u.s pharmaceutical market - c.ymcdn.comc.ymcdn.com/sites/ 25, 2014 · april 2013 ims health...

April 2013

IMS Health Overview

U.S Pharmaceutical Market: Trends

Issues

&

Outlook

Prepared for

HSCA & hisci

By Doug Long

VP Industry Relations

[email protected]

February 25, 2014

All reproduction rights, quotations, broadcasting, publications reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without express written consent of IMS HEALTH.

2013 Strategic management presentation

Most notable things about 2013 • TRXs up

• Dollar sales recovered

• Strong flu season in Q1 2013 but 4th Q 2013 not so hot

• Allergy season mediocre

• Compounding Pharmacies safety problems

• Millions in fines paid on Controlled Substance abuse

• Hycd and Combinations to Schedule 2?

• Higher dosage forms of APAP combinations banned in 2014 and new labeling changes

• Obamacare delays

• More Limited networks

• Medicaid MC and rationing begins: States limiting RXs for Medicaid patients

• Oregon Medicaid study

• Probe finds 3 NC hospitals reaped millions from 340 B programs

• Alzheimer’s costs top Cancer and Heart disease

• Pharma Mergers involving Ireland Tax treatments

• Walgreens/ABC relationship & Walgreens/Kerr Drug merger

• CVS/Cardinal….McKesson and Celesio

Most notable things about 2013 - Generics

• SCOTUS Bartlet Decision (which led to FDA proposed generic labeling rules)

• Generic Price Increases and Drug Shortages– in part caused by generic GMP issues (Ben Venue exits)

• FDA Elevates ODG to Super Office

• M&A Moves Traditional Generics Toward Brand (Actavis+Warner Chilcott; Perrigo+Elan; Valeant+Bausch&Lomb; Mylan+Agila

• Actavis v. FTC Patent Settlement decision

• FDA bans generic versions of original OxyContin but not Opana ER

• Cymbalta (US) and Biosimilar Remicade (Europe)

Total Market

3.2% Brand

1.9%

Generic

9.0%

Branded Generic

3.1%

Orals

-1.3%

Injectables

7.3%

Biologic Molecules

9.6% Oncologics

9.2%

-2%

0%

2%

4%

6%

8%

10%

12%

% G

RO

WTH

Source: IMS Health, National Sales Perspective, Jan 2014

% Growth US$

2013 dollar growth by key segments

Q1 2013 was the strongest FLU quarter in years

32.7MM at Mid Point

Q1 Avg. AP Rank

2000 34,126,678 8

2001 39,991,324 1

2002 38,197,693 4

2003 38,198,388 3

2004 34,791,761 7

2005 39,766,587 2

2006 33,360,745 10

2007 33,190,876 11

2008 33,699,686 9

2009 30,222,500 13

2010 28,839,264 14

2011 35,064,828 6

2012 31,046,147 12

2013 35,356,354 5

10

15

20

25

30

35

40

Millions

Avg. Q1 AP

Note: Prior to 5/9/2009 Affected Population based on Old Methodology

Average Q1 FAN® Affected Population

Average Q4 FAN ® Affected Population

10

15

20

25

30

35

40

Millions

Avg. Q4 AP

Q4 2013 was one of the weakest quarters for FLU

Q4 Avg. AP Rank

1999 34,883,414 2

2000 34,347,304 3

2001 33,427,911 4

2002 32,724,601 5

2003 35,548,861 1

2004 31,481,741 6

2005 30,042,682 7

2006 29,597,235 8

2007 26,925,250 13

2008 25,337,142 14

2009 29,133,746 9

2010 28,964,673 10

2011 27,506,333 12

2012 28,340,513 11

2013 25,239,033 15

Pandemic-09

Peak Season 03

Top Molecules on a TRX Basis- 2013

Rank Molecule TRx (000) Share Growth

1 ACETAMINOPHEN/HYDROCODONE 129,170 3.1% -5.3%

2 LEVOTHYROXINE 115,155 2.7% 2.7%

3 LISINOPRIL 101,521 2.4% 2.4%

4 METOPROLOL 83,910 2.0% 1.7%

5 SIMVASTATIN 79,145 1.9% -11.4%

6 AMLODIPINE 73,957 1.8% 7.0%

7 METFORMIN 72,836 1.7% 7.4%

8 OMEPRAZOLE 70,686 1.7 % 6.1%

9 ATORVASTATIN 66,427 1.6% 23.4%

10 ALBUTEROL 63,500 1.5% 3.7%

TRx

8

Top Molecules on a TRX Basis- 2013

Rank Molecule TRx (000) Share Growth

11 AMOXICILLIN 54,215 1.3% 2.7%

12 HYDROCHLOROTHIAZIDE 50,186 1.2% -2.0%

13 ALPRAZOLAM 49,588 1.2% 0.2%

14 AZITHROMYCIN 48,637 1.2% -11.0%

15 FLUTICASONE 45,262 1.1% 7.5%

16 FUROSEMIDE 44,957 1.1% 2.0%

17 GABAPENTIN 43,855 1.0% 13.5%

18 SERTRALINE 41,672 1.0% 4.9%

19 ZOLPIDEM 41,511 1.0% -5.7%

20 TRAMADOL 41,490 1.0% 5.6%

9

TRX GainsGain

(Mil)TRX Losses

Loss

(Mil.)

