Final Round Case PDF

Gardasil Launch
01/2015-5795
This case was written by Reinhard Angelmar, Emeritus Professor of Marketing and the Salmon and Rameau Fellow of
Healthcare Management, Emeritus, INSEAD, with the assistance of Juliana Kim, INSEAD MBA 08J, and Michael
Schroeder, INSEAD MBA 08J. It is intended to be used as a basis for class discussion rather than to illustrate either
effective or ineffective handling of an administrative situation.
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In mid-2005, managers at Merck & Co were wondering how to prepare the launch of
Gardasil, the first human papillomavirus vaccine. Merck expected to file the FDA application
for Gardasil in December, and obtain approval in mid-2006.
Human Papillomavirus (HPV)

HPV is a family of over 100 viruses that are introduced into the body via breaks in the skin.
Over 40 of them infect the genital area. Transmission most frequently occurs through sexual
intercourse, and less commonly through non-penetrative genital contact (manual-genital, oral-
genital, and genital-genital).
Genital HPV infection is the most common sexually transmitted infection in the US. At least
50% of sexually active men and women are infected at some point in their lives. A study of
women aged 14-59 found HPV prevalence of 26.8%.1 Demographic and behavioural analyses
of the sample revealed that prevalence was highest among women aged 20-24, non-hispanic
blacks, women living with a partner, who had not graduated from high school, living below
the poverty threshold, women who had first had intercourse before the age of 16, who had a
higher number of lifetime sex partners and of sex partners the preceding year. For example,
55.6% of women who had had six or more sex partners the preceding year had HVP (see
Exhibit 1).
Most people with HPV do not develop symptoms and 90% of infections clear within two
years. There is no treatment for HPV, although there are treatments for the diseases it can
cause, namely genital warts, cervical cancer and other less common cancers.
Genital Warts
90% of genital warts are caused by the “low risk” wart-causing HPV types 6 and 11. They
appear weeks or months after sexual contact with an HPV-infected person. Over 500,000 new
cases of genital warts are estimated to occur each year in the US. Among women, prevalence
of genital warts is highest in the 16-24 age group, and among males aged 20-24.2
Genital warts can be treated with medicine, removed via surgery or frozen off, but they often
come back within a few months after treatment, with a profoundly negative impact on the
activities, relationships and psychological well-being of those concerned (see Exhibit 2).
The annual cost of treating genital warts attributable to HPV types 6 and 11 was estimated at
$210 million. Add to this the cost of treating other diseases caused by the two HPV types and
the total amounted to $332 million per year.3
1 Percentage of women with HPV at the time of the study. Dunne et al., JAMA, February 28, 2007
2 Barr E. and H.L. Sings, Vaccine 26 (2008) 6244-6257
3 Chesson, Presentation to the ACIP, October 21, 2009
Copyright © INSEAD 1
Cervical Cancer
In 2006, almost 12,000 women in the US were expected to be diagnosed with cervical cancer,
and 4,000 of them to die from the disease.4 Cervical cancer was the 15th most frequent cause
of death from cancer among US women (Exhibit 3). Incidence was highest among
Hispanics/Latinos, followed by African Americans, the group with the highest mortality from
cervical cancer.
Rigoni-Stern, a doctor in Florence, Italy, was the first to suggest an association between
cervical cancer and sexual activity – in 1842 – after observing that prostitutes and married
women died of cervical cancer but nuns almost never did. Proof that HPV caused cervical
cancer came in the early 1980s, a discovery for which the German researcher Harald zur
Hausen was awarded the Nobel Prize in Medicine in 2008.
High-risk cancer-causing HPV types that persist can lead to pre-cancerous lesions of the
cervix, which reach a peak approximately 10 years after the HPV peaks. If untreated, the
lesions may turn into cancer, which itself reaches a peak another 10 years later (see
Exhibit 4).
Fifteen high-risk cancer-causing HPV types cause virtually all cases of cervical cancer.
Among them, the two HPV types 16 and 18 are responsible for about 70% of all cases. The
annual cost of treating pre-cancerous lesions and cervical cancers attributable to HPV 16 and
18 was estimated to be $1,105 million.5
The earlier pre-cancerous lesions or cancer are detected, the greater the chances of survival. If
pre-cancerous lesions are treated there is virtually a 100% chance of survival.6 If cervical
cancer is detected at the localized stage (59% of diagnosed cases), the patient has a 91%
chance of living for another five years. This drops to 58% for regional cancer (35% of
diagnosed cases), and 17% for distant (metastatic) cancer (11% of diagnosed cases). The
median age at diagnosis for cervical cancer is 48.7
In the US, the incidence of cervical cancer and mortality has declined 67% over the past three
decades, thanks mainly to the Pap test, which allows pre-cancerous lesions to be detected. Pap
test screening is recommended at least every three years for women aged 18-64. 78% of
American women have taken a Pap test within the past three years. The percentage is
significantly lower among less educated women and those with no health insurance (61% vs.
81%). Between 60% and 80% of women with distant (metastatic) cervical cancer had had no
Pap test in the past five years.8
4 CDC, Cervical Cancer Statistics, http://www.cdc.gov/cancer/cervical/statistics/, accessed June 6, 2010.

