Consulting Services
Ensuring commercialization success
For Canadian healthcare market access challenges, InnomarConsulting™ provides solutions across the product lifecycle through unparalleled relationships and valued expertise. By partnering with our team, you help ensure the success of your launch, maximize patient access, improve sales performance, and extend brand relevancy. We help existing manufacturers, as well as those new to Canada, to develop and execute effective commercialization strategies, ensuring patients efficiently gain access to the latest advances in healthcare.
Market access strategy
With extensive experience developing innovative reimbursement strategies for specialty medications and medical devices, we have the expertise to support successful product listings in Canada. Our team works with you to understand your needs, and to develop fully customized market access strategies for the Canadian market. We can assist in your market commercialization and pricing strategy, product listing agreement negotiations, and public, private and hospital submissions.
When to start planning
When do I start planning my marketing authorization and importation submissions to Health Canada?
Importation submissions related to Drug Establishment Licenses with Health Canada may require 250 days or more for approval. New Drug Submissions can only be filed 90 days after the importation submissions have been filed. Approval of New Drug Submissions (NDSs) can take approximately a year, depending on the type of submission (standard or priority). With extensive operational expertise in the Canadian market, Innomar can act as your licensed importer of record and obtain your market authorization from Health Canada.
When should I start planning for my pricing strategy and market access submissions?
Dossiers for public and private drug plans should be prepared and submitted in advance of market authorization, even if you have received an expedited review from Health Canada. The experts at InnomarConsulting can assist in supporting both your strategy and full market access submissions.
Submission strategy and support
A well-developed submission is key to securing a positive listing recommendation and ensuring timely patient access. We help manufacturers demonstrate clinical and economic value to payers by communicating the value proposition of new products within the framework of the payer reimbursement review processes. In alignment with our clients, we develop messaging in submissions that clearly conveys the unique product characteristics that are important in the Canadian market access environment. Whether we manage the complete submission process, or tailor our support to incorporate administrative components for what you’ve already developed, we help ensure that you’re well-positioned for a successful product listing in Canada with both public and private payers.
Health Economics and Outcomes Research
We understand the importance that real-world evidence plays in market access success. Demonstrating the clinical and economic benefit of your product is vital to obtaining reimbursement. Our experienced team of health economists can help you with health economic modeling for submissions; publication and study development, including Observational, Willingness-to-Pay, Pay for Performance models and Burden of Illness studies; and Canadian adaptation of global economic models.
We have extensive experience building budget impact analyses (BIAs) for complex specialty products, including rare disease, oncology and immunology (including biosimilar) products; as well as medical device and diagnostics. Our BIA models are developed within established guidelines of individual public and private payers, and clearly articulate the incremental impact to the drug plan’s bottom-line.
Your questions, answered.
We have the knowledge and expertise to support your market access strategy and submission, as well as delivering HEOR and payer insights in preparation for commercialization. Our team has also led the strategy and execution of device submissions and pricing assessments in therapies and products ranging from cancer screening assays, to injection devices and implantable pump therapies. We can support you in determining the optimal pathway for commercialization for your product.
What should I consider when commercializing a pharmaceutical product in Canada?
In preparation for commercialization, InnomarConsulting has the industry experience and tailored solutions to support both strategy and a focused plan of action. Our trusted team can help you with:
- Market research and landscape assessment requirements
- Pricing strategy, including submission to public and private payers
- Hospital and regional health group planning
- Product listing negotiations
- Health economic modeling
- Publication and study development
- Budget impact analyses
What is the pathway to get a device or diagnostic commercialized in Canada?
The InnomarConsulting team has led the strategy and execution of device submissions and pricing assessments in therapies and products such as cancer screening assays, injection devices and implantable pump therapies. We can support you in determining the optimal pathway for commercialization including key considerations such as:
Regulatory and reimbursement requirements
Health economic evidence requirements for a hospital submission
Companion diagnostic considerations for your molecule
Payer insights and market research
Advisory boards help you recognize your product’s strengths and challenges, allowing you to validate your market access strategy. We work with highly-regarded key opinion leaders and stakeholders in the Canadian market, and can develop insightful advisory boards for your product. We help you elicit feedback from both public and private drug plan managers, leading physicians in specialized therapeutic areas, and patient advocacy groups. Additionally, our in-house market research team conducts qualitative and quantitative research to uncover deep stakeholder insights that guide your commercialization strategy.
Planning for lifecycle management and retention
Can you help me prepare for loss of exclusivity (LOE)?
From comprehensive LOE strategic planning, to evaluating pricing strategy when generic competitors enter the market, our consulting and Cameron Stewart Lifescience teams can help you plan for management and retention at every stage of the product lifecycle.
