INSIGHT | STRATEGY | EXECUTION

The Aequitas Group Advantage

Capabilities Presentation

INSIGHT | STRATEGY | EXECUTION

2

The Aequitas Group Who We Are

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.

Boutique strategic healthcareadvisory firm

Established December 1999

Venture backed

Corporate office in San Diego, California

Analysis that helps maximize product value for stakeholders

Manufacturers

Patients

Providers

Third-party payors

Third-party vendors

Investors

INSIGHT | STRATEGY | EXECUTION

3

The Aequitas GroupWhat 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

4

The Aequitas GroupWhat Differentiates Our Approach

Evaluation of Complex Commercialization Factors

Clinical Assessment

Payor Assessment

Marketing Assessment

Health Policy Assessment

Analysis and strategy for each aspect of the commercialization process

Focus on ALL customers and service providers

Company

Investors

Patients Providers Payors

Specialty Pharmacy &

PBMCall CentersHospital

Administrators

ROI

INSIGHT | STRATEGY | EXECUTION

5

Clinical Study Design Review

Competitive Intelligence

Coverage, Coding, and Payment Plan

Pharmaco-economic Studies

Payor Mix Analysis

Formulary Analysis

Physician and Sales Force Education

Reimbursement Billing Guides

Reimbursement Call Center Training

Patient Assistance Program Design andOIG Guidance

HCPCS Code Applications

Payor Messaging and Presentation Development

Payor Market Research

Competitive Intelligence

Formulary Kit and AMCP Dossier Development

Payor Information Tracking

Formal Policy Response

Pharmacoeconomic Studies

Formulary Placement Appeals

Reimbursement Training

Ad hoc Reimbursement Commercialization Consulting

Competitive Intelligence

The Aequitas Group Maximizing Patient Access By…

Pre-Launch Post-LaunchMarket Launch

Clinical Trials Product Filings (NDA, BLA, 510K, PMA)

Launch Phase IV New Indication

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

INSIGHT | STRATEGY | EXECUTION

6

The Aequitas Group Complementary Specialties

Managed Markets Consulting

Reimbursement, distribution, and access plan development

Payor plan data collection and analysis

Named patient programs

Ad hoc consulting support

Comparative effectiveness and health economic assessments

Reimbursement Training and Patient Educators Programs

Competitive Intelligence

Call CenterDesign and Compliance Auditing

Customized and certified reimbursement training programs

Certified patient educator program

Scenario planning

Competitor review and disruptive technology analysis

Compliance audit of patient assistance and reimbursement hotlines

Process optimization based on patient access, channel design, and budget

INSIGHT | STRATEGY | EXECUTION

Managed Markets ConsultingActivities To Match Perspectives

7

Out-of-Pocket Analysis to Inform Patient Assistance Programs and Foundation Development

Facilitating the Client’s Patient Experience through the Reimbursement and Patient Assistance Process

Enhance Prescriber Access Through Coverage Review and Coding Applications

Collateral Material Development and Website Content Population

Product Analog Analysis

Payor Landscape Review

Payor Marketing Plans and Message Development

Product Dossiers

Competitor Product Review

Provider Perspective Payor PerspectivePatient Perspective1 2 3

Provider Perspective

Patient Perspective Payor Perspective

INSIGHT | STRATEGY | EXECUTION

8

0 100 200 300

Managed Markets Consulting Aequitas Reimbursement Likelihood Ratio™

Lowest Highest

Clinical Value

Reimbursement Likelihood

Eco

no

mic

Val

ue

INSIGHT | STRATEGY | EXECUTION

Managed Markets ConsultingCoverage Dashboards and Payor Tracking Systems

9

INSIGHT | STRATEGY | EXECUTION

Managed Markets ConsultingNamed Patient Program Support

Send PhysicianProduct Named

Patient letter LOA PI Forms Price

Are received

documents complete

Review Requestby Patient Access

Committee

Pass Request to Trade forDelivery of Product to Physician

Ship Product to Physician Using Import Vendor

Receive Confirmation of Delivery ofDrug and Receipt by Physician

Re-label Product as Required

Get Import License

Send Polite “Reject” Letter. Can not Provide Drug

Send polite letter Can not provide

drug

Send Letter to Physician asking for Missing Info

Refer to Partner

No Yes

Yes No

No

Yes

Is Product Covered

by Partner

Authorized Country

Time Frame for Planning a Named Patient Program

6 Months 12 Months

Prepared Documents and Contracts

Information for physicians and pharmacists

Dose and administration of drug

Patient treatment criteria

Named Patient Program Established

Marketing Authorization Anticipated

10

No

Yes

INSIGHT | STRATEGY | EXECUTION

11

Post-Graduate Institute of Medicine Certification

Wholesalers

Group Purchase Organizations

Wholesalers

Specialty Pharmacies

Specialty Distributors

Pharmacy Benefit Managers

Physician Offices

Reimbursement & Patient Educators ProgramsTraining Customized by Product and by Need

