Health economic evaluation of a vaccine for the prevention of herpes zoster (shingles) and post-herpetic neuralgia in adults in Belgium

Abstract

Objective:

To determine the cost-effectiveness of vaccination against herpes zoster (HZ) and post-herpetic neuralgia (PHN) in individuals aged 60 years and older in Belgium.

Methods:

A Markov model was developed to compare the cost-effectiveness of vaccination with that of a policy of no vaccination. The model estimated the lifetime incidence and consequences of HZ and PHN using inputs derived from Belgian data, literature sources, and expert opinion. Cost-effectiveness was measured by the incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life-year (QALY) gained.

Results:

Vaccination in individuals aged 60 years and older resulted in ICERs of €6,799 (third party payer perspective), €7,168 (healthcare perspective), and €7,137 (societal perspective). The number needed to vaccinate to prevent one case was 12 for HZ, and 35 or 36 for PHN depending on the definition used. Univariate sensitivity analyses produced ICERs of €4,959–19,052/QALY; duration of vaccine efficacy had the greatest impact on cost-effectiveness. Probabilistic sensitivity analysis showed at least a 94% probability of ICERs remaining below the unofficial €30,000 threshold.

Discussion:

Key strengths of the model are the combination of efficacy data from a pivotal clinical trial with country-specific epidemiological data and complete sensitivity analysis performed. Main limitations are the use of non country-specific PHN proportion and non Belgian disease-specific utilities. Results are comparable with those recently published.

Conclusions:

HZ vaccination in individuals aged 60 years and older would represent a cost-effective strategy in Belgium.     

The use of Zostavax in Spain: the economic case for vaccination of individuals aged 50 years and older

Background Population aging brings up a number of health issues, one of which is an increased incidence of herpes zoster (HZ) and its complication, post-herpetic neuralgia (PHN). Zostavax vaccine has recently become available to prevent HZ and PHN. This study evaluates the cost-effectiveness of vaccination against HZ in Spain considering a vaccination of the population aged 50 years and older and comparing this to the current situation where no vaccination is being administered.

Methods An existing, validated, and published economic model was adapted to Spain using relevant local input parameters and costs from 2013.

Results Vaccinating 30% of the Spanish population aged 50 years and older resulted in €16,577/QALY gained, €2025/HZ case avoided, and €5594/PHN case avoided under the third-party payer perspective. From a societal perspective, the ICERs increased by 6%, due to the higher price of the vaccine. The number needed to vaccinate to prevent one case was 20 for HZ, and 63 for PHN3. Sensitivity analyses showed that the model was most sensitive to the HZ and PHN epidemiological data, the health state utilities values, and vaccine price used.

Conclusion Considering an acceptable range of cost-effectiveness of €30,000–€50,000 per QALY gained, vaccination of the 50+ population in Spain against HZ with a new vaccine, Zostavax, is cost-effective and makes good use of the valuable healthcare budget.     

Cervical cancer prevention in Morocco: a model-based cost-effectiveness analysis

Abstract

Objective: Cervical cancer is a huge public health issue in Morocco which represents the second most frequent and fatal cancer among women. Countries that have not yet introduced the HPV vaccine could benefit greatly, but before implementation it is necessary to perform country-specific economic assessments that include current screening practices.

Methods: A Markov model was developed to simulate the natural history of HPV and cervical cancer so as to calculate the long-term health benefits and costs of HPV vaccination and current screening by visual inspection with acetic acid (VIA). Starting from a previous transition probability matrix used for a model from Spain, the present model was calibrated to cervical cancer incidence from Morocco. Cost survey data was used to estimate the cost of screening and clinical procedures from the public healthcare perspective. Incremental cost-effectiveness ratios were calculated as 2018US$ per additional year of life saved (YLS) and both costs and health outcomes were discounted at 3%.

