UCB announced findings of the first cost-effectiveness analysis of Vimpat® (lacosamide) as add-on therapy for adults with uncontrolled partial-onset seizures. The findings were presented at the 16th International Society for Pharmacoeconomics and Outcomes Research (ISPOR) annual meeting in Baltimore, MD, USA.
Researchers used a simulated pharmaco-economic model to analyze standard anti-epileptic drug therapy with and without lacosamide as add-on therapy in adults with uncontrolled partial onset seizures over a time horizon of two years in the United States. The analysis found that treatment with lacosamide was associated with:
-- an incremental gain of 6,730 avoided seizures and 38 quality adjusted life years (QALY) for a cohort of 1,000 patients, compared to the standard therapy arm of the analysis
-- an estimated dollar value ranging from $223 to $733 per seizure avoided and an estimated dollar value of $39,574 per QALY gained, compared to the standard therapy arm of the analysis
-- 77% of patient simulations after 2 years of treatment fell within the acceptable thresholds of cost-effectiveness in the US, known as the willingness-to-pay threshold, which is $50,000 per QALY
QALY is a standard calculation used by health economists to compute a dollar amount for each additional year of life added by a therapy and a value for the quality of that life. In standard practice, if the QALY resulting from a therapy is less than $50,000 per year (the estimated value of a year of life in perfect health) then that therapy is seen as meeting the standard of willingness-to-pay.
"Cost- and utility-effectiveness analyses help to quantify the economic rationale for a treatment, which is an important factor in evaluating the use of a potential therapy," said Hicham Benhaddi, Senior Health Economist at UCB. "These findings provide additional support for lacosamide's utility as an antiepileptic drug in the reimbursement community, and among healthcare professionals and patients."
"This analysis shows the potential for cost savings when adding lacosamide to a treatment plan and, when combined with more than five years of efficacy and safety data and more than 100,000 patient exposures worldwide, further underscores lacosamide's role in the treatment of epilepsy," added Kathleen Bos, MD, Vice President, U.S. Medical Affairs, UCB, Inc.
This analysis is based on published data from two pivotal, multi-national, clinical trials that have yielded more than five years of safety and efficacy data supporting long-term use of lacosamide. The model simulated the treatment pathway of a hypothetical cohort of 1,000 patients over two years from the third party payer perspective in the United States in 2010. Standard cost- and utility-effectiveness ratios were calculated based on two years of therapy compared with five other standard therapies: carbamazepine, lamotrigine, levetiracetam, topiramate, and valproate. Separate arms of the cohort compared lacosamide used as an add-on therapy with standard therapies versus those therapies used without lacosamide.
About Cost-Effectiveness Analysis
Cost-effectiveness analyses calculate the dollar value of changes in health status based on the use of a particular therapy versus standard cost of care. They are increasingly used to determine the relative value of therapies by public and private insurers for reimbursement decisions and in the development of clinical practice guidelines. Additionally, the more subjective health benefits resulting from a therapy, known as utility-value, are commonly determined through QALY calculations. QALY calculations calculate a dollar amount for each additional year of life added by a therapy and a value for the quality of that life. Quality is defined according to a variety of measures including physical mobility, ability to carry out activities of daily living, absence of pain and discomfort, and absence of anxiety and depression. In standard practice, if a therapy has shown a QALY under $50,000 per year, it is considered to have met the standard of willingness-to-pay.
Vimpat® was approved by the Food and Drug Administration in 2008 as an adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy 17 years and older. Vimpat® became available in the U.S. in May 2009 as tablet and intravenous formulations. In 2010, Vimpat® was approved as an oral solution.
Vimpat® (film-coated tablets, syrup and solution for infusion) was launched in the European Union in September 2008, as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy, aged 16 years and older. Vimpat® solution for infusion may be used when oral administration is temporarily not feasible.
Important safety information about Vimpat® in the U.S.
Warnings and Precautions
AEDs increase the risk of suicidal behavior and ideation. Patients taking Vimpat® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Patients should be advised that Vimpat® may cause dizziness, ataxia, and syncope. Caution is advised for patients with known cardiac conduction problems, who are taking drugs known to induce PR interval prolongation, or with severe cardiac disease. In patients with seizure disorders, Vimpat® should be gradually withdrawn to minimize the potential of increased seizure frequency. Multi-organ hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, treatment with Vimpat® should be discontinued.
VIMPAT® oral solution contains aspartame, a source of phenylalanine. A 200 mg dose of VIMPAT® oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.
Common Adverse Reactions
The most common adverse reactions occurring in greater than or equal to 10 percent of Vimpat®-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia.
Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. The use of Vimpat® in patients with severe hepatic impairment is not recommended.
Vimpat® is a Schedule V controlled substance.
Vimpat® is a registered trademark under license from Harris FRC Corporation.