Managed Care Decision Makers Research Articles

Managed care considerations of weight management interventions for obesity.

The growing prevalence of obesity in the United States has presented an opportunity to increase knowledge about optimal treatment approaches based on a better understanding of patient and provider biases, health care coverage and practices, and social determinants of health. Guideline-recommended obesity treatment begins with lifestyle intervention, and weight management may be enhanced by metabolic and bariatric surgery or anti-obesity medication (AOM) use. However, patient and provider perceptions surrounding obesity and different treatment modalities may present barriers to discussion and uptake of these interventions. Furthermore, it is uncommon for all effective obesity treatments (particularly AOMs) to be covered by insurance. Limited patient access to these treatments carries the potential for negative health consequences and higher health care costs. For these reasons, managed care decision makers are encouraged to improve access to effective obesity treatments, including coverage of AOMs such as semaglutide 2.4 mg.

Long-chain fatty acid oxidation disorders: managed care and specialty pharmacy implications

Long-chain fatty acid oxidation disorders (LC-FAODs) represent a group of rare inborn errors of metabolism characterized by acute crises of energy metabolism and severe energy deficiency. Clinical manifestations include rhabdomyolysis, liver dysfunction, severe hypoglycemia, and cardiomyopathy. The symptoms associated with these genetic disorders may result in frequent hospitalizations and early death. Many patients with LC-FAODs experience major clinical events and significant morbidity and mortality that portends a substantial need for better therapeutic options for these disorders. Triheptanoin was recently approved for the treatment of LC-FAODs. As with any novel agent for rare diseases, the treatment adoption and coverage criteria for rare disease therapy such as this presents challenges for managed care decision makers. Both managed care decision makers and specialty pharmacists must ensure that healthcare professionals provide appropriate patient and caregiver education surrounding the management of LC-FAODs, including vital information on adopting emerging agents into the therapy armamentarium for these disorders.

PIN62 - Aligned Strategies Identified by Prescribers and Managed Care to Close Treatment Decision Gaps in HCV and HIV

Despite the availability of effective treatments for HCV and HIV, persistent barriers have compromised achievement of patient health goals, including those related to misalignment in policies and practices among treatment decision-makers. This research is aimed at developing a conceptual model of HCV, HIV, or HCV-HIV co-infection therapy decision-making based on prescriber and managed care perspectives, by qualitatively assessing and describing (1) prescriber and managed care considerations for treatment access, treatment differentiation, and patient selection criteria, and (2) barriers to therapy prior-authorization (PA) processes and communication. Qualitative data were collected through trained scribes during 25 accredited education seminars held in 25 US cities, May—November 2017, combining prescriber and managed care professionals who manage patients with HCV and HIV. The discussion texts were analyzed using thematic analysis to generate a conceptual model of interprofessional practice and communication on therapy decision-making. Session data were collected from 270 prescribers and 211 managed care participants (combined sample: 44% pharmacists, 28% physicians, 29% NP/PAs). Findings revealed dominant themes: barriers were identified by both prescribers and managed care related to PA requirements, denials, and application of guidelines within therapy decisions. Specific forms of collaborative communication and practices were identified as aligned across both prescribers and managed care as mechanisms to close decision-making gaps: review guidelines and approval criteria, increase interprofessional communication, improve documentation and develop new protocols for PA submissions. This research suggests that a conceptual model of prescriber and managed care barriers to optimal care of patients with HCV, HIV, and co-infection includes interprofessional alignment on domains that warrant improvement, and discordance in role-specific considerations for decision-making. The findings support the importance of considering the conceptual alignments when developing practical strategies for improved communication among prescribers and managed care decision-makers. Research was supported through education grants from AbbVie and Gilead.

Hemophilia Management via Data Collection and Reporting: Initial Findings from the Comprehensive Care Sustainability Collaborative.

