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Paxil: New Indication, New Patients to Help
 

Paxil: New Indication, New Patients to Help

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As team leader of this project, I was able to lead my team to victory by positioning Paxil for a new indication, smoking cessation, after developing a compelling marketing research plan that included ...

As team leader of this project, I was able to lead my team to victory by positioning Paxil for a new indication, smoking cessation, after developing a compelling marketing research plan that included questionnaire development of patients seeking to take a pharmaceutical anti-depressant for a new indication of smoking cessation.

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  • Source: http://pmmp.cnki.net/Resources/CDDPdf/evd%5C200801%5CJAMA%5C%E9%98%9F%E5%88%97%E7%A0%94%E7%A9%B6%5Cjama2000284112348.pdf
  • Adapted from Annual Reports of GlaxoSmithKline and Pfizer from 2008-2010
  • Viewing the timeline analysis for the launch of SSRIs, it wasn’t until 1980 when SAD entered the medical conditions. In 1987 was now defined for those who struggled through situations that made them anxious and nervous. Finally, in 1999, Paxil received FDA approval for treatment with a new indication for SAD. Byt the end of 1999, there more than a billion mentions of SAD.

Paxil: New Indication, New Patients to Help Paxil: New Indication, New Patients to Help Presentation Transcript

  • Do more, feel better, live longer Talk to your doctor about how PAXIL can give you the confidence to quit smoking, once and for all. THINK YOU ARE ADDICTED TO SMOKING? Get a better idea in just a few minutes. KNOW YOUR PAXIL DOSING OPTIONS. PAXIL has four dosing options to help you on your path towards a smoke free lifestyle. Flexible dosing helps ensure that you have the most support when taking your life back from smoking addiction. PAXIL: New Indication, New Patients to Help Treatment of Smoking Cessation with SSRIsPresented by: Anthony Fisch, Christian O’Brien, Kellie Harris, Susan Le and Michael Walsh
  • Do more, feel better, live longer Tactical Plan for Repositioning PAXILMarketing Position Overview (Incidence & Prevalence of Smoking, Discussion ofTarget Market)Market Dynamics (Pipeline Analysis, Chantix Case Study, Discussion of Share ofVoice and Marketing Plan)New Indication (Medical Guidelines for Smoking Cessation, Timeline of Eventsof Social Anxiety Disorder in SSRI treatment)Patient Flow Analysis (Influence on Treatment, Recommendations)Objectives for Research (Questionnaire for patients & KOLs, Recommendationsabout future research)Marketing BudgetQ & A
  • Do more, feel better, live longer “Cigarette smoking is associated with some anxiety disorders.” Source: Journal of American Medical Association
  • Do more, feel better, live longer Marketing Position •Research has shown a positive association between cigarette smoking and anxiety, currently little is known about the underlying association. •Positioning Statement: PAXIL can be used to treat patients suffering from Social Anxiety Disorder who want to quit smoking.
  • Do more, feel better, live longer Smoking Statistics•Cigarette smoking causes about 1 ofevery 5 deaths in the United Stateseach year.•443,000 deaths annually (includingdeaths from secondhand smoke)•49,400 deaths per year fromsecondhand smoke exposure•269,655 deaths annually among men•173,940 deaths annually amongwomen
  • Do more, feel better, live longer What is PAXIL?•PAXIL (generic name: paroxetine hydrochloride) is an antidepressant medication thatmay be prescribed for bipolar depression, major depressive disorder, social anxietydisorder, panic disorder and obsessive compulsive disorder (OCD).•Side effects are minimal and the benefits are numerous.•The antidepressant market is one of the most saturated markets in the pharmaceuticalindustry and PAXIL holds a marginal market share, while still maintaining $1 billionannual revenue.•The smoking cessation indication will bolster PAXIL’S positioning and help expand thegeneral population’s overall confidence in PAXIL.
  • Do more, feel better, live longer Can PAXIL Prevent Death? • Smoking is the leading preventable cause of death. • If PAXIL can be introduced to an at- risk patient early enough, PAXIL can prevent death. •Worldwide, tobacco use causes more than 5 million deaths per year, and current trends show that tobacco will cause more than 8 million deaths annually by 2030.
