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INSIGHT | STRATEGY | EXECUTION




                                 The Aequitas Group Advantage


                                        Capabilities Presentation
The Aequitas Group
Who We Are


   Boutique strategic healthcare                        Analysis that helps maximize
    advisory firm                                         product value for stakeholders
                                                             Manufacturers
   Established December 1999                                Patients
   Venture backed                                           Providers
                                                             Third-party payors
   Corporate office in                                      Third-party vendors
    San Diego, California                                    Investors



The Aequitas Group Specializes in the Development of Solutions Used to Define and Communicate a
    Product’s Value. We Deliver These Offerings in a Disciplined, Evidence-Driven Environment.


                                                                         INSIGHT | STRATEGY | EXECUTION
                                                                                                      2
The Aequitas Group
What Makes Us Unique


 Industry experts
     Brand, Marketing, and Sales Operations Directors
     Centers for Medicare and Medicaid National Administrator
     Hospital Administrators
     Commercial Payor Medical Directors and Reimbursement Specialists
     Health Economists
     Global Government Affairs Specialists
     Regulatory Affairs Specialists
     Medical Affairs Specialists
     Patient Educators

                                                                 INSIGHT | STRATEGY | EXECUTION
                                                                                              3
The Aequitas Group
What Differentiates Our Approach

 Evaluation of Complex Commercialization Factors

     Clinical            Marketing              Health Policy         Payor
   Assessment           Assessment              Assessment          Assessment


 Analysis and strategy for each aspect of the commercialization process
 Focus on ALL customers and service providers

     Patients      Providers         Payors                       Company

                                                     ROI
    Hospital        Specialty
                   Pharmacy &    Call Centers                     Investors
  Administrators      PBM



                                                                INSIGHT | STRATEGY | EXECUTION
                                                                                             4
The Aequitas Group
Maximizing Patient Access By…

     Obtaining optimal coverage and reimbursement
     Translating product attributes to multiple stakeholders (patients, doctors, HMOs)
     Educating management, field force, and call center staff on product attributes and challenges
     Navigating the increasingly complex competitive landscape and regulatory environment

    Clinical Trials       Product Filings             Launch           Phase IV             New Indication
                        (NDA, BLA, 510K, PMA)


    Pre-Launch                        Market Launch                               Post-Launch
 Clinical Study        Physician and Sales Force Education      Formulary Kit and AMCP Dossier Development
  Design Review         Reimbursement Billing Guides             Payor Information Tracking
 Competitive           Reimbursement Call Center Training       Formal Policy Response
  Intelligence          Patient Assistance Program Design and    Pharmacoeconomic Studies
 Coverage, Coding,      OIG Guidance
  and Payment Plan                                                Formulary Placement Appeals
                        HCPCS Code Applications
 Pharmaco-                                                       Reimbursement Training
                        Payor Messaging and Presentation
  economic Studies       Development                              Ad hoc Reimbursement Commercialization
 Payor Mix Analysis                                               Consulting
                        Payor Market Research
 Formulary Analysis                                              Competitive Intelligence
                        Competitive Intelligence

                                                                                   INSIGHT | STRATEGY | EXECUTION
                                                                                                                5
The Aequitas Group
Complementary Specialties

                                      Reimbursement, distribution, and access plan development
                                      Payor plan data collection and analysis
   Managed Markets Consulting
                                      Named patient programs
                                      Ad hoc consulting support
                                      Comparative effectiveness and health economic assessments


Reimbursement Training and Patient    Customized and certified reimbursement training programs
       Educators Programs
                                      Certified patient educator program


                                      Scenario planning
     Competitive Intelligence
                                      Competitor review and disruptive technology analysis


           Call Center                Compliance audit of patient assistance and reimbursement hotlines
 Design and Compliance Auditing
                                      Process optimization based on patient access, channel design, and budget



                                                                                    INSIGHT | STRATEGY | EXECUTION
                                                                                                                  6
Managed Markets Consulting
Activities To Match Perspectives


                                            Provider Perspective




              Patient Perspective                                             Payor Perspective




1                                     2                                   3
       Patient Perspective                 Provider Perspective                   Payor Perspective

