mmcc53
10-06-2006, 11:40 AM
Data Presented at Academy of Managed Care Pharmacy's Educational
Conference Also Highlight Impact of TYSABRI(R) on Quality of Life and
Cost Effectiveness of MS Therapies
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that
data to be presented today at the Academy of Managed Care Pharmacy's (AMCP) 2006
Educational Conference in Chicago, IL show that in Phase III studies TYSABRI(R)
(natalizumab) therapy significantly reduced corticosteroid use and
hospitalizations, and increased the proportion of MS patients with no disease
activity. Findings will also be presented that demonstrate the positive impact
of TYSABRI on a number of health-related quality of life of measures (QoL) and
the cost-effectiveness of MS therapies.
Data Demonstrate TYSABRI Reduced Corticosteroid Use, Hospitalizations and
Increases the Proportion of Disease-Free Patients
Data presented today from the AFFIRM monotherapy study (two-year, randomized,
multi-center, placebo-controlled, double-blind study of 942 patients conducted
in 99 sites worldwide), showed the impact of TYSABRI on two pre-specified
endpoints, the annualized rate of relapses requiring corticosteroid use and the
annualized rate of hospitalizations due to MS. Data showed there was a 69%
relative reduction in the annualized rate of relapses requiring steroids for
patients treated with TYSABRI compared to those treated with placebo (0.133 in
the TYSABRI group vs. 0.432 in the placebo group(p<0.001)). The study also
showed that TYSABRI therapy resulted in a 65% relative reduction in the
annualized rate of MS-related hospitalizations over two years (0.034 in the
TYSABRI group vs. 0.097 in the placebo group(p<0.001)).
A post-hoc analysis was also conducted to determine the proportion of patients
free of disease activity over two years. To determine this, a retrospective
analysis was conducted to evaluate both clinical and magnetic resonance imaging
(MRI) measures. Patients with no disease activity were defined as patients who
experienced no additional relapses or progression of physical disability and
exhibited stable MRI measures without any new gadolinium-enhancing,
T2-hyperintense, or T1-hypointense lesions. Data presented today suggest that
TYSABRI significantly increased the proportion of disease-free patients by 79%
over two years compared with placebo (28% vs. 6%, respectively; p<0.001).
Cost Effectiveness of MS Therapies
A model was constructed by Xcenda, formerly Applied Health Outcomes, to compare
the cost per relapse avoided among the five approved disease-modifying MS
therapies to treat relapsing forms of MS. Overall cost of therapy was calculated
using the US ********* acquisition drug cost, and costs associated with drug
administration, patient monitoring and treatment of relapses. The costs
associated with adverse events were not assessed as part of this model.
Effectiveness was defined as the number of relapses avoided with treatment,
which was calculated as the number of relapses for a non-treated population
multiplied by published relapse rate reductions for the therapies.(1) Based on
the model developed, the cost per relapse per year avoided was lowest for
TYSABRI. The cost per relapse avoided for TYSABRI was between $12,730 and
$23,274 lower than that of the other approved disease-modifying therapies.
Data Show TYSABRI Had Improvement in Quality of Life Assessments
Quality of Life (QoL) was assessed using three different measures, the Multiple
Sclerosis Quality of Life Inventory (MSQLI), the Short Form-36 Health Survey
(SF-36), which is a component of the MSQLI, and a Visual Analogue Scale (VAS).
