Use of privacy-preserving record linkage to examine the dispensing of pharmaceutical benefits scheme medicines to pregnant women in Western Australia.

PURPOSE: Medications are commonly used during pregnancy to manage pre-existing conditions and conditions that arise during pregnancy. However, not all medications are safe to use in pregnancy. This study utilized privacy-preserving record linkage (PPRL) to examine medications dispensed under the national Pharmaceutical Benefits Scheme (PBS) to pregnant women in Western Australia (WA) overall and by medication safety category. METHODS: In this retrospective, cross-sectional, population-based study, state perinatal records (Midwives Notification Scheme) were linked with national PBS dispensing data using PPRL. Live and stillborn neonates born between 2012 and 2019 in WA were included. The proportion of pregnancies during which the mother was dispensed a PBS medication was calculated, overall and by medication safety category. Factors associated with PBS medication dispensing were examined using logistic regression. RESULTS: PPRL linkage identified matching records for 97.4% of women with perinatal records. A total of 271 739 pregnancies were identified, with 158 585 (58.4%) pregnancies involving the dispensing of at least one PBS medication. Category A medications (those considered safe in pregnancy) were the most commonly dispensed (n = 119 126, 43.8%) followed by B3 (n = 51 135, 18.8%) and B1 (n = 42 388, 15.6%) medication (those with unknown safety). Over the study period, the dispensing of PBS medications in pregnancy increased (OR: 1.06, 95%CI: 1.06, 1.07). The strongest predictor of medication dispensing in pregnancy was pre-pregnancy dispensing (OR: 3.61, 95%CI: 3.54, 3.68). Other factors associated with medication use in pregnancy were smoking, older maternal age, obesity, and prior pregnancies. CONCLUSION: Privacy preserving record linkage provides a way to link cross-jurisdictional data while preserving patient confidentiality and data security. The dispensing of PBS medication in pregnancy was common and increased over time, with approximately 60% of women dispensed at least one medication during pregnancy.

Insulin Fills by Medicare Enrollees and Out-of-Pocket Caps Under the Inflation Reduction Act.

This study uses data from IQVIA's National Prescription Audit to assess the association of the Inflation Reduction Act's cap on cost sharing with insulin fills by Medicare beneficiaries.

Comparison of oral anticoagulation use and adherence among Medicare beneficiaries enrolled in stand-alone prescription drug plans vs Medicare Advantage prescription drug plans.

BACKGROUND: For atrial fibrillation (AF) patients, oral anticoagulants (OACs) can reduce the risk of stroke by 60%; however, nearly 50% of patients recommended to receive OACs do not receive therapy. Integrated insurers that cover pharmacy and medical benefits may be incentivized to improve OAC use and adherence because they benefit from offsets in medical costs associated with prevented strokes. OBJECTIVE: To compare OAC use and adherence between AF patients enrolled in Medicare stand-alone prescription drug plans (PDPs), which only cover pharmacy benefits, and those enrolled in Medicare Advantage prescription drug (MAPD) plans, which cover medical and pharmacy benefits. METHODS: This was a retrospective cohort study, conducted using 2014-2016 Medicare claims data from the Centers for Medicare & Medicaid Services and a large regional health plan in Pennsylvania. Primary outcomes included OAC use and OAC adherence. OAC use was measured as filling at least 1 prescription for an OAC after AF diagnosis. OAC adherence was defined as having greater than or equal to 80% of days covered with an OAC. We constructed conditional logistic regression models in propensity score-matched samples to test the association between enrollment in PDPs or MAPD plans and outcomes. RESULTS: There were 2,551 AF patients enrolled in PDPs and 4,502 in MAPD plans before propensity score matching. The propensity score-matched sample included 2,537 patients in each group. OAC use was higher among MAPD beneficiaries (74%-76%) compared with PDP beneficiaries (70%; P < 0.001), and 41%-42% of MAPD beneficiaries were adherent to OACs, compared with 34% of PDP beneficiaries (P < 0.001). In adjusted analyses among propensity score-matched samples, PDP enrollment was associated with lower odds of OAC use (OR = 0.67, 95% CI = 0.56-0.81) and adherence (OR = 0.68, 95% CI = 0.59-0.78) compared with MAPD enrollment. CONCLUSIONS: AF patients enrolled in MAPD plans were more likely to use and adhere to OACs compared with PDP enrollees. These results may reflect the financial incentives of MAPD plans to improve guideline-recommended OAC use, since MAPD insurers bear the risk of pharmacy and medical costs and thus may benefit from cost savings associated with averted stroke events. As efforts to improve use and adherence of OACs in AF patients increase, focus should be given to how insurance benefit designs can affect medication use. DISCLOSURES: No outside funding supported this study. Hernandez has received personal fees from BMS and Pfizer, unrelated to this study. The other authors have nothing to disclose.

