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PROJECT POKER Measuring The Menopause And VMS Market And Potential Uptake Of XXXXXX Prepared for: Client XXXX Pharmaceuticals Prepared by: Navigate Consulting June 24 th , 2015

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PROJECT POKERMeasuring The Menopause

And VMS Market AndPotential Uptake Of XXXXXX

Prepared for:

Client XXXX Pharmaceuticals

Prepared by:

Navigate Consulting

June 24th, 2015

Contents

Research Background ......................................................................................................................................... 3

Overall Research Approach .............................................................................................................................. 4

Research Aims ....................................................................................................................................................... 5

RESARCH FINDINGS ..................................................................................................................................... 9

SECTION 1 - Our Sample In Context................................................................................................. 11

SECTION 2 – Menopausal Patient Population .................................................................................. 19

SECTION 3 – Menopausal Management .......................................................................................... 23

SECTION 4 – SSRI/SNRI Usage In Focus ............................................................................................. 34

SECTION 5 – XXXX In Focus ............................................................................................................... 43

SECTION 6 – Uptake Levels ................................................................................................................ 49

SECTION 7 – Brand Perceptions ......................................................................................................... 56

Driver Analysis .......................................................................................................................................62

CONCLUSIONS AND RECOMMENDATIONS ............................................................................................. 76

APPENDIX ................................................................................................................................................... 85

Spine Data .....................................................................................................................................................86

Frequency Data ...........................................................................................................................................93

Research Background

Therapies approved for the treatment of Vasomotor Symptoms (VMS) at present only include

hormone or oestrogen therapy (HT). These treatments offer high levels of symptom relief and are

considered the benchmark for comparison for any new market entrant in terms of efficacy.

However, recent media and medical controversy surrounding HT has lead to a significant fall in

usage levels and it is understood that both women and doctors are conservative in their approach

to these therapies. Certain groups of women are also contraindicated to HT such as menopausal

women with ER positive breast cancer or a strong family history of breast cancer, amongst others.

At present there are no non-hormonal therapies indicated for the treatment of VMS, although it is

thought that physicians are looking outside the available therapies with many off label prescriptions

written for VMS. Products utilised off label currently include Efexor (venlafaxine) and Aropax

(paroxetine), which belong to the SNRI / SRRI class of antidepressants, and other agents such as

Neurontin, an anti-convulsant agent, and Catapres, an anti-migraine agent.

XXXX (des-venlafaxine) is an active metabolite of Wyeth’s parent compound – Efexor. At present

trials are being undertaken to evaluate its usefulness in the treatment of VMS and results are

anticipated to be extremely positive for XXXX. It is anticipated that XXXX will compete with not

only HT’s but also Efexor and other off-label prescribing.

Due to the large number of off-label prescriptions and OTC therapies utilised in the treatment of

VMS, accurately defining the potential market for XXXX is not feasible via secondary data sources.

Therefore, primary market research is required to assess the potential market by sizing the total

female population experiencing the menopause and VMS and current treatment algorithms. The

research is also required to understand interest levels in XXXX, project adoption levels, and impact

on Efexor usage as well as to assess uptake under various reimbursement scenarios.

Research Aims

Developing a solid knowledge base in order to optimise the XXXX offering.

To size and define the menopausal

market with a particular focus on the

VMS cluster of symptoms

To profile current treatment

behaviours and usage levels of both

prescription and non-prescription

medications:

– including current usage of

SNRIs/SSRIs and positioning

within the competitive set

To gauge interest in, potential

adoption levels and likely success of

XXXX, including levers and barriers to

usage

To determine uptake of XXXX under

various reimbursement scenarios.

GP Consumer

Determine the incidence of the

Australian VMS market

Measure the number of patients on

prescription and non-prescription

therapy options and their related cost

A comprehensive approach.

Overall Research Approach

In looking at the research aims, we used a two pronged approach:

GP Research

Understanding GPs current treatment

approach, attitudes and interest

in XXXX Measuring the GP menopause and

VMS market and therapeutic

approach to scope potential markets

– measuring the patient population under GP care

– profiling treatment algorithms and current SNRI/SSRI usage within the competitive set

– gauging interest and uptake of XXXX– evaluating uptake of XXXX under

various reimbursement scenarios

Consumer Omnibus

Understanding usage and costs from

consumer perspective

– number of patients suffering from the

condition

– symptom’s suffered from the condition

– number of patients currently treated

with prescription medications

– number of patients on prescription

medication and/or OTC therapies and

their current costs to patients

Research Approach - GPs

Logistics:

– 30 minute survey

– all interviews conducted by trained medical interviewers

– all interviewers personally briefed by Navigate

– all respondents incentivised to encourage participation

– fieldwork conducted w/c 22nd April - w/c12th May, 2015

Sample:

– n=150 GPs

– representative Australian wide sample

– all aged between 30-69 years old

– treat 10 or more patients who currently experience symptoms of menopause or

perimenopause

– treat 5 or more patients per week who currently experience symptoms of menopause

or perimenopause

Methodology:

– CATI (Computer Assisted Telephone Interview)

What Our GP Sample Represents...

The 150 GPs we interviewed represent 14,760 GPs nation wide.

n=18,000 GPs

Target in Australia

n=14,760

Qualifying GPs

5%

participated

95%

declined

to

participate

18%

did not

qualify82%

qualified

3665 phone contacts 182 participants

Research Methodology - Consumers

Methodology:

– telephone omnibus

Sample:

– n=611 females

– all aged between 40-64 years

– representative sample Australia wide

– once prevalence established, those experiencing symptoms of menopause

to continue

Logistics:

– interviews conducted form central location

– conducted by trained interviewers

– research conducted 26th - 31st May and 2nd - 4th June, 20013

CONCLUSIONS AND

RECOMMENDATIONS

Conclusions

In the 40-64 year age group, around three quarters of women are suffering from

menopausal or perimenopausal symptoms. From the consumer omnibus this translates

into 2.4million potential menopausal patients

Though the type and prevalence of symptoms suffered varies by age, patient reporting

is much in line with GP perceptions… led by hot flushes, fatigue, difficulty sleeping and

night-time sweating. GPs note higher incidence of vaginal atrophy, mood swings and

disruption of quality of life - perhaps skewed by consultations with the more impacted

women in this age group.

Only around a tenth of patients are referred to a specialist (generally Gynaecologist or

Endocrinologist) but only a quarter of these then continue to be managed by the

specialist. This illustrates that menopausal management and treatment is well within the

GP realm and remit.

Conclusions (Cont’d)

Currently, HRT is the most widely employed and preferred treatment for menopausal

symptoms but around a third of patients are taking OTC or herbal remedies. Also some

off-label use of SSRI/SNRI classes noted, mostly Zoloft and Efexor:

38

29

10

10

Total prescribing: 1.2 products

% of patients treated:76%

HRT

OTC/Herbal remedies

Livial

Topical/Vaginal oestrogen

Catapres

Anti-convulsant

Other

SSRIs/SNRIs

Treatment Options

1

1

Conclusions (Cont’d)

GPs estimate that 76% of their menopausal patients are currently being treated…this

represents 1.8 million patients in total. In addition, a further fifth (<.5million) of their

menopausal patients choose not to be treated with prescription medications.

