Cost Effectiveness of Subcutaneous Vedolizumab for Maintenance Treatment of Ulcerative Colitis in Canada.

BACKGROUND AND OBJECTIVES: Ulcerative colitis is highly prevalent in Canada and cost-effective ulcerative colitis therapies are warranted. Vedolizumab subcutaneous (SC) formulation was recently approved for ulcerative colitis maintenance therapy. We assessed vedolizumab SC cost effectiveness vs conventional and advanced therapeutics in patients with moderately to severely active ulcerative colitis from a Canadian public healthcare payer perspective. METHODS: A hybrid decision tree/Markov model was developed to evaluate vedolizumab SC costs, quality-adjusted life-years, and cost effectiveness vs conventional therapy, adalimumab SC, infliximab intravenous, golimumab SC, tofacitinib, ustekinumab SC, and vedolizumab intravenous. This model predicts the number of patients achieving clinical response and remission after treatment induction, and sustained benefit during maintenance treatment. To account for statistical uncertainties, the base-case analysis was conducted in a probabilistic manner. Scenario analyses examined the impact of previous treatment with anti-tumor necrosis factor agents, dose escalation, loss of efficacy, and treatment adherence. RESULTS: In the base-case analysis, conventional therapy was the most cost-effective therapeutic option in the overall population. Vedolizumab SC was cost effective and dominant compared with other advanced therapies (adalimumab, golimumab, infliximab, tofacitinib 5 mg, ustekinumab, and vedolizumab intravenous). The annual vedolizumab SC cost per patient was reduced vs ustekinumab SC, tofacitinib 5 mg, vedolizumab intravenous, and golimumab SC by $47,024, $3251, $2120, and $2004 (Canadian dollars), respectively, and exceeded that of infliximab, adalimumab, and conventional therapy by $582, $3293, and $41,024, respectively. Among the treatments, vedolizumab SC generated the highest quality-adjusted life-years overall (14.21), which translated into the best incremental cost per quality-adjusted life-years gained over conventional therapy in the overall population ($109,374) and in anti-tumor necrosis factor-naïve and anti-tumor necrosis factor-experienced patients ($41,658/$114,287). CONCLUSIONS: Conventional therapy offered the most cost-effective therapeutic option followed by vedolizumab SC. Based on a $50,000/quality-adjusted life-year threshold, vedolizumab was cost effective in anti-tumor necrosis factor-naïve patients but not the overall population also when compared to conventional therapy.

Real-World Observational Study on the Characteristics and Treatment Patterns of Allergic Asthma Patients Receiving Omalizumab in Canada.

BACKGROUND: Omalizumab is a treatment option for pediatric and adult patients with moderate to severe allergic asthma poorly controlled with standard inhaled therapies. Clinical trials and observational studies have demonstrated the efficacy of omalizumab. There is limited real-world evidence on the characteristics and treatment patterns of Canadian asthma patients receiving omalizumab. OBJECTIVE: We profiled Canadian omalizumab users to estimate time to omalizumab discontinuation and to assess changes in concurrent medication usage before, during, and after therapy. METHODS: This was a retrospective, observational, cohort study that analyzed data from Canadian prescription claims databases. An algorithm was used to select naïve users of omalizumab with an inferred diagnosis of GINA 5-asthma who made a claim for omalizumab from February 1, 2007, to June 2, 2015. Demographic and baseline characteristics were assessed at index. Outcomes examined over the analysis period included (i) daily omalizumab dose per patient and per claim; (ii) omalizumab discontinuation (defined as ≥100-day gap in making omalizumab claims) and its potential predictors (ie, age, sex, province of residence, drug insurer; assessed by Cox Proportional Hazards Model); and (iii) for patients who discontinued omalizumab, changes in concurrent medication usage before, during, and 6 months after omalizumab usage. RESULTS: The final study cohort consisted of 1160 patients (mean age: 45.8 ± 15.2 years; 64.7% female). During the first year of omalizumab therapy, 29.5% of patients discontinued treatment. The singular characteristic that predicted omalizumab discontinuation with statistical significance was age group (20‒34 years vs 12‒19 years; hazard ratio 1.75, 95% confidence interval 1.11-2.76; P<0.05). There were significant reductions in the use of some concurrent inhaled and oral asthma medications during and/or after omalizumab use (P<0.05). CONCLUSION: Nearly one-third of patients who initiated omalizumab in Canada for refractory, moderate to severe allergic asthma discontinued treatment during the first year.

Prevalence of dry eye disease in Ontario, Canada: A population-based survey.

