Projected Impact of the Medicare Part D Senior Savings Model on Diabetes-Related Health and Economic Outcomes Among Insulin Users Covered by Medicare.

OBJECTIVE: The Medicare Part D Senior Savings Model (SSM) took effect on 1 January 2021. In this study we estimated the number of beneficiaries who would benefit from SSM and the long-term health and economic consequences of implementing this new policy. RESEARCH DESIGN AND METHODS: Data for Medicare beneficiaries with diabetes treated with insulin were extracted from the 2018 Medical Expenditure Panel Survey. A validated diabetes microsimulation model estimated health and economic impacts of the new policy for the 5-year initial implementation period and a 20-year extended policy horizon. Costs were estimated from a health system perspective. RESULTS: Of 4.2 million eligible Medicare beneficiaries, 1.6 million (38.3%) would benefit from the policy, and out-of-pocket (OOP) costs per year per beneficiary would decrease by 61% or $500 on average. Compared with non-White subgroups, the White population subgroups would have a higher proportion of SSM enrollees (29.6% vs. 43.7%) and a higher annual OOP cost reduction (reduction of $424 vs. $531). Among the SSM enrollees, one-third (605,125) were predicted to have improved insulin adherence due to lower cost sharing and improved health outcomes. In 5 years, the SSM would 1) avert 2,014 strokes, 935 heart attacks, 315 heart failure cases, and 344 end-stage renal disease cases; 2) gain 3,220 life-years and 3,381 quality-adjusted life-years (QALY); and 3) increase insulin cost and total medical cost by $3.5 billion and $2.8 billion. In 20 years, the number of avoided clinical outcomes, number of life-years and QALY gained, and the total and insulin cost would be larger. CONCLUSIONS: The Medicare SSM may reduce the OOP costs for approximately one-third of the Medicare beneficiaries treated with insulin, improving health outcomes via increased insulin adherence. However, the SSM will also increase overall Medicare spending for insulin and overall medical costs, which may impact future premiums and benefits. Our findings can inform policy makers about the potential impact of the new Medicare SSM.

Real-world evidence in pain research: a review of data sources.

Outcomes research studies use clinical and administrative data generated in the course of patient care or from patient surveys to examine the effectiveness of treatments. Health care providers need to understand the limitations and strengths of the real-world data sources used in outcomes studies to meaningfully use the results. This paper describes five types of databases commonly used in the United States for outcomes research studies, discusses their strengths and limitations, and provides examples of each within the context of pain treatment. The databases specifically discussed are generated from (1) electronic medical records, which are created from patient-provider interactions; (2) administrative claims, which are generated from providers' and patients' transactions with payers; (3) integrated health systems, which are generated by systems that provide both clinical care and insurance benefits and typically represent a combination of electronic medical record and claims data; (4) national surveys, which provide patient-reported responses about their health and behaviors; and (5) patient registries, which are developed to track patients with a given disease or exposure over time for specified purposes, such as population management, safety monitoring, or research.

Cost implications of formulary decisions on oral anticoagulants in nonvalvular atrial fibrillation.

BACKGROUND: Nonvalvular atrial fibrillation (AF) is a major public health issue. The major complication of AF is an increased risk of stroke. Warfarin, long used for stroke prophylaxis in AF patients, has a narrow therapeutic window and numerous food and drug interactions necessitating regular laboratory monitoring. New oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) may meet the need for predictable anticoagulation with fixed, unmonitored dosing. OBJECTIVE: To review costs of monitoring, bleeding, and stroke in AF patients to analyze costs of anticoagulants for stroke prophylaxis in AF patients. METHODS: A literature search on the costs of treating AF used PubMed/MEDLINE databases (to April 2012) focusing on studies in the United States. Key words or MeSH terms were used, such as "observational studies," "oral anticoagulants," "warfarin," "cost of bleeding," "cost of stroke," and "cost of INR monitoring." RESULTS: The literature focused mainly on short-term, in-hospital expenditures and less on long-term care costs. Annual overall costs per patient for treating AF in the United States ranged from $18,454 to $38,270. Annual incremental costs of treating AF ranged from $8,705 to $16,311. Annual inpatient costs ranged from $7,841 to $22,582 per patient. Annual costs of anticoagulation monitoring ranged from $291 to $943 per patient. Intracranial hemorrhage and major gastrointestinal bleeding with oral anticoagulants were uncommon but expensive: 1-year costs ranged from $7,584 to $193,804. Annual direct costs of stroke in AF patients ranged from $23,143 to $37,620 (incremental cost of $7,824 to $8,232 vs. AF patients without stroke). CONCLUSIONS: AF-associated direct costs are high and can be broken into costs of warfarin monitoring and direct costs of managing consequences of anticoagulant therapy-stroke and bleeding.

A cost-utility analysis of pregabalin versus duloxetine for the treatment of painful diabetic neuropathy.

The objective of the current study was to determine the cost-utility of pregabalin versus duloxetine for treating painful diabetic neuropathy (PDN) using a decision tree analysis. Literature searches identified clinical trials and real-world studies reporting the efficacy, tolerability, safety, adherence, opioid usage, health care utilization, and costs of pregabalin and duloxetine. The proportions of patients reported in the included studies were used to determine probabilities in the decision tree model. The base-case model included the Food and Drug Administration (FDA)-approved doses of pregabalin (300 mg/day) and duloxetine (60 mg/day), whereas "real-world" sensitivity analyses explored the effects over a range of doses (pregabalin 75-600 mg/day, duloxetine 20-120 mg/day). A 6-month time horizon and a US third-party payer perspective were chosen for the study. Outcomes from the model were expressed as cost per quality-adjusted life-year (QALY). In the base-case model, duloxetine cost less and was more effective than pregabalin (incremental cost -$187, incremental effectiveness 0.011 QALYs). Results from two real-world sensitivity analyses indicated that duloxetine cost $16,300 and $20,667 more per additional QALY than pregabalin. Using a decision tree model that incorporated both clinical trial and real-world data, duloxetine was a more cost-effective option than pregabalin in the treatment of PDN from the perspective of third-party payers.