Consumer data indicates this could be higher, especially amongst younger women,

with 55% not treating and 22% utilising OTC remedies. It is not that those using OTC

treatments are suffering less - they still experience an average of nine symptoms each.

Already, GPs are employing the SSRI/SNRI classes in the treatment of menopausal

symptoms for more than just their affect on psychological symptoms, though they do

claim that 74% of women have depressive symptoms when initiated. Beyond that, GPs

see benefits for VMS, hot flushes and fatigue as well as providing an alternative to HRT

and its perceived risks.

They have been encouraged to use SSRI/SNRIs in the management of the menopause

by data in the literature and specialist advice and usage.

Key concerns are side effects, stigma and the fact that the anti-depressants alone can

not treat all symptoms of the menopause.

Conclusions (Cont’d)Much of this is echoed in GPs reactions to the unbranded XXXX profile - which has high appeal

to the GPs. Benefits are seen over and above those of the SSRI/SNRI classes and HRT with XXXX

seen to hold equal efficacy in both physical and psychological symptoms. Coupled with its

good tolerability profile, it makes an attractive addition to GPs armamentarium.

These positive perceptions result in good potential uptake for XXXX,and not surprisingly the PBS

scenario represents the best opportunity for XXXX, where it will not only gain new patients but

also take share from HRT especially:

With XXXX

HRT

OTC/Herbal remedies

Livial

SSRIs/SNRIs

Topical/Vaginal oestrogen

Catapres

Anti-convulsant

Other

Total prescribing: 1.2 products

27

28

24

8

7

XXXX

100%

Source Of

XXXX Volume

40

18

10

11

3

16

2

1

1

% of patients treated:

38

29

10

10

Current

1

1

1.2 products

New

80%76%

Conclusions (Cont’d)

This creates a clear positioning for XXXX to consider moving forward….selling the

benefits of both sets of symptoms will be a hook for XXXX prescribing in this market.

Looking forward to the future, it is clear that the cost, or PBS reimbursement status, of

XXXX will have a real impact on its uptake. GPs also feel that even at the lower private

script price of $40, an average of 50% of patients will refuse XXXX. This is not surprising

when considered in the context of the consumer feedback as most are spending less

than $30 a month on OTC or non-hormonal prescriptions.

Perceptual brand maps clearly show that while XXXX is perceived to be closer to

SSRI/SNRI classes than HRT on various attributes, it in fact straddles the two markets and

is seen to hold attributes of both. Already, XXXX is associated with few side effects and

being a low risk option as well as being useful in menopausal patients.

Conclusions (Cont’d)

Along with uptake levels, drivers for prescribing menopausal medications also vary

depending which market scenario is presented, but it is clear that confidence in the

new product and safety profile will be key selling messages for XXXX:

Secondary:

Primary:

Not

important:

$75

Confidence 13%

Efficacy in

menopausal 11%

Quality of life 9%

Not expensive 9%

Not reluctant to take 8%

Flexible 8%

Easy to dosing 3%

Usefulness 20%

Fast onset 19%

No HRT/Oestrogen, Safety,

Efficacy in depression

$40

Quality of life 7%

Not reluctant to take 6%

No HRT/Oestrogen 5%

Confidence 37%

Safety 18%

Efficacy in

menopausal 16%

Easy dosing 12%

Flexibility, Usefulness, Fast

onset, Efficacy in

depression, Not expensive

Authority

Easy dosing 7%

Efficacy in depression 7%

Quality of life 5%

PT Not reluctant

to take 4%

No HRT/Oestrogen 4%

Fast onset 4%

Usefulness 4%

Confidence 26%

Safety 14%

Efficacy in

menopausal 13%

Flexibility 11%

Not expensive

PBS

Usefulness 8%

No HRT/Oestrogen 8%

Efficacy in

menopausal 7%

Flexibility 6%

Efficacy in depression 5%

Fast onset 3%

Not expensive 2%

Easy dosing 2%

Confidence 31%

Safety 15%

PT Not reluctant

to take 13%

Quality of life

Conclusions (Cont’d)

The research also shows that with minimal information (the unbranded product profile),

the return on investment for such an education piece is clear. Even when the GPs are

exposed to this profile, the benefits of XXXX are clearly apparent, with the wide appeal

and fit for menopausal patients suffering from both sets of symptoms.

This is a really positive result for XXXX, and is an early indication that XXXX education will

be well received.

Recommendations

A positive and receptive market for XXXX launch.

Need to educate and inform that there is a product that can effectively and

safely treat their symptoms and encourage discussion with GP on matter

There are still many patients, especially amongst the younger age group who are

experiencing menopausal symptoms yet are not treating.

A good platform to position XXXX….straddling both HRT and SSRI territories

The PBS scenario results in best uptake for XXXX - with GPs not only switching patients

from HRT but also using the product in the previously untreated… expanding the market.

Employ Efexor’s halo effect to help build and strengthen GP confidence to use

XXXX Leverage XXXX use through KOL and specialist endorsement and

recommendation

Exploit Pristiq’s safety and tolerability perceptions and support efficacy measures

Even without an indication or PBS listing for the treatment of menopausal symptoms, GPs

have already accepted the benefits of using SSRI/SNRIs in this market.

There is early indication of the high return on investments for an education piece for

XXXX…GPs responding well to the product profile and showing a clear understanding of

the role of XXXX in the market.

Continue to push for PBS listing in this area

RESEARCH FINDINGS

A Note On Reading The Charts

All the data has been tested for statistical significance and through close examination

of the data and by using Jigsaw’s experience in this market we have been able to

identify skews and trends in the data which add to our general understanding of the

market:

– however, many of the bases here are too small to identify statistical

significance, so we have identified trends in the data instead

Therefore, when reading the charts we have noted interesting trends with a circle

around a number like this:

– 68%

Skews within the data have been noted through arrows indicating either a positive or

negative skew in a subset of our sample, for example:

– NSW

or:

total patient numbers

SECTION

- Our Sample In Context -

A good mix of demographics included in the omnibus research.

Consumer Demographics

Main Grocery Buyer SESHighest Education

Completed

Household

Income

– yes 95%

– no 5%

– white collar 61%

– blue collar 39%

– primary/

secondary

school 40%

– college/

apprenticeship 29%

– university

degree 31%

– >$30,000 22%

– $30-69,999 31%

– $70,000+ 30%

– refused 17%

State

– NSW 30%

– Vic 25%

– Qld 15%

– SA 13%

– WA 13%

– Tas 4%

Age Work Status Marital StatusChildren Under 18 In

Household

– 40-44 yrs 19%

– 45-49 yrs 22%

– 50-54 yrs 23%

– 55-59 yrs 18%

– 60-64 yrs 18%

– full time 36%

– part time 30%

– do not work 34%

– married/defacto 68%

– not married/ divorced/

separated 32%

– children 33%

– no children 67%

Base: All consumers, n=611

Consumers: The Majority Of Women In This Age Range Suffer From Symptoms Of Menopause

A minority refused to answer details.

