Affordability Of Prescription Drugs Research Articles

PT2 Comparison of Prescription Drug Affordability Boards across the United States

PT2 Comparison of Prescription Drug Affordability Boards across the United States

Associations Between Annual Medicare Part D Low-Income Subsidy Loss and Prescription Drug Spending and Use

The Medicare Part D Low Income Subsidy (LIS) program provides millions of beneficiaries with drug plan premium and cost-sharing assistance. The extent to which LIS recipients experience subsidy losses with annual redetermination cycles and the resulting associations with prescription drug affordability and use are unknown. To examine how frequently annual LIS benefits are lost among Medicare Part D beneficiaries and how this is associated with prescription drug use and out-of-pocket costs. In this cohort study of Medicare Part D beneficiaries from 2007 to 2018, annual changes in LIS recipients among those automatically deemed eligible (eg, due to dual eligibility for Medicare and Medicaid) and nondeemed beneficiaries who must apply for LIS benefits were analyzed using Medicare enrollment and Part D event data. Subsidy losses were classified in 4 groups: temporary losses (<1 year); extended losses (≥1 year); subsidy reductions (change to partial LIS); and disenrollment from Medicare Part D after subsidy loss. Temporary losses could more likely represent subsidy losses among eligible beneficiaries. Multinomial logit models were used to examine associations between beneficiary characteristics and subsidy loss; linear regression models were used to compare changes in prescription drug cost and use in the months after subsidy losses vs before. Analyses were conducted between November 2022 and November 2023. Subsidy loss at the beginning of each year among subsidy recipients in December of the prior year. The main outcomes were out-of-pocket costs and prescription drug fills overall and for 4 classes: antidiabetes, antilipid, antidepressant, and antipsychotic drugs. In 2008, 731 070 full LIS beneficiaries (17%) were not deemed automatically eligible (39% were aged <65 years; 59% were female). Nearly all beneficiaries deemed automatically eligible (≥99%) retained the subsidy annually from 2007 to 2018, compared with 78% to 84% of nondeemed beneficiaries. Among nondeemed beneficiaries, disabled individuals younger than 65 years and racial and ethnic minority groups were more likely to have temporary subsidy losses vs none. Temporary losses were associated with an average 700% increase in out-of-pocket drug costs (+$52.72/mo [95% CI, 52.52-52.92]) and 15% reductions in prescription fills (-0.58 fills/mo [95% CI, -0.59 to -0.57]) overall. Similar changes were found for antidiabetes, antilipid, antidepressant, and antipsychotic prescription drug classes. Beneficiaries who retained their subsidy had few changes. The conclusions of this cohort study suggest that efforts to help eligible beneficiaries retain Medicare Part D subsidies could improve drug affordability, treatment adherence, and reduce disparities in medication access.

Failure to Launch: Why Some Generics Don’t Take

Prescription drug affordability is a growing health policy concern. In 2019, pharmaceutical spending accounted for an estimated 12.6% of overall health spending in the United States.1 The annual rise in US pharmaceutical costs consistently outpaces the consumer price index. In this context, much attention has been devoted to various strategies to mitigate or reign in pharmaceutical expenditures.2 Newer prescription drugs are inherently immune to free market competition on price owing to lengthy patent protections, which pose a considerable barrier to the entry of competitors.

Improving Prescription Drug Affordability Through Regulatory Action

This Health Forum discusses efforts to improve the affordability of prescription drugs spearheaded by the US Department of Health and Human Services, the Centers for Medicare &amp; Medicaid Services, and the US Food and Drug Administration.

HPR38 Drug Spending and Medication Use after Implementing a Formulary That Incorporates Formal Value Assessment

To address prescription drug affordability, the National Academy of Medicine called for formularies that are informed by a drug’s assessed value and that allow for the selective exclusion of drugs from coverage. A non-profit health plan implemented a “Value-Based Formulary-essentials” (VBF-e) program that applied a threshold of $150,000 per quality adjusted life-year to inform cost-sharing levels and exclusion. Estimates of the impact of the VBF-e on drug spending could inform future value-based formulary design.

