Case Studies: Small U.S. Biotech Expands in Canada

the situation

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

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

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