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Title: Evaluation of Tysabri EU By MedPanel, Inc' September 19, 2006


1
Evaluation of Tysabri (EU)By MedPanel,
Inc.September 19, 2006
2
  • Contents
  • Project Objectives 2
  • Methodology Sample 3
  • Respondent Practice Background 4-6
  • Executive Summary 7-11
  • Detailed Findings 12-43
  • MS Treatment Patterns 13-16
  • Tysabri 17-24
  • PML 25-35
  • Future Practice Patterns 36-43

3
Study Objectives
  • Specific Objectives
  • Identify current patient populations and
    treatments for multiple sclerosis (MS)
  • Determine current and anticipated future use of
    Tysabri
  • Distinguish the target population for Tysabri in
    both countries using Tysabri (Germany and the
    United Kingdom) and countries anticipating its
    future use (Italy, Spain, and France)
  • Understand the risk of progressive multifocal
    leukoencephalopathy (PML) as a side effect of
    Tysabri use
  • Clarify anticipated future treatment regimens
    for relapsing remitting MS patients

4
Methodology Sample
  • Survey Specifics
  • A 20-minute, self-administered survey was fielded
    online via MedPanels Web site from September
    8-19, 2006.
  • Sample
  • The total sample comprises 46 neurologists.
  • Respondents were selected from MedPanels
    international database
  • 12 neurologists from Italy, Spain, and France
  • 34 neurologists from Germany and the United
    Kingdom

5
Respondent Practice Background
On average, neurologists from Germany and the UK
reported managing more than twice as many MS
patients as did neurologists in Italy, Spain, and
France.
Mean Number of Current Patients with Multiple
Sclerosis (n46)
Years in Practice IT/SP/FR 13.6 (Range 6-25)
GE/UK 9.7 (2-21)
Time in Clinical Practice IT/SP/FR 86
(70-100) GE/UK 82 (60-100)
S3. Approximately how many years have you been in
practice since completing your residency? S4.
Approximately what of your professional time is
dedicated to clinical practice? S5. Approximately
how many patients do you currently manage who
have or have had a diagnosis of multiple
sclerosis (MS)?
6
Respondent Practice Background
Neurologists from Germany and the UK reported
that they have commercially dosed an average of
23 patients with Tysabri since its approval.
Almost all of the neurologists work in an urban
setting.
Mean Number of Patients Dosed with Tysabri (n34)
Primary Practice Setting (GE/UK) (n34)
Primary Practice Setting (IT/SP/FR) (n12)
S6. Approximately how many patients have you, or
your center dosed commercially with Tysabri to
since it was approved and marketed in your
country? S7. Which of the following describes
your primary practice setting?
7
Respondent Practice Background
About two-thirds of the neurologists in Italy,
Spain, and France, and 88 of the neurologists in
Germany the UK, work in an academic medical
center.
Practice Setting (n34)
Practice Setting (n12)
GE/UK
IT/SP/FR
S8. Please describe the practice setting in which
you see the majority of your MS patients.
8
Executive Summary
9
Executive Summary
  • Current MS Treatment Patterns
  • The groups differed in how many total patients
    and MS patients they see in a typical month
  • Neurologists in Germany and the UK had a mean of
    218 total patients and 66 MS patients in a
    typical month while Italian, Spanish, and French
    neurologists reported an average of 127 total
    patients and 23 MS patients seen in a typical
    month.
  • Relapse remitting patients were the most
    frequently reported MS patients being treated by
    Italian, Spanish, and French neurologists
  • Secondary progressive patients were the most
    frequently reported MS patients in Germany and
    the United Kingdom
  • Avonex (in Italy, Spain, and France) and Rebif
    (in Germany and the UK) were reported as the most
    commonly used treatments for relapse remitting
    patients
  • Tysabri Use
  • Neurologists in Germany and the UK indicated that
    they have used Tysabri on an average of about 13
    patients since it was approved
  • Tysabri is currently most frequently used as a
    second- or third-line treatment
  • Rebif was indicated as the treatment that
    neurologists have most frequently switched their
    patients from to Tysabri
  • Mitoxantrone was selected most frequently as the
    second-line treatment that would be used after
    failure of a first medication if Tysabri was not
    available

