cll landscape questionnaire

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Understanding the Chronic Lymphocytic Leukemia Landscape & Opportunity Assessment for a New Drug in IndiaDraft Discussion Guide: Medical Oncologist/ Hemato-oncologistINDIA

Reference Number: 13195

December 04, 2015

®Proprietary and Confidential

Do not distribute or copy

Physician Name: Dr.Address/City:

Tel: Mob: Email:Interviewer Name Interview Date

INTRODUCTION

Hello, I am from SmartAnalyst, a research and consulting company. Thank you very much for agreeing to participate in this study. In this study, we would like to have your expert insights on the disease and market landscape for CLL in India.

All answers will be kept confidential and will be used only for the purpose of this research. SmartAnalyst follows the Market Research Society of India’s (MRSI) code of conduct, and we will not disclose your name and details to the client or any other party.

To help in the analysis, we would like to record the interview as it would be difficult to take notes while discussing.

This will be an informal discussion; please feel free to voice your opinion openly and freely.

Screener [screener to be kept even if disqualified]

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1. Can you please confirm your specialty?(Visiting Cards/Letter heads to be collected for each respondent)

Medical OncologistHaemotologistOther TERMINATE

2. How many years have you been practicing post residency?____________ Years [TERMINATE IF < 10 YEARS]

3. Typically how many new CLL patients do you manage in a month?____________ New CLL patients/ month [TERMINATE IF LESS THAN 1 NEW PATIENT IN A MONTH]

Section I: Patient Burden and Flow

4. How many CLL patients did you manage in the past 1 year? _________________ patients (Please count unique patients and not revisits.) [mark as “TOTAL PATIENTS”- for reference along the questionnaire]

a. How many of them were diagnosed in the same year (newly diagnosed with CLL)?_________________ new patients

b. At the time of presentation, what is the typical profile of the patients?

c. What are the co-morbid conditions present in the patients? (Please fill SHOW CARD 2) [SELECT ONE PER ROW]

[SHOW CARD 1]

[SHOW CARD 2]

Co-morbidity(ies) that affect CLL treatment descision

Common/frequently associated (in 50%-60% or more of the patients treated per year)

Occasional (in <50%but >10% of the patients treated per year)

Infrequent/rare (in<10% of the patients treated per year)

Hypertension 1 2 3Diabetes 1 2 3Coronary artery disease/angina

1 2 3

Renal disorders/ 1 2 3

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Profile Options % of CLL patientsAge Less than 50

50 to 65More than 65

TOTAL =100%Gender Male

FemaleTOTAL =100%

Local vs outstation patient

Local

Out station patient

TOTAL =100%



decreased renal functionAny other.__________ (please specify)

1 2 3

5. At the time of presentation, of your _________________________[“TOTAL PATIENTS” from Q4] CLL patients managed in the last year,

a. How many patients belonged to the following stages-b. Within the high risk symptomatic patients, how many are ‘fit’vs. ‘unfit’ patients?

[SHOW CARD 3]- KEEP SEPARATE FOR REFERENCE THROUGH THE QUESTIONNAIRE

Stage Symptoms Fitness No. of CLL patientsRai stage 0 Asymptomatic

SymptomaticRai Stage I, II Asymptomatic

SymptomaticRai Stage III, IV Asymptomatic

Symptomatic FitUnfit

TOTAL for all stages

__________: =”TOTAL PATIENTS” from Q4

6. Of all your CLL patients, what proportion of patients were referred to you by other doctors? [SHOULD BE <=100%] ____________ patients

a. [IF REFERAL MORE THAN 0%] Who refers these CLL patients to you? (Please fill proportions in the table below.)

[SHOW CARD 4]

Specialty Proportion of referred patientsGeneral medicinePathologist Other specialty __________ (please specify)

TOTAL 100%

Section II: Current Diagnosis and Treatment Practices

7. Which diagnostic tests are conducted before you confirm the diagnosis?

[SHOW CARD 5]

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Diagnostic tests Performed Or NotComplete Blood Count and Peripheral Blood Smear

Yes No

Flow Cytometry Yes NoBone marrow aspiration and Biopsy Yes NoFISH Yes NoImmunoglobulin testing Yes NoCT Scan Yes NoUltrasound Yes NoAny other ________ (please specify) Yes No

a. How do you measure ‘fitness’? Are there any specific tool that you use?

------------------------------------------------------------------------------------------

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8. [SHOW THE RESPONDENT SHOW CARD 3] Of your CLL patients in various stages of the disease, how many patient are treated with chemotherapy (with/without biologics such as rituximab)?

