Personalized healthcare innovations, such as tumour-agnostic treatments for cancers - which focus on genetic and molecular features regardless of the cancer type or location in the body - do not always fit into the traditional approach for funding recommendations and implementation.
Currently in Canada, a strong signal is being sent that our drug funding evaluation system is not ready to recommend public access to these personalized healthcare innovations. Most recently, both the Canadian Agency for Drugs and Technologies in Health (CADTH), which conducts evaluations of clinical, economic, and patient evidence on cancer drugs through the pan-Canadian Oncology Drug Review (pCODR) process, and its Quebec counterpart, the Institut national d'excellence en santé et services sociaux (INESSS), issued negative recommendations for VITRAKVI® (larotrectinib), Bayer Inc.’s tumour-agnostic cancer treatment. This was mainly because they were unable to accept a novel trial design; one that is required for rare oncogene-driven tumours found in different tissues in both adult and pediatric cancers. This negative recommendation was issued to all provincial and territorial drug plans and cancer agencies, and will limit the possibility that Canadians will have access to this treatment.
If Canadians want access to personalized healthcare innovations, health technology assessment agencies, public payers, and other health system stakeholders need to adapt their assessment and decision-making methods. While other international healthcare systems have specific solutions to manage the entry of approved medicines that may not fit the traditional approach, Canada has yet to develop one for its funding recommendations and implementation bodies. We are lagging behind and not providing our best to Canadian patients. The need for a new approach is clear and urgent.
Some personalized healthcare innovations come with uncertainty, such as rare or tumour-agnostic molecules for which typical randomized control trials (RCTs) are infeasible. For these classes of medicines, other options such as public drug listings conditional upon a reassessment of additional evidence generated, need to be explored in order to ensure public access to promising medicines approved by Health Canada. Public agencies such as pCODR, INESSS and the federal, provincial and territorial drug plans have stated publicly that they’re ready to pilot and build new solutions so treatments become available faster, yet these changes have not yet begun. The Canadian innovative pharmaceutical industry is ready with solutions that can be implemented today. We have the ability to generate a wealth of evidence from our trials and in the real world to appropriately manage the entry and monitor the use of personalized healthcare innovations that don’t fit the traditional approach.
Precision medicine is already changing outcomes
Medicines for rare, tumour-agnostic indications are just some examples of the wave of new personalized healthcare innovations. With a comprehensive genomic profile of their cancer, a physician can identify the genomic alteration driving a patient’s specific cancer and a targeted therapy may be designed against their specific genomic alteration. Given the large number of gene alterations, there has been significant growth in the research and development of targeted therapies.
Today, 90% of the innovative pharmaceutical industry pipeline therapies are developed for individual patients more likely to benefit from its use. This approach is helping patients live longer, better lives by ensuring each person gets the right treatment at the right time. With increasing appreciation for the complexity of cancers, clinical decisions for cancer care are shifting to a more informed approach, based on the growth and development of the disease.
Roche is moving from traditional to personal, by developing cancer medicines that redefine the diagnosis and treatment by the specific way cancer grows or escapes the immune system instead of where it’s located in the body.
Personalized healthcare extends beyond precision medicine
The scope of personalized healthcare innovations is much broader than just medicines. It’s going to change the way we get diagnosed, decide on a treatment, manage our treatment and monitor our health.
Roche is bringing personalized healthcare innovations that enable patients to have access to the best possible diagnosis and the best possible treatment that is personalized, timely and based on meaningful data. Many of these innovations will not fit the traditional approach to funding recommendations and implementation. We are bringing diagnostics for smarter decisions, such as:
- Next-generation sequencing – maps out an individual’s full genetic makeup, tumour mutations, and other defining molecular features
- Non-invasive liquid biopsies – allows patients and clinicians to track how a cancer evolves over time and adjust treatment accordingly, and
- Digital clinical support tools – puts massive amounts of data in the hands of clinicians
These technologies facilitate healthcare discussions and assist in personalized treatment decision-making.
Collaboration is key
Roche is working to ensure personalized medicine becomes the norm. We know we can’t do it alone - we all need to become active participants and advocates for our healthcare system. This is a time of remarkable collaboration across patients, clinicians, researchers, governments and the private sector. Roche is committed to working in partnership with all stakeholders so we can bring healthcare innovations to patients faster. We hope pCODR, INESSS and the Federal, Provincial and Territorial drug plans and cancer agencies take the opportunity to adapt beyond the traditional to enable access conditional upon a reassessment of additional evidence generated for a class of personalized healthcare innovations that need it - medicines with rare, tumour-agnostic indications.
December 10, 2019
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