qualitative research quantitative research profiles medpanel, inc., 44 brattle st., cambridge, ma...

44
Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080 www.medpanel.com KNOWLEDGE CAPTURED. INTELLIGENCE DELIVERED. Evaluation of Tysabri (EU) By MedPanel, Inc. September 19, 2006

Upload: joseph-ferguson

Post on 26-Mar-2015

216 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

Qualitative Research

Quantitative Research

Profiles

MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080 www.medpanel.com

KNOWLEDGE CAPTURED. INTELLIGENCE DELIVERED.

Evaluation of Tysabri (EU)

By MedPanel, Inc.

September 19, 2006

Page 2: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

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

Page 3: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

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

Page 4: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

4

Survey Specifics:A 20-minute, self-administered survey was fielded online via MedPanel’s Web site from September 8-19, 2006.

Sample: The total sample comprises 46 neurologists.

Respondents were selected from MedPanel’s international database 12 neurologists from Italy, Spain, and France 34 neurologists from Germany and the United Kingdom

Methodology & Sample

Page 5: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

5

Respondent Practice Background

Mean Number of Current Patients with Multiple Sclerosis(n=46)

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)?

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.

84.2

209.1

IT/FR/SP (n=12) GE/UK (n=34)

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%)

Page 6: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

6

Mean Number of Patients Dosed with Tysabri

(n=34)

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?

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.

22.6

GE

100%

Urban

Suburban

Rural

Primary Practice Setting (GE/UK)(n=34)

97%

3%

Urban

Suburban

Rural

Primary Practice Setting (IT/SP/FR)

(n=12)

Respondent Practice Background

Page 7: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

7S8. Please describe the practice setting in which you see the majority of your MS patients.

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.

Respondent Practice Background

88%

12%

Private Practice

Academic MedicalCenterCommunity Hospital

Other

8%

67%

25%

Private Practice

Academic MedicalCenterCommunity Hospital

Other

Practice Setting(n=34)

Practice Setting(n=12)

GE/UK IT/SP/FR

Page 8: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

8

Executive Summary

Page 9: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

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

Page 10: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

10

Executive Summary

Tysabri Use (cont’d) 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 didn’t 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.

Page 11: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

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 isn’t 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

Page 12: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

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

Page 13: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

13

Detailed Findings

Page 14: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

14

MS Treatment Patterns

Page 15: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

15

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.

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?

Mean Number of Total Patients Seen in a Typical Month

(n=46)

126.7

217.6

IT/SP/FR GE/UK

Survey Details

MS Treatment Patterns

Mean Number of MS Patients Seen in a Typical Month

(n=46)

22.6

65.7

IT/SP/FR GE/UK

Page 16: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

16

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?

Survey Details

MS Treatment Patterns

MS Patient Classifications

(n=46)

Diagnosis Mean Number of MS Patients Mean % of MS Patients

IT/SP/FR GE/UK IT/SP/FR GE/UK

Relapse-Remitting14.8

(Range: 0-45)

28.2

(Range: 2-120)

48%

(Range: 0-85%)

44%

(Range: 10%-75%)

Secondary Progressive11.3

(Range: 2-70)

30.4

(Range: 1-140)

26%

(Range: 10%-45%)

38%

(Range: 15%-70%)

Primary Progressive6.2

(Range: 1-30)

6.9

(Range: 1-30)

20%

(Range: 4%-60%)

11%

(Range: 5%-25%

Other5.7

(Range: 0-20)

17.0

(0-240)

6%

(Range: 0-40%)

8%

(Range: 0-25%)

Page 17: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

17

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?

Survey Details

MS Treatment Patterns

TreatmentMean % of Relapse-Remitting MS Patients

(n=46)

IT/SP/FR GE/UK

Avonex 30% 17%

Rebif 24% 22%

Copaxone 13% 16%

Betaseron 11% 18%

No Treatment 10% 20%

Mitoxantrone 9% 9%

Methotrexate 5% 2%

Other Immunosupressants 4% 4%

Novantrone 2% 2%

Cyclophosphamide 2% 2%

Other 1% 4%

Tysabri 0% 5%

Page 18: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

18

Tysabri

Page 19: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

19

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?

Survey Details

Tysabri

Mean Patients Dosed with Tysabri

(n=46)

IT/SP/FR GE/UK

Previously N/A12.6

(Range: 0-130)

Next 4 months3.8

(Range: 0-15)

12.0

(Range: 0-60)

Next 12 months18.8

(Range: 0-100)

27.2

(Range: 3-100)

Page 20: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

20

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?

