GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the Scottish Medicines Consortium (SMC) has issued positive advice for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, ‘FF/UMEC/VI’) for restricted use in patients with severe Chronic Obstructive Pulmonary Disease (forced expiratory volume in one second [FEV1] <50% predicted normal).

The evaluation by the SMC means Health Boards across Scotland now have advice that will allow appropriate adult patients access to this new treatment. Trelegy Ellipta is the first once-daily single inhaler triple therapy to be approved in Europe. It is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA), delivered once daily in GSK’s Ellipta dry powder inhaler.

COPD affects approximately 4% of Scotland’s population[1], and breathing problems associated with this progressive disease are a major cause of repeat admissions to hospital in Scotland[2]. It is estimated that NHS Scotland spends around £159 million a year on treating COPD, which is expected to rise to more than £200 million a year by 2030[3].

Graham Doherty, Medical Scientific Liaison for GSK said “COPD can be devastating, with patients affected by persistent symptoms of breathlessness and many experiencing lung attacks or exacerbations all of which negatively impact their quality of life. To manage their condition patients may also have to take multiple medicines on a daily basis, which can also be very burdensome. We are delighted with this positive decision from the SMC, which means that healthcare professionals in Scotland can offer appropriate patients with COPD the opportunity to benefit from this innovative medicine, the first once daily single inhaler triple therapy”.

George Abercrombie, Senior Vice President and Chief Commercial Officer of Innoviva, added, “This positive decision allows a significant advance for those appropriate COPD patients who require the additional therapeutic benefits offered by once daily Trelegy Ellipta. Trelegy Ellipta is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine.”

The SMC decision marks an important milestone for Trelegy Ellipta, and means that GSK now have a range of once-daily treatments that have been approved by the SMC that can meet the different needs of individual patients.

The SMC decision follows marketing authorisation by the European Commission of fluticasone furoate / umeclidinium / vilanterol (as trifenatate) in November 2017. The remit of the SMC is to provide advice for the use of newly licensed drugs that represent demonstrable value for money to NHS Scotland.

The Summary of Product Characteristics for fluticasone furoate / umeclidinium / vilanterol (as trifenatate) is available at: https://www.medicines.org.uk/emc/product/8666

 

 

References

 

  1. http://www.gov.scot/Publications/2017/10/2970/345790 [Last accessed February 2018]
  2. Clinical Standards for Chronic Obstructive Pulmonary Disease Services. Edinburgh: NHS Quality Improvement Scotland, 2010. Available from:www.healthcareimprovementscotland.org/our_work/long_term_conditions/copd_implementation/copd_clinical_standards.aspx [Last accessed February 2018]
  3. McLean, S, Hoogendoorn, M, Hoogenveen, RT, Feenstra, TL, Wild, S, Simpson, CR, Mölken, MR and Sheikh A (2016). Projecting the COPD population and costs in England and Scotland: 2011 to 2030. Sci Rep; 1(6):31893
  4. Official SMC guidance 2018 [online]. Available at www.scottishmedicines.org.uk/SMC_Advice [Last accessed: February 2018]
  5. Global Initiative for Chronic Obstructive Lung Disease Global Initiative for Chronic Obstructive Lung Disease. 2017. Pocket guide to COPD diagnosis, management, and prevention. Available at: http://goldcopd.org/wp-content/uploads/2016/12/wms-GOLD-2017-Pocket-Guide.pdf. [Last accessed February 2018]
  6. Diagnosis of COPD. World Health Organisation. Available at: http://www.who.int/respiratory/copd/diagnosis/en/. [Last accessed February 2018]

 

 

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