Pharmacy Benefit Research Articles

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.

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.

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.

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.

Real-world costs and outcomes associated with biomarker testing by comprehensive genomic profiling (CGP) and non-CGP approaches among patients with metastatic non-small cell lung cancer (mNSCLC).

e20598 Background: Guideline-recommended molecular testing is essential for identifying appropriate targeted therapies (Rx) for treatment of mNSCLC patients (pts). Biomarker testing can be performed by single gene tests, small NGS panels (e.g., < 50 genes), or CGP approaches. There is little evidence on the rate of biomarker testing in the real world setting and the impact of different approaches on Rx utilization and cost of care. This study examined real-world utilization of biomarker testing among mNSCLC pts and outcomes with CGP and non-CGP testing. Methods: De-identified administrative claims data from the Optum Labs Data Warehouse were analyzed to identify newly diagnosed adult mNSCLC pts from 1/2018 to 8/2021; the date of the first claim indicating metastasis was the index date. Continuous enrollment in a commercial (COM) or Medicare Advantage (MA) plan with medical and pharmacy benefits for 12 mo prior to (baseline), and ≥6 mo post index date (follow-up) was required; pts with < 6 mo follow-up due to death were included. Initiation of a line of therapy (LOT1) during follow-up was required. We categorized pts based on receipt and type of biomarker testing prior to LOT1: CGP ( > 50 gene panel), non-CGP (5-50 gene panels or single gene testing), or no testing. Differences in receipt of targeted Rx, overall survival (OS), and total overall per patient per month (PPPM) costs during LOT1 were examined with multivariable regression analyses. Results: 9,945 mNSCLC pts (1,970 COM, 7,975 MA) were identified: 5,484 with no testing, 2,215 with CGP, and 2,246 with non-CGP testing prior to LOT1. Biomarker testing rates prior to LOT1 were low (45%) but increased during the study period from 42% to 48% (p <0.01). Testing rates were higher for the COM vs MA population (49% vs 44%, p <0.01). A higher percent of pts with CGP received targeted Rx compared to the non-CGP and no testing group (17% vs 11% and 5% respectively, p< 0.01); after adjustment, CGP pts were still more likely to receive targeted Rx. Compared to the no testing group, OS was more favorable for the CGP [HR 0.8, 95% CI 0.8-0.9] and non-CGP [HR 0.9, 95% CI 0.8-0.9] groups. There was no significant difference in PPPM costs between tested groups: CGP [CR 1.2, 95%CI 1.1-1.2] vs non-CGP [CR 1.1, 95%CI 1.1-1.2]. Conclusions: Rates of biomarker testing among mNSCLC pts are far from optimal despite well-established guideline recommendations and insurance coverage for testing. There was evidence of improved intermediate outcomes (receipt of targeted Rx) with CGP compared to non-CGP or no testing. In addition, OS was improved for tested pts compared to untested. Interventions to help improve biomarker testing are needed. Given the potential benefits of CGP testing (including assessment of biomarkers that cannot be evaluated using small panels), increasing CGP testing may improve outcomes.

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.

“Having cancer is very expensive”: A qualitative study of patients with ovarian cancer and PARP inhibitor treatment