Results: The expected reduction in lifetime risk of cervical cancer for current screening would be 14% at a cost of US$551/YLS compared with no intervention, assuming VIA every 3 years in women aged 30–49 at 10% coverage. HPV vaccination of pre-adolescent girls at 70% coverage would reduce the lifetime risk of cervical cancer by 62% at a cost of US$1,150/YLS, compared with no intervention. When implementing HPV vaccination in combination with current screening, vaccination would be dominated, and the combined strategy would provide a 69% reduction at a cost of US$2,843/YLS, compared with screening alone. Current screening would be dominated by vaccination when screening coverage is higher than 15%, whereas the combined strategy rapidly exceeds US$4,000/YLS.

Conclusions: HPV vaccination could be highly effective and cost-effective in Morocco. Current screening would be good value for money compared with no intervention, but scaling-up screening coverage would make it inefficient compared with vaccination.     

Cost-effectiveness of glatiramer acetate and interferon beta-1a for relapsing-remitting multiple sclerosis,based on the CombiRx study

Background:

To assess the cost-effectiveness of the Disease Modifying Treatments (DMT), Glatiramer Acetate (GA) and Interferon beta-1a (IFN) in monotherapy alone and in combination for the prevention of relapses among Spanish patients aged between 18–60 years old with established Relapsing–Remitting Multiple Sclerosis (RRMS).

Methods:

A Markov model was developed to represent the transition of a cohort of patients over a 10 year period using the perspective of the Spanish National Health Service (NHS). The model considered five different health states with 1-year cycles including without relapse, patients with suspect, non-protocol defined and protocol defined exacerbations, as well as a category information lost. Efficacy data was obtained from the 3-year CombiRx Study. Costs were reported in 2013 Euros and a 3% discount rate was applied for health and benefits. Deterministic results were presented as the annual treatment cost for the number of relapses. A probabilistic sensitivity analysis was performed to test the robustness of the model.

Results:

Deterministic results showed that the expected annual cost per patient was lower when treated with GA (€13,843) compared with IFN (€15,589) and the combined treatment with IFN?+?GA (€21,539). The annual number of relapses were lower in the GA cohort with 3.81 vs 4.18 in the IFN cohort and 4.08 in the cohort treated with IFN?+?GA. Results from probabilistic sensitivity analysis showed that GA has a higher probability of being cost-effective than treatment with IFN or IFN?+?GA for threshold values from €28,000 onwards, independent of the maximum that the Spanish NHS is willing to pay for avoiding relapses.

Conclusion:

GA was shown to be a cost-effective treatment option for the prevention of relapses in Spanish patients diagnosed with RRMS. When GA in monotherapy is compared with INF in monotherapy and IFN?+?GA combined, it may be concluded that the first is the dominant strategy.     

Cost-effectiveness of a pentavalent rotavirus vaccine in Japan

Abstract

Objective:

To evaluate the impact of universal vaccination with a pentavalent rotavirus vaccine (RV5) on the healthcare burden and costs associated with rotavirus gastroenteritis (RGE) in Japan.

Methods:

The model included a hypothetical cohort of 1,091,156 children followed for their first 5 years of life. In the absence of universal vaccination, there were 19 deaths, 78,000 hospitalizations, and 678,000 outpatient visits due to RGE. The efficacy of RV5 is based on international clinical trial data, which was similar to the efficacy observed in clinical trials conducted in Japan. The primary outcome measure is the cost per quality-adjusted-life-year (QALY) gained. In the base case, the QALY loss per 1000 RGE episodes included 2.2 for children and 1.8 per parent.

Results:

Universal vaccination is projected to reduce hospitalizations by 92%, outpatient visits by 74%, and work-loss days by 73%. For the base case analysis, the total vaccination cost was ¥26 billion. The estimated reduction in medical costs was ¥16 billion. Of 2500 QALYs gained with the vaccination program, approximately half are directly attributed to the child. In the base case analysis, the incremental cost-effectiveness ratio (ICER) for vaccination vs no vaccination is ¥4 million and ¥2 million per quality-adjusted life year (QALY) gained from the healthcare payer and societal perspectives, respectively. The ICERs are ¥8 million and ¥4 million if parental disutilities are excluded.

