Pharmacy Benefit Managers Research Articles

Could the Inflation Reduction Act Maximum Fair Price Hurt Patients?

Background: The Inflation Reduction Act's Medicare Drug Price Negotiation Program allows the federal government to negotiate caps for select medications. These price caps may reduce revenue for the pharmacy benefit managers (PBMs) that negotiate the actual price paid for medicines in the U.S. To offset the resulting pressure on their profit margins, it is possible that PBMs would, in turn, increase patients' out-of-pocket costs for medicines with capped prices. The model presented here evaluates how increased out-of-pocket costs for the anticoagulants apixaban (Eliquis) and rivaroxaban (Xarelto) could impact patients financially and clinically. Methods: Copay distributions for all 2023 prescription fills for apixaban and rivaroxaban managed by the 3 largest PBMs, CVS Caremark, Express Scripts International, and Optum Rx, were used to approximate current copay costs. Increased out-of-pocket costs were modeled as a shift of all apixaban and rivaroxaban prescriptions to the highest copay tier. The known linear relationship between copay costs and treatment abandonment was used to calculate the potential resulting increase in treatment abandonment. Known rates of morbidity and mortality due to abandoning anticoagulants were used to estimate resulting increases in morbidity and mortality. Results: If the 3 largest PBMs all shifted costs onto patients by moving all apixaban and rivaroxaban prescriptions to the highest formulary tier, Tier 6, patients' copay amount would increase by 482 million for apixaban and 206 million for rivaroxaban. Such an increase could lead to 169 000 to 228 000 patients abandoning apixaban and 71 000 to 93 000 abandoning rivaroxaban. The resulting morbidity and mortality could include up to an additional 145 000 major cardiovascular events and up to 97 000 more deaths. Conclusion: The Medicare Price Negotiation Program could impact patients negatively if it causes PBMs to increase patients' out-of-pocket costs for medicines. Policymakers should closely monitor changes in overall affordability, including all patient out-of-pocket expenditures, for medications in the program. Preemptive measures should be considered to ensure that the most vulnerable citizens are not placed in precarious situations, leading to poorer health outcomes.

Impact of the Inflation Reduction Act on Patient Access and Out-of-Pocket Costs

The Inflation Reduction Act (IRA) represents a recent policy enactment that will influence prescription drug pricing. This paper examines the IRA's elements and their impact on patients' access to medications, specifically around programs funded by the Centers for Medicare and Medicaid. This review analyzed grey literature on patient medication access concerning the IRA, along with the legislation itself. It finds that the IRA contains six key provisions with the potential to impact patients' access to medications and stakeholder business practices: insulin and vaccine cost share, OOP cost limits, premium stabilizations, drug negotiations, and low-income subsidy programs. Although the IRA presents cost-saving provisions, it may exert downstream effects on new drug innovation, increased medication utilization management by payers and pharmacy benefit managers (PBMs), and how healthcare providers, manufacturers, and payers/(PBMs) work together to balance patient well being with fair economic returns for all stakeholders.

Prescription rebate guarantees: employerinsights.

To describe (1) rebate arrangements for specialty drugs, (2) the use and influence of benefits brokers and consultants, and (3) the importance of rebate-related factors when selecting a pharmacy benefits manager (PBM) among a sample of employers with self-funded pharmacybenefits. A national survey of employer drug benefit decision makers (N = 110) for organizations with self-insured pharmacy benefits. We summarized respondents' current rebate agreements for specialty drugs and their perspectives on the importance of rebates and rebate guarantees overall as well as by type of rebate agreement and by the person or entity identified as most influential in rebate strategy. Nearly two-thirds of employers reported having rebate agreements with a rebate guarantee for specialty drugs (n = 69; 62.7%). The person or entity most influential to rebate strategy decisions was often a benefits consultant (37.3%), a human resources/benefits leader (29.1%), or a benefits broker (21.8%). Employers with rebate guarantees ascribed a higher level of importance to guarantees when selecting a PBM (median [IQR], 9 [7-10]) than employers receiving rebates without a guarantee (7 [6-8]) and those who do not receive rebates (7.5 [4-9]) (P = .001). These findings shed light on the importance of rebate guarantees and the role of employer benefits consultants and brokers in PBM selection. Asthe public discourse on PBMs and drug rebates continues, it is important to recognize the role employer benefits consultants may play in perpetuating employer reliance on guaranteed rebate arrangements.

