Mundipharma calls for broader stakeholder consensus on pain trial endpoints to meet payer’s requirem

New research unveiled today by Mundipharma highlights inconsistencies in health economic models and measurement methods used in clinical trials for pain therapies. This is the finding of two studies presented at this year’s International Society of Pharmacoeconomics and Outcomes Research (ISPOR) conference in Amsterdam. The research includes the first ever literature review to identify the key endpoints used in chronic pain trials¹.

In response to these studies Mundipharma is leading the industry in developing an ‘open source’ health economic model in pain to be unveiled in 2015. This could support greater convergence in how economic models are developed, to achieve greater predictability and transparency in the assessment of new pain therapies. Further to this, Mundipharma advocates greater consensus in how best to measure economic related outcomes such as quality of life, patient functioning and resource use in order to better meet payer requirements and provide greater access to pain medicines for patients.

‘A Systematic Search and Methodological Review of Economic Models of Analgesics for Chronic Pain’², shows that current health economic models are inconsistent in how they measure the value of new pain therapies across a number of dimensions, and that there is scope for further consensus on the key design attributes of pain models. This includes; time horizon, dose-titration and adverse events. This research reviewed 34 published economic models of chronic pain therapies from which 18 original model structures were identified.

‘Endpoints in Pain: The Suitability for Health Economic Evaluation of Endpoint Designs in Chronic Pain Studies¹’, highlights that the inclusion of payer-relevant outcome measures among clinical trials is inconsistent. The majority of primary endpoints were pure pain measures, most commonly numerical rating scale (NRS) visual analogue scale (VAS) and brief pain inventory (BPI) with other outcome domains often limited to secondary endpoints and inconsistently applied across the studies. Will Dunlop, Head of Health Economics and Outcomes Research at Mundipharma International said;

“We are calling for greater clarity on how pain is measured in clinical trials and health economic models in order to better meet clinicians and payer’s requirements and ensure better access to medicines for patients. This task will require stakeholder coordination across regulatory licensing authorities, clinicians, and payers, and is part of Mundipharma’s goal to cut out complexity and uncertainty in this area through the quality of our evidence.”

These studies form part of a set of four studies submitted to ISPOR by Mundipharma, highlighting two particular therapy areas; pain and respiratory disease.

References

1. Rycroft C, Hirst M, Dunlop W, Pirk O, Mullins CD, Akehurst R. Endpoints in pain: The suitability of endpoint
   designs for health economic evaluation in chronic pain studies. Poster presented at the International Society for
   Pharmacoeconomics and Outcomes Research (ISPOR) 17th Annual European Congress, 8-12th November 2014,
   Amsterdam, NL.
2. Sullivan W, Gladwell D, Fagnani F, Lopez Bastida J, Phillips C, Hirst M, Dunlop W. A Systematic Search and
   Methodological Review of Economic Models of Analgesics for Chronic Pain. Poster presented at the International
   Society for Pharmacoeconomics and Outcomes Research (ISPOR) 17th Annual European Congress, 8-12th November
   2014, Amsterdam, NL.