Atorvastatin 13.0 Simvastatin -10.2

Losartin 6.2 APAP/HYCD -7.2

Gabapentin 5.2 Azithromycin -6.0

Metformin 5.0 Zolpidiem -2.5

Amlodipine 4.8 Esomeprazole -2.1

Pantoprazole 4.1 Rosuvastatin -2.1

Omeprazole 4.1 Citalopram -2.1

Ondansetron 3.3 APAP/OXY -2.1

Fluticasone 3.1 Atenelol -2.0

Escitalopram 3.1 Doxycycline -1.6

Which Molecules gained and lost TRX Volume in 2013?

Source: IMS Health, National Sales Perspectives, Dec 2013, National Prescription Audit, Dec 2013

$94 BN exposed to generic competition by 2019

18.4 16.5

21.5

35.2

9.4

19.2 18.0

12.2 10.6

19.5

5.4

0

5

10

15

20

25

30

35

40

2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019

SPEN

DIN

IG U

S$BN

Value of products at risk 2009-2019 ($US BN)

Source: IMS National Sales Perspectives, Nov 2013; sales in year prior to expiry for 2009-12; MAT Nov 2013 sales shown for 2013-19

2013-2019 LOE exposure: $94 BN

Excluding biologics

NME approvals reached levels not seen in the past

decade, but most are specialist-driven therapies N

UM

BER O

F N

ME A

PPRO

VALS

Source: FDA, IMS Institute for Healthcare Informatics, Feb 2013

Source: IMS Health, National Sales Perspectives, Jan 2014

Top specialty classes dollar sales - 2013

Sales ($MN) Share Growth

U.S. Specialty Market 92,216 100.0% 7.6%

1 Oncology 27,878 30.2% 9.2%

2 Autoimmune 17,861 19.4% 18.0%

3 HIV Antivirals 12,365 13.4% 10.0%

4 Multiple Sclerosis 9,683 10.5% 10.6%

5 Hematopoietic Growth Factors 4,714 5.1% 3.2%

6 Erythropoietin Products 4,151 4.5% -0.6%

7 Other Immunosuppressants 2,320 2.5% 3.3%

8 Viral Hepatitis Products 1,936 2.1% -33.5%

9 Polyval immunogloblulins IV IM 1,894 2.1% -3.0% 10

Growth Hormones 1,618 1.8% 5.8%

Top 10 84,421 91.5% 8.2%

Source: IMS Health, National Sales Perspectives, Jan 2014

Top specialty products dollar sales - 2013


U.S. Specialty Market 92,216 100.0% 7.6%

1 Humira® 5,566 6.0% 24.2%

2 Enbrel® 4,711 5.1% 12.0%

3 Remicade® 4,115 4.5% 7.2%

4 Copaxone® 3,711 4.0% 5.6%

5 Neulasta® 3,588 3.9% 4.4%

6 Rituxan® 3,298 3.6% 5.1%

7 Atripla® 2,885 3.1% 3.1%

8 Avastin® 2,697 2.9% 2.8%

9 Epogen® 2,282 2.5% 5.5%

10 Truvada® 2,257 2.4% 0.8%

Top 10 35,108 38.1% 8.2%

Dollar GainsGain

(Mil)Dollar Losses

Loss

(Mil.)

Humira® 1,076 Incivek® 658

Tecfidera® 880 Avonex® 422

Stribild® 545 Velcade® 93

Avonex Pen® 523 Aranesp® 90

Embrel® 480 Procrit® 57

Zytiga® 305 Betaseron® 35

Afinitor® 297 Erbitux® 25

Stelara® 291 Neupogen® 21

Complera® 284 Reyataz® 16

Remicade® 261 Synagis® 14

Which Specialty Products gained and lost Dollar Sales in 2013?