Physician Office

Hospital Outpatient

Hospital Inpatient

Home

Long Term Care

Dialysis Center

Infusion / Shot Clinic

Ambulatory Surgical Center

Medicare Part A

Medicare Part B

Medicare Part C

Medicare Part D

Medicaid FFS

Managed Medicaid

Private Pay

Medical Benefits

Pharmacy Benefits

Specialty Benefits

Durable Medical

NCPDP

NDC

CPT

ICD-9 and ICD-10

DRG

HCPCS

Active Listening

Probing for Information

Fluency with FAQs

Working all Four (4) Sides of a Case (i.e., Patient, Provider, Payor, Distributor)

Policies

Bulletins

Articles

Contracting

Rebates

Utilization Controls

Formulary

Preferred Drug Lists

Generic Positioning

AWP

ASP

WAC

Best Price

FUL

AMP

Samples

Coupons

Medicare

Managed Care

Medicaid

Veterans Affairs

Department of Defense

Indian Health Service

Initiation Completion

Payor Introduction

Purchasers and

Distributors

Sites of Service

Plan TypesCoverage and

Payment Billing and

Coding

Payment and Alternative

Funding

Objection Handling

INSIGHT | STRATEGY | EXECUTION

12

Reimbursement & Patient Educators ProgramsA Way to Support Your Providers and Your Patients

The Institute of Medicine estimatesthat health literacy generates anannual cost of 73 billion dollars peryear in healthcare

Seventy-five percent of chronically illAmericans have low literacy skills

Poor literacy yields a longer length ofstay in healthcare entities, and it’sbeen estimated that poor “healthliterate” patients cost four times morethan a “health-literate” patient to treat

There is evidence to conclude thatteaching tools, i.e., “videos,brochures, etc., help with teachingpatients, but a healthcare providerwho is trained on how to educate,yields the best outcomes in theprogression patient knowledge

Patient Education Hierarchy

Safety

Disease- Patho-Physiology

Treatment: General & Specific

Problem Solve

Unifywith

Personal Life

Informed Decision

Self Actualization

As patients attain greater knowledge, they move

up the hierarchy which allows greater control & autonomy

in their personal healthcare

INSIGHT | STRATEGY | EXECUTION

Competitive IntelligenceAcross the Commercial Lifecycle

Actionable Intelligence Informs Critical, Key Decisions

May focus on Regulatory, Global Markets, Direct Competitors, Payors, Disruptive Technologies

Informed by primary and secondary research

The Aequitas Group experts filter and interpret data

Anticipate issues for proactive management

Environmental Scan

What factors will Influence the success or failure of my product or service?

What trends may derail my opportunity?

Review potential competitors by modality, target, or therapeutic area

Identify opportunities and threats

Data may inform clinical trials, publication schedules, launch plans

PipelineAnalysis

What other entities have fallen out of development and why?

Who will be competing for my clinical trial patients?

What endpoints do I need to hit for differentiation?

Review best-in-class strategies to develop yours

Test your plan prior to launch

Strengthen your team and develop tactics for strong execution

ScenarioPlanning

Is my strategy informed by the most up-to-date, reliable market information?

Am I looking at the right competitors?

What are the real issues my plan will face in the marketplace?

13

INSIGHT | STRATEGY | EXECUTION

14

Call Center Design and Compliance AuditingIs the Fox Guarding the Hen House?

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

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.

INSIGHT | STRATEGY | EXECUTION

15

Call Center Design and Compliance AuditingKnow the Rules to Design a Sophisticated Program

Pharmacy Switch Only?

Legal Interpretation of Programs Allowed for Government Covered Patients

InsuranceVerification

DocumentationCo-Pay Assistance

Hardship Exception

Language & Literacy

Alternative Funding

Formal SignatureRequirement

Alternative Communication

Collateral

Pre-Populated Website

Advocate Letters

Attestation/Form 4506-T

Drug Expense

Service Expense

Foundation Design

SPAP Utilization

LIS Review

Inclusion of Total Medical Costs

Income Variable or Sliding Scales

FPL or Straight Line Income

Foreign Language Lines

Collateral at Appropriate Language Arts Level

Transportation Costs

Utility Bills

Quality of Life Items (e.g., wig for cancer patients)

Electronic Signatures

Verbal Authorization

Text Messages

Email Based Communication

Web Portals

INSIGHT | STRATEGY | EXECUTION

16

The Aequitas Value Proposition

Insight

Strategy Execution

INSIGHT | STRATEGY | EXECUTION

17

Insight. Strategy. Execution.

12680 High Bluff RoadSuite 110San Diego, CA 92130

T: 858.847.9126F: 858.509.4739

www.theaequitasgroup.com