The Situation
A small U.S. Biotech company with limited Canadian resources and experience in the Canadian market; submissions were required within a very tight timeline.
- No phase 3 RCT
- Significant data gaps
- Complex budget impact analysis
- No Canadian payer or advocate relationships
The Solution
- Recommended development of a network meta-analysis to address the gaps in data
- Immediately put in place a provincial key contact plan to meet important public and private payers
- Streamlined manufacturer’s budget impact model to allow for greater transparency
- Consolidated a number of European submissions to create a clinical value summary forming the basis for HDAP and pCODR submissions
The Results
- PMPRB: Achieved median internal price with no valid comparators in Canada
- pCODR: positive pERC recommendation with criteria according to approved indication
- Delivered on time and on budget