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Rethinking the Risk Equation in Biopharmaceutical Medicine

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Page 1: New healthreport 2012

Rethinking the Risk Equation in Biopharmaceutical Medicine

Page 2: New healthreport 2012

Rethinking the Risk Equation in Biopharmaceutical Medicine

Overvie w

e xpec tatiOns and Obs tacles in He altHc are

patients a s a part Of tHe s ys tem

b iOpHarma’s e vOlving business mOdel

payers seek mOre participatiOn

inves tOr ambivalence, Op timism

mitigating risk : tHe need fOr ne w me tric s

cOnclusiOn

about The New Health Report

about Quintiles

contact information

3

4

8

14

20

24

28

33

t a b l e O f c O n t e n t s

Page 3: New healthreport 2012

3

for a patient, risk largely entails drug safety, such

as concerns over side effects, but patients must

also evaluate the risk of taking one medication

over another, or perhaps none at all. Healthcare

professionals must weigh the risk in using new

drugs versus existing ones. biopharmaceutical

companies, on the other hand, must assess the

risk of moving forward with one investigational

compound or another, proceeding or pausing in

the chain of clinical trials, collaborating with other

stakeholders or going it alone—all of this plus

a host of other concerns. for payers, the risks

involve when and why to reimburse for particular

treatments, while investors seek methods of

analysis to reduce their risks as they decide where

to infuse capital.

The New Health Report 2012 shows, however, that

today’s stakeholders often disagree—between

and within groups—on what risks matter

the most. this study arises from a survey of

biopharmaceutical executives; patients living with

a chronic disease in the united kingdom or the

united states; national Health service (nHs)

executives in the united kingdom; managed care

executives in the united states; and investors

with a focus on the life sciences sector. payer and

patient respondents were deliberately culled from

both the united kingdom and the united states

under the premise that attitudinal differences and

perceptions of healthcare might reveal that an

understanding of risk and benefit is not universal.

further, as the global economic crisis has

produced austerity budgets throughout europe,

cost-conscious payers in these countries need to

make increasingly difficult coverage decisions

that accurately weigh the value and risks of

new treatments.

for stakeholders to make better collective

decisions based on value and risk, they first

need to assimilate the varying perceptions of the

concept, and then take a systematic approach

in order to better manage it. currently, the tools

used to balance healthcare risk versus reward

remain rather rudimentary, and lessons from

other industries could accelerate improvements

in patient outcomes. for example, making the

most of the available data—from preclinical

information to patient outcomes—requires new

tools and sophisticated methods to interrogate

the data. with more robust sources of data,

healthcare players can plan the pathways to the

next generation of lower-risk, higher-benefit

medications that balance the needs of all

stakeholders. as the results of this survey reveal,

considerable evidence already suggests a new

pathway. the stakeholders must function like

teammates, instead of opponents, to make the

most of existing opportunities. the resulting

collaboration could spawn a range of improved

methods for reducing and communicating the

risks and benefits of biopharmaceutical medicine.

overview

The essence of healthcare arises from the tradeoffs between risk and value. Last

year’s New Health Report focused on value, and patients, physicians, payers and

biopharmaceutical executives defined this concept in many ways. For example, only

two percent of patients polled mentioned cost and outcomes when defining value as

opposed to 38 percent of biopharmaceutical executives. As with value in healthcare, risk

extends across the constellation of stakeholders, and each group sees risk from a unique

perspective.

Page 4: New healthreport 2012

www.quintiles.com/newhealthreport

On a fundamental level, risk is always attached to expectations. This idea lies behind the

business concept of the risk-return tradeoff, which states that increasing the potential of

the return raises the risk. To understand the risk-return tradeoffs in healthcare, The New

Health Report 2012 asked biopharmaceutical executives, managed care executives in the

United States, National Health Service executives in the U.K. and healthcare-focused

investors a series of questions designed to uncover different perceptions as to what the

future of healthcare might look like.

In terms of the general health of people born today, most of the respondents see longer

lives ahead. For instance, the majority of biopharma executives and U.K. payers expect

lifespan to reach an average of 90 years, and nearly half of U.S. payers and half of investors

agree. Regarding the health of people in general, just under half of the respondents from

most groups predict improvements, and a slightly higher percentage of U.K. payers agree.

Expectations and Obstacles in Healthcare

Page 5: New healthreport 2012

Expectations and Obstacles in Healthcare 5

Investors Sums may not add to 100% or be equal to components due to rounding

in terms of the capabilities of medicines in the

future, the responses are less certain. fewer than

half of the experts from biopharma and u.s.

payers and even fewer of the investors expect

to see cancer becoming a manageable disease

in the near future, but u.k. payers are more

optimistic. when asked about the likelihood of a

cure for alzheimer’s over the next generation, the

stakeholders answer similarly to their responses

on managing cancer, although the investors rank

alzheimer’s disease as more likely to be cured.

those medical milestones, however, will come at

a cost. for example, less than one-fifth of u.s.

payers and one-quarter of biopharma experts

expect cost-effective healthcare in the united

states over the next generation in comparison

to other countries. in contrast, about half of

u.k. payers expect cost-effective healthcare—

more than twice the amount of their american

counterparts.

r e s t r a i n e d O p t i m i s m f O r a n u n c e r t a i n f u t u r e

l e s s t H a n O n e - f i f t H O f u . s .

p ay e r s a n d O n e - Q u a r t e r

O f t H e b i O p H a r m a e x e c s

e x p e c t c O s t- e f f e c t i v e

H e a lt H c a r e i n t H e u n i t e d

s tat e s O v e r t H e n e x t

g e n e r at i O n i n c O m p a r i s O n

t O O t H e r c O u n t r i e s .

Life expectancy for the average person will be 90 years

Most cancers will become a manageable disease

A cure for Alzheimer’s will be found

The nation will become healthier overall

US / UK healthcare will be considered cost-effective

compared to other developed countries

64% 45%

45% 45%

45% 40%

68% 50%

55% 37%

59% 51%

43% 41%

24% 19%

59% 47%

45% NA

Biopharma, Payers, Investors | Percent who consider it very or somewhat likely that in the lifetime of people born today...

I N V E S T O R SB I O P H A R M A P A Y E R S

Page 6: New healthreport 2012

6 2012 | The New Health Report

www.quintiles.com/newhealthreport

looking more closely at the elements of

tomorrow’s healthcare, stakeholders were asked

about their optimism or pessimism related to

future healthcare quality and pharmaceuticals. in

terms of the quality of healthcare a decade from

now, two-thirds or more of biopharma executives,

u.s. payers and u.k. payers, plus nearly three-

quarters of investors express optimism, but less

than half of u.k. and u.s. patients agree. in fact,

fewer than 40 percent of u.k. patients claim to be

optimistic about tomorrow’s quality of healthcare.

the disconnect between u.k. payers (66 percent)

and u.k. patients (38 percent) is striking and may

indicate an underlying lack of confidence in the

future direction of the nHs.

despite eight out of 10 biopharma executives

being optimistic about the quality of prescription

medications in 10 years, they do anticipate

challenges. foremost, these experts expect to

travel a rough road with regulators from the u.s.

food and drug administration (fda). a lack of

capital and the increased reluctance of payers to

reimburse for new medication are also serious

concerns. in general, investors agree with the

concerns over a changing regulatory landscape,

but show less concern over financing, perhaps

because investors live every day in a world of

financial risk.