Key limitation:

The QALY decrements for children and parents were evaluated using different instruments, and the QALY decrements do not vary based on episode severity. Given the interdependence between children and their parents, excluding parental disutilities may under-estimate the impact of RGE.

Conclusion:

Universal vaccination with RV5 in Japan is projected to have a substantial public health impact and may be cost-effective from both the payer and societal perspectives if parental disutilities are included in the cost-effectiveness ratios.     

Public health impact of comprehensive hepatitis C screening and treatment in the French baby-boomer population

Objective: To estimate the public health impact of comprehensive hepatitis C virus (HCV) screening and access to all-oral, interferon (IFN)-free direct-acting antivirals (DAAs) in the French baby-boomer population (1945–1965 birth cohorts).

Methods: A sequential, multi-cohort, health-state transition model was developed to assess the impact of different hepatitis C screening and treatment strategies on clinical and economic outcomes in the 1945–1965 birth cohorts. Patients newly-diagnosed with chronic HCV were projected each year from 2016 to 2036 under three screening scenarios (70% [low], 75% [intermediate], and 80% [high] HCV awareness in 2036). Healthcare costs and clinical outcomes (number of liver-related deaths, quality-adjusted life-years [QALYs], life-years [LYs] spent in sustained virologic response [SVR] or with decompensated cirrhosis, hepatocellular carcinoma, or liver transplant) were compared among five treatment strategies (no antiviral therapy; IFN?+?ribavirin?+?protease inhibitor for fibrosis stages F2–F4, IFN-based DAAs for stages F2–F4, IFN-free DAAs for stages F2–F4, and IFN-free DAAs for stages F0–F4).

Results: Diagnosis of HCV genotype 1 was projected for 4,953, 6,600, and 8,368 individuals in the low, intermediate, and high screening scenarios, respectively. In the intermediate scenario, IFN-free DAAs for stages F0–F4 had a favorable cost-effectiveness profile vs IFN-based or IFN-free treatment strategies for F2–F4 and offered the greatest return on investment (0.899 LYs gained in SVR and 0.933 QALYs per €10,000 invested).

Conclusion: Comprehensive HCV screening and access to all-oral, IFN-free DAAs is a cost-effective strategy that could help diminish the upcoming burden of HCV in the French baby-boomer population.     

Cost-effectiveness of a pentavalent human–bovine reassortant rotavirus vaccine for children ≤5 years of age in Taiwan

Abstract

Objective:

A Markov model was used to assess the impact of RV5, a pentavalent (G1, G2, G3, G4, P1A[8]) human bovine (WC3 strain) reassortant rotavirus vaccine, on reducing the healthcare burden and cost associated with rotavirus gastroenteritis (RGE) in Taiwan. Other cost-effectiveness analyses for rotavirus vaccination in industrialized countries have produced varying results depending on the input parameters assumed.

Methods:

Vaccination with RV5 is compared to no vaccination in a hypothetical cohort of Taiwanese children during their first 5 years of life to determine the per dose prices at which vaccination would be cost neutral or provide good value based on established standards from the healthcare (direct medical care costs only) and societal (all RGE-related costs) perspectives. The effects of vaccination on RGE healthcare utilization and days of parental work loss missed are based on results from the Rotavirus Efficacy and Safety Trial.

Results:

Without vaccination there would be 122,526 symptomatic episodes of RGE. Universal vaccination would reduce RGE-related deaths, hospitalizations, emergency department, and outpatient visits by 91.7%, 92.1%, 83.7%, and 73.4%, respectively. The price per dose at which vaccination would be cost-neutral is US$ 21.80 (688 NTD) and US$ 26.20 (827 NTD) from the healthcare and societal perspectives, respectively. At $25 per dose, the cost per QALY gained is US$ 2261 (71,335 NTD) from the healthcare perspective and cost saving from the societal perspective.

Key limitations:

The model only assesses the effect of RV5 on vaccinated children and does not account for herd immunity. However, given that high levels of coverage are anticipated in Taiwan, the effects of herd immunity are likely to be short-term.

