Impact of removing prescription co-payments on the use of costly health services: a pragmatic randomised controlled trial.

OBJECTIVES: To determine whether exempting people (with high health needs and living in areas of high deprivation) from a $5 prescription charge reduces hospital use. DESIGN: Two-group parallel prospective randomised controlled trial. SETTING: People living in the community in various regions of New Zealand. PARTICIPANTS: One thousand sixty one people who lived in areas of high socioeconomic deprivation, and either took medicines for diabetes, took antipsychotic medicines, or had chronic obstructive pulmonary disease (COPD). Of the 1053 who completed the study, just under half (49%) were Maori. INTERVENTIONS: Participants were individually randomized (1-1 ratio) to either be exempted from the standard $5 charge per prescription item for one year (2019-2020) (n = 591) or usual care (n = 469). Those in the intervention group did not pay the standard NZ$5 charge, and pharmacies billed the study for these. Participants continued to pay any other costs for prescription medicines. Those in the control group continued to pay all prescription charges for the year although they may have received one-off assistance from other agencies. MAIN OUTCOME MEASURES: The primary outcome was length of stay (hospital bed-days). Secondary outcomes presented in this paper included: all-cause hospitalisations, hospitalisations for diabetes/mental health problems/COPD, deaths, and emergency department visits. RESULTS: The trial was under-powered because the recruitment target was not met. There was no statistically significant reduction in the primary outcome, hospital bed-days (IRR = 0.68, CI: 0.54 to 1.05). Participants in the intervention group were significantly less likely to be hospitalised during the study year than those in the control group (OR = 0.70, CI: 0.54 to 0.90). There were statistically significant reductions in the number of hospital admissions for mental health problems (IRR = 0.39, CI: 0.17 to 0.92), the number of admissions for COPD (IRR = 0.37, CI: 0.16 to 0.85), and length of stay for COPD (IRR 0.20, CI: 0.07 to 0.60). Apart from all-cause mortality and diabetes length of stay, all measures were better for the intervention group than the control group. CONCLUSIONS: Eliminating a small co-payment appears to have had a substantial effect on patients' risk of being hospitalised. Given the small amount of revenue gathered from the charges, and the comparative large costs of hospitalisations, the results suggest that these charges are likely to increase the overall cost of healthcare, as well as exacerbate ethnic inequalities. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12618001486213 registered on 04/09/2018.

Prevalence of joint-specific osteoarthritis and joint pain in British Columbia, Canada.

The objective is to determine the prevalence of self-reported physician-diagnosed osteoarthritis (OA) and musculoskeletal symptoms (pain, stiffness or discomfort) in specific joints among adults in British Columbia (BC), Canada. We carried out a cross-sectional mixed-mode survey in a random population sample of persons 18 years of age and older. Estimates were weighted to reflect the age and sex distribution of the population of BC. We obtained responses from 2,233 individuals. Overall, 18.4% (95% CI 16.8-20.1) of the adult population reported OA. Of those, more than 40% had OA in multiple sites. Prevalence ranged from 8.8% (95% CI 7.6-10.1) in the knee to 2.7% (2.1-3.5) in the foot. One-year prevalence of symptoms ranged from 49.1% (47.0-51.2) in the lower back to 23.3% (21.5-25.1) in the hip. Females reported more symptoms and OA than males in all joints. The most common site of self-reported physician-diagnosed OA in BC is the knee, but OA in the hands, hips, and feet is also common. Having OA in one joint is a strong predictor of OA in other joints.

Examining non-medical prescribing trends in New Zealand: 2016-2020.

