Addressing the role of edaravone in the management of amyotrophic lateral sclerosis and gaps in care and access: expert panel recommendations.

A virtual key opinion leader (KOL) and payer discussion was held on December 5, 2020. In attendance were 2 KOLs, both specialists in amyotrophic lateral sclerosis (ALS) at leading clinics in the United States, and 6 managed care executives from US regional health plans. The objective of this panel was to share opinions, ideas, and information around the treatment of ALS with edaravone, gaps in management and guidelines, and potential solutions. The panel concluded that coverage criteria for edaravone may need to be reassessed and treatment guidelines could be revisited to include a determination of place in therapy for edaravone.

Real-world assessment of concomitant opioid utilization and associated trends in patients with migraine.

Migraine is a debilitating condition that affects approximately 16% of adults and is the fifth leading cause of emergency department visits in the United States. There are several treatment options for migraines; opioids are frequently prescribed. Results from a recent study showed that more than half of the patients with chronic migraine and a third of the patients with episodic migraine received an opioid prescription in the past year. The American Headache Society recognizes the magnitude of this issue and is working to educate providers on the danger of prescribing opioids in the migraine population The objective of this article is to assess the utilization trends of prescription opioid products and evaluate the impact of opioid utilization on healthcare costs in this patient population. This retrospective claims database analysis used real-world medical claims from multiple health plans. The study period was from January 1, 2009, to September 30, 2017. Patients were included if they were 18 years or older and continuously enrolled in the study period for at least 3 years. Patients were included in the migraine cohort if they had any diagnosis of migraine headache during the study period, while patients without a headache related diagnosis were included in the control cohort. Control patients were propensity matched 1:1 to migraine patients. Discrete (count) data are represented by frequencies and percentages. Continuous results are presented as means, medians, and standard deviations. In the study, 107,216 patients met the inclusion criteria, with 53,608 assigned to each cohort. In the migraine and control cohorts, respectively, 28% and 11% were prescribed opioids. In both cohorts, a majority of the patients were female (81.8%). In both cohorts, opioid use was associated with higher total costs compared with patients who were not prescribed opioids: $82,007 for 200 morphine milligram equivalents (MME)/day or more versus $19,792 for no opioid in patients with migraine; and $54,200 for 200 MME/day or more versus $12,060 for no opioid use in control patients; P <.0001. Patients with more than 2 comorbidities who were prescribed opioids had higher costs than patients with more than 2 comorbidities who were not prescribed opioids and patients with less than 2 comorbidities who were prescribed opioids ($65,980, $32,152, and $35,964, respectively, for patients with migraine, and $52,883, $24,641, and $35,748, respectively, for control patients; P <.0001). Patients with migraine have more than twice the healthcare costs as patients without migraines. The additional increase in healthcare costs in patients with migraine who use opioids for treatment and/or have 2 or more comorbidities is significant. Control of the pain associated with migraine, specifically among those with multiple comorbid conditions, may contribute to substantial reductions in healthcare costs.

Concomitant medical conditions and total cost of care in patients with migraine: a real-world claims analysis.

This study evaluates the impact of concomitant medical conditions on patients with and without migraine, assessing healthcare utilization, and total cost of care. Medical and pharmacy claims from multiple health plans, both nationally and internationally, were examined to evaluate overall real-world trends in commercially insured patients diagnosed with migraine. A total of 53,608 patients with diagnosis codes for migraine met the study criteria and were matched 1:1 with controls (81.8% female; mean age, 42 years; mean Charlson Comorbidity Index score, 0.34). During the 3-year measurement period, mean medical costs per patient in the migraine cohort were about 1.7 times that of the control group ($22,429 vs $13,166). Unique encounters and cost per patient by medical service type for the migraine cohort compared with the control group were as follows: emergency department, 4.13 ($4000) versus 2.94 ($2639); hospital inpatient, 3.15 ($17,748) versus 2.67 ($16,010); hospital outpatient, 5.14 ($365) versus 4.85 ($396); physician office, 36.78 ($6803) versus 21.39 ($4069); laboratory, 10.12 ($1433) versus 7.71 ($1057); radiology, 7.64 ($2609) versus 5.94 ($1733). Mean pharmacy costs per patient were approximately 1.8 times higher in the migraine cohort compared with the control cohort ($8441 vs $4588, respectively; P <.0001). These results suggest that patients with migraine have more comorbidities compared with those without migraine. These patients also utilize healthcare resources at a significantly higher rate compared with similar patients without a migraine diagnosis. An unmet need exists for new treatment modalities in this patient population. More effective interventions and proper management may lead to improved patient outcomes and healthcare costs for patients with migraine.

