NPC Archive Item: Scottish Medicines Consortium reviews fluticasone furoate▼ nasal spray for allergic rhinitis

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27th April 2009

The Scottish Medicines Consortium (SMC) has accepted fluticasone furoate▼ (Avamys®) 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). However, there are only limited data comparing this with other available and less costly intranasal steroids such as beclometasone.

The review also advises that doses of fluticasone furoate are not equivalent, on a microgram per microgram basis, to other fluticasone nasal sprays currently available,

Area Prescribing Committees may wish to evaluate the available evidence for fluticasone furoate to determine its role in the local management of allergic rhinitis. There are other intranasal steroids available at a lower cost, e.g. beclometasone, but only limited data comparing fluticasone furoate with these alternatives. Readers should note that SMC recommendations only apply in Scotland.

What is the background to this?
Fluticasone furoate nasal spray (FFNS) is a highly selective intranasal steroid that has been available since January 2009 at a cost of £6.44 for a 120 dose unit. In comparison, generic beclometasone nasal spray costs £2.79 for a 200 dose unit (Drug Tariff, April 2009).  Fluticasone furoate nasal spay is licensed for the treatment of the symptoms of allergic rhinitis in adults, adolescents and children aged 6 to 11 years. Although structurally related to fluticasone propionate it has a different pharmacology.

What does the SMC assessment say?
Efficacy data from 15 randomised double-blind studies were analysed.  Nine of the studies recruited adults with seasonal allergic rhinitis (SAR); three of the studies had active comparators and of the six placebo-controlled studies, two involved an active control. Four efficacy studies, one of which used the active comparator mometasone furoate, recruited adults with perennial allergic rhinitis (PAR).  Paediatric data were provided from one placebo-controlled trial in SAR and one in PAR.  The primary efficacy outcome was based on patients’ assessment of nasal symptoms in all studies – comparing change from baseline between treatment arms.  Ocular symptoms and disease-specific quality of life measures were also assessed in the majority of studies.

The review highlights certain factors which may affect the translation of the trial data to day to day practice. A comparative study of FFNS and fluticasone propionate nasal spray in patients with SAR involved a non-inferiority analysis. However the European licensing agency has advised that non-inferiority trials are not possible in SAR/PAR due to lack of assay sensitivity. The comparison with mometasone furoate nasal spray in the treatment of PAR was primarily a safety study and was not designed to detect treatment differences in efficacy outcomes.  The trials studied FFNS at starting doses, but not at the lower maintenance doses.

It was noted that the EMEA’s European Public Assessment Report (EPAR) of fluticasone furoate did not present evidence from any head to head or active comparator efficacy trials, suggesting, the SMC say, that the efficacy of FFNS was concluded on the basis of placebo-controlled trials. The review includes the EMEA comments that treatment effects relating to nasal symptoms in SAR were in the range expected with marketed products that are effective for allergic rhinitis, and that those relating to ocular symptoms were in the range expected for oral antihistamines used in clinical practice.  In PAR, the nasal treatment effects were considered within the range expected for an intranasal corticosteroid currently used in clinical practice.

Common side effects listed in the Summary of Product Characteristics include nose bleeds, which are generally mild to moderate in intensity, and nasal ulceration.

The SMC assessment suggests that fluticasone furoate could result in modest drug cost savings compared to fluticasone propionate and mometasone furoate, but higher drug costs than beclometasone dipropionate.

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