BACKGROUND: Population growth and general practitioner workforce constraints are creating increasing demand for health services in New Zealand (NZ) and internationally. Non-medical prescribing (NMP) is one strategy that has been introduced to help manage this. Little is known about the NMP practice trends in NZ. The aim of this study was to provide a current overview of the scale, scope, and trends of NMP practice in NZ. METHODS: All claims for community dispensed medicines prescribed by a non-medical prescriber were extracted from the NZ Pharmaceutical Collection for the period 2016-2020. Patient demographics were retrieved from the Primary Health Organisation enrolment collection. These national databases contain prescription information for all subsidised community pharmacy medicines dispensed and healthcare enrolment data for 96% of New Zealanders. RESULTS: The proportion of prescriptions written by all NMP providers and patients receiving NMP prescriptions increased each year from 1.8% (2016) to 3.6% (2019) and 8.4% (2016) to 14.4% (2019) respectively. From 2016 to 2019, the proportion of NMP patients who had at least one NMP prescription increased from 26% to 39% for nurse prescribers, from 1% to 9% for pharmacist prescribers, from 2% to 3% for dietitian prescribers, and decreased from 47% to 22% for dentists, and from 20% to 12% for midwives. The most commonly prescribed medicines were antibiotics (amoxicillin, amoxicillin with clavulanic acid, and metronidazole), and analgesics (paracetamol, and codeine phosphate). While some NMP providers were prescribing for patients with greater health needs, all NMP providers could be better utilised to reach more of these patients. CONCLUSIONS: This study highlights that although the NMP service has been implemented in NZ, it has yet to become mainstream healthcare practice. This work provides a baseline to evaluate the NMP service moving forward and enable policy development. Improved implementation and integration of primary care NMP services can ensure continued access to prescribing services and medicines for our communities.

Pharmacists' perceptions of their working conditions and the factors influencing this: Results from 5 Canadian provinces.

INTRODUCTION: Our previous study in British Columbia (BC) indicated that pharmacists have a poor perception of their working conditions. The objective of this study is to assess pharmacists' perceptions of their working conditions in 4 other Canadian provinces. METHODS: This was a cross-sectional study across Alberta, New Brunswick, Prince Edward Island and Newfoundland and Labrador, using a survey adapted from the Oregon Board of Pharmacy. Data collected previously from BC were also included in the analyses. The survey was emailed to all pharmacist registrants. Respondents were provided with 6 statements and asked to rate their agreement with them, using a 5-point Likert scale. Statements were framed such that agreement with them indicated good perception of working conditions. Logistic regression analyses were used to study the relationship between workplace factors on perception of working conditions. RESULTS: Pharmacists perceived their working conditions to be poor. Pharmacists indicated that they do not have time for break/lunch (48.3% of respondents), work in environments that are not conducive to safe and effective primary care (26.5%), are not satisfied with the amount of time they have to do their job (44.0%) and face shortage of staff (shortage of pharmacists: 33.7%, technicians: 36.4%, clerk staff: 30.3%). Significant factors associated with poor perception were workplace-imposed quotas, high prescription volume, working in chain pharmacies and long prescription wait times. CONCLUSION: A high percentage of Canadian pharmacists perceived their working conditions to be poor. Considering the patient-related consequences of pharmacists' poor working conditions and the system-related reasons identified behind it, we call for collaborative efforts to tackle this issue.

Inhaled corticosteroids and the risk of lung cancer in COPD: a population-based cohort study.

Inhaled corticosteroids (ICSs) are often prescribed in patients with chronic obstructive pulmonary disease (COPD). Their impact on the risk of lung cancer, a leading cause of mortality in COPD patients, remains uncertain.Population-based linked administrative data between the years 1997 and 2007 from the province of British Columbia, Canada, were used to evaluate the association between lung cancer risk and ICS use in COPD patients. COPD was defined on the basis of receipt of three COPD-related prescriptions in subjects ≥50 years of age. Exposure to ICS was incorporated into multivariable Cox regression models using several time-dependent methods ("ever" exposure, cumulative duration of use, cumulative dose, weighted cumulative duration of use and weighted cumulative dose).There were 39 676 patients who met the inclusion criteria. The mean±sd age of the cohort was 70.7±11.1 years and 53% were female. There were 994 (2.5%) cases of lung cancer during follow-up. In the reference case analysis (time-dependent "ever" exposure), ICS exposure was associated with a 30% reduced risk of lung cancer (HR 0.70 (95% CI 0.61-0.80)). ICS exposure was associated with a decrease in the risk of lung cancer diagnosis over all five methods of quantifying exposure.This population-based study suggests that ICS use reduces the risk of lung cancer in COPD patients.

