Specialty drug coupons lower out-of-pocket costs and may improve adherence at the risk of increasing premiums.

Expenditures for specialty drugs account for more than 25 percent of total US drug spending and have been increasing at more than 13 percent annually. We examined insurers' role in maintaining the affordability and accessibility of specialty drugs while maximizing their value. We conducted two analyses: one using an administrative claims database with information on more than ten million commercially insured patients and another using the same database combined with the drug prescription records from a specialty pharmacy. First, we examined the prevalence of specialty drug coupons and the degree to which these reduced patients' out-of-pocket costs, focusing on 264,801 prescriptions. Second, we quantified the association between the magnitude of out-of-pocket costs for specialty drugs and patients' abandonment of their new or restarted therapy, focusing on a group of nearly 16,000 patients. We found that drug coupons accounted for $21.2 million of patients' $35.3 million annual out-of-pocket costs. In the vast majority of cases, coupons reduced monthly cost sharing to less than $250, a point at which patients were far less likely to abandon therapy with biologic anti-inflammatory drugs or with drugs for multiple sclerosis. However, by reducing cost sharing, coupons may also circumvent efforts to encourage patients to use the most cost-effective drugs.

The effects of triiodothyronine on bone metabolism in healthy ambulatory men.

The purpose of the present study was to determine the effects of supraphysiologic doses of triiodothyronine (T(3)) on skeletal metabolism, calcium balance, and the calciotropic hormones. Seven healthy, lean men were studied in an inpatient metabolic unit over a 63-day period. All volunteers received oral T(3) at doses of 50-75 microg/d. There was a prompt and sustained increase in calciuria and an overall net negative calcium balance. The pattern of changes in serum osteocalcin, urinary deoxypyridinoline (DPD)/creatinine ratio, and serum bone-specific alkaline phosphatase indicated an early increase in bone resorption followed by a late, incomplete compensatory increase in bone formation. Cumulative net calcium loss was 18.5 +/- 5.4 g over the 63-day treatment period, averaging 218.5 +/- 41.4 mg/d. This represents 0.22% +/- 0.075% of the total skeletal calcium content. The cumulative net calcium loss over the 63-day treatment period was highly correlated with the change in DPD (r = -0.95, p = 0.001). Prompt increases in corrected serum calcium values resulted in serum intact parathyroid hormone (iPTH) levels decreasing by 30.4% (p = 0.08). Bone mineral density showed no change. We conclude that T(3) accelerates bone turnover and that bone formation does not increase acutely to prevent bone loss.

Single- and multiple-dose pharmacokinetics of caspofungin in healthy men.

Caspofungin, a glucan synthesis inhibitor, is being developed as a parenteral antifungal agent. The pharmacokinetics of caspofungin following 1-h intravenous infusions in healthy men was investigated in four phase I studies. In an alternating two-panel (six men each), rising-single-dose study, plasma drug concentrations increased proportionally with the dose following infusions of 5 to 100 mg. The beta-phase half-life was 9 to 10 h. The plasma drug clearance rate averaged 10 to 12 ml/min. Renal clearance of unchanged drug was a minor pathway of elimination (approximately 2% of the dose). Multiple-dose pharmacokinetics were investigated in a 2-week, serial-panel (5 or 6 men per panel) study of doses of 15, 35, and 70 mg administered daily; a 3-week, single-panel (10 men) study of a dose of 70 mg administered daily; and a parallel panel study (8 men) of a dose of 50 mg administered daily with or without a 70-mg loading dose on day 1. Moderate accumulation was observed with daily dosing. The degree of drug accumulation and the time to steady state were somewhat dose dependent. Accumulation averaged 24% at 15 mg daily and approximately 50% at 50 and 70 mg daily. Mean plasma drug concentrations were maintained above 1.0 microg/ml, a target selected to exceed the MIC at which 90% of the isolates of the most clinically relevant species of Candida were inhibited, throughout therapy with daily treatments of 70 or 50 mg plus the loading dose, while they fell below the target for the first 2 days of a daily treatment of 50 mg without the loading dose. Caspofungin infused intravenously as a single dose or as multiple doses was generally well tolerated. In conclusion, the pharmacokinetics of caspofungin supports the clinical evaluation of once-daily dosing regimens for efficacy against fungal infections.