5 Chesson, Presentation to the ACIP, October 21, 2009
6 American Cancer Society, Care Prevention & Early Detection Facts & Figures 2010
7 SEER Stat Fact Sheets: Cervix Uteri
8 American Cancer Society, Care Prevention & Early Detection Facts & Figures 2010
Gardasil
Gardasil is a quadrivalent vaccine which targets four HPV types:
− HPV 6 and 11, which cause 90% of genital warts

− HPV 16 and 18, which cause about 70% of cervical cancer cases.
Gardasil is a prophylactic vaccine, i.e., designed to prevent diseases associated with the
targeted HPV types, not a treatment for people infected or suffering from an associated
disease.
The results of clinical studies confirmed that Gardasil achieved nearly 100% effectiveness in
preventing pre-cancerous cervical lesions, pre-cancerous vaginal and vulvar lesions, and
genital warts caused by HPV types 6, 11, 16, and 18 in females not previously exposed to the
strains.9 The duration of immunity beyond three years was not established.
Because the vaccine had no effect on individuals who had already contracted the virus, it
seemed logical to administer Gardasil before the age at which exposure occurred, that is,
before the onset of sexual activity. According to one survey, 4% of girls had sexual
intercourse before the age of 13, 27% by 14-15 years, and 42% by 15-16 years,10 and many
engaged in other forms of sexual activity before having intercourse. Merck planned to seek
initial FDA approval for girls and women aged 9-26 to be vaccinated.
Since Gardasil targeted only four HPV types, it did not protect against other HVP strains. It
could therefore significantly reduce, but not eliminate, the incidence of genital warts and
cervical cancer. Nor did it protect against other sexually transmitted infections. Therefore
other preventive measures such as safe sexual practices and regular Pap screenings were
necessary.
The clinical studies showed Gardasil to be safe. Adverse side effects included swelling at the
injection site and low grade fever, symptoms which were reported to be slightly higher than in
the placebo groups. Gardasil was administered through intramuscular injection in three doses.
The second dose was administered two months after the first, with the third dose six months
after the first. It had to be stored at 2°- 8°C (36°- 46°F).
Whereas most children’s vaccines cost less than $50, Merck planned to price each dose at
US$120 ($360 for three). The additional cost of medical appointments could bring the total
cost of vaccination to $600.
Key Stakeholders
The Advisory Committee on Immunization Practices (ACIP)
The market success of a vaccine was strongly influenced by recommendations issued by the
Advisory Committee on Immunization Practices (ACIP), which reported to the CDC (Centers
9 The FUTURE II Study Group, New England Journal of Medicine, May 2007
10 CDC, Youth Risk Behavior Surveillance 2007
for Disease Control and Prevention), which was part of the US Department of Health and
Human Services (HSS). ACIP advised HHS and the CDC on whether a vaccine should be
included on the national immunization schedule. ACIP evaluations ran in parallel with those
performed by the FDA, whose approval was a necessary step before the ACIP finalized its
recommendations. ACIP recommendations specified the recommended age group for
vaccination and what age groups should receive catch-up vaccinations, among others.
The ACIP worked closely with key professional associations to ensure harmonization of
recommendations. The 2005-06 recommended childhood and adolescent immunization
schedule carried the joint approval of the ACIP, the American Academy of Pediatrics, and the
American Academy of Family Physicians. The recommended immunization schedule for
adults was approved jointly by the ACIP, the American College of Obstetricians and
Gynecologists, and the American Academy of Family Physicians.
ACIP recommendations generally set standards of practice for physicians, in addition to

