JMCP Features Articles on Renewed Interest in FDAMA, Cost-Effectiveness of Comprehensive Medication Reviews

Alexandria, Va., April 29, 2015 — The Academy of Managed Care Pharmacy has published the May issue of the Journal of Managed Care & Specialty Pharmacy (JMCP). Featured articles include an in depth look at renewed interest in the 1997 FDA Modernization Act to more readily disseminate health care economic information for formulary decision making, research on the cost-effectiveness of comprehensive medication reviews versus noncomprehensive medication review interventions, and understanding reasons for nonadherence of medications among Medicare beneficiaries.

Below are summaries, backgrounds and objectives of each research article. The May 2015 issue of JMCP may be accessed at

Article: FDAMA Section 114: Why the Renewed Interest?

SUMMARY: The FDA regulates the use of information by biopharmaceutical companies in their promotional activities. Section 114 of the 1997 Food and Drug Administration Modernization Act (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. 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.

Research: Cost-Effectiveness of Comprehensive Medication Reviews Versus Noncomprehensive Medication Review Interventions and Subsequent Successful Medication Changes in a Medicare Part D Population

BACKGROUND: An estimated 1.5 million preventable medication-related adverse events occur annually, with some resulting in serious injury and even death. To help address this issue, the Centers for Medicare & Medicaid Services now require medication therapy management (MTM) programs to offer comprehensive medication reviews (CMRs) to all Medicare Part D beneficiaries at least once a year. During a CMR, patients receive an extensive amount of medication and educational information. In contrast, noncomprehensive medication reviews (non-CMRs) are more targeted and focus on resolving a particular medication-related problem via short patient consultations, patient letters, and direct provider interventions.

OBJECTIVE: To conduct a cost-effectiveness analysis comparing CMRs with non-CMR interventions on successful medication regimen changes and reductions in adverse drug events.

Research: Understanding Reasons for Nonadherence to Medications in a Medicare Part D Beneficiary Sample

BACKGROUND: Poor medication adherence is a predictor of poor health outcomes, especially in populations with chronic diseases. Although several self-reported measures of medication adherence exist, the scope of each is limited.

OBJECTIVE: To identify barriers to medication adherence in order to facilitate effective delivery of telephone-based medication therapy management (MTM) services to beneficiaries of contracted Medicare Part D plans.

Research: Factors Associated with the Initiation of Biologic Disease-Modifying Antirheumatic Drugs in Texas Medicaid Patients with Rheumatoid Arthritis

BACKGROUND: Rheumatoid arthritis (RA) is a progressive autoimmune disorder of joints that is associated with high health care costs, yet guidance is lacking on how early to initiate biologic disease-modifying antirheumatic drugs (DMARDs), a class of medications that is the major cost driver in RA management. Few studies have examined the factors associated with the transition from nonbiologic DMARDs, the first-line therapy for RA, to biologic DMARDs in RA patients.

OBJECTIVE: To examine patient socio-demographics, medication use patterns, and clinical characteristics associated with initiation of biologic DMARDs.

Research: Comparative Efficacy of Novel DMARDs as Monotherapy and in Combination with Methotrexate in RA Patients with Inadequate Response to Conventional DMARDs: A Network Meta-Analysis

BACKGROUND: Given the availability of a number of alternative biologic treatment options and other novel disease-modifying antirheumatic drugs (DMARDs) for the treatment of patients with rheumatoid arthritis (RA), clinicians are faced with an increasingly challenging choice regarding optimal treatment. Biologics are usually combined with traditional DMARDs, primarily methotrexate (MTX), but some biologics and tofacitinib (together referred to in this article as novel DMARDs) have been shown to be efficacious as monotherapy as well. In real-world practice, approximately one-third of RA patients receiving biologics are on monotherapy, primarily because of intolerance of, or noncompliance with, MTX. Limited data, however, are available analyzing the effectiveness of monotherapy compared with combination therapy across novel DMARDs.

OBJECTIVE: To compare American College of Rheumatology responses to approved novel DMARDs used as monotherapy or as combination therapy with methotrexate at 24 weeks in RA patients who have shown inadequate response to conventional DMARDs.

Research: Predictors of Start of Different Antidepressants in Patient Charts Among Patients with Depression

BACKGROUND: In usual psychiatric care, antidepressant treatments are selected based on physician and patient preferences rather than being randomly allocated, resulting in spurious associations between these treatments and outcome studies.

OBJECTIVE: To identify factors recorded in electronic medical chart progress notes predictive of antidepressant selection among patients who had received a depression diagnosis.

About JMCP
The Journal of Managed Care & Specialty Pharmacy (JMCP) publishes peer-reviewed original research manuscripts, subject reviews, and other content intended to advance the use of the scientific method, including the interpretation of research findings in managed care pharmacy. JMCP is dedicated to improving the quality of care delivered to patients served by managed care pharmacy by providing its readers with the results of scientific investigation and evaluation of clinical, health, service, and economic outcomes of pharmacy services and pharmaceutical interventions, including formulary management. JMCP strives to engage and serve professionals in pharmacy, medicine, nursing, and related fields to optimize the value of pharmaceutical products and pharmacy services delivered to patients. JMCP employs extensive bias-management procedures that include (a) full disclosure of all sources of potential bias and conflicts of interest, nonfinancial as well as financial; (b) full disclosure of potential conflicts of interest by reviewers as well as authors; and (c) accurate attribution of each author's contribution to the article. Aggressive bias-management methods are necessary to ensure the integrity and reliability of published work.