  • Do more, feel better, live longer Tactical Plan for Repositioning of PAXILMarketing Position Overview (Incidence & Prevalence of Smoking, Discussion ofTarget Market)Market Dynamics (Pipeline Analysis, Chantix Case Study, Discussion of Share ofVoice)New Indication (Medical Guidelines for Smoking Cessation, Timeline of Eventsof Social Anxiety Disorder in SSRI treatment)Patient Flow Analysis (Influence on Treatment, Recommendations)Objectives for Research (Questionnaire for patients & KOLs, Recommendationsabout future research)Marketing BudgetQ & A
  • Do more, feel better, live longer Pipeline Analysis of Smoking Cessation/Drug Dependency Therapies in Current Market GlaxoSmithKline Pfizer Pipeline Analysis 2008-2010 Pipeline Analysis 2008-2010Drug ID Disease 2008 2009 2010 •Pfizer had its smoking cessation drug Chantix approved in 2006, making it the first State prescription smoking cessation medicine to be598809 Drug Phase approved in 10 years Dependency I •By 2008, Chantix/Champix (trade name outside of US) had lost 4% in sales and was bringing in618334 Drug Phase Phase $846 million dependency I I •2009: Chantix/Champix is still the leading pharmaceutical for smoking cessation in the468816 Smoking Phase world. cessation II •Pfizer supports smoking cessation projects in 46 countriesIn 2009, GSK stopped funding research for smoking •Chantix was not mentioned in the 2010 Annualcessation drugs because OTC sales were down 12%. Report.However, in 2010, although research was notimplemented for smoking cessation treatment, in lightof a hefty tobacco tax in Japan and a governmentsponsored smoking cessation program in Brazil, GSKwas able to record 3% increase in OTC sales in thesmoking cessation category.
  • Do more, feel better, live longer Case Study: Chantix Competitive Advantages and Lessons Learned ChantixChemical name: Verenicline (nicotine blocker) Competitive advantages 1. Dosing Schedule 2. Two Step Approach (Pharmacological Treatment & GETQUIT Program ®) 3. Efficacy 4. Patient Programs to save money on prescription
  • Do more, feel better, live longer Marketing Plan of PAXIL as Indicated for Smoking Cessation• DTC Social Anxiety Disorder•This should be a first line of treatment for people who are anxious andsmoke• Push Strategy•Combination Therapy•Patient Assistance Program Increase Detail Time for PAXIL Example of a Patient Assitance Program
  • Do more, feel better, live longer Tactical Plan for Repositioning of PAXILMarketing Position Overview (Incidence & Prevalence of Smoking, Discussion ofTarget Market)Market Dynamics (Pipeline Analysis, Chantix Case Study, Discussion of Share ofVoice)New Indication (Medical Guidelines for Smoking Cessation, Timeline of Eventsof Social Anxiety Disorder in SSRI treatment)Patient Flow Analysis (Influence on Treatment, Recommendations)Objectives for Research (Questionnaire for patients & KOLs, Recommendationsabout future research)Marketing BudgetQ & A
  • Do more, feel better, live longer Summary of Key Events in SSRI Marketplace 1960’s 1980 1987 1999•Development of Prozac •Social Anxiety Disorder •Social Anxiety Disorder •PAXIL receives FDAbegins when entered the medical (SAD), was a term that approval for treatment ofpharmacologist Ray Fuller lexicon now included “those who new indication, Socialjoined forces with Eli Lilly struggled through Anxiety Disorder (SAD)to develop a “clean” drug situations that made them •May 1999, 400 millionthat would work exclusively anxious” mentions of Socialon increasing serotonin •Approximately 5 million Anxiety Disorder (SAD) bylevels in the brain adults were suffering from nation and local media; SAD end of the year, more than 1 billion mentions Medical Guidelines/ Definition New Indication, Vernacular New Lexicon Status Communication
  • Do more, feel better, live longer In Order to Treat it, You Must Understand it First: Medical Guidelines for Smoking Cessation•Tobacco dependence is a chronic disease that often requires repeatedintervention and multiple attempts to quit. Effective treatments exists, however,that can significantly increase rates of long-term abstinence.•Individual, group, and telephone counseling are effective, and their effectivenessincreases with treatment intensity. Practical counseling (problem solving/skills training) Social support•Numerous effective medications are available for tobacco dependence, andclinicians should encourage their use by all patients attempting to quit smoking. What does this mean for…
  • Do more, feel better, live longer Other Guidelines to Consider When Treating Smoking Cessation•Counseling and medication are effective when used by themselves for treatingtobacco dependence. The combination of counseling and medication is more effectivethan either alone. Thus, clinicians should encourage all individuals making a quitattempt to use both counseling and medication.•Tobacco dependence treatments are both clinically effective and highly cost-effectiverelative to interventions for other clinical disorders. Providing coverage for thesetreatments increases quit rates. Insurers and purchasers should ensure that allinsurance plans include the counseling and medication identified as effective in thisGuideline as covered benefits.-How can PAXIL distinguish itselfwhen pharmacotherapy is notfirst line treatment?-Why should people take anSSRI for smoking cessation??
