opinion: car t-cell therapy delays jeopardize lives of canadians with blood cancer
we call for a multi-stakeholder approach that includes government, regulatory and reimbursement bodies, the pharmaceutical industry, clinician and patient leaders to develop solutions that address both healthcare system challenges and the plight of patients who cannot afford to wait.
6 minute read
access to car t-cell therapy is a challenge in a healthcare system riddled with frustrating delays in the approval process, bureaucratic obstacles, and limited patient access.
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blood cancers represent 10 per cent of all cancer cases in canada and affect people of all ages. it is the third leading cause of cancer-related deaths in canada. car t-cell therapies have changed the treatment paradigm for the management of patients with blood cancers, most notably aggressive b-cell lymphoma and acute lymphoblastic leukemia (all). this new standard of care offers renewed hope to those who have exhausted conventional therapies, and a chance for long-term survival.
clinical trials and real world experiences alike have proven the remarkable potential of car t-cell therapy, demonstrating its ability not only to yield durable remissions but, in some cases, to effect complete responses for patients with relapsed or refractory disease. however, implementation and accessibility pose formidable challenges in a healthcare system riddled with frustrating delays in the approval process, bureaucratic obstacles, and limited patient access (see “car t-cell therapy: a canadian timeline,” below). these delays thrust patients into a state of uncertainty, while the urgency of cancer demands swift action in delivering life-saving treatments. as car-t expands into different indications (like multiple myeloma) and in earlier lines of treatment, providing more people living with cancer more hope, the challenge of providing access to patients will get even more complex.
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access to car t-cell therapy can have an unprecedented impact on patients
where we are today presents a unique opportunity to evaluate the hurdles and explore avenues for widespread and efficient car-t utilization in an equitable and sustainable manner for all patients, in all geographic regions. especially in the context of a public payer healthcare system like canada’s, ensuring the expansion of public funding for car-t cell programs contributes to improving the overall health and well-being of individuals living with cancer. the funding and approval process is not currently set up to keep pace with the science and skill of canadian doctors to deliver the newest and quickly improving life saving therapies. however, the need to inform decision making regarding cart-cell therapy is both critical and pressing.
a comprehensive reform of the reimbursement and approval system is complex and time-consuming, however, timely reimbursement, approval, and increased access to car t-cell therapy can have an unprecedented impact on patient outcomes. this process carries unparalleled implications for healthcare budgets, and resource allocation.
in light of these complexities, we call for a multi-stakeholder approach that includes government, regulatory and reimbursement bodies, the pharmaceutical industry, clinician and patient leaders to develop sustainable solutions that address not only healthcare system challenges, but also the plight of patients who cannot afford the luxury of delay.
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the lives of people living with cancer hang in the balance of these crucial decisions, and we must act decisively to usher in a new era of hope and healing.
sabrina hanna, bsc. is the managing director of the cancer collaborative (colab), the cance collaborative a patient-driven think tank dedicated to bridging science, policy and advocacy, to accelerating policy change, contributing to a more reflective and informed decision-making process in cancer care. and bringing the right people together to think about the unique challenges proactively, and collaboratively.
this piece was written on behalf of keith mcintosh, chair, and dean duffin, advocate, with the advocacy for canadian childhood oncology research network (ac2orn); martine elias, msc., executive director, myeloma canada; antonella rizza, ceo, lymphoma canada; stephane maier, phd executive director, cell therapy transplant canada (cttc); and christina sit, manager, community and strategic partnerships, leukemia & lymphoma society of canada.
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car t-cell therapy: a canadian timeline
the following provides an overview of how long canadians are waiting to access car t-cell therapies across canada. it is meant for informational purposes only.
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tisagenlecleucel (kymriah) pediatric and young adult patients up to and including 25 years of age with b-cell acute lymphoblastic leukemia (all) who are r/r (relapsed or refractory) after allogeneic stem cell transplant (sct) or are otherwise ineligible for sct, or have experienced second or later relapse. (pall) and adult patients with r/r large b-cell lymphoma after two or more lines of systemic therapy including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, high grade b-cell lymphoma and dlbcl arising from follicular lymphoma
- health canada september 2018
- cadth recommendation posted january 2019
- inesss recommendation posted january 2019 pall
- inesss recommendation posted january 2019 dlbcl
- first provincial listing quebec october 2019, ontario december 2019, alberta january 2021
- british columbia november 2022 for out of province access
*did not go through the pcpa process
axicabtagÈne ciloleucel (yescarta) the treatment of adult patients with r/r large b cell lymphoma (lbcl) after two or more lines of systemic therapy, including dlbcl not otherwise specified, primary mediastinal large b-cell lymphoma (pmbcl), hgbl, and dlbcl arising from follicular lymphoma
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- health canada february 2019
- cadth recommendation posted august 2019
- inesss recommendation posted august 2019
- first provincial listing ouébec and ontario december 2020, alberta january 2021
- british columbia for out of province access november 2022
idecabtagene vicleucel (abecma) for adults with multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody, and who are refractory to their last treatment
brexucabtagene ciloleucel (tecartus) the treatment of adult patients with r/r mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor.
- health canada approved october 2021
- cadth submission received december 2020
- cadth review initiated january 2021
- cadth final recommendation posted august 2021
- inesss evaluation posted july 2021
- pcpa engagement letter issued november 2021
- pcpa negotiation process concluded november 2022
- first provincial listing québec – november 2022, ontario – december 2022, alberta – january 2023
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lisocabtagÈne maraleucel (breyanzi)
r/r large b-cell lymphoma after two or more lines of systemic therapy, including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, primary mediastinal large b-cell lymphoma (pmbcl), high grade b-cell lymphoma, and dlbcl arising from follicular lymphoma
tisangenlecleucel (kymriah) for the treatment of adult patients with relapsed or refractory grade 1, 2, or 3a follicular lymphoma (fl) after two or more lines of systemic therapy
- health canada december 2022
- cadth review initiated february 2023
- cadth final recommendation posted september 2023
- inesss no information listed
- pcpa under consideration for negotiation
axicabtagÈne ciloleucel (yescarta) the treatment of adult patients with r/r grade 1, 2 or 3a follicular lymphoma (fl) after two or more lines of systemic therapy
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axicabtagÈne ciloleucel (yescarta) the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl) or high-grade bcell lymphoma (hgbl) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
ciltacabtagene autoleucel (carvktyi) r/r multiple myeloma
brexucabatagene ciloleucel (tecartus) treatment of adult patients with r/r b-cell precursor acute lymphoblastic leukemia (all).
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