10
Executive Summary
  • Tysabri Use (contd)
  • Neurologists reported that patients are more
    likely to be eligible for Tysabri use if it is
    used as a second line of treatment than if it is
    used as a first-line treatment
  • Neurologists didnt show a preference for using
    Tysabri indefinitely versus using it for a
    specified period of time
  • Neurologists from the UK and Germany expect
    typical Tysabri use to last an average of 38
    months per patient, which significantly longer
    than the 23 months predicted by Italian, Spanish,
    and French neurologists
  • More than half of the neurologists in Germany and
    the UK indicated that premium pricing will result
    in limited use of Tysabri while very few of the
    neurologists in Italy, Spain, and France felt
    that premium pricing would result in any limited
    use
  • Neurologists indicated that about 30 of
    relapsing remitting MS patients request Tysabri
    and that about 20 of relapsing remitting MS
    patients will not receive Tysabri because of
    patient refusal
  • PML
  • Neurologists in Italy, Spain, and France reported
    that they require patient check-ups for MS
    patients every 6 months while neurologists in
    Germany and the UK indicated that they require
    these check-ups every 5 months
  • PML monitoring
  • Neurologists reported that they would use other
    monitoring types most frequently
  • Neurologists in Italy, Spain, and France reported
    that follow-up MRIs are most likely to occur 6
    months after the initial infusion
  • Neurologists in Germany and the UK indicated that
    these follow-up MRIs would most likely occur
    every 6 months thereafter.

11
Executive Summary
  • PML Risk
  • Most (68) Italian, Spanish, and French
    neurologists indicated extreme concern while most
    (56) neurologists in the UK and Germany only
    reported being somewhat concerned about the risk
    of PML
  • Both groups of neurologists felt that there is
    more risk for PML when Tysabri is used in
    combination with other treatments than when it is
    used as a monotherapy
  • Neurologists in the UK and Germany found it more
    believable that an MRI scan, CSF testing, and
    frequent neurological assessments would be
    sufficient for PML detection than did Italian,
    Spanish, and French neurologists.
  • PML Education
  • Neurologists in Germany and the UK rated Biogen
    Idec/Elan highly (3.3 on a 5 point scale) in how
    well they educate neurologists for minimizing
    morbidity and mortality due to PML and for
    distinguishing between PML and MS relapse
  • Neurologists in Italy, Spain, and France feel
    that the level of education isnt as high
  • PML Effect on Tysabri Use
  • A little more than half neurologists in the UK
    and Germany indicated that 2-5 cases of PML would
    impact Tysabri usage while half of neurologists
    in Italy, Spain, and France claimed that 5-20
    cases would have an impact

12
Executive Summary
  • Future Practice
  • Rebif and Avonex were reported as the treatments
    that currently are used most frequently and will
    be used the most 4 and 12 months from now for
    relapsing remitting MS patients
  • Currently a very small majority of Italian,
    Spanish, and French neurologists indicated that
    they would use Tysabri only as a salvage therapy
  • In the next 12 months, they reported that Tysabri
    would be more frequently used as a first- or
    second-line treatment
  • Neurologists in the UK and Germany indicated that
    Tysabri currently is used most frequently as a
    third-line treatment. In 12 months, they believe
    it will be used mostly as a second- or third-line
    treatment
  • Neurologists in Italy, Spain, and France stated
    that they would most likely have been using
    Betaseron before switching to Tysabri currently,
    in the next 4 months, and in 12 months
  • Neurologists from Germany and the UK indicated
    that they would most likely have been using Rebif
    before switching to Tysabri currently, in the
    next 4 months, and in the next 12 months