Evaluating Canadians' Values for Drug Coverage Decision Making.

BACKGROUND: Decision makers are facing growing challenges in prioritizing drugs for reimbursement because of soaring drug costs and increasing pressures on financial resources. In addition to cost and effectiveness, payers are using other values to dictate which drugs are prioritized for funding, yet there are limited data on the Canadian public's priorities. OBJECTIVES: To measure the relative societal importance of values considered most relevant in informing drug reimbursement decisions in a representative sample of Canadians. METHODS: An online survey of 2539 Canadians aged 19 years and older was performed in which 13 values used in drug funding prioritization were ranked and then weighted using an analytic hierarchy process. RESULTS: Canadians value safe and efficacious drugs that have certainty of evidence. The values ranked in the top 5 by most of our subjects were potential effect on quality of life (65.4%), severity of the disease (62.6%), ability of drug to work (61.1%), safety (60.5%), and potential to extend life (49.4%). Values related to patient or disease characteristics such as rarity, socioeconomic status, and health and lifestyle choices held the lowest rankings and weights. CONCLUSIONS: Canadians value, above all, treatment-related factors (eg, efficacy and safety) and disease-related factors (eg, severity and equity). Decision makers are currently using additional justifications to prioritize drugs for reimbursement, such as rarity and unmet need, which were not found to be highly valued by Canadians. Decision makers should integrate the public's values into a Canadian reimbursement framework for prioritization of drugs competing for limited funds.

Pharmacist prescribing and care improves cardiovascular risk, but is it cost-effective? A cost-effectiveness analysis of the RxEACH study.

BACKGROUND: The RxEACH randomized trial demonstrated that community pharmacist prescribing and care reduced the risk for cardiovascular (CV) events by 21% compared to usual care. OBJECTIVE: To evaluate the economic impact of pharmacist prescribing and care for CV risk reduction in a Canadian setting. METHODS: A Markov cost-effectiveness model was developed to extrapolate potential differences in long-term CV outcomes, using different risk assessment equations. The mean change in CV risk for the 2 groups of RxEACH was extrapolated over 30 years, with costs and health outcomes discounted at 1.5% per year. The model incorporated health outcomes, costs and quality of life to estimate overall cost-effectiveness. It was assumed that the intervention would be 50% effective after 10 years. Individual-level results were scaled up to population level based on published statistics (29.2% of Canadian adults are at high risk for CV events). Costs considered included direct medical costs as well as the costs associated with implementing the pharmacist intervention. Uncertainty was explored via probabilistic sensitivity analysis. RESULTS: It is estimated that the Canadian health care system would save more than $4.4 billion over 30 years if the pharmacist intervention were delivered to 15% of the eligible population. Pharmacist care would be associated with a gain of 576,689 quality-adjusted life years and avoid more than 8.9 million CV events. The intervention is economically dominant (i.e., it is both more effective and reduces costs when compared to usual care). CONCLUSION: Across a range of 1-way and probabilistic sensitivity analyses of key parameters and assumptions, pharmacist prescribing and care are both more effective and cost-saving compared to usual care. Canadians need and deserve such care.

Risk of preterm delivery and small-for-gestational-age births in women with autoimmune disease using biologics before or during pregnancy: a population-based cohort study.

OBJECTIVES: To assess the risk of preterm delivery and small-for-gestational-age (SGA) births in women with autoimmune diseases using biologics before or during pregnancy. METHODS: Using population-based administrative data in British Columbia, Canada, women with one or more autoimmune diseases who had pregnancies between 1 January 2002 and 31 December 2012 were included. Exposure to biologics was defined as having at least one biologic prescription 3 months before or during pregnancy. Each exposed pregnancy was matched with five unexposed pregnancies using high-dimensional propensity scores (HDPS). Logistic regression modelling was used to evaluate the association between biologics use and preterm delivery and SGA. RESULTS: There were 6218 women with 8607 pregnancies who had an autoimmune disease diagnosis; of which 109 women with 120 pregnancies were exposed to biologics 3 months before or during pregnancy. In unadjusted analyses, the ORs for the association of biologics exposure with preterm deliveries were 1.64 (95% CI 1.02 to 2.63) and 1.34 (95% CI 0.72 to 2.51) for SGA. After HDPS matching with 600 unexposed pregnancies, the ORs for the association of biologics exposure and preterm deliveries were 1.13 (95% CI 0.67 to 1.90) and 0.91 (95% CI 0.46 to 1.78) for SGA. Sensitivity analyses using HDPS deciles, continuous HDPS covariate or longer exposure window did not result in marked changes in point estimates and CIs. CONCLUSIONS: These population-based data suggest that the use of biologics before and during pregnancy is not associated with an increased risk of preterm delivery or SGA births.

