertrophic%20cardiomyopathy%20factsheet%20January%202022.pdf. Accessed September 2023.

[iii] Prinz C, et al. 2011. The Diagnosis and Treatment of Hypertrophic Cardiomyopathy. Dtsch Arztebl Int. 108(13): 209–215. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078548/. Accessed September 2023

[iv] British Heart Foundation. Scan spots signs of future cardiac arrest in young people. Available at: https://www.bhf.org.uk/what-we-do/news-from-the-bhf/news-archive/2019/june/scan-spots-signs-of-future-cardiac-arrest-in-young-people. Accessed September 2023.

[v] National Institute for Health and Care Excellence. Final draft guidance. Mavacamten for treating symptomatic obstructive hypertrophic cardiomyopathy. Available at: https://www.nice.org.uk/guidance/gid-ta10824/documents/674. Accessed September 2023.

[vi] NHS. Cardiomyopathy. Available at: https://www.nhs.uk/conditions/cardiomyopathy/. Accessed September 2023.

[vii] Heart.org. Hypertrophic Cardiomyopathy (HCM). Available at: https://www.heart.org/en/health-topics/cardiomyopathy/what-is-cardiomyopathy-in-adults/hypertrophic-cardiomyopathy#:~:text=People%20with%20HCM%20may%20need,and%20other%20heart%2Drelated%20complications. Accessed September 2023.

[viii] Zaiser E, et al. 2020. Patient experiences with hypertrophic cardiomyopathy: a conceptual model of symptoms and impacts on quality of life. J Patient Rep Outcomes. 4:102. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7708573/. Accessed September 2023.

[ix] Camzyos. Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/product-information/camzyos-epar-product-information_en.pdf. Accessed September 2023.

[x] Olivotto I, et al. 2020. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 396(10253), pp.759-769. Accessed: September 2023.

Editor Details

• Name:
  • Meera Shingadia
• Email:
  • meera@akthealthcomms.com
• Telephone:
  • +447432141468

Source:- Pharmiweb