directionally right.. or precisely wrong? · new decade, new changes in the pharmaceutical...

Directionally Right.. or Precisely Wrong?

Harvesting and linking the best novel data sources for real

market insight.Berlin 2010

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Kathryn Jones and Marion Wyncoll

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Outline for this Paper

New Decade, New Changes in the Pharmaceutical marketplace Existing data model broken – no precise GPS fix, we are back to taking ‘bearings’ :

Case Study 1: I’ve got my bearings – Multiple Sclerosis Case Study 2: I’m looking for my bearings – Eosinophilic GI disorders

in paediatrics Case Study 3: I’ve lost my bearings: Leading Biologic – what are the

sales by indication?

The New World Order

Important Disclaimer

Our objective is to make this paper meaningful and engaging by the use of REAL NAMED market and product data that is available in the public domain.

While all reasonable steps have been taken to ensure that the data presented are accurate, the authors cannot accept responsibility for errors or omissions.

Where it is not public domain, it is sourced and the relevant prior consents obtained.

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New Decade, Changing Market Place, New Challenges

Biologics

The Future of thePharmaceutical Industry

What does this mean forMarket Research?


Biotech/Conventional Sales Split

Biotech 15%

Convent 85%

2002

5

Biotech 31%

Convent 69%

2009

Source: Evaluate Pharma, World Review 2016

Nearly 50% of top 100 products biologics by 2016

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New Decade, Changing Market Place, New ChallengesBiotechs will not compensate for $128 billion patent

losses….pharma revenues <3% CAGR until 2016


The difference with biologics: multiple indications

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5566 5744

6469

56205922

0

1706

10101

8909

73096788

57275159

4848

0

2000

4000

6000

8000

10000

12000

RA, Psoriasis, Chrons., Ank.

Spon., Psor. Arth., Juv Idio Arth.

MCRC, NSCLC, MRCC, MBr C, Gioblastoma

RA, Psoriasis, Ank. Spon., Psor.

Arth., Juv Idio Arth.

Non Hodgkins Lymphoma, RA,

CLL

Crohns, Ulcerative Colitis,

RA, Psor Arth.

Osteoporosis, RA, mult myeloma

Pneumococcal vaccine

Humira Avastin Enbrel Rituxan Remicade Prolia Prevnar

Top Selling Biologics 2016 ($m)

Year 2009

Year 2016

Source: Evaluate Pharma, World Review 2016


So what are the consequences for pharma?

• Biologics are expensive solutions for niche markets • We are in a orphan drug era: high cost drugs for the few

• Complex distribution networks• Difficult to track within a country - almost impossible across countries

• Business focus on driving up profit while sustaining revenue

• Focus on the bottom line:• Finance controls….more constraints on marketing


What this means for Market Research

• Market Research as an investment not a cost• Finance will definitely want MR to do more with less

even in the face of a more complex operating environment.

• Directionally right may well be all that’s required• Unlike primary care products – low level of data

confidence • One size does NOT fit all any more• Traditional data gathering doesn’t work

• Do LESS with less


Why won’t traditional ways of data capture work?Typical Approach to Defining Brand Revenue across

Multiple Indications

• Small market~25,000 patients in the US.• Traditional audited data doesn’t give the

answer• Use of alternative data

• Claims Data• Ad-hoc quantitative surveys• Logic based stock and flow patient models

• Investment of more than $2.5M in data and data analysis

• And whose view matters most?Audits Medica

l ClaimsChart Audits

Quant Survey

s

Physician reported patient numbers appear to overstate the percent of Brand business

Percent of Business from Indication ‘X’: Estimated Business from Indication ‘X’

Sal

es ($

MM

)

Company Internal

Estimate**(2008)

Consultant Patient Model

Estimate (2008)Quant. Survey (2008)

Claims Data (2008)

MD-Reported Patients*

Annual Patients Quarterly Patients

Claims Data (2008)

Per

cent

of B

rand

+/-2.2%

12% lower due to MD recall bias

+/-2.2%

95% Confidence Interval% Business: % Business:

18.8%22.2%

-15%

Percent of Business from Indication ‘X’: Estimated Business from Indication ‘X’

