NY- 1010.483/020312Yn ithHR2 CONFIDENTIAL Duragesic Disease Modeling Workshop 2 Takeaways Synthesis document March 14, 2002 This report is solely for the use of client personnel. No part of it may be circulated, quoted, or reproduced for distribution o utside the client organ ization without prior written approval from McKinsey & Company. Th is materia l was used by McK insey & Company ~l,lfu,i:~ presentation; it is not a complete record of the d isctl§~ . • 6'0b2 NY-1010.483/020312YnithHR2 Contents • Current hypo theses , quest ions , and analyses • Updated aspects of pat ient flow ana lys is - Pat ient pop ulatio n def initio n - Patient segmentation • Updated phys ician flow analysis - Physic ian flow map - Physic ian segmen tat ion • Next steps • Appendix s1253-0003 1 IS1253-004 NY-1010.483/ 020312Yn ithHR2 Workshop# 2 Surfaced Three Fundamental Opportunities 1. Increase share of patients shifting from immediate-release sustained-release opioids captured by duragesic to 2. Increase total flow of chronic back patients from immediate-release to sustained-release opioids 3. Increase retention of chron -ic back pain patients on duragesic whenever medically appropriate NY-1010 .483/020312 YnithHR2 Initial Estimates Of Chronic Back Pain Patient Stocks And Flows PRELIMINARY Pr imary f lows - - • Th ousands of patie nts per year 100 °/o= 8.6 million patie nts* Non-opi oids • Total: 2,800 .. ----~ ___ Self-m edicat ing • Total: 2,700 • Diagnosed: 1,500 • Undiagnosed: 1,200 ___ '-- ,___ Secondary objective is to move patients out of this stock and into sustainedrelease opioids Imm ediat e release opioid s • Total: 2 ,300 • Class Ill & IV: N/A • Class II: N/A • Ultram: 200 .~ . .. 5 Oth er susta ined release opioids* , 500 _ • Total : 525-690 , • Oxycontin: 415-585 I • Others: 110 I I I I I I 1----.oL Potentiall y negligible flows 30 - ♦ • 20 Dur agesic • Tota l: 85-115 <5 . 90 Primary objective is to capture more sha re of patients currently moving to sustainedrelease ooioids * Init ial estimates inc lude only patients with 3 months or greate r of moderate to severe back pain Note : All immediate release opioids (C lass 11, 111,& IV) grouped together due to data limitat ions during preliminary analysis 51253-0QOS Tertiary object ive is to extend the duration of Duragesic use whenever medically appropriate Source: Decision Resources ; Patient Longitudina l Study July 2001; Janssen marketing research ; NDTI ; team analys is 3 NY-1010 .483/020312Ynith HR2 0 portunity #1. Increase Share Of Patients Shifting From Immediaterelease To Sustained-release Opioids Captured By Duragesic PRELIMINARY Strategy Key questions Analysis/data Key contacts • Re-direct sales force toward spec ific physician segments and other key influencers • Are Duragesic prescr iptions cu rrently driven by physician preference or specific patient attributes? • Pareto analysis of chronic back pa in prescr ibing behavior (IMS Exponent data ); Quant itative data on physician behavior (Segmentation study) • Beth Woodhead ; Mike Lee • How many chronic back pain patients are currently receiv ing long-term, highdose regimens of short-acting opioids? Are we currently targeting the physicians who prescr ibe these regimens? • Analysis of chronic back pain prescriptions/patient stocks (Mscan ); Understand Purdue call patterns and implications for Duragesic (Janssen experts, targeted interviews) • Beth Woodhead ; Guy Nuyts • What is pattern of opioid use from chronic back pain in elder ly/long te rm care? Are we properly target ing and influencing prescr iption behavior in this sett ing? • Breakdown patient stocks by age (Mscan, Longitudinal study) ; Understand prescr iptio n dec ision process in long-term care (Janssen experts, targeted interviews) • Guy Nuyts ; Mike Lee • Are we proper ly targeting and influe ncing prescr iption behav ior in the pain clinics? Wou ld creat ive contracting help in this setting? • Breakdown physicia n stocks/dec iles by setting of care ; Understand prescr iption decis ion process in pain clinics (Jansse n experts, targeted interviews) • Beth Woodhead; Ourages ic brand team • Are certain physician specia lties more or