PURPOSE: Population-based cross-sectional survey in Ontario to estimate the 2016 prevalence of dry eye disease (DED) and associated risk factors among adults in Canada. METHODS: We emailed the 5-Item Dry Eye Questionnaire (DEQ-5) to 124,469 Ontario adults (age ≥18 years) in the IQVIA E360 database, March-April 2017. Inclusion criteria were: ≥2 visits to an Ontario based clinic, ≥1 visits in the 1 year before the study; database record with email. DED was defined as a DEQ-5 score of >6/22. The crude prevalence by age/sex of the Ontario sample was adjusted to the 2016 Canadian population (mean age 41.0 years, 51% female). Significance of DED risk factors (age, sex, selected diseases/medical conditions and medications) was evaluated by logistic regression analysis. RESULTS: Of the 5163 (4.1%) patients who completed the survey (59.5% female, median age, 46 years; 40.4% male, 56 years), 1135 respondents reported DED. Prevalence increased with age (p < 0.05) and was highest among those aged 55-64 years (24.7%; 95% CI, 22.1-27.3%) and lowest among those aged 25-34 years (18.4%; 95% CI, 15.9-21.0%). Prevalence was significantly higher (p < 0.001) among women (24.7%; 95% CI, 23.2-26.2%) than men (18.0%; 95% CI, 16.4-19.7%). Other risk factors were not significant. The age-/sex-adjusted Canadian DED prevalence estimate from this sample was 21.3% (95% CI, 19.8-23.2%), corresponding to ∼6.3 million people. CONCLUSIONS: Based on the Ontario sample, we estimate that >6 million Canadian adults may have DED, and that older people and females are more likely to be affected.

Epidemiology and liver transplantation burden of primary biliary cholangitis: a retrospective cohort study.

BACKGROUND: There is a wealth of data documenting the epidemiology of primary biliary cholangitis (PBC) globally; however, the epidemiology of PBC has not been as well studied in Canada. Our study characterized the Canadian prevalence of PBC and the number of liver transplantations because of PBC. METHODS: For this retrospective cohort study we used national hospital administrative records from the Canadian Institute for Health Information, with the exception of Quebec for the prevalence estimate and Quebec and British Columbia for the transplant analysis. Prevalent patients were identified through a diagnostic code for PBC of the Canadian version of the 10th revision of the International Classification of Diseases. PBC transplant patients were identified from their transplant record. Descriptive statistics were used to summarize the characteristics of the study cohorts. RESULTS: In 2015, 8680 patients with PBC were identified in Canada, translating to a prevalence of 318 cases per million. Annual prevalence by province varied, ranging from 283 (95% confidence interval [CI] 269-297) cases per million to 465 (95% CI 426-504) cases per million, and the 6-year PBC liver transplantation rate ranged from 3.17 (95% CI 1.27-6.54) to 5.92 (95% CI 3.71-9.08) per million. The Atlantic provinces exhibited the highest PBC prevalence and close to the highest 6-year liver transplantation rate (465 [95% CI 426-504] cases per million and 5.70 [95% CI 426-504, 3.19-9.56] cases per million, respectively). We observed the lowest PBC prevalence (283 [95% CI 269-297] cases per million) and the second lowest 6-year liver transplantation rate in Ontario (3.37 [95% CI 2.47-4.50] cases per million). INTERPRETATION: The prevalence of PBC that we found in Canada is similar to the prevalence reported in other studies, but our work also indicates geographic variation within this country. Given our finding of geographic clustering of PBC across Canada, we hypothesize that environmental and genetic factors contribute to the pathogenesis of this condition.

The Direct Economic Burden of Gout in an Elderly Canadian Population.

OBJECTIVE: To estimate the direct healthcare cost and resource use from the public payer perspective between patients with incident gout and matched gout-free patients in Ontario. METHODS: Patients with incident gout aged ≥ 66 with uninterrupted Ontario Health Insurance Plan (OHIP) coverage in the 1-year baseline period were included in the study. Patients with gout were indexed at first gout diagnosis or prescription over the study period April 1, 2008, to March 31, 2014. Gout-free patients with no gout diagnosis within history were matched (up to 5:1) to each patient with gout. Linked medical records were analyzed until end of study, death, or OHIP ineligibility. Bang and Tsiatis adjusted healthcare costs and resource use were compared using bootstrap p-values and 95% CI. RESULTS: A total of 29,894 patients with gout and 148,231 gout-free patients were included in the study. Patients were 56% male, had a median Adjusted Clinical Group healthcare resource use band of moderate morbidity, and had a median age of 75-79 years. Baseline comorbidities were similar between groups except for renal disease. Analyzing 5-year total healthcare costs, patients with gout ($44,297) incurred a significantly higher average healthcare cost compared to gout-free patients ($33,965), for an incremental cost of $10,332 (95% CI $9617-$11,039; p < 0.01). Similar trends were observed in all individual healthcare component cost and use metrics. CONCLUSION: Following onset of gout, patients in Ontario incur significantly greater healthcare costs and resource use compared to matched gout-free patients. Alternative gout management strategies should be investigated to reduce the incremental burden of gout borne by the Ontario healthcare system.