Testing the External Validity of a Discrete Choice Experiment Method: An Application to Latent Tuberculosis Infection Treatment.

OBJECTIVES: To explore the external validity and predictive power of stated preferences obtained from a discrete choice experiment (DCE) by comparing the predicted behavior of respondents to their actual choices at an individual level. METHODS: A DCE was performed in patients before being offered treatment for latent tuberculosis infection. A mixed logit model was estimated using hierarchical Bayes. The individual-specific preference coefficients were used to calculate the expected probability of choosing the treatment by each patient. The predicted choice using this probability was compared with their actual decision. We used a receiver-operating characteristic curve and different thresholds to convert probabilities into the predicted choices. The comparability of different distributions for the random parameters was also examined. RESULTS: Our results identified significant heterogeneity in preferences for all attributes among respondents. The best model correctly predicted actual treatment decisions for 83% of the participants. The results from using different thresholds and a receiver-operating characteristic curve also confirmed the compatibility between predicted and actual choices. We showed that individual-specific coefficients reflected respondents' actual choices more closely compared with the aggregate-level estimates. CONCLUSIONS: The results of this study provided support for the external validity of DCEs on the basis of their power to predict actual behavior in this setting. Future investigations are, however, required to establish the external validity of DCEs in different settings.

Societal preferences in the treatment of pediatric medulloblastoma: Balancing risk of death and quality of life.

PURPOSE: Medulloblastoma is the most prevalent childhood brain cancer. Children with medulloblastoma typically receive a combination of surgery, radiation, and chemotherapy. The survival rate is high but survivors often have sequelae from radiotherapy of the entire developing brain and spinal cord. Ongoing genetic studies have suggested that decreasing the dose of radiation might be possible among children with favorable molecular variants; however, this may result in an increased disease recurrence. As such, there is a need to investigate the nature of trade-offs that individuals are willing to make regarding the treatment of medulloblastoma. METHOD: We used best-worst scaling to estimate the importance of attributes affecting the general public's decision making around the treatment of medulloblastoma. After conducting focus groups, we selected three relevant attributes: (1) the accuracy of the genetic test; (2) the probability of serious adverse effects of the treatment(s); and (3) the survival rate. Using the paired method, we applied a conditional logit model to estimate preferences. RESULTS: In total, 3,006 respondents (51.3% female) with an average age of 43 years answered the questionnaires. All coefficients were statistically significantly different from zero and the attribute levels of adverse effects and the survival rate had the most impact on individuals' stated decision making. CONCLUSION: Overall, respondents showed high sensitivity to children experiencing disability particularly in the setting of a good prognosis. However, among children with poor prognostic molecular variants, participants showed tolerance about having a child with mild and partial disability compared to a low rate of survival.

Productivity Losses and Costs in the Less-Common Systemic Autoimmune Rheumatic Diseases.

PURPOSE OF REVIEW: We synthesised the literature on productivity losses and costs in the less-common systemic autoimmune rheumatic diseases: Sjogren's syndrome (SjS), systemic sclerosis (SSc), poly/dermatomyositis (PM/DM), and systemic vasculitides (SV). RECENT FINDINGS: Of 29 studies located, 12 were published 2012 onwards (SSc = 6, SjS = 2, PM/DM = 2, SV = 2). In these, 25% of PM/DM, and 21-26% of SV, were work disabled, 22% of SSc stopped work within 3 years of diagnosis, and annual costs of absenteeism in SSc averaged $12,024 2017 USD. Very few studies reported on costs, presenteeism (working at reduced levels), or unpaid productivity loss. Across multiple systemic autoimmune rheumatic diseases (SARDs), major drivers of lost productivity were generalised items like pain, depression, and fatigue, rather than disease-specific factors. Evidence suggests that work disability is common in SSc and strikes quickly. However, in SSc and other SARDs, more comprehensive estimates are needed, which include absenteeism and presenteeism from paid and unpaid work, costs, and drivers of productivity loss.

