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New HTA Decisions in England
December 2019
Drug name
ELMIRON® (pentosan polysulfate sodium)
Company
Consilient Health
Decision date
10/10/2019
Therapeutic area
Urological conditions
Therapeutic sub area
Urinary tract infection
Decision
Recommended with restrictions
Indication
Pentosan polysulfate sodium is recommended as an option for treating bladder pain syndrome with glomerulations or Hunner's lesions in adults with urinary urgency and frequency, and moderate to severe pain.
Decision Detail
Only if: their condition has not responded to an adequate trial of standard oral treatments it is not offered in combination with bladder instillations any previous treatment with bladder instillations was not stopped because of lack of response it is used in secondary care and the company provides pentosan polysulfate sodium according to the commercial arrangement. There is a simple discount patient access scheme for pentosan polysulfate sodium.
Summary
The company’s clinical effectiveness evidence came from 4 randomised controlled trials comparing pentosan polysulfate sodium with placebo in people with bladder pain syndrome and either glomerulations or Hunner’s lesions. The trials were published between 1987 and 2003. The committee concluded that the company’s evidence for pentosan polysulfate sodium was based on the most relevant trials available but acknowledged the limitations of the trials, including the methodological quality of one trial because of uncertainty about allocation concealment and numbers of patients withdrawing from treatment . It considered that there was substantial uncertainty in the clinical effectiveness evidence. The ERG’s revised ICER using the committee’s preferred assumptions and applying the confidential commercial arrangement was £14,418 per QALY gained when compared with bladder instillations. Based on the ERG’s analysis, the committee concluded that the most plausible cost effectiveness estimate for pentosan polysulfate sodium compared with bladder instillations was likely to be a cost-effective use of NHS resources. So, it is recommended for a defined population. The ERG’s revised ICER using the committee’s preferred assumptions and applying the confidential commercial arrangement was £50,740 per QALY gained when compared with best supportive care. The committee concluded that the most plausible cost-effectiveness estimate for pentosan polysulfate sodium compared with best supportive care was higher than usually considered a cost-effective use of NHS resources .