A primer on formulary structures and strategies.

Formularies are a tool for managing costs, optimizing patient access, and improving overall health outcomes. The general goal of formularies is to provide access to appropriate therapy while promoting effective resource utilization, which allows the managed care pharmacy organization to operate sustainably. Traditional formulary strategies have included open and closed formularies as well as tiered formularies.

Payer perceptions and use of value assessment tools in the United States.

As the United States transitions toward value-based payment, value assessment tools to measure the value of health care interventions are emerging. As the field evolves, it is important to evaluate how these tools are influencing treatment and coverage decisions. To examine payer perceptions and use of US value assessment tools and identify how these tools inform payer decision-making.

Best practices in designing preapproval information engagements for US health care decision makers.

As high-cost and innovative therapies continue to enter the market, health care decision makers (HCDMs) are expressing a need for early information on a product's clinical and economic impacts. Preapproval information exchange (PIE) fulfills these data needs by allowing manufacturers to share drug information with HCDMs prior to US Food and Drug Administration approval. With recent regulatory milestones, such as the Pre-approval Information Exchange Act of 2022, HCDMs look to leverage PIE to forecast budgets and inform reimbursement decisions.

The Impact of Local Education and Resource Distribution on Maternal Health Behaviors.

Introduction: Community forum participants voted for an education and resource distribution program (using a baby box) to help reduce local infant mortality. Although multiple sites have implemented similar programs, there is limited peer-reviewed literature about outcomes.

Methods: A retrospective pre- and immediate post-survey design with an intervention (video and written education and resource distribution) in between was utilized with a follow-up survey.

A Comprehensive Review of Pegvaliase, an Enzyme Substitution Therapy for the Treatment of Phenylketonuria.

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, and place in therapy of a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations, pegvaliase injection.

Data Sources: Searches of MEDLINE (1946-September 1, 2018) were conducted using the terms pegvaliase and phenylalanine ammonia lyase (PAL). Additional data were obtained from the prescribing information, the product dossier obtained from the manufacturer, and Clinicaltrials.

Effectiveness of Ledipasvir/Sofosbuvir and Predictors of Treatment Failure in Members with Hepatitis C Genotype 1 Infection: A Retrospective Cohort Study in a Medicaid Population.

Background: The primary goal of therapy for patients with chronic hepatitis C virus (HCV) infection is eradication of HCV ribonucleic acid, which is predicted by achievement of sustained virologic response at 12 weeks (SVR12). Ledipasvir/sofosbuvir was approved by the FDA in 2014 and 2015 as a once-daily regimen for the treatment of HCV genotype 1 and HCV genotypes 4, 5, and 6, respectively. Although its efficacy has been demonstrated in randomized controlled trials, there is an unmet need for real-world effectiveness data and studies that assess the association of rates of SVR12 with specific clinical and demographic factors in the Medicaid population.

A systematic review of community-based interventions to improve oral chronic disease medication regimen adherence among individuals with substance use disorder.

Background: Poor medication adherence has been shown to cause medical complications, death, and increased healthcare costs and may be of particular importance in patients with substance use disorder (SUD). Concerns regarding adherence in this population may influence a healthcare provider's decision to prescribe a medication requiring high adherence. Guidance defining best practices that promote adherence among individuals with SUD is lacking.

Dapagliflozin/Saxagliptin Fixed-Dose Tablets: A New Sodium-Glucose Cotransporter 2 and Dipeptidyl Peptidase 4 Combination for the Treatment of Type 2 Diabetes.

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, and place in therapy of the fixed-dose combination (FDC) product, QTERN (dapagliflozin/saxagliptin) tablets.

Data Sources: Searches of MEDLINE (1946 to July 1, 2017) were conducted using the keywords QTERN, saxagliptin, and dapagliflozin. Additional data were obtained from the prescribing information, the product dossier, and Clinicaltrials.

Evaluation of Progesterone Utilization and Birth Outcomes in a State Medicaid Plan.

Objectives: Progesterone (hydroxyprogesterone caproate injection and vaginal progesterone) has been shown to reduce preterm birth (PTB) rates by a third among pregnant women at high risk. The purpose of this analysis is to report birth outcomes and medication adherence among Massachusetts Medicaid (MassHealth) members receiving progesterone, evaluate the association between member characteristics and birth outcomes and medication adherence, and compare cost of care with a prior preterm pregnancy.

Methods: This retrospective cohort study used medical claims, pharmacy claims, and prior authorization (PA) request data for MassHealth members who had a PA submitted for progesterone between January 1, 2011, and March 31, 2015.

The Effect of a Federal Controlled Substance Act Schedule Change on Hydrocodone Combination Products Claims in a Medicaid Population.

Background: In 2012, hydrocodone combination products (HCPs) were the most prescribed medications in the United States. Under the Controlled Substance Act of 1970, hydrocodone alone was classified as a Schedule II drug, while HCPs were classified as Schedule III, indicating a lower risk for abuse and misuse. However, according to a Drug Enforcement Agency analysis, the addition of nonopioids has not been shown to diminish abuse potential of hydrocodone.

Overview of Comprehensive Hepatitis C Virus Medication Management in a State Medicaid Program.

Background: Breakthrough direct-acting antivirals set a new standard in the management of hepatitis C virus (HCV) with regard to cure rates and improved tolerability; however, the health care system is challenged by the cost of these medications.

Objective: To describe the effect of a comprehensive HCV medication management program on optimized regimen use, prior authorization (PA) modifications, and medication cost avoidance in a state Medicaid program.

Methods: This program consists of a 2-tiered prescriber outreach: (1) regimen outreach to promote optimized regimen selection and (2) refill outreach to support medication adherence.

The effect of 2- and 4-week ovariectomy on female rabbit urinary bladder function.

Objectives: To evaluate the effect ovariectomy (OVX) after 2 and 4 weeks on bladder function and biochemistry of the adult female rabbit urinary bladder.

Methods: Twelve mature female rabbits were divided into 3 groups: control, 2-week ovariectomized, and 4-week ovariectomized. At the end of the experimental period, the following studies were performed: contractile studies on isolated strips; examinations of the activity of citrate synthase (a marker for mitochondrial function) and thapsigargin-sensitive calcium ATPase (a marker for sarcoplasmic reticular calcium uptake function); and quantification of Rho-kinase (ROK) alpha and beta and myosin light chain kinase by Western blot analyses.

The beneficial effect of coenzyme Q10 and lipoic acid on obstructive bladder dysfunction in the rabbit.

Purpose: Recent evidence indicates that ischemia and reperfusion are major etiological factors in the bladder dysfunction that occurs after partial bladder outlet obstruction. Coenzyme Q10 and alpha-lipoic acid are found naturally in mitochondria and act as potent antioxidants. We investigated the beneficial effects of coenzyme Q10 plus alpha-lipoic acid in a rabbit model of bladder outlet obstruction.

Coenzyme Q10 protect against ischemia/reperfusion induced biochemical and functional changes in rabbit urinary bladder.

Purpose: Ischemia, reperfusion, and free radical generation have been recently implicated in the progressive bladder dysfunction. Coenzyme Q10 (CoQ10) is a pro-vitamin like substance that appears to be efficient for treatment of neurodegenerative disorders and ischemic heart disease. Our goal was to investigate the potential protective effect of CoQ10 in a rabbit model of in vivo bilateral ischemia and ischemia/reperfusion (I/R).