Biopharma, Payers, Investors, Patients | 2012 ; Biopharma, US Payers, Physicians, US Patients | 2011Percent who are somewhat or very optimistic about the future of healthcare

QUALITY OF HEALTHCARE

IMPROVED 10 YEARS FROM NOW

QUALITY OF PRESCRIPTION

MEDICINES IMPROVED

10 YEARS FROM NOW

0 % 2 0 % 4 0 % 6 0 % 8 0 % 1 0 0 %0 %2 0 %4 0 %6 0 %8 0 %1 0 0 %

2 0 1 1 2 0 1 2

U S P H Y S I C I A N SU K P A Y E R S I N V E S T O R SB I O P H A R M A U S P A Y E R S U S P A T I E N T S U K P A T I E N T S

64%

63%

44%

54%

72%

76%

59%

72%

69%

68%

66%

74%

49%

38%

80%

81%

93%

68%

N/A

N/A

N/A

N/A

N/A

N/AN/A

N/A

N/A

N/A

Page 7: New healthreport 2012

Expectations and Obstacles in Healthcare 7

Investors Sums may not add to 100% or be equal to components due to rounding

29% More difficult FDA approval process

12% Increased requests for more data

19% Increased payer reluctance to cover new medications

10% Global economic downturn

20% Lack of funding / capital

9% Other

Biopharma | Which is the biggest challenge facing your company? a l a c k O f c a p i ta l a n d t H e

i n c r e a s e d r e l u c ta n c e

O f p ay e r s t O r e i m b u r s e

f O r n e w m e d i c at i O n s a r e

s e r i O u s c O n c e r n s .

Page 8: New healthreport 2012

www.quintiles.com/newhealthreport

One could argue that patients take on the most risk in healthcare because their quality of

life hangs in the balance. Consequently, they stand to gain the most from understanding

their own health. Yet when asked to rate their overall health, three-quarters of U.S. patients

consider their health good to excellent which seems unlikely in a country where more

than two-thirds of the population is overweight or obese. By comparison, only about 50

percent of U.K. patients give themselves similar assessments. In short, U.S. patients see

themselves as healthy—probably healthier than they are—and U.K. patients are likely

providing somewhat more accurate self-evaluations.

Patients as a Part of the System

Page 9: New healthreport 2012

Patients as a Part of the System 9

Investors Sums may not add to 100% or be equal to components due to rounding

given that the population of patients in this

survey all suffer from a chronic disease, no

surprise comes from their overwhelming response

to being adequately informed about the benefits

of taking their medicines. more than 90 percent

of both u.k. and u.s. patients feel they know the

benefits of taking their medication—an expected

result from respondents in which two-thirds take

at least three prescription medications, and more

than a quarter of them take more than five (data

not shown).

some variations among the patients start to

appear when examining their beliefs about the

risks behind those prescriptions. although both

patient groups show this drop in confidence when

moving from understanding the benefits of a

medication to assessing its side effects, the data

do reveal differences between the two cohorts.

for instance, u.s. patients appear far more

confident than u.k. patients when it comes to

information about side effects, 86 to 69 percent,

respectively. likewise, u.s. patients exhibit a

similar offset when it comes to knowing about a

drug’s potential risk (84 percent), when compared

with the u.k. patients (64 percent).

direct-to-consumer advertising in the united

states may partly explain these differences, as

patients are bombarded with lengthy disclaimers

about potential side effects and safety concerns.

another explanation may be the litigious nature

of the united states, where physicians are more

apt to discuss the side effects and not just the

benefits of medications. in any case, these data

reveal an opportunity for biopharmaceutical

companies to better communicate the risk-benefit

tradeoffs of medicines in terms meaningful

to patients.

in the u.s and the u.k., patients give the

biopharmaceutical industry little credit for making

medications safe and effective. both patient

populations believe that physicians do the best

job of that, followed by patient-advocacy groups.

in addition, fewer than half of the patients feel

like the biopharmaceutical industry does a good

job of making new medications available as

Patients | Percent who feel adequately informed about...

U S P A T I E N T S U K P A T I E N T S

The benefits of taking your medication

94%

92%

Side effects

86%

69%

64%

Potential risks of taking it

84%

How the drug works in your body

71%55%

How it compares to existing medication

66%

51%

u . s . p at i e n t s a p p e a r fa r

m O r e c O n f i d e n t t H a n u . k .

p at i e n t s w H e n i t c O m e s

t O i n f O r m at i O n a b O u t

s i d e e f f e c t s .

Page 10: New healthreport 2012

1 0 2012 | The New Health Report

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quickly as possible. given that getting new drugs

on the market provides the income that feeds

biopharma, the industry seems unlikely to halt

or slow down drug development for anything

other than risk or benefit concerns. notably, both

groups of patients realize the role of regulators

in the timing of medicines reaching the market.

a misunderstanding of the process is clearly

evident, however, as more than 60 percent of

u.s. patients credit physicians with making drugs

available as soon as possible, and more than

a third of patients in the u.s. and the u.k. feel

patient advocacy groups have significant bearing

on drug development.

despite both patient populations showing a

lack of faith in the biopharmaceutical industry’s

ability to ensure safe and effective drugs, patients

want the industry to work even faster. nearly 90

percent of u.k. patients think that it takes too

long to get new drugs to patients. some of the

negative responses from u.k. patients, however,

might have been heightened by media coverage

which regularly highlights instances in which the

nHs has declined to fund a new medication.

although the majority of u.s. patients seems to

think that no one—except physicians—does a

very good job of getting drugs on the market as

fast as possible, only 69 percent of those patients

say that the process takes too long, which is

nearly 20 percent fewer than u.k. patients.

perhaps most interesting of all, a high percentage

of both patient populations express an interest

in taking more risk with medications. more than

70 percent of u.s. patients and four out of five

u.k. patients believe it should be their right to

take a high-risk medication if they hope for some

improvement in their health. in other words,

these responses indicate that many patients want

Patients | Group does an excellent/ good job of…

DOCTORS

PATIENT ADVOCACY GROUPS

PHARMACEUTICAL COMPANIES

REGULATORY AUTHORITIES

HEALTH INSURANCE PROVIDERS

0 % 2 0 % 4 0 % 6 0 % 8 0 %0 %2 0 %4 0 %6 0 %8 0 %

MAKING SURE MEDICATIONS ARE SAFE AND EFFECTIVE

MAKING SURE NEW DRUGS ARE AVAILABLE TO PUBLIC AS QUICKLY AS POSSIBLE

U S P A T I E N T S U K P A T I E N T S

Page 11: New healthreport 2012

Patients as a Part of the System 1 1

Investors Sums may not add to 100% or be equal to components due to rounding

medicines faster rather than safer, if they must

choose. nonetheless, half of u.s. patients also

feel that medications get approved too quickly

without balancing safety. taken together, the

responses from u.s. patients highlight some

disconnected thinking regarding risk: they want

and expect medications quickly, but aren’t fully

aware of the trade-offs involved.