ObjectiveTo examine patient barriers and facilitators to PARP inhibitor (PARP-I) maintenance therapy in ovarian cancer. PARP-I improves survival in ovarian cancer, but these multi-year therapies cost around $100,000 annually and are under-prescribed. MethodsWe recruited patients with ovarian cancer treated with PARP-I maintenance therapy at an academic health system for a semi-structured interview. Patient demographics, including genetics and PARP-I cost, were self-reported. We assessed patient experiences with barriers and facilitators of PARP-I usage. Two team members used a thematic approach to analyze and identify key themes. ResultsIn May 2022, we interviewed 10 patients (mean age = 65 years; 80% White; 60% with a germline genetic mutation). Patients paid on average $227.50 monthly for PARP-I, straining resources for some participants. While sampled patients were insured, all patients identified having no or inadequate insurance as a major barrier to PARP-I. At the same time, all participants prioritized clinical effectiveness over costs of care. Patients identified PARP-I delivery from specialty pharmacies, separate and different from other medications, as a potential barrier, but each had been able to navigate delivery. Patients expressed significant initial side effects of PARP-I as a potential barrier yet reported clinician communication and prompt dose reduction as facilitating continuation. ConclusionsPatients identified cost, restrictive pharmacy benefits, and initial side effects as barriers to PARP-I usage. Having insurance and a supportive care team were identified as facilitators. Enhancing communication about PARP-I cost and side effects could improve patient experience and receipt of evidence-based maintenance therapy in ovarian cancer.

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.

A Treatment-at-Home Pilot: Barriers to Home Cancer Care

In Brief During the COVID-19 public health emergency, patients with cancer faced significant challenges presenting for their in-clinic visits. In-home administration of intramuscular and subcutaneous therapies provided an opportunity to deliver antineoplastic therapy while lowering infection risk. This quality improvement study of adult patients with neuroendocrine and breast cancers at Memorial Sloan Kettering Cancer Center was conducted from February 16, 2022, to October 14, 2022, and involved nurses delivering outpatient pharmacy-dispensed in-home intramuscular or subcutaneous treatments. The study concluded that while home administration of antineoplastic therapies was safe and patient-centric, administrative barriers—primarily pharmacy benefit denial—prevented the study from achieving its primary end point. As cancer care evolves, there should be a focus on regulatory changes that minimize financial and time toxicity and allow for patient convenience.

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.

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.

Real-World Adherence to and Persistence with Vibegron in Patients with Overactive Bladder: A Retrospective Claims Analysis.

Vibegron is a β3-adrenergic receptor agonist approved for overactive bladder (OAB). This analysis assessed real-world adherence and persistence with vibegron in patients with OAB, along with demographics and clinical characteristics associated with adherence and persistence. This retrospective study used the Optum Research Database to identify patients treated with vibegron from April 2021 to August 2022 (identification period). Patients had ≥ 60days of continuous pharmacy coverage in a commercial or Medicare Advantage plan following the index fill (follow-up). Adherence was assessed as proportion of days covered (PDC) from index to end of follow-up and was defined as PDC ≥ 80%. Persistence was measured as days to discontinuation of therapy (30-day gap) or end of follow-up. Data for adherence and persistence are presented descriptively. Characteristics associated with adherence and persistence were analyzed using multivariable models among patients with medical and pharmacy benefits during the 90days before index (baseline). Overall, 9992 patients had a vibegron claim during the identification period; 9712had ≥ 2months of follow-up. Mean (SD) age was 74.2 (10.7) years; 68.2% were female. Mean (SD) PDC was 0.64 (0.34). Median (95% confidence interval) persistence was 142 (132-153) days. Of the 5073 patients who were ≥ 18years old with continuous baseline pharmacy and medical benefits ≥ 90days before index, 2497 (49.2%) were adherent. Patients were more likely to be adherent and persistent if they received a greater days' supply for the index fill and had baseline medication count ≥ 6. Patients were more likely to discontinue if their index copay was > $45. Nearly half of the patients initiating vibegron were adherent. Factors associated with adherence and persistence were more likely to be related to prescribing practices than patient characteristics. These results suggest it may be best to follow up with patients approximately 4to5months after initiating treatment with vibegron.

