Tuesday, June 18, 2024

Early Access to Promising Oncology Drugs: A Look at Canada’s Successful NOC/c Policy

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Health Canada’s Notice of Compliance with Conditions (NOC/c) policy has proven effective in providing Canadians with faster access to new oncology drugs based on promising data. A retrospective cohort analysis published in the Canadian Journal of Health Technologies supports this by reviewing NOC/c approvals, focusing on confirmatory studies, the time to confirmatory evidence submission, and how many therapies have become standard care. This report, produced by the Real-World Evidence (RWE) Oncology Working Group under the Real-World Evidence Steering Committee’s auspice, chaired by Health Canada and Canada’s Drug Agency (CDA-AMC), offers valuable insights. The findings present an opportunity to understand trends related to Canada’s NOC/c policy and address uncertainties or evidence gaps identified in conditional regulatory approvals.

The trend of NOC/c authorizations for oncology drugs has significantly increased, with 94% of NOC/c issued from 2018 to 2021 for oncology drugs, compared to 11% from 1998 to 2001. More than half of the NOC/c authorizations for oncology drugs had all conditions lifted within five years. The majority (85.7%) of oncology drugs issued a NOC/c between 2018 and 2021 are now integrated into standard care guidelines for their indications in Canada, highlighting the regulatory pathway’s benefits.

The analysis suggests potential enhancements to the regulatory pathway, such as strategies to reduce the time for completing confirmatory trials and considering complementary RWE to address evidence gaps.Globally, health technology assessment (HTA) bodies, including CDA-AMC, are also working to meet decision-makers’ information needs for drugs approved through expedited pathways. For drugs receiving an NOC/c from Health Canada and meeting other criteria, CDA-AMC may issue a time-limited reimbursement recommendation. Additionally, a parallel review process allows drug sponsors to submit up to 180 days before Health Canada’s regulatory decision, minimizing delays between regulatory and reimbursement decisions.

Streamlining Access and Evidence: Collaboration for Effective Oncology Drugs

These efforts ensure that HTA and regulatory pathways work in parallel, supporting earlier access to promising new drugs and creating mechanisms to revisit clinical and economic evidence as it evolves. This collaborative approach aims to maintain the balance between timely access to innovative therapies and ensuring that these treatments are backed by robust evidence.

The establishment of the time-limited reimbursement recommendation category for drugs with NOC/c approval, launched in 2023, is one example of how CDA-AMC is adapting to changes in drug development and regulation. This initiative reflects a broader trend in health policy, where regulatory and HTA bodies collaborate more closely to streamline the approval and reimbursement processes.

The positive impact of the NOC/c policy on oncology treatments in Canada cannot be overstated. By facilitating quicker access to new drugs, the policy helps address the urgent needs of cancer patients who require innovative treatments. The integration of most NOC/c-approved oncology drugs into standard care guidelines demonstrates the policy’s success in ensuring that promising therapies reach patients more swiftly. Moreover, the policy’s emphasis on confirmatory studies ensures that the initial approval based on promising data is rigorously validated through subsequent research. This approach balances the need for expedited access with the assurance that treatments meet high standards of safety and efficacy.

Oncology Drugs

Learning from Success: NOC/c Policy in Oncology Paves the Way for Wider Applications

The success of the NOC/c policy in oncology is paving the way for its application in other therapeutic areas. A subsequent project by the RWE Steering Committee’s Non-Oncology Working Group will explore the NOC/c policy’s impact on non-oncology drugs. This report is expected to be published later in 2024 and will provide further insights into the policy’s broader applications. As the healthcare landscape continues to evolve, policies like the NOC/c demonstrate the importance of adaptive regulatory frameworks that can respond to the fast-paced developments in drug research and development. The ongoing collaboration between regulatory bodies, HTA agencies, and drug developers is crucial in ensuring that patients receive timely access to new and effective treatments.

In conclusion, Health Canada’s NOC/c policy has significantly improved access to promising oncology therapies in Canada. The policy balances expedited access and ensuring treatment efficacy and safety by enabling faster approval based on early data and requiring subsequent confirmatory studies. The collaborative efforts of regulatory and HTA bodies, as seen in the parallel review process, further enhance the efficiency of the approval and reimbursement pathways.

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As this policy continues to evolve and expand to other therapeutic areas, it represents a critical step towards more responsive and adaptive healthcare regulations. The success of the NOC/c policy in oncology sets a precedent for different regions and regulatory frameworks to follow, highlighting the potential of conditional approvals to transform patient access to innovative treatments.

 

Resource: Canada’s Drug Agency, May 30, 2024

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