Methodology for conducting a comprehensive product review in managed care.

The high degree of complexity of the product-review process and differences in procedures between organizations have resulted in a need for best practices and an overall product-review process to create efficiencies for health care decision makers. In an effort to streamline product-review concepts, this article outlines the different components of the review process, including clinical and economic review, formulary placement determination, and evaluation of alternatives within a drug class. The article also details opportunities for the near future, as technology continues to advance and alignment between medical and pharmacy benefits is desired. DISCLOSURES: Drs Linnerooth, Penley, Ha, and Craven report employment with Xcenda, which provided funding for the manuscript. Drs Sauvageau and Hydery report employment Xcenda, which provided funding for the manuscript, and stock holdings with AmerisourceBergen. Dr Feeney reports support for attending meetings and/or travel provided by Highmark, Inc. Dr Thomas reports receipt of consulting fees from ActiveRADAR, board member roles with ActiveRADAR and RoundtableRx, an adjunct professor role with the University of Minnesota, and stock options and pensions with Eli Lilly and Aetna/CVS. Dr Watkins reports payment or honoraria from ISPOR and for articles written for Value and Outcomes Spotlight, and support for attending meetings and/or travel by AMCP.

Considerations for managed care pharmacy in evaluating mavacamten, a novel agent for obstructive hypertrophic cardiomyopathy.

DISCLOSURES: Dr Taddei-Allen was a PRIME Education Moderator on Hypertrophic Cardiomyopathy CE at AMCP Nexus 2021; AJMC article on managed care considerations for hypertrophic cardiomyopathy. No funding was contributed toward the writing of this commentary.

Hypertrophic cardiomyopathy considerations for the managed care pharmacist.

Hypertrophic cardiomyopathy (HCM) is often seen in patients as an autosomal dominant genetic heart disease with a variable clinical course. It is characterized by left ventricular hypertrophy, and with some patients, there is no evidence of a genetic etiology or presence of HCM in family members. Young age at diagnosis and the presence of a pathogenic or likely pathogenic sarcomere variant predict greater lifelong risk for stroke, heart failure, ventricular arrhythmia, atrial fibrillation, or mortality. Most individuals affected with HCM live to an average lifespan due to improvements in earlier diagnosis, sudden cardiac death risk stratification, family screening, pharmacologic therapy, devices, and invasive septal reduction therapy. Although these interventions have improved mortality, they are associated with significant costs and morbidities. There are burdensome costs related to genetic testing, family screening, implantable cardioverter-defibrillators, alcohol septal ablation, septal myectomy, pacemaker placement, and cardiac transplantation. In addition to these economic considerations, patients with HCM may experience a diminished health-related quality of life. Shared decision making between the patient and physician, use of multidisciplinary teams at HCM centers, and judicious use of exercise when appropriate have been shown to improve patient outcomes. Currently, treatments for HCM do not treat the underlying illness. Although not yet approved by the FDA, cardiac myosin inhibitors have recently shown promise in clinical trials to treat the underlying pathology of HCM. If approved by the FDA, managed care pharmacists should be ready to assess their safety and efficacy to improve the clinical burden and quality of life of those affected by HCM and reduce medical costs for these patients against standard of care. Long-term safety and efficacy data showing reductions in hospitalizations, morbidity, and mortality will be needed to determine their actual utility in managing HCM and ultimate place in therapy.

Evolution of the Pharmacy Benefit Manager/Community Pharmacy Relationship: An Opportunity for Success.

DISCLOSURES: No funding supported the writing of this commentary. The author has nothing to disclose.

Economic burden and managed care considerations for the treatment of insomnia.

Insomnia is a common sleep disorder in adults that can have many negative health impacts. The aggregate total of direct and indirect insomnia healthcare costs has been estimated to be as high as $100 billion US dollars per year. In addition to the societal cost burden, insomnia also negatively affects patients' quality of life (QOL), including social and occupational functioning or productivity as well as impaired cognition or mood. Insomnia may also exacerbate and increase morbidity and complications from psychological disorders, such as depression, as well as have serious consequences, such as increased risk of suicide. Comorbidities, medications, and/or psychosocial contributors may negatively influence QOL. Many medications for the treatment of insomnia have adverse effect (AE) profiles that increase the risk of falls and related injuries, cognitive impairment, and motor vehicle accidents. These AEs place additional burden on the already vulnerable older adult population and those with comorbidities. Managed care organizations must evaluate clinical considerations, including safety profiles and the negative impact of disease on patients' QOL, to develop strategies for cost-effective treatment plans for patients with insomnia and to ensure appropriate use of these medications.

Efficacy of oral semaglutide: overview of the PIONEER clinical trial program and implications for managed care.

