NICE recommends elmiron® for the treatment of Bladder Pain Syndrome
Consilient Health welcomes the decision by the National Institute for Health and Care Excellence (NICE) to recommend elmiron® (pentosan polysulfate sodium) for bladder pain syndrome (BPS) within its marketing authorisation1. elmiron® is indicated for the treatment of bladder pain syndrome characterised by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition. NICE has recommended that elmiron®, the only licensed oral medication for BPS with glomerulations or Hunner’s lesions (referred to as interstitial cystitis/BPS)1,2,3.
NICE recommended elmiron® as a treatment option in secondary care, and if the individual’s condition has not responded to standard oral treatments. It also recommended that elmiron® should not be offered in combination with bladder instillations, or if there was a lack of response with such treatment previously.1 The recommendation came after Consilient Health agreed a Patient Access Scheme with NICE which makes elmiron® available to the National Health Service (NHS).
Mr Jonathan Goddard, Consultant Urological Surgeon, Leicester General Hospital said: “This positive recommendation from NICE will allow patients with this chronic and difficult to treat condition to benefit from elmiron®, an effective and well-tolerated treatment for BPS”.
Susannah Fraser, Communication and Media Manager, Bladder Health UK said: “BPS is a debilitating condition and has a considerable detrimental impact on the individual’s lifestyle, ability to work, emotional health and relationships. Their quality of life is hugely compromised. For individuals to be able to access elmiron® on the NHS is really good news.”
Amanda Paxon, Consilient Health UK Country Manager Pharmaceuticals said: “This is a condition with a significant unmet clinical need and the company is delighted that elmiron® has been recommended for the treatment of IC/BPS”.
1. National Institute for Health and Care Excellence. Final appraisal determination. Pentosan polysulfate sodium for treating bladder pain syndrome. November 2019.
2. bene-Arzneimittel GmbH. elmiron® (pentosan polysulfate sodium) 100 mg hard capsules Summary of Product Characteristics. July 2019
3. Committee for Medicinal Products for Human Use (CHMP) Assessment report elmiron® EMA/287422/2017 23 March 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Public_assessment_report/human/004246/WC500229392.pdf