The New Decade Of Healthcare:

Can We Evolve Post-Market Platforms To Inform Coverage Decisions?FDA CMS SUMMIT • Washington, DC • December 9, 2010

Nathan White, CPC

Executive Director, Reimbursement Strategy

inVentiv Health

The pharmaceutical industry is embarking on a perilous journey,bracing itself for the perfect storm

The inefficiencies of managing vendor and consultant relationships

The complexities of proving value to payers

The uncertainties of healthcare reform

What does the perfect storm look like

Medicare and Medicaid expansion Comparative Effectiveness Research

Increasing premiums and cost sharing

Insurance exchanges

Access to affordable coverage

Premium subsidies

Doughnut hole rebatesSafety

Outcomes

Quality

Patient Protection and Affordable Care ActPatient Protection and Affordable Care Act

Uncertainties with new Congress

Future legislative changes

Expansion of coverage

Cost Containment

Quality and outcomes

The Value Equation: Safety + Efficacy + Comparative Cost/Clinical Effectiveness

AHRQ NIH

Patients and providersPayers(CMS & Private)

PCORI

Who’s Responsibility Is It?

Industry

Let’s focus on the Patient… Patient Reported Outcomes (PRO)

Helps to develop evidence of effectiveness outside an artificial controlled environment (RCT)

“Self-reports” by a patient

Data collected through self-administered questionnaires or interviews− Generic

− Disease specific

Attempts to assess:− Impairments to well-being

− Disabilities

− Health perceptions

− Quality of Life (QoL)

− Other healthcare ratings

PRO Tools & Instruments

SF-36 Health Survey

SF-12 Health Survey

Sickness Impact Profile

EQ-5D (EuroQol)

Other disease specific tools:− Adult Asthma Quality of Life Questionnaire

− National Eye Institute Visual Functioning Questionnaire

− Seattle Angina Questionnaire

Federal Initiatives Using PRO

SOURCES: www.nihpromis.org;

http://effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-the-decide-network/

PROMIS®: Patient Reported Outcomes Measurement SystemNIH-funded development of PRO tools through primary research sites & coordinating centers

AHRQ DEcIDE Network

Group of Principal Investigators, working through 13 Research Centers, conducts studies on outcomes, effectiveness, safety and usefulness of medical treatments

MANUFACTURER

Exchange of Dialogue

GOVERNMENTAFFAIRS

MANAGEDMARKETS

BRAND

Patient Focused Initiatives May Be Generating Data Valuable To Payers…

?Exchange of Dialogue

PAYER

CMS

FDA

STRATEGIES

STRATEGIES

STRATEGIES

MANUFACTURER

PATIENT

PROVIDER

• Registries/REMS• Reimbursement/Patient Assistance• Adherence

…But HOW or IS it being used by decision makers?

TOMORROW?TODAY

Registries/REMS Programs

Historically, registries were marketing tools but have evolved

Most focused on safety in the confines of REMS

Results of ETASU & patient education effectiveness used principally by FDA

2010 Kaiser Permanente study found registries play an important role in CER

Does patient education have an impact on outcomes?

Could measurements of effectiveness of patient education be useful to payers?

Could PRO instruments could be adapted to measure effectiveness of education?

Genzyme’s Gaucher Registry is model for the future

TOMORROW?TODAY

Reimbursement (RB) / Free Drug (PAP) Programs

Focused on helping patients with reimbursement access barriers (RB) and assisting the uninsured (PAP)

Used primarily as marketing tools to encourage prescribing

Captures some data which could be valuable to managed markets teams

Typically doesn’t capture PRO

How could a PAP be evolved to collect PRO data?

What confounding factors would inhibit such an evolution?

Would patient advocates object to muddying the waters of a free drug program?

Could a RB/PAP be incorporated into a Phase IV study to reduce sponsor cost?

TOMORROW?TODAY

Adherence Programs (opt-out and specialty pharmacy)

Focused on generating additional revenues (opt-out) and improving patient health outcomes (specialty pharmacy)

Opt-out programs typically administered through 3rd party and use claims data to intelligently message patients

Specialty pharmacy programs use a high touch, case management approach

Would patients be willing to respond to PRO questionnaires in an opt-out program?

How can specialty pharmacies partner with payers and manufacturers to utilize PRO more effectively?

Clinical Data Elements

Disease Severity− Rheumatoid Arthritis: Health Assessment Questionnaire (HAQ-II)

− Crohn’s Disease: Harvey Bradshaw Index (HBI)

− Psoriasis: % Body Surface Area (BSA) & Psoriasis Quality of Life (PQOL)

− HIV/MD/Hepatitis C: Patient Health Questionnaire (PHQ 2 & 9)

− Hepatitis C: Sustained virologic response (SVR) and Genotype

Adherence & Persistency Data− Medication Possession Ratios (MPR)

− Daily Average Consumption

− % Drop off at Certain Time in Therapy

SOURCES: www.nihpromis.org;

http://effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-the-decide-network/

Sample High Touch Adherence Program

Data points − Prior therapies, length of prior therapies

− PQOL-12, % body surface area

− Reasons for discontinuation

− Insurance type, Co-pay amount

− Dosing changes

− Prescriber specialty

− % of second and third doses

Benefits− Used to identify trends in utilization

− Used to develop strategies to develop or optimize business strategies

− Plan to publish data

− Plan to link data with satisfaction survey results

Specialty Pharmacy MS Adherence Rates

Simplified Calculation: Medication Possession Ration modified (MPR) = Days’ Supply : Days in Period1,2

References 1.Sclar DA, Chin A, Skaer TL, Okamato MP, Nakahiro RK, Gill MA. Effect of health education in promoting prescription refill compliance among patients with hypertension. Clin Ther. 1991;13:489-4952.Sclar DA, Skaer TL, Chin A, Okamoto MP, Gill MA. Utility of a transdermal delivery system for antihypertensive therapy. Part 2. Am J Med. 1991;91:57S-60S.

54%

85%

96.7%

Nat’l Avg. MS Adherence Rates

SpecialtyPharmacy

15

Final Thoughts…

Free drug programs have a lot of potential to be integrated with evidence based medicine initiatives

Pharmacy-based opt-out adherence programs with multimedia (SMS/email/web) are key to an intelligent PRO collection strategy

More effective PRO instruments need to be developed

Payers (federal, state and private) will need to weigh in on how PRO data will be integrated into their coverage decision making practices

THE BIG QUESTION: Will practitioners alter clinical practices based on PRO/CER studies?

RECOMMENDATION!

Read the paper “Healthcare Reform’s Wild Card: The Uncertain Effectiveness of Comparative Effectiveness Research” by Richard Saver, Assoc. Professor of Law, UNC School of Law

To schedule a complimentary on-site

consultation with the embarx BridgeTeam,

contact:

Nathan White, CPCNathan White, CPC

(703) 662-1851(703) 662-1851

nwhite@inventivhealth.comnwhite@inventivhealth.com