Revolutionizing Pharmacy Benefit Management: Cost-Reduction through Artificial Intelligence and Data Analytics in Healthcare

Pharmacy Benefit Managers (PBMs) are third party companies that function as intermediaries between insurance providers and pharmaceutical manufacturers. PBMs create formularies, negotiate rebates (discounts paid by a drug manufacturer to a PBM) with manufacturers, process claims, create pharmacy networks, review drug utilization, and occasionally manage mail-order specialty pharmacies. [1] Pharmacy benefit management (PBM) is important for keeping prescription drug costs under control. But the problem is that drug prices keep going up, which makes things tough for the healthcare industry. In this article, we look at how fancy technology like artificial intelligence (AI) and data analysis can help PBM find new ways to save money. By using advanced technology to study a large amount of information, PBMs can find patterns and make educated guesses about how to best use medications. Artificial intelligence makes this even more advanced by helping to quickly find and stop fraud, personalize medication plans, and predict costs more accurately. Remember this: AI and data analytics are being used to make pharmacy benefit programs work better. This helps save money and makes things better for patients. We look at how machine learning models can predict patient adherence, how natural language processing (NLP) can improve medication reviews, and how blockchain technology can keep supply chains transparent and secure. Real-world examples show how these technologies are already making a difference, such as cutting down on administrative work, reducing drug waste, and getting the most out of drug utilization. As more healthcare systems start using these advanced tools, it’s becoming clear that continual innovation and the inclusion of AI and data-driven methods are essential. This article highlights the importance of staying updated with the ever-changing ways of controlling prescription drug expenses by using new technology. For pharmacy benefit managers (PBMs) focused on offering the best value and working effectively despite increasing healthcare costs, adopting these advancements is not just a good choice, it's necessary.

Implementing a letter template to expedite specialty medication appeal letter submission

BackgroundPrior authorizations (PAs) for biologic medications, used to treat inflammatory bowel disease (IBD), are often denied by pharmacy benefits managers and can require a complex appeal process for patients to gain access to medication. ObjectiveThis quality improvement project evaluated the impact of implementing a standardized appeal letter template and customizable clinical rationale letter content on specialty pharmacist workflow and workload in an integrated hospital health system specialty pharmacy (HSSP) IBD clinic. Practice descriptionThis initiative was conducted in an IBD outpatient clinic at a tertiary academic medical center with an integrated HSSP whose specialty pharmacists work collaboratively with providers to manage specialty medications. Practice innovationA letter template was created in the electronic health record (EHR) for pharmacists to use when submitting appeal letters. The template automatically populates patient results from recent labs, imaging, and clinic visit notes as part of the appeal documentation. Clinical rationale letter content was developed for the most common appeal reasons using EHR functionality that allows the creation of standardized notes that can be shared among team members and customized at time of use. Evaluation methodAn analysis of 2 months of data preimplementation/postimplementation was conducted using descriptive statistics to report the number of appeals submitted, time from PA denial to appeal submission, and appeal approval rate. A pharmacist postimplementation satisfaction score was also collected. ResultsThe number of appeals submitted preimplementation (n = 73) and postimplementation (n = 73) was the same. Postimplementation, 89% of appeals were submitted within 3 days of PA denial compared to 29% preimplementation. PA approval rate was high (93%) preimplementation and postimplementation. Overall pharmacist satisfaction was 9.7 out of 10. ConclusionImplementation of an appeal letter template and standardized clinical rationale letter content in the EHR led to decreased time to appeal submission and high specialty pharmacist satisfaction.

Utilization of Lean Six Sigma and the DMAIC process on oral treatment regimen entry and consent to improve patient care and mitigate practice risk.