simply thinking about risk often differs from

acting on it. instead of wondering how patients

respond when faced with the risks related to

prescription pharmaceuticals, their behaviors

provide a much clearer picture. to get at those

behaviors, patients were asked if they ever turned

down or stopped taking a medication because of

safety or side-effect concerns. roughly speaking,

only about one-third of u.k. patients said that

they had, compared to half of u.s. patients. so

even if most u.s. patients want the right to take

a risky medicine if they choose to, at least half

of them might forego the drug for fears related

to safety or side effects. again, the safety- and

side effect–laden advertising in the united states

—and the related litigious environment—might

cause some of this difference between the patient

populations.

to explore how patients approach assessing

risk and value, they were presented with several

Patients | Do you agree or disagree that...

The process of getting new drugs to patients takes too long.

69%

88%

We take too long to make drugs available, which costs lives by forcing people to go without potentially beneficial therapies.

71%

87%

81%

Patients should be able to choose to take potentially risky medication even if it is not approved for use if they feel it is their only chance to improve their health.

72%

In this country, we are too quick to approve new prescription medications without understanding all of the possible safety issues.

% who agree

50%

31%

U S P A T I E N T S U K P A T I E N T S

Patients | Have you ever….

Turned down a medication that your doctor has prescribed because of concerns about safety or side effects.

% answering yes

51%

27%

Stopped taking a medication before checking with your doctor because of side effect or safety concerns.

46%

35%

U S P A T I E N T S U K P A T I E N T S

m O r e t H a n 7 0 p e r c e n t O f

u . s . p at i e n t s a n d n e a r ly

9 0 p e r c e n t O f u . k . p at i e n t s

b e l i e v e i t s H O u l d b e t H e i r

r i g H t t O ta k e a H i g H - r i s k

m e d i c at i O n i f t H e y H O p e

f O r s O m e i m p r O v e m e n t i n

t H e i r H e a lt H .

Page 12: New healthreport 2012

1 2 2012 | The New Health Report

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hypothetical scenarios with varying degrees of

both benefit and risk. in circumstances in which

a cancer drug could extend a person’s life by a

decade, the patients considered two side-effect

risks, one related to nausea (a 15 or 75 percent

risk) and another related to heart attack (a 5 or

50 percent risk). across all of these scenarios,

u.k. patients express far more willingness to

accept the risks for the potential 10-year return.

even when facing a 50 percent risk of a heart

attack, nearly 80 percent of u.k. patients still

want the treatment, but less than half of u.s.

patients do.

u.k. patients continue to show less aversion

to risk than u.s. patients when presented with

chronic pain–based scenarios, but in almost all

cases patients in both countries were less willing

to accept an increased risk for a lesser benefit.

while nearly six out of 10 u.s. patients and nine

out of 10 u.k. patients would be interested in a

drug that reduced chronic pain to a manageable

level with a 15 percent risk of nausea, the number

of patients interested in the same drug with a 50

percent risk of heart attack drops precipitously

among both groups (26 percent for u.s. patients,

40 percent for u.k. patients).

these findings have several implications for

the biopharmaceutical industry. as with other

stakeholders, patients go through a process of

assessing risk versus benefit by weighing factors

of varying importance to them. as shown above,

patient tolerance for risk is dependent upon

the perceived value of a medication relative to

its safety profile, although it appears that many

patients struggle with assessing risk based on the

probability of an adverse event. this underscores

the industry’s imperative to better communicate

U S P A T I E N T S

20%

20%

60%

U K P A T I E N T S

21%

29%

50%

Very/Somewhat Interested

Not sure

Not very/Not at all interested

Patients | If there were a new medication that was available that could reduce the symptoms you currently have and improve your day-to-day life, but had an increased risk of a serious event like a heart attack, how interested would you be in it?

U S P A T I E N T S

26%

20%

54%

U K P A T I E N T S

20%

33%

47%

Patients | If there were a new medication that was available that could improve your condition so much that you would live longer, but had an increased risk of a serious event like a heart attack for some, how interested would you be in it?

Very/Somewhat Interested

Not sure

Not very/Not at all interested

Page 13: New healthreport 2012

Patients as a Part of the System 1 3

Investors Sums may not add to 100% or be equal to components due to rounding

the value and risks of new medications in terms

that are meaningful to patients. further, coupled

with increasing payer scrutiny for demonstrable

proof of a new product’s superiority versus

existing therapies, the biopharmaceutical industry

must strive to develop more sensitive measures

that incorporate patient-important outcomes into

clinical development.

15% RISK OF NAUSEA

75%

RIS

K O

F N

AU

SE

A

5%

RI S

K O

F H

EA

RT

AT

TA

CK

5 0 % R

I S K O F H E A R T A T T A C K

46%

77%

84%

48%

88%

49%

92%

55%

1 5 % R I S K O F

7 5 % R I S K OF

5% R

I SK

OF

50

% R

I SK

OF

15

% R

ISK

OF

75%

RIS

K O

F

5% RISK OF

50% RISK OF

N A U S E A

N A U S E A

HE

AR

T A

TT

AC

K

HE

AR

T A

TT

AC

K

NA

US

EA

NA

US

EA

HEART ATTACK

HEART ATTACK

E L I MI N

AT E S P AI N

MA

NA

GE

AB

LE PAIN LEVEL

75%54%

60%

83%

59%

63%58%

84%

89%

42%47%

40%

26%

31%

86%

48%

We tested a series of 12 scenarios around a hypothetical new medication, which included a condition (cancer or chronic pain), a benefit (extended life or better QOL) and a risk (safety or side effect). Each patient indicated how interested he/she would be in the new medication.

U S P A T I E N T S U K P A T I E N T S

C A N C E R / E X T E N D L I F E 1 0 Y E A R S C H R O N I C P A I N

% who are interested

Page 14: New healthreport 2012

www.quintiles.com/newhealthreport

While patients provide clear but disparate answers about accepting risk, biopharmaceutical

executives paint a much more clouded picture. Asked to assess the level of risk their

company must take when exploring new opportunities, the group as a whole could not

agree. Roughly equal amounts of them respond that they should reduce their risk, keep the

same risk or take on more risk. Although these data seem to suggest confusion, the lack

of a homogenous perception of risk may be partly explained by various companies’ current

location on the risk tolerance spectrum. Those with stronger pipelines and less patent

exposure may have less of an appetite for risk than those who are facing such challenges.

