Pharmerit capabilities


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Pharmerit capabilities

  1. 1. Pharmerit International<br />Loes van Erp <br /><br />Pharmerit BV<br />Marten Meesweg 107<br />3068 AV Rotterdam<br />The Netherlands<br /><br />Direct line: +31 (0) 88 4400 114<br />Cell: +31 (0) 6 232 843 82<br />
  2. 2. Pharmerit International<br />Our mission:<br />“To improve patients’ access to medical care through evidence, worldwide”<br />Why work with Pharmerit?<br />An independent team of creative, experienced, solution-driven HE/OR and market access specialists<br />
  3. 3. Global Presence<br />Pharmerit International <br />30+ Researchers<br />
  4. 4. Pharmerit services<br />Pharmerit can <br />help define, <br />build and<br />communicate <br />your product’s <br />clinical, <br />humanistic<br /> and economic <br />value through:<br />
  5. 5. Pharmerit experience<br />
  6. 6. Scientific Innovation and Leadership<br />Ben van Hout, PhD<br />Pharmerit Scientific Director<br />Professor at University of Sheffield<br />Founding Member of EuroQol Group <br />H. Heemstra, PhD<br />Senior consultant <br />Orphan drugs<br />M. Botteman<br />Partner, Pharmerit US <br />B. Heeg, MSc<br />Director, Pharmerit Europe<br />N. Houwing, MSc<br />Senior consultant Pharmacokinetics/ Pharmacodynamic Modeling<br />F. de Charro, PhD<br />Executive Director & Founding Member of EuroQol Group <br />Kucmin, MSc<br />Consultant Eastern Europe <br />S. Thurston, MSc<br />Senior consultant UK<br />J Stephens, PharmD<br />Partner, Pharmerit US, Clinical Director<br />M. Treur, MSc<br />Senior consultant Modeling <br />C. Solem, PhD<br />EuroQol Member Multiple Award-Winning Researcher<br />B. Verheggen, PharmD<br />Senior consultant Reimbursement dossiers <br />M. Hensen, MSc<br />Senior consultant Strategic Market Access<br />
  7. 7. StudyBackgrounds<br />The right combination of study backgrounds results in an efficient <br />and high quality end-result:<br />Pharmacy<br />Econometrics <br />Medical doctors<br />Health Policy researchers <br />Health economists <br />Bio statisticians <br />Mathematical modeling <br />
  8. 8. Executive Summary<br />Service Offered<br />
  9. 9. Health Economics<br />Service<br />
  10. 10. Cost effectiveness models<br />The Pharmerit staff has been innovative in the field of health economic model development. Our staff has conducted dozens of models in: <br />Virtually every therapeutic area<br />Using a very wide range of techniques<br />Decision trees<br />Markov models<br />Micro-simulations<br />Trial simulations<br />Using models to quantify the value of the product<br />Early modeling <br />Using various software and applications<br />Primarily MS Excel +/- Visual Basic (VBA) and R<br />Java / SAS / others<br />In many countries around the world<br />EU / US / Canada<br />Other markets (e.g., Columbia, Brazil, Korea, UAE)<br />
  11. 11. HTA submissions<br />Pharmerit has developed and submitted dossiers to decision authorities throughout the world, including: <br />UK – NICE; SMC & AWMSG <br />Benelux (CVZ & RIZIV)<br />Nordic (NMA; TLV; FINOHTA & LMS)<br />Iberia & Italy (CIPM; INFARMED & AIFA)<br />Turkey<br />Baltics (SMPRA; EHIF & SHIF)<br />USA (AMCP)<br />Canada (including Provinces such as Quebec)<br />South Korea (HIRA)<br />
  12. 12. Budget impact models<br /> Recent therapeutic areas<br />HIV<br />Epilepsy<br />Advanced prostate cancer<br />CML<br />Infectious disease<br />Hereditary angioedema<br />Schizophrenia<br />Indication-unspecific budget impact template<br />Interfaces<br />Excel and Visual Basics (VBA)<br />PowerPoint and VBA<br />FLASH<br />Basecase<br />Interactive budget impact tool <br />Validated with end-users<br />Interview with affiliates / payers<br />
  13. 13. Outcomes research<br />Service<br />