  • Do more, feel better, live longer Tactical Plan for Repositioning of PAXILMarketing Position Overview (Incidence & Prevalence of Smoking, Discussion ofTarget Market)Market Dynamics (Pipeline Analysis, Chantix Case Study, Discussion of Share ofVoice)New Indication (Medical Guidelines for Smoking Cessation, Timeline of Eventsof Social Anxiety Disorder in SSRI treatment)Patient Flow Analysis (Influence on Treatment, Recommendations)Objectives for Research (Questionnaire for patients & KOLs, Recommendationsabout future research)Marketing BudgetQ & A
  • Do more, feel better, live longer Depression Category Symptoms are High in Smoking Market Total Current Smokers in USA % Adult smokers trying to quit in 2008 in 2010 9% 21% 30% 20% 36% 22% 35% 27% 18 - 44 yrs old 45 - 64 yrs old 18 - 24 yrs old 25 - 44 yrs old 65 - 74 yrs old ≥ 75 yrs 45 - 64 yrs old ≥ 65 yrs old Depression vs. No Depression After Ever Depression vs. No Depression Before Smoking Quit Smoking in ‘05-’08 Cessation in ‘05-’08 80%80%60% 60%40% 40%20% 20%0% 0% Depression 20 - 39 40 - 54 ≥ 55 No Depression 20 - 39 40 - 54 ≥ 55
  • Do more, feel better, live longer Front – line Therapy Pharmacotherapy 2nd Line Substance Abuse (Bupropion SR vs. Pharmacotherapy Specialists Nicotin Medicaition) (Clonidine - Counseling Therapy Catapres, Nortriptylin e) Counseling Therapy WillingSmokers Referral Relapsed Smokers Unwilling Smokers Front – Line Therapy PCP & Other Pharmacotherapy Driven (Bupropion SR vs. Nicotin PAXIL Medication)
  • Do more, feel better, live longer Tactical Plan for Repositioning of PAXILMarketing Position Overview (Incidence & Prevalence of Smoking, Discussion ofTarget Market)Market Dynamics (Pipeline Analysis, Chantix Case Study, Discussion of Share ofVoice)New Indication (Medical Guidelines for Smoking Cessation, Timeline of Eventsof Social Anxiety Disorder in SSRI treatment)Patient Flow Analysis (Influence on Treatment, Recommendations)Objectives for Research (Questionnaire for patients & KOLs, Recommendationsabout future research)Marketing BudgetQ & A
  • Do more, feel better, live longer Questionnaire:Paroxetine (Paxil) is a compound molecule with a broad array of indications designed to help those with debilitating mental diseases. Several current indications include:depression, anxiety, OCD, and PTSD. New research at the Department of Psychiatry and Behavioral Sciences of Stanford University is investigating the use ofantidepressants in the treatment of smoking cessation.Directions: Please respond to the following questions to the best of your knowledge and as truthfully as possible. I. Screener1. Are you a male or female? Male 01 Female 022. How old were you when you first tried smoking? Less than 13 years old 01 (Continue) Between 13-19 years old 02 (Continue) Between 20-35 years old 03 (Continue) Between 36-51 years old 04 (Continue) Between 51-64 years old 05 (Continue) Older than 64 years old 06 (Continue) Don’t Know 97 (Terminate) Refused 98 (Terminate)3. How many packs a day do you smoke? <1 pack 01 1-2 packs 02 3-4 packs 03 >4 packs 04 II. Smoking History4. Were you given your first cigarette from a peer? Yes 01 No 02
  • Do more, feel better, live longer5. Is there a family history of smoking? Yes 01 No 026. Does anyone else in your household smoke? Yes 01 (Continue) No 02 (Skip to Question 11)7. If Yes, Please indicate which household member currently smokes. Mother 03 Father 04 Brother 05 Sister 06 Grandmother 07 Grandfather 08 Roommate 09 Other 10 III. Personal Attitudes8. What do you enjoy about smoking?9. What do you not enjoy about smoking?