Conclusion:

A pentavalent rotavirus vaccination program is likely to substantially reduce the healthcare burden associated with rotavirus gastroenteritis at a cost per QALY ratio within the range defined as cost-effective.     

Cost-effectiveness analysis of quadrivalent influenza vaccination in at-risk adults and the elderly: an updated analysis in the UK

Abstract

Objective:

To update an earlier evaluation estimating the cost-effectiveness of quadrivalent influenza vaccination (QIV) compared with trivalent influenza vaccination (TIV) in the adult population currently recommended for influenza vaccination in the UK (all people aged ≥65 years and people aged 18–64 years with clinical risk conditions).     

Impact of a step-therapy protocol for pregabalin on healthcare utilization and expenditures in a commercial population

Abstract

Objective:

To compare changes in healthcare resource utilization and costs among members with painful diabetic peripheral neuropathy (pDPN), postherpetic neuralgia (PHN), or fibromyalgia (FM) in a commercial health plan implementing pregabalin step-therapy with members in unrestricted plans.

Methods:

Retrospective study of outcomes associated with implementation of a pregabalin step-therapy protocol using claims data from Humana (‘restricted’ cohort) and Thomson Reuters MarketScan (‘unrestricted’ cohort). Members aged 18–65 years receiving treatment for pDPN, PHN, or FM during 2008 or 2009 were identified; cohorts were matched on diagnosis and geographic region. Baseline to follow-up changes in healthcare resource utilization and costs were determined using difference-in-differences (DID) analysis. Statistical models adjusting for covariates explored relationships between restricted access and outcomes.

Results:

A total of 3876 restricted cohort members were identified and matched to 3876 unrestricted cohort members. FM was the predominant diagnosis (84.7%). The unrestricted cohort was older (mean?=?49.0 (SD?=?10.4) years vs 47.6 (SD?=?10.5) years; p?<?0.001), and had greater comorbidity (RxRisk-V score?=?5.4 (SD?=?3.2) vs 4.4 (SD?=?2.9), p?<?0.001) than the restricted cohort. Compared with the unrestricted cohort, the restricted cohort demonstrated a greater year-over-year decrease in pregabalin utilization (?2.6%, p?=?0.008), and greater increases in physical therapy and disease-related outpatient utilization (3.7%, p?=?0.010 and 3.6%, p?=?0.022, respectively). There were no statistically significant net differences in all-cause or disease-related total healthcare, medical, or pharmacy costs between cohorts. After adjusting for baseline compositional differences between cohorts, restricted plan membership was associated with a net increase in all-cause medical ($1222; p?=?0.016) and disease-related healthcare costs ($859; p?=?0.002). Limitations include use of a combined analysis for pDPN, PHN, and FM, especially since the observed results were likely driven by FM; an inability to link the prescribing of a medication with the condition of interest, which is common to claims analyses; and lack of pain severity information.

Conclusions:

Implementation of a pregabalin step-therapy protocol resulted in lower pregabalin utilization, but this restriction was not associated with reductions in total healthcare costs, medical costs, or pharmacy costs.     

Health and economic impact of PHiD-CV in Canada and the UK: a Markov modelling exercise

Abstract

Objective:

The spectrum of diseases caused by Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) represents a large burden on healthcare systems around the world. Meningitis, bacteraemia, community-acquired pneumonia (CAP), and acute otitis media (AOM) are vaccine-preventable infectious diseases that can have severe consequences. The health economic model presented here is intended to estimate the clinical and economic impact of vaccinating birth cohorts in Canada and the UK with the 10-valent, pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared with the newly licensed 13-valent pneumococcal conjugate vaccine (PCV-13).

Methods:

The model described herein is a Markov cohort model built to simulate the epidemiological burden of pneumococcal- and NTHi-related diseases within birth cohorts in the UK and Canada. Base-case assumptions include estimates of vaccine efficacy and NTHi infection rates that are based on published literature.

Results:

The model predicts that the two vaccines will provide a broadly similar impact on all-cause invasive disease and CAP under base-case assumptions. However, PHiD-CV is expected to provide a substantially greater reduction in AOM compared with PCV-13, offering additional savings of Canadian $9.0 million and £4.9 million in discounted direct medical costs in Canada and the UK, respectively.

