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
Dec 13, 2014
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
[email protected]@inventivhealth.com