The MSQLI is an MS-specific battery of 10 scales that measure disease impact on
QoL, including fatigue, pain, sexual function, bowel and bladder function,
visual impairment, mental health and need for social support. The SF-36 is
comprised of 36 questions designed to assess patients' physical and mental
well-being. General well-being was also measured using the VAS. In data
presented today from the AFFIRM study, patients in the TYSABRI-treated group
realized a significant improvement in physical measures of the SF-36 compared
with a decline in the placebo-treated group (p=0.003). A significant improvement
was also seen in the mental component of the SF-36 in patients treated with
TYSABRI compared with a decline in the placebo-group (p=0.011). Significant
benefits were also seen using the VAS (p=0.007). About TYSABRI
In the US, TYSABRI is approved as a monotherapy treatment for relapsing forms of
MS. TYSABRI increases the risk of progressive multifocal leukoencephalopathy
(PML), an opportunistic viral infection of the brain that usually leads to death
or severe disability. Patients should be monitored at regular intervals for any
new or worsening signs or symptoms suggestive of PML. Because of the increased
risk of PML, TYSABRI is generally recommended for patients who have had an
inadequate response to, or are unable to tolerate, alternate MS therapies. It is
available in the US only through a restricted distribution program called the
TOUCH Prescribing Program. According to product labeling, after two years,
TYSABRI treatment led to a 67% relative reduction (p<0.001) in the annualized
relapse rate compared to placebo and reduced the relative risk of disability
progression by 42% (p<0.001). TYSABRI treatment also resulted in sustained and
statistically significant reductions in brain lesion activity as measured by
MRI. Changes in MRI findings often do not correlate with changes in the clinical
status of patients (e.g., disability progression). The prognostic significance
of the MRI findings in these studies has not been evaluated.
In the European Union, TYSABRI is indicated as a single disease-modifying
therapy in highly active relapsing-remitting MS patients. Because of the
increased risk of PML, it is for patients with high disease activity despite
treatment with a beta-interferon or in patients with rapidly evolving severe
relapsing-remitting MS. According to product labeling in the EU, after two
years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the
annualized relapse rate compared to placebo and reduced the relative risk of
disability progression by 42-54% (p<0.001).
Serious adverse events that occurred in TYSABRI-treated patients included
hypersensitivity reactions (e.g., anaphylaxis), infections, depression and
gallstones. In MS trials, the incidence and rate of other serious and common
adverse events, including the overall incidence and rate of infections, were
balanced between treatment groups. Herpes infections were slightly more common
in patients treated with TYSABRI. Serious opportunistic and other atypical
infections have been observed in TYSABRI-treated patients, some of whom were
receiving concurrent immunosuppressants. Common adverse events reported in
TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary
tract infections, joint and limb pain, lower respiratory infections, rash,
gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.
For more information about TYSABRI please visit www.tysabri.com,
www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
Conference Also Highlight Impact of TYSABRI(R) on Quality of Life and
Cost Effectiveness of MS Therapies
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that
data to be presented today at the Academy of Managed Care Pharmacy's (AMCP) 2006
Educational Conference in Chicago, IL show that in Phase III studies TYSABRI(R)
(natalizumab) therapy significantly reduced corticosteroid use and
hospitalizations, and increased the proportion of MS patients with no disease
activity. Findings will also be presented that demonstrate the positive impact
of TYSABRI on a number of health-related quality of life of measures (QoL) and
the cost-effectiveness of MS therapies.
Data Demonstrate TYSABRI Reduced Corticosteroid Use, Hospitalizations and
Increases the Proportion of Disease-Free Patients
Data presented today from the AFFIRM monotherapy study (two-year, randomized,
multi-center, placebo-controlled, double-blind study of 942 patients conducted
in 99 sites worldwide), showed the impact of TYSABRI on two pre-specified
endpoints, the annualized rate of relapses requiring corticosteroid use and the
annualized rate of hospitalizations due to MS. Data showed there was a 69%
relative reduction in the annualized rate of relapses requiring steroids for
patients treated with TYSABRI compared to those treated with placebo (0.133 in
the TYSABRI group vs. 0.432 in the placebo group(p<0.001)). The study also
showed that TYSABRI therapy resulted in a 65% relative reduction in the
annualized rate of MS-related hospitalizations over two years (0.034 in the
TYSABRI group vs. 0.097 in the placebo group(p<0.001)).
A post-hoc analysis was also conducted to determine the proportion of patients
free of disease activity over two years. To determine this, a retrospective
analysis was conducted to evaluate both clinical and magnetic resonance imaging
(MRI) measures. Patients with no disease activity were defined as patients who
experienced no additional relapses or progression of physical disability and
exhibited stable MRI measures without any new gadolinium-enhancing,
T2-hyperintense, or T1-hypointense lesions. Data presented today suggest that
TYSABRI significantly increased the proportion of disease-free patients by 79%
over two years compared with placebo (28% vs. 6%, respectively; p<0.001).