Limitations:

The main limitations of the study are the difficulties in modelling indirect vaccine effects (herd effect and serotype replacement), the absence of PHiD-CV- and PCV-13-specific efficacy data and a lack of comprehensive NTHi surveillance data. Additional limitations relate to the fact that the transmission dynamics of pneumococcal serotypes have not been modelled, nor has antibiotic resistance been accounted for in this paper.

Conclusion:

This cost-effectiveness analysis suggests that, in Canada and the UK, PHiD-CV’s potential to protect against NTHi infections could provide a greater impact on overall disease burden than the additional serotypes contained in PCV-13.     

Medical resource utilization and costs for total hip arthroplasty: benchmarking an anterior approach technique in the Medicare population

Aims: The anterior approach (AA) for total hip arthroplasty (THA) is associated with more rapid recovery when compared to traditional approaches. The purpose of this study was to benchmark healthcare resource utilization and costs for patients with THA via AA relative to matched patients.

Materials and methods: This study queried Medicare claims data (2012–2014) to identify patients who received THA via an AA from experienced surgeons, and matched these patients to a control cohort (all THA approaches). Direct and propensity-score matching were employed to maximize similarity between patients and hospitals in the two cohorts. Hospital length of stay (LOS), the proportion of patients discharged to home or home health, and post-acute claim payments during the 90-day episode were assessed. Generalized estimating equations were applied to control for imbalances between the cohorts and clustering of outcomes within hospitals.

Results: A total of 1,794 patients were included after patient matching. Patients who received AA had significantly lower mean hospital LOS vs patients in the control group (2.06?±?1.36 vs 2.98?±?1.58 days, p?<?.0001). The adjusted proportion of patients discharged to home was nearly 20 percentage points higher in the AA cohort vs the control cohort (87.3% vs 68.7%, p?<?.0001). Post-acute claim payments for AA patients were nearly 50% lower than those for control patients ($4,139 vs $7,465, p?<?.0001).

Conclusion: AA patients had significantly lower post-acute care resource use when compared to control patients. Further research is warranted to evaluate the cost effectiveness of AA among surgeons of varying experience levels.     

The cost effectiveness of a quadrivalent human papillomavirus vaccine (6/11/16/18) in Hungary

Abstract

Objective: A transmission dynamic model was used to assess the epidemiological and economic impact of a quadrivalent human papillomavirus (HPV) (6/11/16/18) vaccine in preventing cervical cancer, cervical intraepithelial neoplasia grades 2 and 3 (CIN 2/3), CIN 1 and genital warts in Hungary.

Methods: The routine vaccination of 12-year-old girls and the routine vaccination of 12-year-old girls plus a temporary catch-up programme for girls and women aged 12–24 years was evaluated.

Results: The model projected that at year 100, both strategies could reduce the incidence of HPV 6/11/16/18-related cervical cancer, CIN 2/3, CIN 1 and genital warts cases among Hungarian women by 90%, 90%, 85% and 93%, respectively. Twenty-five years after the introduction of HPV vaccination in the population, routine vaccination of girls by the age of 12 reduced the cumulative number of cases of cervical cancer, CIN 2/3, CIN 1 and genital warts by 685, 13,473, 3,423 and 163,987, respectively. The incremental cost-effectiveness ratios of the two vaccination strategies were €9,577 and €10,646 per quality-adjusted life-year (QALY) gained over a time horizon of 100 years.

Key limitations: The model did not account for the health and economic impact of other HPV diseases which may result from HPV 16, 18, 6, and 11 infections such as vaginal, vulvar, penile, anal and head-neck cancers, and recurrent respiratory papillomatosis. Epidemiological data from Hungary on these other HPV diseases as well genital warts are needed.

Conclusion: A quadrivalent HPV vaccination programme can reduce the incidence of cervical cancer, CIN and genital warts in Hungary at a cost-per-QALY ratio within the range defined as cost effective.     