MS Patients Currently Treated with Tysabri (GE/UK Only)

(n=34)

TreatmentMean Number of

Relapsing Remitting MS Patients

Mean % of Relapsing Remitting MS

Patients

First-Line (interferon, copaxone naïve)0.9

(Range: 0-10)

5%

(Range: 0-40%)

After failure of one other MS therapy (interferon, copaxone)

11.0

(Range: 0-75)

31%

(Range: 0-80%)

After failure of two or more therapies (interferon, copaxone)

9.6

(Range: 0-50)

45%

(Range: 0-100%)

Only as salvage therapy9.7

(Range: 0-100)

16%

(Range: 0-100%)

Survey Details

Tysabri

Page 21: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

21

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?

Patients Switching to Tysabri (GE/UK Only)

(n=34)

TreatmentMean Number of Relapsing

Remitting Patients Switched From Mean % of Overall Tysabri

Use

Rebif 4.4 (Range: 0-20) 27% (Range: 0-60%)

Betaseron 2.9 (Range: 0-7) 34% (Range: 0-100%)

Copaxone 2.5 (Range: 0-10) 24% (Range: 0-50%)

Avonex 1.5 (Range: 0-5) 21% (Range: 0-40%)

Mitoxantrone 1.2 (Range: 0-5) 10% (Range: 0-50%)

Other Immunosupressants 0.9 (Range: 0-5) 3% (Range: 0-10%)

Methotrexate 0.7 (Range: 0-5) 0%

Other 0.4 (Range: 0-3) 3% (Range: 0-20%)

No Treatment 0.3 (Range: 0-1) 20% (Range: 0-100%)

Novantrone 0.2 (Range: 0-2) 0%

Cyclophosphamide 0.1 (Range: 0-1) 1% (Range: 0-5%)

Survey Details

Tysabri

Page 22: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

22

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?

Second-Line Replacement Treatment for Tysabri (GE/UK Only)

(n=34)

Treatment Mean % of Relapsing Remitting MS Patients

Mitoxantrone 30% (Range: 0-100%)

Rebif 26% (Range: 0-70%)

Copaxone 21% (Range: 0-50%)

Avonex 16% (Range: 0-50%)

Other Immunosupressants 15% (Range: 0-70%)

Betaseron 11% (Range: 0-40%)

Novantrone 11% (Range: 0-90%)

No Treatment 9% (Range: 0-2%)

Cyclophosphamide 8% (Range: 0-25%)

Methotrexate 7% (Range: 0-25%)

Other 5% (Range: 0-20%)

Survey Details

Tysabri

Page 23: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

23

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.

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. Tysabri’s 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?

Mean Percent Eligible for Tysabri Treatment (n=46)

32%

48%

38%

55%

First-Line Patients Second-Line Patients

IT/SP/FRGE/UK

Mean % of Patients for Tysabri Use(n=46)

48%52%

49%51%

Use indefinitely Use for a pre-determined period of

time

IT/SP/FR

GE/UK

Survey Details

Tysabri

Page 24: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

24

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.

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.

Mean Duration (Months) for Treating a Patient with Tysabri(n=46)

23.2

38.1

IT/SP/FR GE/UK

Survey Details

Tysabri

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 GermanHealthcare system (8)-Cost (2)-No insurance coverage (2)No Limits:-Not an issue since it isn’t a first-lineTreatment (1)-”I am working in an academic center” (1)

Page 25: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

25

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.

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?

Mean % of Relapse-Remitting MS Patients Who Request Tysabri

(n=46)30%

27%

IT/SP/FR GE/UK

Survey Details

Tysabri

21% 21%

IT/SP/FR GE/UK

Mean % of Relapse-Remitting MS Patients Who Will Not Receive Tysabri Due to Patient Refusal

(n=46)

Page 26: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

26

PML (Progressive Multifocal Leukoencephalopathy)

Page 27: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

27

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.

Q16/Q12. On average, how frequently do you require patient check-up for relapsing remitting MS patients?

Mean Frequency in Months for Requiring Patient Check-Up(n=46)

5.9

4.8

IT/SP/FR GE/UK

Survey Details

PML

Page 28: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

28

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?