influencing funding decisions. It also decided whether to add a vaccine to the federal Vaccine
for Children (VFC) programme, which provided vaccines at no cost to children aged 9-18
who were covered by Medicaid, to children of Alaskan-Native and Native American origin,
and some underinsured or uninsured children.
ACIP recommendations had a strong influence on state policies. US states could decide to
promote a vaccine, fund vaccinations for children and adults, require vaccine coverage by
private insurance plans, and make vaccination mandatory for entry to schools, colleges, and
other institutions.11Vaccine coverage decisions by private insurers also tended to follow ACIP
recommendations. Most private health insurance plans provided at least partial coverage for
immunization. Cost sharing was generally higher for adults than for children and adolescents.
Studies showed that even modest prices or co-pays reduced vaccination rates.
Whereas there was a well-established tradition of routine immunization of children, with

vaccination rates among children 19-35 months ranging from 68% to 93% (average 84%) for
the recommended childhood vaccines, routine vaccination of healthy adolescents and adults
with vaccines developed specifically for these age groups was new. Before 2005, the only
recommended routine vaccinations for healthy adolescents comprised one booster shot and
three catch-up vaccinations in case individuals had not received them as a child. Healthy
adults aged 19-49 were merely advised to get booster shots for some vaccines.
During 2005, two new classes of single-dose vaccines designed primarily for adolescents
became available. The meningitis vaccine Menactra, from Sanofi Pasteur, commanded a price
of $82. Two tetanus-diphtheria-acellular pertussis (Tdap) vaccines – Adacel from Sanofi
Pasteur, and Boostrix from GlaxoSmithKline – were priced at $33.50 and $34 respectively.
The ACIP recommended these for children aged 11-12, and for 13-18 year-olds (catch-up
cohort) if not received earlier. It was expected that 11% of those aged 11-18 would receive
these vaccinations by the end of 2006.
In the event that it was approved by the FDA and recommended by the ACIP for individuals
aged 9-26, Gardasil would become the third new vaccine recommended for routine
11 Many jurisdictions allowed exemptions from mandatory vaccination for medical or religious reasons, or
when parents had philosophical or personal belief objections to vaccination
vaccination of healthy adolescents, and the first for routine vaccination of healthy young
adults.
Potential Vaccinees and Parents