4%

refused to

answer

73%

experience

menopausal

symptoms

Base: n=611 respondents

Women 40-64

23%

do not experience

menopausal

symptoms

Those suffering from menopausal

symptoms equivalent to 2.40 million

A good mix represented here.

GP Demographic Profile

Area AgeMetro/Rural

– NSW/ACT 35%

– Vic/Tas 33%

– Qld/NT 20%

– SA 6%

– WA 7%

Base: All GPs, n=150

Gender

– metro 69%

– rural 31%

– female 51%

– male 49%

– 30-39 years 15%

– 40-49 years 34%

– 50+ years 51% Rural

VIC/TAS

QLD/NT

QLD/NT

Work StatusNumber Of GPs

Work In PracticePractice Profile

Mean: 5

– full time 79%

– part time 21%

– solo 19%

– group 55%

– medical centre 26%

– 2-3 29%

– 4-5 29%

– 5 19%

– 6-7 19%

– 8-9 13%

– 10 + 10%

Male

Female Female

40-49

Minority of GP’s having more than 10,000 patients.

On Average, GPs Have A Total Of 2,568 Patients On Their Books

4

8

10

11

23

26

19

0% 25% 50%

QH: “How many patients do you have on your books in total, who are under your personal care for any condition?”

Mean: 2568

<999

1,000-1,999

2,000-2,999

3,000-3,999

4,000-4,999

5,000-9,999

10,000+

Base: All GP’s , n=150

Total Number Of Patients

Number of

patients

Part time Female

NSW/ACT

Metro Full time

Full time 40+

Those seeing 1,000+ menopause patients, skewed towards working in a group practice.

Nearly Ten Percent Of A GPs Patient Population Are Menopausal Women

6

10

5

10

17

7

21

16

7

0% 25%

QI: “How many patients do you have under your personal care in total, who currently experience symptoms of the menopause or perimenopause?”

<50

50-99

100-149

150-199

200-299

300-399

400-499

500-999

1,000+

Base: All GP’s. n=150

Number Of Menopausal/Perimenopausal Patients

Number of

patients Medical centre

Group

Mean: 300 patients with menopause

A minority seeing high numbers.

And, In A Typical Week, Treating 18 Menopausal PatientsQJ: “How many do you see in a typical week who currently experience symptoms of the menopause or perimenopause?”

3

5

7

21

9

25

11

20

0% 25%

5

6-9

10-14

15-19

20-29

30-49

50-69

70+

Base: All GP’s, n=150

Patients Experiencing Menopause/

Perimenopause Symptoms

Mean: 18 patients

Number of

patients

Rural

NSW/ACT

With an average of 4 new patients presenting

with menopause symptoms per week.

A High Number Of Menopausal Patients Are Repeat Patients

QK: “How many of these patients are presenting for the first time with their menopausal/perimenopausal symptoms? And how many are repeat patients?”

3

5

7

4

13

5

7

26

29

0% 25% 50%

1

2

3

4

5

6-9

10-19

20+

None

New Patients

Mean: 4

5

5

8

14

13

14

8

23

10

0% 25% 50%

1-3

4-5

6-7

8-9

10-14

15-19

20-29

30-39

40+

Repeat Patients

Mean: 14

New

Base: All GP’s, n=150

NSW/ACT

Part time

Full time

SECTION

- Menopausal Patient

Profile -

With over half experiencing night sweats,

disruption of quality of life and mood swings.

GP: From The GP Point Of View, The Majority Of Patients Suffer From Hot Flushes

Q1: “What proportion of your total menopausal and perimenopausal patients experience each of the following symptoms?”

20

30

31

34

34

37

37

42

46

50

51

52

53

57

68

49

0% 50% 100%

Hot flushes

Night sweats

Disruption of quality of life

Mood swings

Fatigue

Difficulty sleeping

Vasomotor symptoms

Vaginal atrophy

Daytime sweating

Difficulty concentrating

Depressive symptoms

Dry skin

Anxiety symptoms

Bladder urgency and/or frequency

Stiffness/pain joints

Palpitations

Menopausal Symptoms

NSW/ACT

Base: All GP’s, n=150

Consumers: Periods Stopping And Hot Flushes Are TheMain Symptoms Suffered Overall By Our Sample

Q: “Can you please tell me which of the following symptoms you experience on a regular basis

(once a week or more often) as part of the menopause or lead up to the menopause?”

Menopause Symptoms

3.8

14

11

21

22

24

24

28

29

32

34

35

36

37

38

38

40

41

42

53

0% 50% 100%

Periods have slowed/stopped

Hot flushes

Fatigue

Difficulty sleeping

Night time sweating

Tension/irritability

Stiffness/joint pain

Dry skin

Feelings of depression

Mood swings

Feelings of anxiety

Difficulty concentrating

Day time sweating

Bladder urgency

Vaginal dryness

Palpitations

Disruption of quality of life

Pain during sex

None

Refused

Base: All respondents, n= 611

Mean: 6 symptoms

-

68

51

50

57

-

30

34

37

52

34

37

42

31

46

20

53

-

-

-

GP Data

n=150

For the younger women, the psychological

symptoms are the main symptoms suffered.

Consumers: However, The Patient Research Tells Us That Experience Of Symptoms Does Vary By Age

Q: “Can you please tell me which of the following symptoms you experience on a regular basis

(once a week or more often) as part of the menopause or lead up to the menopause?”

Overall

(n=611)

Periods have slowed/stopped

Hot flushes

Fatigue

Difficulty sleeping

Night time sweating

Tension/irritability

Stiffness/Joint pain

Dry skin

Feelings of depression

Mood swings

Feelings of anxiety

Difficulty concentrating

Daytime sweating

Bladder urgency

Vaginal dryness

Palpitations

Disruption of quality of life

Pain during sex

Not experiencing menopause

53

42

41

40

38

38

37

36

35

34

32

29

28

24

24

22

21

11

9.5

40-44

(n=118)

19

9

23

15

16

30

21

16

21

29

21

18

7

12

7

9

8

2

21

60-64

(n=107)

55-59

(n=111)

50-54

(n=138)

45-49

(n=137)

28

32

41

37

28

36

33

27

29

31

27

29

23

18

15

19

18

6

5

75

63

58

55

53

42

47

48

42

40

36

40

40

30

34

24

27

15

1

82

59

44

54

54

44

43

48

49

44

42

31

45

63

37

33

31

15

2

76

53

43

49

46

41

48

49

40

25

35

30

32

31

36

30

25

22

4

% % % % % %

SECTION

- Menopausal Management -

Reflecting the high engagement of GPs in this area.

In The Management Of These Patients, On Average, Only A Tenth Of Total Menopausal Patients Have Been Referred To A Specialist

Specialist Type

(n=130)

5

1

2

2

4

5

7

7

38

88

0% 50% 100%

Q: “Which specialists do you typically refer

these patients to?”

Gynaecologist

Endocrinologist

Obstetrician

Psychologist/Psychiatrist

Urologist

Menopause specialist/clinic

Cardiologist/heart specialist

Women’s health

Surgeon

Other

n=130

GPs have

referred patients

Others include:

– dermatologist

– rheumatologist

Q: “Thinking again about menopausal/perimenopausal patients

you have on your books in total, how many have been referred to

a specialist at some point for their symptoms?”

