Pentosan polysulfate sodium (Elmiron®) for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions
The National Health Care Institute has completed its assessment whether pentosan polysulfate sodium (Elmiron®) is interchangeable with a product that has been included in the Medication Reimbursement System (GVS). The National Health Care Institute's advice is to include pentosan polysulfate sodium (Elmiron®) in Appendix 1B and Appendix 2 of the Health Insurance Regulation and to impose additional conditions.
Registered indication
Elmiron® is registered for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition. Elmiron® is available as a hard capsule containing 100 mg of pentosan polysulfate sodium.
Assessment
The National Health Care Institute has come to the conclusion that clinically relevant improvements are found in subjective patient-reported outcome parameters after treatment with Elmiron® in placebo-controlled studies for bladder pain syndrome characterised by glomerulations or Hunner's lesions (HL). Given the high unfulfilled treatment needs and the likely positive effect on the quality of life, pentosan polysulfate sodium (Elmiron®) has an added value.
Because Elmiron® is not interchangeable with other medicinal products included in the GVS, it is eligible for placement on Appendix 1B of the Health Insurance Regulation.
The National Health Care Institute's advice
Based on the considerations mentioned in the report, the National Health Care Institute advises the Minister for Medical Care to include PPS-Na (Elmiron®) in Appendix 1B and Appendix 2 of the Health Insurance Regulation.
Appendix 2 condition PPS-Na (Elmiron®)
Only for an insured person aged 18 years or older with bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition.
This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.