13
Detailed Findings
14
MS Treatment Patterns
15
Survey DetailsMS Treatment Patterns
German neurologists and neurologists from the
United Kingdom reported seeing an average of 218
patients a month with 66 MS patients per month.
Italian, Spanish, and French neurologists report
an average of 127 total patients and 23 MS
patients per month.
Mean Number of Total Patients Seen in a Typical
Month (n46)
Mean Number of MS Patients Seen in a Typical
Month (n46)
Q1. How many total patients, regardless of
condition, do you see in a typical month? Q2. Of
these patients you see in a typical month, how
many have MS?
16
Survey DetailsMS Treatment Patterns
Out of all of the MS patient classifications,
relapse-remitting MS patients were reported as
the most common MS patients in Italy, Spain, and
France. Secondary progressive were most common
in Germany and the UK.
Q3. Approximately how many and what percent of
your MS patients fall under the following
classifications?
17
Survey DetailsMS Treatment Patterns
Avonex was reported as the most frequently used
treatment for relapse-remitting MS patients in
Italy, Spain, and France while Rebif was reported
as the most frequently used in Germany and the
UK. Tysabri was reported as being used in an
average of only 5 of relapse-remitting MS
patients in Germany and the UK.
Q4. Regarding your relapsing-remitting MS
patients, what percentage of these patients
currently receive the following treatments?
18
Tysabri
19
Survey DetailsTysabri
Neurologists in the UK and Germany reported that
they have dosed an average of 13 patients with
Tysabri since it was approved. German and UK
neurologists also reported that they anticipate
dosing the drug more frequently than neurologists
in Italy, Spain, and France in the next 4 months
and the next 12 months.
Q5. Approximately how many patients have you
dosed commercially with Tysabri since it was
approved and became available commercially in
your country? Q6/Q5. Approximately how many
additional patients do you expect to dose
commercially with Tysabri in the next 4
months? Q7./Q6. Approximately how many additional
patients do you expect to dose commercially with
Tysabri in the next 12 months?
20
Survey DetailsTysabri
Patients who have failed one of the other MS
therapies were reported as the group most
frequently treated with Tysabri. MS patients who
have had two or more failed treatments were
reported as the highest percentage of
relapse-remitting MS patients on Tysabri.
Q8. Of the patients you currently treat with
Tysabri, how have you distributed your use by
line of therapy?
21
Survey DetailsTysabri
Patients were most frequently switched from Rebif
to Tysabri. Neurologists in Germany and the UK
also reported that an average of about 3 patients
on Betaseron had been switched to Tysabri.
Q9. What treatment (if any treatment was being
given previously) have you actively switched
patients off of to put them on Tysabri?
22
Survey DetailsTysabri
Mitoxantrone was the treatment identified most
frequently as the therapy that would be
prescribed after first-line failure if Tysabri
was not available.
Q10. If Tysabri were not available, which therapy
would you have prescribed for non-responders
after first-line failure?
23
Survey DetailsTysabri
Neurologists in Germany, the UK, Italy, Spain,
and France stated that second-line patients would
more likely be eligible for Tysabri than
first-line patients. Very minimal differences
were reported for whether neurologists would use
Tysabri indefinitely or with a pre-determined
period of time.
Mean Percent Eligible for Tysabri Treatment (n46)
Mean of Patients for Tysabri Use (n46)
Q11/Q7. Tysabri is approved in the EU as a
monotherapy in highly active relapsing remitting
MS for patients with A) highly active disease
activity despite treatment with a beta-interferon
or B) patients with rapidly evolving severe
relapsing remitting MS. What percentage of each
group would you estimate is eligible for Tysabri
treatment (not immune-compromised/suppressed)? Q12
/Q8. Tysabris EU label shows efficacy out to 2
years of treatment. For what percentage of
patients would you plan to use Tysabri
indefinitely (assuming it will work for the
patient) vs. using for a pre-determined fixed
time period?
24
Survey DetailsTysabri
Neurologists in Germany and the UK claimed that
they treat patients with Tysabri for an average
of 38 months while neurologists in Italy, Spain,
and France treat patients with Tysabri for only
23 months.
Comments on Limited Use of Tysabri Due to
Premium Pricing IT/SP/FR Does Limit 8 Does
not Limit 92 No Limits -Depends on Efficacy
(5) -Reimbursed in eligible patients
(1) GE/UK Does Limit 61 Does not Limit
39 Limits -There is a budget or limit in the
German Healthcare system (8) -Cost (2) -No
insurance coverage (2) No Limits -Not an issue
since it isnt a first-line Treatment (1) -I am
working in an academic center (1)
Mean Duration (Months) for Treating a Patient
with Tysabri (n46)
Q13/Q9. What do you expect will be the average
duration you will treat a patient with Tysabri
(assuming it will work for the patient)? Q14/Q10.
Tysabri will likely be priced at a premium to
other relapsing remitting MS treatments. Does
this limit your usage of the therapy? Please
comment.
25
Survey DetailsTysabri
Neurologists reported that about 30 of
relapse-remitting MS patients request Tysabri and
about 20 of the same patient group will not
receive Tysabri due to patient refusal.
Mean of Relapse-Remitting MS Patients Who
Request Tysabri (n46)
Mean of Relapse-Remitting MS Patients Who Will
Not Receive Tysabri Due to Patient Refusal (n46)
Q15a/Q11a. In your best estimation, what of the
relapsing remitting MS patients request
Tysabri? Q15b/Q11b. In your best estimation, what
of the relapsing remitting MS patients you
recommend Tysabri to will not receive it due to
patient refusal?
26
PML (Progressive Multifocal Leukoencephalopathy
)
27
Survey DetailsPML
Neurologists in Italy, Spain, and France
indicated that they require patient check-ups an
average of every 6 months while neurologists in
Germany and the UK require these check-ups at an
average of 5 months.
Mean Frequency in Months for Requiring Patient
Check-Up (n46)
Q16/Q12. On average, how frequently do you
require patient check-up for relapsing remitting
MS patients?
28
Survey DetailsPML
Neurologists reported that they would use other
monitoring types most frequently. In Germany and
the United Kingdom, neurologists indicated that
MRI monitoring would be second most frequent and
in Italy, Spain, and France monitoring for
opportunistic infections would be second most
frequent.
Q17/Q13. Please describe the frequency of your
expected surveillance program for PML monitoring
for patients in Tysabri?
29
Survey DetailsPML
Neurologists in Italy, Spain, and France reported
that follow-up MRIs are most likely to occur at 6
months after the initial infusion. Neurologists
in Germany and the UK indicated that these
follow-up MRIs would most likely occur every 6
months thereafter.
Likelihood of Conducting a Follow-up MRI

