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We asked our speakers the following question regarding the latest regulatory and payer updates, and they were kind enough to share their insights with us:
What are the main challenges to ensure fast access to treatments?
BC Ministry of Health
Public drug plans need to balance various considerations when making drug coverage decisions and the “time-to-listing” is just one of them. Public drug plans use various process mechanisms to help select drugs that are safe, efficacious, clearly address an unmet need and are cost-effective and affordable. Such national mechanisms include the CADTH Common Drug Review (CDR) and the pan-Canadian Pharmaceutical Alliance (pCPA). Drug products that provide clear clinical and economic value and are affordable will typically move efficiently through. However, products with unclear clinical value with high concerning costs are more challenging.
As Drug Access Navigators, the main challenges we see with ensuring fast access to treatments is the processing time from private insurance and government. Once a physician has seen a patient and prescribed a medication, the clock starts ticking. Most of our drugs require prior authorization due to their high prices and these often take a week or more to get approval. This can be very stressful to patients who need to start as soon as possible. If an appeal must be made, the delay can extend another week or more. For public coverage in Ontario, there is the processing times for the Exceptional Access Program (EAP) and Trillium enrollments that cause delays. If more information is requested by government, delays can stack up.
The current regulatory system for approval of therapeutic products was designed with limited consideration of health care system needs.
Like our international counterparts, to address this, Health Canada must become more flexible and adaptable by facing the following challenges to improve access to necessary treatments:
- Prioritizing the review of therapeutic products that meet healthcare system needs
- Reducing lag times between new product reviews and funding decision; and
- Increasingly use post-marker data to inform regulatory decisions across the product life cycle.
In an environment where submission requirements and deadlines are clear, the main challenges to fast access to treatments is with managing how submissions for innovative treatments are being received and reviewed. This involves communication with the leads for submissions in the public and private markets, and stakeholders who want the benefit of a new treatment being available in the Canadian market, most notably patients and health care providers seeking to improve the lives of patients. To ensure expedited reviews, a value proposition supported by clear and relevant evidence is essential to helping busy government and private market staff work through a product proposal. And while the submission process evolves with the incorporation of real-world evidence and risk-sharing, the less hinged a submission is on other factors, the easier it is to interpret, review and ideally, ensure optimized patient access to innovative treatments.
Kidney Cancer Canada
From the cancer patient perspective, the main challenges include lack of essential infrastructure within and across provinces/territories to measure the effectiveness of treatments — to collect real world outcomes data, including outcomes that matter most to patients and their families.