Diagnosis and Treatment of Pediatric Bipolar Disorder in a Commercially Insured Population

Recent reports indicate that bipolar disorder diagnosis is increasing in U.S. children. Increased diagnoses are concerning as diagnostic criteria are unclear and most medications prescribed to treat bipolar disorder have not been tested or approved for children. No studies have been conducted to assess the use of clinical treatment guidelines in children with bipolar disorder. This is troubling as current prescribing guidelines should dictate treatment in this population. The objectives of this dissertation are to examine the medication use patterns for privately insured children with bipolar spectrum disorders, and to assess the consistency of prescribing patterns with treatment guidelines. MarketScan Commercial Claims and Encounters data (2005-2007) were used to identify children with diagnoses of bipolar disorder. Patient demographic and treatment characteristics were summarized for the cohort. Additionally, two measures were constructed to assess the quality of care received among children with bipolar I disorder. These measures, receipt of (1) appropriate first-line treatment, and (2) adequate duration of initial medication treatment, were used to determine whether a patient received guideline-recommended care. Generalized linear models were used to determine factors associated with receiving guideline-recommended care. We found an average annual prevalence of any bipolar spectrum disorder was 0.25% among privately insured children. Most children received pharmacotherapy, and treatments were similar across all bipolar subtypes. Anticonvulsants, atypical antipsychotics, antidepressants, and stimulants were prescribed commonly. Approximately 40% of the population received polypharmacy. Among children with bipolar I disorder, 84% received potentially inappropriate first line treatment. A majority of these children received either no medication or antidepressant medications without mood stabilizers. Several factors were associated with the receipt of recommended first line treatment, including bipolar episode type, having comorbid major depressive disorder diagnoses, and receiving care from a psychiatrist. Regarding early treatment regimen changes, 41% of children had initial treatment trials shorter than 6 weeks. However, none of the factors tested were consistently related to early regimen changes. These results highlight the high prevalence of bipolar diagnoses and deficiencies in the diagnosis and treatment of bipolar spectrum disorders among children by identifying trends in prescribing and gaps in the quality of care received by children

Mind the Gap: Why Closing the Doughnut Hole Is Insufficient for Increasing Medicare Beneficiary Access to Oral Chemotherapy

Orally administered anticancer medications are among the fastest growing components of cancer care. These medications are expensive, and cost-sharing requirements for patients can be a barrier to their use. For Medicare beneficiaries, the Affordable Care Act will close the Part D coverage gap (doughnut hole), which will reduce cost sharing from 100% in 2010 to 25% in 2020 for drug spending above $2,960 until the beneficiary reaches$4,700 in out-of-pocket spending. How much these changes will reduce out-of-pocket costs is unclear

Reforming Reimbursement for the US Food and Drug Administration’s Accelerated Approval Program to Support State Medicaid Programs

Importance The US Food and Drug Administration (FDA) has an accelerated approval program that has become the subject of scholarly attention and criticism, not only for the FDA’s oversight of the program but also for its implications for payers. Observations State Medicaid programs’ legal obligations to provide reimbursement for accelerated approval products have created fiscal challenges for Medicaid that have been exacerbated by industry’s changing use of the accelerated approval program over time. Although strategies for accelerated approval reforms have been proposed, most focus on reforming the FDA’s accelerated approval pathway and product regulation without taking into account the implications of this pathway for state Medicaid programs. There is a need for policy reforms that balance the goal of speeding approval of important medicines with states’ real concerns regarding spending on medications with little evidence of clinical benefits. Areas of potential reform include formulary exclusion, Medicaid rebates, value-based pricing, and consolidated purchasing or carve outs. Conclusions and Relevance Policy makers may wish to consider options for reforming reimbursement for accelerated approval products in addition to reforms to the FDA’s operation of the pathway. Policy reform proposals can provide a range of options to evaluate trade-offs of access and pricing

Low Uptake of Human Papillomavirus Vaccine Among Postpartum Women, 2006–2012

Background: Young adult women find it acceptable to be offered the human papillomavirus (HPV) vaccine postpartum. Little is known about the practice of administering the HPV vaccine during the postpartum period

Early Impact of the Affordable Care Act on Uptake of Long-acting Reversible Contraceptive Methods

The Affordable Care Act (ACA) required most private insurance plans to cover contraceptive services without patient cost-sharing as of January 2013 for most plans. Whether the ACA’s mandate has impacted long-acting reversible contraceptives (LARC) use is unknown