Sal

es ($

MM

)

Company Internal

Estimate**(2008)

Consultant Patient Model

Estimate (2008)Quant. Survey (2008)

Claims Data (2008)

MD-Reported Patients*

Annual Patients Quarterly Patients

Claims Data (2008)

Per

cent

of B

rand

+/-2.2%

12% lower due to MD recall bias

+/-2.2%

95% Confidence Interval% Business: % Business:

18.8%22.2%

-15%Brand Manager:

OK so its down to my experience –my gut feel says

21%

Physician reported patient numbers appear to overstate the percent of Brand business

New Decade, Changing Market Place, New ChallengesProvide meaningful Decision Support at lower cost

and acceptable limitations

Gaining insight into specialty markets Decisions will be made So creativity is essential Data are available: from novel/non-standard sources Interpret with care Flexibility and courage are essential!

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Existing Model Broken

Our ‘GPS’ is broken:

Old way=100% precision

100% precision = not achievable in the new world order

?What does this mean for Market Research

Existing Model BrokenWe learn from sailors: We need to take bearings

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X

X

X

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Existing Model Broken: Taking Bearings

The sailor takes a fix off 3 lines of position. Where they intersect is the ‘cocked hat’.

This is where the boat is.

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The market researcher can also use this triangular ‘3 fix’ approach to develop and refine market insight

Secondary sources

ExpertsPrimary sources

Critical Business Answers

Existing Model Broken

Taking BearingsThree case studies for Market Researchers

Case Study 1: I’ve got my bearings

• Multiple Sclerosis

Case Study 2: I’m looking for my

bearings

• Eosinophilic GI Disorder in Paediatrics

Case Study 3: I’ve lost my bearings

• Innovative Diagnosis Profiling

High Profile Market with growth potential Easily defined by available drug therapy 5 Major Brands: Avonex, Betaferon, Copaxone,

Rebif and Tysabri Strong development pipeline


Case Study 1: I’ve got my bearings…I want to do an assessment of the Multiple Sclerosis market

High Profile Market with growth potential Easily defined by available drug therapy 5 Major Brands: Avonex, Betaferon, Copaxone,

Rebif and Tysabri Strong development pipelineBut difficult to track performance and monitor Incomplete channel reporting in some countries… Tysabri in the USA dispensed through tightly

controlled program UK: all products distributed through Homecare


Case Study 1: I’ve got my bearings…I want to do an assessment of the Multiple Sclerosis market


Case Study 1: I’ve got my bearings, I want to do an assessment of the Multiple Sclerosis market.

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Case Study 1: I’ve got my bearingsEpidemiology and assessing unsatisfied potential,

where can I go for the information?

Atlas of MS, WHO 2008 Study covering: Epidemiology: incidence and prevalence Diagnosis, Management, Treatment Support and Quality of Life, issues in Care

112 countries reported 88% of the world’s population

Qualitative and quantitative data

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Case Study 1: I’ve got my bearingsEpidemiology and assessing unsatisfied potential,

where can I go for the information?

Atlas of MS, WHO 2008 Study covering: Epidemiology: incidence and prevalence Diagnosis, Management, Treatment Support and Quality of Life, issues in Care

112 countries reported 88% of the world’s population

Qualitative and quantitative data

• And its free• BUT there are limitations

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WHO Region Number of MS sufferers %

Total 1,300,000

Europe 630,000 48

Americas 520,000 40

East Med 66,000 5

West Pacific 56,000 4

SE Asia 31,500 2

Africa 11,000 1

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Case Study 1: I’ve got my bearingsEpidemiology: how many sufferers are there

worldwide?

Atlas of MS, WHO 2008

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World Average 30 per 100,000 populationHigh income countries 80 per 100,000 population

Altas of MS WHO 2008

Existing Model Broken: Taking BearingsCase Study 1: I’ve got my bearings: What is the prevalence

worldwide?