13

5

13

10

11

7

17

14

8

0% 50% 100%

1-4

5-9

10-14

15-19

20-29

30-49

50-99

100+

None

Specialist Referred

(n=150)

Mean: 32 patients

Number of

patients

GPs only referring if there is a problem or at patient request.

This Engagement Is Demonstrated By Referral Rationale

Q: “And of the patients you have referred to specialists, typically what were the main reasons for the referrals?”

Base: GPs referred to specialist,

n=130

Physical symptoms 53%

– abnormal bleeding 19%

– urinary/bladder symptoms 12%

– not tolerating HRT 12%

– gynaecological problems 5%

– vaginal dryness 5%

– severe flushing/hot flushes 5%

– vaginal problems 3%

Poor control/Poor response to treatment 43%

– not responding to medication/

treatment 37%

– not responding to hormone

replacement therapy 8%

Patient request 30%

– patient wanting second opinion 28%

– patient worrying 2%

Psychological symptoms 15%

– anxiety/depression 8%

– loss of libido/problem with sex life 8%

– mood swings 2%

Metro

Rural

Confirmation/Advice/Assessment 14%

– to assess/advise patients for HRT 7%

– management issues/medical issues 5%

– confirming diagnosis/rule out

other problems 3%

Severe/Complicated cases 13%

– complicated cases 7%

– severe menopausal symptoms 7%

Safety concerns 8%

– concerns regarding HRT 5%

– cardiac/hypertension/stroke concerns 3%

Advice on alternative treatments 5%

Female

Medical

centre

Rural

History of breast cancer concerns 9%

The majority return to their GP’s care.

On Average, A Quarter Of Those ReferredTo A Specialist Continue To Be Managed By The Specialist

Q2d: “Thinking about the patients who have been referred to a specialist at some point, how many continue to be managed by the specialist?”

Mean: 8

8

12

6

16

22

8

5

22

0%

25%

1 2 3-4 5-9 10-19 20-29 30+ None

Percentage

Of GPs

Specialist Patient Management

Base: GPs referring to specialist,

n=130

Rural

VIC/TAS

Female

Number Of Patients

Currently, GPs Believe That While HRT Is A Lead Option, Patients Are Also Utilising OTC Remedies

Currently, lower use of the anti-depressant classes…reflecting their off-label status.

Also illustrating the importance of DTC as lots of OTC usage.

Base: All GPs, n=150

Q3a: “Thinking about the menopausal patients you have on your books in total, how many are treated with or use each of the fo llowing options?”

38

29

10

10

Total prescribing: 1.2 products

% of patients treated:76%

HRT

OTC/Herbal remedies

Livial

Topical/Vaginal oestrogen

Catapres

Anti-convulsant

Other

SSRIs/SNRIs

Treatment Options

1

1

A tiny minority admitting they use the SSRIs/SNRIs.

In Terms Of Preferred Choice, The Majority Of GPsFavour HRT

Q4a: “Thinking of therapies currently available for the treatment of

menopause or perimenopausal symptoms, which is your preferred therapy?”

61

20

2 1 1

106

0%

50%

100%

Hormone

Replacement

Therapy

Livial/

tibolone

Efexor/

Venlafaxine

Cipramil/

Citalopram

Luvox/

FLuvoxamine

OTC/Herbal

supplements

or remedies

Tailor therapy

to patient/

no preferred

therapy

Nett SSRIs/SNRIs

3%

Base: All GP’s, n=150

Percentage

Of GPs

Male

Female

50yrs +

rural

Low Efexor

prescribers

Using

SSRI/SNRI less

than a year

Similar to OTC therapies, which are also preferred

due to efficacy and lower risk profile.

Good Tolerability Profile Noted As A Reason To Use The SSRIs/SNRIs

– nett few side effects (n=6)

– effective for symptom relief (n=5)

– nett reduce HRT risk (n=4)

– safe (n=3)

– patients like it (n=2)

– patient prefers natural

treatment first (n=2)

OTC

(n=15)

Base: Those with preferred

therapy

Q4b: “And why is (Q4a) your preferred therapy?”

SSRI/SNRI(n=5)

– few side effects, simple

to use, not addictive (n=1)

Cipramil

(n=1)

Luvox

(n=1)

– improves quality of sleep,

has few side effects, less breast

cancer risks and not addictive (n=1)

Efexor

(n=3)

– low/no side effects (n=3)

– effective for hot flushes (n=1)

– proven in studies (n=1)

Still a high number of women who are suffering symptoms that are not treated

with prescription meds… either because they can’t or won’t take the medications.

Most Patients That Are Contraindicated To HRT Are Contraindicated To Oestrogen Therapy Specifically

Base: All GP’s, n=150

Q3b: “And of the menopausal/perimenopausal patients you have on your books,

in total, how many are contraindicated to treatment with…?”

Hormone Replacement Therapy

Mean: 38 patients

(None: 2% of GPs)

Oestrogen Therapy Specifically

Mean: 36 patients

(None: 2% of GPs)

Represents 11.4% of total patient

population

Represents 10.8% of total patient

population

Q3c: “And of the menopausal/perimenopausal patients you have on your books in total, how many

completely refuse or chose not to take prescription medication for their symptoms?”

Patients Refuse To Take

Prescribed Medication

Mean: 71 patients

(None: 5% of GPs)

Represents 21.3% of total patient

population

Consumer: In Line With This, Over Half The Consumer Sample Are Not On Any Form Of Menopausal Treatment

Maybe many potential patients out there

that have not consulted with their GP?

73%

experience

menopausal

symptoms

Q: “And which of the following treatment options do you use to manage your menopausal symptoms?”

Consumer SampleCurrent Therapies For

Menopause

23%

do not

experience

menopausal

symptoms4%

refused

to

answer

Base: All omnibus respondents

suffering menopausal

symptoms, n=448

55%

None ( 40-44)

22%

OTC/Herbal remedies

( full time work)

5%

Non-hormonal

prescriptions

medication

( 55-59)

24%

Hormone/oestrogen

replacement therapy

( 55-59) ( Blue SES)

Base: All respondents, n=611

Consumers: Whilst Symptoms Are Common To All, Variations Noted Amongst The Different Management Algorithms

Those taking over the counter/herbal remedies

reported slightly fewer symptoms.

63

72

51

60

42

67

47

41

64

63

59

52

37

45

60

75

43

27

Base: All on current treatment, n= 223

Hormone/Oestrogen

Replacement Therapy

Non-Hormonal

Prescription Medications

Over The

Counter/Herbal

Remedies Medication

Average no. of symptoms 10.6 11.2 9.7

Night time sweating

Hot flushes

Feelings of anxiety

Feelings of depression/low mood

Palpitations

Fatigue

Difficulty in concentrating

Disruption of quality of life

Tension/Irritability

Difficulty sleeping

Mood swings

Daytime sweating

Bladder urgency/frequency

Dry skin

Stiffness/joint pain

Periods have slowed/stopped

Vaginal dryness

Pain during sex

66

77

60

62

49

74

50

47

67

70

58

60

46

62

66

84

41

22

55

70

70

70

54

88

61

36

76

71

75

76

41

58

74

70

59

22

SECTION

- SSRI/SNRI Usage In Focus -

A minority have been using the medications in this way for quite some years.

