Dalfampridine prior authorization program: a cohort study.

BACKGROUND: Dalfampridine (Ampyra) is indicated to improve walking in patients with multiple sclerosis (MS) and was found to be effective in 35%-43% of individuals with MS in clinical trials. Dalfampridine may increase seizure risk, particularly in patients with renal impairment. A U.S. managed care expert consensus panel agreed that patient access to dalfampridine is best managed by a prior authorization (PA) in accordance with the FDA-approved labeling. To ensure safe and appropriate dalfampridine use, a health plan developed and implemented a 2-phase point-of-sale PA program. OBJECTIVES: To evaluate dalfampridine PA review decisions, utilization, and pharmacy expenditures following the implementation of a dalfampridine safety and clinical PA program compared with a group of dalfampridine utilizers unexposed to a PA program. METHODS: The study utilized retrospective administrative pharmacy claims data from a commercial health plan averaging 1.3 million members per month. The plan implemented a 2-phase dalfampridine safety and effectiveness PA program on August 1, 2010. A comparison group that did not implement the dalfampridine PA program was identified from a commercially insured population with approximately 350,000 members per month. Members in both groups were required to be continuously enrolled from August 1, 2010, through January 31, 2011. A member's earliest paid or rejected claim found from August 1, 2010, through October 31, 2010, was defined as the index claim. Dalfampridine-weighted 30-day supply claims were summed and compared between groups from index date through January 31, 2011. A pharmacy cost avoidance estimate was calculated using the difference in average claims per member from index claim through January 31, 2011, multiplied by dalfampridine wholesale acquisition cost. Overall, dalfampridine utilization was evaluated between the intervention and comparison populations from August 2010 (implementation of PA in intervention group) through December 2011. Linear regression and Poisson models were used to test the trend differences. RESULTS: The 60 PA-exposed dalfampridine members' average follow-up was 157 days. Phase 1 approval was obtained by 32 (53.3%) members; 4 (6.7%) members received a denial because of renal impairment; 8 (13.3%) members received a denial due to inability to obtain walking time; 1 (1.7%) member with relapse-remitting MS was denied a PA due to no concomitant disease-modifying agent; and 15 (25.0%) members did not initiate the PA process. Phase 2 approval was obtained by 23 (38.3%) of the 60 members. The 60 PA members had a total of 126 claims and an average utilization of 2.1 (SD 1.8) claims per member. The 20 non-PA dalfampridine members' average follow-up was 157 days. The comparison group members had a total of 84 claims and an average utilization of 4.2 (SD 2.0) claims per member. The PA program resulted in an average of 2.1 (P less than 0.001) fewer claims per member in the PA group. The total dalfampridine cost avoidance estimate was $143,010 or $0.03 per member per month. The overall measure of a monthly claims utilization difference over time was statistically significantly different at P less than 0.001, using the linear regression slope trend test. The trend line slope was not statistically significantly different, P = 0.841, between the intervention and comparison populations. CONCLUSIONS: The study indicates that a dalfampridine PA program potentially improved safety and minimized dalfampridine costs. A PA program is effective in selecting appropriate utilizers for initial therapy. Addition of care management may further optimize use by encouraging adherence and tracking patient response.

Considerations for the optimal use of immunoglobulin.

Immunoglobulins are large Y-shaped proteins produced by B-cells and plasma cells that are used by the immune system to identify and neutralize foreign objects such as bacteria and viruses. Immunoglobulin G (IgG) preparations are approved by the US Food and Drug Administration for the treatment of primary immunodeficiency disease, idiopathic thrombocytopenic purpura, Kawasaki disease, chronic lymphocytic leukemia with frequent infections, bone marrow transplantation, to prevent infection in pediatric human immunodeficiency virus, and chronic inflammatory demyelinating polyneuropathy. However, IgG products are frequently used off label in many autoimmune conditions. The advent of numerous intravenous and subcutaneous formulations of IgG presents new opportunities impacting patient preferences, site of care, and costs. The appropriate and optimal use of IgG is reviewed based on discussions from an expert roundtable panel and review of the scientific literature. Clinicians and payers should consider patient preferences, evidence- based guidelines, and policies when selecting an IgG product.

Rosiglitazone prior authorization safety policy: a cohort study.

BACKGROUND: Prior authorizations (PA) are intended to promote safe and cost-effective medication use. Unwanted outcomes may occur, however, such as a patient forgoing drug therapy after a PA. The label for rosiglitazone was revised in November 2007 to include the warning of contraindicated use with nitrates or insulin, creating an opportunity for a PA directed at safe use. OBJECTIVE: To evaluate antidiabetic drug utilization after the implementation of an electronic PA that denied a claim for rosiglitazone if the patient had a history of either insulin or nitrate supply in the previous 60 days. METHODS: This quasi-experimental study used pharmacy claims for 1.4 million commercially insured members who were exposed to a rosiglitazone PA beginning on January 1, 2009, compared with a group of approximately 2 million commercially insured members who did not have this safety PA intervention. Continuously enrolled members were identified who had a rejected (intervention group) or paid (comparison group) claim for rosiglitazone during the period from January 1, 2009, through June 30, 2009. Pharmacy claims were assessed for the presence of nitrates, insulin, rosiglitazone, other antidiabetic therapy, or no antidiabetic therapy supply on days 30, 60, 90, and 180 after the rejected/paid claim. A time-series analysis using rosiglitazone claims for all health plan members from January 2008 through December 2009 was used to evaluate the impact of the PA on rosiglitazone utilization overall. RESULTS: At 30 days, there were 134 patients (60.4% of 222) in the comparison group with concurrent supply of rosiglitazone with insulin and/or nitrates versus 4 patients (2.4% of 168, P less than 0.001) in the PA intervention group, and the utilization rate remained significantly higher at 180 days in the comparison group (37.8%, n = 84) versus the PA group (2.4%, n = 4, P less than 0.001). Beginning at 60 days, there was no significant difference in the percentage of members with no antidiabetic therapy in the comparison and PA intervention groups (9.9% vs. 15.5%, respectively, P = 0.133), and the rates remained similar through 180 days (15.3% vs. 13.7%, respectively, P = 0.760). The PA was associated with an absolute decrease of 5.1 average monthly rosiglitazone claims per day per million members (P less than 0.001). CONCLUSIONS: This PA, intended to reduce known cardiovascular event risks among health plan members with type 2 diabetes, was associated with a significant reduction in concurrent use of rosiglitazone with nitrates or insulin.