 Out-of-Pocket Analysis to Inform     Enhance Prescriber Access          Product Analog Analysis
  Patient Assistance Programs           Through Coverage Review and        Payor Landscape Review
  and Foundation Development            Coding Applications
                                                                           Payor Marketing Plans and
 Facilitating the Client’s Patient    Collateral Material Development     Message Development
  Experience through the                and Website Content
  Reimbursement and Patient             Population                         Product Dossiers
  Assistance Process                                                       Competitor Product Review

                                                                                   INSIGHT | STRATEGY | EXECUTION
                                                                                                                7
Managed Markets Consulting
Aequitas Reimbursement Likelihood Ratio™

                                      Clinical Value



                Economic Value




              Lowest             Reimbursement Likelihood   Highest




          0                           100          200      300

                                                                      INSIGHT | STRATEGY | EXECUTION
                                                                                                   8
Managed Markets Consulting
Coverage Dashboards and Payor Tracking Systems




                                       INSIGHT | STRATEGY | EXECUTION
                                                                    9
Managed Markets Consulting
 Named Patient Program Support
                                                       Is                                                  Send Physician
                                                    Product         No                           Yes       Product Named
                                                    Covered                    Authorized
                                                      by
                                                                                Country                     Patient letter
                                                    Partner                                               LOA PI Forms Price
                                                                                                                     Yes
                                                          Yes                        No
                                                                                                                 Are                            Send Letter to
                                                                                                               received                  No
                                                 Refer to Partner                                                                              Physician asking
                                                                                                              documents                        for Missing Info
                                                                                                               complete
                                                                            Send polite letter                       Yes
                                                                            Can not provide
                                                                                 drug
                                                                                                            Review Request               No   Send Polite “Reject”
                                                                                                           by Patient Access                    Letter. Can not
                                                                                                              Committee                          Provide Drug
   Time Frame for Planning a Named
           Patient Program                                          Re-label Product as                Pass Request to Trade for              Get Import License
                                                                         Required                   Delivery of Product to Physician

Prepared Documents
   and Contracts                                                                                 Ship Product to Physician Using Import
                                                                                                                 Vendor
 Information for                    Marketing Authorization
  physicians and                          Anticipated
  pharmacists                                                                                      Receive Confirmation of Delivery of
 Dose and                                                                                           Drug and Receipt by Physician
  administration of drug      Named Patient
 Patient treatment        Program Established
  criteria




         6 Months                       12 Months


                                                                                                                            INSIGHT | STRATEGY | EXECUTION
                                                                                                                                                                     10
Reimbursement & Patient Educators Programs
Training Customized by Product and by Need

                                   Post-Graduate Institute of Medicine Certification

                     Purchasers                                                                                      Payment and
     Payor                                Sites of                             Coverage and        Billing and                          Objection
                         and                                Plan Types                                                Alternative
 Introduction                             Service                                Payment            Coding                              Handling
                     Distributors                                                                                      Funding



     Initiation                                                                                                                     Completion
 Medicare          Wholesalers       Physician Office    Medicare Part A    Policies          NCPDP             AWP            Active Listening
 Managed Care      Group Purchase  Hospital              Medicare Part B    Bulletins         NDC               ASP            Probing for
 Medicaid           Organizations      Outpatient          Medicare Part C    Articles          CPT               WAC             Information
 Veterans Affairs  Wholesalers       Hospital            Medicare Part D    Contracting       ICD-9 and ICD-    Best Price     Fluency with
                    Specialty          Inpatient                                                   10                                 FAQs
 Department of                                             Medicaid FFS       Rebates                              FUL
  Defense            Pharmacies        Home                                                       DRG                               Working all
                                                            Managed            Utilization                          AMP             Four (4) Sides
 Indian Health     Specialty         Long Term Care       Medicaid            Controls          HCPCS
                     Distributors                                                                                     Samples         of a Case
  Service                              Dialysis Center     Private Pay        Formulary                                             (i.e., Patient,
                    Pharmacy                                                                                         Coupons
                                       Infusion / Shot     Medical            Preferred Drug                                        Provider, Payor,
                     Benefit            Clinic                                                                                         Distributor)
                     Managers                                Benefits            Lists
                                       Ambulatory          Pharmacy           Generic
                    Physician          Surgical Center
                     Offices                                 Benefits            Positioning
                                                            Specialty
                                                             Benefits
                                                            Durable Medical


