Formulary tiers, medication cost sharing, and transparency in bronze and silver qualified health plans in 2014 vs 2018.

BACKGROUND: In 2014, qualified health plans sold in the Affordable Care Act (ACA) marketplaces were accused of providing drug coverage that was too restrictive and costly. After the change in administration in 2016, efforts to repeal portions of the ACA led to increases in premiums, decreases in enrollment, and overall uncertainty. OBJECTIVE: To examine how the number of formulary tiers and medication cost sharing, as well as transparency around these aspects, in qualified bronze and silver health plans in California, Florida, and Illinois changed from 2014 to 2018. METHODS: A search of all bronze and silver qualified health plans in California, Florida, and Illinois was performed in 2014 and in 2018 through the marketplace and issuer websites. RESULTS: From 2014 to 2018, the total number of bronze and silver qualified health plans offered in California, Florida, and Illinois remained relatively stable (36 to 35, 123 to 122, and 60 to 74, respectively). Over the same time period, the median number of formulary tiers remained constant for California and Florida (four and five) and increased from five to seven for Illinois. Of note, most Illinois plans shifted from a formulary with five or fewer tiers (92% of plans) to seven tiers (73% of plans) between 2014 and 2018. There was also an increase in the use of coinsurance instead of copay for each of the four following formulary tiers: generic (19% to 27% of plans), preferred brand (21% to 38%), nonpreferred brand (33% to 52%), and specialty (76% to 91%). Additionally, there was an increase in the median coinsurance rates for each of the aforementioned tiers: 0% to 25%, 0% to 35%, 30% to 40%, and 30% to 40%, respectively. The proportion of plans that provided their formularies on the marketplace website increased from 82% to 97% from 2014 to 2018, with the increase mostly driven by California plans (0% to 80%). There was a small increase in the proportion of plans that reported medication cost sharing through the medical benefit from 2014 (19%) to 2018 (25%). CONCLUSIONS: Between 2014 and 2018, qualified health plans increased their use of formularies with greater numbers of tiers, the use of coinsurance for each tier, and higher coinsurance rates. Availability of formularies on marketplace websites increased, but cost sharing transparency for medications covered by the medical benefit could greatly improve. DISCLOSURES: No funding supported this study. Hung reports past employment by Blue Cross Blue Shield Association, CVS Health, and a grant from PhRMA outside of the submitted work. She was an intern at the Biotechnology Industry Organization when this work began. Sauvageau has no disclosures. This work was presented as a poster at the AMCP 2018 Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

US Trends in Opioid Access Among Patients With Poor Prognosis Cancer Near the End-of-Life.

PURPOSE: Heightened regulations have decreased opioid prescribing across the United States, yet little is known about trends in opioid access among patients dying of cancer. METHODS: Among 270,632 Medicare fee-for-service decedents with poor prognosis cancers, we used part D data to examine trends from 2007 to 2017 in opioid prescription fills and opioid potency (morphine milligram equivalents per day [MMED]) near the end-of-life (EOL), defined as the 30 days before death or hospice enrollment. We used administrative claims to evaluate trends in pain-related emergency department (ED) visits near EOL. RESULTS: Between 2007 and 2017, the proportion of decedents with poor prognosis cancers receiving ≥ 1 opioid prescription near EOL declined 15.5% (relative percent difference [RPD]), from 42.0% (95% CI, 41.4 to 42.7) to 35.5% (95% CI, 34.9 to 36.0) and the proportion receiving ≥ 1 long-acting opioid prescription declined 36.5% (RPD), from 18.1% (95% CI, 17.6 to 18.6) to 11.5% (95% CI, 11.1 to 11.9). Among decedents receiving opioids near EOL, the mean daily dose fell 24.5%, from 85.6 MMED (95% CI, 82.9 to 88.3) to 64.6 (95% CI, 62.7 to 66.6) MMED. Overall, the total amount of opioids prescribed per decedent near EOL (averaged across those who did and did not receive an opioid) fell 38.0%, from 1,075 morphine milligram equivalents per decedent (95% CI, 1,042 to 1,109) to 666 morphine milligram equivalents per decedent (95% CI, 646 to 686). Simultaneously, the proportion of patients with pain-related ED visits increased 50.8% (RPD), from 13.2% (95% CI, 12.7 to 13.6) to 19.9% (95% CI, 19.4 to 20.4). Sensitivity analyses demonstrated similar declines in opioid utilization in the 60 and 90 days before death or hospice, and suggested that trends in opioid access were not confounded by secular trends in hospice utilization. CONCLUSION: Opioid use among patients dying of cancer has declined substantially from 2007 to 2017. Rising pain-related ED visits suggests that EOL cancer pain management may be worsening.