• Global disease: more so that previously thought• More common in women• Symptoms appear around 30

Epidemiology

• Access to neurologist/MRI scanners varies widely• Onset to diagnosis can take months or even years • Health care professionals lack training to identify and

treat

Diagnosis

• Lack of understanding/education/socio economic cost• Few patient driven support groups in many countries• Non access/availability to disease modifying drugs: • 36% MS sufferers/32% health care professionals

Support and Treatment

• More MS will be found as knowledge grows, resources become available and diagnosis improvesConclusion

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Existing Model Broken: Taking BearingsCase Study 1: I’ve got my bearings. What is the unsatisfied

potential?

Atlas of MS, WHO 2008

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Existing Model Broken: Taking BearingsCase Study 1: I’ve got my bearings

So what is the drug therapy currently available?

Source: Biogen Idec website

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.

Source: Merck Serono website

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.

“Global sales of Rebif… jumped 17% to EUR 429 million in the first quarter…mainly due to the fact that U.S. wholesalers received an extra 20 days supply … because Merck’s EMD Serono subsidiary in the United States was converting to a new computer system during April, precluding shipments then. Consequently, second- quarter sales will be lower in the United States”Merck News Release April 28 2010

Source: Merck Serono website

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Existing Model Broken: Taking BearingsCase Study 1: I’ve got my bearings: The trick is pulling this all together,

drilling from worldwide to region/country..and then updating it

Q1 08 Q2 08 Q3 08 Q4 08 Q1 09 Q2 09 Q3 09 Q4 09 Q1 10

Avonex 358 337 381 429 425 420 405 395 436

Betaferon 274 274 291 305 301 320 283 310 283

Copaxone 362 360 373 451 476 484 542 495 585

Rebif 313 320 338 360 368 387 381 401 429

Tysabri 106 128 157 164 174 180 195 196 215

0

100

200

300

400

500

600

700

Major Products used in MS, Global '000 euro

Avonex

Betaferon

Copaxone

Rebif

Tysabri

Source: Company Press releases

Common Food Allergens

Dairy

Egg

Peanut

Tree Nut

Fish

Wheat

Soy

Existing Model Broken: Taking BearingsCase Study 2: I’m looking for my bearingsEosinophilic GI Disorder in Paediatrics

Case Study 2: I’m looking for my bearingsEosinophilic GI Disorder in Paediatrics

Market Knowledge: - Growing numbers of children with food allergies, food

intolerance- Impact: failure to thrive - Increasing number of clinical studies- Active pipeline

Who would be a candidate for treatment with IL-5 ?

Business Question: What is the size of the market opportunity?


General “catch-all” codes- insufficient specificity


Epidemiology Prevalence of EE Diagnosis and treatment

Treatment Algorithm Overall schematic Nutrition and drug treatment options Medical trends and influences

Current and Future Competitors Pipeline compounds

Market Forecast with Assumptions

How to do it?


1 in 10,000 in a Mid-Western community 0.89 per 10,000 – small W. Australia Study 23 per 1000,000 – Switzerland 42.96 per 100,000 in children in Cincinnati

References:1. Noel, Putnam,Rothenberg. Eosinophilic esophagitis. NEJM 2004; 351:940-1 Referenced by Nielsen and Husby J.Ped.

Gastorenterology and Nutrition 45: 281-289 20072. Cherian, Smith, Forbes Rapidly increasing prevalence of EE in Western Australia. Arch. Dis. Child 2006;91:1000-43. Strauman Simon. EE: escalating epidemiology? J Allergy Clin Immunol 2005; 115: 418-94. Noel, Putnam,Rothenberg. Eosinophilic esophagitis. NEJM 2004; 351:940-1 Referenced by Chang and Anderson Pathology

(Jan 2008) 40(1) pp 3-8

US Paediatric Population(Age 5-19)

Extrapolation

6,300

5,600

1,500

26,838

Published Prevalence Data in EE differ widely

Too wide !

Case Study 2: I’m looking for my bearingsHow is EE diagnosed and Treated?