                                                                                                                     INSIGHT | STRATEGY | EXECUTION
                                                                                                                                                          11
Reimbursement & Patient Educators Programs
A Way to Support Your Providers and Your Patients

  The Institute of Medicine estimates
   that health literacy generates an                       Patient Education Hierarchy
   annual cost of 73 billion dollars per
   year in healthcare                                                                     As patients attain greater
                                                              Self                          knowledge, they move
  Seventy-five percent of chronically ill           Actualization
                                                                                                   up the hierarchy
   Americans have low literacy skills                                      Unify
                                                                           with               which allows greater
                                                                       Personal Life           control & autonomy
  Poor literacy yields a longer length of                                                         in their personal
   stay in healthcare entities, and it’s                                                                 healthcare
   been estimated that poor “health                                   Problem Solve
   literate” patients cost four times more     Informed
   than a “health-literate” patient to treat   Decision
                                                                        Treatment:
                                                                     General & Specific
  There is evidence to conclude that
   teaching    tools,    i.e.,  “videos,
   brochures, etc., help with teaching                         Disease- Patho-Physiology
   patients, but a healthcare provider
   who is trained on how to educate,
   yields the best outcomes in the                                        Safety
   progression patient knowledge

                                                                                       INSIGHT | STRATEGY | EXECUTION
                                                                                                                       12
Competitive Intelligence
 Across the Commercial Lifecycle
                 May focus on Regulatory, Global Markets, Direct Competitors, Payors,
                  Disruptive Technologies                                                        What factors will Influence the
Environmental    Informed by primary and secondary research
                                                                                                  success or failure of my product
                                                                                                  or service?
    Scan         The Aequitas Group experts filter and interpret data
                                                                                                 What trends may derail my
                                                                                                  opportunity?

                 Anticipate issues for proactive management

                                                                                                 What other entities have fallen
                 Review potential competitors by modality, target, or therapeutic area           out of development and why?
  Pipeline       Identify opportunities and threats
                                                                                                 Who will be competing for my
                                                                                                  clinical trial patients?
  Analysis       Data may inform clinical trials, publication schedules, launch plans
                                                                                                 What endpoints do I need to hit
                                                                                                  for differentiation?



                                                                                                 Is my strategy informed by the
                                                                                                  most up-to-date, reliable market
                 Review best-in-class strategies to develop yours                                information?
  Scenario       Test your plan prior to launch
                                                                                                 Am I looking at the right
                                                                                                  competitors?
  Planning       Strengthen your team and develop tactics for strong execution
                                                                                                 What are the real issues my
                                                                                                  plan will face in the
                                                                                                  marketplace?



                    Actionable Intelligence Informs Critical, Key Decisions

                                                                                          INSIGHT | STRATEGY | EXECUTION
                                                                                                                                     13
Call Center Design and Compliance Auditing
Is the Fox Guarding the Hen House?

Call center audits are normally delivered by specialized firms who possess expertise regarding
     the industry and who are trained to identify gaps and propose methods of correction.

                                        Performance gaps: The gaps may cover specific teams, the entire operation, and
                                         even identify individual contributors
                                        Compliance: Review of how well the organization observes the various laws and
                                         regulations that guide the operations and responses
                                        Organizational Risks: Listing of various factors that constitute an internal or an
                                         external risk
                                        Reporting: The audit may cover metrics and other information used by managers
                                         to guide their decisions
                                        Opportunities: Internal and external situations that present improvement or cost
                                         minimization opportunities
                                        Weaknesses: Any areas that are clearly not at par and that must be addressed in
                                         order to improve the overall functioning of the call center
                                        Technology: An in depth look at the technology used by the call center to handle
                                         call routing, staffing, forecasting, etc.
                                        Quality: Call center QA scores, approach to scoring and coaching, feedback loop
                                        Management: Support staff competency, career paths, management philosophy
                                         and approach


                                                                                          INSIGHT | STRATEGY | EXECUTION
                                                                                                                              14
Call Center Design and Compliance Auditing
Know the Rules to Design a Sophisticated Program


