Patient liability, treatment adherence, and treatment persistence associated with state bans of copay accumulator adjustment programs.

BACKGROUND: Health insurers have increased the use of copay accumulator adjustment programs (CAAPs) to control costs; however, some states within the United States have banned the use of CAAPs to protect patients from rising out-of-pocket expenses. OBJECTIVE: To assess the impact of state CAAP bans on patient liability, treatment adherence, and treatment persistence. METHODS: This was a retrospective cohort study using administrative claims recorded in the IQVIA PharMetrics Plus database. Data were extracted for patients with fully insured commercial plans receiving autoimmune or multiple sclerosis drugs between January 1, 2017, and December 31, 2021. Patient liability was defined as the difference in insurer allowed and paid amounts. Treatment adherence was measured as the proportion of days covered over a 1-year period, with "adherent" defined as a proportion of days covered greater than or equal to 80%. Treatment persistence was defined as time from treatment initiation to discontinuation (a period of 60 days without supply of treatment). The analysis compared differences in outcomes in states that implemented a CAAP ban during the study period (Arizona, Georgia, Illinois, Virginia, West Virginia) with states that did not, for before and after the date of ban. RESULTS: States that implemented a CAAP ban had relative reductions in patient liability after the first 2 months, which ranged from 41% to 63%, with monthly savings ranging from $128 to $520. Patients in states with a CAAP ban had 14% greater odds of being adherent to their treatment after policy implementation than patients in states without a CAAP ban and a 13% reduction in risk of discontinuing. CONCLUSIONS: The implementation of state legislation to restrict the use of CAAPs in state-regulated plans was associated with reductions in patient liability and improvements in treatment adherence and persistence for the 5 states that were early implementers of a CAAP ban. These results may offer insights for states that have recently implemented a CAAP ban, as well as for those considering enacting similar legislation.

Medicare Part D: The First Fifteen Years.

In this month's column, the author reflects on the initial concerns of the Medicare Part D program and the actual results of the program 15 years after it became law.

Patient and Plan Spending after State Specialty-Drug Out-of-Pocket Spending Caps.

BACKGROUND: Specialty drugs are used to treat complex or life-threatening conditions, often at high financial costs to both patients and health plans. Three states - Delaware, Louisiana, and Maryland - passed legislation to cap out-of-pocket payments for specialty drugs at $150 per prescription. A concern is that these caps could shift costs to health plans, increasing insurance premiums. Estimates of the effect of the caps on patient and health-plan spending could inform future policies. METHODS: We analyzed a sample that included 27,161 persons under 65 years of age who had rheumatoid arthritis, multiple sclerosis, hepatitis C, psoriasis, psoriatic arthritis, Crohn's disease, or ulcerative colitis and who were in commercial health plans from 2011 through 2016 that were administered by three large nationwide insurers. The primary outcome was the change in out-of-pocket spending among specialty-drug users who were in the 95th percentile for spending on specialty drugs. Other outcomes were changes in mean out-of-pocket and health-plan spending for specialty drugs, nonspecialty drugs, and nondrug health care and utilization of specialty drugs. We compared outcomes in the three states that enacted caps with neighboring control states that did not, 3 years before and up to 3 years after enactment of the spending cap. RESULTS: Caps were associated with an adjusted change in out-of-pocket costs of -$351 (95% confidence interval, -554 to -148) per specialty-drug user per month, representing a 32% reduction in spending, among users in the 95th percentile of spending on specialty drugs. This finding was supported by multiple sensitivity analyses. Caps were not associated with changes in other outcomes. CONCLUSIONS: Caps for spending on specialty drugs were associated with substantial reductions in spending on specialty drugs among patients with the highest out-of-pocket costs, without detectable increases in health-plan spending, a proxy for future insurance premiums. (Funded by the Robert Wood Johnson Foundation Health Data for Action Program.).

Evaluating a Stone of Hope: ICER's 2019 Review of Treatments for Duchenne Muscular Dystrophy.

DISCLOSURES: No funding contributed to the writing of this commentary. Brandsema reports consulting for Alexion, Audentes, AveXis, Biogen, Cytokinetics, PTC Therapeutics, Sarepta, and WaVe and has received research funding as a site investigator from Alexion, AveXis, Biogen, CSL Behring, Cytokinetics, Fibrogen, Pfizer, PTC Therapeutics, Sarepta, Summit, and WaVe.

Examining Misaligned Incentives for Payers and Manufacturers in Value-Based Pharmaceutical Contracts.