Persistent Prescription Drug Affordability Challenges for Medicare Beneficiaries With Multiple Chronic Conditions—What Goes Up Must Come Down?

Persistent Prescription Drug Affordability Challenges for Medicare Beneficiaries With Multiple Chronic Conditions—What Goes Up Must Come Down?

Generics and Biosimilars: Barriers and Opportunities

Generics and Biosimilars: Barriers and Opportunities

Stakeholder point of view on prescription drug affordability - a systematic literature review and content analysis

ObjectivesThe objectives of this research were to: 1) understand perspectives on affordability of pharmaceutical drugs from the point of view of stakeholders as reported in published peer-reviewed journals and conferences; 2) evaluate if (and how) perspectives on affordability overlapped across stakeholders. MethodsThe systematic literature review followed Cochrane and PRISMA guidelines. Content analysis with iterative and systematic coding of text was conducted, to identify themes. ResultsA total of 7,372 unique citations were eligible, and 126 articles included for final synthesis. For patients, 6 core themes emerged: financial barriers, adherence, access, patient-provider communication, financial distress, and factors that impact affordability. For payers, 5 core themes: financing schemes, cost-effectiveness, budget impact, private vs. public preferences, and ethics. For providers, 3 themes: patient-provider communication, physician prescribing behavior, and finding alternatives to support patient access. For policymakers, 2 themes: measuring affordability and the role of government. Limited articles representing the manufacturer perspective were identified. Perspectives of decision makers (payers, policymakers) did not overlap with those affected by affordability (patients, providers). ConclusionsThis research highlights the multi-dimensionality of drug “affordability.” Multiple factors beyond cost influence patient affordability implying interventions can help alleviate affordability issues for some patients. The lack of overlap highlights potential hazards that decisions related to out-of-pocket spending, insurance coverage, reimbursement, and rationing occur without explicitly considering patient and provider perspectives.

Prescription Drug Priorities under the Biden Administration.

In January 2021, the incoming Biden administration inherited urgent priorities for curbing health care spending and expanding health care coverage to millions of Americans while also addressing the COVID-19 pandemic and resulting economic downturn. Among these competing priorities is the issue of access to and affordability of prescription drugs. Here, the authors outline Biden's plan for directly lowering prescription drug spending for payers and patients and for expanding access to prescription medications through improved health insurance coverage. These policies could provide important financial protections for Americans against high prescription drug prices. Despite widespread public support for addressing prescription drug prices, many of Biden's plans rely on congressional action, which will be complicated by the narrow majority held by Democrats in the House and an evenly divided Senate. However, there may be other opportunities for reducing prescription drug spending and improving health insurance enrollment among the uninsured. While directly lowering drug prices would provide the most widespread savings for payers and patients alike, any successful effort for increasing the number of Americans enrolled in health insurance or rendering it more affordable will still likely effectively lower patients' out-of-pocket costs and improve access to prescription drugs.

The Price to Consumers of Generic Pharmaceuticals: Beyond the Headlines.

Generic drug prices have received a great deal of attention in the past few years. Many agencies have conducted investigations into the pricing patterns for generic drugs. Price spikes for several specific generic drugs have also been widely reported in the media. Today, 90% of all retail prescriptions sold in the United States are generic drugs. Thus, these prices affect affordability of prescription drugs. We construct two Laspeyres chained price indexes for generic prescription drugs. The first reflects direct out-of-pocket payments by consumers to pharmacies for dispensing generic prescription drugs. The second measures the total price received by the pharmacy (the direct out-of-pocket payment plus the price paid to the pharmacy by the insurer). The chained direct out-of-pocket consumer price index we construct shows a roughly 50% decline for generic prescription drugs between 2007 and 2016. The total consumer price index for generic prescription drugs fell by nearly 80%.

How The ACA Reframed The Prescription Drug Market And Set The Stage For Current Reform Efforts.