 Insurance                                            Co-Pay                     Hardship
                            Documentation
 Verification                                         Assistance                 Exception

 Pharmacy Switch            Collateral                 Drug Expense           Inclusion of Total
  Only?                      Pre-Populated              Service Expense         Medical Costs
 Legal Interpretation of     Website                    Foundation Design      Income Variable or
  Programs Allowed for       Advocate Letters           SPAP Utilization        Sliding Scales
  Government Covered         Attestation/Form                                   FPL or Straight Line
  Patients                                               LIS Review
                              4506-T                                              Income



 Language                    Alternative              Formal Signature           Alternative
 & Literacy                  Funding                  Requirement                Communication

 Foreign Language           Transportation           Electronic               Text Messages
  Lines                       Costs                     Signatures               Email Based
 Collateral at              Utility Bills            Verbal Authorization      Communication
  Appropriate                Quality of Life Items                              Web Portals
  Language Arts Level         (e.g., wig for cancer
                              patients)


                                                                               INSIGHT | STRATEGY | EXECUTION
                                                                                                           15
The Aequitas Value Proposition




                  Insight



           Strategy     Execution


                                    INSIGHT | STRATEGY | EXECUTION
                                                                16
Insight. Strategy. Execution.




              12680 High Bluff Road
              Suite 110
              San Diego, CA 92130

              T: 858.847.9126
              F: 858.509.4739

              www.theaequitasgroup.com

                                         INSIGHT | STRATEGY | EXECUTION
                                                                     17

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The Aequitas Group Capabilities Overview