Source: IMS Health, National Sales Perspectives, Feb 2014

Top 10 therapy classes

MAT Feb 2014


U.S. Market 334,424 100.0% 5.3%

1 Oncology 28,466 8.5% 10.5%

2 Antidiabetes 25,195 7.5% 15.0%

3 Mental Health 23,993 7.2% 0.7%

4 Respiratory 20,584 6.2% -2.8%

5 Pain 18,980 5.7% 4.5%

6 Autoimmune 18,480 5.5% 19.5%

7 Lipid Regulators 13,631 4.1% -11.9%

8 HIV Antivirals 12,763 3.8% 11.5%

9 Antihypertensives 12,469 3.7% -4.9%

10 Multiple Sclerosis 10,951 3.3% 21.8%

Top 10 185,514 55.5% 5.8%



MAT Feb 2014


11 Anti-Ulcerants 10,052 3.0% 2.7%

12 ADHD 9,860 2.9% -4.6%

13 Dermatologicals 8,949 2.7% 13.6%

14 Antibacterials 8,514 2.5% 7.9%

15 Nervous System Disorders 8,351 2.5% 18.5%

16 Anticoagulants 7,565 2.3% -11.5%

17 Vaccines excl flu 6,045 1.8% -1.6%

18 Sex Hormones 5,821 1.7% 8.9%

19 Ophthalmology 5,768 1.7% 13.5%

20 Hormonal Contraceptives 5,596 1.7% 1.0%

Top 20 262,037 78.4% 5.3%



MAT Feb 2014


21 Other Cardiovasculars 5,384 1.6% 14.6%

22 GI Products 4,841 1.4% 13.9%

23 Hematopoietic Growth Factors 4,728 1.4% 3.3%

24 Erythropoietins 4,165 1.2% 0.0%

25 Other CNS 3,125 0.9% 10.6%

26 Antithyroid 3,082 0.9% 16.8%

27 Anti-Alzheimers 2,795 0.8% 9.8%

28 Erectile Dysfunction 2,599 0.8% 14.5%

29 Viral Hepatitis Products 2,576 0.8% -6.7%

30 Urinary Incontinence 2,382 0.7% 9.9%

Top 30 297,714 89.0% 5.6%

Source: IMS Health, National Prescription Audit, Feb 2014


MAT Feb 2014

TRx (000s) Share Growth

U.S. Market 4,213,871 100.0% 0.9%

1 Antihypertensives 697,549 16.6% 0.9%

2 Mental Health 519,819 12.3% 1.6%

3 Pain 476,236 11.3% -1.0%

4 Antibacterials 262,592 6.2% -3.8%

5 Lipid Regulators 261,822 6.2% -1.3%

6 Antidiabetes 192,824 4.6% 3.2%

7 Nervous System Disorders 167,407 4.0% 6.0%

8 Anti-Ulcerants 164,652 3.9% 3.0%

9 Respiratory 161,605 3.8% 2.0%

10 Antithyroid 126,280 3.0% 3.5%

Top 10 3,030,787 71.9% 0.8%



MAT Feb 2014


11 Dermatologicals 104,669 2.5% 1.4%

12 Hormonal Contraceptives 95,664 2.3% 4.2%

13 ADHD 80,279 1.9% 4.6%

14 Anticoagulants 75,496 1.8% -0.3%

15 Vitamins And Minerals 74,426 1.8% 2.6%

16 Corticosteroids 61,290 1.5% 1.7%

17 GI Products 57,982 1.4% 2.5%

18 Nasal Preps Topical 51,611 1.2% 6.1%

19 Other Cardiovasculars 49,116 1.2% -2.9%

20 Sex Hormones 44,642 1.1% 0.1%

Top 20 3,725,961 88.4% 1.0%



MAT Feb 2014


21 Ophthalmology 43,271 1.0% 0.0%

22 BPH 37,093 0.9% 3.5%

23 Cough Cold Flu 35,967 0.9% -10.8%

24 Myotics & Antiglaucoma 31,350 0.7% 2.5%

25 Cancer Detox & Antinausea 26,577 0.6% 12.3%

26 Allergy Systemic & Nasal 26,309 0.6% -3.8%

27 Anti-Alzheimers 22,684 0.5% 4.9%

28 Anti-Gout Preparations 21,801 0.5% 3.2%

29 Osteoporosis 20,172 0.5% -13.5%

30 Systemic Antifungal Agents 19,748 0.5% 1.0%

Top 30 4,010,932 95.2% 0.9%

Products Company US$mn% Market

Share% Growth

US Industry 329,259 100.0 3.2

1 Abilify® OTS 6,545 2.0 14.7

2 Nexium® AZN 6,181 1.9 5.1

3 Humira® AV1 5,566 1.7 24.2

4 Crestor® AZN 5,372 1.6 8.4

5 Cymbalta® LLY 5,278 1.6 14.5

6 Advair Diskus® GSK 5,185 1.6 8.0

7 Enbrel® AAI 4,711 1.4 12.0

8 Remicade® JAN 4,115 1.3 7.2

9 Copaxone® TVN 3,711 1.1 5.6

10 Neulasta® AAI 3,588 1.1 4.4

Top 10 50,251 15.3 10.6

MAT Dec 2013

Dollar Sales of leading products - 2013

Source: IMS Health, National Sales Perspectives, Dec 2013


Share% Growth

11 Rituxan® GTC 3,298 1.0 5.1

12 Lantus Solostar® S.A 3,035 0.9 41.0

13 Spiriva Handihaler® B.I 3,034 0.9 10.9

14 Atripla® BMG 2,885 0.9 3.1

15 Januvia® MSD 2,872 0.9 10.2

16 Avastin® GTC 2,697 0.8 2.8

17 Lantus® S.A 2,588 0.8 16.8

18 Oxycontin® PUF 2,554 0.8 -8.1

19 Lyrica® PFZ 2,455 0.7 24.3

20 Epogen® AAI 2,282 0.7 5.5

Top 20 77,950 23.7 10.4

MAT Dec 2013

Dollar Sales of 11-20 products - 2013



Share% Growth

21 Celebrex® PFZ 2,270 0.7 17.1

22 Truvada® GS- 2,257 0.7 0.8

23 Diovan® NVR 2,171 0.7 6.9

24 Herceptin® GTC 1,945 0.6 5.3

25 Gleevec® NVR 1,900 0.6 9.6

26 Namenda® FOR 1,869 0.6 9.3

27 Lucentis® GTC 1,860 0.6 13.4

28 Vyvanse® SHI 1,761 0.5 10.1

29 Zetia® MU& 1,728 0.5 19.3

30 Symbicort® AZN 1,585 0.5 28.4

Top 30 97,295 29.5 10.5

MAT Dec 2013

Dollar Sales of 21-30 products - 2013


DollarsAC

US$mnTotal Rx Dispensed

AC

TRxsmn

Humira® (Av1) 1,084 atorvastatin ca (atx) 16.6

Lantus Solostar® (S.A) 883 atorvastatin ca (drl) 10.2

Tecfidera® (Bge) 880 atorvastatin ca (myn) 9.2

Abilify® (Ots) 838 atorvastatin ca (gso) 7.8

Xarelto® (Jan) 751 omeprazole (rx) (zyd) 7.4

Cymbalta® (Lly) 668 lorazepam (sdz) 6.7

Stribild® (Gs-) 551 escitalopram oxal (cm7) 5.3

Combivent Respimat® (B.I) 545 omeprazole (rx) (atx) 5.3

Avonex Pen® (Bge) 526 levothyroxine (myn) 5.1

Enbrel® (Aai) 506 prednisone (rox) 5.1

Largest absolute growth by leading products, Sales & TRx (2013)


