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Strategic Implementation: A-to-B Shift

ZELMAC

Patient Categories

Fully understand Patient categories… from the doctors perspective…

Female Patients with Irr itable Bowel Syndrome

with constipation as predominant symptom: C-IBS

MILD MODERATE SEVERE…

5

How do they bucket???

Mild

Moderate

Severe

1st 3rd2nd

Nothing Diet/ LSC ASP

AS ASP++ TCA/ Z

AS++ ZELMAC

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Live with itPositive Natural

TreaterOpen and Pro-Active To better therapies

HighlyBothered and dissatisfied

Socially Inhibited

/ low self esteemlife highly impacted by Syndrome

The Patient Spectrum…C-IBS Females

Doctor / Rx Avoider

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A-to-B Shift Strategy: IBS (Doctors)

Physician does not recognize IBS asa legitimate condition

Physician does not recognize the IBS-C patient

Physician diagnoses IBS-C and treats with diet/lifestyle and single-symptom therapies

Physician uses Zelmac first-line for all appropriate patients

STEP # 1

STEP # 2

STEP # 3

STEP # 4

Physician uses Zelmac in some,not all, appropriate patients

Physician does not know how todiagnose the IBS-C patient

Physician uses Zelmac in the same way as he uses an antispasmodic or laxative

STEP # 5

STEP # 6

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Physician does not recognise IBS as a legitimate condition

Summary of Issues, Barriers, and Hurdles

• Doctor is sceptical of legitimacy of IBS as a real medical disorder

• Does not believe that he has many IBS patients in his practice

• Does not understand underlying cause• Does not believe that this condition has any impact

on the patient (her quality of life and daily activities) as well as the community at large (cost implication)

Probing Questions

• What do you believe is the cause of IBS?• How often do you prescribe antispasmodics or

laxatives to female patients?• How often do you regularly treat female patients for

abdominal pain and/or constipation, yet the symptoms always return?

• How often do you see patients with A,B or C?• How often do you see patients with a combination of

these symptoms?

Key Zelmac Messages

• IBS is a prevalent condition in the community with prevalence ranging from 10%-20%

• IBS is a chronic condition with serotonin playing a major role

• IBS has a significantly negative effect on a patient’s quality of life

• It is vital that the IBS sufferer be treated so that her quality of life can be improved

Call ObjectiveHighlight that IBS is a prevalent and legitimate condition in the community & has more of an impact on quality of life versus other chronic, episodic conditions

Suggested location in the Zelmac Global A-B A B

Key Resources

Detail aid pages:• Pg 3 - Impact of IBS showing prevalence, costs

and consultations• Pg 4 – IBS impact on QoL versus other chronic,

episodic conditions (asthma and migraine)• Page 5 – IBS impact on QoLTrials:• Hungin et al, Franke et al, Camilleri et al , Gershon et

al

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Physician does not recognise the IBS-C patient


• Does not think of IBS-C when the patient complains of individual symptoms of abdominal pain, bloating or constipation

• Does not ask the correct questions to uncover her history and cluster of symptoms

• The patient is uncomfortable and will not volunteer all her symptoms unless the doctor asks her

Probing Questions

• Do you have patients who you see repeatedly and are complaining of the same symptoms?

• Do you have patients who are using antispasmodics and laxatives frequently?

• Do you have patients who have come to see you because the abdominal pain has been unbearable?

• Do you have patients who complain that their bloating is so bad that they battle to fit into their clothes?

• Do you have patients, who on further questioning, admit that their symptoms are interfering with their quality of life?

Key Zelmac Messages

• The IBS-C patient’s predominant symptoms are abdominal pain, bloating and constipation

• She has a longstanding history of intermittent episodes of symptoms

• Her symptoms impact on her QoL

Call Objective Enable the doctor to recognise the IBS-C patient


Key Resources

Detail aid pages:• Pg 1 – IBS-C patient profile• Pg 2 – IBS-C patient profileTrials:• Hungin et all, Camilleri et al , IFFGD website, Chang

et al

10

Physician does not know how to diagnose the IBS-C patient


• GP refers “query IBS-C” patients to a specialist• Worries that he will misdiagnose organic disease• Only gives a diagnosis of IBS-C after ruling out all

other diseases• Does not know what questions to ask the patient

during the diagnosis

Probing Questions

• How do you currently establish a diagnosis of IBS-C?• Do you perform exclusion tests?• Do you refer patients who you suspect have IBS-C?• What would be your reasons for referring? • On further questioning, do you find that your patients

have more symptoms and concerns than what she originally described?