Most vaccinations were administered at preventive or well-care visits. But adolescents and
young adults made few preventive visits compared with young children. Only 28% of girls
aged 11-21 had at least one preventive physician visit within 12 months, and a mere 3% made
the three visits necessary to receive the HPV vaccine doses. Administering Gardasil during
any type of outpatient visit would increase the vaccination opportunities: 59% of 11-21 year-
old girls/women had at least one outpatient visit of any kind within 12 months, and 10% made
three such visits.12
Adolescents under 18 had low awareness of HPV, and very few thought they were at risk of
HPV infection. Awareness of genital warts was higher than of cervical cancer, but concern
about cervical cancer was higher than about genital warts. Very few associated genital warts
and cervical cancer with HPV. When provided with information about HPV, its transmission
through sexual activity, genital warts, cervical cancer and information about a hypothetical
HPV vaccine, factors that were positively associated with interest in such a vaccine were its
efficacy, low cost, recommendation by a physician, parental support for vaccination, having
had vaginal sex, and having at least one friend that had had sexual intercourse.
A national survey carried out in February-August 2005 among women aged 18-75 found that
40% had heard of HPV (aided awareness), 48% of these believed it caused cervical cancer.
Awareness varied by age and other characteristics (see Exhibits 5 and 6).
In focus groups with adults, once participants with little HPV knowledge learned that HPV
caused genital warts, a number expressed concern that genital warts were more serious than
they originally believed. When the relationship between HPV and cervical cancer was
introduced, an increase in anxiety and tension among participants was noted.13 When
informed about a hypothetical HPV vaccine, many young women (18-30 years) expressed a
high level of interest in receiving it. Factors associated with high interest included HPV
knowledge, a greater number of lifetime sexual partners, the belief that “most people
important to self” (e.g., parents, a husband or steady sexual partner, health care providers)
would support vaccination, vaccine safety, and low cost.14
Parents were key decision makers for girls under-18 because every state required parental
consent for the vaccination of minors. A majority of states required parental consent for each
injection when more than one was required to complete a series. In response to a study among
parents of daughters aged 9-17, 49% said they “know a lot/know some” about genital warts,
and 60% about cervical cancer. When provided with information about the incidence of
cervical cancer, genital warts, the role of sexual activity in contracting these diseases, and a
hypothetical HPV vaccine, 30% of parents said they would definitely, and 32% would
12 Rand et al., September 2007

13 STD Communications Database : General Public Focus Group Findings, Report submitted to the CDC,
2004
14 Dekker, JAOA, Supplement 1, March 2006
probably have their daughters vaccinated before her 18th birthday. Parents’ likelihood to have
their daughter vaccinated increased with the strength of physician recommendation
(Exhibit 7).
Parents’ willingness to vaccinate increased as the proposed age at which daughters should be
vaccinated increased.15 Other factors associated with a greater willingness to vaccinate
included the perception that their child was at risk of HPV infection, the severity of diseases
associated with HPV infection, a desire to protect their child, a positive attitude to vaccines in
general, having children that were up-to-date on all previous vaccinations, the belief that the
vaccine was effective and safe, and that their peers or the child’s physician would want them
to vaccinate their child.
Parents less likely to endorse HPV vaccination or opposed to it had the following beliefs:
their child was not engaged in sexual activity and not at risk of HPV, HPV could be prevented
in other ways, the vaccine could cause HPV infection/be unsafe, vaccination would encourage
sexual behaviour, strong religious views.16
Whether the vaccine provided protection against genital warts in addition to protection against
cervical cancer did not make much difference in one study.17 Participants in another study
preferred a vaccine that provided protection against 70% of cervical cancer and 100% of
genital warts to one that protected against 85% of cervical cancers and provided no protection
against genital warts.18
Informational intervention about HPV increased vaccine acceptability from 55% to 73% in
one study, most of the increase coming from previously undecided parents.19 But what should
be communicated about HPV? Focus group studies indicated that the term “sexually
transmitted disease” (STD) was widely associated with negative behaviours such as
unprotected sex, promiscuity, drug and alcohol abuse, and provoked feelings of guilt,
embarrassment and discomfort. The public relations firm Ogilvy recommended that the term
“STD” be avoided because HPV itself was not a disease and cervical cancer would be
stigmatized if it was associated with an STD.20
Physicians
In the US, most vaccines are dispensed by physicians, who usually stock both public and
private vaccines in their refrigerator. Public vaccines are purchased by the authorities and
made available to physicians at no cost. Private vaccines are purchased under a “buy and bill”
arrangement by physicians, who are reimbursed after vaccine administration by the third-
party insurer and/or patient. When purchasing private vaccines, physicians incur costs for
vaccine ordering, shipping, refrigeration, inventory holding costs (including the cost of loss
and breakage), the purchase of syringes to deliver the vaccine, nurses’ salaries and other costs
of administering the vaccination, and bad debts.
15 Dempsey et al., Pediatrics, May 2006