Despite being a rare disorder, hemophilia represents a significant driver of health care resource utilization and requires expert hematologic and multidisciplinary services to achieve optimal outcomes. Since their inception nearly 40 years ago, hemophilia treatment centers (HTCs) have served as centers of excellence in providing the intensive care and ancillary services necessary for this unique patient base; however, the full capabilities of these centers may be underused in the current framework of managed care, largely because of a lack of communication and information shared between payers and HTC stakeholders. In an effort to enact tangible change toward improving the quality of care for bleeding disorders, the National Hemophilia Foundation developed an ongoing initiative among 18 leading clinicians and managed care decision makers called the Comprehensive Care Sustainability Collaborative (CCSC). The primary aim of the CCSC is to develop a framework for quality improvement pilot programs that can be replicated across the United States between payers and HTCs to facilitate cost-effective hemophilia management by integrating the HTC comprehensive care model. After CCSC committee members shared perspectives on care delivery, quality, and value, actionable data points were reviewed at length in order to develop meaningful metrics to facilitate information sharing between HTC and payer stakeholders. The following pragmatic measures will be reported by HTCs and payers via a series of pilot programs (reporting group is indicated in brackets): (a) patient classification by diagnosis (type, severity, and inhibitor status) [HTC]; (b) total cost of clotting factor [payer]; (c) prescribed factor dose/dispensed dose/patient weight (± range) [payer and HTC]; (d) emergency department visits/hospitalizations [payer and HTC]; (e) home infusion of clotting factor (%) [HTC]; (f) total cost per patient [payer]; and (g) patient contacts (e.g., clinic visits, follow-ups, telemedicine, and e-mail) [HTC]. Routine information sharing between HTCs and payer stakeholders is paramount to improving the quality and reducing the cost of hemophilia care, and the CCSC initiative provides a unique forum for such dialogue. Over the course of several consensus meetings, the CCSC has rigorously developed a set of quality improvement and cost management metrics. These metrics will be used in a first-of-its-kind series of pilot projects that are anticipated to forge innovative collaboration between payers and HTCs so as to improve outcomes in the management of bleeding disorders. The preparation of this article was funded as part of the Comprehensive Care Sustainability Collaborative (CCSC) initiative, which is jointly sponsored by the National Hemophilia Foundation (NHF) and Impact Education, LLC, and supported via a charitable donation from Shire. Tarantino and Pindolia are members of the CCSC and were part of the NHF CCSC group that developed the metrics included in this article. Both authors received honorariums from the NHF for content development and expert review of the manuscript. Both authors contributed equally to the concept and design of this article and to analysis and manuscript preparation.

Budget-Impact Analysis of Alternative Herpes Zoster Vaccine Strategies: A U.S. HMO Perspective.

BACKGROUND: A herpes zoster vaccine has been approved by the FDA for use in prevention of herpes zoster in individuals who are aged 50 years or older. The Advisory Committee on Immunization Practices (ACIP) recommends vaccination only in individuals who are aged 60 years and older. OBJECTIVES: To (a) estimate the overall budget and health impact of either the introduction of a new vaccination strategy (individuals over the age of 50 years vs. individuals over the age of 60 years) within a hypothetical health plan or simply an increase in coverage within the population aged 60 years and over and (b) discern what effect copayments and changes to copayments have on the health plan's budget. METHODS: A decision-analytic economic model was developed to inform managed care decision makers of the potential effect on costs and outcomes associated with the use of the herpes zoster vaccine for prevention of herpes zoster (i.e., simple zoster or shingles). The model took a U.S. payer perspective. The number of eligi...

FDAMA Section 114: Why the Renewed Interest?

The FDA regulates the use of information by biopharmaceutical companies in their promotional activities. Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) was specifically designed to allow companies to more readily disseminate health care economic information (HCEI) to those who need it for formulary decision making. However, very little HCEI has been distributed promotionally under this provision over the past 17 years. There are recent discussions by stakeholders regarding the need for updates, revisions, or guidance regarding Section 114.In light of recent renewed interest in Section 114 of the FDAMA, the purpose of this commentary is to equip managed care decision makers with the information they need to understand and respond to industry communications that are governed by Section 114. This commentary reviews and synthesizes the regulatory history and language of the statute and changes to the promotion regulation generated by Section 114. It explores the reasons for the section's limited use to date, for recent renewed interest, and why changes by various stakeholders are suggested at this time. Also discussed is what managed care pharmacists need to know about Section 114, and suggestions are included regarding the active role pharmacists can play in this change process.Renewed interest in FDAMA Section 114 appears to stem largely from the increasingly visible and growing interest in comparative effectiveness research, the emergence of "big data," the expanding range of data sources available for deriving HCEI, and recent court decisions that might indicate a change in the regulatory environment. Various stakeholders are proposing recommendations regarding changes to FDAMA Section 114. Managed care pharmacists should be aware that companies are restricted when communicating HCEI promotional messages; this may mean seeing the use of FDAMA Section 114 as the "competent and reliable" effectiveness standard in promotion. If the managed care pharmacy community communicates clearly about what information it needs and the format in which it wants to receive that information, companies, policymakers, and regulatory bodies can work collaboratively with managed care pharmacy to create a regulatory environment that supports transparent communication of desired information.