  • 1. INSIGHT | STRATEGY | EXECUTION The Aequitas Group Advantage Capabilities Presentation
  • 2. The Aequitas Group Who We Are  Boutique strategic healthcare  Analysis that helps maximize advisory firm product value for stakeholders  Manufacturers  Established December 1999  Patients  Venture backed  Providers  Third-party payors  Corporate office in  Third-party vendors San Diego, California  Investors The Aequitas Group Specializes in the Development of Solutions Used to Define and Communicate a Product’s Value. We Deliver These Offerings in a Disciplined, Evidence-Driven Environment. INSIGHT | STRATEGY | EXECUTION 2
  • 3. The Aequitas Group What Makes Us Unique  Industry experts  Brand, Marketing, and Sales Operations Directors  Centers for Medicare and Medicaid National Administrator  Hospital Administrators  Commercial Payor Medical Directors and Reimbursement Specialists  Health Economists  Global Government Affairs Specialists  Regulatory Affairs Specialists  Medical Affairs Specialists  Patient Educators INSIGHT | STRATEGY | EXECUTION 3
  • 4. The Aequitas Group What Differentiates Our Approach  Evaluation of Complex Commercialization Factors Clinical Marketing Health Policy Payor Assessment Assessment Assessment Assessment  Analysis and strategy for each aspect of the commercialization process  Focus on ALL customers and service providers Patients Providers Payors Company ROI Hospital Specialty Pharmacy & Call Centers Investors Administrators PBM INSIGHT | STRATEGY | EXECUTION 4
  • 5. The Aequitas Group Maximizing Patient Access By…  Obtaining optimal coverage and reimbursement  Translating product attributes to multiple stakeholders (patients, doctors, HMOs)  Educating management, field force, and call center staff on product attributes and challenges  Navigating the increasingly complex competitive landscape and regulatory environment Clinical Trials Product Filings Launch Phase IV New Indication (NDA, BLA, 510K, PMA) Pre-Launch Market Launch Post-Launch  Clinical Study  Physician and Sales Force Education  Formulary Kit and AMCP Dossier Development Design Review  Reimbursement Billing Guides  Payor Information Tracking  Competitive  Reimbursement Call Center Training  Formal Policy Response Intelligence  Patient Assistance Program Design and  Pharmacoeconomic Studies  Coverage, Coding, OIG Guidance and Payment Plan  Formulary Placement Appeals  HCPCS Code Applications  Pharmaco-  Reimbursement Training  Payor Messaging and Presentation economic Studies Development  Ad hoc Reimbursement Commercialization  Payor Mix Analysis Consulting  Payor Market Research  Formulary Analysis  Competitive Intelligence  Competitive Intelligence INSIGHT | STRATEGY | EXECUTION 5
  • 6. The Aequitas Group Complementary Specialties  Reimbursement, distribution, and access plan development  Payor plan data collection and analysis Managed Markets Consulting  Named patient programs  Ad hoc consulting support  Comparative effectiveness and health economic assessments Reimbursement Training and Patient  Customized and certified reimbursement training programs Educators Programs  Certified patient educator program  Scenario planning Competitive Intelligence  Competitor review and disruptive technology analysis Call Center  Compliance audit of patient assistance and reimbursement hotlines Design and Compliance Auditing  Process optimization based on patient access, channel design, and budget INSIGHT | STRATEGY | EXECUTION 6
  • 7. Managed Markets Consulting Activities To Match Perspectives Provider Perspective Patient Perspective Payor Perspective 1 2 3 Patient Perspective Provider Perspective Payor Perspective  Out-of-Pocket Analysis to Inform  Enhance Prescriber Access  Product Analog Analysis Patient Assistance Programs Through Coverage Review and  Payor Landscape Review and Foundation Development Coding Applications  Payor Marketing Plans and  Facilitating the Client’s Patient  Collateral Material Development Message Development Experience through the and Website Content Reimbursement and Patient Population  Product Dossiers Assistance Process  Competitor Product Review INSIGHT | STRATEGY | EXECUTION 7
  • 8. Managed Markets Consulting Aequitas Reimbursement Likelihood Ratio™ Clinical Value Economic Value Lowest Reimbursement Likelihood Highest 0 100 200 300 INSIGHT | STRATEGY | EXECUTION 8
  • 9. Managed Markets Consulting Coverage Dashboards and Payor Tracking Systems INSIGHT | STRATEGY | EXECUTION 9
  • 10. Managed Markets Consulting Named Patient Program Support Is Send Physician Product No Yes Product Named Covered Authorized by Country Patient letter Partner LOA PI Forms Price Yes Yes No Are Send Letter to received No Refer to Partner Physician asking documents for Missing Info complete Send polite letter Yes Can not provide drug Review Request No Send Polite “Reject” by Patient Access Letter. Can not Committee Provide Drug Time Frame for Planning a Named Patient Program Re-label Product as Pass Request to Trade for Get Import License Required Delivery of Product to Physician Prepared Documents and Contracts Ship Product to Physician Using Import Vendor  Information for Marketing Authorization physicians and Anticipated pharmacists Receive Confirmation of Delivery of  Dose and Drug and Receipt by Physician administration of drug Named Patient  Patient treatment Program Established criteria 6 Months 12 Months INSIGHT | STRATEGY | EXECUTION 10