[SHOW CARD 6]

Stage Symptoms FitnessNo. of patients treated

[EACH CELL SHOULD BE<=CLL PATIENTS FROM SHOW CARD 1]

Rai stage 0 AsymptomaticSymptomatic

Rai Stage I, II AsymptomaticSymptomatic

Rai Stage III, IV AsymptomaticSymptomatic Fit

UnfitTOTAL __________:<=”TOTAL

PATIENTS” from Q4

9. Within the treated patients, in the low-risk/ intermediate-risk patients, are there any patients who were on ‘wait and watch’? (Please Tick)

1. Yes2. No

If yes, what proportion in each group was on ‘wait and watch’

[SHOW CARD 7]

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Stage No. of patients on Wait & WatchLow Risk (Rai stage 0)Intermediate Risk (Rai stage I, II)High Risk (Rai stage III, IV)



10. What drugs or regimens do you prescribe for each patient segment (who is treated) within different risk groups?

a. To how many patients do you prescribe these regimens?b. What duration do you prescribe these regimens?c. What is the patient compliance rate for each of these options.

Compliance rate is defined as the numer of patients who complete the recommended duration of therapy.

[SHOW CARD 8]Moderator: The treatment options to be omitted for the patient segment which the doctor does not treat (see the answers to SHOW CARD 6 – Q8)

Patient segment Drugs Line of

therapy

Number of patients

prescribed to

Duration Of Therapy

Compliance rate

Low risk (Rai Stage 0) (If treated)

R-CVP

R-CHOP

Intermediate risk (Rai Stage I and II)

R-CVP

R-CHOP

High risk (Rai Stage III and IV) – Fit patients

FCR

BR

Any other ____ (pl specify)

High Risk (Rai Stage III and IV) – Unfit patients

BR

FCR

Any other ___ (pl specify)

TOTAL __________=

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NO OF PATIENTS from Q8, SHOWCARD 6

11. Here are some drug related attributes that you may evaluate before selecting a treatment for your CLL patients. Please rank each attribute based on its importance to you towards deciding the therapy to use (Please rank using a scale of 1 to 9 where 1 is ‘Most important attribute’ and 9 is ’least important’) [SHOW CARD 9]

Attributes Rank(1-9)

Safety profileQuality of lifeFixed duration of therapyOverall response rate (ORR)Complete response (CR)Overall survival (OS)Progression free survival (PFS)Minimal residual disease (MRD)Affordability to patientsOther (pl specilfy)

12. What is your opinion about MRD (minimal residual disease) as an endpoint in CLL. Please select the statement that you agree with the most. [SINGLE RESPONSE ONLY]

[SHOW CARD 10]

Opinion on MRDIt will be accepted as a standard endpoint in CLL in the near future

1

It will never be accepted as a standard endpoint in CLL in the near future

2

It may or may not be accepted as a standard endpoint in CLL in the near future

3

13. Below are the unmet needs in CLL treatment for each patient segment? Please rank each unmet need in CLL treatment (Please rank using scale of 1 to 3 where 1 is ‘Most important unmet need’ and 3 is ’least important’)

[SHOW CARD 11]

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Unmet needs Rank (1-3)

Residual disease after primary therapyBetter OSManagement of older patients with co-morbiditiesOther (pl specilfy)



Section IV: Target Product Profile Testing for Product X

[SHOW CARD 12] - TPP

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Target Product Profile of Product X

Mechanism of Action

Next generation glycoengineered, type II humanized anti-CD20 antibody

Fully Humanized- shows less propensity for immune reactions

The product showed Increased direct cell death induction, Enhanced ADCC, Decreased complement-dependent cytotoxicity

Indication Product X, in combination with chlorambucil, is indicated for

the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)

Clinical Efficacy

Response rates

ORR: Product X + Chlorambucil- 78.4% vs. Rituximab + Chlorambucil- 65.1%

CR: Product X + Chlorambucil- 20.7% vs. Rituximab + Chlorambucil- 7%

PFS Product X + Clb- 29.2 months vs. R + Clb-15.4 months (HR: 0.40, P<0.001)

Safety

Product X + Chlorambucil vs. Rituximab + ChlorambucilGrade 3-4 AEs: Infusion-related reaction (20% vs. 4%), neutropenia (33% vs. 28%), thrombocytopenia (10% vs. 3%), febrile neutropenia (2% vs 1%)