Biopharma’s Evolving Business Model

Page 15: New healthreport 2012

Biopharma’s Evolving Business Model 1 5

Investors Sums may not add to 100% or be equal to components due to rounding

biopharmaceutical executives agree, however,

that regulators should accept more risk. when

asked to indicate which stakeholders should take

on more risk in the healthcare industry, 65 percent

of biopharma execs say government regulators

in the u.s. or the u.k. nearly 60 percent of the

executives also believe that payers should accept

more risk.

perhaps surprisingly, half of the biopharmaceutical

executives point the risk finger at their own

industry. taken collectively with the previous

indication that only 36 percent of the executives

B I O P H A R M AE X E C U T I V E S

38% Reduce risk profile

36% Take on more risk

27% Maintain existing risk profile

Biopharma | For your company to be successful in the future, will it need to...

0 %

2 0 %

4 0 %

6 0 %

8 0 %

1 0 0 %

Biopharma | Which group(s) need to take or accept more risk to improve pharmaceutical agents and public health?

B I O P H A R M A

The FDA Health insurance companies

Pharmaceutical companies

Investors Physicians

t H i r t y- s i x p e r c e n t O f

b i O p H a r m a e x e c u t i v e s f e e l

t H e i r c O m p a n y s H O u l d

ta k e O n m O r e r i s k . t H i s

f i n d i n g u n d e r s c O r e s t H e

l a c k O f a g r e e m e n t w i t H i n

t H e b i O p H a r m a c e u t i c a l

i n d u s t r y O n i t s r O l e

i n r i s k a n d w H e r e t O

t r a n s f e r i t.

Page 16: New healthreport 2012

1 6 2012 | The New Health Report

www.quintiles.com/newhealthreport

feel their company should take on more risk, this

finding underscores the lack of agreement within

the biopharmaceutical industry on its role in risk

and where to transfer it.

for the industry to be successful in transferring

or mitigating risk, it is helpful to determine where

in the development process biopharma execs

perceive the most risk.

asked to estimate the risk across the drug

development and clinical testing cycle, 55 percent

of biopharma respondents understandably say

that phase iii testing poses the largest risk. at

both the early and post-marketing stages, the

executives see relatively small risks. the focus on

phase iii as the highest risk makes perfect sense,

given the high cost of this stage of testing, as well

as the overall investment of resources and time

that are on the line at this point.

confidence among biopharma execs to accurately

assess the risk/opportunity ratio at the various

development phases raises some questions,

however. Overall, the executives show high

confidence in their ability to assess risk across the

drug creation cycle. the surprise comes in the

trend—indicating higher confidence in their ability

to assess risk versus opportunity at earlier stages

and progressively less as the process moves

forward. it would seem intuitive that biopharma

companies would have more data to assess risk

over time as they gather more evidence and a

better understanding of the drug. but a lack of

confidence in the underlying data used for phase

iii risk assessment is an acknowledgement that

the level of risk is higher. that only 62 percent

of biopharma execs feel they have adequate

information to assess risk at phase iii is likely a

reflection of the increasing stakes at this stage

from a financial and reputational perspective.

nonetheless, with nearly four out of 10 execs

saying they don’t have enough information, the

need for more robust sources of data becomes

very clear.

if the biopharmaceutical industry applied a wider,

more encompassing lens to gathering data and

then relied on more sophisticated tools and

techniques to unearth the true insights embedded

in the data, it could start along a path toward

better decisions about risk-value tradeoffs. for

example, better endpoints at early development

stages could make phase iii results more

confirmatory, and thereby less prone to risk.

P H A S E I T E S T I N G

P H A S E I I T E S T I N G

P H A S E I I I P O S TA P P R O VA L

Biopharma | At what stage(s) of the drug development process do you see the greatest risks?

Biopharma | Percent who feel they have necessary data to accurately assess risk vs. opportunity for new products

B I O P H A R M A

P R E C L I N I C A L T E S T I N G

B I O P H A R M A

B I O P H A R M A

77%

11%

77%

15%

69%

31%

62%

55%

61%

16%

Page 17: New healthreport 2012

Biopharma’s Evolving Business Model 1 7

Investors Sums may not add to 100% or be equal to components due to rounding

in addition to incorporating better sources of

data into clinical development to alleviate some

of the risk along the development lifecycle, risk-

sharing agreements between biopharmaceutical

companies and payer organizations hold potential

as well. in fact, 60 percent of biopharma execs

expect to see more risk- and cost-sharing

agreements with payers in the next five years.

further benefits—beyond the obvious reduction

of risk for the biopharmaceutical industry—

should come from such sharing. respondents

see enhanced patient population targeting as the

top potential benefit of such agreements, as data

collected by payers could help biopharmaceutical

companies improve their ability to personalize

prescriptions to a population that would benefit

more than others. likewise, the executives believe

that such agreements would improve access to

drugs and accelerate time to market. such risk-

sharing agreements between drug companies

and payers might also drive earlier interactions

between the two stakeholders, which could

fuel faster, broader access to new drugs. the

collaborations could also enhance outcomes data,

according to 60 percent of the executives.

getting these stakeholders to interact throughout

the process could lead to other benefits. for

example, more than half of them believe that

such risk-sharing would increase sales and nearly

half expect such risk-sharing to improve patient

adherence.Biopharma | Do you think risk- and/or cost-sharing agreements with payers will become more common in the next five years?

60% YES

r i s k - s H a r i n g a g r e e m e n t s b e t w e e n d r u g c O m p a n i e s

a n d p a y e r s m i g H t a l s O d r i v e e a r l i e r i n t e r a c t i O n s

b e t w e e n t H e t w O s t a k e H O l d e r s .

i f t H e b i O p H a r m a c e u t i c a l

i n d u s t r y a p p l i e d a w i d e r ,

m O r e e n c O m p a s s i n g l e n s

t O g at H e r i n g d ata a n d

t H e n r e l i e d O n m O r e

s O p H i s t i c at e d t O O l s a n d

t e c H n i Q u e s t O u n e a r t H

t H e t r u e i n s i g H t s e m b e d -

d e d i n t H e d ata , i t c O u l d

s ta r t a l O n g a p at H t O wa r d

b e t t e r d e c i s i O n s a b O u t

r i s k- va l u e t r a d e O f f s .

