NICE approval committee recommends elmiron® for the treatment of Bladder Pain Syndrome
Consilient Health welcomes the draft final appraisal document published today by the National Institute for Health and Care Excellence (NICE) Appraisal Committee recommending elmiron® (pentosan polysulfate sodium) for Bladder Pain Syndrome (BPS) within its marketing authorisation1. elmiron® is the only licensed oral medication for BPS with glomerulations or Hunner’s lesions (referred to as interstitial cystitis/BPS) 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. Consilient Health has agreed a Patient Access Scheme with NICE which makes elmiron® available to the National Health Service (NHS).
Reiterating his previous comments during the NICE appraisal, Mr Jonathan Goddard, Consultant Urological Surgeon, Leicester General Hospital said: “BPS is a chronic condition and difficult to treat, and patients often try several treatments before finding one that is effective. It’s crucial that clinicians have access to a range of treatments; elmiron® is effective and well-tolerated, and should be an available option.”
On behalf of Bladder Health UK Susannah Fraser, Communication and Media Manager said: “BPS is a debilitating condition and can have a considerable detrimental impact on the individual’s lifestyle, ability to work, emotional health and relationships. It’s important that individuals with BPS have access to a range of treatment options.”
The Department of Health asked NICE to produce guidance on the use of elmiron® for use to the NHS in England. The draft Final Appraisal Determination (FAD) available today is now open for consultation and comment; the FAD is expected to be published on the 13th November 2019.
Amanda Paxon, Consilient Health UK Country Manager Pharmaceuticals said: “This is a condition with significant unmet clinical need, and elmiron® is a much needed treatment option. Consilient Health is hopeful that this draft document will be formally agreed by November.”
1. National Institute for Health and Care Excellence. Draft final appraisal determination. Pentosan polysulfate sodium for treating bladder pain syndrome. October 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
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