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.
Highlights
Once sufficient clinical trials data are available to support an application for drug approval, many companies apply first to the United States (US) Food and Drug Administration (FDA)
If approved by CADTH, the drug passes to the pan-Canadian Pharmaceutical Alliance, which negotiates a price with the company on behalf of all provinces and territories except Quebec. pCPA aims to complete its negotiations in 6.5 months [32]
The decrease in value is even greater than 80% because the 1970s target was in US dollars and CADTH’s current target is in cheaper Canadian dollars
Summary
The most important factor that causes delays is the time required for clinical trials that are needed to demonstrate drug efficacy. 2. Drug Development and Clinical Trials It takes too long to accrue the data required for drug approval. Drug Development and Clinical Trials It takes too long to accrue the data required for drug approval Several factors slow clinical trials and thereby contribute to the long timelines for drug development [4,5]. Some people have even advocated regulatory changes that would further slow the development and availability of new anticancer drugs Their rationale is that these changes would lessen the potential negative impact of cancer spending on other areas of healthcare [6]. We urgently need major reforms that are lifesaving by being timesaving [9]
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