Associations of health services utilization by prescription drug coverage and immigration category in Ontario, Canada.

Canada is the only high-income country with a universal healthcare system that does not provide prescription drug coverage for all its residents. This study examines whether Canadians' prescription drug coverage status is associated with their health services use and how this association differs by gender across non-migrants and three categories of migrants: economic immigrants, family-class immigrants, and refugees. Very few studies have examined differences across these migrant groups, and there is a need to do so as they experience varying health disparities. This study contributes to the prescription drug coverage, migration and health literature by employing an intersectional lens to analyze a sample of Ontario working-aged residents (n=39,792) generated from linking the Canadian Community Health Survey (2005, 2008, 2013, 2014) and Longitudinal Immigrant Database. Predicted probabilities and average marginal effects from multivariable logistic regression models were generated, and interaction effects between prescription drug coverage and immigrant status were examined. The study reveals important differences in the use of health services across prescription drug coverage groups by immigration status. As the general debate about universal pharmacare in Canada is ongoing, this study reveals that drug insurance is positively associated with health services use of most migrants and non-migrants, however, some immigrant women may still experience barriers to access general practitioner services. If pharmacare is introduced, ongoing evaluation is needed to ensure that its implementation produces equitable outcomes for all.

The impact of expanding health insurance coverage for anti-cancer drugs on cancer survival in Korea.

BACKGROUND: To reduce out-of-pocket costs, the Korean government expanded health insurance reimbursement in anti-cancer drugs for cancer patients in 2013. Our objective was to examine the impact of the benefit coverage expansion policy on healthcare utilization and overall survival (OS) among patients with six types of solid cancer after the policy of expanding health insurance coverage. METHODS: This study analyzed a before-and-after retrospective cohort of patients newly diagnosed with six types of solid cancer (stomach cancer, colorectal cancer, lung cancer, liver cancer, breast cancer, and prostate cancer) from January 1, 2009 to December 31, 2015 in Korea. The intervention was the expansion of reimbursement in 2013. Multivariate Cox proportional hazards regression was used to estimate the policy effect. RESULTS: In total, 142,579 before and 147,760 patients after the benefit expansion, and after matched by age, gender, and stage, 132,440 before and 132,440 patients after policy were included in the analysis. Almost total medical expenditure increased for five types of cancer increased. The expansion of health insurance reimbursement was associated with significantly lower overall mortality compared with pre-policy mortality for all six cancer sites. CONCLUSION: The policy of expanding health insurance reimbursement might have been associated with a significant increase in survival among cancer patients by ensuring access to health care and medicine. Although the reimbursement expansion timing differs for each cancer, it is believed that eliminating delayed treatment might rather lead to reduce medical expenses and improve health outcomes.

Patient access to chronic medications during the Covid-19 pandemic: Evidence from a comprehensive dataset of US insurance claims.