The validity of the SF-12 and SF-6D instruments in people living with HIV/AIDS in Kenya.

BACKGROUND: Health-related quality of life (HRQoL) and health state utility value (HSUV) measurements are vital components of healthcare clinical and economic evaluations. Accurate measurement of HSUV and HRQoL require validated instruments. The 12-item Short-Form Health Survey (SF-12) is one of few instruments that can evaluate both HRQoL and HSUV, but its validity has not been assessed in people living with HIV/AIDS (PLWHA) in east Africa, where the burden of HIV is high. METHODS: This cross-sectional study used baseline data from a randomized trial involving PLWHA in Kenya. Data included responses from a translated and adapted SF-12 survey as well as key demographic and clinical data. Construct validity of the survey was examined by testing the SF-12's ability to distinguish between groups known in advance to have differences in their health based on their disease severity. We classified disease severity based on established definitions from the US Center for Disease Control (CDC) and WHO, as well as a previously studied viral load threshold. T-tests and ANOVA were used to test for differences in HRQoL and HSUV scores. Area under the receive operator curve (AUC) was used to test the discriminative ability of the HRQoL and HSUV instruments. RESULTS: Differences in physical component scores met the minimum clinically important difference among participants with more advanced HIV when defined by CD4 count (4.3 units) and WHO criteria (compared to stage 1, stages 2, 3 and 4 were 2.0, 7.2 and 9.8 units lower respectively). Mental score differences met the minimum clinically important difference between WHO stage 1 and stage 4 patients (4.4). Differences in the HSUV were statistically lower in more advanced HIV by all three definitions of severity. The AUC showed poor to weak discriminatory ability in most analyses, but had fair discriminatory ability between WHO clinical stage 1 and clinical stage 4 individuals (AUC = 0.71). CONCLUSION: Our findings suggest that the Kiswahili translated and adapted version of the SF-12 could be used as an assessment tool for physical health, mental health and HSUV for Kiswahili-speaking PLHWA. TRIAL REGISTRATION: Clinical trials.gov identifier: NCT00830622 . Registered 26 January 2009.

Preferences for 'New' Treatments Diminish in the Face of Ambiguity.

New products usually offer advantages over existing products, but in health care, most new drugs are 'me-too', comparable in effectiveness and side effects to existing drugs, but with a more ambiguous evidence base around adverse effects. Despite this, new treatments drive increased health care spending, suggesting a preference for 'newness' in this setting. We explore (1) whether preferences for treatments labeled 'new' exist and (2) persist once the ambiguity in the evidence base reflecting newness is described. We use a Canadian general population sample (n = 2837) characterized by their innovativeness in adopting new products in normal markets. We found that innovators/early adopters (n = 173) had significant preferences for 'newer' treatments (B = 0.162, p = 0.038) irrespective of comparable benefits and side effects and all respondents had significant preferences for less ambiguity in benefit/side effect estimates. Notably, when 'newness' was combined with ambiguity, no significant preferences for new treatments were observed regardless of respondent innovativeness. We conclude that preferences for new products exist for some people in health care markets but disappear when the implication of ambiguity in the evidence base for new treatments is communicated. Physicians should avoid describing treatments as 'new' or be mindful to qualify the implications of 'new' treatments in terms of evidence ambiguity. Copyright © 2016 John Wiley & Sons, Ltd.

Do inhaled corticosteroids protect against lung cancer in patients with COPD? A systematic review.

