The Scottish Medicines Consortium (SMC) Approves Avamys (fluticasone Furoate) For Allergic Rhinitis

Main Category: Ear, Nose and Throat
Also Included In: Allergy;  Regulatory Affairs / Drug Approvals
Article Date: 16 Apr 2009 - 7:00 PDT

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The Scottish Medicines Consortium (SMC) has today accepted Avamys for use within NHS Scotland. Avamys is a new intranasal steroid (INS) manufactured by GlaxoSmithKline (GSK), for the treatment of the symptoms of allergic rhinitis (AR).1

Approximately 16 million people in the UK, which equates to over a quarter of the population, suffers from allergic rhinitis.2 Allergic rhinitis is the most common chronic recurrent disease in all socioeconomically developed countries and remains on the increase.3

Avamys, which offers symptom relief for 24 hours at a time,4 has been approved for use within NHS Scotland for the treatment of the symptoms of AR in adults, adolescents (12 years and over) and children (6 to 11 years).1

Within the summary of evidence, the SMC has highlighted that in two patient-preference studies with the same design a significantly greater proportion of patients with seasonal allergic rhinitis expressed a preference for fluticasone furoate nasal spray (Avamys) than for fluticasone propionate nasal spray. This preference was in respect to the sensory attributes scent/odour, leaking out of nose/down throat, gentleness of mist, and reduced aftertaste.1

Through the SMC's assessment, a cost minimisation analysis was conducted comparing fluticasone furoate nasal spray and beclometasone dipropionate, fluticasone propionate and mometasone furoate - the three most frequently used intranasal steroid products for allergic rhinitis in Scotland. The analysis showed that displacing each of the comparators proportionate to their use in Scotland was estimated to result in a minor cost saving with Avamys.1

Avamys is generally well tolerated, side effects include epistaxis and nasal ulceration which are well recognised side effects of the intranasal steroid class of medicines.4

Approval from the SMC:

Full advice from the SMC: following a full submission (fluticasone furoate) Avamys is accepted for use within NHS Scotland for the treatment of the symptoms of allergic rhinitis in adults, adolescents (12 years and over) and children (6 to 11 years). Evidence to support its efficacy comes from a number of comparator- and placebo-controlled studies conducted in adults and children with seasonal and perennial allergic rhinitis. Prescribers should be aware that the recommended doses of fluticosone furoate are not equivalent, on a microgram per microgram basis, to other fluticasone nasal sprays currently available. Other intranasal steroids are available at a lower cost.1

About Avamys:

-- Avamys is a new treatment for the symptoms of allergic rhinitis (AR). It is within the class of intranasal corticosteroids and has been shown in in vitro studies to have a higher affinity for the glucocorticoid receptor compared with other commonly used intranasal steroids (INS).5,6 The clinical significance of this data is not known.

-- Avamys has been shown to provide relief from both nasal and ocular symptoms associated with seasonal allergic rhinitis (SAR) in adult and adolescent patients.7,8 In these SAR studies Avamys has shown:

- A statistically significant nasal and ocular symptom improvement 7,8
- Improvement in quality of life including sleep and daily activities8

-- Its advanced device has been awarded a gold medal in the Medical Design Excellence Awards 2008 for 'delivering patient-centred medicine using design excellence. Award information can be found below.9*

-- The Avamys device provides comfort, a consistent dose, little or no drip down throat/nose and minimal or no aftertaste.10

References:

1 Avamys (fluticasone furoate). NHS Scotland. Scottish Medicines Consortium, http://www.scottishmedicines.org.uk Accessed 14th April 2009

2 Bauchau V, Durham SR. Prevalence and rate of diagnosis of allergic rhinitis in Europe. Eur Respir J. 2004;24(5):758-64.

3 Ryan D et al. Primary Care: The Cornerstone of Diagnosis of Allergic Rhinitis. Allergy 2008; 63: 981-982.

4 Avamys Summary of Product Characteristics 2008

5 Salter M, Biggadike K, Matthews JL et al. Pharmacological properties of the enhanced-affinity glucocorticoid fluticasone furoate in vitro and in an in vivo model of respiratory inflammatory disease. Am J Physiol Lung Cell MoI Physiol 2007; 293: 660-667.

6 Valotis A & Högger P. Human receptor kinetics and lung tissue retention of the enhanced-affinity glucocorticoid fluticasone furoate. Respir Res 2007; 8: 54.

7 Fokkens WJ, Jogi R, Reinartz D et al. Once daily fluticasone nasal spray if effective in seasonal allergic rhinitis caused by grass pollen. Allergy 2007: 62: 1078-10841

8 Kaiser HB, Naclerio RM, Given J et al. Fluticasone furoate nasal spray: a single treatment option for the symptoms of seasonal allergic rhinitis. J Allergy Clin Immunol 2007; 119(6): 1430-1437

9 Medical Design Excellence Awards http://www.mdawards.com Accessed: 14th April 2009

10 Berger WE, Godfrey JW, Slater AL. Intranasal corticosteroids: the development of drug delivery device for fluticasone furoate as a potential step toward improved compliance. Exper Opin Drug Deliv. 2007; 4(6): 689-701

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

* Medical Design Excellence Award 2008 winner.

The award is based upon descriptive materials submitted to the jurors; the jurors and the competition operators did not verify the accuracy of any submission or of any claims made and did not test the item to which the award was given. For further information please visit http://www.mdeawards.com

Source
Scottish Medicines Consortium