April 2013

IMS Health Overview

A View of the Hospital and Clinic Market Segment

December 2013

Hospitals & GPO Demographics Some Observations as of 2Q2013

•Number of Hospitals: 5,862 ◦ Definition: Acute, non-federal facilities

• Number of Hospital GPOs: 48

• Ratio of GPOs per Hospital: 1.23:1 ◦ Historic high was nearly 5:1

− Top 10 GPOs represent over 95% of Hospitals

− 75% of Hospitals are members of IDNs

Source: IMS Health Marketing Initiatives Inc

Top Hospital GPOs

Source: IMS Health Marketing Initiatives Inc

Members

(all hospitals)

Licensed Beds

(Hospitals)*

Licensed Beds

(all hospitals)

MedAssets, Inc 2,068 256,838 289,496

Premier, Inc 1,612 264,183 274,990

Novation (VHA Inc) 1,488 229,814 239,792

HealthTrust Purchasing Group 1,094 153,201 158,244

Amerinet, Inc 897 98,932 105,782

Novation (UHC) 232 56,670 59,076

Provista, LLC 91 12,222 14,560

GNYHA Services, Inc 86 25,649 26,865

FirstChoice Cooperative 81 4,509 4,729

Minnesota Multistate Contracting

Alliance for Pharmacy 60 839 15,464

Sum 7,709 1,102,857 1,188,998

Percentage of National Total 93.7% 93.5% 93.5%

National Total 8,226 1,179,524 1,271,990

*acute_non_federal_hospitals

U.S. Hospital Demographics, Q2 2013

Hospital Counts by Staffed Beds

0

500

1000

1500

2000

2500

< 50 50-99 100-199

200-299 300-399 >=400

The Pharmaceutical Market – 2013

72%

13%

9%5% 1%

RETAIL

CLINICS

HOSPITALS

LTC/HHC

HMO, Other

Source: IMS Health National Sales Perspectives

Roughly one-fourth of domestic prescription sales volume are in the Non-Retail Market

Hospital and Clinic Sales Volume Sales 2008-2013

$0

$5

$10

$15

$20

$25

$30

$35

$40

$45

2008 2009 2010 2011 2012 2013

CLINIC

HOSPITAL

Sales in billions of US dollars (Includes federal hospitals)


Hospital and Clinic Market Share 2008-2013 Percent share of total US Pharmaceutical Market

(Includes federal hospitals)


0%

2%

4%

6%

8%

10%

12%

14%

2008 2009 2010 2011 2012 2013

CLINIC

HOSPITAL

Top Therapeutic Classes - 2013 Hospitals* (Federal and Non-Federal Hospitals) + Clinics

Dollars

% Share % Change in Millions Hospitals* + Clinics 73,943 3.5%

1 30000 ANTINEOPLASTIC AGENTS 17,468 23.6% 2.7%

2 48000 BLOOD FACTORS 8,591 11.6% 2.6%

3 27000 BIOLOGICALS 6,190 8.4% 7.5%

4 23000 GASTROINTESTINAL 4,929 6.7% 7.6%

5 11000 HEMOSTATIC MODIFIERS 3,512 4.7% -7.5%

6 15000 ANTI-INFECTIVES SYSTEMIC 3,009 4.1% 0.9%

7 61000 OPHTHALMIC PREPARATIONS 2,395 3.2% 11.4%

8 82000 ANTIVIRAL 2,160 2.9% 14.9%

9 86000 IMMUNOLOGIC AGENTS 2,025 2.7% 12.1%

10 78000 MISCELLANEOUS PREPS 1,969 2.7% 7.9%

11 53000 HOSPITAL SOLUTIONS 1,880 2.5% -7.0%

12 59000 MUSCULOSKELETAL 1,873 2.5% -9.9%

13 40000 DIAGNOSTIC AIDS 1,821 2.5% -4.1%

14 28000 RESPIRATORY THERAPY 1,758 2.4% -5.3%

15 64000 PSYCHOTHERAPEUTICS 1,573 2.1% -5.0%

16 09000 ANTIARTHRITICS 1,530 2.1% 4.7%

17 04000 ANESTHETICS 1,397 1.9% 11.0%

18 02000 ANALGESICS 1,049 1.4% 18.6%

19 39000 DIABETES THERAPY 922 1.2% 5.3%

20 17000 ANTINAUSEANT 865 1.2% 2.6%

Top 20 66,918 90.5% 2.9%

Top Pharmaceutical Products by Sales - 2013 Hospitals* (Federal and Non-Federal Hospitals) + Clinics