The Affordable Care Act contained a range of provisions that altered prescription drug access and affordability for patients, payers, and providers. Yet the act stopped short of instituting systemic changes in the pricing of drugs, in part to address concerns that more fundamental changes might disrupt the development of new medicines. Looking back a decade after the Affordable Care Act became law, we found that new drug approvals have accelerated and the therapeutic advances embodied in some novel medicines are substantial-as are the prices that companies are charging for them. The lack of affordability of prescription drugs has become an increasing challenge for American patients and payers, particularly those with limited budgets. In this article we consider how things have changed in the past decade and how missed opportunities in the Affordable Care Act's passage figure prominently in the current drug pricing debate.

Legal Strategies for Reining in 'Unconscionable' Prices for Prescription Drugs

Policy discussions about the affordability of prescription drugs in the United States are infused with the theme that drug prices are unconscionably high. Many of the policy interventions proposed in Congress, the White House, and the states adopt this frame, authorizing regulatory action when prices exceed particular thresholds or otherwise constitute “price gouging” on the part of drug companies. Unsurprisingly, such initiatives have prompted legal challenges by the biopharmaceutical industry. State laws in particular are vulnerable on a number of grounds. In this Article, we focus on one avenue of challenge that has received little scholarly attention in the context of drug pricing: void-for-vagueness claims under the Due Process Clause. These challenges allege that the laws’ definition of “excessive” or “unconscionable” drug prices is so ambiguous as to fail basic requirements of procedural due process. To better understand how federal and state legislation can be designed to survive vagueness challenges, we review and extract lessons from four adjacent areas of law in which a standard of “unconscionable” or “excessive” price has been operationalized: (1) price-gouging laws relating to times of emergency, (2) contract law, (3) consumer lending law, and (4) public utilities rate regulation. We analyze the approaches taken in each field and their potential applicability to the prescription-drug context. We conclude that consumer lending law offers the most promising model, particularly if advanced via federal legislation, and offer a series of recommendations for drafting legislation aimed at identifying and curbing excessive drug prices.

Cost-related nonadherence to medicines in people with multiple chronic conditions

Multimorbidity is common and frequently associated with medicine nonadherence. Although cost is a common reason for nonadherence, very little research has quantified cost-related nonadherence (CRNA) to medicines specifically in people with multimorbidity, the prevalence of CRNA for different conditions nor the impact of cost when prioritising treatment between conditions. To determine the extent of CRNA in people with multimorbidity and the patient characteristics associated with these behaviours. People reporting two or more chronic conditions responding to a rapid response module regarding prescription drug affordability fielded between January 1 and June 30 2016 in the Canadian Community Health Survey, a cross-sectional household survey. Ordinal logistic regression, adjusted for key sociodemographic, clinical and treatment related variables, of weighted population estimates of self-reported CRNA within one group of conditions, across multiple groups of conditions, or no CRNA. 10.2% of 8420 Canadians with multimorbidity reported CRNA. The majority (61%) reported CRNA within one group of conditions, especially respiratory (16%) and mental health disorders (17%). CRNA was more common in younger adults, people without employer or association drug insurance plans, poorer health status, more chronic conditions, and increased out-of-pocket prescription costs. Having no prescription insurance was associated with a higher probability of CRNA across multiple groups of conditions. People with multimorbidity primarily forego medicines because of cost within one group of conditions. However, those without drug insurance extended these behaviours to multiple condition groups. Further work is needed to determine how people prioritise the conditions and treatments that are foregone because of cost, and how to best incorporate this information into treatment plans.

Frontline Physicians Flex Medicine’s Muscle on Capitol Hill Regarding Patient Care

A coalition of physician organizations, including APA, presented a united front on Capitol Hill to encourage reforms important to physicians and their patients.

The consequences of patient charges for prescription drugs in Canada: a cross-sectional survey.