  14. 14. Utilitycollection<br />Several of our staff members are Euroqol members:<br />Frank de Charro, PhD<br />Ning Yan Gu, PhD<br />Ben van Hout, PhD<br />Caitlyn Solem, PhD<br />EuroQol Research:<br />Actively involved in utility and preference elicitation research <br />Includes members and/or founders of the EuroQol Group<br />EuroQoL co-located in Pharmerit’s Rotterdam, NL offices <br />Type of utility elicitation: <br />Standard gamble<br />Discrete choice experiment<br />Time trade-off<br />Mapping<br />EQ-5D questionnaire<br />
  15. 15. Patientreportedoutcomes<br />Several of our staff members are specialists in PRO assessment:<br />Ning Yan Gu, PhD<br />Caitlyn Solem, PhD<br />Jennifer Stephens, PharmD<br />Kim Tran Carpiuc, MPH, MS<br />PRO Research: <br />Willingness to pay research<br />New instrument development (satisfaction, HRQoL)<br />Preference and utility elicitation research<br />Patient satisfaction assessment<br />Instrument selection/recommendations for prospective studies<br />Analyses of PRO data<br />
  16. 16. Retrospective databases<br />We have conducted dozens of retrospective databases analyses using data from:<br />Goal: <br />Various setting of care<br />Inpatient / Outpatient / Emergency room<br />Various countries / regions<br />US<br />EU (UK/NL)<br />Various vendors<br />Private<br />Government<br />VA<br />Medicare <br />Medicaid<br />National (HCUP [NIS/NEDS/KID], NAMCS, NHAMCS [ED/OPD], MEPS)<br />Various specialties<br />SEER / SEER Medicare<br />Multicenter AIDS Cohort Study (MACS)<br />For a wide range of indications<br />
  17. 17. Systematicliteraturereview<br />Conducted across indications:<br />Hemophilia<br />Oncology<br />Mental illness<br />Cardiovascular<br />Diabetes<br />Pain<br />Allergy<br />Infectious disease<br />Review consists of:<br />The actual search of the databases<br />Data extraction<br />Evidence synthesis<br />Summary tables<br />Assessment of quality of studies<br />Reporting<br />
  18. 18. Meta-analysis<br />Conducted across indications:<br />DVT after hip/knee replacement<br />Epilepsy<br />Hemophilia<br />HIV <br />MRSA<br />Multiple myeloma<br />OA pain<br />Proton pump inhibitors<br />Types:<br />Bayesian meta-analyses <br />Classical meta-analyses<br />Mixed treatment comparisons<br />Meta-regression<br />Program languages:<br />SPSS<br />SAS<br />R<br />Winbugs<br />
  19. 19. Value dossier<br />Service<br />
  20. 20. Value Dossier goals<br />Global value dossiers are developed for internal use to support <br />affiliates in preparations for the launch of the product.<br />Goals:<br />Clearly communicate the value of the product for a payer audience<br />Present arguments and data to support value messages<br />Support reimbursement, funding, and formulary listing negotiations across global markets<br />Prevent restrictions by budget holders<br />
  21. 21. Value dossier<br />Clinical data<br />Health economic data<br />Ad board Validate value messages<br />Literature review<br />Value dossier<br />Product X<br />Modelling<br />
  22. 22. Structure of Value Dossier<br />Proposed structure:<br />Summary value messages<br />Burden of illness<br />Treatment guidelines<br />Overview competitors<br />Unmet needs<br />Clinical data on product X<br />Health Economic data<br />References<br />Appendix<br />Each value dossier will be customized to the needs of the client<br />
  23. 23. Value Dossier Therapeutic Areas<br />Pharmerit team members have developed many global dossiers for <br />therapies including: <br />Nausea and vomiting<br />Pain<br />Targeted oncology therapies<br />Benign prostatic hyperplasia <br />Hypertension<br />Congestive heart disease<br />Infectious diseases<br />Orthopedic conditions <br />
  24. 24. Strategic market access<br />