Trends and Factors Associated With Insurer Approval of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Prescriptions.

OBJECTIVES: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is)-innovative yet costly cholesterol-lowering agents-have been subject to substantial prior authorization (PA) requirements and low approval rates. We aimed to investigate trends in insurer approval and reasons for rejection for PCSK9i prescriptions as well as associations between patients' demographic, clinical, pharmacy, payer, and PCSK9i-specific plan/coverage factors and approval. METHODS: We examined trends in PCSK9i approval rates and reasons for rejection using medical and prescription claims from 2015 to 2017 for individuals who received a PCSK9i prescription. We used multinomial logistic regression to estimate quarterly risk-adjusted approval rates for initial PCSK9i prescriptions and approval for any PCSK9i prescription within 30, 90, and 180 days of the initial PCSK9i prescription. For a 2016 subsample for whom we had PCSK9i-specific plan policy data, we examined factors associated with approval including PCSK9i-specific plan formulary coverage, step therapy requirements, and number of PA criteria. RESULTS: The main sample included 12 309 patients (mean age 64.8 years [SD = 10.8], 52.1% female, 51.5% receiving Medicare) and was similar in characteristics to the 2016 subsample (n = 6091). Approval rates varied across quarters but remained low (initial prescription, 13%-23%; within 90 days, 28%-44%). Over time, rejections owing to a lack of formulary coverage decreased and rejections owing to PA requirements increased. Lack of formulary coverage and having ≥11 PA criteria in the plan policy were associated with lower odds of PCSK9i prescription approval. CONCLUSIONS: These findings confirm ongoing PCSK9i access issues and offer a baseline for comparison in future studies examining the impact of recent efforts to improve PCSK9i access.

Incentives and disincentives to drug innovation: evidence from recent literature.

Aim: Drug innovation is strongly driven by economic incentives. How these incentives work in determining or changing the level of activity of innovators and the direction of their innovation remains understudied. We seek to address these issues in reviewing recent literature on drug innovation, which offers one major unifying theme of pharmacoeconomic scholarship presented at the 2019 AEA-ASSA annual convention. Methods: Drawn from three AEA-ASSA convention panel sessions, papers were reviewed for newly charted research terrains and new research trajectories, and their theoretical and practical implications on efficiency, effectiveness, and value in the production and utilization of pharmaceutical products. Results: While high and continuously rising drug prices are typically claimed as the price of scientific innovation, the reviewed literature finds that this link only partially accounts for the problem. High risk aversion owing to information asymmetries and vastly intractable uncertainties is prevalent among innovating firms. Predatory business models abound. Reverse predatory strategies also exist to maintain product exclusivity without much added clinical benefits, and to constrain generic competition. CEO compensation practices contribute to rising drug prices. Finally, the US government's hands-off policy on drug list prices leave the forces of supply and demand to allocate them and reward innovation (at times perversely), even as the government extensively regulates or over-regulates practically every other aspect of innovation. Conclusions: Price-elasticity of demand is critical in drug innovation. The drug value chain is price-sensitive to the balance of incentives and disincentives to innovation. American health policy should consider charting a middle course that introduces some form of regulatory price control, while stimulating and sustaining the benefits of market competition. That should incentivize stakeholders to take into account both resources and value for money in making decisions based on best-quality, clinical-economic evidence.

A will and a way to fund medicines for rare diseases: the story of human growth hormone replacement for adults with growth hormone deficiency.

Growth hormone (GH) replacement therapy was recently recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme for adults with severe GH deficiency and impaired quality of life. This approval was significant for two reasons. First, the application was initiated and coordinated by a health professional working group, who prepared a 'public interest' submission to PBAC. Second, it resulted in a recommendation to subsidise therapy for a rare disease after two prior rejections on the basis of uncertainty about efficacy and cost effectiveness. There are important lessons to learn about the power of professional groups to drive health policy and attain funding for rare diseases.