16 Zimet et al., Vaccine, August 2006 (Supplement 3)
17 Zimet et al., J Women’s Health & Gender-Based Medicine, 2000 (1)
18 Hoover et al., Health Care for Women International, 2000, 375-391
19 Davis et al., 2004.
20 Ogilvy Public Relations Worldwide, HPV Creative Materials Testing Final Report, Apr 2005
Paediatricians, family physicians and obstetricians/gynaecologists (Ob/Gyns) were the main
types of physicians seen by girls and young women, with the specialty mix depending on age
(Exhibit 8). Vaccine administration was routine for paediatricians, somewhat less common for
family practitioners, and rare for Ob/Gyns.
Many paediatricians had gaps in their knowledge of HPV (Exhibit 9a). The likelihood that
they would recommend the HPV vaccine increased with patient age (Exhibit 9b), and almost
all would follow the recommendations of the American Academy of Pediatrics, CDC and
ACIP (Exhibit 9c). Believing that the vaccine was highly effective, and that other new
adolescent vaccines would make it easier to introduce HPV into the practice raised their
likelihood of giving the HPV vaccine to 10-12 year old female patients. The likelihood was
lower for paediatricians who considered it necessary to discuss sexuality before
recommending HPV vaccination, thought that parents of 10-12 year-olds would be upset if a
vaccine against a sexually transmitted infection were offered, and believed that refusal of
vaccination by female patients’ parents would be a barrier (Exhibit 9d).
Other studies among paediatricians and family physicians confirmed the presence of HPV
knowledge gaps, the importance of a recommendation by professional associations, the
greater likelihood to recommend HPV vaccination for older patients, and the negative impact
of a physician’s reluctance to talk about sexuality and his or her concerns with parental
resistance to HPV vaccination.21 Parental resistance was considered an extremely important
barrier (5%), very important barrier (28%), or somewhat important barrier (40%) to the
vaccination of patients aged 9-18.22
The willingness of Ob/Gyns to recommend HPV vaccination to a patient was most strongly
influenced by whether or not it would be recommended by the American College of
Obstetricians and Gynecologists. Vaccine efficacy was the second most important factor, and
patient age the third. Like paediatricians and family physicians, Ob/Gyns’ willingness to
vaccinate increased with the vaccinee’s age, and they had a slight preference for a vaccine
which covered both cervical cancer and genital warts over one that covered only cervical
cancer.23
Focus groups and individual interviews with physicians suggested that in addition to
preferring vaccination of older individuals, some physicians might restrict vaccination to
individuals judged to be at high risk of HPV, instead of recommending HPV vaccination to all
adolescents and young women. “We know there are certain populations where sexual activity
with multiple partners is more common … We treat them frequently for various STDs,” was a
typical comment.24 Physicians’ also worried that HPV vaccination could result in a decline in
Pap testing: “Many women might be under the false pretence that becoming vaccinated
eliminates the need for screening, which could have the paradoxical effect of increasing the
incidence of cervical cancer.”25
Exhibit 10 shows the key stakeholders and the main relationships between them.
21 For example, Riedesel et al., 2006

22 MVD Business Research, Merck & Co, 2004
23 Raley et al., Infectious Diseases in Obstetrics and Gynecology, 2004, 127-133
24 Tissot et al., J of Adolescent Health, 2007, 119-125
25 Herzog et al., Gynecologic Oncology 2008, S4-S11
Competition: Cervarix from GlaxoSmithKline
GlaxoSmithKline (GSK) was developing Cervarix, a bivalent prophylactic HPV vaccine
which targeted the two high cancer-risk HPV types 16 and 18, but not the two HPV strains
responsible for genital warts. Another difference between Cervarix and Gardasil was their
adjuvant, a substance added to a vaccine to increase the body's immune response. While
Gardasil was formulated with a common adjuvant, Cervarix was the first vaccine to include a
novel adjuvant thought to trigger a faster and stronger immune response. GSK expected that
Cervarix would not only provide longer lasting immunization compared to Gardasil, but also
protect against HPV strains other than the two high cancer-risk HPV types for which it was
designed. GSK planned to file the FDA application by the end of 2006, which would allow it
to launch Cervarix during the second half of 2007 if approved.
Issues for Decision