  25. 25. Strategic market access research<br />Strategic research leading to clear market access recommendations for a wide range of products globally<br />Objectives<br />Optimizing pricing and market access<br />Identify and prioritize factors driving reimbursement decisions<br />Define optimal target product profile<br />Test preliminary product profile to inform go/no go decisions<br />Validate value story <br />Focus depending on questions regarding P&R strategy of client<br />Acceptability of target product profile for reimbursement<br />Landscape analysis<br />Payer surveys<br />Pricing research<br />Market access tool <br />Global Reach<br />EU<br />North America (including Canada, Mexico)<br />Emerging Markets (Latin America, North Africa, Middle East, Asia [China, Korea, with possibilities in Japan and India])<br />
  26. 26. Price & Reimbursement strategy<br />Match and gap analysis<br />P&R strategy<br />Payer survey<br />Product X<br />
  27. 27. Methodology <br />Analysis, synthesis and recommendations for P&R strategy<br />Validation in primary/payer research<br />Match & Gap analysis  generation of market access hypotheses<br />Assessment of current landscape / desk research<br />Product X<br />P&R strategy<br />Payer survey<br />Match & gap analysis<br />Step 4<br />Step 3<br />Step 2<br />Step 1<br />Externalstakeholders<br />Pilot<br />Main phase<br />Pharmerit in-house knowledge<br />
  28. 28. Payer survey<br /><ul><li>In-depth interviews with stakeholders
  29. 29. Stakeholders will be selected based on specific product, e.g.:
  30. 30. national decision-makers
  31. 31. regional budget holders
  32. 32. hospital pharmacists
  33. 33. clinical KOL
  34. 34. policymakers
  35. 35. Typically 5-10 respondents per country
  36. 36. Possibility to include countries outside EU </li></ul>France<br />HAS<br />Transparency committee<br />Hospital pharmacists<br />United Kingdom<br />SMC<br />Ministry of Health<br />PCTs<br />Hospital pharmacist<br />Spain<br />Ministry of Health<br />Regional health authorities<br />Hospital pharmacists<br />Italy<br />Ministry of Health<br />AIFA<br />Regional health authorities<br />Hospital pharmacists<br />Germany<br />Ministry of Health<br />Health insurers<br />Hospital pharmacists<br />Poland<br />Ministry of Health<br />National/regional insurers<br />KOL’s (national/local consultancies)<br />Hospital pharmacists<br />Red countries = previous experience in other surveys<br />
  37. 37. Value messages development<br />Goal: <br />Develop a value story based on the results of your landscape analysis<br />Methods:<br />Match and gap analysis<br />Scenario analysis<br />Validation with clinical experts<br />
  38. 38. P&R strategy – example content report<br />Introduction<br />Overview of pricing & reimbursement research<br />Strategic pricing/reimbursement recommendations - overall<br />Describe optimal positioning of the product<br />Line<br />Target groups<br />Pricing<br />Advice on future research to improve pricing/reimbursement<br />Country specific issues<br />Describe optimal pathway<br />DRG<br />Outpatient<br />Early access schemes<br />Stakeholder targeting and market entry<br />Who to target in considered countries for reimbursement<br />Timelines <br />What data to submit<br />Strengths, weaknesses, opportunities and threats (SWOT)<br />
  39. 39. Pharmerit market access tool<br />Objective is to combine all forecasts for:<br />Per Statistical prediction model<br />Per Country<br />Merge over statistical models<br />Merge over countries (statistical model)<br />
  40. 40. 1) EMA Registration<br />2) Local EU reimbursement<br />3) Localintroductionprice<br />4) Localprice over time<br />5) Market share over time<br />Statistical forecast<br />Outc = registration<br />Explainedby<br /><ul><li>Efficacy
  41. 41. Safety
  42. 42. Indication
  43. 43. Trial size
  44. 44. Etc
  45. 45. …</li></ul>Statistical forecast<br />Outc = localreimbursement<br />Explainedby<br /><ul><li>Efficacy
  46. 46. Safety
  47. 47. Indication
  48. 48. Trial size
  49. 49. ICER
  50. 50. Price
  51. 51. comparators
  52. 52. BI
  53. 53. ….</li></ul>Statistical forecast<br />Outc= localrelativeprice<br />Explainedby<br /><ul><li>Efficacy
  54. 54. Safety
  55. 55. Indication
  56. 56. Trial size
  57. 57. ICER
  58. 58. Formulation
  59. 59. Price
  60. 60. Comparators
  61. 61. Price lowest
  62. 62. number?
