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Epi slides November 16, 2021

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Page 1: Epi slides

Epi slides

November 16, 2021

Page 2: Epi slides

Not for Product Promotional Use

Solid Tumor Oncology

2

Page 3: Epi slides

Not for Product Promotional Use

NSCLCMetastatic

(inc. EGFR/ALK)

106.0

43.0

139.0

54.5

0

70

140

210

280

1L Treated 2L+ Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

*Figures only contain incident patients and do not include patients who recur

Source: Decision Resources Group; BMS Internal Analysis; AJCC 8th Edition Staging

Early Stage* (Treatable population)

33.0

10.05.0 8.0

22.5

13.5

3.0

14.5

8.0

5.0

8.5

29.0

19.5

4.5

0

15

30

45

60

Stage IA Stage IB Stage IIA Stage IIB Stage IIIA Stage IIIB Stage IIIC

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

• EGFR/ALK: 15-20%

Treatment rates:

• Stage IB-II : 35% - 45%

• Stage III : 55% - 60%

Resection rates

• Stage I-II resected: ~60%

• Stage IIIA resected: ~40%

• Stage IIIB resected: ~15%

• Stage IIIC resected: ~ 2%

Page 4: Epi slides

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SCCHN

Metastatic

19.011.0

21.0

12.0

0

15

30

45

60

1L Treated 2L Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Early Stage

25.0

32.0

0

15

30

45

60

LAD Treatable

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Source: Decision Resources Group

• LAD txt rate: 60% - 85%

Page 5: Epi slides

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Melanoma

Metastatic Early Stage Disease

Source: Decision Resources Group, BMS Internal Analysis

Early stage txt rate: 60 – 80%

10.0

9.0

0

10

20

30

40

1L Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

17.5

16.5

0

10

20

30

40

Adjuvant Treatable

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Page 6: Epi slides

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RCC

Metastatic

18.5

15.0

0

10

20

30

40

1L Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Early Stage

54.5

47.0

0

30

60

90

120

Stage I-III Incidence

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

• Break out by IMDC risk category (metastatic):

• Intermediate/Poor Risk: 75%

• Favorable: 25%

• Early stage txt rate: 10-15%

• Break out by IMDC risk category (early stage):

• Intermediate Risk: 25%

• High Risk: 20%

Page 7: Epi slides

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Bladder

Early Stage DiseaseMetastatic

Source: Decision Resources Group; BMS Internal Analysis

Cystectomy rates in MIBC are ~50%

Early stage treatment rates

MIBC txt rate: 70% - 85%

18.5

32.0

0

15

30

45

60

1L Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

17.5

37.5

0

15

30

45

60

MIBC Treatable

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Page 8: Epi slides

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Prostate

Metastatic

Source: Decision Resources Group

28.5

26.5

0

15

30

45

60

1L Castrate-Resistant Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Page 9: Epi slides

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HCC

Early Stage DiseaseMetastatic

Source: Decision Resources Group; BMS Internal Analysis

High risk ablated or resected: 10 – 20% of Early Stage

Early stage txt rate: 30-60%

14.0

14.5

0

10

20

30

40

1L Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

20.0

17.5

0

10

20

30

40

Early & Intermediate Incidence

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Page 10: Epi slides

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Gastric*

*Data represents adenocarcinoma only and includes GEJC

Early Stage DiseaseMetastatic

Source: Decision Resources Group

Cardia incident: 12% - 32% (avg. 25%) Stage II and III GEJC: ~20-24%

Treatment rates

Localized & resectable locally advanced txt rate: 60% - 70%

Unresectable locally advanced txt rate: 70% - 80%

13.5

25.0

0

10

20

30

40

1L Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

10.0

19.5

0

10

20

30

40

Non-metastatic Incidence (Stage IB-IIIC)

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Page 11: Epi slides

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Esophageal*

Early Stage DiseaseMetastatic

*Data represents adenocarcinoma and squamous only

Source: Decision Resources Group; BMS Internal Analysis

Eso stage II, stage III and stage IVA Resectable patients: ~70%

Treatment Rates:

Localized & resectable locally advanced txt rate: 60% - 75%

Unresectable locally advanced txt rate: 65% - 75%

11.0

14.5

0

10

20

30

40

1L Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

11.5

15.5

0

10

20

30

40

Non-metastatic Incidence

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Page 12: Epi slides

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GBM

Metastatic

13.5

10.5

0

10

20

30

40

1L Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Source: Decision Resources Group