Merck was optimistic that the FDA would approve Gardasil around mid-2006 for the
prevention of genital warts, cervical cancer, and other diseases caused by HPV types 6, 11, 16
and 18 in girls and women aged 9-26. This left one year to prepare the launch. A successful
launch was important for capturing a significant share of the HPV vaccine market, which
some analysts valued at $2.5-$3.1 billion in 2010 (Exhibit 11).
Merck’s managers wondered whether they should target all girls and young women in the 9-
26 segment or whether to initially focus on a sub-segment and, if so, which one. They then
needed to define key behavioural and communication goals for the target vaccinees and other
stakeholders.
Which Gardasil positioning would best achieve these goals was another subject of intense
discussion. Should they position Gardasil as a vaccine that prevented:
• HPV
• genital warts
• cervical cancer, or
• genital warts and cervical cancer?
Exhibit 1
Prevalence of Any HPV Infection among U.S. Women aged 14-59
Source: Dunne et al., JAMA, February 28, 2007
Exhibit 2
Focus Groups with Individuals with Genital Warts: Selected Results
Many focus group participants had feelings of guilt or anger because they had not protected
themselves and others more carefully. All participants had developed lower self-esteem and a negative
body perception as a result of the disease.
“Sometimes, when you think about it or you notice them [the GWs], you just become so
discouraged and sad because...you can’t do anything about it. I mean, you just have to
wait and there’s nothing you can do yourself, is there? And then I get this feeling that I
simply can’t relate to my own body or even look at it. Then I feel repulsive, you see?”
[22-year-old woman]
The participants described themselves as ‘impure, repulsive and sexually unattractive’ and seriously
questioned how others might find them attractive when they did not even like themselves. Problems
often arose in existing relationships because of worries about the source of the infection or a lack of
sexual desire.
The majority of participants indicated that it was their sex and love life that had suffered most from
having GWs. Their libido was low and their sexual initiative was reduced, and pleasure and
spontaneity was often lost during intercourse because of awareness of the warts, fear of transmitting
the disease or repulsing the partner, negative self-perception and soreness due to treatment. This
affected steady relationships and for those who were single it affected their ambition to seek a new
partner.
Because of fear of stigmatisation, the participants wanted to control who knew they had GWs. They
were worried that others might find them unclean, careless or “of easy virtue” - the latter applied to
girls and women as well as to boys and men. They were afraid that the disease would be an important
factor in shaping others’ opinions about them.
“You’re afraid of being stigmatised. I remember having heard that somebody had a
venereal disease... And that’s just what you’ll always remember about them, even if you
don’t even see them anymore. Or if you’ve heard that about a boy that you might have
thought was quite cute, then you would think ‘Wasn’t it him who had that thing?’ In the
same way you think that’s probably how others will think about you when you have GWs,
that they think ‘Oh, it’s that girl with GWs’. That’s why I have only told people I’m very
close to. [17 year old girl]
Several participants mentioned that the disease is particularly stigmatising because it is infectious and
they were concerned about people’s ignorance about the danger of infection. As a consequence, some
participants stopped doing sport or other activities that might reveal their disease. Some women felt
unattractive because they could not shave intimately as well as they would have liked. Some men were
concerned that others might spot the GWs or the ulcerations caused by treatment. The fear of
stigmatisation also meant that the participants avoided informing other people that they were attending
the venereal diseases clinic for treatment. Many had to take significant time away from their studies
and work that was not easy to explain. Most participants had only spoken about their disease to their
closest relatives and friends.
Exhibit 3
Number of Estimated Deaths from Cancer, by Cancer Site, US Women, 2007
0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000
Lung & bronchus

