Information intended for healthcare professionals only.

This formulary decision guide was developed from content provided by Glenmark Pharmaceuticals Europe Ltd in a format developed by Guidelines in Practice.

View prescribing information here

Key points

  • Stalpex is a branded generic inhaled corticosteroid (ICS) and long-acting β2 agonist (LABA) alternative to Seretide™ Accuhaler™ available as 50 mcg/500 mcg dose
  • Stalpex provides dosing equivalence to Seretide™ Accuhaler™, at 25% lower acquisition cost1,2
  • Stalpex offers the same handling experience as the existing standard of care, at the highest dose for treatment available.3

 

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Drug name

Stalpex (salmeterol xinafoate/fluticasone propionate 50 mcg/500 mcg dose inhalation powder, pre-dispensed)

Indication 

  • Stalpex is an ICS/LABA indicated for use in:4
    • patients ≥12 years with severe asthma where use of a combination product is appropriate
    • patients with chronic obstructive pulmonary disease (COPD), with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

Dosage

  • Stalpex is available in one dose strength:4 salmeterol xinafoate/fluticasone propionate 50 mcg/500 mcg (PIP 4098661)
  • For optimum benefit, Stalpex should be used daily, even when asymptomatic4
  • The recommended dose for asthma and COPD is one inhalation twice daily4
  • See Summary of Product Characteristics4 for additional dosage information.

Inhaler

  • Stalpex comes in blisters made from polyamide (OPA)/aluminium/polyvinyl chloride (PVC)/aluminium/polyethylene terephthalate (PET)/paper contained in a molded plastic inhaler equipped with a mouthpiece and dose counter4
  • One inhaler contains 60 inhalations4
  • The operating principles and pharmaceutical dosage form of Stalpex are equivalent to those of Seretide™ Accuhaler™3
  • The handling of the two inhalation devices (Stalpex and reference product) is equivalent.3

Budgetary implications

  • Stalpex could provide acquisition cost savings of 25% compared to the existing standard of care.2,5
Potential cost savings with Stalpex5
Current annual cost to NHS for ICS/LABA prescriptions (50 mcg/500 mcg dose) £30.5 million
Potential annual acquisition cost savings to NHS using Stalpex versus Seretide™ Accuhaler™ £8 million

Bioequivalence

  • The bioequivalence of Stalpex compared to Seretide™ Accuhaler™ has been confirmed1
  • Equivalence of the two devices was confirmed by a comparative handling study.3

BTS/SIGN recommendations

  • ICS are the recommended preventer drug for adults and children to achieve treatment goals6
  • First choice add-on therapy: LABA in adults; inhaled LABA or leukotriene receptor antagonist (LTRA) in children6
  • Combination inhalers are recommended to improve treatment adherence6
  • Patient preference and local cost are the most important factors to consider when prescribing an inhaler6
  • Generic prescribing of inhalers should be avoided so that patients are not given unfamiliar devices.6

References

  1. Medicine and Healthcare products Regulatory Agency (MHRA). Public assessment report. Stalpex 50 microgram/500 microgram/dose inhalation powder, pre-dispensed (salmeterol xinafoate and fluticasone propionate). UK/H/6498/003/DC. December 2018. Available at www.mhra.gov.uk/home/groups/par/documents/websiteresources/con952562.pdf 
  2. Monthly Index of Medical Specialities website. MIMS online. www.mims.co.uk/drugs/respiratory-system/asthma-copd/seretide-accuhaler (Accessed August 2019).
  3. Glenmark Pharmaceuticals Europe Ltd data on file. Device specifications.
  4. Glenmark Pharmaceuticals Europe Ltd. Stalpex 50 microgram/500 microgram/dose inhalation powder, pre-dispensedsummary of product characteristics
    www.medicines.org.uk/emc/product/9682/smpc
  5. Glenmark Pharmaceuticals Europe Ltd data on file. Stalpex cost comparison.
  6. British Thoracic Society, Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. SIGN 153. BTS/SIGN, 2016. Available at
    www.brit-thoracic.org.uk/standards-of-care/guidelines/btssign-british-guideline-on-the-management-of-asthma/

Seretide Accuhaler is a registered trademark of GlaxoSmithKline UK.

PP-UK-STAL-0020

Date of preparation: August 2019