GPs Started Using The SSRI/SNRI Medications In Menopausal Women An Average Of 5 Years Ago

1

8

11

7

34

27

13

0% 25% 50%

Q5c: “How long ago did you personally start using SSRI/SNRI medications for the treatment of menopausal/perimenopausal symptoms?”

Base: All GPs using SNRI/SSRI,

n=133

Time Since Started Using SSRI/SNRI

Mean: 5 years ago

<1 year

2-3 years

4-5 years

6-7 years

8-10 years

11+ years

Don’t know

Some also moved to act following specialist advice…

another leverage point for XXXX.

GPs Have Begun Using The Medications In This Way As They Know That The Depressive Symptoms Of Menopause Will Be Treated

Q5f: “And what prompted you to commence using these agents in menopausal/perimenopausal patients?”

Base: All GPs using SSRI/SNRI

medications, n=133

Treats psychological symptoms 40%

– depression/anxiety/stress 26%

– patient symptoms suit that drug 14%

– mood swings 5%

– helps insomnia/sleep disturbances 2%

Literature 36%

– clinical data/trials/studies 14%

– medical journal articles 13%

– reading articles/drug books 12%

– medical magazines 3%

Patients not wanting HRT 14%

Info from drug reps 14%

Relief of symptoms 12%

Failure of other therapies 5%

Contra-indications for other treatments 5%

Personal experiences with patients 17%

Specialist advice 32%

– specialist usage/advice 19%

– info from medical meetings/conferences 17%

Zoloft And Efexor Are The Currently Favoured SSRI/SNRI Medications Used In Treatment Of Menopausal Symptoms

Q3ai: “You said you prescribed patients SSRI/SNRI medications for their menopausal symptoms,

of those how do they fall out between the different brands of SSRI/SNRI?”

Base: All prescribing SSRI/SNRI,

n=133

Treatment Options

Not

treated

24%

Base: All patients of all GPs

SSRI/SNRI

10%

No one brand particularly associated with menopause…

GPs probably employing their favoured brand

6

6

8

9

9

21

29

<1

15

Zoloft/sertraline

Efexor/venlafaxine

Cipramil/citalopram

Lexapro/escitalopram

Prozac/Lovan/fluoxetine

Aropax/paroxetine

Avanza/mirtazapine

Luvox/fluvoxamine

Other

Others mentioned <1%:

– Tricyclics

– Aurorix/moclobemideSSRI/SNRI Brands

In addition, a third of GPs see physical benefits… and a lower risk profile.

Unsurprisingly, The Medications Are Utilised For Their Impact On Psychological Symptoms

Help control physical symptoms 31%

– hot flushes controlled 17%

– better for motor/vasomotor symptoms 8%

– less fatigue/better concentration 6%

HRT risks avoided 30%

– HRT risks avoided/alternative 25%

– HRT risk of breast cancer avoided 11%

Well tolerated 10%

– side effects are few 6%

– well tolerated 5%

Effective/fast acting 9%

Safe in overdose/long term safety 8%

Normal lifestyle maintained 7%

Easy to take/less stigma 5%

Cost effective/PBS listed 5%

None 5%

Q5a: “What are the key advantages you see of these medications for patients experiencing menopausal/perimenopausal symptoms?”

Base: All GPs, n=150

Psychological symptoms 84%

– anti depressant effect 58%

– mood is more stable/less irritability 37%

– anxiety control 31%

– sleep is better 15%

– treat mental/psychological/

emotional symptoms 6%

A quarter of GPs also perceiving the SSRI/SNRI class

to be incapable of treating all symptoms of menopause.

However, The SSRI/SNRIs Are Not WithoutTheir Own Concerns For GPs And Patients

Does not treat all symptoms 27%

– hot flushes will persist 13%

– does not always work or treat

all symptoms 13%

Does not address real menopause symptoms 12%

Long time to work/may have to be used longer 7%

Cost/expensive/2 costs if used with HRT 4%

None/not applicable 8%

Q5b: “What are the key disadvantages you see of these medications for patients experiencing menopausal/perimenopausal symptoms?”

Base: All GP’s, n=150

Side effects 63%

– side effects 21%

– nausea 17%

– insomnia 13%

– drowsiness/sedation 11%

– anxiety/agitation 9%

– cramps/urinary side effects 9%

– libido can decrease 8%

– headaches 8%

– gastro intestinal side effects 7%

– weight gain 7%

– dizziness 6%

– dry mouth 5%

– sweating 3%

Stigma attached/patient concern or reluctance 27%

Some effect seen for those suffering physical symptoms too. Opportunity for XXXX to build on this platform of understanding.

The Benefits Of The SSRI/SNRI Classes CentreOn Their Ability To Impact Psychological Symptoms

Q5c: “And which menopausal/perimenopausal patients in particular do you typically

see as benefiting from these agents? For example what is the typical patient profile?”

Base: All GPs, n=150

Psychological issues 81%

– depression 61%

– anxiety 32%

– mood swings 24%

– insomnia 13%

– irritable 8%

– emotional symptoms

(crying/getting upset easily) 5%

– history of depression 5%

– psychological issues/problems 4%

– relationship/family problems 4%

Physical Symptoms 20%

– hot flushes 11%

– tired/fatigued/lethargic 5%

– vasomotor symptoms 3%

– sweats 3%

Younger/Middle aged women 6%

– 40-45 years 3%

– younger age group 3%

Working/Active 5%

– working full time 3%

– have active lifestyle 2%

Breast cancer risks 9%

– previous/history of breast cancer 7%

– concerned about breast cancer 3%

Over 50 years 9%

Menopausal symptoms 7%

Don’t want to take HRT 7%

Perimenopausal 7%

Unable to tolerate HRT 17%

– unable to tolerate/respond to HRT 17%

– oestrogen contra-indication 4%

But again, efficacy seen for physical symptoms too.

Overwhelmingly, It Is The Psychological Symptoms That Lead GPs To Employ The SSRI/SNRI Classes

Q5d: “When you think of initiating a SSRI/SNRI in your menopausal/perimenopausal patients,

which symptoms of the menopause in particular are you targeting with this treatment?”

Base: All GPs, n=150

Physical Symptoms 48%

– hot flushes 25%

– fatigue 13%

– vasomotor symptoms 5%

– night sweats 5%

– daytime sweating 3%

– palpitations 3%

– stiffness and/or pain in joints 2%

Psychological symptoms 96%

– depression symptoms 76%

– anxiety symptoms 57%

– mood swings 48%

– difficulty in sleeping 27%

– tension/irritability 17%

– difficulty in concentrating 4%

… and high numbers of these patients seen.

It Follows Then That GPs Are Mostly Using These Medications Amongst Depressed Women…

2

43

7

13

7

3

11

4

3

5

5

0% 25% 50%

Q5e: “And of the patients currently treated with an SSRI or SNRI medication for their symptoms what proportion

were also experiencing depressive symptoms at the time you initiated their medication?”

