HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE FLUTICASONE FUROATE (AVAMYS) FOR ALLERGIC RHINITIS – NOT RECOMMENDED Name: generic What it is Indication Date Decision Decision NICE / SMC Guidance (trade) last revised Status Fluticasone furoate Intranasal Allergic September Final NICE - none (Avamys ®) corticosteroid rhinitis 2012 SMC – accepted for use HMMC Recommendation: Fluticasone furoate (Avamys ®) nasal spray is NOT RECOMMENDED for prescribing. HMMC RECOMMENDED choices of intranasal corticosteroids for allergic rhinitis should be in accordance with previous HMMC recommendations (available at http://www.hertfordshire.nhs.uk/pharmacy/index.php/local-decisions-about-medicines/6-hmmc ): 1st Line: Beclometasone – prescribe as Beconase ® (cheaper than generic) 2nd Line: Budesonide – prescribe as Rhinocort Aqua ® (cheaper than generic) 3rd Line: Mometasone (Nasonex ®) OR Fluticasone propionate – prescribe as Nasofan® (only cost-effective when prescribed by this brand and NOT when prescribed generically or as Flixonase ®). EFFICACY SAFETY • Trials in adults and adolescents have shown fluticasone furoate • Main adverse effects - epistaxis, nasal nasal spray to be more effective than placebo for SAR. Trials in ulceration and headache. PAR have shown improvements in nasal symptoms. • Systemic effects of nasal corticosteroids • Evidence vs active comparators is limited showing comparable may occur when prescribed for prolonged efficacy to fluticasone propionate & mometasone furoate. periods. COST PATIENT FACTORS • Several intranasal corticosteroid products can be bought OTC. • Other products available at lower costs (eg beclometasone). • Patent does not expire until 2023. Although current price is the same as Nasofan, fluticasone propionate is already off patent and hence more products are likely to become available. Assessment against Ethical Framework Evidence of Clinical Effectiveness • Randomised controlled trials in adults and adolescents have shown fluticasone furoate to be more effective than placebo for seasonal allergic rhinitis (SAR). Trials in perennial allergic rhinitis (PAR) have shown improvements in nasal symptoms. Studies in children have shown more variable results. • Evidence for fluticasone furoate vs intranasal corticosteroid comparators is limited. Limited unpublished studies have shown comparable efficacy to fluticasone propionate and mometasone furoate. • Claims of greater receptor affinity or selectivity for fluticasone furoate have yet to be shown to make a real difference in clinical use. • SPC for fluticasone furoate lists main adverse effects as epistaxis, nasal ulceration & headache. • Systemic effects of nasal corticosteroids may occur when prescribed for prolonged periods. Cost of treatment and Cost Effectiveness • Several products can be bought over the counter for use in adults with lower cost than the prescription charge. • Other intranasal corticosteroids are available at a lower cost (eg beclometasone, budesonide). • Although the cost of Avamys ® is currently the same as Nasofan ® the patent for Avamys ® does not expire until 2023. The patent has expired for fluticasone propionate intranasal spray and hence more products are likely to become available which will likely reduce costs. The Needs of the population • The needs of the population appear to be low as alternative intranasal corticosteroids are available. The Needs of the community • If Avamys ® is currently being used instead of, or replaced, cheaper alternatives, then this would create a cost pressure which may have an impact on the local health economy which already has to identify savings. Equity Selected References (all references available in HMMC application paper) • No issues identified. • Summary of Product Characteristics. www.medicines.org.uk . • Fluticasone furoate, 27.5 micrograms/actuation nasal spray (Avamys®). Scottish Medicines Consortium Policy Drivers assessment. 06 march 2009. Available via www.scottishmedicines.org.uk . Accessed June 2012 • None identified, existing local • Fluticasone furoate nasal spray. UKMI New Medicines Profile. Issue No. 09/03. May 2009. Available recommendations in place. online at www.nelm.nhs.uk . Accessed June 2012. • Scadding GK et al. BSACI (British Society for Allergy and clinical Immunology) guidelines for the Implementability management of allergic and non-allergic rhinitis. Clinical and Experimental Allergy, 2008; 38: 19-42. • No issues anticipated. Available from www.bsaci.org. Accessed June 2012. .