281 Background: Oral medication (chemo/hormone) volumes in oncology treatment selection will continue to increase year over year. In 22’, oral meds accounted for the largest market share in dollars at 51% vs IV treatment at 49%. Oral medication volume is projected to increase by proliferation and utilization, though revenues may decrease due to decreasing drug margins. Medication regimen consent is a critical part of specialty pharmacy accreditation through one of the national accrediting organizations. This accreditation is vital to meeting the requirements and maintaining contracts with pharmacy benefit managers (PBMs) and specialty-focused pharmacy services administrative organizations (PSAO). Without improved and continued consent compliance, OHC was at a significant risk of losing the ability to provide care for this impacted patient population, thus resulting in increased risk of financial toxicity. PBMs and accreditations require quality components be completed to maintain the ability to run a specialty oncology pharmacy. When a new oral prescription is written, the oral must be 1.) entered as a regimen and not a single script-only in the EHR and 2.) must have a completed teaching visit and legal consent. Methods: Following the DMAIC (define, measure, analyze, implement and control) process, OHC’s Lean Team deployed Lean Six Sigma strategies and tools in PY23’ to bridge the gap to goal for both oral medication risk areas. OHC followed the lean methodology A3 process using DMAIC, deployed implementation strategies and curated data analytic reports to ensure oral medications were entered as regimens vs script-only, that teaching/consents were completed, and that the control phase maintained a steady state. Results: In 23’, OHC providers accurately prescribed in the EHR a new oral chemo/hormone at 98% (1037/1055) accuracy vs 22’ at 69% (586/845). Additionally, OHC achieved a 93% (986/1055) teach/consent compliance rate vs 22’ at 59% (499/845). With mitigation of compliance risk (est. at 12,114,000), OHC ensured no loss of pharmacy accreditation and contracts. Increased oral medication teaching visits capture rate increased (n=399) resulting in $114,000 additional return on investment in calendar year 23’. Conclusions: Utilizing Lean Six Sigma tools and the DMAIC process, OHC was able to implement strategies to meet both measure goals in one performance year, resulting in improved patient care, organizational risk mitigation, and sustainable profitability. The results have been maintained in the control phase of PY24’. Lean Six Sigma and the DMAIC process are vital to organization success. Tactics deployed have proven to be reproducible and scalable to other projects. Measure PY2022 PY2023 Goal Oral Medication Regimen NCCN Entry vs Script-only 69% (586/845) 98% (1037/1055) 90% Oral Medication Regimen Teach/Consent 59% (499/845) 93% (986/1055) 93%

Pharmacy benefit managers and drug affordability policy proposals for enhancing access in underserved communities

Pharmacy Benefit Managers (PBMs) play a pivotal role in the pharmaceutical supply chain, yet their practices have increasingly contributed to the rising costs of prescription drugs and limited access to essential medications, particularly in underserved communities. This paper critically examines the role of PBMs, highlighting their challenges to drug affordability and accessibility. It explores the limitations of existing policies and proposes comprehensive reforms to enhance transparency, accountability, and fairness in PBM operations. The proposed policy interventions include mandatory transparency in PBM rebates and formularies, regulations on rebate retention, and fair reimbursement rates for pharmacies. Additionally, broader strategies such as government regulation of drug prices, expanded subsidies for low-income populations, and value-based contracts are discussed as potential solutions. The paper concludes with recommendations for policymakers, healthcare providers, and PBMs, emphasizing the need for collaborative efforts to ensure the successful implementation of these reforms. Addressing the issues posed by current PBM practices, these policy proposals aim to significantly improve drug affordability and access in underserved communities, ultimately contributing to a more equitable healthcare system. Keywords: Pharmacy Benefit Managers (PBMs), Drug Affordability, Healthcare Access, Underserved Communities, Policy Reform, Pharmaceutical Supply Chain.

Pharmacy Benefit Manager Market Concentration for Prescriptions Filled at US Retail Pharmacies

This study analyzes pharmacy benefit manager market concentration for commercial insurance, Medicare Part D, and Medicaid managed care in the US.

