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Background The Pharmaceutical Benefits Scheme (PBS) is Australia’s national drug subsidy program. This paper provides a practical guide to researchers using PBS data to examine prescribed medicine use. Findings Excerpts of the PBS data collection are available in a variety of formats. We describe the core components of four publicly available extracts (the Australian Statistics on Medicines, PBS statistics online, section 85 extract, under co-payment extract). We also detail common analytical challenges and key issues regarding the interpretation of utilisation using the PBS collection and its various extracts. Conclusions Research using routinely collected data is increasing internationally. PBS data are a valuable resource for Australian pharmacoepidemiological and pharmaceutical policy research. A detailed knowledge of the PBS, the nuances of data capture, and the extracts available for research purposes are necessary to ensure robust methodology, interpretation, and translation of study findings into policy and practice.

US health care spending increased 5.3 percent to $3.0 trillion in 2014. On a per capita basis, health spending was $9,523 in 2014, an increase of 4.5 percent from 2013. The share of gross domestic product devoted to health care spending was 17.5 percent, up from 17.3 percent in 2013. The faster growth in 2014 that followed five consecutive years of historically low growth was primarily due to the major coverage expansions under the Affordable Care Act, particularly for Medicaid and private health insurance, which contributed to an increase in the insured share of the population. Additionally, the introduction of new hepatitis C drugs contributed to rapid growth in retail prescription drug expenditures, which increased by 12.2 percent in 2014. Spending by the federal government grew at a faster rate in 2014 than spending by other sponsors of health care, leading to a 2-percentage-point increase in its share of total health care spending between 2013 and 2014.

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.

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.

ObjectivesTo assess the effects of costs on access to medicines in 11 developed countries offering different levels of prescription drug coverage for their populations.DesignCross-sectional study of data from the Commonwealth Fund 2014 International Health Policy Survey of Older Adults.SettingTelephone survey conducted in 11 high-income countries: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the UK and the USA.Participants22 532 adults aged 55 and older and living in the community in studied countries.Primary outcome measureSelf-reported cost-related non-adherence (CRNA) in the form of either not filling a prescription or skipping doses within the last 12 months because of out-of-pocket costs.ResultsEstimated prevalence of CRNA among all older adults varied from <3% in the France, Norway, Sweden, Switzerland and the UK to 16.8% in the USA. Canada had the second highest national prevalence of CRNA (8.3%), followed by Australia (6.8%). Older adults in the USA were approximately six times more likely to report CRNA than older adults in the UK (adjusted OR=6.09; 95% CI 3.60 to 10.20). Older adults in Australia and Canada were also statistically significantly more likely to report CRNA than older adults in the UK. Across most countries, the prevalence of CRNA was higher among lower income residents and lower among residents over age 65.ConclusionsObserved differences in national prevalence of CRNA appear to follow lines of availability of prescription drug coverage and the extent of direct patient charges for prescriptions under available drug plans.

Background: Centralized administrative databases enable low-cost pragmatic randomized trials (PRTs) of drug effectiveness and safety. We simplified the PRT strategy by using designed delays (DD) to evaluate drug policies. Objectives: To reassess our DD trial of a cost-saving nebulizer-toinhaler conversion policy and a proposed DD trial of reduced restrictions on Cox-2 inhibitors. Research Design: We randomized 52 pairs of communities and clusters of physician practices to the policy either on time or after a 6-month delay. Our 2-stage qualitative reassessment comprised: (1) applying criteria for reporting PRTs and (2) assessing DD trials in 3 domains of responsibility: policymakers' decisions, researchers' decisions, and joint decisions involving negotiation. Measures: A draft checklist of 22 Consolidated Standards of Reporting Trials (CONSORT). Researchers' recollections of their degree of influence on decisions. Results: DD trials deviated from ideal PRTs in the policymakers' domain: the policies affected mixtures of drugs, users, and illnesses, and implementation was not by strict protocol. Aspects negotiated by researchers and policymakers also deviated from ideal: length of delay; size and location of control group; unit of randomization; additional data collection; and communications to physicians. The DD trials complied better with CONSORT in the researchers' domain of analysis and interpretation. Conclusions: DD trials can be negotiated with policymakers. Low cost and simplicity of DD trials partly compensate for some limitations for evaluating drug safety and effectiveness. The ethics question of whether a DD is routine evaluation or research depends on its purpose and generalizability.