Cost Effectiveness of MS Therapies
A model was constructed by Xcenda, formerly Applied Health Outcomes, to compare
the cost per relapse avoided among the five approved disease-modifying MS
therapies to treat relapsing forms of MS. Overall cost of therapy was calculated
using the US ********* acquisition drug cost, and costs associated with drug
administration, patient monitoring and treatment of relapses. The costs
associated with adverse events were not assessed as part of this model.
Effectiveness was defined as the number of relapses avoided with treatment,
which was calculated as the number of relapses for a non-treated population
multiplied by published relapse rate reductions for the therapies.(1) Based on
the model developed, the cost per relapse per year avoided was lowest for
TYSABRI. The cost per relapse avoided for TYSABRI was between $12,730 and
$23,274 lower than that of the other approved disease-modifying therapies.
Data Show TYSABRI Had Improvement in Quality of Life Assessments
Quality of Life (QoL) was assessed using three different measures, the Multiple
Sclerosis Quality of Life Inventory (MSQLI), the Short Form-36 Health Survey
(SF-36), which is a component of the MSQLI, and a Visual Analogue Scale (VAS).
The MSQLI is an MS-specific battery of 10 scales that measure disease impact on
QoL, including fatigue, pain, sexual function, bowel and bladder function,
visual impairment, mental health and need for social support. The SF-36 is
comprised of 36 questions designed to assess patients' physical and mental
well-being. General well-being was also measured using the VAS. In data
presented today from the AFFIRM study, patients in the TYSABRI-treated group
realized a significant improvement in physical measures of the SF-36 compared
with a decline in the placebo-treated group (p=0.003). A significant improvement
was also seen in the mental component of the SF-36 in patients treated with
TYSABRI compared with a decline in the placebo-group (p=0.011). Significant
benefits were also seen using the VAS (p=0.007). About TYSABRI
In the US, TYSABRI is approved as a monotherapy treatment for relapsing forms of
MS. TYSABRI increases the risk of progressive multifocal leukoencephalopathy
(PML), an opportunistic viral infection of the brain that usually leads to death
or severe disability. Patients should be monitored at regular intervals for any
new or worsening signs or symptoms suggestive of PML. Because of the increased
risk of PML, TYSABRI is generally recommended for patients who have had an
inadequate response to, or are unable to tolerate, alternate MS therapies. It is
available in the US only through a restricted distribution program called the
TOUCH Prescribing Program. According to product labeling, after two years,
TYSABRI treatment led to a 67% relative reduction (p<0.001) in the annualized
relapse rate compared to placebo and reduced the relative risk of disability
progression by 42% (p<0.001). TYSABRI treatment also resulted in sustained and
statistically significant reductions in brain lesion activity as measured by
MRI. Changes in MRI findings often do not correlate with changes in the clinical
status of patients (e.g., disability progression). The prognostic significance
of the MRI findings in these studies has not been evaluated.
In the European Union, TYSABRI is indicated as a single disease-modifying
therapy in highly active relapsing-remitting MS patients. Because of the
increased risk of PML, it is for patients with high disease activity despite
treatment with a beta-interferon or in patients with rapidly evolving severe
relapsing-remitting MS. According to product labeling in the EU, after two
years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the
annualized relapse rate compared to placebo and reduced the relative risk of
disability progression by 42-54% (p<0.001).
Serious adverse events that occurred in TYSABRI-treated patients included
hypersensitivity reactions (e.g., anaphylaxis), infections, depression and
gallstones. In MS trials, the incidence and rate of other serious and common
adverse events, including the overall incidence and rate of infections, were
balanced between treatment groups. Herpes infections were slightly more common
in patients treated with TYSABRI. Serious opportunistic and other atypical
infections have been observed in TYSABRI-treated patients, some of whom were
receiving concurrent immunosuppressants. Common adverse events reported in
TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary
tract infections, joint and limb pain, lower respiratory infections, rash,
gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.
For more information about TYSABRI please visit www.tysabri.com,
www.biogenidec.com or www.elan.com, or call 1-800-456-2255.