Inhaled corticosteroids (ICS) are commonly prescribed to COPD patients, particularly those with more advanced stages of the disease. These patients are also at increased risk of lung cancer. A systematic review was undertaken to identify studies that examined the association between lung cancer risk and ICS therapy in COPD patients. The search strategy was created in MEDLINE and extended to EMBASE as well as other relevant databases. Both randomized controlled trials (RCTs) and observational studies were considered for inclusion. Studies were required to have incident lung cancer or deaths from lung cancer as an outcome in order to be included in the review. Six studies met the inclusion criteria. Two observational studies directly addressed the specific research. Four RCTs presented sufficient data to calculate the relative risk of lung cancer in COPD patients. None of the identified RCTs showed a statistically significant association of ICS use with lung cancer risk. Observational studies showed a protective effect from ICS use, particularly at high doses. Given the observational evidence and the low numbers of lung cancer events in the RCTs, these results may be prone to type II error. The observational studies dealt with very specific patient populations and exposure definitions, which might not have adequately captured the complex relationship between ICS exposure and lung cancer risk. Results from RCTs suggest no effect of ICS on the risk of lung cancer. However, results from observational studies suggest the potential that ICS may confer a protective effect, particularly at high doses.

Cost-effectiveness of pharmacist care for managing hypertension in Canada.

BACKGROUND: More than half of all heart disease and stroke are attributable to hypertension, which is associated with approximately 10% of direct medical costs globally. Clinical trial evidence has demonstrated that the benefits of pharmacist intervention, including education, consultation and/or prescribing, can help to reduce blood pressure; a recent Canadian trial found an 18.3 mmHg reduction in systolic blood pressure associated with pharmacist care and prescribing. The objective of this study was to evaluate the economic impact of such an intervention in a Canadian setting. METHODS: A Markov cost-effectiveness model was developed to extrapolate potential differences in long-term cardiovascular and renal disease outcomes, using Framingham risk equations and other published risk equations. A range of values for systolic blood pressure reduction was considered (7.6-18.3 mmHg) to reflect the range of potential interventions and available evidence. The model incorporated health outcomes, costs and quality of life to estimate an overall incremental cost-effectiveness ratio. Costs considered included direct medical costs as well as the costs associated with implementing the pharmacist intervention strategy. RESULTS: For a systolic blood pressure reduction of 18.3 mmHg, the estimated impact is 0.21 fewer cardiovascular events per person and, discounted at 5% per year, 0.3 additional life-years, 0.4 additional quality-adjusted life-years and $6,364 cost savings over a lifetime. Thus, the intervention is economically dominant, being both more effective and cost-saving relative to usual care. DISCUSSION: Across a range of one-way and probabilistic sensitivity analyses of key parameters and assumptions, pharmacist intervention remained both effective and cost-saving. CONCLUSION: Comprehensive pharmacist care of hypertension, including patient education and prescribing, has the potential to offer both health benefits and cost savings to Canadians and, as such, has important public health implications.

Opinions and preferences of British Columbia pharmacists and physicians on medication management services.

BACKGROUND: Medication management (MM) services are being provided by pharmacists across Canada in various forms, but pharmacist-physician collaboration is still not a routine practice in most jurisdictions. This survey aimed to gather pharmacists' and physicians' opinions and preferences for MM provision. METHODS: Two parallel, cross-sectional online surveys, including best-worst scaling tasks, were designed for pharmacists and physicians in British Columbia to capture and compare their preferences for a number of attributes of MM. RESULTS: Surveys were completed by 119 pharmacists and 146 physicians. Results indicate that pharmacists and physicians had similar opinions on many aspects of MM. Ninety-five percent of pharmacists and 69% of physicians believed that additional health services are needed to help patients optimize the use of their medications. However, the majority of each group felt that they were the most important health care professional in providing this service. Most pharmacists (79%) and some physicians (25%) thought that optimizing use of medications would result in both decreased costs and utilization to the health care system. Both pharmacists and physicians felt that the best attribute of an MM service would be if the services resulted in improved health and medication use for patients. Both groups were motivated by increased remuneration for MM; however, the relative strength of preference for this was higher among physicians. Interestingly, physicians valued improved medication adherence as a result of MM more highly than pharmacists did. DISCUSSION AND CONCLUSION: Most pharmacists and physicians agreed that improving patients' health and medication use would be the best attribute of MM and that there is a need for such services. However, physicians also had strong preferences for being remunerated for participating in MM provision.