Food elimination / food challenges Therapy with H2/PPI but if they fail…. Endoscopy in three locations needed for diagnosis of EE

Biopsies oesophagus, stomach and duodenum Diagnosis made based on high number of eosinophils

found in oesophagus >or+ 15 eosinophils/ high-power field (HPF) to as high

as 24/HPF

Useful

Images courtesy of Dr. Chris Liacouras, Children’s Hospital of Philadelphia

Case Study 2: I’m looking for my bearingsCurrent Pathway to Diagnosis of Paediatrics with EE

Market Research Mirrors the Treatment Algorithm

Sources:US Census IMS-National Prescription Audit™ HIP / HOPKOL AdvisersUK In–hospital procedureswww.Hesonline.nhs.uk

US Paediatric Population: 63 MM

Treated PPIs/H2: 820K

Referred to Hospital

EDG/Biopsy: 9.8K

Positive diagnosis of EE: 5K (50%)

Social Media as a Resource

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Case Study 3: I’ve lost my bearingsThe Problem: how to attribute sales between indication?

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Resource allocation and investment decisions

• Important for the business• Promotion – field force support/ multi-channel marketing, media

spend• ROI analyses – decision support, measuring promotional impact • Headcount – sales, market access, marketing, medical staff

The issue for Market Research?

• Can we find a cost efficient methodology?

Case Study 3: I’ve lost my bearingsApproaches tried and failed

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Unable to capture all the distribution channels

Audits Biased by specialty and lack of hospital data

Medical Claims Expensive and

time consuming

Chart Audits

Very expensive for tracking

Quant Surveys

Note: This is a marketing survey – NOT a market research survey.

Case Study 3: I’ve lost my bearingsMethodology: “Cheque Study”

Low cost methodology

•Mail survey from your chosen universe•Quick response•Response rate 15-20%•Cost effective for ongoing tracking

Unique insight

•Quick answer to the question of the moment• Individual prescribing behaviour• Link to physician id

Case Study 3: I’ve lost my bearingsUK pilot test

150 physicians in one region 75 Rheumatogists 75 Oncologists

Low value cheque

9 questions including preferred method of communication with pharma co’s.

Opt in option

And the results are…….. With special thanks to Charles Russell at RMS

research

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Case Study 3: I’ve lost my bearingsUK pilot test…and the results are….interesting

23% response rate

• half responses by end week 1• 6% incomplete

27 completed questionnaires

• Half described themselves as early adopters• 20 never or hardly see reps

But the bank stamp!

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Case Study 3: I’ve lost my bearingsUK pilot test…and the results are….more interesting when looking at the profiles

Ref 6201: Rheumatologist

• Caseload 360 patients• Never sees reps• Symposia• Early adopter

Ref 6556: Oncologist

• Caseload 1500 patients• Sees 1-3 reps month• Lunch and learn• Early adopter

Proof of Concept successful

Expand to target audiences to determine split of business by diagnosis

Very valuable information on potential target customers…

Potential for utility in emerging markets

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Case Study 3: I’ve lost my bearingsUK pilot test…Conclusions

Section 3: The New World Order

Pharma Industry changed irrevocably

New Commercial Model

The New World Order

What we’ve heard…….

Do less with less

Base your decision on a degree of certainty-

don’t pursue an absolute

Use your good judgment and be

creative

Adopt new ways to look

at things

75% accuracy – then we

need to move

Look for redundancies in

current MR activities eg

tracking/testing

I want to get closer to my Customers

Improved targeting and productivity

The New World Order

New Challenges for Market Research

Primary care –based Simple distribution Single channel

marketing Marketing centric

One size fits all Measuring and

tracking Turnkey MR

Niche markets with multiple indications

Complex distribution Multi-channel marketing Customer centric

Judgment and creativity Forward looking directional Information agnostic Customer intimacy

FOCUS SHIFT: PRODUCT

TO CUSTOMER

MARKET RESEARCH

SHIFT: AVERAGE TO INDIVIDUAL

OLD WORLD NEW WORLD

The New World OrderNew Opportunities for Market Research

Be information agnostic Develop new competency for synthesizing across

wide range of open-source information resources

Explore / exploit the web and your natural abilities for enquiry

The New World Order Exquisite Customer Intimacy

directionally right.. or precisely wrong? · new decade, new changes in the pharmaceutical...

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