-Mean Rating Scores-

(n46)
Q18/Q14. Would you conduct a follow-up MRI during
the course of treatment even without clinical
signs of PML?
30
Survey DetailsPML
Most Italian, Spanish, and French neurologists
indicated extreme concern while most neurologists
in the UK and Germany reported being only
somewhat concerned about the risk of PML.
Q19/Q15. Given what you know about PML and the
measures taken to minimize its morbidity and
mortality, what is your level of concern related
to the risk of PML developing in patients given
Tysabri?
31
Survey DetailsPML
Tysabri in combination with Avonex or with other
interferons or Copaxone were indicated to be a
lot more risky for the development of PML than
Tysabri as a monotherapy.
Q16. Please indicate which of the following
scenarios you believe to be at risk for PML?
32
Survey DetailsPML
Neurologists from Germany and the UK indicated
similar risk levels as the neurologists in Italy,
Spain, and France for PML development.
Q20. Please indicate which of the following
scenarios you believe to be at risk for PML?
33
Survey DetailsPML
Neurologists in Germany and the UK reported a
higher level of education by Biogen Idec/Elan for
minimizing morbidity and mortality due to PML and
for distinguishing between PML and MS relapse
than did neurologists in Italy, Spain, and France.
Level of Education by Biogen Idec/Elan

-Mean Rating Scores-

(n46)
Q21/Q17. Do you feel you have been adequately
educated by Biogen Idec/Elan to minimize
morbidity and mortality due to PML? Rated on a
scale where 1Not well educated and 5Very well
educated. Q22/Q18. Do you feel Biogen Idec/Elan
have adequately educated you to distinguish
between PML and MS relapse? Rated on a scale
where 1Not well educated and 5Very well
educated.
34
Survey DetailsPML
Neurologists in Germany and the UK found it more
believable that an MRI scan, CSF testing, and
frequent neurological assessments would be
sufficient for PML detection than did Italian,
Spanish, and French neurologists.
Level of Believability that an MRI Scan, CSF
Testing, and Frequent Neurological Assessments
Will Be Sufficient for PML Detection