Patient access and adherence to chronic medications is critical. In this work, we evaluate whether disruptions related to Covid-19 have affected new and existing patients' access to pharmacological therapies without interruption. We do so by performing a retrospective analysis on a dataset of 9.4 billion US prescription drug claims from 252 million patients from May, 2019 through August, 2020 (about 93% of prescriptions dispensed within those months). Using fixed effect (conditional likelihood) linear models, we evaluate continuity of care, how many days of supply patients received, and the likelihood of discontinuing therapy for drugs from classes with significant population health impacts. Findings indicate that more prescriptions were filled in March 2020 than in any prior month, followed by a significant drop in monthly dispensing. Compared to the pre-Covid era, a patient's likelihood of discontinuing some medications increased after the spread of Covid: norgestrel-ethinyl estradiol (hormonal contraceptive) discontinuation increased 0.62% (95% CI: 0.59% to 0.65%, p<0.001); dexmethylphenidate HCL (ADHD stimulant treatment) discontinuation increased 2.84% (95% CI: 2.79% to 2.89%, p<0.001); escitalopram oxalate (SSRI antidepressant) discontinuation increased 0.57% (95% CI: 0.561% to 0.578%, p<0.001); and haloperidol (antipsychotic) discontinuation increased 1.49% (95% CI: 1.41% to 1.57%, p<0.001). In contrast, the likelihood of discontinuing tacrolimus (immunosuppressant) decreased 0.15% (95% CI: 0.12% to 0.19%, p<0.001). The likelihood of discontinuing buprenorphine/naloxone (opioid addiction therapy) decreased 0.59% (95% CI: 0.55% to 0.62% decrease, p<0.001). We also observe a notable decline in new patients accessing these latter two therapies. Most US patients were able to access chronic medications during the early months of Covid-19, but still were more likely to discontinue their therapies than in previous months. Further, fewer than normal new patients started taking medications that may be vital to their care. Providers would do well to inquire about adherence and provide prompt, nonjudgmental, re-initiation of medications. From a policy perspective, opioid management programs seem to demonstrate a robust ability to manage existing patients in spite of disruption.

Effect of Carving in Pharmacy Benefits on Utilization and Costs.

BACKGROUND: Rising medical costs are a significant concern for employers offering health benefits to employees, and there is interest in identifying insurance plan designs that optimize the effect of pharmacy benefits on overall costs. For instance, employers must decide between plans that carve in pharmacy benefits (where medical and pharmacy benefits are integrated into 1 package through an insurer) versus plans that carve out pharmacy benefits (where pharmacy benefits are separately administered through a pharmacy benefit manager). Little is known about the effect of carving in pharmacy benefits on medical utilization and costs. OBJECTIVE: To compare the effect of carving in versus carving out pharmacy benefits on medical utilization, medical costs, and health management program participation in commercial health plans. METHODS: We performed a propensity score-matched analysis comparing carve-in and carve-out members of a regional health plan in 2018. Our primary outcomes were medical utilization (annual medical claims/1,000 members) and costs (medical costs per member per month [PMPM]). We categorized these into the following domains: inpatient, emergency department, outpatient/ambulatory surgery, urgent care, primary care, specialist services, and diagnostics (laboratory testing/imaging). We additionally assessed participation in health plan-based health management programs. RESULTS: We analyzed 9,633 carve-in members matched with 9,633 carve-out members. Compared with carving out pharmacy benefits, carving in was associated with 3.7% lower medical costs, with an $8.73 reduction in PMPM ($225.87 vs. $234.60), and no significant difference in medical utilization; significantly lower inpatient and urgent care claims (reduction of 9.29 claims/1,000 and 51.3 claims/1,000, respectively) and costs ($10.08 and $0.12 PMPM reduction, respectively); lower injectable medical therapy costs ($4.32 PMPM reduction); and higher durable medical equipment costs ($2.14 PMPM increase). Carve-in members also experienced 4.9% higher health management program participation. CONCLUSIONS: As employers attempt to understand the value of carving in versus carving out pharmacy benefits to health plans, our findings suggest that carving in pharmacy benefits is associated with reduced medical costs and hospitalizations. Our findings can assist in informing employer decision-making processes and, as a result, reducing costs of care. DISCLOSURES: No outside funding supported this study. Parekh was and Huang and Good are employed by the UPMC Centers for High-Value Health Care and Value-Based Pharmacy Initiatives. Manolis is employed by the UPMC Health Plan within the UPMC Insurance Services Division. Papa, Drnach, and Spiegel are employed by WorkPartners within the UPMC Insurance Services Division.

