Factors influencing delays in patient access to new medicines in Canada: a retrospective study of reimbursement processes in public drug plans

© 2019 Salek, Lussier Hoskyn, Johns, Allen and Sehgal.Individuals who rely on public health payers to access new medicines can access fewer innovative medicines and must wait longer in Canada compared to major markets around the world. New medicines/indications approved by Health Canada and reviewed for eligibility for reimbursement by the Common Drug Review or the pan-Canadian Oncology Drug Review (CDR/pCODR) from the beginning of 2012 through to the end of December 2016 were analyzed, with data taken from the relevant bodies’ websites and collected by IQVIA. This analysis investigated individual review segments – Notice of Compliance (NOC) to Health Technology Assessment (HTA) submission, HTA review time, pan-Canadian Pharmaceutical Alliance (pCPA) negotiation time, and public reimbursement decision time, and analyzed the trends of each over time and contributions to overall time to listing decisions. Average overall timelines for public reimbursement after NOC were long and most of this time is taken up by HTA and pCPA processes, at 236 and 273 days, respectively. This study confirms that Canadian public reimbursement delays from 2013-2014 to 2015-2016 lengthened from NOC to listing (Quebec + 53%, first provincial listing + 38%, and country-wide listing + 22%), reaching 499, 505, and 571 days, respectively. Over the same period, time from NOC to completion of HTA has increased by 33%, and time from post-HTA to first provincial listing by 44%. The pCPA process appears to be the main contributor to this increasing time trend, and although some provinces could be listing more quickly post-pCPA, they appear to be listing fewer products. Reasons for large delays in time to listing include the many-layered sequential process of reviews conducted before public drug plans decide whether to provide access to new innovative medicines. Although there has been some headway made in certain parts of the review processes (e.g., pre-NOC HTA), total time to listing continues to increase, seemingly due to the pCPA process and other additional review processes by drug plans. More clarity in the pCPA and provincial decision-making processes and better coordination between HTA, pCPA, and provincial decision-making processes is needed to increase predictability in the processes and reduce timelines for Canadian patients and manufacturers.Peer reviewedFinal Published versio

Essays on Pharmaceutical Economics

This thesis presents an introduction, Chapter One, and three research papers on pharmaceutical economics. In Chapter Two I examine the effect of the regulations restricting price increases on the evolution of pharmaceutical prices. A novel theoretical model shows that this policy leads firms to price new drugs with uncertain demand above the expected value initially. Price decreases after drug launch are more likely, the higher the uncertainty. I empirically test the model’s predictions using data from the Canadian pharmaceutical market. The level of uncertainty is shown to play a crucial role in drug pricing strategies. In Chapter Three, I analyze the timing of approvals and submissions of new pharmaceutical products in Canada and explore possible reasons for delays based on available data. Some commentators have claimed that Health Canada’s process for approving new drugs is excessively slow, thereby delaying access to these drugs by Canadians. However, I found that submission of new drugs to Health Canada for approval is systematically delayed compared with submissions to regulatory agencies in the United States and the European Union, which delays the availability of new drugs in Canada. I also explore the likely effects of a harmonized process of submissions between the US Food and Drug Administration and Health Canada. In Chapter Four, I investigate the effect of value-based pricing (VBP) schemes on the behaviour of innovative pharmaceutical companies when their new technology offers potential to be used for more than one patient type. I allow for the division of patients to be determined both exogenously and endogenously. When the division of patients is determined exogenously, the payer needs to consider two effects in choosing the pricing schemes: distortion in seeking approval and distortion in the prices of incumbent technologies. Marginal value-based pricing, in which price is set based on the health benefits of the patient-type with the smallest health benefits, brings both distortions. Average value-based pricing, where the price is set based on the average health benefits across patient types, does not deprive any patient type from the new technology, though it brings price distortion for both patient types. Differential value-based pricing, in which price of the new technology for each patient type is set separately, does not create any distortion. When the division of patient populations is determined endogenously, the pricing schemes do not affect the behaviour of manufacturers in seeking approval and validating marker. However, value-based pricing by itself and the cost of validating marker are the main determinants of the manufacturer’s behaviour

Price-cap regulation, uncertainty and the price evolution of new pharmaceuticals

This paper examines the effect of the regulations restricting price increases on the evolution of pharmaceutical prices. A novel theoretical model shows that this policy leads firms to price new drugs with uncertain demand above the expected value initially. Price decreases after drug launch are more likely, the higher the uncertainty. We empirically test the model's predictions using data from the Canadian pharmaceutical market. The level of uncertainty is shown to play a crucial role in drug pricing strategies

Global prevalence of microsporidia infection in cats: A systematic review and meta-analysis of an emerging zoonotic pathogen

Microsporidiosis in pet and stray cats is an emerging zoonotic threat with public health significance worldwide. However, the epidemiological patterns of feline microsporidiosis is still neglected around the world. Hence, current systematic review and meta-analysis aimed at characterizing the prevalence estimates and genotypes of microsporidian parasites among cats of the world. Several databases (PubMed, Web of Science, Scopus, and Google scholar) were systematically explored to find relevant studies. Evaluation of the weighted prevalences among included studies was done using random-effects model. Totally, 30 studies (34 datasets) reported from 19 countries were included in the present work. Microsporidia infection demonstrated higher prevalence rates using microscopy 29.7 (19.7�42.2 ), followed by serology and molecular techniques with 11 (4.6�24.2 ) and 8.2 (5.9�11.4 ), respectively. Moreover, molecular data showed Enterocytozoon bieneusi as the most dominant reported species with 7.4 (5.1�10.5 ). Also, investigations (11 studies) mostly isolated D genotype among all E. bieneusi genotypes. These results highlight cats as a potential reservoir for acquisition of microsporidia infection in humans, and surveillance programs should be implemented in high-risk areas. © 2021 Elsevier B.V

Global prevalence of Cryptosporidium spp. in cats: a systematic review and meta-analysis

The One-Health approach highlights that the health of human populations is closely connected to the health of animals and their shared environment. Cryptosporidiosis is an opportunistic zoonotic disease considering as global public health concern. Cats are considered as one of potential host for transmitting the Cryptosporidium spp. infection to humans. A random-effects meta-analysis model was used to estimate the overall and the subgroup-pooled prevalence of Cryptosporidium spp. across studies, and the variance between studies (heterogeneity) were quantified by I2 index. Eighty articles (including 92 datasets), from 29 countries met eligibility criteria for analysis. The pooled global prevalence (95% CI) of Cryptosporidium spp. in cats was 6% (4–8%), being highest in Africa 14% (0–91%) and lowest in South and Central America 4% (3–7%) countries. Considering the detection methods, the pooled prevalence was estimated to be 26% (1–67%) using serological detection methods, 6% (3–10%) using coproantigen detection methods, 5% (3–7%) using molecular detection methods, and 4% (3–7%) using microscopic detection methods. The highest prevalence of Cryptosporidium spp. was found in stray cats 10% (5–17%), while pet (domestic) cats 4% (3–7%) had the lowest prevalence. These results emphasize the role of cats as reservoir hosts for human-infecting Cryptosporidium spp. Prevention and control of this zoonosis in cats should receive greater attention by health officials and health policymakers, especially in countries where prevalence are highest