  • Do more, feel better, live longer10. Ho w many people do you know smoke when they are anxious? (Example: Before a test, presentation, review meeting with their boss, etc.) Please respond on a Scale of 1-5 with 1= nobody and 5 = many, almost all my friends 1 01 2 02 3 03 4 04 5 0511. What emotions do you feel when you are smoking?12. Do you believe smoke addiction to be a mental disease? Please respond on a scale from 1-5 with 1 being not at all and 5 being 100% 1 01 2 02 3 03 4 04 5 05IV. Smoking Cessation13. Do you surround yourself with others who are less inclined to quit smoking? Yes 01 No 0214. How many people do you know seek help for smoking cessation? Please respond on a scale from 1-5 with 1 = nobody and 5 = most of my friends are in search 1 01 2 02 3 03 4 04 5 05
  • Do more, feel better, live longer15. Have you ever tried to quit smoking? Yes 01 No 02 If Yes, why and how many times? <1 01 1-2 02 2-3 03 >3 0416. What is the hardest thing about trying to quit smoking?17. Have you talked to a doctor about the possibility of quitting smoking or resources available to help you become smoke free? Yes 01 No 02 If Yes, What did the doctor recommend? Addiction therapy group 01 OTC patch 02 Prescription medication 03 Alternative therapy like yoga 04 Exercise 05 Did not recommend anything specific 0618. If a nonconventional method for smoking cessation was available would you being willing to try it? Yes 01 No 02
  • Do more, feel better, live longer19. If a once-daily drug therapy was able to improve smoking cessation, would you be inclined to ask your doctor for more information? Yes 01 No 02 Maybe 03 Not Sure 0420. Are you aware of the smoking cessation benefits provided by antidepressant/anti anxiety medications like SSRIs? Yes 01 No 0221. Would you be inclined to seek antidepressant therapy for smoking cessation if treatment was safe and efficacious? Yes 01 No 02 Not Sure 03 If No, please elaborate:22. If a pharmaceutical option for smoke cessation was available, which age group would be the most receptive to its use in their treatment of smoke cessation? Less than 13 years old (with parental consent) 01 Between 13-19 years old (with parental consent) 02 Between 20-35 years old 03 Between 36-51 years old 04 Between 51-64 years old 05 Older than 64 years old 06
  • Do more, feel better, live longerV. ATTITUDE OF KEY OPINION LEADERS ABOUT USING PAXIL AS A FRONT LINE NON-NICOTINE MEDICATION FOR SMOKING CESSATION TREATMENT: Q1. What is your habit of first line therapy when patients are being treated for smoking cessation? Bupropion SR 01 Nicotine gum 02 Nicotine inhaler 03 Nicotine lozenge 04 Nicotine nasal spray 05 Nicotine patch 06 Varenicline 07 Others 08 Q2. In what level you would evaluate you patients’ satisfaction with their first therapy? Completely satisfied 01 Somehow satisfied 02 Not satisfied 03 Q3. Have you ever had any patient who failed drug therapy? Yes 01 (Go to Q4) No 02 (Go to Q6) Q4. What are your options if your patients failed on their prescribed treatment(s)? Q5. How likely do you feel comfortable adding SSRI antidepressant drugs on your patients’ treatments if they failed on the previous treatment? Completely comfortable 01 Somehow comfortable 02 Not comfortable at all 03
  • Do more, feel better, live longer Q6. Have your patients ever had symptoms of anxiety when they are smoking? Yes 01 No 02 Q7. How likely you think adding on SSRIs would contribute a significant difference to your patients’ success on smoking cessation who already have symptoms of anxiety? Completely difference 01 Somehow difference 02 No difference at all 03 Q8. Have your patients ever asked you to add other medications to their current treatment? Yes 01 If yes, what is it?________________________________________________ No 02 Q9. Have you ever heard or studied any information related to SSRIs drugs which could benefit your patients on smoking cessation? Yes 01 No 02
  • Do more, feel better, live longer Recommendations for How to Analyze Data from Questionnaire• Two questions that we cross tabbed were question 5 (Is there a family history of smoking?) and question 6 ( Does anyone else in your household smoke?).• Another two questions that we cross tabbed are question 17 (Have you talked to a doctor about the possibility of quitting smoking or resources available to help you become smoke free? ) and question 18 (If a nonconventional method for smoking cessation was available would you being willing to try it? )
  • Do more, feel better, live longer Tactical Plan for Repositioning of PAXILMarketing Position Overview (Incidence & Prevalence of Smoking, Discussion ofTarget Market)Market Dynamics (Pipeline Analysis, Chantix Case Study, Discussion of Share ofVoice)New Indication (Medical Guidelines for Smoking Cessation, Timeline of Eventsof Social Anxiety Disorder in SSRI treatment)Patient Flow Analysis (Influence on Treatment, Recommendations)Objectives for Research (Questionnaire for patients & KOLs, Recommendationsabout future research)Marketing BudgetQ & A
  • Do more, feel better, live longer Marketing Budget $200,000Research Group: 800 psychs with 5 patients=40,00040,000 X 10 X $20 (incentive) = $120,000Data Scrub=$30,000 $150,000Outside Research Company Fee= $10,000Outside Research Company Fee (IMS and NDTI)=$10,000Detailing=$30,000 Approximate Total $200,000