Changes in PBM Business Practices in 2019: True Innovation or More of the Same?

In 2019, pharmacy benefit managers (PBMs) responded to intense public criticism with business model changes described as movements toward full transparency and innovation to reduce costs for benefit plan sponsors. We critically analyze these changes in light of key challenges in specialty drug management: pharmaceutical manufacturer practices (price increases driven by coverage mandates and lack of price control, intensive and sometimes misleading advertising, patent extensions), FDA changes (increased reliance on manufacturer funding, weakened evidentiary base for drug approvals), and provider prescribing patterns (lag from evidence to routine practice, manufacturer influences on the knowledge base, direct manufacturer payments to frequent prescribers). The persistence of controversial PBM practices suggests that business model changes were mostly cosmetic, without altering key marketplace dysfunctions. Examples include "spread" pricing, in which PBMs pay pharmacies less than employer-paid amounts; rebate-influenced formulary development; and shifting of prescription volume to PBM-owned pharmacies. Spread in Medicaid was estimated at $224.8 million in Ohio and $123.5 million in Kentucky in 1-year periods and is the subject of an ongoing federal investigation. Rebate influence on formulary development is suggested by slow biosimilar adoption and a study documenting little association between brand exclusions and clinical or cost-effectiveness. Even in 100% passthrough arrangements, the price differential between rebated products and lower-cost alternatives may far exceed revenues returned to the payer. Shifting of business to PBM-owned pharmacies was identified in Florida managed Medicaid in 2018, where the state's 5 largest specialty pharmacies, all owned by managed care organizations or PBMs, collected 28% of prescription drug profit despite dispensing only 0.4% of claims. Finally, contract provisions and terms typically limit the ability of plan sponsors to monitor PBM performance. These include "offsetting," changes in definitions (e.g., "single-source generic") during the contract term, restrictions on audit rights, and exclusion of some pharmaceutical manufacturer revenues from "100%" passthroughs. We conclude that ostensibly positive changes in PBM practices have been offset by undisclosed business arrangements, shifts to alternative revenue sources, and opaque contractual terms. Establishing and maintaining a sustainable benefit will require fundamental alterations to this dysfunctional market DISCLOSURES: This work was funded solely by Archimedes, with no external funding. Motheral is the CEO of Archimedes, a specialty drug management company, and EpiphanyRx, a PBM that provides alternatives to the business models described in this article. Fairman is a consultant to Archimedes.

Detecting Medicine Safety Signals Using Prescription Sequence Symmetry Analysis of a National Prescribing Data Set.

INTRODUCTION: Medicine safety signal detection methods employed by the medicine regulator in Australia (Therapeutic Goods Administration [TGA], Department of Health) rely predominantly on analysis of spontaneous adverse event (AE) reports, sponsor notifications or information shared by international agencies. The limitations of these methods and the availability of large administrative health data sets has given rise to greater interest in the use of administrative health data to support pharmacovigilance (PV). OBJECTIVE: We explored whether prescription sequence symmetry analysis (PSSA) of Pharmaceutical Benefits Scheme (PBS) data can enhance signal detection by the TGA, using the AE, heart failure (HF) as a case study. METHODS: We applied the PSSA method to all single-ingredient medicines dispensed under the PBS between 2012 and 2016, using furosemide initiation as a proxy for new-onset HF. A signal was considered present if the lower limit of the 95% confidence interval for the adjusted sequence ratio was > 1. We excluded medicines known to cause HF, indicated for HF treatment or indicated for diseases that may contribute to HF. RESULTS: Of the 654 tested medicines, 26 potential new HF signals were detected by PSSA. Five signals had additional support for the possible association provided by biological plausibility, consistency and disproportionate reporting of cases of HF to the TGA and the World Health Organization; and clinical impact. CONCLUSION: PSSA was able to identify potential signals for further evaluation. With the increasing availability of different administrative health data sources, the strengths and weaknesses of methods used to analyse these data for the purpose of regulatory PV should be evaluated.