Act for the future of community pharmacy

Community pharmacies serve as a vital gateway to primary care and public health, offering face-to-face pharmacist expert care to assure safe and effective medication use. However, they are disappearing at an alarming rate, with 20%-30% of all community pharmacy locations projected to close within the next year. The objective of this commentary is to highlight the critical need for systemic reforms and collective action within our profession to address the unique challenges faced by community pharmacies, ensuring their sustainability and continued role in providing essential health care services for patients. Key issues and evidence are provided to help pharmacy professionals better articulate why pharmacy closures are happening now and how we can work toward a transformed future. Pharmacy closures stem from an unsustainable business model characterized by declining reimbursement for prescription medications, opaque and anticompetitive pricing practices of pharmacy benefit managers, and limited reimbursement for clinical services. Among these challenges, our profession has the opportunity to create a future for community pharmacy where every person has local access to pharmacist expert care and medications through sustainable, integrated community pharmacy practice. Our profession must embrace community pharmacy teams’ role in patient care, champion opportunities to integrate community pharmacists and their support staff as members of the health care team, and advocate for payment transparency and transformation. Creating this future will take all pharmacists and all pharmacy professionals.

Predicting pharmaceutical supply chain disruptions before and during the COVID-19 pandemic.

Disruptions to the pharmaceutical supply chain (PSC) have negative implications for patients, motivating their prediction to improve risk mitigation. Although data analytics and machine learning methods have been proposed to support the characterization of probabilities to inform decisions and risk mitigation strategies, their application in the PSC has not been previously described. Further, it is unclear how well these models perform in the presence of emergent events representing deep uncertainty such as the COVID-19 pandemic. This article examines the use of data-driven models to predict PSC disruptions before and during the COVID-19 pandemic. Using data on generic drugs from the pharmacy supply chain division of a Fortune 500 pharmacy benefit management firm, we have developed predictive models based on the naïve Bayes algorithm, where the models predict whether a specific supplier or whether a specific product will experience a supply disruption in the next time period. We find statistically significant changes in the relationships of nearly all variables associated with product supply disruptions during the pandemic, despite pre-pandemic stability. We present results showing how the sensitivity, specificity, and false positive rate of predictive models changed with the onset of the COVID-19 pandemic and show the beneficial effects of regular model updating. The results show that maintaining model sensitivity is more challenging than maintaining specificity and false positive rates. The results provide unique insight into the pandemic's effect on risk prediction within the PSC and provide insight for risk analysts to better understand how surprise events and deep uncertainty affect predictive models.

The Neurologist's Guide to Drug Pricing in the United States.

As newer, innovative neurology drugs enter the US health care system, neurologists should consider the cost of these treatments in addition to their efficacy, safety, and tolerability. To do so thoughtfully requires an understanding of how prescription drugs are priced in the United States. The process of drug pricing is linked to the distribution supply chain and the many stakeholders involved. Stakeholders include pharmaceutical manufacturers; wholesalers; pharmacies; pharmacy benefit managers; payers, including health insurers; hospital systems; neurologists and other clinicians; and patients. Drug pricing has taken center stage as the Inflation Reduction Act of 2022 has set maximum out-of-pocket expenses for Medicare beneficiaries for the first time in the program's history and limits drug price increases for a select group of Medicare Part D drugs. This article describes the US drug distribution supply chain and its stakeholders and introduces key drug pricing terms; a brief description of how rebates are generally estimated will also be discussed. Finally, as newer neurology outpatient drugs enter the market, the "value" of drugs will be described through cost-effectiveness terminology and their utility for the clinical neurologist.

Considerations for US coverage and reimbursement: Which digital health products to evaluate? Findings from a modified Delphi study.