Many Canadians face substantial out-of-pocket charges for prescription drugs. Prior work suggests that this causes some patients to not take their medications as prescribed; however, we have little understanding of whether charges for prescription medicines lead patients to forego basic needs or to use more health care services. Our study aimed to quantify the consequences of patient charges for medicines in Canada. As part of the 2016 Canadian Community Health Survey, we designed and fielded cross-sectional questions to 28 091 Canadians regarding prescription drug affordability, consequent use of health care services and trade-offs with other expenditures. We calculated weighted population estimates and proportions, and used logistic regression to determine which patient characteristics were associated with these behaviours. Overall, 5.5% (95% confidence interval 5.1%-6.0%) of Canadians reported being unable to afford 1 or more drugs in the prior year, representing 8.2% of those with at least 1 prescription. Drugs for mental health conditions were the most commonly reported drug class for cost-related nonadherence. About 303 000 Canadians had additional doctor visits, about 93 000 sought care in the emergency department, and about 26 000 were admitted to hospital at the population level. Many Canadians forewent basic needs such as food (about 730 000 people), heat (about 238 000) and other health care expenses (about 239 000) because of drug costs. These outcomes were more common among females, younger adults, Aboriginal peoples, those with poorer health status, those lacking drug insurance and those with lower income. Out-of-pocket charges for medicines for Canadians are associated with foregoing prescription drugs and other necessities as well as use of additional health care services. Changes to protect vulnerable populations from drug costs might reduce these negative outcomes.

Paying for Cures: How Can We Afford It? Managed Care Pharmacy Stakeholder Perceptions of Policy Options to Address Affordability of Prescription Drugs.

High-priced medications with curative potential, such as the newer hepatitis C therapies, have contributed to the recent growth in pharmaceutical expenditure. Despite the obvious benefits, health care decision makers are just beginning to grapple with questions of how to value and pay for curative therapies that may feature large upfront cost, followed by health benefits that are reaped over a patient's lifespan. Alternative policy options have been proposed to promote high value and financially sustainable use of these therapies. It is unclear which policy options would be most acceptable to health care payer and biomedical manufacturer stakeholders. To (a) briefly review pharmaceutical policy options to address health system affordability and (b) assess the acceptability of alternative policy options to health care payers and biomedical manufacturers before and after an Academy of Managed Care Pharmacy (AMCP) continuing pharmacy education (CPE) session. We searched MEDLINE and Cochran databases for pharmaceutical policy options addressing affordability. With input from a focus group of managed care professionals, we developed CPE session content and an 8-question survey focusing on the most promising policy options. We fielded the survey before and after the CPE session, which occurred as part of the 2016 AMCP Annual Meeting. We first conducted a chi-squared goodness-of-fit test to assess response distributions. Next, we tested how responses differed before and after by using an ordered logit and a multinomial logit to model Likert scale and unordered responses, respectively. Although risk-sharing payments over time remained the most favorable choice before (37%) and after (35%) the CPE session, this choice was closely followed by HealthCoin after the session, which increased in favorability from 4% to 33% of responses (P = 0.001). About half of the respondents (54%) indicated that legislative change is the most significant barrier to the implementation of any policy. As high-cost curative drugs reach the market, managed care stakeholders need information from a balanced education source regarding alternative policies to address affordability. We found that after the AMCP CPE session, risk-sharing payments over time and HealthCoin were the most favorable options. No funding was provided for this research. Carlson reports consulting fees from Genentech, Pfizer, and Seattle Genetics. The other authors have nothing to disclose. Study concept and design were contributed by Yeung, Garrison, and Carlson. Yeung collected the data, which were interpreted by Yeung and Basu. The manuscript was written by Yeung, Suh, and Bansal and revised by Yeung. A portion of this research was presented at the Academy of Managed Care & Specialty Pharmacy Annual Meeting as a continuing education session entitled "Paying for Cures: How Can We Afford It?" on April 20, 2016, in San Francisco, California.

