November 28, 2016
Companion Diagnostics and Personalized Medicine in Canada: An Overview of the Current Landscape
In September 2016, Innomar Strategies hosted its fifth InnomarLive Conference Series, Companion Diagnostics and Personalized Medicine, to discuss the evolving needs and changing healthcare landscape in Canada with the advent of CDx. The expert panel highlighted gaps and opportunities in the fragmented Canadian ecosystem, and how the market might embrace CDx. Throughout the session, three major themes were clear: there is limited Canadian healthcare policy to support uptake and innovation in CDx; there is an unclear CDx regulatory pathway; and most importantly, there is a lack of clarity and consistency in the market access pathway.
Limited Canadian CDx Healthcare Policy
The ability to use CDx in clinical practice, and incentivize investment and development in CDx, is related to a supportive health policy; however, limited policies have been put in place. Katherine Bonter, representing BioCanRX, a not-for-profit network of Centres of Excellence, described a project she has initiated with the organization called “Alliance for Innovation in Molecular Diagnostics”. This alliance with public and private stakeholders was created “to inform Canadian policy and improve the innovation environment for CDx”. Their first step was to collect a list of all healthcare system CDx implementation issues described in Canadian publications to ensure that all issues were clearly understood. Among issues identified were: disjointed coverage decisions; a non-transparent evaluation process; lack of clarity in how decision-makers prioritize tests for evaluation; and hospital- and Health Technology Assessment (HTA)-based decisions which differ within each province. The BioCanRX plan is to gather public and private stakeholders to prioritize and propose solutions to the identified issues as a “call to action”.
Katherine Bonter also highlighted the interprovincial variability in regulations and operations, and data requirement as issues that affect CDx uptake and deters development. Regulation of diagnostic services is at the provincial level, which can lead to different regulatory frameworks and approaches. In addition, the process to gain access to diagnostic tests, and operations of diagnostic labs can vary dramatically across the provinces. Finally, although data to support the value and utility of CDx is important, criteria used may be ill-defined, and payers put the onus on manufacturers to bear the costs of data and analytics.
Unclear CDx Regulatory Pathway
In Canada, the regulatory environment has not kept up with the advances in personalized medicine. According to Anne Tomalin, President of Therapeutic Products Inc., a leading Canadian regulatory consulting firm, there is no clear definition of CDx, nor regulation, guideline or policy that deals with CDx in Canada. She cautions that this lack of clarity in the CDx regulatory pathway has the “high potential to result in mismatched approved drug/device combinations in the clinical setting.”
From a regulatory perspective, Tomalin advised that a CDx is considered an in vitro diagnostic device (IVDD) and is submitted separately from its corresponding drug product: IVDDs are regulated through the Medical Device Bureau of the Therapeutic Products Directorate (TPD), and the drug product is regulated by the TPD or the Biologics and Genetics Therapies Directorate (BGTD). Although difficult to coordinate, the review process should occur in parallel to ensure that the drug and CDx receive marketing authorization at the same time. In addition, it is advisable that the IVDD is part of the corresponding drug product pivotal studies, and the IVDD and drug product are written into each other’s label, to optimize the use of the matched CDx in clinical practice.
Lastly in the regulatory process, a CDx sponsor must also submit an application for a Medical Device Establishment License (MDEL) in order to distribute the device in Canada. According to the Medical Device Classification, a CDx is typically a class II or class III device, depending on the level of risk1.
Variability in CDx Market Access
The CDx market access evaluation framework and funding decision process differs for a CDx, and can vary across jurisdictions. Ron Weingust, a Consultant, from Diagnosis, Solutions & Results Inc., reviewed the challenges to align the review and reimbursement for CDx.
Currently, HTAs are used to inform reimbursement recommendations for CDx, but in addition to CADTH, the HTA may come from a variety of sources: provincial HTA agencies (e.g. INESSS, OHTAC), provincial ministries of health, and hospitals. Once a recommendation has been made, funding for CDx may come from different sources, including hospitals, provincial cancer agencies, pharmaceutical companies and private payers.
Payers have different views on the utility of CDx. Ned Pojskic, Pharmacy Strategy Leader at Green Shield Canada, highlighted that many payers are intrigued with the potential benefits of pharmacogenomics testing, but cautions that CDx are “one approach to help optimize drug therapy and not a panacea” and until cost and clinical effectiveness have been well-established, “should we pay for it?”
At the hospital level, hospital laboratories are the gatekeepers for access to a CDx. Dr. Michael Mengel, Chair of the Department for Laboratory Medicine and Pathology at the University of Alberta, provided insights into how CDx are adopted, and the realities of diagnostic testing in a public healthcare system. Dr. Mengel described the fact that hospital laboratories have finite budgets: listing a new diagnostic test can mean delisting another and “taking away health from someone else”. In addition to the acquisition costs of the test kit, there are also system-wide costs they must take into consideration, including labour, IT infrastructure, knowledge, and capital investment. Currently, Alberta is adopting a step-wise iterative process to make decisions on diagnostic test listing, delisting, and usage.
Need for a Comprehensive Solution
The need for drugs with a CDx and a comprehensive solution for access is critical due to the potential impact on patient outcomes. In her presentation on the struggles to gain access to CDx from a patient perspective, Louise Binder, Health Policy Consultant at the Canadian Cancer Survivor Network, related that CDx can be a cornerstone of effective cancer treatment and access to tests is crucial. Durhane Wong-Reiger, President and CEO of the Canadian Organization for Rare Disorders (CORD), highlighted that the use of CDx can translate into improved care: access to diagnostics is life-changing in the rare disease space – it leads to better treatments and better therapies; however, without change, “and [if we] use the existing pathway, it’s not going to work.”
The pathway to CDx market access is complex, and the requirements for innovation adoption are often unclear; however, there is a sense of urgency and recognition that stakeholders need to work together toward reform, due in particular to the robust drug/CDx pipeline, in order to provide real value and change in patient management.
1. Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016), Health Canada, Health Products and Food Branch Inspectorate. April 1, 2013 http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0016-eng.php