Base: All GPs using SSRI/SNRI, n=133

Patients Experiencing Depressive Symptoms

Mean: 74% of patients1-10%

11-20%

21-30%

31-40%

41-50%

51-60%

61-70%

71-80%

81-90%

91-100%

None

percentage

of patients

SECTION

- XXXX In Focus -

What We Told GPs About XXXX (Product X)…

Product X:

− Product X is a non-hormone medication that works on the central nervous system to treat moderate to

severe vasomotor symptoms associated with the menopause

− Product X is a serotonin and norepinephrine reuptake inhibitor (SNRI). Product X will also be used as an

anti-depressant

– Product X has several benefits across several symptoms of the menopause:

• patients will experience a 60% reduction in both the severity and frequency of hot flushes

(those that occur both during the day and night)

• patients will experience relief within 21-28 days

• patients will experience fewer episodes of sleep disturbances associated with hot flushes, and

may have an improved quality of sleep

• patients will experience a positive impact on workplace efficiency, including achievement of

full activity and productive days and also experience improved quality of life (eg reduction in

symptoms, fewer side effects, improved social functioning)

− Safety:

• Product X has no hormone-related side effects or risks (for example no breakthrough bleeding,

no endometrial or breast tissue stimulation)

• at higher doses product X is associated with a 2mm hg increase in Systolic Blood Pressure in 2-

3% patients

− Tolerability:

• product X has a 25% incidence of mild to moderate nausea and/or dizziness (which is transient

for 2 to 3 weeks)

• Product X has no effect on sexual function

− Dosing product X is an oral tablet taken once daily

A really positive result for XXXX!

Upon Hearing Pristiq’s Profile, GPs IndicateThat They Are Very Interested In The New Product

1% 1%

3% 10% 22% 26% 37%

1 Not very interested 2 3 4 5 6 7 Very interested

Q6a: “Recognising that there are already a wide range of products available for use, on a scale of 1-7,

where 1 is not very interested and 7 = very interested, can you tell me how interested you are in this new product?”

Base: All GPs, n=150

Level Of Interest

Mean: 6

Not interested

5%

Neutral

32%

Interested

63%

Equal efficacy in physical and psychological symptoms.

A good tolerability profile is also helping positive perceptions.

The Biggest Advantage OfXXXX Is Considered To Be Its Efficacy Profile

Few side effects/well tolerated 63%

– low side effect profile 39%

– good safety profile 10%

– will not affect sexual function 10%

– well tolerated drug 8%

– not stimulate endometrial tissue 5%

Q6b: “Based on all the information you heard from Product X, what do you consider to be its main advantages?”

Base: All GPs, n=150

EFFICACY 83%

Efficacy: Physical Symptoms 39%

– good for hot flushes 24%

– helps vasomotor symptoms 11%

Efficacy: Psychological symptoms 39%

– good for depression 21%

– good for sleep disturbances 18%

– good for stabilising mood swings 6%

Overall efficacy profile 49%

– effective for menopause symptoms 20%

– treats a wide range of

menopausal symptoms 13%

No hormonal therapy 51%

– non hormonal therapy 41%

– no HRT risk 9%

Improve lifestyle 15%

– improves quality of life 11%

– better performance for patient 6%

Easy to use 12%

– once daily dosing 9%

– single pill 3%

– easy to take/use 3%

Fast acting 5%

– works quickly 3%

– relief within 21 days 3%

Alternative offer 5%

No breast cancer scare 17%

– no increase in breast cancer/can use on

patients with breast cancer 11%

– will not stimulate/affect breast tissue 7%

The lack of effect on hormones a concern for others.

However, For Some,The Potential Side Effects Raise Concerns

Q6c: “And based on all the information you have heard for Product X, what do you consider to be the main disadvantages?”

Base: All GPs, n=150

Side effect concerns 65%

– blood pressure rise 20%

– causes nausea 20%

– problem with side effects 15%

– causes dizziness 9%

– 25% nausea too high 9%

– nausea 2-3 weeks a concern 6%

– side effect with SSRI drug type 5%

Less effective than HRT 25%

– no bone protection 7%

– not as effective as HRT 5%

– no positive hormonal effects 5%

– lack of efficacy in controlling menopausal

symptoms 4%

Patients unwilling to take antidepressants 17%

– patients compliance issues 11%

– antidepressant puts patients off 10%

Slow onset of action 15%

– takes a month to work 14%

Unsure of cost 6%

– may be expensive 5%

Drug not proven yet 5%

None 11%

Greater emphasis on treating the physical and

overall menopause symptoms

Even With Limited Information Available, GPs Already Able To Perceive Benefits Of XXXX Above Those Of The SSRI/SNRI Classes In General

Q6d: “And which patients in particular do you anticipate that Product X would be useful for… typical patient profile?”

Base: All GPs, n=150

Those with psychological issues 57%

– depression 32%

– mood swings 15%

– insomnia 15%

– anxiety 15%

– loss of concentration 5%

– not coping with day to day activities 5%

Those with physical symptoms 35%

– hot flushes 22%

– vasomotor symptoms 13%

Menopausal symptoms 25%

Unable to tolerate HRT 22%

– unable to tolerate HRT 15%

– oestrogen contra-indications 7%

Don’t want to take HRT 21%

Perimenopausal 13%

All other treatments failed 6%

Severe symptoms 6%

Breast cancer risks 13%

– history of breast cancer 7%

– concerned about breast cancer 5%

(%) = SSRI/SNRI patient suitability profile

(20%)

(7%)

(7%)

(7%)

(81%) (9%)

(7%)

(-)

(-)

SECTION

- Uptake Levels -

What We Did….

Gauged uptake of XXXX , and where its share of market would come from in each scenario

After taking a measure of current prescribing in the market, we

presented the GPs with the XXXX profile.

In order to gauge uptake of XXXX in a range of hypothetical potential future

market reimbursement scenarios, we presented the GPs with four different

scenarios.

Pristiq’s presence in this scenario is unlikely to motivate GPs

to prescribe treatment to any new patients.

XXXX Can Gain 5% Share Mostly From HRT, If It Is Introduced As A Private Prescription For $75

100%

Source Of XXXX Volume

68

13

15

4 SSRIs/SNRIs

Cipramil 49%

Zoloft 28%

Prozac 16%

Avanza 4%

Tricyclics 2%

With XXXX

1.2 products

5

34

28

10

10

1

2

76%

XXXX

As A Private Prescription For $75

Q: “Thinking about the menopausal patients you have on your books in total, how many are treated with or use each of the following option?”

Q: “ Imagine that Product X is now available as a private prescription with a cost of $75 per month, how would your prescribing now typically

fall out between the different treatments available?”

Base: GPs, n=74

SSRIs/SNRIs

XXXX

1

1

38

29

10

10

Current

HRT

OTC/Herbal remedies

Livial

Topical/Vaginal oestrogen

Catapres

Anti-convulsant

Other

Total prescribing: 1.2 products

% of patients treated:76%

Cannibalisation of some Efexor use is also noted.