Page 18: New healthreport 2012

1 8 2012 | The New Health Report

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despite the numerous perceived benefits of

risk-sharing agreements with payers, biophar-

maceutical executives appear hesitant to actually

put them into practice. when asked about

potential issues that could cause problems, most

of the executives indicate trouble from all of them.

at the top, 71 percent of the biopharmaceutical

executives say that the agreements will eat up too

much in administrative costs. the executives do

indeed expect improved outcomes data from such

agreements, yet claim that understanding clinical

versus real-world outcomes could be another

obstacle exacerbated by risk-sharing agreements

with payers. the list goes on, and the executives

paint a picture in which such agreements look

far off at best and maybe unlikely at all.

as an overview of the opinions that the

biopharmaceutical executives express, they

appear to see the need for changes in how they

handle risk, but they see no way forward. in fact,

they still perceive regulators as the bottleneck,

while appearing unable to agree on whether the

pharmaceutical industry itself should accept more

or less risk. in addition, the executives indicate—

across a variety of metrics—the potential value of

developing risk-sharing agreements with payers,

but then check off virtually every reason that

precludes such forward motion.

Biopharma | Percent saying risk-sharingagreements would mean significant/slight improvements in...

B I O P H A R M A

Enhanced patient population targeting

70%

Increased patient access to drugs that otherwise would not make it to market

65%

Drugs available to patients more quickly

63%

Improved outcomes data

60%

Increased sales for manufacturers

53%

Shorter timeline to market formanufacturer

52%

Improved adherence

47%

b i O p H a r m a e x e c u t i v e s

a c k n O w l e d g e t H e

p O t e n t i a l va l u e O f

d e v e l O p i n g r i s k- s H a r i n g

a g r e e m e n t s w i t H p ay e r s ,

b u t t H e n c H e c k O f f

v i r t u a l ly e v e r y r e a s O n

t H at p r e c l u d e s s u c H

f O r wa r d m O t i O n .

Page 19: New healthreport 2012

Biopharma’s Evolving Business Model 1 9

Investors Sums may not add to 100% or be equal to components due to rounding

Biopharma | Percent saying these are somewhat/significant problems with risk-sharing agreements

B I O P H A R M A

Administration costs too high

71%

Difficult to pre-assess what outcomes will result in real-world use of agent, rather than clinical trials

69%

Difficult to agree on definition of success with payers / manufacturers

68%

Regulatory risk

63%

Information produced might be useful to competitors

63%

Difficult to accurately measure success in a performance-based risk-sharing agreement

60%

Have to shift post-marketing resources from enhancing the product to proving the product

54%

Page 20: New healthreport 2012

www.quintiles.com/newhealthreport

In healthcare, organizations providing coverage most likely perform some of the most

focused analysis of risk. For this study, the payers consist of managed care executives

in the United States (U.S. payers) and National Health Service executives in the U.K.

(U.K. payers). In assessing their own allocation of risk versus opportunity, the majority

of payers—nearly two-thirds—express confidence that they get the balance about right.

Despite the vast differences that distinguish the single-payer system in the United

Kingdom and the multi-payer system in the United States, the two payer groups take very

similar views on their organizations’ current handling of risk.

When it comes to other stakeholders, however, payers want them taking on more risk to

improve pharmaceutical agents and public health. Both U.K. and U.S. payers—68 and

77 percent, respectively—want the biopharmaceutical industry to accept more risk, and

more than half of both groups also feel that regulators should shoulder more risk. Perhaps

surprisingly, particularly given the payers’ claims of effective risk balancing, nearly half of

U.S. payers and 39 percent of U.K. payers reply that their own groups also need to accept a

higher level of risk to benefit public health. Unlike U.S. payers, half of U.K. payers feel that

investors must risk more, as well. Overall, the payers favor spreading risk across a wide

section of healthcare stakeholders.

Payers Seek More Participation

Page 21: New healthreport 2012

Payers Seek More Participation 2 1

Investors Sums may not add to 100% or be equal to components due to rounding

in addition to a strong preference for spreading

risk among multiple stakeholders, payers also

seek increasing involvement in the entire lifecycle

of a medicine. as a step toward this, the payers

in this survey—70 percent of the u.k. payers and

79 percent of u.s. payers—expect more risk- and

cost-sharing agreements between themselves

and the biopharmaceutical industry over the

next five years. in parallel with that evolution, the

payers want more interaction across the drug-

development cycle.

portions of the payers already indicate some

participation in drug development. among u.k.

payers, for example, one-quarter or less of them

indicate taking part in preclinical and phase i

testing. for phases ii and iii, the percentages

increase, rising to 52 percent for the latter. for

post-marketing surveillance, 59 percent of u.k.

payers claim some level of involvement. so out

of those five stages of drug development, the

majority of u.k. payers only participate toward

the end. a similar trend appears in the responses

from u.s. payers, although with slightly higher

involvement at the preclinical stage, and then less

involvement at the other stages in comparison

with u.k. payers. for instance, only 31 percent of

u.s. payers—21 percentage points fewer than

U S P A Y E R S

11%

27%

63%

U K P A Y E R S

23%

18%

59%

Payers | Which comes closest to your feeling about how your organization balances risks and opportunities?

We need to reduce risk by taking a more conservative approach

We need to take more risks to capture more opportunities

We do a good job balancing risks and opportunities

0 %

2 0 %

4 0 %

6 0 %

8 0 %

1 0 0 %

Payers | Which group(s) need to take or accept more risk to improve pharmaceutical agents and public health?

U K P A Y E R SU S P A Y E R S

The FDA; UK: Government

regulators

Health insurance companies;

UK: Primary Care Trusts and other

providers

Pharmaceutical companies

Investors Physicians Patients

Page 22: New healthreport 2012

2 2 2012 | The New Health Report

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the u.k. ones—claim to participate in phase iii

testing. given the general consensus that phase

iii carries the highest risk of all, payers clearly

desire more involvement at that stage of drug

development.

in fact, this survey finds that payers want

more involvement at every stage. in a general

comparison of the responses for current versus

desired involvement, the numbers nearly double

in many instances. for preclinical testing, for

instance, only 18 percent of u.k. payers claim

current involvement, but 43 percent—nearly two

and a half times as many—say that they should be

involved. as expected, both groups of payers also

show strong interest in gaining more involvement

in phase iii testing.

the lack of involvement by payers in drug

development indicates that the biopharmaceutical

industry does not interact effectively with its

customers—who are increasingly the payers,

more so than physicians and patients—about the

products that it should be making.

if the payers’ predicted increase in risk-sharing

agreements does arise in the next five years, these

stakeholders also expect significant returns—

particularly for patients. as a group, the payers

believe that risk-sharing between themselves and

the biopharmaceutical industry will give patients

quicker access to drugs. interestingly, u.k payers

respond more strongly on these points than u.s.

payers. indeed, such risk-sharing should return

higher benefits in a single-payer system, where a

Payers | How involved is your organization / how involved should it be at the following stages of drug development?