It is important to distinguish CER from patient-centered outcomes research. Introduction.

OBJECTIVES: To (a) enable decision making based on indicators of treatment outcomes for multiple myeloma (e.g., overall survival, progression-free survival, etc.) and markers of clinical efficacy (e.g., complete response, partial response, progressive disease, etc.); (b) coordinate oncology care and health plan medical and pharmacy management services to improve outcomes for patients with multiple myeloma; (c) enable the use of decision support tools to appropriately invest resources and reduce treatment variability with multiple myeloma therapies; (d) construct a benefit design model for multiple myeloma drugs; (e) recommend methods to improve patient outcomes with supportive care for multiple myeloma within a health plan setting; and (f) implement accurate and appropriate counsel, as part of the treatment team, that will improve patient adherence to treatment recommendations. SUMMARY: The first article in this supplement, “Identifying Indicators of Outcomes and Implementing Treatment Pathways,” reviews outcomes measures typically used in phase 3 clinical trials investigating novel oncology therapies and how these measures influence clinical decision making in the treatment of multiple myeloma. The second article, “Applying Oncology Formulary and Benefit Design Innovations to the Management of Multiple Myeloma in the Managed Care Setting,” discusses how comparative effectiveness research is used to generate data that can be utilized by policy makers, plan administrators, payers, and patients to identify therapies that provide the greatest value. The third article, “Multiple Myeloma: Supportive Care Requirements and Coordination of Patient-Centered Care,” identifies the elements of supportive care for multiple myeloma and discusses techniques to keep the patient experience as the focal point of the treatment plan. CONCLUSION: Multiple myeloma is representative of a disease in which the introduction of novel therapies has increased survival and patient quality of life. Increasing use of these innovative yet expensive drugs has motivated efforts to redesign the oncology pharmacy benefit in a way that promotes both enhanced clinical outcomes and cost control. This process relies on robust economic and clinical data; however, these data are limited. To determine the best value-based strategies for the treatment of patients with multiple myeloma, managed care decision makers must continue to assess the evolving landscape of treatment options and consider both clinical outcomes and treatment costs in their analyses.

Refill Rates and Budget Impact of Glaucoma Lipid Therapy

Drugs in the lipid class of glaucoma medications, including bimatoprost, travoprost and latanoprost, are effective at lowering intraocular pressure. In addition to clinical efficacy, the budget impact of long-term therapy with each medication is important for patients, physicians and managed-care decision makers to differentiate between the products and make informed decisions regarding the choice of therapy. This study aimed to determine the average number of days between refills for latanoprost, travoprost and bimatoprost, and to estimate the potential effect of differences in refill rates on pharmacy budgets. In this retrospective database analysis of pharmacy records, the dispensing patterns of patients with glaucoma lipid therapies were obtained. Patients with a pharmacy prescription for the 2.5 mL bottle of latanoprost, travoprost or bimatoprost between September 2002 and December 2002, and receiving continuous treatment defined as having at least one prescription for the same lipid agent and bottle size 1 year later between September 2003 and December 2003, were included in this study. The main outcome measures were mean number of days between refills, mean number of refills, cost per patient per year (based on the average wholesale price [AWP]), and annual refill cost differences between cohorts. The mean number of days between refills was 46.74 days, 53.65 days and 51.98 days for latanoprost, travoprost and bimatoprost, respectively (p < 0.0001, ANOVA). The mean number of refills per year was 7.1, 6.2 and 6.4 for latanoprost, travoprost and bimatoprost, respectively. Based on this and the AWP, the average cost per patient per year was $US435.16 for latanoprost, $US385.58 for travoprost and $US397.44 for bimatoprost. The cost savings per year if the population of patients using latanoprost (n = 79,820) used bimatoprost or travoprost instead would be approximately $US3.0-$US3.9 million. A statistically significant difference in mean days between refills was found among the three studied drugs. Latanoprost presented the highest annual cost followed by bimatoprost and travoprost.