100%

Source Of XXXX Volume

16

30

3

13

6

29

SSRIs/SNRIs

Efexor 37%

Lexapro 25%

Zoloft 12%

Aropax 11%

Prozac 5%

Avanza 5%

Luvox 5%

Aurorix 1%

1

2

New

With XXXX

1.2 products

15

36

24

10

81

80%

XXXX

As A Private Prescription For $40

Q: “Thinking about the menopausal patients you have on your books in total, how many are treated with or use each of the following option?”

Q: “ Imagine that Product X is now available as a private prescription with a cost of $40 per month, how would your prescribing now typically

fall out between the different treatments available?”

Base: GPs, n=76

OTC/herbal remedies and to a lesser degree, HRT can expect to lose share to XXXX.

HRT

OTC/Herbal remedies

Livial

SSRIs/SNRIs

Topical/Vaginal oestrogen

Catapres

Anti-convulsant

Other

Total prescribing:

XXXX

% of patients treated:

38

29

10

10

Current

1

1

1.2 products

76%

Pristiq’s Introduction As A Private Prescription For $40 Is Expected To Bring In New Patients, As Well As Take Share From Some Current Treatment Options

Pristiq’s entry in this scenario also provides GPs a reason to prescribe

to patients currently not receiving any treatment.

100%

Source Of XXXX Volume

36

17

14

12

17

SSRIs/SNRIs

Efexor 24%

Zoloft 22%

Lexapro 11%

Cipramil 10%

Avanza 9%

Aropax 8%

Prozac 8%

Luvox 6%

Aurorix 1%

2

2

New

With XXXX

1.2 products

16

33

26

8

8

1

1

79%

XXXX

As PBS With Authority Requirement

Base: All GPs, n=150

HRT

OTC/Herbal remedies

Livial

SSRIs/SNRIs

Topical/Vaginal oestrogen

Catapres

Anti-convulsant

Other

Total prescribing:

XXXX

% of patients treated:

38

29

10

10

Current

1

1

1.2 products

76%

As A PBS Prescription With Authority Requirement, XXXX Is Likely To Take Share More From HRT Than OTC/Herbal Remedies

Q: “Thinking about the menopausal patients you have on your books in total, how many are treated with or use each of the following option?” Q: “ Imagine that Product X is now available as a PBS prescription with the following authority requirements, how would your prescribing now

typically fall out between the different treatments available?”

This can lead to HRT losing almost half of its current patient base.

Pristiq’s introduction will lead to an increase in market size.

XXXX Can Potentially Attain One Third Market Share If It Is Introduced As A PBS Prescription Without Restriction

100%

Source Of XXXX Volume

40

18

10

11

3

16

2

SSRIs/SNRIs

Zoloft 27%

Efexor 23%

Cipramil 9%

Aropax 9%

Lexapro 8%

Avanza 8%

Prozac 8%

Luvox 7%

New

With XXXX

1.2 products

27

28

24

8

7

1

1

80%

XXXX

As A PBS Prescription

Q: “Thinking about the menopausal patients you have on your books in total, how many are treated with or use each of the following option?”

Q: “ Assuming that Product X is now available as a PBS prescription, how would your prescribing now typically fall out between the different

treatments available?”

Base: All GPs, n=150

HRT

OTC/Herbal remedies

Livial

SSRIs/SNRIs

Topical/Vaginal oestrogen

Catapres

Anti-convulsant

Other

Total prescribing:

XXXX

% of patients treated:

38

29

10

10

Current

1

1

1.2 products

76%

Not surprisingly, refusal rates rise with increased cost of XXXX.

GPs Think Half Their Patients WillRefuse XXXX If It Is Priced Of $40 A Month

Refused With Cost

of $40 per month

(n=76)

Mean: 50% of patients

Q7: “Imagine a hypothetical scenario in which product X is

available on the market as a private prescription with a cost

of $40 per month, what proportion of your patients do you

think would refuse the product in the basis of this cost?”

Refused With Cost

of $75 per month

(n=74)

Mean: 75% of patients

Q7: “Imagine a hypothetical scenario in which product X is

available on the market as a private prescription with a cost

of $75 per month, what proportion of your patients do you

think would refuse the product in the basis of this cost?”

Base: All GPs, n=150

(None: 3% of GPs) (None: 1 % of GPs)

Mostly less than even the lower proposed XXXX pricing of $40 currently.

Consumers:This Is In Line With What Consumers Really Spend…

Q: “And, in a typical month, how much do you typically pay for your over the counter medication

and / or a herbal remedy or supplements, or non-hormonal prescription medication in total?”

Average Spend Per Month:

OTC Medication(n=104)

– 40-44 year old: $20 per month

– 45-49 year old: $33 per month

– 50-54 year old: $33 per month

– 55-59 year old: $28 per month

– 60-64 year old: $29 per month

Mean: $30

(Range : $10 - $100+)

Average Spend Per Month:

Non-Hormonal Prescription Medication(n=98)

Mean: $27

(Range : $10 - $100+)

– 40-44 year old: $17 per month

– 45-49 year old: $31 per month

– 50-54 year old: $17 per month

– 55-59 year old: $41 per month

– 60-64 year old: $17 per month

SECTION

- Brand Perceptions -

What We Did

The data not presented may be found in the Appendix.

No one technique is perfect… we need to look at all the techniques to get an idea of the market.

– Brand Mapping:

• allows us to look visually at how brands are perceived in the market

– Driver Analysis:

• takes a measure of behaviour and looks at what may be impacting this behaviour. The data is associative only, so we have to assume cause and effect

– XXXX/Efexor Performance Vs Driver Maps:

• looks at the strengths and weaknesses of XXXX and Efexor particularly

– Frequency Data:

• shows the differences in raw scores between products and allows us to look at

the absolute differences in scores

– Spine Data:

• looks at the profiles of each brand. It shows the relative strengths and weaknesses of each brand compared to the average

There are many ways to look at the performance of products. We have chosen 5 ways which

work together to tell a story:

Brand Maps

The closer an attribute is to a brand, the more it is associated with the brand.

Brand maps provide a visual summary of how the products are

perceived in the market, relative to the competitors shown. Attributes

nearer to the centre of the map are common to all brands.

The closer brands are together, the more similarly they are perceived. A brand

that sits apart on the map is more differentiated from its competitors.

Livial

HRTOther SSRI/SNRIs

Efexor

Product X

Expensive

Has data for use in menopausal

PT reluctant to take

Efficacy benefits in depressive

symptoms

Efficacy in Vasomotor

Confident in prescribing

Variety of dosages

Easy dosing schedule

Low risk option Reduces hot flushes severity

Reduces hotflushes frequency

Has a fast onsetof action

Improves PT sleep Improves PT quality of life

Variety of admin formats

Useful in menopausal PT

No oestrogenNo HRT

Few side effects

Safe

Approved for vasomotor treatment

HRT Is Perceived To Have Fast Onset OfAction And A Variety Of Administration Formats

It is also most associated with patients

reluctance to take the medication.

Efexor And The Other SSRI/SNRIsAre Positioned In A Very Similar Way

These medications own the

depressive symptom efficacy attribute in this market.