Early supportive medication use and end-of-life care among Medicare beneficiaries with advanced breast cancer

A randomized controlled trial of cancer patients has linked early supportive care with improved hospice use and less aggressive end-of-life care. In practice, the early use of supportive interventions and potential impact on end-of-life care are poorly understood. We sought to describe early use of medications to treat common breast cancer symptoms (pain, insomnia, anxiety, and depression) and to assess the relationship between early use of these treatments and end-of-life care

Financial Relationships With Industry Among National Comprehensive Cancer Network Guideline Authors

Financial conflicts of interest (FCOIs) among authors of clinical practice guidelines have the potential to influence treatment recommendations. To quantify FCOIs with industry among authors of the National Comprehensive Cancer Network (NCCN) guidelines. We assessed FCOIs occurring during 2014 among NCCN guideline authors in the United States. All were physician members of the NCCN guideline committees for lung, breast, prostate, and colorectal cancer as of the end of 2014. The data source for FCOIs was Open Payments, which is publically reported by the Centers for Medicare and Medicaid Services. This study was cross-sectional. The proportion of NCCN authors having FCOIs with industry; the average amount received from industry sources per author. Of 125 guideline authors, 108 (86%) had at least 1 reported FCOI. Authors received an average of $10 011 (range,$0-$106 859) in general payments (GPs), which include consulting, meals, lodging, and similar transfers of value, and$236 066 (range $0-$2 756 713) in industry research payments (RPs), including funding associated with clinical trials. Approximately 84% of authors received GPs, while 47% received RPs. Eight (6%) had FCOIs in excess of the $50 000 net and/or$20 000 single-company maximums stipulated by NCCN. Among NCCN guideline authors, FCOIs involving RPs were of greater value, while those involving GPs were more prevalent. Although FCOIs may result from engaging in important scholarship, FCOIs may still influence guideline authors in counterproductive ways. Research is needed to understand how best to manage author FCOIs during guideline creation

Factors Associated With Tyrosine Kinase Inhibitor Initiation and Adherence Among Medicare Beneficiaries With Chronic Myeloid Leukemia

There is substantial concern surrounding affordability of orally administered anticancer therapies, particularly for Medicare beneficiaries. We examined rates of initiation and adherence to tyrosine kinase inhibitors (TKIs) among Medicare beneficiaries with chronic myeloid leukemia (CML) with and without cost-sharing subsidies. We selected TKIs given their effectiveness and strong indication for use among patients diagnosed with CML

Early Posttherapy Hospitalizations Among Survivors of Childhood Leukemia and Lymphoma

Long-term survivors of childhood cancers are at increased risk for hospitalization. To test the hypothesis that many treatment-related morbidities are identifiable in the early post-therapy period, we determined the rates and causes for hospitalization among survivors of leukemia and lymphoma during the first three years post-therapy. Using a health plan claims database, we identified patients aged 0-21 years-old treated for leukemia or lymphoma from 2000-2010. Survivors were matched 10:1 with similar children without a history of cancer. Hospitalization rates over three years were compared using Cox proportional hazards regression and risks of cause-specific hospitalization were compared using log-binomial models. Nineteen percent of childhood leukemia and lymphoma survivors were hospitalized in the first three years off therapy. Leukemia survivors (N=529) experienced over six times (HR: 6.3, 95%CI: 4.9-8.0) and lymphoma survivors (N=454) over three times the hospitalization rate of controls (HR: 3.2, 95%CI: 2.5-4.2). Compared with children without a cancer history, survivors were at increased risk for hospitalization due to infectious causes (leukemia RR: 60.0, 95%CI: 23.4-154.0; lymphoma RR: 10.0, 95%CI: 4.4-22.9). Additionally, lymphoma survivors were at increased risk for cardiovascular-(RR: 15.0, 95%CI: 5.4-42.0) and pulmonary-(RR: 8.1, 95%CI: 3.9-16.8) related hospitalizations. These findings highlight the morbidity experienced by survivors and suggest that treatment-associated complications may be emerging soon after therapy completion

Investigation of Racial Disparities in Early Supportive Medication Use and End-of-Life Care Among Medicare Beneficiaries With Stage IV Breast Cancer

Early supportive care may improve quality of life and end-of-life care among patients with cancer. We assessed racial disparities in early use of medications for common cancer symptoms (depression, anxiety, insomnia) and whether these potential disparities modify end-of-life care