Direct-to-consumer drug ads increasingly seen as problem

AMA’s vote highlighted growing concerns among health care providers and consumers about the affordability of prescription drugs and whether marketing by drug companies arti cially in ates medication costs and pressures providers to prescribe expensive medications when less costly alternatives are available. In a statement following the vote in November, AMA’s board chair-elect, Patrice A. Harris, MD, MA, said support for “an advertising ban re ects concerns among physicians about the negative impact of commercially driven promotions and the role that marketing costs play in fueling escalating drug prices.” Harris added that DTC “advertising also in ates demand for new and more expensive drugs, even when those drugs may not be appropriate.” According to AMA, the United States and New Zealand are the only two countries in the world that allow DTC advertising of prescription drugs.

The issue of drug spending

Abstract Drug pricing and spending has been become an ever present issue that continues to gain attention. Many Americans experience difficulty when it comes to the affordability of prescription drugs, specialty drugs, or even branded

The Affordable Care Act, health care reform, prescription drug formularies and utilization management tools.

The U.S. Patient Protection and Affordable Care Act (hence, Affordable Care Act, or ACA) was signed into law on March 23, 2010. Goals of the ACA include decreasing the number of uninsured people, controlling cost and spending on health care, increasing the quality of care provided, and increasing insurance coverage benefits. This manuscript focuses on how the ACA affects pharmacy benefit managers and consumers when they have prescriptions dispensed. PBMs use formularies and utilization control tools to steer drug usage toward cost-effective and efficacious agents. A logic model was developed to explain the effects of the new legislation. The model draws from peer-reviewed and gray literature commentary about current and future U.S. healthcare reform. Outcomes were identified as desired and undesired effects, and expected unintended consequences. The ACA extends health insurance benefits to almost 32 million people and provides financial assistance to those up to 400% of the poverty level. Increased access to care leads to a similar increase in overall health care demand and usage. This short-term increase is projected to decrease downstream spending on disease treatment and stunt the continued growth of health care costs, but may unintentionally exacerbate the current primary care physician shortage. The ACA eliminates limitations on insurance and increases the scope of benefits. Online health care insurance exchanges give patients a central location with multiple insurance options. Problems with prescription drug affordability and control utilization tools used by PBMs were not addressed by the ACA. Improving communication within the U.S. healthcare system either by innovative health care delivery models or increased usage of health information technology will help alleviate problems of health care spending and affordability.

Compliance with pharmacological treatment among patients after minimally invasive coronary bypass grafting

We sought to evaluate patients' adherence to optimal pharmacotherapy as recommendedby the European Society of Cardiology, together with the assessment of potential clinical determinants of medical non-compliance in a large cohort of patients after endoscopic atraumatic coronary artery bypassing (EACAB). This cross sectional study was conducted in a group of 706 individuals who underwent EACAB between April 1998 and December 2010. Data covering current pharmacological treatment with antiplatelet agents, beta-blockers (BB) (or heart rate lowering calcium channel blockers [CCB] in case of intolerance and/or poor efficacy of beta-blockade), angiotensin-converting enzyme (ACE) inhibitors (or angiotensin receptor blockers [ARB]) and statins was acquired. Mean duration of observation after the surgery was 2132 ± 1313 days. Complete follow-up data has been obtained from 415 living patients (341 males). Amongst them, 353 (85%) received antiplatelet agents, while BB or CCB were routinely ingested by 349 (84%) patients. Statins were used by 310 (74.7%) individuals and 274 (66%) subjects took ACE inhibitors or ARB. Baseline demographic and clinical features, including major co-morbidities had no impact on patients' compliance with all investigated medications. There was no clear association between adherence to treatment and risk of rehospitalization or occurrence of major cerebral and cardiovascular events. EACAB patients' compliance with pharmacotherapy guidelines is insufficient and is unrelated to demographic and clinical features of the subjects. Multidisciplinary approach involving health education, enhancement in prescription drug affordability and a better rapport between doctors and patients should be incorporated into clinical practice to overcome therapeutic disobedience.