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

Abstract

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.

Beyond Participation: Evaluating the Role of Patients in Designing Oncology Clinical Trials

“…This blanket approach does not take into account the very different risk–reward decision-making criteria facing patients with lethal diseases, who are virtually certain of near-term death and poor quality of life without access to promising treatments. The current approach not only impedes timely access to promising treatments for patients with life-threatening conditions but also makes them more costly [ 52 ]. These delays and costs lead to a significant loss of life years [ 53 , 54 ].…”

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

“…The threshold was originally proposed in the 1980s for end-stage renal disease kidney dialysis cost-effectiveness and became widely used for the cost-effectiveness of medications in the 1990s [9]; it has never been updated for inflation, the complexity of new medicines, or the increase in drug prices. In addition, 94.4% strongly agreed that pCPA-negotiated rebates should be reinvested in provincial cancer drug programs and not into general government accounts Over 83% of the participants agreed or strongly agreed that planned PMPRB restrictions will limit Canadian patients' access to clinical trials [3][4][5][6] (one participant commented that "this is already a reality") and compassionate access programs. There was consensus that risksharing agreements should be sought by the pCPA for new drugs.…”

“…For example, between 2006 and 2014, just under 90% of new oncology drugs submitted for regulatory review in the United States and/or the European Union were submitted to Health Canada as well. However, the percentage of oncology medicines approved in the United States or the European Union coming to Canada steadily decreased from an average of 86% between 2006 and 2014 to only 50% in 2020 [2] when Patented Medicine Prices Review Board (PMPRB) reforms were proposed that would drastically reduce Canadian drug pricing [3][4][5][6]. These reforms were well intended but ill-considered and soundly rejected after national uproar, using unrealistic cost thresholds and not considering the special issues facing drugs for cancer or rare disorders.…”