Dollars


1 REMICADE 3,604 4.9% 6.6%

2 NEULASTA 3,355 4.5% 4.6%

3 RITUXAN 3,169 4.3% 4.5%

4 AVASTIN 2,607 3.5% 2.4%

5 EPOGEN 2,253 3.0% 5.6%

6 HERCEPTIN 1,890 2.6% 5.0%

7 LUCENTIS 1,809 2.4% 13.6%

8 ALIMTA 1,164 1.6% 5.1%

9 XGEVA 768 1.0% 18.9%

10 PREVNAR 13 755 1.0% 3.7%

11 NEUPOGEN 697 0.9% -1.2%

12 PROCRIT 682 0.9% 0.4%

13 ARANESP 681 0.9% -9.1%

14 GARDASIL 673 0.9% 21.4%

15 TREANDA 663 0.9% 14.9%

16 ERBITUX 631 0.9% -3.2%

17 VELCADE 599 0.8% -13.4%

18 SANDOSTATIN LAR 567 0.8% 9.9%

19 ORENCIA 550 0.7% 0.7%

20 YERVOY 540 0.7% 7.2%

Top 20 27,657 37.4% 5.0%

Top Pharmaceutical Products by Sales Hospital Market Segment Year 2013


Dollars

% Share % Change in Millions

Non-Fed Hospitals 29,029 1.04%

1 REMICADE 932 3.2% 6.9%

2 RITUXAN 868 3.0% 4.2%

3 NEULASTA 778 2.7% 14.2%

4 AVASTIN 513 1.8% 3.2%

5 CUBICIN 460 1.6% 3.5%

6 ACTIVASE 431 1.5% 36.8%

7 ANGIOMAX 420 1.4% 2.4%

8 NEUPOGEN 377 1.3% 0.4%

9 HERCEPTIN 352 1.2% 7.9%

10 ZYVOX 348 1.2% -3.2%

11 ZOSYN 309 1.1% -9.5%

12 LEXISCAN 307 1.1% -4.7%

13 PROCRIT 300 1.0% 0.2%

14 PRIVIGEN 296 1.0% -19.8%

15 PRECEDEX 261 0.9% 22.2%

16 TYSABRI 259 0.9% 5.4%

17 ARANESP 237 0.8% -6.9%

18 ALIMTA 233 0.8% 3.6%

19 LOVENOX 221 0.8% -32.1%

20 OMNIPAQUE 215 0.7% 6.1%

Top 20 8,115 28.0% 2.57%

Top Pharmaceutical Products by Sales Clinic Market Segment Year 2013


Dollars

% Share % Change in Millions

Clinics 42,417 6.04%

1 REMICADE 2,662 6.3% 6.6%

2 NEULASTA 2,572 6.1% 2.1%

3 RITUXAN 2,293 5.4% 4.5%

4 EPOGEN 2,214 5.2% 5.8%

5 AVASTIN 2,089 4.9% 2.2%

6 LUCENTIS 1,710 4.0% 15.4%

7 HERCEPTIN 1,533 3.6% 4.4%

8 ALIMTA 927 2.2% 5.5%

9 XGEVA 643 1.5% 17.5%

10 PREVNAR 13 636 1.5% 3.1%

11 GARDASIL 558 1.3% 22.4%

12 TREANDA 519 1.2% 16.4%

13 ERBITUX 494 1.2% -4.0%

14 ORENCIA 448 1.1% 1.1%

15 ARANESP 442 1.0% -10.3%

16 SANDOSTATIN LAR 433 1.0% 9.4%

17 VELCADE 423 1.0% -15.7%

18 ABRAXANE 421 1.0% 44.7%

19 VARIVAX 400 0.9% -39.7%

20 YERVOY 389 0.9% 9.3%

Top 20 21,807 51.4% 4.34%

Top Pharmaceutical Manufacturers - 2013 Hospitals* (Federal and Non-Federal Hospitals) + Clinics

Dollars


1 GENENTECH,INC. 11,625 15.7% 10.9%

2 AMGEN CORPORATION 8,792 11.9% 6.8%

3 JOHNSON & JOHNSON 5,602 7.6% 7.3%

4 SANOFI AVENTIS 4,411 6.0% -12.7%

5 MERCK & CO 3,448 4.7% -3.4%

6 PFIZER 3,332 4.5% -1.5%

7 NOVARTIS 2,557 3.5% -18.2%

8 LILLY 2,257 3.1% 2.9%

9 GLAXOSMITHKLINE 1,931 2.6% 4.2%

10 BRISTOL-MYERS SQUI 1,636 2.2% -5.2%

11 HOSPIRA INC 1,476 2.0% 8.9%

12 TEVA PHARM USA 1,321 1.8% 8.7%

13 BAXTER HEALTHCARE 1,309 1.8% 1.2%

14 FRESENIUS KABI 1,236 1.7% -3.8%

15 ABBOTT 1,163 1.6% -4.0%

16 CELGENE INC 1,103 1.5% 18.0%

17 GILEAD SCIENCES, I 1,006 1.4% 25.8%

18 EISAI CORP 862 1.2% -11.4%

19 ASTELLAS US LLC 849 1.1% 2.7%

20 ASTRAZENECA CORP 783 1.1% -7.7%

Top 20 56,697 76.7% 2.0%

Biologics growth more than double that of total pharma

This trend places biologics at the forefront of budget concerns in mature markets, driving opportunity for biosimilars