Livial

HRTOther SSRI/SNRIs

Efexor

Product X

Expensive

Has data for use in menopausal

PT reluctant to take

Efficacy benefits in depressive

symptoms

Efficacy in Vasomotor

Confident in prescribing

Variety of dosages

Easy dosing schedule

Low risk option Reduces hot flushes severity

Reduces hotflushes frequency

Has a fast onsetof action

Improves PT sleep Improves PT quality of life

Variety of admin formats

Useful in menopausal PT

No oestrogenNo HRT

Few side effects

Safe

Approved for vasomotor treatment

Livial

HRTOther SSRI/SNRIs

Efexor

Product X

Expensive

Has data for use in menopausal

PT reluctant to take

Efficacy benefits in depressive

symptoms

Efficacy in Vasomotor

Confident in prescribing

Variety of dosages

Easy dosing schedule

Low risk option Reduces hot flushes severity

Reduces hotflushes frequency

Has a fast onsetof action

Improves PT sleep Improves PT quality of life

Variety of admin formats

Useful in menopausal PT

No oestrogenNo HRT

Few side effects

Safe

Approved for vasomotor treatment

XXXX Is Perceived To HoldBenefits Of Both HRT And Anti-Depressants

Straddles both markets.

Likely to strengthen positive perceptions with further education.

- Driver Analysis -

Driver Analysis Methodology

A robust multivariate approach to understand menopausal/perimenopausal

prescribing choice with Product X under the different reimbursement scenarios.

Latent class multi-nominal logit modelling (MNL) is used to determine the relative

drivers.

Factor analysis is used to remove inter-correlation between the attributes tested,

simplifying them into common themes as perceived by GPs.

The factors derived have then been fed into four separate regression models

to understand their relationships to prescribing menopausal/perimenopausal

treatments with Product X available:

– as a private prescription scenario with a cost of $75 per month

2. as a private prescription scenario with a cost of $40 per month

3. as a PBS prescription with authority requirements (Oestrogen

contraindicated)

3. as a PBS prescription

From The List Of 21 Attributes,Twelve Correlating Groups Of Factors Emerged

Efficacy In Menopausal

– reduces the frequency of hot

flushes

– reduces the severity of hot

flushes

– has excellent efficacy benefits

in Vasomotor symptoms

– is approved for the treatment

of vasomotor symptoms

– has data for use in

menopausal patients

No HRT/Oestrogen

– use in patients who are

contraindicated to HRT

– use in patients who are

contraindicated in oestrogen

therapy

– is a low risk option

Flexibility

– has a good variety of

administration formats

– has a good variety of

dosages

Safety

– has few side effects

– is safe

Usefulness

– useful in all menopausal

patients

Quality Of Life

– improves patients quality of

life

12 Factors Emerged From The List Of Attributes (Cont’d)

GPs prescribe menopausal symptom treatments on 12 key dimensions.

Expensive

– is an expensive product

Confidence

– I feel confident prescribing

these agents

PT Reluctant to take

– patients are reluctant to take

this medication

Fast onset

– has a fast onset of action

Efficacy in depression

– has excellent efficacy benefits

in depressive symptoms of the

menopause

– improves patient sleep

Easy dosing

– easy dosing schedule

The Drivers Of Prescribing ChoiceAre Impacted By The Market Situation

In most scenarios, GP confidence and safety are key but a more expensive

product will also need to be highly useful for patients if they are to pay more.

Secondary:

Primary:

Not

important:

$75

Confidence 13%

Efficacy in

menopausal 11%

Quality of life 9%

Not expensive 9%

Not reluctant to take 8%

Flexible 8%

Easy to dosing 3%

Usefulness 20%

Fast onset 19%

No HRT/Oestrogen, Safety,

Efficacy in depression

$40

Confidence 37%

Safety 18%

Efficacy in

menopause 16%

Easy dosing 12%

Authority

Confidence 26%

Safety 14%

Efficacy in

menopausal 13%

Flexibility 11%

PBS

Confidence 31%

Safety 15%

PT Not reluctant

to take 13%

Quality of life 7%

Not reluctant to take 6%

No HRT/Oestrogen 5%

Flexibility, Usefulness, Fast

onset, Efficacy in

depression, Not expensive

Easy dosing 7%

Efficacy in depression 7%

Quality of life 5%

PT Not reluctant

to take 4%

No HRT/Oestrogen 4%

Fast onset 4%

Usefulness 4%

Not expensive

Usefulness 8%

No HRT/Oestrogen 8%

Efficacy in

menopausal 7%

Flexibility 6%

Efficacy in depression 5%

Fast onset 3%

Not expensive 2%

Easy dosing 2%

Quality of life

The Frequency Data Shows Pristiq’sStrength In The Safety Dimension

Even with minimal information available to GPs, XXXX is already associated with

efficacy measures. An excellent platform to start from.

Q8: “I’m now going to read out a list of statements associated with different therapies in the menopausal and perimenopausal market. I

would like you to nominate the product or products from the list you have written down which you feel most strongly are associated with

each statement read out to you”

LivialOther

SSRI/SNRIHRTProduct X Efexor

Confidence

− I feel confident in prescribing these agents 53 65 72 79 76

Safety

− has a few side effects

− is safe

57

64

21

54

27

57

30

37

49

55

Base: n=150

Efficacy in menopause

− reduces the frequency of hot flushes

− reduces the severity of hor flushes

− has excellent efficacy benefits in vasomotor

symptoms

− is approved for the treatment of vasomotor

symptoms

− has data for use in menopausal patients

65

69

58

58

46

31

29

12

21

38

23

24

11

17

39

91

94

80

79

91

64

63

46

50

80

See appendix for remainder of

frequency data

Unsurprisingly, XXXX Performs Less Well On Most Primary Drivers If Priced At $75

In addition to lack of GPs confidence, XXXX also needs to address

concerns surrounding ‘usefulness’ and ‘fast onset action’ as these are primary drivers.

Easy dosing

Flexibility

Not reluctant to take

Not expensive

Quality of life

Efficacy in menopausal

Confidence

Fast onset

Usefulness

High

Importance

Low

Importance

Low

Performance

High

Performance

Support Exploit

FixDe-Prioritise

$75 - XXXX

XXXX Performs Well On AllBut The Top Driver Of Confidence If Priced At $40

Safety and efficacy in menopausal area are attributes to exploit in this scenario.

No HRT/

Oestrogen

Not reluctant

to take

Quality of life

Easy dosing

Efficacy in menopausal

Safety

Confidence

High

Importance

Low

Importance

Low

Performance

High

Performance

SupportExploit

FixDe-Prioritise

$40 - XXXX

XXXX Has A Number Of Leverageable Assets, Including Efficacy In The PBS Scenario

But, at this early stage, as expected for a new product,

a need for confidence building.

Easy dosing

Not expensive

Fast onset

Efficacy in depression

Flexibility

Efficacy in menopausal

No HRT/Oestrogen

Usefulness

PT Not reluctant to take

Safety

ConfidenceHigh

Importance

Low

Importance

Low

Performance

High

Performance

Support

Exploit

Fix

De-Prioritise

PBS - XXXX