The natural history of severe asthma and influences of early risk factors: a population-based cohort study.

BACKGROUND: Severe asthma is associated with disproportionately high morbidity, but little is known about its natural history and how risk factors at first year of diagnosis modify its subsequent development. METHODS: Using administrative health data, we retrospectively followed patients 14-55 years of age with newly diagnosed severe asthma in British Columbia, Canada. Based on intensity of resource use (drug therapy) and occurrence of exacerbations, each patient-year was classified into mild, moderate, or severe asthma. We estimated the probability of transition between severity levels or to death over the study period using a four-state Markov model, and used this to assess the 10-year trajectory of severe asthma and the influence of baseline risk factors. RESULTS: We followed 13,467 patients. Ten years after incident severe asthma, 83% had transitioned to a less severe level (mild: 43%, moderate: 40%). Low socioeconomic status, high comorbidity burden, and high adherence (proportion of days covered (PDC) by asthma controller therapy) in the first year were independently associated with, respectively, 10%, 24% and 35% more time in severe asthma over the next 10 years. Sex was not associated with the clinical course. CONCLUSIONS: Most patients with incident severe asthma used fewer resources over time, indicating a long-term transition to milder asthma. Potentially modifiable risk factors for poor prognosis of severe asthma include low socioeconomic status and high comorbidity burden. The association between PDC and future asthma severity is likely due to residual confounding by disease severity.

Excess medical costs in patients with asthma and the role of comorbidity.

Asthmatic patients frequently have comorbidities, but the role of comorbidities in the economic burden of asthma is unclear. We examined the excess direct medical costs, including asthma- and comorbidity-related costs, in patients with asthma.We created a propensity score-matched cohort of patients newly diagnosed with asthma and non-asthmatic comparison subjects, both aged 5-55 years, from health administrative data (1997-2012) in British Columbia, Canada. Health services use records were categorised into 16 major disease categories based on International Classification of Diseases codes. Excess costs (in 2013 Canadian dollars ($)) were estimated as the adjusted difference in direct medical costs between the two groups.Average overall excess costs were estimated at $1058/person-year (95% CI 1006-1110), of which $134 (95% CI 132-136) was attributable to asthma and $689 (95% CI 649-730) to major comorbidity classes. Psychiatric disorders were the largest component of excess comorbidity costs, followed by digestive disorders, diseases of the nervous system, and respiratory diseases other than asthma. Comorbidity-attributable excess costs greatly increased with age but did not increase over the time course of asthma.These findings suggest that both asthma and comorbidity-related outcomes should be considered in formulating evidence-based policies and guidelines for asthma management.

The Impact of Price-cap Regulations on Exit by Generic Pharmaceutical Firms.

BACKGROUND: In 1998, the Province of Ontario in Canada adopted price-cap "70/90" regulations whereby the first generic entrant was required to be priced at ≤70% of the associated brand-name product and subsequent generics were priced at ≤90% of the first generic price. The price-caps were further lowered to 50% in 2006 and 25% in 2010. This study assessed the impact of such price-cap regulations on exit by generic drug firms. METHODS: Formulary (2003-2012) listings of prescription drugs covered under the Ontario Drug Benefit program were used. The formulary tracks the "status" (on formulary, discontinued by manufacturer, and delisted for other reasons) for each drug. Markets were defined based on unique active ingredient and form within Ontario. Firm exit occurred when a manufacturer discontinued all its generic drugs within a market. The exit rate was defined as the number of generic firm-market exits divided by total generic firm-market follow-up years. Poisson regression was used to compare the exit rates during the 3 policy periods ("25," "50," and "70/90"). RESULTS: A total of 1126 generic manufacturers paired with 290 markets were identified. The exit rate ratio during the 25% price-cap period compared with the 70%/90% period was 2.42 (95% confidence interval, 1.56-3.77). A small manufacturer or a manufacturer in a market with ≥3 competitors or in an older market was more likely to exit. CONCLUSIONS: Lowering the price-cap level is associated with a higher incidence of generic firm exit from markets. Continuously reducing price-caps may have the unintended consequence of forcing generic firms to exit.