Are Recently Evaluated Drugs More Likely to Receive Positive Reimbursement Recommendations in South Korea? 11-year Experience of the South Korean Positive List System.

PURPOSE: The South Korean government in 2014 introduced various policies to enhance accessibility of pharmaceuticals. This study sought to examine whether positive reimbursement recommendations of pharmaceuticals have increased since 2014. METHODS: Industry submissions evaluated from January 2007 to December 2018 were identified, and characteristics relevant to reimbursement recommendations were extracted. Logistic regression analyses with robust SEs were used to quantify the likelihood of positive recommendations for pharmaceuticals, after controlling for relevant factors influencing the recommendations. FINDINGS: During the study period, 355 (72.9%) of 487 submissions were positively recommended; the drugs evaluated after 2014 (77.8%) were significantly more likely to receive positive reimbursement recommendations than the drugs evaluated before 2014 (69.5%). In the multivariable logistic regression analysis, several factors (labeled a noncancer drug, priced less than alternatives, considered clinically superior, and having budget impact >10 billion South Korean won) were significantly associated with positive recommendations (P < 0.05). When considering interaction effects between evaluation year and other variables, only the interaction between comparative clinical benefit and evaluation year was significant. Specifically, clinically noninferior drugs evaluated after 2014 had 2.85 times the odds of receiving positive recommendations compared with the clinically noninferior drugs evaluated earlier. IMPLICATIONS: Recently evaluated drugs are more likely to receive positive reimbursement recommendations, especially those drugs whose comparative clinical benefits are noninferior.

Prevalence and incidence of type 1 diabetes in Ireland: a retrospective cross-sectional study using a national pharmacy claims data from 2016.

OBJECTIVES: The aim of this study is to estimate the prevalence and incidence of type 1 diabetes in the Irish population using a national pharmacy claims database in the absence of a national diabetes register. DESIGN: National, population-based, retrospective, cross-sectional study. SETTING: Community care with data available through the Health Service Executive Pharmacy Claims Reimbursement Scheme from 2011 to 2016. PARTICIPANTS: Individuals with type 1 diabetes were identified by coprescription of insulin and glucometer test strips without any prolonged course (>12 months) of oral hypoglycaemic agents prior to commencing insulin. Those claiming prescriptions for long-acting insulin only, without any prandial insulin, were excluded from the analysis. Incidence was estimated based on the first claim for insulin in 2016, with no insulin use in the preceding 12 months. MAIN OUTCOME MEASURES: Prevalence of type 1 diabetes in children (<18 years) and adults (≥18 years); incidence of type 1 diabetes in children (≤14 years) and adolescents and adults (>14 years). RESULTS: There were 20 081 prevalent cases of type 1 diabetes in 2016. The crude prevalence was 0.42% (95% CI 0.42% to 0.43%). Most prevalent cases (n=17 053, 85%) were in adults with a prevalence of 0.48% (95% CI 0.47% to 0.48%). There were 1527 new cases of type 1 diabetes in 2016, giving an incidence rate of 32 per 100 000 population/year (95% CI 30.5 to 33.7). There was a significant positive linear trend for age, for prevalence (p<0.0001) and incidence (p=0.014). The prevalence and incidence were 1.2-fold and 1.3-fold higher in men than women, respectively. Significant variations in prevalence (p<0.0001) and incidence (p<0.001) between the different geographical regions were observed. CONCLUSIONS: This study provides epidemiological estimates of type 1 diabetes across age groups in Ireland, with the majority of prevalent cases in adults. Establishing a national diabetes register is essential to enable updated epidemiological estimates of diabetes and for planning of services in Ireland.