Impact of Unrestricted Access to Pregabalin on the Use of Opioids and Other CNS-Active Medications: A Cross-Sectional Time Series Analysis.

Objective: Access to pregabalin via Ontario's public drug insurance program was expanded to an unrestricted model on April 1, 2013, from a prior authorization model. This study aims to identify the effect of expanded access on the rate of pregabalin use by publicly insured persons and to assess the characteristics of new patients initiating pregabalin following this expanded access. Methods: We conducted a cross-sectional time series analysis using the linked health administrative records of residents of Ontario, Canada, with public drug coverage who were dispensed a prescription for pregabalin between April 1, 2006, and December 31, 2014. Results: A total of 108,047 publicly insured persons were dispensed pregabalin over the study period. The overall rate of pregabalin use increased from 1.0 per 1,000 individuals in Q1 of 2013 to 22.0 per 1,000 individuals in Q4 of 2014. Musculoskeletal (81.6%) and neurological (68.1%) conditions were the most prevalent diagnoses in patients who initiated pregabalin following the expansion of access. Past and concomitant use of opioids, nonsteroidal anti-inflammatory drugs, and antidepressants was also common in this population. Conclusions: Formulary changes in Ontario have led to expanded access to pregabalin, which may have led to an increase in off-label use of these products and potential patient risk associated with concomitant use of pregabalin with central nervous system-depressing drugs.

Hospitalizations for Chronic Conditions Among Indigenous Australians After Medication Copayment Reductions: the Closing the Gap Copayment Incentive.

BACKGROUND: To close health disparities between Indigenous and non-Indigenous Australians, the Australian government in 2010 reduced medication copayments for Indigenous Australians living with, or at risk of, a chronic disease. Patients were registered for this incentive by their general practitioner. OBJECTIVE: To assess rates of hospitalizations for chronic conditions among Indigenous Australians before and after copayment reductions. DESIGN: Observational time-trend study of hospitalizations for chronic conditions sensitive to medication adherence.. PARTICIPANTS: Indigenous persons age 15 years and older in 16 urban, regional, and remote locations. The population ranged from 40,953 in 2009 to 42,651 in 2011. MAIN OUTCOMES: Hospitalizations for diabetes, asthma, chronic obstructive pulmonary disease, hypertension, heart failure, and cardiovascular events. KEY RESULTS: Approximately 22 % of Indigenous persons registered for the medication copayment incentive in the first 18 months of implementation. In areas with rates of incentive uptake exceeding 22 %, the age-standardized rate of hospitalizations for chronic conditions among Indigenous Australians declined from 103.4/1000 (95 % CI 88.8/1000 to 118.0/1000) in 2009 to 60.0/1000 (95 % CI 49.3/1000 to 70.7/1000) in 2011. In areas with below-average uptake of the incentive, we observed non-significant reductions in age-standardized hospitalization rates (from 63.3/1000 [95 % CI 52.9/1000 to 73.7/1000] in 2009 to 58.0/1000 [95 % CI 48.5/1000 to 67.5/1000] in 2011). Among Indigenous Australians, the rate of admission for acute conditions (pneumonia, influenza, urinary tract infection, pyelonephritis, and dehydration) was 38.4/1000 (95 % CI 32.4/1000 to 44.3/1000) in 2009 and 36.2/1000 (95 % CI 30.4/1000 to 41.8/1000) in 2011. Among the non-Indigenous population, we found substantially lower rates of hospitalizations and modest declines from 2009 to 2011. CONCLUSIONS: Though we cannot make causal inferences from the results of this study, we observed marked declines in hospitalizations for chronic conditions among Indigenous Australians following targeted reductions in medication copayments for this population. These declines were largely limited to areas with higher uptake of the copayment incentive and were not observed for admissions related to acute conditions.

Affordable Care Act's Mandate Eliminating Contraceptive Cost Sharing Influenced Choices Of Women With Employer Coverage.