The rapid growth of digital health tools, including digital applications, wearables, sensors, diagnostics, digital therapeutics (DTx), and prescription DTx, offers new ways to treat patients and close gaps in care. Payers need transparent, credible, and efficient processes to differentiate products for potential reimbursement from the larger universe of digital health products. To identify areas of agreement, disagreement, and rationale for payers to determine which digital health products should be evaluated for formulary consideration and to develop generalizable criteria for health care decision-makers developing policies and approaches for digital health products. Experts from the Academy of Managed Care Pharmacy DTx Advisory Group Payer Evaluation subcommittee rated whether a pharmacy and therapeutics committee, health technology assessment group, or an innovation center within a health plan or pharmacy benefit manager should consider 14 hypothetical products for potential formulary coverage. Using a 4-step modified Delphi approach, experts rated whether it was appropriate for a payer to evaluate each product on a scale of 1 (strongly disagree) to 9 (strongly agree). Quantitative agreement was assessed using terciles of responses, medians, and the distribution of appropriateness scores. The corresponding discussions are summarized to identify generalizable criteria for payers to consider as they develop approaches to determine which digital health products to evaluate. Among the 14 hypothetical products, 4 achieved quantitative agreement that payers should evaluate the product. 5 products had quantitative disagreement, and the remaining were indeterminant. Payers were most likely to review a product if it (1) was reviewed by the US Food and Drug Administration, (2) required a prescription, (3) was intended to be paid for using premium dollars, (4) treated rather than diagnosed or monitored a clinical condition, (5) had a low clinical opportunity cost, and (6) could address population health metrics. The rapid availability of digital health and DTx options can be daunting for health care decision-makers when determining which products to evaluate. These generalizable criteria can help payers develop a more efficient process.

Sustaining competition for biosimilars on the pharmacy benefit: Use it or lose it.

Congress passed the Biologic Price Competition and Innovation Act of 2009, specifically to offer market competition as a counterweight to the rising costs of biologic medicines. As of April 15, 2024, 49 biosimilars have been approved by the US Food and Drug Administration in 15 biologic categories. Biosimilar competition has been undeniably successful: Through 2022, biosimilars have saved the US health system $23.6 billion, without significant care disruption or reduced quality. Through 2023, adalimumab biosimilar competition has added an additional $6.5 billion to this total, primarily through greater rebates from the reference manufacturer. Despite launching at discounts as great as 85%, adalimumab biosimilars have not been given preferred formulary positioning in the vast majority of cases and have thus gained only 3% of market share through 2023, largely because of payers' and pharmacy benefit managers' preference for rebates over discounts. This situation may negatively influence future biosimilar development, posing a threat to a biosimilar pipeline that represents hundreds of billions in savings over the next 10 years.

Creating a national model to build anti-cancer stewardship and quality improvement initiatives.

e23219 Background: The Department of Veterans Affairs (VA) Pharmacy Benefits Management (PBM) Services created a national stewardship with focus on anti-cancer therapeutics within a disease-specific cohort. Building a model to focus on Veterans with a common malignancy is a novel approach. A toolkit was built containing resources to support initiatives to promote standardization of practice and monitor outcomes as a continual quality improvement process. This model was piloted in Veteran patients with Chronic Myeloid Leukemia (CML) since Tyrosine Kinase Inhibitors (TKIs) account for the second highest utilization among outpatient oral anti-cancer therapies in VA . Methods: Business rules identified Veterans Integrated Service Network (VISN) CML cohorts by using data and diagnostic coding (ICD-10; SNOMED CT) from the VA Electronic Health Record (EHR): primary care and hematology/oncology visits, inpatient stays, and problem lists. Medication Use Evaluations (MUEs) were developed: MUE #1: Veterans who received a drug other than imatinib as their initial VA prescription If new initiation, documented reason(s) for drug selection If continuation, prior drug therapy history MUE #2: Veterans who switched from first to second-line TKI Documented reason(s) for switch to 2L Documentation of adverse drug reaction (ADR) in the EHR. Results: 16 VISNs participated in the MUEs. Patient counts are each ~25% of the total CML cohort; ~50% of patients received imatinib 1L and have not switched to 2L. Responses for MUE #1 (N = 559) 293 (52%) continued therapy originally started outside VA with 71% of these patients (n = 208) without documentation of prior imatinib 266 (48%) newly initiated therapy with top documented reasons Intermediate/high risk scoring: 109 (41%) Reason not documented: 80 (30%) Cited FDA indication for CML without clinical justification: 35 (13%) Responses for MUE #2 (N = 576) Top documented reasons for switch from 1L to 2L therapy ADR: 325 (56%) Resistance / inadequate response: 132 (23%) Disease progression: 117 (20%) Only 59 (18%) who experienced an ADR had it documented in the EHR allergies / adverse reactions section. Conclusions: Disease-focused oncology stewardship in a national healthcare system is feasible. Imatinib remains the preferred TKI and accounts for the highest utilization. Oncology Stewardship activities based on the results include education on disease coding, an educational document on why to use imatinib in the 1L setting, and a medication safety article to emphasize documentation of ADRs. In our 1L to 2L MUE, ADRs were the most common reason for patients to be switched to 2L. Future activities include an education sheet on managing TKI ADRs and criteria for a potential treatment-free remission. Further interventions in TKI prescribing may be instituted in select sites. Following initiatives for CML, Anti-Cancer Stewardship Program will be expanded to other oncologic diseases.

