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Strategic Implementation:
A-to-B Shift
ZELMAC
Patient Categories
Fully understand Patient
categories… from the
doctors perspective…
Female Patients with
Irritable Bowel Syndrome
with constipation as
predominant symptom: C-IBS
MILD MODERATE SEVERE…
How do they bucket???
Mild
Moderate
Severe
1st 3rd2nd
Nothing Diet/ LSC ASP
AS ASP++ TCA/ Z
AS++ ZELMAC
Live with it
Positive Natural
Treater
Open and Pro-Active
To better therapies
Highly
Bothered and dissatisfied
Socially Inhibited
/ low self esteem
life highly impacted by Syndrome
The Patient Spectrum…C-IBS Females
Doctor /
Rx Avoider
123
4
A-to-B Shift Strategy: IBS (Doctors)
Physician does not
recognize IBS as
a 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 to
diagnose the IBS-C patient
Physician uses Zelmac in the
same way as he uses an
antispasmodic or laxative
STEP # 5
STEP # 6
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 Objective
Highlight 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 QoL
Trials:
• Hungin et al, Franke et al, Camilleri et al , Gershon et
al
Physician does not recognise the IBS-C patient
Summary of Issues, Barriers, and Hurdles
• 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
Suggested location in the
Zelmac Global A-B A B
Key Resources
Detail aid pages:
• Pg 1 – IBS-C patient profile
• Pg 2 – IBS-C patient profile
Trials:
• Hungin et all, Camilleri et al , IFFGD website, Chang
et al
Physician does not know how to diagnose the IBS-
C patient
Summary of Issues, Barriers, and Hurdles
• 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 Objective
Enable the doctor to diagnosis IBS-C by using the ROME II criteria to make a positive,
symptomatic diagnosis
Suggested location in the
Zelmac Global A-B A B
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
Physician diagnoses IBS-C and treats with
diet/lifestyle and traditional therapies
Summary of Issues, Barriers, and Hurdles
• 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 Objective
Convince the doctor that traditional therapies do not address the underlying pathophysiology
of IBS-C and treat individual symptoms only, often exacerbating other symptoms
Suggested location in the
Zelmac Global A-B A B
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
Physician uses Zelmac in the same way as he uses
an antispasmodic or laxative
Summary of Issues, Barriers, and Hurdles
• 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 Objective
Convince the doctor to use Zelmac for a full month and to completely differentiate Zelmac from
the traditional therapies
Suggested location in the
Zelmac Global A-B A B
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.
Physician uses Zelmac in some, but not all
appropriate patients
Summary of Issues, Barriers, and Hurdles
• 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
Suggested location in the
Zelmac Global A-B A B
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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A to b

  • 3. Fully understand Patient categories… from the doctors perspective…
  • 4. Female Patients with Irritable 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
  • 6. Live with it Positive Natural Treater Open and Pro-Active To better therapies Highly Bothered and dissatisfied Socially Inhibited / low self esteem life highly impacted by Syndrome The Patient Spectrum…C-IBS Females Doctor / Rx Avoider 123 4
  • 7. A-to-B Shift Strategy: IBS (Doctors) Physician does not recognize IBS as a 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 to diagnose the IBS-C patient Physician uses Zelmac in the same way as he uses an antispasmodic or laxative STEP # 5 STEP # 6
  • 8. 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 Objective Highlight 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 QoL Trials: • Hungin et al, Franke et al, Camilleri et al , Gershon et al
  • 9. Physician does not recognise the IBS-C patient Summary of Issues, Barriers, and Hurdles • 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 Suggested location in the Zelmac Global A-B A B Key Resources Detail aid pages: • Pg 1 – IBS-C patient profile • Pg 2 – IBS-C patient profile Trials: • Hungin et all, Camilleri et al , IFFGD website, Chang et al
  • 10. Physician does not know how to diagnose the IBS- C patient Summary of Issues, Barriers, and Hurdles • 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 Objective Enable the doctor to diagnosis IBS-C by using the ROME II criteria to make a positive, symptomatic diagnosis Suggested location in the Zelmac Global A-B A B 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
  • 11. Physician diagnoses IBS-C and treats with diet/lifestyle and traditional therapies Summary of Issues, Barriers, and Hurdles • 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 Objective Convince the doctor that traditional therapies do not address the underlying pathophysiology of IBS-C and treat individual symptoms only, often exacerbating other symptoms Suggested location in the Zelmac Global A-B A B 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
  • 12. Physician uses Zelmac in the same way as he uses an antispasmodic or laxative Summary of Issues, Barriers, and Hurdles • 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 Objective Convince the doctor to use Zelmac for a full month and to completely differentiate Zelmac from the traditional therapies Suggested location in the Zelmac Global A-B A B 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.
  • 13. Physician uses Zelmac in some, but not all appropriate patients Summary of Issues, Barriers, and Hurdles • 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 Suggested location in the Zelmac Global A-B A B 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.

Editor's Notes

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