Use of health-related quality of life information in managed care formulary decision-making

Background The extent to which the increased volume of available health-related quality of life (HRQOL) information and heightened education has increased the acceptance and use of HRQOL remains unclear. Likewise, the value of HRQOL information in the formulary decision-making process continues to be undefined. Objective To investigate the perceptions and use of HRQOL by managed care decision-makers in the formulary development process. Methods A mail survey was sent to a nationwide sample of 108 Academy of Managed Care Pharmacy (AMCP) members who were involved in formulary management. Survey candidates were identified according to their job titles listed in the 1999-2000 AMCP membership directory. The survey process began in May 2000 and ended in August 2000. The main outcome measures included ( a) managed care formulary decision-makers' assessment of HRQOL as a treatment outcome, ( b) the existing role and future use of HRQOL information in formulary decisions, and ( c) the level of understanding of HRQOL concepts and the benefits attributable to favorable HRQOL results. Results A response rate of 51.9% was obtained. Most of the respondents (>70%) believed that patients consider HRQOL as an important treatment outcome. Fewer respondents (43%) felt that payers view HRQOL outcomes as an important quality indicator. Most respondents (95%) considered HRQOL data in making formulary decisions, and many (73%) believe that HRQOL outcomes will play a more important role in future formulary decisions. Respondents indicated a better understanding of disease-specific and generic HRQOL measurements than utility measurement and interpretation of results. A minority of respondents (34%) would be willing to pay a higher price for a product with better HRQOL outcomes. When asked which factors would lead to increased use of HRQOL information, respondents indicated that health care cost savings and increased productivity were considered important (77% and 65%, respectively). Conclusions A drug product with better HRQOL outcomes alone will not command a favorable listing on managed care formularies. HRQOL information needs to be made more applicable to managed care decision-making. Future studies should focus on the link between positive HRQOL outcomes, health care cost savings, and increased productivity.

Economic, Patient Preference, and Health-Related Quality of Life Considerations for Intranasal Corticosteroids in Allergic Rhinitis

Allergic rhinitis, as a medical condition, merits attention because of its prevalence in the population as well as the substantial economic impact of treating it. By virtue of their efficacy and low adverse effect profile, intranasal corticosteroids have gained recognition by healthcare providers as the first-line therapy for allergic rhinitis. For managed care decision makers, the use of intranasal corticosteroids as the gold standard of treatment in allergic rhinitis makes comparative economic and humanistic (patient preference or health-related quality of life [HR-QOL]) data between the various intranasal corticosteroids increasingly important for formulary decisions.

PHP13: INDICES FOR EVALUATION OF DRUG COST/UTILIZATION: EVERY SILVER LINING HAS A GRAY CLOUD

OBJECTIVE: Given the high cost of pharmaceuticals, particularly “blockbuster” drugs such as the COX-II inhibitors, the issue of value-for-dollar is an increasingly important one for managed care decision-makers. Due to the complexity of conducting full economic evaluations, it is often tempting to try to reduce such analyses to the most simplistic methods possible—either by assuming equal effectiveness of two drugs and performing a cost-minimization analysis, or by using an index of drug cost/utilization such as DDD (number of defined daily doses of a drug used in a population), PMPM (per member per month cost/utilization), PPPM (per patient per month cost/utilization), ADC (average daily cost of drug therapy), or DACON (daily average consumption of a drug in a population). If a partial economic evaluation based on drug cost/utilization is necessary or preferred, decision-makers should bear in mind the relative strengths and limitations of these approaches prior to making policy decisions. The objectives of this paper are: (1) to describe several indices of drug cost/utilization, (2) to discuss their strengths and limitations, (3) to provide illustrations of their use, and (4) to offer suggestions for appropriate interpretation. METHODS: Using numerical examples focusing on COX-II inhibitors, several indices of drug cost/utilization are described and compared, including DDD, PMPM, PPPM, ADC, and DACON. General limitations and assumptions of “partial” economic evaluations based solely upon cost/utilization data are discussed, including assumptions of equal effectiveness, compliance, continuation and safety; as well as confounding by indication, severity of illness and time on market. RESULTS: Depending upon the index used, results (data) on drug cost/utilization for COX-II inhibitors vary. CONCLUSION: Numerous indices are used to describe and evaluate drug cost/utilization. Each has its own strengths and limitations, and must be interpreted in the appropriate context to best inform pharmaceutical policy decision-making.