Page 13: Epi slides

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Ovarian Cancer

Early Stage DiseaseMetastatic

Source: Decision Resources Group

16.5

19.0

0

10

20

30

40

1L Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

4.0

4.5

0

10

Early Stage Drug Treatable

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Page 14: Epi slides

Not for Product Promotional Use

Autoimmune Disease

14

Page 15: Epi slides

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Rheumatoid Arthritis (RA)

2.301.80

1.30

2.00

1.56

1.10

0.0

1.5

3.0

4.5

6.0

Diagnosed Prevalent Cases Diagnosed Mod-Severe Prevalent Cases Drug-Treated Mod-Severe Prevalent Cases

2020 P

ati

ent

Est

imate

s (i

n M

illions)

US EU5

• We define total prevalent cases of RA according to the 1987 ACR criteria, which requires fulfillment of at least four of seven criteria: ▪ 1. Morning stiffness. 2. Arthritis of three or more joint areas. 3. Arthritis of hand joints. 4. Symmetric arthritis. 5. Rheumatoid nodules. 6. Serum rheumatoid factor. 7. Radiographic

changes

• Alternatively, a patient's symptoms are considered to be satisfying the ACR definition if they include at least criteria 2 and 3, 2 and 6, 2 and 7, 4 and 6, or 3 and 6

• We limit our analysis to persons aged 15 or older because RA that occurs prior to this age is designated as JIA, JCA, or JRA and is diagnosed according to different criteria than

are used in the ACR 1987 classification system

25-30% treated with

targeted therapies

(biologics / orals)

Source: Decision Resources Group, BMS Internal Analysis

Page 16: Epi slides

Not for Product Promotional Use

Psoriasis

6.00

1.70 1.24

5.30

1.501.23

0.0

3.0

6.0

9.0

12.0

Diagnosed Prevalent Cases Diagnosed Mod-Severe Prevalent Cases Drug-Treated Mod-Severe Prevalent Cases

2020 P

ati

ent

Est

imate

s (i

n M

illions)

US EU5

• We define diagnosed prevalent cases of psoriasis based on physical examination performed by physicians. Although psoriatic lesions often exhibit a typical appearance, there

are no standardized criteria in the clinical setting. Thus, we estimate only those cases of psoriasis that are physician-diagnosed, even those that may not be exhibiting

symptoms at the time data were collected and are therefore in remission

• Excludes asymptomatic patients. Includes comorbid psoriatic arthritic patients. Severity is based on physician's subjective assessment

25-30% are treated with

systemic therapies

(biologics / orals)

Note: Severity defined

based on physician

subjective assessment,

not by %BSA

Source: Decision Resources Group, DataMonitor, Global Data, Adelphi patient chart audits, SHS Claims data, BMS Internal Analysis

Page 17: Epi slides

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Psoriatic Arthritis

1.00

0.50

0.90

0.45

0.0

0.5

1.0

1.5

2.0

Diagnosed Prevalent Cases Drug-Treated Prevalent Cases

2020 P

ati

ent

Est

imate

s (i

n M

illions)

US EU5

• We used published studies and opinions of thought leaders throughout the major markets to derive the proportion of patients diagnosed and treated

• Patients included have confirmed psoriasis diagnosis. Unlike psoriasis, labels of branded therapies for psoriatic arthritis are not restricted to patients based on disease severity

Source: Decision Resources Group; BMS Internal Analysis

Page 18: Epi slides

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Ulcerative Colitis Patient Dynamics

0.94

0.56 0.48

0.70

0.400.34

0.0

0.5

1.0

1.5

2.0

Diagnosed Prevalent Cases Diagnosed Mod-Severe Prevalent Cases Drug-Treated Mod-Severe Prevalent Cases

2020 P

ati

ent

Est

imate

s (i

n M

illions)

US EU5

• We base our estimates of diagnosed prevalence of UC on studies that confirmed diagnosis of the condition at initial examination or within two to six months of initial

examination based on clinical history and either (1) endoscopic examination of the colonic mucosa indicating continuous diffuse granular or friable mucosa or (2) radiological

barium studies indicating continuous mucosal involvement. (Prevalence rates are based on Shivashankar et al., 2017 and Kappleman et al., 2013

• Other companies appear to be using Kappleman et al., 2013 only, resulting in lower prevalence rates)

• Treatment rate includes all conventional, targeted oral, and biologic treatments

Note: 50-60% of Patients

are Moderate-to-Severe

Source: Decision Resources Group; BMS Internal Analysis

~80% of Mod-Sev pts are

treated, of which 35-60%

gets novel therapies

(biologics/JAKs)

