National Institute for Health and Care Excellence (NICE) recommendation.

elmiron^® is recommended by NICE as an option for treating BPS with glomerulations or Hunner’s lesions in adults with urinary urgency and frequency, and moderate to severe pain, only if:¹

• the 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 elmiron^® according to the Patient Access Scheme (PAS)

Clinical considerations: Positioning of treatment

• NICE acknowledged that the treatment pathway for BPS was complex and varied between services¹
• The clinical experts advised NICE that elmiron^® would generally be used before bladder instillations or for people who could not have bladder instillations¹
• elmiron^® should be used in patients that have not responded to an adequate trial of standard, less expensive oral treatments ^1*
• elmiron^® is an oral therapy offering convenience and reduces the risks and costs associated with bladder instillations¹
• elmiron^® is likely to be a cost-effective use of NHS resources compared with bladder instillations¹
• The economic models did not capture the cost-effectiveness of elmiron^® when taken after a lack of response to bladder instillations or in combination with bladder instillations. The committee concluded that it could not assess the cost-effectiveness of elmiron^® for these populations¹

*Note: these treatments may be being used outside of their marketing authorisations

All Wales Medicines Strategy Group (AWMSG) recommendation

elmiron^® is recommended by AWMSG as an option for treating BPS with glomerulations or Hunner’s lesions in adults with urinary urgency and frequency, and moderate to severe pain, only if:^1,2

• the 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 elmiron^® according to the Patient Access Scheme (PAS)

For further information on the clinical considerations regarding the positioning of elmiron® in the treatment pathway, refer to NICE guidance: click here

To read full AWMSG guidance

Scottish Medicines Consortium (SMC) recommendation

Following a full submission under the orphan equivalent process, elmiron^® is accepted for use within NHS Scotland¹

Indication under review

For the treatment of BPS characterised by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition¹

• In this patient group, elmiron^® was associated with significantly more patients achieving at least moderate improvement in overall symptoms of bladder pain syndrome compared with placebo¹
• This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of elmiron^®. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower¹
• elmiron^® meets SMC orphan equivalent criteria. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting¹
• elmiron^® increases the treatment choice for patients and its oral administration offers convenience and reduces the risks and costs associated with bladder instillations¹
• With the Patient Access Scheme (PAS), pentosan polysulfate sodium was the dominant treatment compared to bladder instillation (cheaper, more effective)¹