Big Wins in Record Time for Gaining Market Access with Phase II Data

By Innomar Strategies |

How Innomar Strategies delivered local market expertise, vast experience, and comprehensive services to help a foreign manufacturer secure market access in Canada.

The Client Situation

Imagine you’re leading a market access team of a non-Canadian pharmaceutical company with a novel oncology therapy coming to market. You’ve been tasked with developing the market access strategy for entering Canada, but you are unfamiliar with the Canadian healthcare landscape and its complex reimbursement requirements and regulations. Obtaining market adoption within Canada is strategically crucial, so you look for a seasoned guide to ensure your product’s success.

You want to work with professionals who you can partner with closely, and who will function as an extension of your team. You’re looking for an innovative company with best-in-class skills, local market knowledge, and real world experience. Most of all, you need someone who is committed to your product as much as you are.

When faced with this situation, our client turned to Innomar Strategies to leverage our vast experience in market access and reimbursement and our comprehensive service capabilities to help bring their oncology product to the Canadian market.

The Innomar Strategies Solution

After reviewing the product’s clinical data, our consultants immediately recognized that obtaining reimbursement in Canada would be met with several challenges. Firstly, we identified that our client’s product would have difficulty meeting federal and provincial requirements for drug submissions since it was only approved with Phase II clinical trial data. In addition, our client assumed their product would only need a single submission for Canadian market access, when in fact they needed two submissions for each indication of their product.

After already helping our client identify and mitigate some serious obstacles, Innomar Strategies began developing a solid strategic plan to secure coverage for their product.

We kicked off the project with a commitment to partnership. By leveraging our full scope of services, Innomar Strategies became the Canadian affiliate to our client that would guide their product through the intricate reimbursement process. Together, we agreed on the following key goals:

  • Educate our client on the market access and reimbursement landscape in Canada.
  • Develop a comprehensive submission, including optimal pricing and launch strategies.
  • Expedite access by coordinating and facilitating productive discussions and negotiations with key drug plan representatives within both the public and private markets.

To achieve these goals, our team employed several healthcare consulting services and solutions to ensure our client’s success: 

  • Landscape Assessment: A thorough review and assessment of the oncology reimbursement pathway in Canada.
  • Submission Planning: Development of strategic public and private submission plans, and coordination of pre-submission meetings and attendance.
  • PMPRB Submission: Executing a PMPRB submission using our knowledge of optimal pricing given the product’s value proposition and market needs.
  • Strategic Pricing Recommendations: Pricing strategy development and Product Listing Agreement (PLA) recommendations and guidance.
  • Primary Market Research: Validation of the global pharmacoeconomic model for customization in Canada, and development of Budget Impact Analyses (BIAs).
  • Development of Market Access Submissions: In collaboration with our client, our consultants developed and managed the drug submission process for each indication, which required customized components for each submission.
  • PLA Negotiations: Management of PLAs through the pan-Canadian Pricing Alliance to secure coverage across the provinces.

The Outcome

In a little over a year, Innomar Strategies helped our client achieve overwhelming success in the Canadian marketplace. Major successes include:

  • Two successful pCODR recommendations based only on Phase II data
  • Successful provincial recommendations and listings
  • Breakthrough product pricing considering the clinical evidence
  • An invitation to participate in pan-Canadian Pricing Alliance, with our consultants being included in negotiations and the execution of the pending agreement

Our client continued to partner with us even after the submission process was completed. They have come to rely on Innomar Strategies’ consulting team for their strategic guidance and services to ensure key stakeholders continue to recognize their product’s value and expand access to all patients in Canada.

Start a Conversation

Whether your company is new to Canada or already established, you will need strong knowledge and expertise to navigate your product through the complex Canadian market access and reimbursement environment. With Innomar Strategies as your guide, you will benefit from our years of experience and dedicated in-house team of experts to get your product covered as quickly as possible. As your partner, we are committed to finding innovative solutions and working with you to push the boundaries of your brand. Our full-service solutions will help take your product past the critical launch phase to ensure continued success over the long-term. Partner with Innomar Strategies to improve product access, increase supply chain efficiency, and enhance patient care.