The FDA's regulation of health economic information.

Section 114 of the Food and Drug Administration Modernization Act of 1997 was intended to increase the flow of health economic information from pharmaceutical manufacturers to managed care decisionmakers. But the legislation raises a host of complex questions and has provoked diverse opinions from inside and outside the pharmaceutical industry. Moreover, the Food and Drug Administration (FDA) has yet to issue interpretative guidance on the subject. The challenge in implementing Section 114 lies in developing a policy that improves health economic information exchange while protecting consumers from misleading claims and preserving incentives for manufacturers to conduct rigorous studies.

A Predictive Cost Analysis Model for Estimating Formulary Impact of New Products in Managed Care

Competition among new pharmaceutical products for unrestricted formulary inclusion continues to dominate the concerns of managed care decision makers. These competitive pressures may originate when a formulary appears to be overcrowded and underfunded based on what it is expected to deliver-primarily financial management of an ever-increasing list of new products in addition to day-to-day pharmaceutical needs. For those managers facing the daunting task of improving quality of pharmaceutical care with finite resources, appropriate product selection has become a dual consideration involving assessment of the new product's competitive clinical features and benefits, in tandem with an assessment of its formulary cost impact. We present a simple and objective financial model that, based on historical utilization data, will help predict a priori an accurate estimate of the cost impact of a new product. We illustrate our financial model with a new calcium antagonist (CA), T-Block. T-Block is the first of a new generation of nondihydropyridine, T-channel selective CAs entering a crowded therapeutic area for the treatment of hypertension and angina pectoris. This model compares the weighted average cost-per-prescription for CAs before and after the formulary inclusion of T-Block. Three key variables of the model-utilization ratios of available strengths, market share for the new product, and annual CA prescription volume-facilitate preparation of customized financial analyses. Accordingly, the model's simple three-way sensitivity analysis defines specific financial scenarios under various conditions of uncertainty. The model also can be used as a post-formulary utilization management and market share tracking tool.

What makes health economics research useful to decision-makers?

Arecent US national study of managed-care decision-makers, conducted by the Zitter Group, shows very encouraging results for the field of pharmacoeconomics and outcomes research. More than 75% of respondents were either‘somewhat satisfied’or‘very satisfied’with the health economics research that they evaluate. Furthermore, most of these decision-makers want to see a lot more of this type of research. President of the Zitter Group Mark Zitter presented these positive findings at the Third Annual Meeting of the International Society for Pharmacoeconomics and Outcomes Research [Philadelphia, US; May 1998].

MGB6 Formulary Impact Decision Modeling in HMG-COA Reductase Inhibitors

According to the NHANES III data, a majority of patients require 20–30% reduction in their LDL-cholesterol to achieve their NCEP goal. Fluvastatin, a HMG-CoA reductase inhibitor (statin), has been shown to be both safe and effective in achieving 20–30% reductions in LDL cholesterol, and of all the statins, it has the lowest drug acquistion cost. OBJECTIVE: The purpose of this model was to assess the economic impact of using a two-drug formulary that includes fluvastatin and another statin, versus a one-statin ormulary. METHODS: In a hypothetical cohort of 10,000 patients, a two-drug formulary with fluvastatin as the statin of choice for mild to moderate LDL-cholesterol reduction and another agent for those patients requiring additional reduction was compared with a one-drug formulary of atorvastatin, pravastatin, or simvastatin. NHANES III data was utilized to estimate the percentage of patients requiring <30% or ≥ 30% LDL-cholesterol reduction. Doses used in this model were the average daily doses required for adequate LDL reduction as estimated by 1997 IMS data, and costs of drug therapy using a weighted AWP. The cost savings was estimated by subtracting the combined drug acquisition costs of the two statins from the cost of a single statin prescribed for 100% of the patients. Sensitivity analyses were also performed on key parameters of the model. RESULTS: Based on NHANES III estimation, over 70% of patients would require a <30% LDL-cholesterol reduction. A two-drug formulary using fluvastatin was shown to provide more cost savings than a single-drug formulary using any of the other agents, with annual cost difference ranging from $1.2 million to $3 million per 10,000 patients. CONCLUSIONS: Using formulary modeling, managed care decision-makers can measure the economic impact of their statin choice. This model demonstrates the economic benefit of using fluvastatin in formulary management.