Patient cost sharing for contraceptive prescriptions was eliminated for certain insurance plans as part of the Affordable Care Act. We examined the impact of this change on women's patterns of choosing prescription contraceptive methods. Using claims data for a sample of midwestern women ages 18-46 with employer-sponsored coverage, we examined the contraceptive choices made by women in employer groups whose coverage complied with the mandate, compared to the choices of women in groups whose coverage did not comply. We found that the reduction in cost sharing was associated with a 2.3-percentage-point increase in the choice of any prescription contraceptive, relative to the 30 percent rate of choosing prescription contraceptives before the change in cost sharing. A disproportionate share of this increase came from increased selection of long-term contraception methods. Thus, the removal of cost as a barrier seems to be an important factor in contraceptive choice, and our findings about long-term methods may have implications for rates of unintended pregnancy that require further study.

Changes in Consumer Cost-Sharing for Health Plans Sold in the ACA's Insurance Marketplaces, 2015 to 2016.

This brief examines changes in consumer health plan cost-sharing--deductibles, copayments, coinsurance, and out-of-pocket limits--for coverage offered in the Affordable Care Act's marketplaces between 2015 and 2016. Three of seven measures studied rose moderately in 2016, an increase attributable in part to a shift in the mix of plans offered in the marketplaces, from plans with higher actuarial value (platinum and gold plans) to those that have less generous coverage (bronze and silver plans). Nearly 60 percent of enrollees in marketplace plans receive cost-sharing reductions as part of income-based assistance. For enrollees without cost-sharing reductions, average copayments, deductibles, and out-of-pocket limits remain considerably higher under bronze and silver plans than under employer-based plans; cost-sharing is similar in gold plans and employer plans. Marketplace plans are more likely than employer-based plans to impose a deductible for prescription drugs but no less likely to do so for primary care visits.

National Health Spending In 2014: Faster Growth Driven By Coverage Expansion And Prescription Drug Spending.

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.

[The relevance of multiple sclerosis drugs in private health insurance (PHI)]. / Die Bedeutung von Multiple-Sklerose-Medikamenten in der PKV.

The development of expenses and prescriptions in the pharmacotherapy for multiple sclerosis (MS) is examined on the basis of prescription data of 14 PHI firms. The drugs for the treatment of MS are among the most top-selling drugs in the PHI. From 2007 to 2012, the expenses increase 2.33-fold. The main cause is the increas of the prescription figures. In 2012, about 8,400 privately insured persons receive an MS drug. The prevalence of MS is 2.3 times higher in women than in men Impro ved diagnostic possibilities and expensive new drugs will lead to a dynamic cost de velopment in the next years.

Design, implementation, and first-year outcomes of a value-based drug formulary.

BACKGROUND: Value-based insurance design attempts to align drug copayment tier with value rather than cost. Previous implementations of value-based insurance design have lowered copayments for drugs indicated for select "high value" conditions and have found modest improvements in medication adherence. However, these implementations have generally not resulted in cost savings to the health plan, suggesting a need for increased copayments for "low value" drugs. Further, previous implementations have assigned equal copayment reductions to all drugs within a therapeutic area without assessing the value of individual drugs. Aligning the individual drug's copayment to its specific value may yield greater clinical and economic benefits. In 2010, Premera Blue Cross, a large not-for-profit health plan in the Pacific Northwest, implemented a value-based drug formulary (VBF) that explicitly uses cost-effectiveness analyses after safety and efficacy reviews to estimate the value of each individual drug. Concurrently, Premera increased copayments for existing tiers. OBJECTIVE: To describe and evaluate the design, implementation, and first-year outcomes of the VBF. METHODS: We compared observed pharmacy cost per member per month in the year following the VBF implementation with 2 comparator groups: (1) observed pharmacy costs in the year prior to implementation, and (2) expected costs if no changes were made to the pharmacy benefits. Expected costs were generated by applying autoregressive integrated moving averages to pharmacy costs over the previous 36 months. We used an interrupted time series analysis to assess drug use and adherence among individuals with diabetes, hypertension, or dyslipidemia compared with a group of members in plans that did not implement a VBF.  RESULTS: Pharmacy costs decreased by 3% compared with the 12 months prior and 11% compared with expected costs. There was no significant decline in medication use or adherence to treatments for patients with diabetes, hypertension, or dyslipidemia. CONCLUSIONS: The VBF and copayment changes enabled pharmacy plan cost savings without negatively affecting utilization in key disease states.

The unintended effects of the Medicare Part D low income subsidy.