I S I N V O L V E D

S H O U L D B E I N V O L V E D

I S I N V O L V E D

S H O U L D B E I N V O L V E D

PRECLINICAL

PHASE I

TES

TIN

G

PH

AS

E I

I T

ES

TIN

G

PH

ASE

III

TESTIN

G

POST APPROVAL

23%

45%

24%44%

27%

48%

31%

61%

42%

76%

PRECLINIC AL

PHASE I TESTIN

G

PH

AS

E II T

ES

TIN

G

PH

ASE III TESTIN

G

POST APPROVAL

18%

43%

25%

48%

36%

64%

52%70%59%

84%

U S P A Y E R S U K P A Y E R S

Page 23: New healthreport 2012

Payers Seek More Participation 2 3

Investors Sums may not add to 100% or be equal to components due to rounding

coordinated attack on disease might be easier to

orchestrate than in the u.s. multi-payer system.

somewhat oddly, and like the biopharmaceutical

executives surveyed, about half of payers expect

such risk-sharing agreements to improve patient

adherence, although such a connection does

not seem immediately obvious. moreover,

few strategies can boast making significant

improvements in adherence, which is notoriously low.

similar to the biopharmaceutical executives,

the payers convey many concerns that must

be addressed to implement such risk-sharing

agreements. Of significant interest, these

responses indicate the different level of control

that might be possible in a single- versus a multi-

payer system. for example, u.k. payers express

less concern over related administration costs and

the related parties’ ability to agree on successful

outcomes. so although both groups of payers

seek more involvement in the drug development

process, neither shows high confidence that

risk-sharing agreements can be developed in the

current climate.

Payers | Percent saying risk-sharingagreements would mean significant/slight improvements in...

Increased patient access to drugs that otherwise would not make it to market

68%

89%Drugs available to patients more quickly

59%93%

75%

Improved outcomes data

61%Increased sales for manufacturers

Shorter timeline to market for manufacturer

Real-world validation of pharmaceutical risk/benefit

Improved adherence

61%77%

69%70%

U S P A Y E R S U K P A Y E R S

61%69%

44%59%

Payers | Percent saying these are somewhat/significant problems with risk-sharing agreements

Administration costs too high

72%

59%

Difficult to pre-assess what outcomes will result in real- world use of agent, rather than clinical trials

64%

59%

64%

Difficult to agree on definition of success with payers / manufacturers

61%

Difficult to accurately measure success in a performance-based, risk-sharing agreement

Have to shift post-marketing resources from enhancing the product to proving the product

56%50%

U S P A Y E R S U K P A Y E R S

59%

75%

Page 24: New healthreport 2012

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The healthcare-focused investors surveyed for this report rate the biopharmaceutical

industry as high-risk. In fact, 94 percent of the investors see more risk in placing capital

in the biopharmaceutical industry than in other sectors. Moreover, almost none of the

investors—only 6 percent—rate the biopharmaceutical industry as less risky for investing

than other areas. Consequently, this high-risk expectation forms one of the strongest

examples of consensus in the results of this year’s survey.

Investor Ambivalence, Optimism

Page 25: New healthreport 2012

Investor Ambivalence, Optimism 2 5

Investors Sums may not add to 100% or be equal to components due to rounding

despite the high risk of investing in the

biopharmaceutical industry, 73 percent of

investors feel optimistic about the prospects for

investments in this area. One-third of investors

even expect to invest more in this industry over

the next three to five years, and only 17 percent

intend to invest less. still, even more of the

investors—65 percent—expect to increase their

investments in biotechnology specifically, and

only 13 percent expect to invest less in that field.

given that investors see high risk in investing in

the biopharmaceutical market as it is, one would

imagine that could keep them from suggesting

that the drug industry should take on any more

risk. in fact, 47 percent of the investors feel that

the biopharmaceutical industry does a good job

of balancing risk with rewards. among those who

disagree, however, most of them—37 percent—

believe that the drug industry should take on

additional risk. with investors always interested

in spreading the risk and feeling that they already

take big risks to invest in this industry, some

of them naturally want to see the drug industry

raising its risk bar, too.

I N V E S T O R S

44% Significantly greater risk

50% Slightly greater risk

6% Less risk

Investors | Does investment in the biopharmaceutical sector represent greater or less risk than other sectors?

Investors | Are you pessimistic or optimistic about the investment prospects in the biopharmaceutical industry in the next 5 years?

I N V E S T O R S

73% Optimistic

27% Pessimistic

s e v e n t y t H r e e p e r c e n t O f i n v e s t O r s f e e l O p t i m i s -

t i c a b O u t t H e p r O s p e c t s f O r i n v e s t m e n t s i n t H e

b i O p H a r m a c e u t i c a l i n d u s t r y .

O n ly s i x p e r c e n t O f i n v e s -

t O r s r at e t H e b i O p H a r m a -

c e u t i c a l i n d u s t r y a s l e s s

r i s k y f O r i n v e s t i n g t H a n

O t H e r s e c t O r s .

Page 26: New healthreport 2012

2 6 2012 | The New Health Report

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when it comes to risk- and cost-sharing between

biopharma and payers, investors display

ambivalence. Only 42 percent of them expect

such agreements to be common in five years.

likewise, investors stand largely divided on

the potential benefits of such agreements for

themselves and for patients.

Investors | Increasing / decreasing investment in specific sectors in the next three to five years

D E C R E A S EI N C R E A S E S T A Y T H E S A M E

P H A R M A C E U T I C A L C O M P A N I E S

B I O T E C H N O L O G Y C O M P A N I E S

17%

50%

33%

65%

22%

13%

Investors | Do you think risk/cost-sharing agreements between biopharmaceutical companies and payers will become more common in the next five years?

I N V E S T O R S

42% Yes

58% No

I N V E S T O R S ’ V I E W O FB I O P H A R M A I N D U S T R Y

They need to reduce risk by taking a more conservative approach

They need to take more risks to capture more opportunities

They do a good job balancing risks and opportunities

Investors | Which statement comes closest to your feeling about how the biopharmaceutical industry balances risks and opportunities?

16%

37%

47%

Page 27: New healthreport 2012

Investor Ambivalence, Optimism 2 7

Investors Sums may not add to 100% or be equal to components due to rounding

Investors | What are the implications of risk-sharing agreements between biopharma and managed care for firms like yours?

D I S A G R E EA G R E E N E I T H E R

These agreementswill generally mean less return on our

investment.

We will invest less in this sector if these

agreements become more common.

These agreementswill mean more access

to the market fornew drugs.

49%

14%

37%22%

53%

46%

45%

9%

25%

i n v e s t O r s a r e r a t H e r i n d i f f e r e n t w i t H r e g a r d s t O

r i s k - a n d c O s t - s H a r i n g a g r e e m e n t s b e t w e e n b i O p H a r -

m a c e u t i c a l c O m p a n i e s a n d p a y i n g O r g a n i z a t i O n s .

Page 28: New healthreport 2012

www.quintiles.com/newhealthreport

Although biopharmaceutical executives and payers from the U.S. and the U.K. expect

more risk-sharing ahead, such agreements could come in many forms. The form itself,

however, will determine the likelihood of success from such arrangements. Despite that

fact, biopharmaceutical executives and payers express different views on the most likely

risk-sharing plans.