Dosing

Loading dose: intravenous infusion on day 1, 8, 15 of Cycle 1 of 28 day cycle

Remaining cycles 2-6: Administered on Day 1 only Recommended for 6 cycles only

Management of Infusion related reactions (IRR)

Premedicate at least 1 hour prior to the start of infusions Avoid antihypertensive medicines for 12 hours before,

during and 1 hour after the completion of infusions Split the first infusion dose. If IRRs occur during the first 100

mg infusion at the slow rate, give the remaining 900 mg on Day 2

Emergency resuscitation facilities should be available during infusion



14. Based on the profile you just reviewed, what do you feel are the advantages of Product X? [DO NOT PROMPT] [ALLOW MULTIPLE RESPONSE]

[SHOW CARD 13]

Advantages of Product X Please tickTargeted therapy 1Better safety profile 2Convenient dosage 3Improves quality of life 4Better OS 5Better PFS improvement 6Better ORR and CR 7Other (pl specilfy) 8

15. And what concerns do you have with Product X? [DO NOT PROMPT] [ALLOW MULTIPLE RESPONSE]

[SHOW CARD 14]

Concerns with Molecule X Please tickInfusion related reactions 1Lack of data in comparison to BR regimen 2May be expensive 3Other (Pl sp) 4

16. [MODERATOR; PLACE SHOW CARD 8 INFRONT OF RESPONDENT] Please see card as a reference to your response on current treatment practice

Assume that Product X performs as stated and is available for your use in India. Without considering price, how do you expect your current treatment practice to change after the launch of the Product X?

a. Will there be a change in line of therapy for existing regimens/ what is the expected line of therapy for Product X

b. To how many patients will each of these regimens be prescribedc. Will there be a change in duration of therapy for any of the regimens/ what is the expected

duration of therapy for Product Xd. Is a change in compliance rate expected for existing regimens/ what would be the expected

compliance rate for Product X

[SHOW CARD 15]

Patient segment Drugs a. Line of

therapy

b. Number of patients

prescribed to

c. Duration Of Therapy

d. Compliance rate

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Low risk (Rai Stage 0) (If treated)

R-CVP

R-CHOP

Product X

Intermediate risk (Rai Stage I and II)

R-CVP

R-CHOP

Product X

High risk (Rai Stage III and IV) – Fit patients

FCR

BR

Any other ____ (pl specify)

Product X

High Risk (Rai Stage III and IV) – Unfit patients

BR

FCR

Any other ___ (pl specify)

Product X

TOTAL

__________= NO OF PATIENTS from Q8, SHOWCARD 6

17. What will be the profile of patients who will be recommended Product X?[SHOW CARD 16]

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Profile OptionsAge Less than 50 1

50 to 65 2More than 65 3

Gender Male 1Female 2

Comorbid conditions

Hypertension

1

Diabetes 2Coronary artery disease/angina

3

Renal disorders/ decreased renal function

4

Others (Pl specify) 5Line of therapy 1st line 1

2nd line 2Both 1st & 2nd line 3

Others (Pl specify)



Section V: Pricing

18. Assuming that you are planning to prescribe Product X,

a. Could you please tell at what cost (per month) would you consider this Product X –

i. Too cheap

ii. Inexpensive

iii. Expensive

iv. Too Expensive

b. For each of these price points to what number of your CLL patients would you prescribe Product X

c. What would be the expected patient compliance at each price point [Moderator: Compliance rate is defined as the numer of patients who complete the recommended duration of therapy]

[SHOW CARD 17]

19.

Doctor, assuming that Product X in now available in the market, at cost of treatment of INR 24 lakhs for the treatment of CLL [6 cycles]

a. If made available at this price, in what proportion of your “TOTAL CLL patients will you prescribe it? ____________% patients

20. Now assume that Product X is available in the market, at a cost of treatment of INR 21 lakhs for the treatment of CLL [6 cycles]

a. If made available at this price, in what proportion of _____________“TOTAL PATIENTS” from Q4 patients will you prescribe it? _____________# of patients

21. Assume that Product X is available in the market, at a monthly cost of treatment of INR 18 lakhs for the treatment of CLL [6 cycles]

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Price Point [6 cycles]

No of patients prescribed to at given price point

[<=”TOTAL PATIENTS”] IN Q4 for each cell

Expected % patient compliance at given price point<=100% for each cell

Too Cheap Rs.

Inexpensive Rs.

Expensive Rs.

Too Expensive Rs.