Breast
Colon
Pancreas
Ovary
Non-Hodgkin lymphoma
Uterine corpus
Brain & other nervous system
Liver & intrahepatic bile duct
Multiple myeloma
Kidney & renal pelvis
Stomach
Urinary bladder
Acute myeloid leukemia
Cervical cancer
Esophagus
Melanoma-skin
Other leukemia
Gallbladder & other biliary
Chronic lymphocytic leukemia
Source: CA Cancer J Clin 2007; 57: p. 45
Exhibit 4
Lifetime Evolution of HPV Infection and Cervical Cancer
Source: Schiffman & Castle, NEJM, November 17, 2005
Exhibit 5
Awareness of HPV and its Role as Cause of Cervical Cancer
Percent of Heard of HPV Aware HPV causes

all women (40% of all women cervical cancer among
18-75 years 18-75 years) those having heard of
HPV (48% overall)
% of Proba- % of HPV Proba-
segment bility aware in bility
segment
Age segment (years) 0.00 0.12
18-29 24 46 45
30-64 65 41 50
65-75 12 22 39
Race/Ethnicity 0.00 0.01
Non – Hispanic White 69 45 45
Hispanic 12 28 64
Non – Hispanic Black 12 33 42
Other 7 36 68
Education 0.00 0.02
<High school 13 16 47
High school graduate 30 27 36
Some college 33 47 47
College graduate 24 61 54
Household income ($) 0.00 0.21
<15,000 6 28 65
15,000-34,999 25 31 43
35,000-49,999 15 41 48
50,000+ 54 50 51
Health insurance 0.39 0.24
Yes 86 41 46
No 16 37 55
Visit with health care provider in past year 0.02 0.47
Yes 89 42 47
No 11 31 54
Trust sources of health information 0.00 0.54
Does not trust one or more sources 58 31 47
Trusts all sources 42 52 49
Family member had cervical cancer 0.07 0.68
Yes 4 51 44
No 97 40 48
Family member had non-cervical cancer 0.00 0.07
Yes 73 43 46
No 27 33 54
Pap test 0.00 0.67
Never/not recent 18 24 45
Recent 7 26 56
Regular 76 45 48
Source: adapted from Tiro et al., Cancer Epidemiol Biomarkers Prev, February 2007
Exhibit 6
HPV knowledge among the 40% of women aged 18-75
who have heard of HPV
0% 20% 40% 60% 80% 100%
Do you think that HPV is a sexually transmitted

64%
disease? (True)
Do you think that HPV is rare? (False) 30%
Do you think HPV will often go away on its own

4%
without treatment? (True)
Do you think HPV can cause abnormal Pap

79%
smears? (True)
Do you think that HPV can affect a woman's

87%
ability to get pregnant? (False)
Do you think that HPV causes cervical cancer?

48%
(True)
Source: Tiro et al., 2007
Exhibit 7
Impact of Physician Recommendation on Parents’ Likelihood
to Vaccinate their Daughter
Source: Lenar et al., Parental receptiveness to a hypothetical HPV vaccine, Merck & Co, 2004
Exhibit 8
Outpatient Visits by Young Girls and Women, by Physician Specialty
Number of annual preventive outpatient visits by females 11-21 years old
Age
Total number of annual outpatient visits by females 11-21 years old
AgeAge
FP = family practice; IM = internal medicine; Ob/Gyn = obstetricians/gynecologists
Source: Rand et al., March 2007
Exhibit 9
Results from Surveys among Paediatricians
9 a: Paediatricians’ Knowledge Regarding HPV Infections (n=294)
Source: Daley et al., 2006
9 b: Paediatricians’ likelihood of recommending HPV vaccine to female patients, by age

group (n=294)
9 c: Percent of paediatricians likely to follow the vaccination recommendations of the

following organizations and individuals (n=513)
Source: Kahn et al., 2005
9 d: Bivariate (Unadjusted Odds Ratio OR) and Multivariate Association (Adjusted OR)
between Paediatrician Attitudes/Beliefs and Being Very/Somwhat Likely to Give HPV
Vaccine to 10- to 12-year old Female Patients (n=294)
Exhibit 10
Key Stakeholders for HPV Vaccination
Physician
Professional ACIP* / CDC
Societies
Routine vaccination recommendation
Federal funding State funding &