The impact of multiple pharmacy use on medication adherence in individuals with colorectal cancer.

11041 Background: Colorectal cancer (CRC) is the third most common cancer diagnosed in the US. The pharmacological care of older and often comorbid members with CRC is a growing healthcare issue. Cancer members are prone to the unintended consequences of multiple pharmacy use, as they often receive chemotherapy and symptom-relieving agents, in addition to medications they may be taking for other comorbidities. The purpose of this study was to assess multiple pharmacy use and adherence in a cohort of individuals with CRC. Methods: Adult pharmacy benefit manager (PBM) members who had at least 2 fills of either regorafenib, encorafenib, or trifluridine + tipiracil at specialty pharmacies between 1/1/2022 and 12/31/2022 were included. Any fills must have included one of the following diagnosis codes: C18.X, C19.X, C20.X, C21.8, C78.5, C78.6, D37.4, D37.5. Members were excluded if they did not maintain continuous eligibility for the 180 days prior to initiation in the study. Specialty pharmacy type included CVS Specialty, Competitor Specialty and Competitor non-specialty. Multiple pharmacy use was defined as utilizing more than one pharmacy for medication fills. The primary outcome was adherence determined by the medication possession ratio (MPR), defined as the number of days supplied/number of days in the evaluation period; optimal adherence was defined as MPR ≥ 0.8. Continuous and categorical variables were assessed with standard statistical tests. Bivariate logistic regression models were constructed for each covariate; significant variables were included in the multivariate model. Odds ratios (OR) and 95% confidence intervals (CI) are presented; p values < 0.05 were significant. Results: 891 members met all inclusion criteria; 362 (40.6%) met the definition of multiple pharmacy use. Members were on average 59.6 ± 11.2 years old and 54.3% were male. No differences in member demographics between specialty pharmacy type were found (all p > 0.05). Adherence was high with 79.5% of members having a MPR ≥ 0.8. Members with multiple pharmacy use had significantly lower adherence rates (76.0% vs. 81.9%; p=0.04) and MPRs (mean ± SD) (1.06 ± 0.45 vs. 1.15 ± 0.53; p=0.011). Controlling for specialty pharmacy type, medication used, and gender, multiple pharmacy use was significantly associated with decreased likelihood of optimal adherence compared to single pharmacy use (OR [95% CI]: 0.705 [0.507-0.98]; p= 0.038). Male gender was associated with significantly higher likelihood of optimal adherence (OR [95% CI]: 1.517 [1.093-2.107]; p=0.013). Conclusions: In this study of individuals with CRC receiving regorafenib, encorafenib, or trifluridine + tipiracil, utilizing multiple pharmacies for non-CRC medications was associated with a 29.5% decreased likelihood of optimal adherence compared to those who only utilized one pharmacy. Further examinations are warranted that include other modulators of adherence.