24. In your best estimate, what would be the likely compliance rate among your patients? [Moderator: Compliance rate is defined as the numer of patients who complete the recommended duration of therapy]

[SHOW CARD 18]

Section VI: Message Testing

25. Doctor given below are the statements that support the effectiveness and role of Product X in CLL. The key messages for every parameter is framed in different ways. (Please rank the 8 statements 1-8 on each of the parameters:

a) Conviction to prescribe, where ‘1 corresponds to the highest conviction to prescribe and 8 corresponds to the lowest conviction to prescribe

b) Clinically Relevant, where ‘1 corresponds to the highest relevance and 8 corresponds to the lowest relevance

[SHOW CARD 19] (Please rotate statements)

Statements Conviction to Clinically

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Cost of treatment [6 cycles] % Patient Compliance

Rs. 24,00,000 %

Rs. 21,00,000 %

Rs. 18,00,000 %

Rs. 15,00,000 %

Rs. 12,00,000 %



prescribe Relevant1) The patient population in CLL11

trial is representative of CLL patients seen in clinical practice, with a median age of 73 and a range of coexisting medical conditions including hypertension, diabetes, and renal dysfunction

2) Most Phase III, pivotal first-line CLL trials to date are not representative of the typical CLL patient (median age of 71; 89% of CLL patients with at least one coexisting medical condition)

3) CLL11 is the first and largest Phase III trial to report results of antibody-based treatment in CLL patients with coexisting medical conditions

4) Product X demonstrated an OS benefit for the typical CLL patients when combined with Clb vs. Clb monotherapy (p=0.002)

5) Product X demonstrated superior overall response rates when combined with Clb vs. Rituxan + Clb (78.4% vs. 65%), and similarly superior complete response rates (21% vs. 7%)

6) Product X demonstrated a superior rate of molecular remission (minimal residual disease negative, blood) when combined with Clb vs. Rituxan + Clb (38% vs. 3%)

7) Product X is the first glycoengineered, type II anti-CD20 monoclonal antibody that has been designed for increased antibody-dependent cellular cytotoxicity (ADCC) and Direct Cell Death versus Rituxan

8) The administration of Product X resulted in a greater incidence of IRRs than Rituxan. This was noted especially during the first 1000mg administered (Day 1 and Day 2)

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when all grade 3 to 4 IRRs occurred, and where extra vigilance will be required. At all subsequent infusions, only Grade 1 and 2 IRRs were reported. All the IRRs were generally manageable; no fatal IRR occurred and most patients were able to benefit from the full course of treatment with Product X

26. Doctor given below are the statements that support the effectiveness and role of Product X in CLL. The key messages for every parameter is framed in different ways. (Please rate the 8 statements, 1-7 on each of the parameters:

a) Conviction to prescribe, where 1 corresponds to the ‘lowest conviction’ and 7 corresponds to the ‘highest conviction’

b) Clinically Relevant, where 1 corresponds to the ‘Not at all relevant’ and 7 corresponds to the ‘most relevant’

[SHOW CARD 19] (Please rotate statements)

Statements Conviction to prescribe Clinically Relevant

1) The patient population in CLL11 trial is representative of CLL patients seen in clinical practice, with a median age of 73 and a range of coexisting medical conditions including hypertension, diabetes, and renal dysfunction

2) Most Phase III, pivotal first-line CLL trials to date are not representative of the typical CLL patient (median age of 71; 89% of CLL patients with at least one coexisting medical condition)

3) CLL11 is the first and largest Phase III trial to report results of antibody-based treatment in CLL patients with coexisting medical conditions

4) Product X demonstrated an OS benefit for the typical CLL patients when combined with Clb vs. Clb monotherapy (p=0.002)

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5) Product X demonstrated superior overall response rates when combined with Clb vs. Rituxan + Clb (78.4% vs. 65%), and similarly superior complete response rates (21% vs. 7%)

6) Product X demonstrated a superior rate of molecular remission (minimal residual disease negative, blood) when combined with Clb vs. Rituxan + Clb (38% vs. 3%)

7) Product X is the first glycoengineered, type II anti-CD20 monoclonal antibody that has been designed for increased antibody-dependent cellular cytotoxicity (ADCC) and Direct Cell Death versus Rituxan

8) The administration of Product X resulted in a greater incidence of IRRs than Rituxan. This was noted especially during the first 1000mg administered (Day 1 and Day 2) when all grade 3 to 4 IRRs occurred, and where extra vigilance will be required. At all subsequent infusions, only Grade 1 and 2 IRRs were reported. All the IRRs were generally manageable; no fatal IRR occurred and most patients were able to benefit from the full course of treatment with Product X

Thank you for giving your valuable time and insights.

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cll landscape questionnaire

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