Changes in healthcare resource use and costs associated with early versus delayed initiation of atypical antipsychotic adjunctive treatment in major depressive disorder

Aims: The study compared all-cause and major depressive disorder (MDD)-related healthcare resource use (HRU) and costs in patients with MDD treated with atypical antipsychotic (AAP) adjunctive therapy early or later in treatment.

Materials and methods: Adults with MDD and antidepressant treatment (ADT) who newly initiated adjunctive aripiprazole, brexpiprazole, lurasidone, or quetiapine between October 1, 2014 and September 30, 2015 were identified in the IQVIA Real-World Data Adjudicated Claims database; the index date was the date of the first AAP claim. Patients were stratified into three cohorts: AAP initiated in the first year (Y1); in the second year (Y2); and more than 2 years (Y3) of first ADT use. Within each cohort, HRU and costs were compared between the 12 months before and after the index date. Pre–post changes in HRU and costs were then compared between cohorts.

Results: Five hundred and six (36.7%) patients were categorized as Y1; 252 (18.3%) as Y2; and 622 (45.1%) as Y3. AAP use was associated with significantly decreased rates of all-cause and MDD-related hospitalization and emergency department visits, and increased rates of pharmacy fills and physician office visits; and the magnitude of changes was largest in cohort Y1. Cohort Y1 had the largest reductions in mean (±SD) all-cause medical costs per patient (?$10,496?±?$85,022, p?=?.015) compared to Y2 (?$2,474?±?$85,022, p?=?.572) and Y3 (?$472?±?$31,334, p?=?.823), mainly due to the reduction in hospitalization. After adjusting for differences in baseline characteristics, the largest reductions in hospitalization and medical costs were observed in cohort Y1. Similar increases in all-cause pharmacy costs were seen in all cohorts. A similar trend in costs was observed in MDD-related healthcare services.

Limitations and conclusions: AAP treatment was associated with reductions in all-cause and MDD-related medical costs, primarily in decreased hospitalization. The reductions were largest among patients who initiated treatment in the first year.     

The cost-effectiveness of extended-release calcifediol versus paricalcitol for the treatment of secondary hyperparathyroidism in stage 3–4 CKD

Abstract

Aims: Patients with chronic kidney disease (CKD) not on dialysis frequently have vitamin D insufficiency (VDI) and secondary hyperparathyroidism (SHPT), which are associated with an increased risk of cardiovascular (CV) disease, fracture, CKD progression, and death. This study estimated the cost-effectiveness of extended-release calcifediol (ERC) vs paricalcitol for the treatment of patients with CKD stages 3–4 that have SHPT and VDI.

Materials and methods: An economic analysis of SHPT treatments among a hypothetical cohort of 1,000 patients with CKD Stage 3 and 4 with SHPT and VDI was developed to estimate differences in the rates and costs of CV events, fractures, CKD stage progression, and mortality in patients treated with ERC and paricalcitol. A Markov model was developed with 1-year cycles and a 5-year time horizon from a US Medicare payer perspective with costs valued in 2017?US dollars.

Results: The outcomes of the model were rates of clinical events, total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER). Across a 1,000-person cohort, ERC was the dominant (less costly, more effective) treatment strategy when compared with paricalcitol. Treatment with ERC resulted in cost savings of $14.8?M (95% CI = –$10.0?M–$45.2?M) and an incremental gain of 340 QALYs (95% CI = 200–496) compared to treatment with paricalcitol.

Limitations: Bridging biochemical levels to clinical outcomes may not represent real-world risk of the clinical events modeled. Future real-world outcomes of patients treated with ERC and paricalcitol may be used to evaluate the model results.

Conclusions: This model demonstrated favorable short- and long-term clinical benefits associated with the use of ERC in patients with CKD Stage 3 and 4 with SHPT and VDI, suggesting ERC may be cost-effective from the Medicare perspective compared to paricalcitol.     