Source: IMS Health, MIDAS, MAT Dec 2012

0%

2%

4%

6%

8%

10%

12%

14%

-

20

40

60

80

100

120

140

160

180

2006 2007 2008 2009 2010 2011 2012

Gro

wth

, LC

US

$

Sale

s,

US

$ b

illio

ns

Biologics Sales Biologics Growth

Total Pharma growth

9.1%

7.5%

13.2%

21.6%

48.6%

Japan Pharmerging ROW EU5 US

8.1%

14.7%

13.3%

14.1%

49.8%

Biologics – Share of sales

Biologics – Share of growth

Global market trends Sales and Growth

© 2013, IMS HEALTH

Biosimilars and NOBs start to make inroads into the burgeoning biologics market

Growth Evolution

% Share of Biologic spend

NOBs 0.5%

0.0% Biosimilars

1.0%

0.4% 4-10%

CAGR 2007-12 CAGR 2012-20

$2.4Bn

Source: IMS Health, MIDAS, MAT Dec 2012. IMS analysis & estimates. NOBs are recombinant and synthesised only.

+4 to +5% +9%

+34% +21 to +34%

2007 2012 2020

Total Biologic Market

Biologic (all others)

NOBs/Biosimilars

$106 Bn

© 2013, IMS HEALTH

$11-25Bn $0.5Bn

$250 Bn $169 Bn

Biosimilars

The first of a new wave of monoclonal antibody (mAb) biosimilars — treating chronic conditions in the largest areas of biologic spend — has recently been approved in the EU. The European Medicines Agency (EMA) permitted indication extrapolation in the above approval… and the biosimilar itself is produced by an unexpected source: a South Korean firm. A non-original version of filgrastim, an equivalent of the biosimilar versions of filgrastim already available in Europe, has been approved for marketing in the U.S. and was launched in 2013. For the first time, a biosimilar has eclipsed an originator product in volume share in Europe. Several important and very large biologic therapy areas are facing loss of exclusivity (LoE) in the next few years, including monoclonal antibody oncologics, modern insulins, and anti-tumor necrosis factor monoclonal antibodies (anti-TNF mAbs).

The Nation's Health Dollar ($2.7 Trillion), Calendar Year 2011: Where It Went

1 Includes Research (2%) and Structures and Equipment (4%). 2 Includes Durable (1%) and Non-durable (2%) goods. 3 Includes expenditures for residential care facilities, ambulance providers, medical care delivered in non-traditional settings (such as community centers, senior citizens centers, schools, and military field stations), and expenditures for Home and community Waiver programs under Medicaid. Note: Sum of pieces may not equal 100% due to rounding. SOURCE: Centers for Medicare & Medicaid Services, Office of the Actuary, National Health Statistics Group.

Source: 2011 CBO Long-Term Budget Outlook

Spending on health care is driving US federal deficits

Source: National Association of State Budget Officers, State Expenditure Report, 2010-2012; Congressional Budget Office

Medicaid as a Proportion of National and State Budgets

Medicaid consumes 11% of the Federal government budget and 24% of State budgets

US Federal Budget 2011 $3.6 Trillion

Total of States’ Budgets 2011 $1.6 Trillion

Medicaid Defense Social Security Elementary & Secondary Education Higher Education All other spending

Source: IMS Health, National Disease and Therapeutic Index, IMS Hospital CDM, Dec 2012

Fewer patients made office visits, while ER visits increased

Percent Change in Hospital Admissions & Office Visits

A minority of patients account for the vast majority of healthcare costs

Percent of Health Plan Members Ranked by Healthcare Spending ($)

Source: IMS PharMetrics, Jun 2012

Top 1% (≥$48,735)

Cost Containment Opportunities

Sources: 1. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among Patients in the Medicare Fee-for-Service Program. New England Journal of Med. 2009;360(14):1418–28 2. MedPAC. Report to Congress: Promoting Greater Efficiency in Medicare, Oct 2008 3. David Blumenthal, MD, “More focus on high-cost patients could save $300B,” Healthcare Finance News, Apr. 2012 4. IMS Institute, Advancing the Responsible Uses of Medicines, October 2012 5. Lars Osterberg and Terrence Blaschke, “Adherence to Medication,” New England Journal of Medicine, 2005

Coordination of Care

Treating 60% of high-cost chronic condition patients yields $300B in savings

over 10 years3

1.1% of global total health expenditure or 62B worldwide, can be avoided

with timely treatment4

$62B

$300B

Pharmacy

Prescriptions not taken as directed5 drive $260B in

additional care costs4

8% of total health expenditure = $500B globally can be avoided with optimized

use of medicines4

$500B

50%

Readmissions

1 in 5 Medicare FFS patients readmit within 30 days

of discharge1

13.4% or 21,000 AMI Medicare admissions readmit within

15 days, at a cost of $136M2

20%

AMI

readmissions

21K

$105.4

$39.5

$35.1$20.0

$11.9 $1.3 $213.2

The economic stakes are high for the healthcare system

Delayed evidence-

based treatment practice

Mismanaged polypharmacy in the elderly

Total avoidable

costs

Suboptimal generics

use

Medication errors

Antibiotic misuse

Nonadherence

Source: Avoidable Costs in U.S. Healthcare Study

Estimated avoidable costs by lever ($Bn), 2012

Focus of study was limited to six areas

Medicine access and pricing were not addressed

Medication nonadherence

Delayed evidence-based treatment

Medication errors

Suboptimal generics use

Mismanaged polypharmacy

Antibiotic misuse

Improvement in health outcomes

Decline in healthcare

costs

Increase in medicines

value

The financial costs are caused by avoidable use of healthcare services by patients