Page 19: Epi slides

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Crohn’s Disease Patient Dynamics

0.810.57 0.51

0.60

0.330.30

0.0

0.5

1.0

1.5

2.0

Diagnosed Prevalent Cases Diagnosed Mod-Severe Prevalent Cases Drug-Treated Mod-Severe Prevalent Cases

2020 P

ati

ent

Est

imate

s (i

n M

illions)

US EU5

• We define a diagnosed prevalent case of CD based on a physician diagnosis of clinical symptoms (abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding) and

histological, endoscopic, radiological, and/or surgical findings. (Prevalence rates are based on Shivashankar et al., 2017 and Kappleman et al., 2013

• Other companies appear to be using Kappleman et al., 2013 only, resulting in lower prevalence rates)

• Treatment rate includes all conventional, targeted oral, and biologic treatments

~90% of Mod-Sev pts are

treated, of which 40-60%

gets novel therapies

(biologics)

Note: 55-70% of Patients

are Moderate-to-Severe

Source: Decision Resources Group; BMS Internal Analysis

Page 20: Epi slides

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Multiple Sclerosis

RRMS

363255

416

275

0

200

400

600

800

1,000

Diagnosed Prevalent Cases Drug-Treated Prevalent Cases

2020 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

SPMS

82

40

93

28

0

50

100

150

200

250

Diagnosed Prevalent Cases Drug-Treated Prevalent Cases

2020 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

• We define MS based on the McDonald criteria (McDonald WI, 2001; Milo R, 2014) and MS diagnostic codes recorded in nationally representative health insurance, research, and long-term

disability databases. In our definition, we also include cases of CIS. When using data that include diagnoses made prior to 2001, we additionally use the Poser criteria to define MS, and include

clinically definite, probable, and possible MS cases in our definition. The possible cases include cases of CIS and/or suspected MS cases. We restrict our analyses to individuals aged ten or older,

because MS is rarely diagnosed in children. We define subtypes of prevalent MS cases based on physician diagnosis: RR-MS, CP-MS, which is further categorized into PP-MS and SP-MS, and CIS ,

i.e. cases that have not yet progressed to MS at the time of diagnosis. The drug-treated estimates include patients in 2020 who were treated with DMTs—excluding corticosteroids for acute

relapses. Drug-treatment rates in our model continue to be lowest in the United Kingdom owing to long-standing barriers in access to specialty MS care in that country.

Source: Decision Resources Group; BMS Internal Analysis

Page 21: Epi slides

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Systemic Lupus Erythematosus (Includes Lupus Nephritis)

330264

165

132

0

250

500

750

Diagnosed Prevalent Cases Drug-Treated Prevalent Cases

2020 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

• Definition of SLE is important. These numbers are based on criteria used by clinicians to diagnose SLE: the presence of four or more ACR criteria or three ACR criteria along

with an SLE diagnosis by a rheumatologist, a biopsy-confirmed diagnosis of LN, or a diagnosis of SLE-related ESRD. In addition, we categorize SLE cases identified from national

administrative databases under clinically defined SLE. These prevalence numbers represent patients with any organ affected. LN patients represent ~30% of all SLE cases

Source: Decision Resources Group; BMS Internal Analysis

Page 22: Epi slides

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Eosiniphilic Esophagitis (EoE)

EoE Diagnosed Prevalence

354

313

0

200

400

600

800

Diagnosed Prevalence

2020 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

Page 23: Epi slides

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Atopic Dermatitis

10.9

6.1

10.5

6.1

0

5

10

15

20

Diagnosed Prevalent Cases Drug-Treated Prevalent Cases

2020 P

ATIE

NT E

STIM

ATES (

IN M

ILLIO

NS)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

• Diagnosed Prevalent Cases includes all ages population with mild, moderate & severe AD. We categorized AD by severity in people aged 15 or older in all countries under study

using the severity distribution from a population-based study conducted in the United States (Silverberg JI, 2018). To categorize pediatric patients by severity, we applied the

ratio between the severity distributions in 12-month total prevalent cases (Silverberg JI, 2018) and diagnosed prevalent cases (Barbarot S, 2018) in adults to the severity

distribution of diagnosed prevalence cases in children younger than nine in each of the countries under study (Barbarot S, 2018; Ben-Gashir M, 2004; Silverberg JI, 2018;

Willemsen M, 2009).