Adherence for members taking oral oncolytic agents undergoing dose modification strategies.

e23058 Background: The use of oral oncolytic agents has transformed oncology care. Previous studies have reported that patient, treatment, and health system-related factors may influence adherence rates in patients prescribed oral oncolytic agents. The purpose of this study is to assess adherence rates in members of a large national pharmacy benefit manager taking oral oncolytic agents who experienced a modification to their dosing regimen. Methods: Adult members receiving palbociclib, abemaciclib, ribociclib, axitinib, lenvatinib, or cabozantinib between 01/01/2021 and 12/31/2022 were eligible for the study. Members who did not maintain continuous eligibility for 180 days prior to and 2 years after the first fill in the study period were excluded. Members were stratified by presence of dose modification, defined by a change in daily dose from one prescription to the next. Adherence was assessed via the proportion of days covered (PDC) which is the total days with medication coverage divided by the number of days between the index fill and exhaust of the final fill in the study period. Optimal adherence was defined as PDC ≥ 0.85. Standard statistical tests for continuous and categorical variables were utilized. Logistic regression was performed with the endpoint of optimal adherence. P values < 0.05 are significant. Results: 13,641 members were included in the final analysis, with 7,093 (52%) experiencing a modification to their dosing regimen during the study period. Several significant differences in sociodemographic variables were present in this study with members experiencing a dose modification being older (mean [standard deviation (SD)]: 65.7 [11.9] vs. 64.9 [13.0] yr; p < 0.001), more likely to be male (23.3% vs. 15.0%; p < 0.001), more likely to reside in high socioeconomic status (SES) regions (23.7% vs. 21.5%; p = 0.005) and more likely to receive tyrosine kinase inhibitors (TKIs) (37.6% vs. 23.6%; p < 0.001). Adherence was high overall with 74.6% of members achieving a PDC ≥ 0.85; however, members with dose modifications were less likely to be adherent (69.7% vs. 80.0%; p < 0.001). Holding other confounders constant, having a dose modification was associated with a decreased likelihood of adherence (Odds Ratio [95% Confidence Interval]: 0.6 [0.55-0.65]; p < 0.001). Conclusions: Dose modification was associated with significant decreases in adherence to oral oncolytic medications. Interventions designed to minimize dose modifications or to provide additional member support during a dose modification may optimize oral oncolytic adherence.

Health care decision-maker perceptions and trends in the utilization of preapproval information for formulary decision-making.

Preapproval information exchange (PIE) has increased between biopharma companies and health care decision-makers (HCDMs) over the last several years. However, there still exists a gap in what HCDMs need and what biopharma companies are providing. To assess trends in the utilization of preapproval information by HCDMs and identify resources that may best support organizations in evaluating product information for formulary coverage prior to US Food and Drug Administration approval. A double-blinded, web-based survey was fielded to a research panel of HCDMs from FormularyDecisions from May 16, 2022, to May 23, 2022. A total of 30 advisors were invited to take the survey and 17 responded to the survey, with representation largely from health plans (41%), pharmacy benefit managers (24%), and integrated delivery networks (12%) across commercial, Medicare, and Medicaid lines of business. Of the respondents, 47% noted that the availability of preapproval information has shortened the time to make a formulary decision. Almost all respondents (90%) ranked the availability of clinical and economic information in a timely manner to evaluate budget impact as a top benefit for PIE. Respondents noted that Academy of Managed Care Pharmacy (AMCP) preapproval dossiers (88%), AMCP PIE webinars (76%), preapproval presentations/videos (65%), and posters and abstracts of clinical trials results (59%) were the main resources used to facilitate PIE. The availability of preapproval information for HCDMs (particularly content related to anticipated place in therapy and product pricing) has an impact on shortening formulary decision-making timelines.

Discordance Between Insurance Coverage of Antiviral Medications and Nicotine Replacement Therapy Among Individuals With Human Immunodeficiency Virus Who Smoke.