14045

22

6

10 million hospital visits

78 million outpatient visits

246 million prescriptions

4 million emergency room visits

Source: Avoidable Costs in U.S. Healthcare Study

Millions of lives affected $213 Bn

Avoidable Costs, US ($Bn)

Utilization

4.8 5.1

23.2

72.3

ER Pharmacy Outpatient Hospital

Avoidable costs due to nonadherence in the six disease areas studied are substantial

105.4

$105.5

Avoidable costs by disease, US$Bn Avoidable costs by settings of care, US$Bn

Source: Avoidable costs in healthcare study

15.5

18.6

24.6

44.0

Congestive Heart Failure HIV

Osteoporosis Hypertension

Diabetes Hypercholesterolemia

1.8 1.0

105.4

Medication adherence is now a more addressable issue

What’s different now Evidence

The economics of adherence have changed

• Greater availability of low-cost medicines • Increased impact from broader range of

lower-cost interventions

New information and analytics capabilities can be applied

• Advent of mobile health, social media and electronic records • Predictive analytics to understand patient behavior

More stakeholders care

• Payers are paying more attention (e.g. CMS Star Ratings)

• Pharmacies more actively engaged • ACO performance metrics

Solutions do not have to be high-tech or complex

• Growing role for relatively low-cost solutions • (e.g. mHealth) • Improved segmentation of interventions to

lower average cost

0.7 1.3 2.1

35.3

Atrial Fibrillation HCV

CHD Diabetes

Avoidable costs due to delayed evidence-based treatment practice are substantial in diabetes

Avoidable cost, by disease, US$Bn

0.9

4.4

14.4

19.8

ER Pharmacy

Hospital Outpatient

39.5 39.5

Avoidable costs by settings of care, US$Bn


Timely evidence-based treatment is also receiving more attention

What’s different now Evidence

Access to healthcare is expanding

• Introduction of exchanges and expansion of Medicaid program brings new potential patients into the healthcare system

Diagnostics increasingly available at no patient cost

• Expansion of no-cost diagnostic tests recommended by NPSTF

• Greater focus by risk-based providers on getting high-cost diseases diagnosed early

Clinical guidelines reinforced by use of EHRs

• EHRs can build in evidence-based guidance for clinicians on risk factors, testing protocols, and treatment initiation guidelines

Greater availability of more convenient medicine forms

• New and more medicine options, including oral forms, becoming available for many diseases e.g. Atrial fibrillation, Hepatitis C

48

103

174

368

272

URI Otitis Media Pharyngitis Bronchitis Sinusitis

1.0

34.1

Prescriptions Hospital

2

3

6

11

9

Avoidable costs due to antibiotics misuse are primarily hospital-based

Avoidable cost by settings of care US$Bn Avoidable outpatient prescriptions by disease


35.1 965 31

Costs, US$Mn Prescriptions, Mn

Antibiotic prescriptions for the common cold and flu are declining

Source: IMS NDTI, Dec 2012

20%

14%

7%

12%

7% 6%

0%

5%

10%

15%

20%

25%

0

2

4

6

8

10

12

2007 2008 2009 2010 2011 2012

RATE O

F I

NAPPRO

PRIA

TE P

RESCRIB

ING

NU

MBER O

F D

IAG

NO

SES A

ND

PRESCRIP

TIO

NS (

MN

)

Antibiotic prescriptions for the common cold and flu are declining

Common cold and flu diagnoses

Antibiotic prescriptions

Rate of inappropriate prescribing

Medication errors trigger 4 million hospital admissions and 1.4 million outpatient visits per year

$1.5

$18.2

Outpatient

Pharmacy ($0.2)*

Inpatient

ER ($0.2)

$20.0

Avoidable cost, $BN

*Note: Refers to Pharmacy-related avoidable costs to switch prescription rather than the cost of the prescription itself.

Outpatient visits 1.4 Mn

Hospital admissions

4 Mn

ER visits 0.6 Mn


The generic efficiency rate has risen to 95.1% but still provides some avoidable cost opportunity

$11.9

Avoidable cost, $BN

Pharmacy scripts* 85 Mn

*Note: Refers to prescriptions which could be switched to generics.


90.8 92.2 92.8 93.5 94.3 95.1

2007 2008 2009 2010 2011 2012

Generic Efficiency Rate

Our global research developed five top recommendations based on outcome impact, timing and cost

1 Support greater role of pharmacists to own medicines management

2 Invest in medical audits targeting elderly patients

3 Implement mandatory reporting of antibiotic use

4 Encourage a “no blame” culture towards error reporting

5 Support targeted disease management programs for prevalent noncommunicable diseases

Pharmacists can, for example, play critical roles in a large number of potential improvement areas

Examples of high value pharmacist role

Medication nonadherence

Delayed evidence-based treatment

Medication errors

Suboptimal generics use

Mismanaged polypharmacy

Antibiotic misuse

• Direct and meaningful patient engagement • Tailored programs in support of segments of patients likely to be nonadherent

• Availability of low barrier/cost diagnostics • Medication therapy management programs

• Patient awareness of appropriate antibiotic use • Monitoring and reporting of atypical utilization

• No-blame culture of error reporting • Systematic approach to developing corrective actions

• Active substitution efforts where permitted

• Medication therapy management programs • Priority for elderly patients

The most effective and innovative approaches are possible only

through collaboration among multiple healthcare stakeholders

PROVIDERS

PATIENTS PAYERS

PHARMACEUTICAL MANUFACTURERS

POLICYMAKERS

Areas of Avoidable

Costs

PHARMACISTS

Barriers to pharmacies playing their full potential role are formidable but addressable

Proof of value on outcomes and economic basis

Reimbursement approach

Regulatory considerations

Operational and technical

Change wrought by ACA implementation can reduce impediments to change

Getting Started: What pharmacies stakeholders can do today

• Understand what role you play in causing or addressing avoidable costs

How much am I contributing to this issue, or preventing it from being worse?