Healthcare costs of urinary tract infections and genital mycotic infections among patients with type 2 diabetes mellitus initiated on canagliflozin: a retrospective cohort study

Objective: To assess the economic impact of urinary tract infections (UTIs) and genital mycotic infections (GMIs) among patients with type 2 diabetes mellitus (T2DM) initiated on canagliflozin.

Methods: Administrative claims data from April 2013 through June 2014 MarketScan^® databases were extracted. Adults with ≥1 claim for canagliflozin, T2DM diagnosis, and ≥90 days enrollment before and after canagliflozin initiation were propensity score matched to controls with T2DM initiated on other anti-hyperglycemic agents (AHAs). UTI and GMI healthcare costs were evaluated 90-days post-index and reported as cohort means.

Results: Rates of UTI claims 90 days post-index were similar in patients receiving canagliflozin for T2DM (n?=?31,257) and matched controls (2.7% vs 2.8%, p?=?.677). More canagliflozin than control patients had GMI claims (1.2% vs 0.6%, p?p?p?=?.150). GMI treatment costs were higher for the canagliflozin cohort ($3.68 vs $2.44, p?=?.041). Combined costs to treat either UTI and/or GMI averaged $31.29 per patient for the canagliflozin cohort v $39.77 for controls (p?=?.211). Rates and costs of UTIs and GMIs were higher for females than males, but the canagliflozin vs control trends observed for the overall sample were similar for both sexes. There were no significant cost differences between the canagliflozin and control cohorts among patients aged 18–64. Among patients aged 65 and above, GMI treatment costs were not significantly different, but costs to treat UTIs and either UTI and/or GMI were significantly lower for canagliflozin patients vs controls.

Conclusions: In a real-world setting, the costs to payers of treating UTIs and GMIs are generally similar for patients with T2DM initiated on canagliflozin vs other AHAs.     

A real-world analysis of healthcare costs and relative risk of hyperprolactinemia associated with antipsychotic treatments in the United States

Abstract

Aims: Antipsychotic medications are associated with an increased risk of hyperprolactinemia, but differ in their propensity to cause this complication. This study aimed to assess the economic burden of hyperprolactinemia, and to compare its risk among adult patients using atypical antipsychotics (AAs) with a mechanism of action associated with no/low vs high/moderate prolactin elevation.

Methods: This retrospective cohort study was based on US Commercial and Medicaid claims databases. Healthcare costs were compared between matched hyperprolactinemia and hyperprolactinemia-free cohorts using a two-part model. Risk of hyperprolactinemia was compared between patients receiving AAs with a mechanism of action associated with no/low (no/low prolactin elevation cohort) vs high/moderate prolactin elevation (high/moderate prolactin cohort) using logistic regression.

Results: In the commercially insured sample, compared to the hyperprolactinemia-free cohort (n?=?499), the hyperprolactinemia cohort (n?=?499) was associated with incremental total healthcare costs of $5,732 ($20,081 vs $14,349; p?=?.004), and incremental medical costs of $3,861 ($13,218 vs $9,357; p?=?.040), mainly driven by hyperprolactinemia-related costs. In the Medicaid-insured sample, compared to the hyperprolactinemia-free cohort, the hyperprolactinemia cohort was associated with incremental total healthcare costs of $10,773 ($30,763 vs $19,990; p?=?.004), and incremental medical costs of $9,246 ($20,859 vs $11,613; p?=?.004), mainly driven by hyperprolactinemia-related and mental health-related costs. The odds of hyperprolactinemia in the no/low prolactin elevation cohort were 4–5-times lower than that in the high/moderate prolactin elevation cohort (odds ratio =0.21; p?<?.001).

Limitations: Hyperprolactinemia may be under-reported in claims data.

Conclusions: Hyperprolactinemia is associated with substantial healthcare costs. AAs associated with no/low prolactin elevation reduce the risk of hyperprolactinemia by 4–5-times compared to AAs associated with moderate/high prolactin elevation. Treatment options with minimal impact on prolactin levels may contribute to reducing hyperprolactinemia burden in AA-treated patients.     