Key Zelmac Messages

• Safe, confident, positive diagnosis through identifying the predominant symptoms of abdominal pain with constipation (ROME II criteria); probing to establish what other symptoms the patient has and how long she has had the symptoms, eliminating any red flags

Call ObjectiveEnable the doctor to diagnosis IBS-C by using the ROME II criteria to make a positive, symptomatic diagnosis


Key Resources

- ROME II diagnosis folder with the list of questions -Detail aid pages:• Pg 1 – IBS-C patient profile• Pg 2 – IBS-C patient profile• Pg 6 – IBS-C impact on QoL -Trials:Gershon et al, Hungin et al , Camilleri et al, Chang

et al

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Physician diagnoses IBS-C and treats with diet/lifestyle and traditional therapies


• Doctor is resistant to change and sees no need to change

• Feels that his current approach is risk- free• Does not perceive the patient’s unmet needs• Does not understand the impact on the patient’s QoL

Probing Questions

• What treatment do you recommend to your IBS-C patients?

• Do you follow up with these patients?• To treat the multiple symptoms, do you prescribe

combination therapy?• Do any of your IBS-C patients ever complain that their

symptoms get worse?• Is there any reason you have not prescribed Zelmac?

Key Zelmac Messages

• Traditional therapies do not meet the need and only treat individual symptoms

• Traditional therapies can exacerbate other symptoms• Traditional therapies do not address the underlying

pathophysiology of IBS-C• Traditional therapies do not provide global

multisymptom relief

Call ObjectiveConvince the doctor that traditional therapies do not address the underlying pathophysiology of IBS-C and treat individual symptoms only, often exacerbating other symptoms


Key Resources

Detail aid pages:• Pg 7 – traditional therapies only treat individual

symptoms• Pg 8– what would be the ideal IBS-C treatment?Trials:• Camilleri et al, Brandt et al, Novick et al, Corsetti, M

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Physician uses Zelmac in the same way as he uses an antispasmodic or laxative


• Doctor not convinced of the role of serotonin in mediating GI motility, stool consistency, visceral hypersensitivity

• Doctor wants to use Zelmac as PRN treatment to provide symptomatic relief

Probing Questions

• How long do you Rx Zelmac for?• Why would you Rx Zelmac for 7 days only?• How do you describe how Zelmac differs from the

traditional therapies to your patients?• How do you explain Zelmac dosing schedule to your

patients?

Key Zelmac Messages

• Zelmac MOA is different to that of the laxatives and antispasmodics

• Zelmac is the only drug which mimics serotonin and thus works in 3 ways to provide multi-symptom relief (describe the 3 ways on page 10 in your detail aid) for IBS-C

• Zelmac MOA provides rapid and sustained clinical efficacy throughout the treatment period

Call ObjectiveConvince the doctor to use Zelmac for a full month and to completely differentiate Zelmac from the traditional therapies


Key Resources

Detail aid pages:• Pg 8 – What would be the ideal IBS-C treatment?• Pg 9 – First in a new class to address the

underlying cause of IBS-C• Pg 10 – First in a new class to address the

underlying cause of IBS-C• Pg 11 – Mutisymptom relief• Pg 12 - Mutisymptom relief • Trials:• Hungin et al, Franke et al, Camilleri et al , Gershon et

al, Muller-Lissner et al, Brandt et al.

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Physician uses Zelmac in some, but not all appropriate patients


• Doctor perceives Zelmac to be for the more severe IBS-C patients

• Doctor is reserving Zelmac for a number of reasons (you would have to probe to establish the reason):

•Efficacy•Cost

Probing Questions

• What would stop you from using Zelmac first line in appropriate patients?

• What have your patients said about Zelmac?• What differentiates Zelmac from other therapies you

have used?• Why would you reserve Zelmac ?

Key Zelmac Messages

• Zelmac is the only drug that addresses the underlying pathophysiology of IBS-C which needs to be addressed in all IBS-C patients

• Traditional therapies only address one symptom and may worsen others

• Zelmac has demonstrated efficacy and safety in clinical trials where the patients had been experiencing symptoms for various time periods

• Zelmac, as monotherapy has an advantage in terms of convenience and efficacy

Call Objective Convince the doctor to use Zelmac first line for all IBS-C patients and not to reserve Zelmac


Key Resources

Detail aid pages:• Pg 9- First in a new class to address the

underlying cause of C-IBS• Pg 10 – First in a new class to address the

underlying cause of C-IBS• Pg 11, 12, 13, 14 – Multisymptom relief • Trials:

Camilleri et al , Drossman et al, Muller-Lissner et al

Brandt et al, Lacy et al , Ringel et al, Kim et al.

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