The first tablet formulation of a glucagon-like peptide-1 receptor agonist(GLP-1RA), oral semaglutide, was approved in September 2019 for the treatment of adults with type 2 diabetes (T2D). This article reviews data from the PIONEER phase 3a clinical trial program, which assessed the efficacy and safety of oral semaglutide in more than 9500 patients at different stages on the disease trajectory (mean diabetes duration,3.5-15 years) and on a range of background treatment regimens(monotherapy, added to 1 or 2 oral glucose-lowering agents, or added to insulin). The studies compared oral semaglutide (doses of 3 mg, 7 mg, or14 mg) with placebo, and selected commonly used glucose-lowering agents (empagliflozin 25 mg, sitagliptin 100 mg, or liraglutide 1.8mg). Across the studies, oral semaglutide provided greater glycated hemoglobin (A1C) reductions than placebo, empagliflozin, or sitagliptinat 26 weeks, and similar A1C reductions as liraglutide. The proportion of patients achieving the A1C level recommended by the American Diabetes Association of less than 7.0% (53 mmol/mol) was greater with oral semaglutide (7 mg, 42%-69%; 14 mg, 55%-77%) than placebo (7%-31%)and active comparators (25%-62%), with durable target achievement. Oral semaglutide was associated with similar reductions in body weight as empagliflozin and greater reductions than placebo, sitagliptin, or liraglutide. Oral semaglutide was also efficacious in patients with T2D and moderate renal impairment. These findings indicate that oral semaglutide presents a valuable option for treating patients with T2D in a managed care setting, with the potential to expand the number of patients benefiting from GLP­1RAs.

The importance of patient-reported outcomes in type 2 diabetes: insight from the PIONEER program with oral semaglutide.

Patient-reported outcomes (PROs), including treatment satisfaction, patient well-being, and quality of life, are becoming increasingly important contributors to treatment decisions in clinical practice and the evaluation of health care services. PROs have been included in a number of clinical trials in patients with type 2 diabetes (T2D), including those investigating glucagon-like peptide-1 receptor agonists (GLP-1RAs). The first oral GLP-1RA, oral semaglutide, was approved in the United States in 2019. Four PROs were included in the PIONEER clinical study program that evaluated oral semaglutide in patients with T2D across the full diabetes disease spectrum. PRO findings in the PIONEER studies were generally similar for oral semaglutide and comparators, with some exceptions. Improvements in a number of the 36-item Short Form Survey domains were observed for oral semaglutide versus placebo, including general health, bodily pain, physical component summary, social functioning, and mental health. For general health and social functioning, differences significantly favored oral semaglutide versus empagliflozin, whereas role-physical and the physical component summary significantly favored empagliflozin compared with oral semaglutide. The Diabetes Treatment Satisfaction Questionnaire findings indicated that oral semaglutide improved feelings of unacceptably high blood sugars versus placebo (in PIONEER 4, 5, and 8) and sitagliptin (in PIONEER 7). Significant improvements in craving control and craving for savory were observed with oral semaglutide versus empagliflozin in the Control of Eating Questionnaire (in PIONEER 2). These data provide valuable information that can facilitate a patient-centered approach and guide decision-making in managed care to optimize each patient's treatment experience.

Cardiovascular outcomes, safety, and tolerability with oral semaglutide: insights for managed care.

It is important to consider the safety profile of new medications in type 2 diabetes (T2D) when selecting the most appropriate treatment option for each patient. This can help ensure that patients achieve optimal response, that those experiencing adverse events are appropriately managed, and that treatment is tailored for those with pre-existing conditions such as cardiovascular disease (CVD), which is the leading cause of death in patients with T2D. The American Diabetes Association and American Association of Clinical Endocrinologists/American College of Endocrinology recommend a glucagon-like peptide-1 receptor agonist (GLP-1RA) or sodium-glucose cotransporter 2 inhibitor with proven cardiovascular (CV) benefit in patients with established CVD or those at high risk of CVD. Injectable semaglutide is approved by the FDA for reducing the risk of major CV events in adults with T2D and established CVD. In PIONEER 6, the CV safety of the first GLP-1RA tablet, oral semaglutide, was noninferior to placebo, and a longer-term study (SOUL; NCT03914326) powered to assess a potential CV benefit is ongoing. The safety and tolerability profile of oral semaglutide across the PIONEER clinical trial program was consistent with the GLP-1RA class. The most common adverse events were gastrointestinal (GI) (eg, nausea, diarrhea, and vomiting), which were typically mild to moderate and transient. In clinical practice, oral semaglutide expands the treatment options available to patients with T2D and can be considered in patient populations suitable for injectable GLP-1RAs.