(e.g., VFC)** mandating
Recommendations
Private
insurance
Funding/ Mandating
Reimbursement
Patients &
Physicians
parents
* Advisory Committee on Immunization Practice

** Vaccines for Children Program
Exhibit 11
HPV Vaccine Revenue Forecasts for the US Market
3,500 3,122
3,000
2,402
2,500 2,518
$ million
2,000 1,767
1,839
1,500 Credit Suisse (March 2005)*
901
1,000 623 Ci group (June 2005)
381 MorganStanley (April 2005)
500 850 900
500
300
-
2006 2007 2008 2009 2010
* Credit Suisse Forecast Assumptions

2006 2007 2008 2009 2010
1
Total female population 9-49 yrs (m) 98.0 100.2 102.4 104.6 106.9
Nr non-vaccinated (m)2 98.0 99.0 99.2 96.1 91.2
Cumulative vaccination rate (% of total female pop'n 9-49) 1.3% 3.2% 8.4% 15.0% 23.1%
Cumulative nr of vaccinees (m) 1.2 3.2 8.6 15.7 24.7
Annual nr of vaccinees (m) 1.2 2.0 5.4 7.1 9.0
in percent of the non-vaccinated 1% 2% 5% 7% 10%
Average price per dose (increasing by 3% per year)3 $103 $106 $109 $113 $116
Nr of doses 3 3 3 3 3
Total annual revenue ($ m) $381 $623 $1,767 $2,402 $3,122
1
The average population per age cohort (e.g., the number of 9 year old girls) is 2 million
2
Calculated as the total female population aged 9-49 of the year minus the cumulative number of vaccinees of the
preceding year
3
The average price assumes a price below $120 per dose for federal purchases

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Human Papillomavirus (HPV)

4 CDC, Cervical Cancer Statistics, http://www.cdc.gov/cancer/cervical/statistics/, accessed June 6, 2010.

− HPV 6 and 11, which cause 90% of genital warts

ACIP recommendations generally set standards of practice for physicians, in addition to

Whereas there was a well-established tradition of routine immunization of children, with

Potential Vaccinees and Parents

12 Rand et al., September 2007

15 Dempsey et al., Pediatrics, May 2006

21 For example, Riedesel et al., 2006

Issues for Decision

Source: Dunne et al., JAMA, February 28, 2007

Lung & bronchus

Source: CA Cancer J Clin 2007; 57: p. 45

Source: Schiffman & Castle, NEJM, November 17, 2005

Percent of Heard of HPV Aware HPV causes

0% 20% 40% 60% 80% 100%

Do you think that HPV is a sexually transmitted

Do you think that HPV is rare? (False) 30%

Do you think HPV will often go away on its own

Do you think HPV can cause abnormal Pap

Do you think that HPV can affect a woman's

Do you think that HPV causes cervical cancer?

Source: Tiro et al., 2007

Number of annual preventive outpatient visits by females 11-21 years old

Total number of annual outpatient visits by females 11-21 years old

9 a: Paediatricians’ Knowledge Regarding HPV Infections (n=294)

Source: Daley et al., 2006

9 b: Paediatricians’ likelihood of recommending HPV vaccine to female patients, by age

Source: Daley et al., 2006

9 c: Percent of paediatricians likely to follow the vaccination recommendations of the

Source: Kahn et al., 2005

Source: Daley et al., 2006

Federal funding State funding &

* Advisory Committee on Immunization Practice

* Credit Suisse Forecast Assumptions

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