Tobacco contributes to the leading causes of morbidity and mortality among persons with human immunodeficiency virus (PWHs). Nonetheless, medications for tobacco use disorder are widely underused, particularly among PWHs. We sought to characterize the extent to which insurance barriers impacted access to medications for tobacco use disorder and, in comparison, to access to antiretroviral therapy (ART). This is a secondary analysis of data on individuals enrolled in a randomized clinical trial to address tobacco use involving nicotine replacement therapy and, for some, additionally, varenicline or bupropion. Medication prescriptions are transmitted electronically from the clinic to neighborhood pharmacies. Data sources included participant assessments and intervention visit tracking forms. Of 93 participants enrolled from September 2020 to July 2021, 20 (22%) were unable to fill or had difficulty filling their nicotine replacement therapy (NRT) prescriptions because of insurance barriers. These fell into 2 broad categories: enrollment in a publicly insured managed care plan in which the pharmacy benefit manager excluded nonprescription NRT and lack of understanding by the pharmacy of the scope of coverage. Of these 20 participants, 5 (25%) were unable to obtain medications at all, and 3 of these participants dropped out of the study. One additional participant paid out-of-pocket to obtain NRT. No participant was denied coverage of ART, bupropion, or varenicline. Gaps in insurance coverage may result in PWHs receiving ART without simultaneous medical management of their tobacco use. This may undermine the efficacy of antivirals. Mandated insurance coverage of nonprescription NRT may improve the health of PWHs who smoke.

Lessons From Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications.

Escalating insulin prices have prompted public scrutiny of the practices of drug manufacturers, pharmacy benefit managers, health insurers, and pharmacies involved in production and distribution of medications. As a result, a series of policies have been proposed or enacted to improve insulin affordability and foster greater equity in access. These policies have implications for other diabetes and obesity therapeutics. Recent legislation, at both the state and federal level, has capped insulin out-of-pocket payments for some patients. Other legislation has targeted drug manufacturers directly in requiring rebates on drugs with price increases beyond inflation rates, an approach that may restrain price hikes for existing medications. In addition, government negotiation of drug pricing, a contentious issue, has gained traction, with the Inflation Reduction Act of 2022 permitting limited negotiation for certain high expenditure drugs without generic or biosimilar competition, including some insulin products and other diabetes medications. However, concerns persist that this may inadvertently encourage higher launch prices for new medications. Addressing barriers to competition has also been a priority such as through increased enforcement against anticompetitive practices (e.g., "product hopping") and reduced regulatory requirements for biosimilar development and market entry. A novel approach involves public production, exemplified by California's CalRx program, which aims to provide biosimilar insulins at significantly reduced prices. Achieving affordable and equitable access to insulin and other diabetes and obesity medications requires a multifaceted approach, involving state and federal intervention, ongoing policy evaluation and refinement, and critical examination of corporate influences in health care.

Modeling the Effects of Formulary Exclusions: How Many Patients Could Be Affected by a Specific Exclusion?

Background: Medication formularies, initially designed to promote the use of cost-effective generic drugs, are now designed to maximize financial benefits for the pharmacy benefit management companies that negotiate purchase prices. In the second-largest pharmacy benefit management formulary that is publicly available, 55% of mandated substitutions are not for generic or biosimilar versions of the same active ingredient and/or formulation and may not be medically or financially beneficial to patients. Methods: We modeled the effect of excluding novel agents for atrial fibrillation/venous thromboembolism, migraine prevention, and psoriasis, which all would require substitution with a different active ingredient. Using population data, market share of the 2 largest US formularies, and 2021 prescription data, we calculated how many people could be affected by such exclusions. Using data from the published literature, we calculated how many of those individuals are likely to discontinue treatment and/or have adverse events due to a formulary exclusion. Results: The number of people likely to have adverse events due to the exclusion could be as high as 1 million for atrial fibrillation/venous thromboembolism, 900 000 for migraine prevention, and 500 000 for psoriasis. The numbers likely to discontinue treatment for their condition are as high as 924 000 for atrial fibrillation/venous thromboembolism, 646 000 for migraine, and 138 000 for psoriasis. Conclusion: Substitution with a nonequivalent treatment is common in formularies currently in use and is not without substantial consequences for hundreds of thousands of patients. Forced medication substitution results in costly increases in morbidity and mortality and should be part of the cost-benefit analysis of any formulary exclusion.