Mean Frequency (Months) of Expected Surveillance Program for PML Monitoring

(n=46)

Frequency IT/SP/FR GE/UK

MRI Monitoring7.1

(Range: 2-12)

8.2

(Range: 3-36)

Cerebral Spinal Fluid (CSF)

Analysis

14.1

(Range: 0-60)

10.7

(Range: 0-24)

Opportunistic Infections (Other than PML)

6.3

(Range: 0-36)

8.6

(Range: 0-24)

Other2.1

(Range: 0-12)

5.1

(Range: 0-12)

Survey Details

PML

Page 29: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

29

Likelihood of Conducting a Follow-up MRI -Mean Rating Scores-

(n=46)

3.3

3.7

3.9

2.0

3.8

3.6

3 months after theinitial infusion

6 months after theinitial infusion

Every 6 monthsthereafter

IT/SP/FR GE/UK

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.

Q18/Q14. Would you conduct a follow-up MRI during the course of treatment even without clinical signs of PML?

Percentage ‘Very

Likely’

30%

33%

30%

25%

15%

25%

Survey Details

PML

Page 30: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

30

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?

Mean Percentage Level of Concern About Risk of PML

(n=46)

Level IT/SP/FR GE/UK

Extremely Concerned68%

(Range: 0-100%)

20%

(Range: 0-100%)

Somewhat Concerned18%

(Range: 0-60%)

56%

(Range: 0-100%)

Not Concerned14%

(Range: 0-100%)

24%

(Range: 0-95%)

Survey Details

PML

Page 31: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

31

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?

Mean Percentage of Scenarios at Risk for PML (IT/SP/FR)

(n=12)

ScenarioDefinitely

NOT at Risk Possibly at Risk

Probably at Risk

Definitely at Risk

Tysabri as monotherapy (no previous or concurrent interferon or copaxone use)

25% 50% 25% 0%

Tysabri as monotherapy (after previous immunosuppressant use)

0% 50% 42% 8%

Tysabri in combination with Avonex 8% 33% 17% 42%

Tysabri in combination with other interferons or Copaxone

8% 16% 42% 33%

Survey Details

PML

Page 32: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

32Q20. Please indicate which of the following scenarios you believe to be at risk for PML?

Mean Percentage of Scenarios at Risk for PML (GE/UK)

(n=34)

ScenarioDefinitely

NOT at Risk Possibly at Risk

Probably at Risk

Definitely at Risk

Tysabri as monotherapy (no previous or concurrent interferon or copaxone use)

9% 73% 18% 0%

Tysabri as monotherapy (after previous immunosuppressant use)

0% 48% 52% 0%

Tysabri in combination with Avonex 0% 27% 43% 30%

Tysabri in combination with other interferons or Copaxone

0% 30% 58% 12%

Survey Details

PML

Neurologists from Germany and the UK indicated similar risk levels as the neurologists in Italy, Spain, and France for PML development.

Page 33: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

33

Level of Education by Biogen Idec/Elan -Mean Rating Scores-

(n=46)

2.5

2.7

3.3

3.3

Educated todistinguish betweenPML and MS relapse

Educated to minimizemorbidity and

mortality due to PML

IT/SP/FR GE/UK

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.

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 1=Not well educated and 5=Very 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 1=Not well educated and 5=Very well educated.

Percentage ‘Well Educated’

14%

17%

17%

8%

Survey Details

PML

Page 34: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

34

Level of Believability that an MRI Scan, CSF Testing, and Frequent Neurological Assessments Will Be Sufficient for PML Detection -Mean Rating Scores-

(n=46)

3.6

3.8

Sufficiency of testing

IT/SP/FR GE/UK

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.

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?

Percentage ‘Very Believable’

14%

8%

Survey Details

PML

Page 35: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

35Q23/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?

Survey Details

PML

Reasons for “Believability” Rating(n=46)

CountryRating of 1 or 2

“Not Believable”Rating of 3

Rating of 4 or 5

“Very Believable”

IT/SP/FR

”No specificity of these explorations”

-These tests may be refused by patients

-PML is hard to diagnose

-”This represents all measures available to diagnose PML”

GE/UK

-Untreatable

-early diagnosis doesn’t necessarily prevent serious complications

-There is no reliable marker of early detection

-No continuous monitoring possible

-MRI and CSF testing will detect most cases

-Both methods are reliable tests

Page 36: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

36

8%

8%

50%

25%

8%

6%

17%

18%

53%

6%

Would continue using despite number ofcases of PML

20+ cases

5-20 cases

2-5 cases

1 case

IT/SP/FR GE/UK

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.