  63. 63. BI
  64. 64. ….</li></ul>Statistical forecast<br />Outc = price over time<br />Explainedby<br /><ul><li>Comparators
  65. 65. LowestPrice
  66. 66. Generic
  67. 67. Paraleltrade
  68. 68. number
  69. 69. ….</li></ul>Statistical forecast<br />Outc = market share over time<br />Explainedby<br /><ul><li>Relativeefficacy
  70. 70. Relativesafety
  71. 71. Comparators
  72. 72. LowestPrice
  73. 73. number?
  74. 74. Formulation
  75. 75. Price
  76. 76. Budget impact (BI)
  77. 77. …….</li></ul>Createsynergy over these models (e.g. optimization) bymerging<br />Combine these databases over EU countries<br />Available data<br />EMA 2007-2001<br />Canbeextended<br />Available data<br />Scottish Medicines Consortium (SMC 07-11)<br />Canbeextendedtoothercountries<br />Available data<br /><ul><li>DK 6 yrs
  78. 78. SWE 6 yrs
  79. 79. FIN 6 yrs
  80. 80. Canbeextended</li></ul>For all drugs<br />Available data<br /><ul><li> DK 6 yrs
  81. 81. SWE 4 yrs</li></ul>For all drugs<br />Available data<br /><ul><li>DK 6 yrs
  82. 82. SWE 6 yrs
  83. 83. FIN 6 yrs
  84. 84. Canbeextended</li></ul>For all drugs<br />
  85. 85. education<br />Service<br />
  86. 86. Education<br />Pharmerit has developed a variety of medical and scientific communication tools and sessions, including: <br />Training sessions<br />Health economics<br />Introduction<br />Advanced<br />Markov modeling<br />Mixed treatment comparisons<br />Introduction to market access <br />Courses can be developed and customized to the needs of the client.<br />User manuals for economic models<br />White papers (e.g., HIV, drug-resistant infections) <br />Slide decks for value communications, medical liaisons, value dossiers<br />
  87. 87. Why Pharmerit<br />
  88. 88. StrengthsPharmerit<br />Dedicated team of professionals<br />Pharmaceutical/policy/econometrical trained team<br />Strong communication (during projects)<br />Aware of importance of timelines<br />Close link to NICE (Prof van Hout)<br />Apply state of the art techniques<br />Creative<br />Result orientated but not driven by results alone<br />A stable company<br />
  89. 89. SynergybetweenPharmerit services:<br />Pricing & Reimbursement strategy<br />Landscape analysis<br />Payer research<br />Clinical trial data<br />Cost-effectiveness<br />Budget impact<br />WTP<br />Early modelling<br />Pricing tool<br />Value messages<br />Synergy<br />No loss of information<br />Don’tpayfor overlap of research<br />Economy of scale<br />Efficientcommunication<br />Value dossier<br />
  90. 90. Why Pharmerit <br />With Pharmerit you get the benefits of a consultancy service with staff who are capable of adapting to the ever-changing science of Health Economics<br />
  91. 91. Therapeutic areas of Expertise<br />Overview<br />
  92. 92. Pharmerit’s therapeutic areas of expertise<br />Pharmerit’s staff members have extensive experience in the following therapeutic areas:<br />Alzheimer’s<br />Asthma / Allergies<br />COPD<br />CVD (lipid lowering / anti-platelets / direct thrombin inhibitors / VTE/DVT)<br />Depression<br />Diabetes <br />Molecular diagnostics/monitoring Hemophilia<br />Hepatitis<br />HIV/AIDS<br />Other infectious diseases (MRSA/fungal)<br />Lupus<br />Malaria<br />Medical devices<br /> Migraine<br /> Musculoskeletal/Inflammation (OA/RA/AS/PSA)<br />Neurology<br />Oncology (renal cell, lung, leukemia, bladder cancer, multiple myeloma)<br />Ophthalmology<br />Orphan indications<br />Pain (neuropathic / OA / low back pain / post-operative)<br />Renal failure<br />Schizophrenia<br />Sepsis<br />Sleep medicine<br />Supportive cancer care (anemia, thrombocytopenia, neutropenia, CINV)<br />Transfusion<br />Urinary (BPH, OAB, LUTS)<br />Vaccines (infectious)<br />Vision (AMD, uveitis)<br />Women’s health (vasomotor symptoms, osteoporosis)<br />