less likely to prescr ibe long-acting opioids? Can we influence flo ws to take advantage of this diffe rence? • Breakdown physician stocks/deciles by spec ialty; Op iod prescript ion behavior by spec ialty (NDTI ) • Bet h Woodhead; Jenna Kelly; Durages ic brand team s1253-0006 4 NY-1010.483/020312YnithHR2 Opportunity #1: Increase Share Of Patients Shifting From lmmediaterelea IMINA RY • Re-direct s force towar spec ific ph· segmen ts other key influencers head; • saes head ; owar I I s1c1an Mike ead; rand ead· ' rand • 1n uencers 4 NY-1010.483/020312YnithHR2 • Are we properly targe ting a nd influencing presc ription behavior in the pa in clinics? ould crea tive co ntr act ing help in this sett ing? • Are we properly targeting and influe ncing prescr iption behavior in the pain clinics? Would creat ive contracting help in this sett ing? • Breakdownphysicianst settingof care;Understand decision processin painclln •---Are--certain-physician ..-specialties-more-o less likely to presc ribe long-act ing opioids? Can we influence flows to take advantage of this diffe rence? • Breakdown physician stocks/deciles by specialty; Opiod prescription behavior by spec ialty (NDTI) agesic brand team vu, ' expe rts, ta rgeted Interviews) s1253-0006 • Beth Woodhead; Jenna Kelly; Duragesic brand team 4 NY-1010.483/020312YnithHR2 Opportunity #1: Increase Share Of Patients Shifting From Immediaterelease To Sustained-release Opioids Captured By Duragesic PRELIMINARY Strategy Ke~ Questions Analysis/data • Re-direct sales for • Are Duragesic prescr iptions currentl y driven by physician preference or specific patient attributes? • Pareto analysis of chronic back pain • Beth Woodhead ; presc ribing behav ior (IMS Exponen t data ); Mike Lee Quantitativedata on physician Key co ntacts (Segmentationstudy) • How man chronic back p in patents • Are Duragesic prescriptions currently driven by physician preference or specific patient attributes? s1253-0006 4 NY-1010.483/020312Ynith HR2 Opportunity #1: Increase Share Of Patients Shifting From Immediaterelease To Sustained-release O ioids Ca tured B Dura esic continued 1spay cases • Target high abuse-risk patients (e.g., males under 40) • What are the patient segment breakdowns for Duragesic and Oxycontin for chronic back pain (i.e. , age , gender)? • Use clinical data to influence physician/payor choice of longacting opioid • What data will influence payors/physicians ' choice in near-term? Is there a potential role for return to functionality data (i.e., Thomas Jefferson University)? c 01ce o ongacting opio id unc 1ona 1ty a a 1.e., Jefferson Univers ity)? omas 81253-0007 _______,. NY-1010.483/020312YnithHR2 Opportuni lmmedi nts From Strategy PRELIMI NARY Strategy ~ • Move physicians Key contact s 1 who are ''stuck in Class 111/IV opioids to Class 11 opiods • Move physicians who are "stuck" in Class 111/IV op ioids to Class II op iods ' • Ada pt marketing tactics to changing regulations (e.g., triplicate sc ripts) • • Adapt marketing tactics to changing regulations (e .g., triplicate scripts) s of • Beth Woodhead ; Mike Lee • Beth Woodhead ws sen • Duragesic brand team • Jeff Mathis; Duragesic brand team 6 NY-1010.483/020312Yn ithHR2 Opportunity #3: Increase Retention Of Chronic Back Pain Patients On Duragesic Whenever Medically Appropriate PRELIMINARY Stat egy Key questions An alysis/ data • Intervene to stem specific patient out-flows • What does the current Duragesic duration profile look like? Do patients that leave Duragesic early flow to a different destination than those which stay on Durages ic for a long time? • Duragesic duration and out-flow analysis of long itud inal or crosssectional database (Mscan, Duragesic longitudina l study) • Target patient/phys ician segments with high Duragesic duration • Does average durat ion vary systemat ically accord ing to pat ient segments (e.g., age , gender)? • Segment by segment duration analysis of longitudina l or cross-sect ional databases (Mscan , Duragesic longitudinal study) • Does average duration vary systematically according to physician segments (e.g., specialty, setting of care)? • Segment by segment duration analysis