Value-based pharmaceutical contracts (VBPCs) are performance-based reimbursement agreements between health care payers and pharmaceutical manufacturers in which the price, quantity, or nature of reimbursement is tied to value-based outcomes. As value-based payment models have permeated through much of the health care payment landscape via reimbursement to payers and providers, VBPCs offer opportunities for manufacturers to similarly engage in performance-based models. This article compares 2 VBPC schemes: "pay-for-failure" schemes, in which manufacturers offer rebates or discounts to payers for treatment failure, and "pay-for-success" schemes, in which manufacturers offer rebates or discounts to payers for treatment success. Each method has its own short-term and long-term trade-offs, and both lead to some degree of misaligned incentives between payers and manufacturers. These incentive differences have important downstream effects, influencing patient selection, provision of wraparound services, and nature of reimbursements. This analysis contrasts potential benefits and disadvantages for each of these approaches and offers potential solutions to address misalignment. For example, although pay-for-success models may be more aligned between payers and manufacturers, pay-for-failure contracts can be innovative and effective in controlling costs and/or improving outcomes. To illustrate, VBPCs aimed to reduce costs could incorporate total cost of care reduction as a value-based outcome. The authors encourage payers and manufacturers to consider a blended alternative where pay-for-failure and pay-for-success outcomes could be incorporated as VBPC outcomes. Since little is known about the effect of each scheme on outcomes, further research on VBPCs is necessary to fully understand how differing incentives ultimately affect clinical outcomes and costs. DISCLOSURES: No outside funding supported the writing of this article. Good and Kelly are employed by the UPMC Centers for Value-Based Pharmacy Initiatives and High-Value Health Care, and Parekh was employed by the UPMC Centers for Value-Based Pharmacy Initiatives and High-Value Health Care at the time of this study. The authors have no other disclosures to report.

Policy Recommendations for Pharmacy Benefit Managers to Stem the Escalating Costs of Prescription Drugs: A Position Paper From the American College of Physicians.

Recent discussions about the increasing prices of prescription drugs have focused on pharmacy benefit managers (PBMs), third-party intermediaries for various types of employers and government purchasers who negotiate drug prices in health plans and thus play a crucial role in determining the amount millions of Americans pay for medications. In this position paper, the American College of Physicians expands on its position paper from 2016 by offering additional recommendations to improve transparency in the PBM industry and highlighting the need for reliable, timely, and relevant information on prescription drug pricing for physicians and patients.

Pharmacy Benefit Managers: Practices, Controversies, and What Lies Ahead.

Issue: Pharmacy benefit managers (PBMs) are responsible for negotiating payment rates for a large share of prescription drugs distributed in the U.S. Recently, policymakers have expressed concern that certain PBMs' business practices may not be consistent with public policy goals to improve the value of pharmaceutical spending. Goal: We sought to explain key controversies related to PBM practices and their roles in driving value in the pharmaceutical market. Methods: Literature review and feedback from top experts on PBM business practices and potential policy solutions. Key Findings and Conclusion: In some cases, PBMs' use of rebates has contributed to high pharmaceutical costs, yet proposed solutions to the rebate controversy--including passing the rebate through to payers or patients--will not on their own reduce overall pharmaceutical spending without other policies that drive toward value. Policymakers seeking to reform pharmaceutical reimbursement beyond the practice of rebates will need to consider these changes in light of the recent mergers between PBMs and insurers and the entry of new market competitors.

Income-Related Monthly Adjustment Amounts for Medicare Part B and Prescription Drug Coverage Premiums. Final rule.

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) changed the modified adjusted gross income (MAGI) ranges associated with Medicare Part B and Medicare prescription drug coverage premiums for years beginning in 2018. The Bipartisan Budget Act of 2018 (BBA 2018) revised the MAGI ranges again for years beginning with 2019. We consider a beneficiary's MAGI and tax filing status to determine: The percentage of the unsubsidized Medicare Part B premium that the beneficiary must pay; and the percentage of the cost of basic Medicare prescription drug coverage the beneficiary must pay. This final rule makes our regulations consistent with the MAGI ranges specified by MACRA and BBA 2018.

Small Changes or Big Ones? The Case of Limits on Prescription Drug Copayments in California.

Despite standardization, advocates for various industries and certain patient needs continue to propose changes in coverage rules. Much of the advocacy is occurring at the state level with a focus on pharmaceutical coverage, such as equalizing cost sharing between oral and infused oncology drugs or setting limits on cost sharing for prescriptions.