Among the biopharmaceutical executives, nearly three-quarters of them support

agreements in which patient adherence determines future discounts to the manufacturer.

They also show similar support of agreements in which some aspect of patient outcome

serves as the goal. The biopharma execs show less enthusiasm for some other possible

forms of risk-sharing, including population-based performance guarantees. As the

numbers show, however, this group spreads its interests across a collection of approaches

to risk-sharing.

Mitigating Risk: The Need for New Metrics

Page 29: New healthreport 2012

A Need for New Metrics 2 9

Investors Sums may not add to 100% or be equal to components due to rounding

in comparison, the payers display equally

widespread opinions. both groups of payers prefer

agreements based on coverage with evidence

development (ced), which depends on how well

a drug performs against a specific outcome, and

the population-based performance approach, in

which in drug must meet some long-term benefit

to merit coverage. more than biopharmaceutical

executives or u.s. payers, u.k. payers provide the

most aligned opinion, with 95 percent of them

supporting the ced-based option. notably, this

option ties for first among u.s. payers and ranks

second with the biopharmaceutical executives.

so despite the support of a variety of options in

risk-sharing agreements, these data indicate that

these three groups of stakeholders could possibly

agree on how to get started with this transition.

if the biopharmaceutical industry and payer

organizations could agree on a way forward,

that might generate a variety of risk-sharing

agreements. two key interests, especially from the

patient perspective, involve getting new therapies

to the market faster and making those therapies

more effective. with regard to speed-to-market,

half of biopharmaceutical executives feel that risk-

sharing agreements will decrease that time, but

that expectation drops to 43 and 32 percent for

u.s. and u.k. payers, respectively. in terms of risk-

sharing agreements increasing the innovative and

effective aspects of new therapies, nearly three-

quarters of u.k. payers show optimism there, and

a majority of the respondents from u.s. payers

and biopharma agree.

when considering a range of other ways to

decrease the time-to-market for new therapies,

none generates a strong consensus among the

stakeholders. even with the most agreed-upon

concept—pre-competitive collaborations among

biopharma companies—it only gains favor from

about half of most of the groups, and even less

from u.k. payers. Overall, the options generate

widely disparate responses and the lack of

majority support.

to enhance the innovation of new drugs, however,

the stakeholders display some level of agreement.

Biopharma, Payers | Percent who support specific types of risk-sharing plans

U S P A Y E R S U K P A Y E R SB I O P H A R M A

Adherence-based deals

Coverage with Evidence

Development (CED)

Individual performace guarantees

Discounts to managed care plans for better formulary placement

Contracting to provide copay offsets

Population-based performance

guarantee

0 %

2 0 %

4 0 %

6 0 %

8 0 %

1 0 0 %

73%77%

66% 69%

84%

95%

67%59%

69%

60%68%

61% 59%64%

30%

56%

84%89%

Page 30: New healthreport 2012

3 0 2012 | The New Health Report

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upwards of three-quarters of biopharmaceutical

executives and payers, plus 61 percent of

investors, hold hope for pre-competitive

collaborations among biopharmaceutical

companies. nonetheless, other responses (data

not shown) in this survey indicate that 69 percent

of biopharmaceutical executives support pre-

competitive alliances, but only 37 percent of them

claim that their company currently participates

in them. Overall, the responses suggest that

some biopharma executives believe that pre-

competitive alliances might extend—or at least

not shorten—the time that it takes to bring a new

drug to market, but the alliances could increase

the innovative aspects of new drugs. although

that could create a more precise approach than

today’s often scattershot strategy, a majority of

these executives also indicate that creating such

alliances must overcome a series of problems,

including defining the boundary between

pre-competitive and proprietary data and

protecting intellectual property. so these alliances

might appeal to the executives more in theory

than in practice.

to manage risk effectively, stakeholders need

reliable ways to measure it. that is, the healthcare

industry needs powerful tools to estimate

the risk/benefit tradeoffs generated by a new

drug. the results from this survey show that

the biopharmaceutical industry and payers in

the u.k. and the u.s. apply a variety of tools

to address this problem. for example, most of

them look at patient-reported outcome measures

and minimum clinical efficacy, and about half

use quality-adjusted life years. for each of these

metrics, though, the stakeholders only rate these

tools as more or less mediocre in assessing the

risk-benefit profile of a new drug. for example,

nearly three-quarters of u.k. payers rely on

52%43%

32%

50%57%

41%

31%

28%32%

72%

25%41%

43%

41%41%

Biopharma, Payers | Percent who feel the following will decrease time-to-market for new therapies

U S P A Y E R S U K P A Y E R SB I O P H A R M A

Risk-sharing agreements between biopharma and payers/managed care

Pre-competitive collaborations among biopharma companies

Direct government participation in drug development

Outcomes research from quasi-governmental bodies governing real-world research practices such as PCORI/NICE

Managed care / payer input in drug development

55%63%

73%

75%72%73%

27%44%

55%

31%60%

57%

32%29%

36%

Biopharma, Payers | Percent who feel the following will mean getting more innovative and effective therapies to market

U S P A Y E R S U K P A Y E R SB I O P H A R M A

Risk-sharing agreements between biopharma and payers/managed care

Pre-competitive collaborations among biopharma companies

Direct government participation in drug development

Outcomes research from quasi-governmental bodies governing real-world research practices such as PCORI/NICE

Managed care / payer input in drug development

Page 31: New healthreport 2012

A Need for New Metrics 3 1

Investors Sums may not add to 100% or be equal to components due to rounding

patient-reported outcome measures, but only

a bit more than half of them judge this as an

excellent or good tool for measuring risk. in other

cases, the stakeholders give high marks to some

tools that they use infrequently. for instance,

nearly three-quarters of u.s. payers believe

that minimum clinical efficacy measures risk

effectively, but only 44 percent of them use this

tool. to some extent, these responses indicate

that stakeholders use some of their least

favorite methods and forego some of the more

effective ones.

these data illustrate one of the problems with

most risk-based tools: that they fail to recognize

the underlying predispositions toward value and

therefore make it extremely difficult to understand

the tradeoffs involved in such equations.

without considering the values attached to the

risk—which can sway the perception of the risk/

benefit proposition—stakeholders are unable to

assign the proper weight to different values that

influence perception of risk.

Patient Reported Outcome (PROs)

Minimum Clinical Efficacy (MCE)

Quality Adjusted Life Years (QALYs)

Number Needed to Treat (NNT)

Clinical Utility Index (CUI)

Number Needed to Harm (NNH)

Disability Adjusted Life Years (DALYs)

Proprietary instruments

Biopharma, Payers | How well do the following types of data do in accurately assessing a biopharmaceutical product’s risk/benefit profile?