Modeling Episode-Based Payments for Cancer Using Commercial Claims Data.

BACKGROUND: Innovative health care reimbursement models are gaining attention as a way to move away from a payment system that rewards quantity of service over quality of care. One such alternative payment model is episode-based payment, such as the Oncology Care Model (OCM) being piloted by the Center for Medicare & Medicaid Innovation. OBJECTIVE: To adapt the OCM methodology to a commercially insured population to understand the challenges and potential implications of implementing an episode-based payment model in a commercial health plan. METHODS: Administrative claims databases from 3 regional commercial health plans were used to identify continually eligible patients (aged ≥ 18 years) with breast cancer, lung cancer, melanoma, or chronic myelogenous leukemia (CML). Episode triggers were identified using the OCM methodology. In calculating the episode-based payments, adjustments to the OCM methodology were necessary to adapt the methodology to a commercial population, since not all Medicare data elements used in the OCM algorithm are available in commercial claims data. RESULTS: The adapted OCM-like model was applied to data from 39,967 patients with 1 of 4 cancer types. Approximately 13% of patients had at least 1 episode per year and the average number of episodes per patient per year for patients with at least 1 episode ranged from 1.42 for patients with melanoma to 1.94 for patients with CML. The percentage of total annual costs included in episodes was 49%, 60%, 34%, and 52% for breast cancer, lung cancer, melanoma, and CML, respectively. CONCLUSIONS: As health care financing shifts to alternative payment models, insurers may look to adopt episode-based payments for oncology, similar to the OCM. This study shows that implementing an OCM-like model in a commercial health plan is feasible but will require adjustments to the OCM algorithm to make it implementable and applicable to populations beyond Medicare. DISCLOSURES: This study was conducted by Magellan Rx Management with funding contributed by Novartis. Zacker is an employee of Novartis. The other authors are employed by Magellan Rx Management and have nothing to disclose.

Clinical and Economic Impact of Hyperkalemia in Patients with Chronic Kidney Disease and Heart Failure.

BACKGROUND: Hyperkalemia (HK) is a concern for patients with chronic kidney disease (CKD) and heart failure (HF), and for those receiving treatments that inhibit the renin-angiotensin-aldosterone system (RAASi). An analysis of 1.7 million medical records of patients in the United States revealed that among individuals with more than 2 potassium values during 2007 to 2012, HK was detected in 34.6% of patients with CKD and 30.0% of patients with HF. OBJECTIVE: To evaluate the association of HK and use of RAASi therapies at optimal and suboptimal doses in patients with CKD and/or HF with health care resource utilization and overall cost of care in a diverse cohort of commercially insured patients. METHODS: This retrospective cohort study was conducted using medical and pharmacy claims from multiple regional health plans. Qualifying patients were ≥ 18 years old, continuously enrolled for 6 months before and throughout the study period (January 1, 2014, to December 31, 2015) and had an ICD-9-CM or ICD-10-CM diagnosis code of CKD and/or HF. Health care resource utilization, including hospital visits, length of stay, office visits, and associated medical and pharmacy costs, were assessed according to the 3 cohorts (CKD alone, HF alone, and concomitant CKD and HF). For the 3 cohorts, the results were also compared between patients with and without HK and between patients with and without RAASi use at optimal and suboptimal doses. Generalized linear models were used to further examine the predictors of medical and overall costs. RESULTS: In this study, 15,999 patients met inclusion criteria. Among patients using RAASi therapy, 26.8% received the optimal dose. Optimal dosing of RAASi was associated with decreased median outpatient office visits (8, 10, and 15, respectively, for patients with CKD, HF, and both CKD and HF) compared with suboptimal dosing of RAASi (12, 15, and 23, respectively). Similarly, optimal dosing of RAASi was associated with decreased overall median medical costs ($2,092, $4,144, and $7,762, respectively, for patients with CKD, HF, and both CKD and HF) compared with suboptimal dosing of RAASi ($3,121, $8,289, and $12,749, respectively). Patients with CKD, HF, or both CKD and HF, all in combination with HK, had higher overall costs, compared with those without HK. CONCLUSIONS: The results of this real-world analysis suggest that HK and suboptimal dosing of RAASI were associated with a median increase in outpatient office visits as well as increased overall medical costs among patients with CKD and/or HF. This evaluation of median costs suggests effective HK management may potentially reduce costs in patients with CKD and/or HF, including those currently receiving RAASi therapy. DISCLOSURES: This study was conducted by Magellan Rx Management and funded by Relypsa. Brenner, Alvarez, and Oestreicher were employed by Relypsa during the development of this study and the writing of this manuscript. Polson, Lord, Kangethe, Speicher, and Farnum are employees of Magellan Rx Management, which received funding from Relypsa for conducting the retrospective study and writing the manuscript. Study concept and design were contributed by Lord, Polson, Brenner, Alvarez, and Oestreicher. Data collection and interpretation were performed by Polson and Kangethe, with assistance from Lord. The manuscript was written by Farnum, with assistance from Kangethe and Speicher and revised by all authors.