Medications requiring prior authorization across health insurance plans.

OBJECTIVE: To determine the amount of variation in numbers and types of medications requiring prior authorization (PA) by insurance plan and type. METHODS: Most health insurance companies require PA for medications to ensure safe and effective use and contain costs. We generated 4 lists of medications that required PA during 2017 for commercial, marketplace, Medicaid, and Medicare plans. We aggregated medications according to the generic medication name equivalent using codes and medication names. We compared these medications to assess how many of the medications required PA by 1, 2, 3, or all 4 of the insurance plans. We counted all prescription orders written for a patient age 18 years or older with health plan insurance during 2017 for any of the medications that appeared on the health plan's PA lists by querying the electronic health record. RESULTS: PA was required for 600 unique medications in 2017 across the 4 plans. Of 691,457 prescription orders written for 114,159 members, 31,631 (5%) were written for 1 of the 600 medications that required PA by at least 1 insurance plan. There were 12,540 medication orders (written for 6,642 members) that potentially required PA. The marketplace plan required PA for the greatest number of medications (440), followed by the Medicare (272), commercial (271), and Medicaid (72) plans. The most commonly prescribed classes of medications for which PA was required by at least 1 plan were antihyperlipidemics (22% of orders potentially requiring PA), narcotic analgesics (13%), hypnotics (12%), antidiabetic medications (9%), and antidepressants (9%). For only 25% of medications (151 of 600) was PA required by at least 3 plans, and for only 5% (32 of 600) was PA required by all 4 insurance types. CONCLUSION: Medications requiring PA can differ within a single health insurance company, but this variation may be unavoidable due to external factors.

Medical Costs and Health Care Utilization Among Self-Insured Members with Carve-In Versus Carve-Out Pharmacy Benefits.

BACKGROUND: Pharmacy benefit can be purchased as part of an integrated medical and pharmacy health package-a carve-in model-or purchased separately and administered by an external pharmacy benefit manager-a carve-out model. Limited peer-reviewed information is available assessing differences in use and medical costs among carve-in versus carve-out populations. OBJECTIVE: To compare total medical costs per member per year (PMPY) and utilization between commercially self-insured members receiving carve-in to those receiving carve-out pharmacy benefits overall and by 7 chronic condition subgroups. METHODS: This study used deidentified data of members continuously enrolled in Cambia Health Solutions self-insured Blue plans without benefit changes from 2017 through 2018. Cambia covers 1.6 million members in Oregon, Washington, Idaho, and Utah. The medical cost PMPY comparison was performed using multivariable general linear regression with gamma distribution adjusting for age, gender, state, insured group size, case or disease management enrollment, 7 chronic diseases, risk score (illness severity proxy), and plan paid to total paid ratio (benefit richness proxy). Medical event objectives were assessed using multivariable logistic regression comparing odds of hospitalization and emergency department (ED) visit adjusting for the same covariates. Sensitivity analyses repeated the medical cost PMPY comparison excluding high-cost members, greater than $250,000 annually. Chronic condition subgroup analyses were performed using the same methods separately for members having asthma, coronary artery disease, chronic obstructive pulmonary disease, heart failure, diabetes mellitus, depression, and rheumatoid arthritis. RESULTS: There were 205,835 carve-in and 125,555 carve-out members meeting study criteria. Average age (SD) was 34.2 years (18.6) and risk score (SD) 1.1 (2.3) for carve-in versus 35.2 years (19.3) and 1.1 (2.4), respectively, for carve-out. Members with carve-in benefits had lower medical costs after adjustment (4%, P < 0.001), translating into an average $148 lower medical cost PMPY ($3,749 carve-out vs. $3,601 carve-in annualized). After adjustment, the carve-in group had an estimated 15% (P < 0.001) lower hospitalization odds and 7% (P < 0.001) lower ED visit odds. Of 7 chronic conditions, significantly lower costs (12%-17% lower), odds of hospitalization (22%-36% lower), and odds of ED visit (16%-20% lower) were found among members with carve-in benefits for 5 conditions (all P < 0.05). CONCLUSIONS: These findings suggest that integrated, carve-in pharmacy and medical benefits are associated with lower medical costs, fewer hospitalizations, and fewer ED visits. This study focused on associations, and defining causation was not in scope. Possible reasons for these findings include plan access to both medical and pharmacy data and data-informed care management and coordination. Future research should include investigation of integrated data use and its effect across the spectrum of integrated health plan offerings, provider partnerships, and analytic strategies, as well as inclusion of analyzing pharmacy costs to encompass total cost of care. DISCLOSURES: This study received no external funding. The study was jointly conducted by employees of Cambia Health Solutions and Prime Therapeutics, a pharmacy benefit manager servicing Cambia Health Solutions. Smith, Lam, Lockwood, and Pegus are employees of Cambia Health Solutions. Qiu and Gleason are employees of Prime Therapeutics.