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

ExcellentGood

B I O P H A R M A

ExcellentGood

U S P A Y E R S

ExcellentGood

U K P A Y E R S

N/A

Patient Reported Outcome (PROs)

Minimum Clinical Efficacy (MCE)

Quality Adjusted Life Years (QALYs)

Number Needed to Treat (NNT)

Clinical Utility Index (CUI)

Number Needed to Harm (NNH)

Disability Adjusted Life Years (DALYs)

Proprietary instruments

56% 60% 71%

53% 44% NA

47% 44% 66%

41% 31% 46%

29% 24% 21%

17% 20% 21%

12% 19% 16%

22% 31% 11%

Biopharma, Payers | Do you currently use the following types of data?

B I O P H A R M A

P A Y E R S

% answering yes

Page 32: New healthreport 2012

3 2 2012 | The New Health Report

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in the context of assessing risk and benefit,

one area that warrants further examination is

comparative effectiveness research (cer). as

payers and quasi-governmental agencies in the

u.s. rush to embrace cer, some clarity as to the

utility and construct of cer can be gleaned by

looking at the perception among u.k payers as

to the benefits produced by health technology

assessments (Hta)—a different yet related form

of product appraisal.

u.k. payers seem unimpressed by the overall

performance of Hta on a number of different

measures. less than a third of them feel that

Hta initiatives perform very or extremely well

on improving patient outcomes, and less than a

quarter feel that Hta does a good job of ensuring

that the right patient population receives the right

medication. these findings contrast sharply with

the perception of cer among u.s. payers, the

majority of whom say that cer performs well on

both measures.

given that the u.k. has more than 10 years

experience in putting Hta into practice, u.k.

payer skepticism as to their utility should be

seen as a learning opportunity for u.s.-based

organizations looking to conduct cer initiatives.

critical to the future application of cer is the

data and methodology employed in the research.

cer methods should not only address technical

aspects of study design, subject selection,

analytic techniques, and process and outcome

measurement, but also address such weighty

issues as ethical, humanistic and feasibility

considerations related to real-world research.

Payers | Percent who believe current CER / HTA initiatives are doing extremely / very well on...

U S P A Y E R S U K P A Y E R S

Improving patient outcomes / improving effectiveness

56%

32%

Ensuring the right patient population receives the right medication

51%

23%

43%

Improving patient safety

44%

Controlling cost for members in your plan

40%

5%

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3 3

Given risk’s fundamental place in healthcare—from patients’ well-being to

biopharmaceutical companies’ financial security—the interconnected stakeholders

know surprisingly little about how to measure and manage it. Overall, each group of

stakeholders desires more control over the risks that they face and prefers to reduce their

own risk by transferring it to others whenever possible. These perceptions may arise from

a law of nature of sorts—protect yourself. But risk in healthcare involves us all. As such,

the risks must be balanced so that each stakeholder accepts a fair share, and the members

of the healthcare system must find ways to accurately measure and communicate risk and

benefit to each other.

Conclusion

Page 34: New healthreport 2012

3 4 2012 | The New Health Report

www.quintiles.com/newhealthreport

much of the data analyzed in this report reveals

the need for deeper knowledge of the inherent

risks in healthcare and medicine. for example,

some of the patient responses indicate a lack

of understanding of how the drug development

process actually works. likewise, the comparison

of patients from the u.k. and the u.s. shows a

need for better education about balancing risk

and benefit. at the same time, biopharmaceutical

executives report little confidence in many of the

tools that they use to evaluate the risk/benefit

balance of a drug in development.

in today’s world of data and informatics,

computation should improve risk assessment

and management, but access to robust sources

of data to feed the model is severely lacking.

instead, no one stands behind a confident

consensus regarding how to measure risk, how

to reduce it, how to manage it or how to weigh

the tradeoffs. without that confidence in the data

which underpins assessments, a more effective

system to enhance health around the world cannot

be built.

to address this challenge, the biopharmaceutical

industry must develop new approaches—and do

that as soon as possible. the results of this survey

indicate that the biopharmaceutical industry

can act now in several ways: collaborating

early with payers on new compounds under

development; striking pre-competitive alliances

among industry competitors to enhance the

innovative characteristics of new compounds; and

developing risk-sharing agreements to enhance

patient-population targeting.

if the biopharmaceutical industry fails to adapt to

the changing landscape of risk in healthcare, other

stakeholders—perhaps the paying organizations,

well-versed as they are in measuring and working

with risk—will move ahead on their own, and

the responses from both u.k. and u.s. payers

about their interests in earlier involvement in drug

development presages that possibility.

the ultimate goal revolves around reducing risk

for everyone. to enhance the health of patients—

while keeping the biopharmaceutical industry and

investors financially healthy and payers balancing

their inputs and outlays—healthcare must

accurately assess the value of and risks behind

a promising compound as soon as possible and

then track that balance across the entire drug

development cycle. Only then can the world make

the most of modern medical capabilities.

Page 35: New healthreport 2012

3 5

about the new health report

The New Health Report is based on surveys of biopharmaceutical executives, managed care executives

in the u.s., national Health service executives in the u.k., patients living with chronic disease in both

the u.s. and the u.k., and investors who focus on the healthcare sectors. each survey was conducted

by richard day research of evanston, illinois, u.s.a., a market probe company, on behalf of Quintiles.

richard day research was responsible for all survey design, data analysis and data reporting.

data for this survey were collected between January 8 and march 14, 2012. screened and included in

the sample were 102 biopharmaceutical executives at the director level or above, 75 managed care

executives in the united states at the director level or above, 72 national Health service executives

(director or above) in the u.k., 509 u.s. and 500 u.k. adults ages 18+ diagnosed with a chronic

health condition who are receiving treatment, and 100 investment professionals (vice president and

above) employed in private equity firms, investment banks, or venture capital firms that focus on the

healthcare/biopharma sector.

professionals were recruited via postal mail, telephone, fax and e-mail and completed the survey

in a self-administered online questionnaire. patient interviews were conducted via landline and

cellular telephone.

with pure probability samples of these sizes, one could say with 95 percent probability that the results

have a sampling error of +/– 10 percentage points for biopharmaceutical executives and investors, +/– 11

percentage points for managed care executives, +/– 4 percentage points for u.s. and u.k. patients.

about quintiles

Quintiles is the only fully integrated

biopharmaceutical services company offering

clinical, commercial, consulting and capital

solutions worldwide. Our network of more than

25,000 professionals in 60 countries has an eye

on the future while delivering results today with

an unwavering commitment to patients, safety

and ethics. Quintiles helps biopharmaceutical

companies develop and commercialize products

to improve and lengthen patients’ lives while

demonstrating value to stakeholders. visit

www.quintiles.com for more information and

www.quintiles.com/news for additional

company news.

contact info

for media inquiries:

mari mansfield, Media Relations, Quintiles

+1 919 998 2639

[email protected]

for all other inquiries:

adam istas, Corporate Communications, Quintiles

+1 708 948 7070

[email protected]

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