  • 11. Reimbursement & Patient Educators Programs Training Customized by Product and by Need Post-Graduate Institute of Medicine Certification Purchasers Payment and Payor Sites of Coverage and Billing and Objection and Plan Types Alternative Introduction Service Payment Coding Handling Distributors Funding Initiation Completion  Medicare  Wholesalers  Physician Office  Medicare Part A  Policies  NCPDP  AWP  Active Listening  Managed Care  Group Purchase  Hospital  Medicare Part B  Bulletins  NDC  ASP  Probing for  Medicaid Organizations Outpatient  Medicare Part C  Articles  CPT  WAC Information  Veterans Affairs  Wholesalers  Hospital  Medicare Part D  Contracting  ICD-9 and ICD-  Best Price  Fluency with  Specialty Inpatient 10 FAQs  Department of  Medicaid FFS  Rebates  FUL Defense Pharmacies  Home  DRG  Working all  Managed  Utilization  AMP Four (4) Sides  Indian Health  Specialty  Long Term Care Medicaid Controls  HCPCS Distributors  Samples of a Case Service  Dialysis Center  Private Pay  Formulary (i.e., Patient,  Pharmacy  Coupons  Infusion / Shot  Medical  Preferred Drug Provider, Payor, Benefit Clinic Distributor) Managers Benefits Lists  Ambulatory  Pharmacy  Generic  Physician Surgical Center Offices Benefits Positioning  Specialty Benefits  Durable Medical INSIGHT | STRATEGY | EXECUTION 11
  • 12. Reimbursement & Patient Educators Programs A Way to Support Your Providers and Your Patients  The Institute of Medicine estimates that health literacy generates an Patient Education Hierarchy annual cost of 73 billion dollars per year in healthcare As patients attain greater Self knowledge, they move  Seventy-five percent of chronically ill Actualization up the hierarchy Americans have low literacy skills Unify with which allows greater Personal Life control & autonomy  Poor literacy yields a longer length of in their personal stay in healthcare entities, and it’s healthcare been estimated that poor “health Problem Solve literate” patients cost four times more Informed than a “health-literate” patient to treat Decision Treatment: General & Specific  There is evidence to conclude that teaching tools, i.e., “videos, brochures, etc., help with teaching Disease- Patho-Physiology patients, but a healthcare provider who is trained on how to educate, yields the best outcomes in the Safety progression patient knowledge INSIGHT | STRATEGY | EXECUTION 12
  • 13. Competitive Intelligence Across the Commercial Lifecycle  May focus on Regulatory, Global Markets, Direct Competitors, Payors, Disruptive Technologies  What factors will Influence the Environmental  Informed by primary and secondary research success or failure of my product or service? Scan  The Aequitas Group experts filter and interpret data  What trends may derail my opportunity?  Anticipate issues for proactive management  What other entities have fallen  Review potential competitors by modality, target, or therapeutic area out of development and why? Pipeline  Identify opportunities and threats  Who will be competing for my clinical trial patients? Analysis  Data may inform clinical trials, publication schedules, launch plans  What endpoints do I need to hit for differentiation?  Is my strategy informed by the most up-to-date, reliable market  Review best-in-class strategies to develop yours information? Scenario  Test your plan prior to launch  Am I looking at the right competitors? Planning  Strengthen your team and develop tactics for strong execution  What are the real issues my plan will face in the marketplace? Actionable Intelligence Informs Critical, Key Decisions INSIGHT | STRATEGY | EXECUTION 13
  • 14. Call Center Design and Compliance Auditing Is the Fox Guarding the Hen House? Call center audits are normally delivered by specialized firms who possess expertise regarding the industry and who are trained to identify gaps and propose methods of correction.  Performance gaps: The gaps may cover specific teams, the entire operation, and even identify individual contributors  Compliance: Review of how well the organization observes the various laws and regulations that guide the operations and responses  Organizational Risks: Listing of various factors that constitute an internal or an external risk  Reporting: The audit may cover metrics and other information used by managers to guide their decisions  Opportunities: Internal and external situations that present improvement or cost minimization opportunities  Weaknesses: Any areas that are clearly not at par and that must be addressed in order to improve the overall functioning of the call center  Technology: An in depth look at the technology used by the call center to handle call routing, staffing, forecasting, etc.  Quality: Call center QA scores, approach to scoring and coaching, feedback loop  Management: Support staff competency, career paths, management philosophy and approach INSIGHT | STRATEGY | EXECUTION 14
  • 15. Call Center Design and Compliance Auditing Know the Rules to Design a Sophisticated Program Insurance Co-Pay Hardship Documentation Verification Assistance Exception  Pharmacy Switch  Collateral  Drug Expense  Inclusion of Total Only?  Pre-Populated  Service Expense Medical Costs  Legal Interpretation of Website  Foundation Design  Income Variable or Programs Allowed for  Advocate Letters  SPAP Utilization Sliding Scales Government Covered  Attestation/Form  FPL or Straight Line Patients  LIS Review 4506-T Income Language Alternative Formal Signature Alternative & Literacy Funding Requirement Communication  Foreign Language  Transportation  Electronic  Text Messages Lines Costs Signatures  Email Based  Collateral at  Utility Bills  Verbal Authorization Communication Appropriate  Quality of Life Items  Web Portals Language Arts Level (e.g., wig for cancer patients) INSIGHT | STRATEGY | EXECUTION 15
  • 16. The Aequitas Value Proposition Insight Strategy Execution INSIGHT | STRATEGY | EXECUTION 16
  • 17. Insight. Strategy. Execution. 12680 High Bluff Road Suite 110 San Diego, CA 92130 T: 858.847.9126 F: 858.509.4739 www.theaequitasgroup.com INSIGHT | STRATEGY | EXECUTION 17