Q24/Q20. How many reported and confirmed cases of PML would impact your Tysabri usage? Please select one.

Mean Number of Reported PML Cases That Would Impact Tysabri Usage(n=46)

Survey Details

PML

Page 37: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

37

Future Practice Patterns

Page 38: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

38

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.

Mean % of Relapse-Remitting Patients Who Would Receive the Treatments (IT/SP/FR)

(n=12)

Treatment CurrentNext 4

monthsNext 12 months

Avonex 32% 28% 25%

Rebif 25% 22% 20%

Copaxone 15% 14% 14%

Betaseron 14% 13% 10%

No Treatment 10% 15% 13%

Tysabri 7% 15% 25%

Mitoxantrone 7% 8% 8%

Other Immunosuppresants 6% 4% 4%

Cyclophosphamide 5% 6% 4%

Methotrexate 3% 1% 1%

Others 3% 3% 3%

Novantrone 2% 2% 2%

Survey Details

Future Practice Patterns

Page 39: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

39

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.

Survey Details

Future Practice Patterns

Mean % of Relapse-Remitting Patients Who Would Receive the Treatments (GE/UK)

(n=34)

Treatment CurrentNext 4

monthsNext 12 months

Rebif 25% 24% 22%

Avonex 20% 19% 17%

Betaseron 19% 19% 17%

Copaxone 16% 16% 15%

No Treatment 12% 11% 11%

Mitoxantrone 11% 10% 9%

Other Immunosuppresants 8% 8% 8%

Tysabri 6% 10% 16%

Methotrexate 3% 3% 3%

Novantrone 3% 3% 3%

Others 3% 3% 3%

Cyclophosphamide 2% 2% 2%

Page 40: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

40

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?

Tysabri Distribution (IT/SP/FR)

(n=12)

Treatment CurrentNext 4

monthsNext 12 months

First-line (interferon, copaxone naïve) 28% 31% 31%

After failure of one other MS therapy (interferon, copaxone)

21% 28% 32%

After failure of two or more therapies (interferon, copaxone)

21% 30% 24%

Only as Salvage therapy 30% 11% 13%

Survey Details

Future Practice Patterns

Page 41: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

41

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.

Tysabri Distribution (GE/UK)

(n=34)

Treatment CurrentNext 4

monthsNext 12 months

First-line (interferon, copaxone naïve) 8% 13% 13%

After failure of one other MS therapy (interferon, copaxone)

32% 36% 36%

After failure of two or more therapies (interferon, copaxone)

38% 38% 38%

Only as Salvage therapy 23% 16% 14%

Survey Details

Future Practice Patterns

Page 42: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

42

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?

Mean % Treatments Switched to Tysabri (IT/SP/FR)

(n=12)

Treatment CurrentNext 4

monthsNext 12 months

Betaseron 35% 36% 38%

Avonex 29% 29% 33%

Rebif 29% 27% 29%

Copaxone 21% 22% 25%

Mitoxantrone 20% 19% 21%

Other Immunosuppresants 19% 22% 24%

Novantrone 16% 16% 17%

Cyclophosphamide 16% 20% 23%

Others 3% 3% 3%

No Treatment 2% 3% 3%

Methotrexate 0% 0% 0%

Survey Details

Future Practice Patterns

Page 43: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

43

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?

Mean % Treatments Switched to Tysabri (GE/UK)

(n=34)

Treatment CurrentNext 4

monthsNext 12 months

Rebif 23% 22% 23%

Mitoxantrone 18% 14% 13%

No Treatment 18% 20% 20%

Avonex 17% 17% 18%

Betaseron 16% 17% 19%

Copaxone 15% 14% 14%

Other Immunosuppresants 11% 11% 11%

Novantrone 8% 8% 8%

Others 8% 8% 8%

Methotrexate 5% 6% 6%

Cyclophosphamide 4% 3% 3%

Survey Details

Future Practice Patterns

Page 44: Qualitative Research Quantitative Research Profiles MedPanel, Inc., 44 Brattle St., Cambridge, MA 02138 617-661-8080  KNOWLEDGE CAPTURED

44Q28/Q24. Please feel free to make any qualitative comments regarding the launch of Tysabri in the EU and your expectations for its future use.

Survey Details

Future Practice Patterns

Comments on the Launch of TysabriIT/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”