-Mean Rating Scores-

(n46)
Q23/Q19. How believable do you think it is that
an MRI scan, CSF testing for JC viral DNA, and
frequent neurological assessments will be
sufficient to enable PML to be detected early
enough to prevent any serious problems?
35
Survey DetailsPML
Q23/Q19. How believable do you think it is that
an MRI scan, CSF testing for JC viral DNA, and
frequent neurological assessments will be
sufficient to enable PML to be detected early
enough to prevent any serious problems?
36
Survey DetailsPML
Approximately half of neurologists in the UK and
Germany indicated that 2-5 cases of PML would
impact Tysabri usage. Half of neurologists in
Italy, Spain, and France claimed that 5-20 cases
would have an impact.
Mean Number of Reported PML Cases That Would
Impact Tysabri Usage (n46)
Q24/Q20. How many reported and confirmed cases of
PML would impact your Tysabri usage? Please
select one.
37
Future Practice Patterns
38
Survey DetailsFuture Practice Patterns
Avonex would be used most frequently, followed by
Rebif, as treatments for relapsing remitting MS
patients in Italy, Spain, and France.
Q21. Please estimate total of
relapsing-remitting patients who would receive
each treatment individually regardless of whether
it is a monotherapy or in combination with
another drug.
39
Survey DetailsFuture Practice Patterns
Neurologists in Germany and the UK stated that
Rebif would be the most commonly used treatment
either as monotherapy or in combination with
another drug for relapsing remitting MS patients.
Q25. Please estimate total of
relapsing-remitting patients who would receive
each treatment individually regardless of whether
it is a monotherapy or in combination with
another drug.
40
Survey DetailsFuture Practice Patterns
Currently a very small majority of Italian,
Spanish, and French neurologists indicated that
they would use Tysabri only as a salvage therapy.
In the next 12 months, they reported that Tysabri
would be more frequently used as a first- or
second-line treatment.
Q22. Of the patients you expect to treat with
Tysabri, how will you have distributed your use
of Tysabri by line of therapy?
41
Survey DetailsFuture Practice Patterns
Neurologists in Germany and the UK indicated that
Tysabri is currently used most frequently as a
third-line treatment. In 12 months, they believe
it will be used mostly as a second- or third-line
treatment.
Q26. Of the patients you expect to treat with
Tysabri, how will you have distributed your use
of Tysabri by line of therapy.
42
Survey DetailsFuture Practice Patterns
Neurologists in Italy, Spain, and France stated
that they would most likely have been using
Betaseron before switching to Tysabri currently,
in the next 4 months, and in 12 months.
Q23. Of the patients you expect to treat with
Tysabri in the future, what treatment (if any
treatment was being given prior) will you have
actively switched patients off of to put them on
Tysabri?
43
Survey DetailsFuture Practice Patterns
Neurologists in Germany and the UK indicated that
they would most likely have been using Rebif
before switching to Tysabri currently, in the
next 4 months, and in 12 months.
Q27. Of the patients you expect to treat with
Tysabri in the future, what treatment (if any
treatment was being given prior) will you have
actively switched patients off of to put them on
Tysabri?
44
Survey DetailsFuture Practice Patterns
  • Comments on the Launch of Tysabri
  • IT/SP/FR
  • It is an alternative therapeutic
  • Very good efficacy
  • Depends on the observed incidence of PML
  • Hoping that the drawbacks will be low for a high
    level of efficiency
  • Better control of active MS
  • GE/UK
  • I am excited with regard to clinical application
    and long-term use data
  • I hope for more safety data concerning the PML
    and early diagnosis
  • There is the need for more information on
    Tysabri at European MS congresses
  • Educational efforts have been important
  • The take-up is likely to be slow

Q28/Q24. Please feel free to make any qualitative
comments regarding the launch of Tysabri in the
EU and your expectations for its future use.
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