“Anytime you get something on the table that generates cost-savings, people perk up”
Public drug plan representative
“Patients want drug access—effective medicines to Canadians in a timely manner. The role of SEBs will be to provide Canadian patients a range of drugs at a range of prices.”
“Merlot is not the same as a cabernet, but what if there are two cabernets but made at different wineries? When it comes to SEBs, physicians will tell you there are differences between those wines.”
Biologic drugs are an integral and rapidly growing segment of the global pharmaceutical market. In Canada alone, combined sales for the four top-selling biologic brands exceeded $1.3 billion in 2011. In anticipation of the upcoming loss of patent on many top-selling biologics, PDCI Market Access conducted extensive interviews with more than 20 stakeholders, including representatives of the pharmaceutical industry, federal and provincial governments, provincial and private drug plans, patients, patient advocates, researchers and clinicians. PDCI Market Access asked them to provide their insights on the opportunities and challenges for subsequent entry biologics (SEBs) (also referred to as biosimilars) and their potential impact on pricing and reimbursement of biologics in Canada.
The 52-page report outlines the market landscape for SEBs in Canada and compares it with the environment in Europe and the United States. Stakeholders were posed questions such as:
- What are the key issues and opportunities associated with expanding SEB use in Canada?
- How will public and private drug plan managers reimburse SEBs? What evidence will be required for listing decisions?
- Will payers use preferential listing criteria to achieve cost-savings? If so, how much savings can payers expect?
- How will physicians feel about prescribing SEBs to patients who have had success with brand biologics?
- What are the issues and opportunities for patients in the evolving SEB market landscape?
- What expectations concerning the price of SEBs should manufacturers and industry representatives have?
- How will guidelines surrounding regulatory approval of SEBs evolve as more of these drugs enter the Canadian market?
As an added feature, Part 2 of the report contains the anonymized qualitative results from stakeholder interviews providing further insights and details from the stakeholder discussions. An appendix to the report also offers the general discussion guide used in the interviews.
To order your electronic copy of the Executive Report: Subsequent Entry Biologics in Canada: Stakeholders Discuss the Regulatory, Pricing and Reimbursement Landscape, please complete and submit the online order form or please contact Courtney Abunassar.
The cost of this report is $1,950.00 CDN, plus HST/GST or $1,950.00 USD.