Abstract Objective To compare the results of a randomised and an observational evaluation of the same policy that restricted reimbursement for nebulised respiratory medications in adult patients in a community setting. Designs Cluster randomised controlled trial and observational time series with historical controls. Setting Pharmacare, the government funded drug benefits plan for elderly people and patients receiving social assistance in British Columbia, Canada. Participants In the randomised controlled trial 104 clusters of medical practices, pair matched by geography and approximately by practice size, were randomised to the intervention group (449 patients affected by the policy on 1 March 1999), and the control group (offered a six month exemption, affecting 386 patients). The observational analysis included all Pharmacare beneficiaries (excluding the 386 exempt patients) who had used any nebulised drugs six months before the policy (4624 patients). Intervention Pharmacare restricted reimbursement for nebulised bronchodilators, steroids, and cromoglycate to patients whose doctors applied for an individual patient's exemption, giving an appropriate clinical reason. Main outcome measures Number of contacts with doctors and services, emergency admissions to hospital, and utilisation of and expenditure for respiratory drugs in databases of British Columbia's Ministry of Health. Results Contacts with doctors or emergency admissions to hospital did not increase in association with the restriction, regardless of the analytical approach. In the observational analysis, we found a reduction of $C24 per patient month in all nebulised drug use (95% confidence interval 19 to 29) and an increase of $C3 per patient month in all expenditure for inhalers (1.4 to 4.5). The randomised evaluation found savings of $C8 per patient month for nebulisers (P = 0.24) and no increase in spending on inhalers (P = 0.79). Correcting for 60% non-compliance by exempt doctors in a sensitivity analysis yielded similar results as the observational evaluation. Conclusions Observational as well as randomised analyses found moderate net savings and no increase in unintended healthcare outcomes after restricting reimbursement for nebulised respiratory drugs. Randomised policy trials are feasible and, if carefully implemented, likely to be concordant with observational evaluations.

Many patients do not adhere to treatment because they cannot afford their prescription medications, putting them at increased risk of adverse health outcomes. We determined the prevalence of cost-related nonadherence and investigated its associated characteristics, including whether a person has drug insurance. Using data from the 2007 Canada Community Health Survey, we analyzed the responses of 5732 people who answered questions about cost-related nonadherence to treatment. We determined the national prevalence of cost-related nonadherence and used logistic regression to evaluate the association between cost-related nonadherence and a series of demographic and socioeconomic variables, including province of residence, age, sex, household income, health status and having drug insurance. Cost-related nonadherence was reported by 9.6% (95% confidence interval [CI] 8.5%–10.6%) of Canadians who had received a prescription in the past year. In our adjusted model, we found that people in poor health (odds ratio [OR] 2.64, 95% CI 1.77–3.94), those with lower income (OR 3.29, 95% CI 2.03–5.33), those without drug insurance (OR 4.52, 95% CI 3.29–6.20) and those who live in British Columbia (OR 2.56, 95%CI 1.49–4.42) were more likely to report cost-related nonadherence. Predicted rates of cost-related nonadherence ranged from 3.6% (95% CI 2.4–4.5) among people with insurance and high household incomes to 35.6% (95% CI 26.1%–44.9%) among people with no insurance and low household incomes. About 1 in 10 Canadians who receive a prescription report cost-related nonadherence. The variability in insurance coverage for prescription medications appears to be a key reason behind this phenomenon.

Previous reviews have shown that changes in prescription drug insurance benefits can affect medication use and adherence. We conducted a systematic review of the literature to identify studies addressing the association between prescription drug coverage and health outcomes. Studies were included if they collected empirical data on expansions or restrictions of prescription drug coverage and if they reported clinical outcomes. We found 23 studies demonstrating that broader prescription drug insurance reduces use of other health care services and has a positive impact on patient outcomes. Coverage gaps or caps on drug insurance generally led to worse outcomes. States should consider implementing the Affordable Care Act expansions in drug coverage to improve the health of low-income patients receiving state-based health insurance.

The case of generic imatinib demonstrates several potential barriers to effective generic price competition for specialty prescription drugs, including fewer market entrants, smaller-than-expected price reductions, shifts in prescribing toward more expensive brand-name treatments, and limited uptake of the generic product.The case of generic imatinib demonstrates several potential barriers to effective generic price competition for specialty prescription drugs, including fewer market entrants, smaller-than-expected price reductions, shifts in prescribing toward more expensive brand-name treatments, and limited uptake of the generic product.