Clinical and Economic Impact of Hyperkalemia in Patients with Chronic Kidney Disease and Heart Failure.

BACKGROUND: Hyperkalemia (HK) is a concern for patients with chronic kidney disease (CKD) and heart failure (HF), and for those receiving treatments that inhibit the renin-angiotensin-aldosterone system (RAASi). An analysis of 1.7 million medical records of patients in the United States revealed that among individuals with more than 2 potassium values during 2007 to 2012, HK was detected in 34.6% of patients with CKD and 30.0% of patients with HF. OBJECTIVE: To evaluate the association of HK and use of RAASi therapies at optimal and suboptimal doses in patients with CKD and/or HF with health care resource utilization and overall cost of care in a diverse cohort of commercially insured patients. METHODS: This retrospective cohort study was conducted using medical and pharmacy claims from multiple regional health plans. Qualifying patients were ≥ 18 years old, continuously enrolled for 6 months before and throughout the study period (January 1, 2014, to December 31, 2015) and had an ICD-9-CM or ICD-10-CM diagnosis code of CKD and/or HF. Health care resource utilization, including hospital visits, length of stay, office visits, and associated medical and pharmacy costs, were assessed according to the 3 cohorts (CKD alone, HF alone, and concomitant CKD and HF). For the 3 cohorts, the results were also compared between patients with and without HK and between patients with and without RAASi use at optimal and suboptimal doses. Generalized linear models were used to further examine the predictors of medical and overall costs. RESULTS: In this study, 15,999 patients met inclusion criteria. Among patients using RAASi therapy, 26.8% received the optimal dose. Optimal dosing of RAASi was associated with decreased median outpatient office visits (8, 10, and 15, respectively, for patients with CKD, HF, and both CKD and HF) compared with suboptimal dosing of RAASi (12, 15, and 23, respectively). Similarly, optimal dosing of RAASi was associated with decreased overall median medical costs ($2,092, $4,144, and $7,762, respectively, for patients with CKD, HF, and both CKD and HF) compared with suboptimal dosing of RAASi ($3,121, $8,289, and $12,749, respectively). Patients with CKD, HF, or both CKD and HF, all in combination with HK, had higher overall costs, compared with those without HK. CONCLUSIONS: The results of this real-world analysis suggest that HK and suboptimal dosing of RAASI were associated with a median increase in outpatient office visits as well as increased overall medical costs among patients with CKD and/or HF. This evaluation of median costs suggests effective HK management may potentially reduce costs in patients with CKD and/or HF, including those currently receiving RAASi therapy. DISCLOSURES: This study was conducted by Magellan Rx Management and funded by Relypsa. Brenner, Alvarez, and Oestreicher were employed by Relypsa during the development of this study and the writing of this manuscript. Polson, Lord, Kangethe, Speicher, and Farnum are employees of Magellan Rx Management, which received funding from Relypsa for conducting the retrospective study and writing the manuscript. Study concept and design were contributed by Lord, Polson, Brenner, Alvarez, and Oestreicher. Data collection and interpretation were performed by Polson and Kangethe, with assistance from Lord. The manuscript was written by Farnum, with assistance from Kangethe and Speicher and revised by all authors.