of longitudinal or cross-sectional databases (Mscan, Duragesic longitud inal study) • Wh ich adverse events are most likely to cause patients to terminate use of Duragesic? • Adverse event rate analysis of clinical studies; Targeted physician interviews ; Janssen experts • Are particular patient segments more prone to adverse events? • Adverse event rate analysis of clinical studies ; Jansse n experts • Decrease impact of adverse events on duratio n of use 51253-0009 Key co ntacts • Guy Nuyts ; Mike Lee • Juergen Haeuss ler; Durages ic brand team 7 NY-1010 .483/020312Yn ithHR2 Opportunity #3: Increase Retention Of Chronic Back Pain Patients On Dur RY • , • Tar. pati seg hig dur I a ....... 1en se~ ens • 1...... ....- ura I S(Clan • I • es1c r· ' It ura 10n 7 NY-1010.483/020312Yn ithHR2 Opportunity #3: Increase Retention Of Chronic Back Pain Patients On Duragesic Whenever Medically Appropriate PRELIMINARY • NY-1010.483/020312Y nithHR2 Duragesic Patient Segments Segmentation Segments Rationale Age • Under 40 • Duragesic may have natural advan tage in older patients (e.g., less active, diffic ulty swallow ing) •40-64 • 65 and over • Duragesic currently trails Oxycontin in under-40 market even its though abuse advantage is strongest here Gender • Male • Fema le • Duragesic has traditional advantage over Oxyconti n wit h females • Durag esic may have a natural advantage in males due to abuse conce rns s1253-0012 10 NY-1010.483 /0203 12Ynit hHR2 Chronic Back Pain Physician Flows 100°/o = All physicians who treat back pain • What are settings of care for opio id high-p rescr ibe rs and treaters of back pain (e.g., elderly/long-term care)? • Are we currently ta rgeting and influenc ing these groups properly? Prescrib es non-opioids only Prescribes Class Ill/IV opioids only • How can data min ing influence physicians/payers to prefer Durages ic over other sustained release opioids? Prescribes Class II opioids, immediate release only • Which phys icians are currently prescribing the U .S.'s 80 million hydrocodone scripts? • Are they cu rrently being detaile d for Duragesic? • How can they be inf luenced? Prescribed sustained release Class II opioids, but rarely Duragesic Prescribes Duragesic often as first choice Class II sustained release opioid s1253-0013 11 - • i --- M- a are se • o • ,,,..., 101 .-... • ta,#' rea ers o e ,...er • on , --- -- 1n~ s o care ...-,i 1 · --- rescr1 - • .. ers an ....,a1n e. ac - erm or care ., ? I re we curren I an e 1n I 1n uenc1n _ rou ~S ar _,., ese ro ...,er ?• 11 NY-1010.483/0203 12YnithHR2 Chronic Back Pain Physician Segments Segmentation Segments Rationale Sett ing of care • Pain clinic • Share of vo ice is setti ng-depe nde nt • Elder ly/long -term ca re • Key influencers of presc ription behavior vary among settings • Other Physician specia lty • GP • Orthoped ist • Pain spec ialists • Neurologists • Comfort with opioids likely to va ry systematically with specialty • Encounter patients at diffe rent points in treatment path s1253-0014 12 NY-10 10.483/020312YnithHR2 Gender Of Oxycontin And Duragesic Patients Oxycontin Per cent prescriptions Male Duragesic Percent prescriptions 35 45 55 o/o Female 65 3/o Sou rce: Patient Long itudi nal Study 2000 ; Janssen marketing research s1253-0019 Fema le 17 NY-10 10.483/020312Yn lthHR2 Patient Stocks Calculation Duragesic To tal prescriptions 2001 Oxycontin 3,430 ,000 1 , 183,ooo Pe rcent of Rx prescribed for back pain * 20% Rx wr itten for MS Contin I Morphine Sulfate (generic) Confidenc e 1,099,0 00 34% 34% 34% 686,000 2,427,712 253,147 371,440 Avg number of Rx per patient 5.8 5.8 5.8 5.8 • Assumption: 140 days per patient/24 days per prescriptio n Number of back pain patients 117,600 416,179 43 ,397 63 ,675 • (Rx written for back pai n)/ (Average number of Rx per patient) * 34% based on 20% for Durages ic and 30% for ove rall market Sou rce: IMS; Janssen marketing research; team analysis High 0 Low Source 749,o oo back pain • • IMS - National Prescrip tion Audit; Janssen Marketing Research 0 • IMS - National Drug and The rapeutic Index; Ja nssen Marketing Resea rch 0 • (Tota l Rx) x (Percent due to back pain) s1253-0020 18