What types of real-world evidence studies do U.S. commercial health plans cite in their specialty drug coverage decisions?

PURPOSE: To examine the RWE U.S. commercial health plans cite in their specialty drug coverage decisions. METHODS: We used the Tufts Medical Center Specialty Drug Evidence and Coverage Database to identify specialty drug coverage decisions (n = 7267) issued by 17 large commercial health plans. We categorized the clinical evidence plans cited in these coverage decisions (n = 5227) as randomized controlled trials (RCTs), RWE studies, and other clinical studies (studies other than RCT or RWE study). We categorized RWE studies with respect to study type, for example, case series, studies based on medical records, and so on. We compared the frequency that plans cited different categories of RWE, cited RWE for different diseases, and cited RWE for drugs on the market for different time periods. RESULTS: RWE comprised 16% of cited clinical studies. Health plans cited RWE with different frequencies (5%-31% of the cited clinical evidence). Overall, plans cited RWE categorized as medical records most often (26% of cited RWE studies). Plans varied in the frequency they cited different RWE categories. Plans most frequently cited RWE for gastroenterological diseases (35% of clinical study citations) and least frequently for respiratory diseases (11% of clinical study citations). Plans cited RWE more for drugs that have long been on the market. CONCLUSIONS: Health plans varied with respect to the number and types of RWE studies they cited in their specialty drug coverage decisions. Plans cited RWE more often for some diseases than others, and cited more RWE for older drugs.

Prescription medication cost, insurance coverage, and cost-related nonadherence among people with spinal cord injury in Canada.

STUDY DESIGN: Observational cross-sectional study. OBJECTIVES: To describe the most common prescription medications used and the extent of out-of-pocket cost, insurance coverage, and cost-related nonadherence (CRNA) for those medications by people with spinal cord injury (SCI) in Canada. SETTING: Community in Canada. METHODS: It was an observational study wherein data were collected through a cross-sectional online survey from individuals living with an SCI in Canada. We used descriptive statistics to describe the extent of drug cost, insurance coverage and CRNA among study sample, and analytical statistics to find association of CRNA with sociodemographic, injury-related and medication-related characteristics of the sample. RESULTS: Individuals with an SCI (n = 160) used an average of five medications and spent a median of $49 (interquartile range: $234.75) per month on their medications. More than 90% of participants had some form of drug insurance, though 37% reported CRNA. The most common medications that were forgone due to cost included opioids, antidepressants, and drugs for genitourinary and muscular spasms. Individuals with paraplegia and nontraumatic SCI had higher drug costs, though injury-related characteristics did not influence CRNA. Sex, monthly drug expenditure, and monthly additional healthcare costs were significantly associated with CRNA. CONCLUSIONS: People with SCIs are at risk of experiencing CRNA to their prescription medications despite having insurance coverage. Decision makers for the national pharmacare in Canada should account for their concerns judiciously.