• Treated population includes the percentages of all ages diagnosed population with mild, moderate & severe AD in 2018 who received drug treatment with key drug classes used

to manage the disease (e.g., TCSs, TCIs, conventional oral immunosuppressants, oral corticosteroids) in each of the seven markets under study.

Page 24: Epi slides

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Hematology

24

Page 25: Epi slides

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Lymphoma

DLBCL

31.2

12.1 11.0

28.0

10.07.0

0

20

40

60

80

1L Treated 2L Treated 3L+ Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

FL

11.2

3.9 5.9

10.9

3.9

5.9

0

10

20

30

40

1L Treated 2L Treated 3L+ Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

Page 26: Epi slides

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Multiple Myeloma

Treated Population

18.3

11.2

18.5

12.29.8

12.7

14.4

15.2

8.5

5.7

0

10

20

30

40

1L SCT Eligible 1L SCT Ineligible 2L 3L 4L+

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

Page 27: Epi slides

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Leukemia

CLL+SLL

19.1

9.96.2

15.7

8.6

5.6

0

10

20

30

40

1L Treated 2L Treated 3L+ Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

AML (excluding APL*)

16.6

13.7

0

10

20

30

40

Diagnosed Incident

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Source: Decision Resources Group; BMS Internal Analysis *APL = acute promyelocytic leukemia

Page 28: Epi slides

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MDS

Lower-Risk MDS Treated Incident Population

11

5

8

3

0

2

4

6

8

10

12

14

16

18

20

ESA Naïve (1L) ESA R/R (2L)

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

• ~40% of lower-risk patients are RS Positive

Note: ~40% RS Positive already applied to ESA R/R (2L)

Page 29: Epi slides

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Myelofibrosis

Incident Cases

3.8

4.1

0.0

2.5

5.0

7.5

10.0

Diagnosed

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

Page 30: Epi slides

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Beta Thalassemia

Prevalent Cases

6

11

0

4

8

12

16

20

Drug-Treated

2021 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

• NTD: 35%

• TD: 65%

Page 31: Epi slides

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Cardiovascular

31

Page 32: Epi slides

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Secondary Stroke Prevention

Ischemic Stroke Events

0.74 0.67

0.65

0.55

0.0

0.4

0.8

1.2

1.6

Total Events Diagnosed Events

2020 P

ati

ent

Est

imate

s (i

n M

illions)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

Page 33: Epi slides

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Acute Coronary Syndrome

ACS

0.79

1.01

0.0

0.5

1.0

1.5

2.0

Diagnosed Events

2020 P

ati

ent

Est

imate

s (i

n M

illions)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

Page 34: Epi slides

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Atherosclerotic Cardiovascular Disease

CAD/PAD

15.80

5.00

11.60

5.30

0.0

5.0

10.0

15.0

20.0

25.0

30.0

Diagnosed Prevalent Cases (CAD) Diagnosed Prevalent Cases (PAD)

2020 P

ati

ent

Est

imate

s (i

n M

illions)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

Page 35: Epi slides

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Venous Thromboembolism

VTE Tx

0.79

5.29

0.88

5.75

0.0

3.0

6.0

9.0

12.0

Diagnosed incident Cases (first ever) Diagnosed 10-year Prevalent Cases

2020 P

ati

ent

Est

imate

s (i

n M

illions)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

Page 36: Epi slides

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Atrial Fibrillation

AF

7.35

9.42

0.0

5.0

10.0

15.0

20.0

Diagnosed Prevalence

2020 P

ati

ent

Est

imate

s (i

n M

illions)

US EU5

Source: Decision Resources Group; BMS Internal Analysis

Page 37: Epi slides

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Hypertrophic Cardiomyopathy (HCM)

HCM

Source: Decision Resources Group; Maron BJ, 1995, Maron BJ, 1999, Maron BJ, 2004 BMS Internal Analysis

660

150 90 60

635

15090

600

200

400

600

800

1000

1200

1400

Total Prevalence Diagnosed Prevalent HCM Obstructive HCM Non-Obstructive HCM

2020 P

ati

ent

Est

imate

s (i

n 0

00’s

)

US EU5

• Numbers reflect base case estimates; Total HCM prevalence assumes a (~1/500) rate based on literature sources (below); Diagnosed prevalence estimates are variable due

to HCM being a highly undiagnosed and misdiagnosed disease; Due to limited literature, it is recommended to utilize ranges vs. absolute point estimates

(100 – 200) (75 – 120) (30 – 75)

(75 – 110)

(105 – 220)

(40 – 75)

(550-750)

(550-750)