• Establish a set of relevant performance metrics for your business that can be used to measure improvement over time

How will I know if things are getting better or worse 1, 2, 5 years from now?

• Proactively seek collaborators whose interests align with yours and identify barriers to improvement that can be addressed jointly

How can I avoid being a player on the sideline?

• Seize new opportunities fueled by informatics, technology, reforms

What am I doing differently in these areas today compared with 2 years ago and what will I be doing differently 2 years from now?

• Contribute to a clearinghouse of demonstrated success stories that underscore the contribution you are making to addressing avoidable costs

What success can I showcase to others?

Common principles applied to successful improvement programs

Consistent focus on high-risk patients most vulnerable to suboptimal medicines use and require costliest interventions

Steadfast engagement with patients as responsible and capable partners

Rigorous assessment of impact and ROI in design and implementation of interventions for optimum avoidable cost reduction

Continuous measurement and accountability as basis for multi-stakeholder approaches

Alignment of compensation/incentive models with new healthcare delivery models

US changes in the healthcare system by 2020 will be substantial

Newly insured:

40 million

Medicaid program

expansion: $500Bn

Net increased spending:

$2.1Tn

Healthcare delivery

restructured – ACOs,

IDNs, IHNs

Shift of spending

from fee-for- service:

65%

New entities:

IPAB, PCORI, CMMI

EMR adoption:

90+%

Physician payments disclosed:

$10Bn

What rate and pace?

What political overlay?

What level of risk?

Healthcare reform elements may provide support for positive positioning of medicines and increased usage

Expanded patient access to healthcare

Increased diagnosis of asymptomatic conditions

Greater adherence to clinical guidelines

Improved compliance and persistency rates

ACO

IPAB

HIT

CMMI

PCORI

Medicines are an

increased share of lower

normalized healthcare spending?

Things to consider for Pharmacies

• Generic opportunities are abundant in the near term for orals!

• Generic & Specialty prices are going up

• The generic small molecule opportunities start to dry up mid decade but Follow on Biologics present themselves

• Innovation is strong in Specialty—Can you get a piece as more Specialty will be Orals?

• Specialty Pharmacies are exploding

• Adequate reimbursement will be a challenge for everyone!

• More regulation is inevitable!

• Controlled substances will be closely monitored—don’t get the DEA’s attention!

• Stay tuned on Patent Settlements and Labeling decisions!

• How can you improve adherence and help drive down Health Care costs?

Things to consider for US Generics

• More commoditization in Generics going forward

• Fewer small molecule opportunities going forward

• Fewer exclusivity periods going forward

• Generic companies are moving up the value chain and doing Portfolio optimization

• Follow-on biologics and biosimilars are big opportunities

• The Quality of Innovation is improving

• Incremental improvements in innovation are no longer valued

• OGD backlogs at record levels

• Keep an eye on Patent settlements

• Drug shortages on Generic injectables get public attention

• More reimbursement and regulatory challenges going forward

• Big increase in M&A in Generics in the future (Actavis, Fougera & Par)

• Ireland Tax treatment

Things to watch for in 2014 - Generics

• How does the Generic Labeling Rule Play Out?

• Copaxone Generic

• FDA Guidance on Biosimilars (Naming, etc.)

• Rx to OTC Switches (Lipitor; Nexium)

• Impact of Consolidated Global Generic Purchasing Walgreens+ABC+AllianceBoots

Cardinal+CVS

McKesson+Celesio

• More mergers expected

Things to consider for US Brands

• The US market growth is rebounding

• Generics and Specialty will grow faster than the market

• Generics will dominate many therapy areas as New Therapy starts are likely to be generic

• A bad economy has led to less patient visits

• Innovation is improving particularly in Specialty but in some Primary Care classes

• The market still values true innovation but more Comparative Effectiveness and Real World Evidence studies will be needed to prove value

• Successful launches are getting more difficult

• More Reimbursement and Regulatory challenges ahead

• Payers have more control but patient’s influence is growing

• We may see more “Lipitor” like defense strategies

• More mergers can be expected/Ireland Tax treatment

Base case forecast for the U.S. is for 1-4% CAGR

U.S. Spending and Growth, 2008-2017

-4%

-2%

0%

2%

4%

6%

8%

10%

0

50

100

150

200

250

300

350

400

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

GRO

WTH

CO

NST U

S$ S

PEN

DIN

G U

S$BN

Sales Growth

2013-17 CAGR, 1-4%

Forecast

Source: IMS Health Market Prognosis, September 2013

By Doug Long VP Industry Relations [email protected]

u.s pharmaceutical market - c.ymcdn.comc.ymcdn.com/sites/ 25, 2014 · april 2013 ims health...

Documents