Is Insurance a Barrier to HIV Preexposure Prophylaxis? Clarifying the Issue.

Clinical trials have demonstrated that preexposure prophylaxis (PrEP) protects against HIV infection; yet, even with its approval by the Food and Drug Administration (FDA) in 2012, less than 10% of eligible users in the United States are currently taking PrEP.While there are multiple factors that influence PrEP uptake and pose barriers to PrEP implementation, here we focus on PrEP's cost in the United States, which, at the current list price of $2000 per month and with high levels of cost sharing, can leave insured users with more than $1000 in out-of-pocket costs every year. We discuss how patient deductibles, monthly premiums, copayments, and coinsurance vary widely and may increase the financial burden. Although drug payment-assistance programs have made PrEP more affordable to uninsured and underinsured users, lack of insurance is a barrier to PrEP accessibility. The FDA approved a generic version in 2017; however, that version has not been distributed to US consumers and may not be more affordable.As other countries begin implementing PrEP programs, the extent of PrEP's availability as a tool in the global fight against HIV remains to be seen.

Appropriateness of Otic Quinolone Use among Privately Insured US Patients.

OBJECTIVE: Considering emerging safety concerns involving otic quinolones, we assessed the extent of otic quinolone use for questionable indications. STUDY DESIGN: Descriptive cross-sectional study of a national sample of privately insured patients. SETTING: Outpatient encounters in the United States. SUBJECTS AND METHODS: Children and adults with outpatient pharmacy-dispensing claims for new prescriptions of otic or ophthalmic quinolones in 2017 were identified within the IBM MarketScan Commercial Claims & Encounters and the Medicare Supplemental Database. Each dispensing ≥30 days apart constituted a unique episode. Only claims with supporting ear-related diagnoses on outpatient encounters ±3 days of dispensing were considered. Ophthalmic drops were excluded if eye-related diagnoses were found ±30 days. Prescribing was classified as appropriate, questionable, or undetermined. RESULTS: We found 214,897 episodes in 200,270 patients. Adults were twice as likely as children to have otic treatment with questionable indications (6.2% vs 3.0%). Sensitivity analyses with broader time windows to ascertain diagnoses showed similar proportions of questionable use. Otalgia and cerumen impaction constituted 90% of questionable indications. Family physicians (6.8%) and internists (8.0%) had higher percentages of questionable use than other specialties. CONCLUSION: Based on the demonstrated risks of quinolone ear drops, opportunities exist to decrease otic quinolone use, especially in adults.

Universal drug coverage and income-related disparities in glycaemic control.

AIMS: To examine whether income-related disparities in glycaemic control decline after the age of 65 years, when publicly funded universal drug insurance is acquired in Ontario, Canada. METHODS: We conducted a population-based cross-sectional study using linked administrative healthcare databases. Adults with diabetes, aged 40-89 years, with available HbA1c data were included (N = 716 297). Income was based on median neighbourhood household income. Multiple linear regression was used to test for effect modification of age ≥65 years on the relationship between income and HbA1c . RESULTS: There was a significant inverse association between income and HbA1c level. After adjusting for baseline factors, the effect of income on HbA1c level was significantly greater for individuals aged <65 years (mean difference HbA1c for lowest vs highest income group +2.5 mmol/mol, 95% CI +2.3 to +2.7 [+0.23%, 95% CI 0.21 to 0.24]) than for those aged ≥65 years (+1.2 mmol/mol, 95% CI +1.0 to +1.3 [+0.11%, 95% CI 0.10 to 0.12]; P < 0.0001 for interaction). CONCLUSIONS: Despite universal access to healthcare, people with diabetes with lower incomes had significantly worse glycaemic control compared with their counterparts on higher incomes. However, income gradients in glycaemic control were markedly reduced after the age of 65 years, possibly as a result of access to prescription drug coverage.