Longitudinal analysis of healthcare costs: a case study of patients with major depressive disorder treated with duloxetine

Abstract

Objective:

To develop and apply a longitudinal model that adjusts for pre-treatment covariates to examine the trajectory of healthcare costs in duloxetine patients with major depressive disorder (MDD).

Methods:

Retrospective healthcare cost data from Thomson Reuters Marketscan® Database included 10,987 patients with MDD, aged 18–64, receiving duloxetine at low (<60?mg/day), standard (60?mg/day), or high (>60?mg/day) initial doses. A linear mixed-effects model for repeated measures used dose, month, and dose*month as fixed effects and patient (dose) as a random effect, and adjusted for demographics, comorbidities, body system disorders, and prior medication history. Model goodness-of-fit was evaluated with R². Rates of change (slopes) were estimated from the fitted model and differences in the cost trajectory among dosing cohorts were tested using the F-test. Bootstrapping and propensity score (PS) stratification were conducted to provide sensitivity analyses.

Results:

Main effects and covariates were all significant (p?<?0.05). Adjustment by pre-treatment covariates greatly improved the model fit (R^2?=?0.43). The model revealed a significant increase in healthcare costs in the 6 months preceding and a significant decrease in the 6 months following duloxetine initiation for each initial dose cohort and the overall cohort (p?<?0.05). In both the pre- and post-treatment periods, the high initial-dose cohort had higher healthcare costs than standard or low initial-dose cohorts (p?<?0.05). Bootstrapping and PS stratification confirmed these test results.

Limitations:

The analyses performed here were based on non-randomized, observational data, and thus subject to potential biases due to unmeasured confounding.

Conclusions:

Longitudinal models, compared with conventional mean-based methods, provide better opportunities to assess changes in cost trajectory patterns around the time of changes in medical treatment. In insured patients with MDD started on duloxetine, healthcare costs increased before duloxetine initiation, perhaps signaling a clinical deterioration that led to a change in treatment strategy. Healthcare costs then decreased following duloxetine initiation.     

Treatment discontinuation of long-acting injectables or oral atypical antipsychotics among Medicaid recipients with schizophrenia

Abstract

Aims: Among patients with schizophrenia, poor adherence and persistence with oral atypical antipsychotics (OAA) often results in relapse and hospitalization. Second-generation antipsychotic long-acting injectables (SGA LAI) have demonstrated higher adherence than first-generation antipsychotic LAI and OAA therapies. This study aimed to determine whether SGA LAIs are associated with better persistency compared to OAA among Medicaid recipients with schizophrenia.

Materials and methods: From the MarketScan Medicaid Database (January 1, 2010–June 30, 2016), patients aged ≥18?years with schizophrenia and ≥2 pharmacy claims more than 90?days apart for the same SGA LAI or OAA were selected. New users of the specific antipsychotic agent were classified, based on their index agent, as: OAA, paliperidone palmitate LAI (PPLAI), aripiprazole LAI (ALAI), and risperidone LAI (RLAI). Discontinuation during 1 year of follow-up was defined as a?≥?60-day gap in the index OAA or SGA LAI medication past the exhaustion of the previous claim’s supply. Inverse probability of treatment weights (IPTW) balanced the cohort characteristics, and weight outliers (<0.1 or >0.9) were excluded. IPTW-weighted Cox proportional hazards regression estimated hazard ratios for discontinuation.

Results: Cohorts included 7,029 OAA, 4,302 PPLAI, 586 ALAI, and 1,456 RLAI patients. Mean age was 38.0–41.0?years and 44.0–46.6% were female. Persistence was significantly longer in the SGA LAI cohorts than in the OAA cohort. Adjusted hazard ratios (95% confidence intervals) for discontinuation were 0.60 (0.56–0.64) for PPLAI, 0.69 (0.60–0.79) for ALAI, and 0.70 (0.64–0.77) for RLAI vs OAA.

Limitations: Results may not be generalizable to patients covered by commercial or Medicare insurance, and limitations inherent to any claims-based retrospective analysis apply.

Conclusions: SGA LAI may be a valuable option for treating schizophrenia given the improvement in persistence.