Demand Inertia and the Hidden Impact of Pharmacy Benefit Managers

Do pharmacy benefit managers (PBMs) reduce spending on prescription drugs? Reduced-form evidence suggests that PBMs enforce a tradeoff between net-of-rebate prices and access to drugs within each market. However, net-of-rebate prices grow consistently over time and appear unresponsive to competitor entry. We argue that inertia in drug demand can reconcile these facts. To formally analyze the roles played by PBMs and demand inertia, we build a dynamic structural model of drug pricing and estimate it using net-of-rebate prices of three major statins from 1996 to 2013. Counterfactuals suggest that, relative to a market with price-setting by drug manufacturers and patients who face coinsurance, PBMs reduce overall spending by 28%, without greatly limiting patient access. Without demand inertia, the presence of PBMs would cause prices to fall significantly as competitors enter. This paper was accepted by Raphael Thomadsen, marketing. Funding: This work was supported by the National Institutes on Aging [Grants R24-AG048059 and T32-AG000186] and the National Institute for Healthcare Management Foundation. Supplemental Material: The online appendices and data files are available at https://doi.org/10.1287/mnsc.2021.03331 .

A primer on quality measurement and reporting in pharmacy benefit plans.

Pharmacy benefit plans in the United States are evaluated on quality measures and other requirements of the government and accrediting organizations. This primer describes the roles of key organizations involved in measuring and reporting quality in pharmacy benefit plans and explains the methods that pharmacy benefit plans use to promote quality of medication use.

Heartburn Relief Is the Major Unmet Need for Drug Development in Gastroesophageal Reflux Disease: Threshold Value Analysis

Background and AimsHeartburn symptoms contribute to healthcare-seeking among patients with gastroesophageal reflux disease (GERD). Despite clinical guidance, management is often dictated by insurance restrictions. Several potassium-competitive acid blockers (PCABs) are under development as a new class of therapy. We performed economic analyses to align GERD drug development with the needs of gastroenterologists, insurers and patients in a value-based environment. MethodsA decision-analytic model was constructed to compare vonoprazan 20 mg daily (an example of a PCAB), common over-the-counter or prescription proton pump inhibitor regimens, and no treatment over a 1-year time horizon. Clinical responses were evaluated based on the proportions of heartburn-free days in a recent phase 3 multicenter trial. Healthcare utilization for persistent reflux symptoms was derived from national observational studies compared with healthy control subjects. Costs and quality-adjusted life years were reported. ResultsWithout insurance coverage for appropriate therapy, patients spend $4443 and insurers spend $3784 on average per year for inadequately treated GERD symptoms. Our model estimates that PCABs could save at least $3000 in annual costs to patients and insurers, could generate quality-adjusted life year gains (+0.06 per year), and could be cost-saving to insurers as a covered option at a price up to $8.57 per pill, if these drugs are able to demonstrate similar effectiveness to proton pump inhibitors in future trials evaluating heartburn relief and erosive esophagitis healing to regulators. Threshold prices reflect pricing after all pharmacy benefits manager rebates and discounts. DiscussionWe demonstrate that aiming GERD-related drug development toward heartburn relief appears critical to align cost-effective incentives for industry and insurers with those of patients and gastroenterologists.

Pharmacy Assistance Programs for Oral Anticancer Drugs: A Narrative Review.

Oral anticancer medications (OAMs) are high priced with a significant cost-sharing burden to patients, which can lead to catastrophic financial, psychosocial, and clinical repercussions. Cost-conscious prescribing and inclusion of low-cost alternatives can help mitigate this burden, but cost transparency at the point of prescribing remains a major barrier to doing so. Pharmacy assistance programs, including co-payment cards and patient assistance programs administered by manufacturers and foundation-based grants, remain an essential resource for patients facing prohibitive co-payments for OAMs. However, access to these programs is fraught with complexities, including lack of trained financial navigators, limited transparency on eligibility criteria, onerous documentation burdens, and limits in available funding. Despite these drawbacks and the potential for such programs to incentivize manufacturers to keep list prices high, assistance programs have been demonstrated to improve financial well-being for patients with cancer. The increasing development of integrated specialty pharmacies with dedicated, trained pharmacy staff can help improve and standardize access to such programs, but these services are disproportionately available to patients seen at tertiary care centers. Multistakeholder interventions are needed to mitigate the burden of cost sharing for OAMs, including increased clinician knowledge of financial resources and novel assistance mechanisms, investment of institutions in trained financial navigation services and centralized platforms to identify assistance programs, and policies to cap out-of-pocket spending and improve transparency of rates charged by pharmacy benefit managers to a health plan.

