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.

Expert Panel Recommendations for the Identification and Management of Hyperkalemia and Role of Patiromer in Patients with Chronic Kidney Disease and Heart Failure.

Virtual panel meetings were conducted among 7 physicians, all of whom are independent experts, including 3 nephrologists, 2 cardiologists, and 2 emergency medicine physicians (the panel). The panel met with the purpose of discussing the current treatment landscape, treatment challenges, economic impact, and gaps in care for patients with hyperkalemia that is associated with heart failure and chronic kidney disease. The stated goal of the panel discussion was to develop practical solutions in the identification and management of hyperkalemia in this patient population. The panel noted that hyperkalemia is a serious condition that can lead to life-threatening complications, yet the treatment paradigm for hyperkalemia has remained without major advances for approximately 50 years, until the approval of patiromer. A number of issues still exist in the management of this patient population, including the lack of uniform treatment guidelines and consensus regarding the approach to treatment. As part of its effort, the panel developed an algorithm, the Proposed Diagnostic Algorithm for Hyperkalemia Treatment in the Acute Care Setting/Chronic Care. The panel agreed that patiromer appears to be a viable option for the management of hyperkalemia in patients with chronic kidney disease and/or heart failure and in patients who experience chronic hyperkalemia. DISCLOSURES: This panel discussion was funded by Relypsa and facilitated by Magellan Rx Management. Rafique is a principal investigator for Relypsa and serves as a consultant for Instrumentation Laboratory, Magellan Health, Relypsa, and ZS-Pharma. Butler serves as consultant for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, CardioCell, Janssen, Merck, Novartis, Relypsa, and ZS-Pharma. Lopes and Farnum are employed by Magellan Rx Management. Rafique designed the management protocol for this panel discussion and contributed to the writing and editing of this report document. The other authors report no conflicting interests. Relypsa is the manufacturer of Veltassa (patiromer).

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.

Biosimilars: Opportunities to Promote Optimization Through Payer and Provider Collaboration.

A panel was convened that consisted of 1 medical director, 2 pharmacy directors, and 2 oncologists, who represented the University of Pittsburgh Medical Center Health Plan, an integrated delivery network, and Florida Blue, a progressive regional health plan. This panel met in order to share ideas, discuss challenges, and develop practical solutions to promote optimal utilization in order to encourage collaboration between payers and providers to help ensure the success of biosimilar entrants into the marketplace. Live meetings were conducted in Orlando, Florida, and Pittsburgh, Pennsylvania, and were followed by virtual meetings to solidify ideas and concepts for this supplement. It is important for biosimilar manufacturers to identify potential payer, provider, and patient obstacles in order to develop strategic and tactical plans to preemptively address these potential obstacles. Gathering payer and provider insights will shed light on various issues such as access and reimbursement. Biosimilar manufacturers must be proactive in the education of payers, providers, and patients to ensure access to biosimilars. A strong factor emphasized among this group was that the assumption surrounding biosimilar development and use is the potential for health care cost savings. According to the panel, payers and providers must carefully consider economic implications and potential cost-effectiveness in order to increase the acceptance or understanding of biosimilars in clinical practice. The group identified 3 major challenges surrounding biosimilar adoption: (1) provider confidence in biosimilar education and clinical value, (2) provider confidence in reimbursement for new biosimilars, and (3) creating shared payer and provider cost-savings. After identification of the 3 challenges, the group posed potential solutions to help with biosimilar adoption.