Potential Life-Years Lost: The Impact of the Cancer Drug Regulatory and Funding Process in Canada

Gotfrit, Joanna; Shin, John; Mallick, Ranjeeta; Stewart, David J.; Wheatley‐Price, Paul

doi:10.1634/theoncologist.2019-0314

Cited by 24 publications

(34 citation statements)

References 49 publications

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“…Drug manufacturers then negotiate with individual provincial (state) health care payers or the pan-Canadian Pharmaceutical Alliance, which can combine negotiating power across provinces; however, the price of affordable cancer therapy in the Canadian system includes delayed regulatory submissions, prolonged price negotiations, and delayed patient access. 88,89 Although compassionate access programs and clinical trials may help bridge the gap, the impact on patients remains substantial.…”

Section: Moving Forwardmentioning

confidence: 99%

An Arm and a Leg: The Rising Cost of Cancer Drugs and Impact on Access

Leighl

Nirmalakumar

Ezeife³

et al. 2021

American Society of Clinical Oncology Educational Book

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Increasing cancer drug prices present global challenges to treatment access and cancer outcomes. Substantial variability exists in drug pricing across countries. In countries without universal health care, patients are responsible for treatment costs. Low- or middle-income countries are heavily impacted, with limited patient access to novel cancer treatments. Financial toxicity is seen across cancer types, countries, and health care systems. Those at highest risk include younger patients, new immigrants, visible minority groups, and those without private health coverage. Currently, cancer drug pricing does not correlate with value or clinical benefit. Value-based pricing of oncology drugs may incentivize development of higher-value medicines and eliminate excess spending on drugs that yield little benefit. Generics and biosimilars in oncology can also improve affordability and patient access, offering dramatic reductions in drug spending while maintaining patient benefit. Oncologists can promote value-based care by following evidence-based clinical guidelines that avoid low-value treatments. Researchers can also engage in value-based research that critically explores optimal cancer drug dosing, schedules, and treatment duration and defines patient populations most likely to benefit (e.g., through biomarker selection). Cancer Groundshot proposes that we improve outcomes for today's patients with cancer, including broader global access for high-value treatments, promotion of affordable cancer control strategies, and reduction of cancer morbidity and mortality through low-cost prevention and screening initiatives. Moving forward, major oncology societies recommend promoting uniform global access to essential cancer medicines and avoiding financial harm for patients as key principles in addressing the affordability of cancer drugs.

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Section: Moving Forwardmentioning

confidence: 99%

An Arm and a Leg: The Rising Cost of Cancer Drugs and Impact on Access

Leighl

Nirmalakumar

Ezeife³

et al. 2021

American Society of Clinical Oncology Educational Book

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“…With this revised timetable, pCPA met the targets in over 90% of submissions in 2019. Multiple procedural changes have been implemented to assist in reducing delays for new treatment options for Canadians, thereby improving social welfare [ 14 ].…”

Section: Discussionmentioning

confidence: 99%

FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment

Lim

Regier

2022

Current Oncology

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Accelerated approval (AA) by the FDA enables earlier access to promising new therapies. Health Canada has a similar process. Canada implemented a national health technology assessment (HTA) for reimbursement decisions in 2011. This study evaluated regulatory and funding timelines and decisions for FDA AA cancer therapies in Canada. The FDA’s AA of malignant hematology and oncology from January 2000–December 2019 was reviewed. Dates from Health Canada, HTA decisions and provincial listings were collected. There were 94 FDA AAs, two of which were subsequently withdrawn. Of the 92 AAs, 70 received full (46)/conditional (24) Health Canada approval, and 22 were not filed. Since the introduction of HTA, 31 out of 45 of Health Canada’s approved indications underwent HTA review: 18 received a positive recommendation conditional on cost-effectiveness, 8 were not recommended and 5 were withdrawn/suspended. The median time from the AA to any Health Canada approval is 9.4 months, from any Health Canada approval to HTA decision is 5.8 months and from HTA decision to the first formulary listing is 12.0 months. The access and timeline for the first formulary listing differences were observed between the USA and Canada due to the decision of pharmaceutical companies to submit (or not) to regulatory/HTA bodies, national procedural delays with different healthcare delivery models and submission timelines. This study demonstrates that there is delayed access to promising new therapies in Canada.

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“…Thousands of additional Canadian life-years may be lost due to delays in drug companies applying for Canadian approval plus the year or more that it takes to fund a new drug after it is approved by Health Canada [ 35 ].…”

Section: Impact Of Cumulative Delaysmentioning

confidence: 99%

Treatment Access, Health Economics, and the Wave of a Magic Wand

Bradford¹,

Batist

2022

Current Oncology

Self Cite

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New drugs are expensive, in part due to excessive drug development costs. Governments are trying to reduce drug prices. This can delay access to effective agents. A country’s access to new drugs correlates with prices they agree to pay. After Health Canada approves a drug, the Canadian Agency for Drug and Technologies in Health (CADTH) assesses it. CADTH’s approval is usually contingent on it costing ≤CAD 50,000 per quality adjusted life year (QALY) gained. This value (unchanged from the 1970s) is inappropriately low. An inflation-adjusted CAD 50,000 1975 QALY should translate into a CAD 250,000 2021 QALY. CADTH’s target also does not consider that drug development costs have risen much faster than inflation or that new precision therapies may only be used in small populations. In a separate process, proposals from the Patented Medicines Price Review Board (PMPRB) would decrease initial Canadian drug prices by 20%, but prices would fall further as sales increased, with ultimate price reductions of up to 80%. PMPRB claims its proposal would not reduce drug access, but multiple analyses strongly suggest otherwise. Government price controls target the symptom (high prices), not the disease. They translate into shortages without solving the problem. CADTH and PMPRB approaches both threaten access to effective drugs.

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Potential Life-Years Lost: The Impact of the Cancer Drug Regulatory and Funding Process in Canada

Cited by 24 publications

References 49 publications

An Arm and a Leg: The Rising Cost of Cancer Drugs and Impact on Access

An Arm and a Leg: The Rising Cost of Cancer Drugs and Impact on Access

FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment

Treatment Access, Health Economics, and the Wave of a Magic Wand

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