BALTIMORE, May 31, 2011 /PRNewswire/ -- 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:
"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.
Study Details
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.
About Vimpat®
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.
For full prescribing information on Vimpat®, visit http://www.vimpat.com/prescribing-information.aspx, and for more information on Vimpat®, visit Vimpat.com or contact UCB at (800) 477-7877.
Vimpat® is a Schedule V controlled substance.
Vimpat® is a registered trademark under license from Harris FRC Corporation.
Important safety information about Vimpat® in the EU and EEA
Vimpat® is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy aged 16 years and older. Lacosamide solution for infusion is an alternative for patients when oral administration is temporarily not feasible. Contraindications: Hypersensitivity to the active substance or any of the excipients; known second- or third-degree atrioventricular (AV) block. Special warnings and precautions for use: Treatment with lacosamide has been associated with dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine. Prolongations in PR interval with lacosamide have been observed in clinical studies. Cases with second and third degree AV block associated with lacosamide treatment have been reported in post-marketing experience. Lacosamide should be used with caution in patients with known conduction problems or severe cardiac disease such as a history of myocardial infarction or heart failure. Caution should especially be exerted when treating elderly patients as they may be at an increased risk of cardiac disorders or when lacosamide is used in combination with products known to be associated with PR prolongation. Second degree or higher AV block has been reported in post-marketing experience. In the placebo-controlled trials of lacosamide in epilepsy patients, atrial fibrillation or flutter were not reported; however both have been reported in open-label epilepsy trials and in post-marketing experience. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheaded and fainting) and of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid or irregular pulse, shortness of breath). Patients should be counseled to seek medical advice should any of these symptoms occur. Suicidal ideation and behavior have been reported in patients treated with anti-epileptic agents. Therefore patients should be monitored for signs of suicidal ideation and behaviors and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behavior emerge. Lacosamide syrup contains sodium methylhydroxybenzoate (E219), which may cause allergic reaction (possibly delayed). Patients with rare hereditary problems of fructose intolerance should not take this medicine. The syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria. Both the syrup and solution for infusion contain sodium. To be taken into consideration for patients on a controlled sodium diet. Effects on ability to drive and use machines: Lacosamide may have minor to moderate influence on the ability to drive and use machines. Lacosamide treatment has been associated with dizziness and blurred vision. Accordingly patients should be advised not to drive a car or to operate other potentially hazardous machinery until they are familiar with the effects of lacosamide on their ability to perform such activities. Laboratory abnormalities: Abnormalities in liver function tests have been observed in controlled trials with lacosamide in adult patients with partial-onset seizures who were taking 1-3 concomitant antiepileptic drugs. Elevations of ALT to greater than or equal to 3XULN occurred in 0.7% (7/935) of lacosamide patients and 0% (0/356) of placebo patients. Multiorgan Hypersensitivity Reactions: Multiorgan hypersensitivity reactions have been reported in patients treated with some antiepileptic agents. These reactions are variable in expression but typically present with fever and rash and can be associated with involvement of different organ systems. Potential cases have been reported rarely with lacosamide and if multiorgan hypersensitivity reaction is suspected, lacosamide should be discontinued. Undesirable effects: The most common adverse reactions (greater than or equal to 10 %) are dizziness, headache, diplopia, and nausea. Other common adverse reactions (greater than or equal to 1%<10 %) are depression, confusional state, insomnia, balance disorder, coordination abnormal, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, disturbance in attention, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, injection site pain or discomfort (specific to solution for infusion), irritation (specific to solution for infusion), fall, and skin laceration. Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 06 May 2011.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000863/WC500050338.pdf (Accessed 19th May 2011)
About Epilepsy
Epilepsy is a chronic neurological disorder affecting approximately 40 million people worldwide and three million people in the US—making it as common as breast cancer. Anyone can develop epilepsy; it occurs across all ages, races and genders. Uncontrolled seizures and medication side effects pose challenges to independent living, learning and employment, so the goal of epilepsy treatment is seizure freedom with minimal side effects. More than 1 million patients in the US continue to have seizures despite initial therapy, and more than 800,000 patients in the US continue to have seizures despite treatment with two or more therapies. New medications and treatments give hope to those living with uncontrolled seizures.
Further InformationAndrea Levin, Senior Manager, Communications & PR, CNS, UCB, Inc.T 770.970.8352 M [email protected]
Laura FinleyCooney/Waters GroupT [email protected]
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8,000 people in about 40 countries, the company generated revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB).