OBJECTIVES: Medicare Part D is the voluntary program that provides insurance for prescription drugs to 37 million US elderly. This form of public insurance is delivered exclusively through a choice-based private insurance market, where Medicare pays various types of subsidies. The objective of this paper is to analyze how the subsidy paid to low income enrollees induces insurers to distort their plan premiums. METHODS: Combining both an analysis of the incentives created by the different regulations and empirical evidence obtained from plan level data for the years between 2006 and 2013, the paper evaluates the presence of premium distortions associated with insurers response to the low income subsidy. RESULTS: The findings indicate that insurers cluster premiums at the value that maximizes the rents they earn on enrollees receiving the low income subsidies. Moreover, insurers use the possibility of offering multiple insurance plans to manipulate the amount of the subsidy and increase further their rents. CONCLUSIONS: This study indicates the need to reform the subsidy system in Medicare Part D and offers guidance on the essential elements of the low income subsidy reform.

Patterns of use and expenses associated with mail-service pharmacy in adults with diabetes.

OBJECTIVES: To identify socioeconomic factors associated with mail-service pharmacy use and compare the differences in disease-specific prescription medication and medical utilization expenses in a nationally representative sample of adults with diabetes. DESIGN: A retrospective, longitudinal, cross-sectional study. SETTING: United States in 2006-11. PARTICIPANTS: Medical Expenditure Panel Survey household component (MEPS-HC) participants aged 18 years or older diagnosed with diabetes and prescribed antidiabetic medications. MAIN OUTCOME MEASURES: Likelihood of mail-service pharmacy use, diabetes-related medical utilization, and medication expenses. RESULTS: Among 4,430 eligible participants identified in the 2006-11 surveys, representing more than 83 million U.S. individuals, nearly 13% of the participants obtained two-thirds or more of their antidiabetic medications via mail service predominantly. Mail-service pharmacy users were older, had high school or college degrees, had higher incomes, and were more likely to be covered by private insurance. There were no significant differences in diabetes-related medical utilization and drug expenses between the two groups. CONCLUSION: Besides pharmacy benefit design, sociodemographic and economic factors influenced drug dispensing channel use (mail service versus community pharmacy). No significant differences in diabetes-related drug and medical expenses between mail-service and community pharmacy users were observed.

Revolution then evolution: the advance of health economic evaluation in Australia.

All governments face immense challenges in providing affordable healthcare for their citizens, and the diffusion of novel health technologies is a key driver of growth in expenditure for many. Although important methodological and process variations exist around the world, health economic evaluation is increasingly seen as an important tool to support decision-making around the introduction of new health technologies, interventions and programmes in countries of varying stages of economic development. In Australia, the assessment of the comparative cost-effectiveness of new medicines proposed for subsidy under the country's national drug subsidy programme, the Pharmaceutical Benefits Scheme, was introduced in the late 1980s and became mandatory in 1993, making Australia the first country to introduce such a requirement nationally. Since then the use of health economic evaluation has expanded and been applied to support decision-making across a broader range of health technologies, as well as to programmes in public health.

The impact of health economic evaluations in Sweden.

The responsibility for healthcare in Sweden is shared by the central government, county councils and municipalities. The counties and municipalities are free to make their own prioritizations within the framework of the state healthcare laws. To guide prioritization of healthcare resources in Sweden, there is consensus that cost-effectiveness constitutes one of the three principles. The objective of this paper is to describe how cost-effectiveness, and hence health economic evaluations (HEE), have a role in pricing decisions, reimbursement of pharmaceuticals as well as the overall prioritization and allocation of resources in the Swedish healthcare system. There are various organizations involved in the processes of implementing health technologies in the Swedish healthcare system, several of which consider or produce HEEs when assessing different technologies: the Dental and Pharmaceutical Benefits Agency (TLV), the county councils' group on new drug therapies (NLT), the National Board of Health and Welfare, the Swedish Council on Health Technology Assessment (SBU), regional HTA agencies and the Public Health Agency of Sweden. The only governmental agency that has official and mandatory guidelines for how to perform HEE is TLV (LFNAR 2003:2). Even though HEEs may seem to have a clear and explicit role in the decision-making processes in the Swedish healthcare system, there are various obstacles and challenges in the use and dissemination of the results.