pentosan polysulfate sodium (Elmiron)

following a full submission considered under the orphan equivalent process:

pentosan polysulfate sodium (Elmiron®) is accepted for use within NHSScotland.

Indication under review: 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.

In patients with bladder pain syndrome and glomerulations or Hunner’s lesions, pentosan polysulfate sodium was associated with significantly more patients achieving at least moderate improvement in overall symptoms of bladder pain syndrome compared with placebo.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of pentosan polysulfate sodium. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.