Access to Oncology Medicines in Canada: Consensus Forum for Recommendations for Improvement

Abstract

Patient access to new oncology drugs in Canada is only possible after navigating multiple sequential systemic checkpoints for national regulatory approval, health technology assessment (HTA) and collective government price negotiation. These steps delay access and prevent health care providers from being able to prescribe optimal therapy. Eighteen Canadian oncology clinicians from the medicine, nursing and pharmacy professions met to develop consensus recommendations for defining reasonable government performance standards around process and timeliness to improve Canadian cancer patients’ access to best care. A modified Delphi methodology was used to identify consensus on 30 questions involving five themes: accountability, disparities, endpoints, timeliness, and cost-effectiveness. It was agreed that greater transparency is required across regulatory and HTA processes. Health professionals in oncology are frustrated for their patients because they are unable to deliver the modern guideline-supported therapies they want to provide due to delays in approval or funding. Canadian health care providers request improvements in timely access to life-saving therapeutics in line with other comparator countries. Clinicians expect urgent improvements in Canadian health systems to give our patients their best chance of survival.

Timeliness of Health Technology Assessments and Price Negotiations for Oncology Drugs in Canada

“…Patients and providers are often frustrated and concerned about the lack of transparency in CADTH's and the pCPA's processes. [29][30][31]40,41 CADTH and the pCPA are both non-profit corporations, not government departments. As such, they do the work for governments, but the traditional accountability tools and requirements of freedom of information requests, independent ombudsperson appeals, and parliamentary auditor-general performance reviews do not apply to them.…”

“…Many calls have been made for Canada to reduce delays in patient access to new oncology medicines via government drug plans. [3][4][5]11,12,15,[29][30][31]47 Canada's governments have established HTA and price negotiation organizations and allowed them to develop procedures without accountable performance targets. Even when a drug has passed through these processes, government drug plans do not automatically list the medicine, leading to further delays.…”

“…28 Health professionals want to be able to prescribe what they consider to be optimal therapy for their patients as soon as the drugs are available and patients are concerned that their access is not delayed. 15,[29][30][31] Delays due to processes like HTAs and price negotiations exacerbate these concerns. The objective of this work was to evaluate whether the CADTH and pCPA time standards are achieved for oncology therapies with a reimbursement recommendation issued during the 10-year period, January 2014 to December 2023.…”

New Anticancer Drugs: Reliably Assessing “Value” While Addressing High Prices

“…Unlike Germany, England and Wales, France, Italy and Australia, Canada does not have a mechanism to permit publiclyfunded early access to innovative oncology therapies prior to HTA assessment [107]. Compounding this is the problem that the HTA process for drugs in Canada is uniquely long and complex [109]. It involves several different bodies and stakeholders [110].…”

“…While there recently have been examples of a few drugs being recommended for approval based on single-arm phase II data [111], there are other instances where this has not been the case [114,115]. The lack of consistency and transparency from pCODR in this context is a source of frustration [109].…”