A primer on brand-name prescription drug reimbursement in the United States.

Branded prescription drug reimbursement in the United States is complex and comprises multiple transactions among the parties involved in the drug supply chain, including manufacturers, wholesalers, pharmacies, health care providers, health plans or insurers, pharmacy benefit managers, and patients. This primer provides an overview of the parties involved in the reimbursement of brand-name drugs under both the pharmacy and medical benefits of an insurance policy and the flow of products and payments among them. Prescription drug spending in the United States grew from $30 billion in 1980 to $335 billion in 2018, and 80% of spending is on brand-name drugs.1,2 Pharmaceutical spending and drug prices have been the focus of intense debate in recent years, which has brought attention to the complexity of the drug supply chain. This primer provides a high-level overview of the distribution and reimbursement of brand-name drugs (italicized words are defined in the Glossary) used in the outpatient setting and covered by health plans or insurers in the United States. The focus is on the parties involved and the flow of products and payments among them. The purchase of drug products outside of insurance and differences in drug reimbursement between private and public insurers are outside of the scope of this primer.

Comparison of Treatment Patterns in Patients with Migraine Initiating Calcitonin Gene-Related Peptide Monoclonal Antibodies: A Retrospective Real-World US Study.

Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are indicated for migraine prevention in the United States. Limited data comparing real-world treatment patterns for CGRP mAbs are available. To compare the treatment patterns among patients with migraine initiating galcanezumab, fremanezumab, and erenumab. This retrospective study included adult patients with one or more claims for a self-injectable CGRP mAb (galcanezumab, fremanezumab, or erenumab), with continuous enrollment in medical and pharmacy benefits for 12 months pre-index and 6 and 12 months post-index using MerativeTM MarketScan® Commercial and Medicare databases from May 2017 through March 2021. Propensity-score matching was used to address confounding by observed covariates. Outcomes analyzed included proportion of days covered (PDC), medication-possession ratio (MPR), persistence (≤60-day gap), treatment discontinuation, and switch to a non-index drug. Descriptive X2 and t-test analyses were conducted. At the 12-month follow-up, matched galcanezumab and fremanezumab cohorts each comprised 2674 patients and the galcanezumab and erenumab cohorts 3503 each. The mean (SD) PDC and MPR were both 0.6 (0.3) across all cohorts. Based on PDC ≥0.80 and MPR ≥0.80, a greater proportion of galcanezumab vs fremanezumab (46.2% vs 43.7%, p=0.053; 46.8% vs 44.3%, p=0.053) and galcanezumab vs erenumab (46.2% vs 44%, p=0.156; 46.7% vs 44.5%, p=0.262), respectively, initiators were adherent. Compared to galcanezumab, fremanezumab (248.0 days vs 236.5 days, p=0.001), and erenumab (247.8 days vs 241.7 days, p=0.061) initiators had lower mean persistence. Galcanezumab initiators were less likely to discontinue treatment than fremanezumab (47.8% vs 51.7%, p=0.005) and erenumab (47.7% vs 50.2%, p=0.040) initiators. Across cohorts, most switchers initiated onabotulinum toxin A as subsequent treatment. Similar results were observed for 6-month follow-up cohorts. Patients with migraine who initiated treatment with galcanezumab showed higher persistence and lower treatment discontinuation rates than those initiating either fremanezumab or erenumab.

Recently Proposed Federal and State Legislation To Constrain Pharmacy Benefit Managers Would Not Reduce Drug Costs

Recently Proposed Federal and State Legislation To Constrain Pharmacy Benefit Managers Would Not Reduce Drug Costs