Forward-looking statements
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
SOURCE UCB
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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:
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- 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
"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.
Study Details
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.
About Vimpat®
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.
For full prescribing information on Vimpat®, visit http://www.vimpat.com/prescribing-information.aspx, and for more information on Vimpat®, visit Vimpat.com or contact UCB at (800) 477-7877.
Vimpat® is a Schedule V controlled substance.
Vimpat® is a registered trademark under license from Harris FRC Corporation.
Important safety information about Vimpat® in the EU and EEA
Vimpat® is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy aged 16 years and older. Lacosamide solution for infusion is an alternative for patients when oral administration is temporarily not feasible. Contraindications: Hypersensitivity to the active substance or any of the excipients; known second- or third-degree atrioventricular (AV) block. Special warnings and precautions for use: Treatment with lacosamide has been associated with dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine. Prolongations in PR interval with lacosamide have been observed in clinical studies. Cases with second and third degree AV block associated with lacosamide treatment have been reported in post-marketing experience. Lacosamide should be used with caution in patients with known conduction problems or severe cardiac disease such as a history of myocardial infarction or heart failure. Caution should especially be exerted when treating elderly patients as they may be at an increased risk of cardiac disorders or when lacosamide is used in combination with products known to be associated with PR prolongation. Second degree or higher AV block has been reported in post-marketing experience. In the placebo-controlled trials of lacosamide in epilepsy patients, atrial fibrillation or flutter were not reported; however both have been reported in open-label epilepsy trials and in post-marketing experience. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheaded and fainting) and of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid or irregular pulse, shortness of breath). Patients should be counseled to seek medical advice should any of these symptoms occur. Suicidal ideation and behavior have been reported in patients treated with anti-epileptic agents. Therefore patients should be monitored for signs of suicidal ideation and behaviors and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behavior emerge. Lacosamide syrup contains sodium methylhydroxybenzoate (E219), which may cause allergic reaction (possibly delayed). Patients with rare hereditary problems of fructose intolerance should not take this medicine. The syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria. Both the syrup and solution for infusion contain sodium. To be taken into consideration for patients on a controlled sodium diet. Effects on ability to drive and use machines: Lacosamide may have minor to moderate influence on the ability to drive and use machines. Lacosamide treatment has been associated with dizziness and blurred vision. Accordingly patients should be advised not to drive a car or to operate other potentially hazardous machinery until they are familiar with the effects of lacosamide on their ability to perform such activities. Laboratory abnormalities: Abnormalities in liver function tests have been observed in controlled trials with lacosamide in adult patients with partial-onset seizures who were taking 1-3 concomitant antiepileptic drugs. Elevations of ALT to greater than or equal to 3XULN occurred in 0.7% (7/935) of lacosamide patients and 0% (0/356) of placebo patients. Multiorgan Hypersensitivity Reactions: Multiorgan hypersensitivity reactions have been reported in patients treated with some antiepileptic agents. These reactions are variable in expression but typically present with fever and rash and can be associated with involvement of different organ systems. Potential cases have been reported rarely with lacosamide and if multiorgan hypersensitivity reaction is suspected, lacosamide should be discontinued. Undesirable effects: The most common adverse reactions (greater than or equal to 10 %) are dizziness, headache, diplopia, and nausea. Other common adverse reactions (greater than or equal to 1%<10 %) are depression, confusional state, insomnia, balance disorder, coordination abnormal, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, disturbance in attention, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, injection site pain or discomfort (specific to solution for infusion), irritation (specific to solution for infusion), fall, and skin laceration. Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 06 May 2011.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000863/WC500050338.pdf (Accessed 19th May 2011)
About Epilepsy
Epilepsy is a chronic neurological disorder affecting approximately 40 million people worldwide and three million people in the US—making it as common as breast cancer. Anyone can develop epilepsy; it occurs across all ages, races and genders. Uncontrolled seizures and medication side effects pose challenges to independent living, learning and employment, so the goal of epilepsy treatment is seizure freedom with minimal side effects. More than 1 million patients in the US continue to have seizures despite initial therapy, and more than 800,000 patients in the US continue to have seizures despite treatment with two or more therapies. New medications and treatments give hope to those living with uncontrolled seizures.
Further InformationAndrea Levin, Senior Manager, Communications & PR, CNS, UCB, Inc.T 770.970.8352 M [email protected]
Laura FinleyCooney/Waters GroupT [email protected]
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8,000 people in about 40 countries, the company generated revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB).
Forward-looking statements
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
SOURCE UCB
