The impact of willingness-to-pay threshold on price reduction recommendations for oncology drugs: a review of assessments conducted by the Canadian Agency for Drugs and Technologies in Health.

Since late 2020, the Canadian Agency of Drugs and Technologies in Health (CADTH) has been using a threshold of $50,000 (CAD) per quality-adjusted life-year (QALY) for both oncology and non-oncology drugs. When used for oncology products, this threshold is hypothesized to have a higher impact on the time to access these drugs in Canada. We studied the impact of price reductions on time to engagement and negotiation with the pan-Canadian Pharmaceutical Alliance for oncology drugs reviewed by CADTH between January 2020 and December 2022. Overall, 103 assessments reported data on price reductions recommended by CADTH to meet the cost-effectiveness threshold for reimbursement. Of these assessments, 57% (59/103) recommendations included a price reduction of greater than 70% off the list price. Eight percent (8/103) were not cost-effective even at a 100% price reduction. Of the 47 assessments that had a clear benefit, in 21 (45%) CADTH recommended a price reduction of at least 70%. The median time to price negotiation (not including time to engagement) for assessments that received at least 70% vs >70% price reduction was 2.6 vs 4.8 months. This study showed that there is a divergence between drug sponsor's incremental cost-effectiveness ratio (ICER) and CADTH revised ICER leading to a price reduction to meet the $50,000/QALY threshold. For the submissions with clear clinical benefit the median length of engagement (2.5 vs 3.3 months) and median length of negotiation (3.1 vs 3.6 months) were slightly shorter compared with the submissions where uncertainties were noted in the clinical benefit according to CADTH. This study shows that using a $50,000 per QALY threshold for oncology products potentially impacts timely access to life saving medications.

Do reimbursement recommendation processes used by government drug plans in Canada adhere to good governance principles?

In democratic societies, good governance is the key to assuring the confidence of stakeholders and other citizens in how governments and organizations interact with and relate to them and how decisions are taken. Although defining good governance can be debatable, the United Nations Development Program (UNDP) set of principles is commonly used. The reimbursement recommendation processes of the Canadian Agency for Drugs and Technologies in Health (CADTH), which carries out assessments for all public drug plans outside Quebec, are examined in the light of the UNDP governance principles and compared with the National Institute for Health and Care Excellence system in England. The adherence of CADTH's processes to the principles of accountability, transparency, participatory, equity, responsiveness and consensus is poor, especially when compared with the English system, due in part to CADTH's lack of genuine independence. CADTH's overriding responsibility is toward the governments that "own," fund and manage it, while the agency's status as a not-for-profit corporation under federal law protects it from standard government forms of accountability. The recent integration of CADTH's reimbursement recommendation processes with the provincial public drug plans' collective system for price negotiation with pharmaceutical companies reinforces CADTH's role as a nonindependent partner in the pursuit of governments' cost-containment objectives, which should not be part of its function. Canadians need a national organization for evaluating drugs for reimbursement in the public interest that fully embraces the principles of good governance - one that is publicly accountable, transparent and fair and includes all stakeholders throughout its processes.

Respiratory infection and otitis media visits in relation to pneumococcal conjugate vaccine use in Saskatchewan.

BACKGROUND: In Saskatchewan, pneumococcal conjugate vaccination (PCV) was offered to high-risk children in 2002 and to all infants in 2005. OBJECTIVE: To describe trends in the frequency of medical visits for lower respiratory tract infection (LRI) and otitis media (OM) in relation to PCV use during the period 1990 to 2008. METHODS: Statistics regarding the number of children covered by the health insurance plan, PCV administration, and medical visits with a diagnostic code associated with LRI and OM were provided by Saskatchewan Health. Monthly rates were analyzed using dynamic state space models. RESULTS: In all series, there was a marked seasonal cycle and some higher-than-expected winter peak values, possibly associated with epidemics of specific respiratory viruses. Three abrupt decreases in baseline rate were observed for LRI and the final one, in February 2007, could be related to the increased proportion of children vaccinated with PCV. There was no statistical correlation between PCV use and OM visit frequency. CONCLUSION: Many environmental, biological and administrative factors may influence health services use, and an effect of low magnitude of a particular vaccine pertaining to nonspecific outcomes could be obscured in time-series analyses.

HISTORIQUE: En Saskatchewan, le vaccin conjugué contre le pneumocoque (VCP) est offert aux enfants très vulnérables depuis 2002, et à tous les nourrissons depuis 2005. OBJECTIF: Décrire les tendances en matière de fréquence de rendezvous chez le médecin pour des infections des voies respiratoires inférieures (IVRI) ou une otite moyenne (OM) par rapport à l'utilisation du VCP entre 1990 et 2008. MÉTHODOLOGIE: Santé Saskatchewan a fourni les statistiques relatives au nombre d'enfants couverts par le régime d'assurance-maladie, à l'administration du VCP et aux rendez-vous médicaux dont le code médical s'associait à une IVRI ou à une OM. Les chercheurs ont analysé les taux mensuels au moyen de modèles dynamiques à espace d'état. RÉSULTATS: Dans toutes les séries, les chercheurs ont constaté un cycle saisonnier marqué et certaines valeurs hivernales de pointe plus élevées que prévu, qui s'associaient peut-être à des épidémies de virus respiratoires particuliers. Ils ont observé trois diminutions abruptes des taux de départ pour ce qui est des IVRI. La dernière, en février 2007, pourrait être liée à l'augmentation de la proportion d'enfants ayant reçu le VCP. Ils n'ont remarqué aucune corrélation statistique entre l'utilisation du VCP et la fréquence des rendez-vous liés à l'OM. CONCLUSION: De nombreux facteurs environnementaux, biologiques et administratifs peuvent influer sur l'utilisation des services de santé, et l'effet marginal d'un certain vaccin sur des issues non spécifiques peut être masqué dans des analyses de séries chronologiques.