Value Based Drug
Assessment
Terri Corbo, PharmD, BCPS, FASHP, Vice President, Pharmacy
Services, Christiana Care Health System
Brian Sayre, PharmD, Health System Director of Pharmacy,
Charleston Area Medical Center
Martin Caponi, RPh, Director of Pharmacy, PeaceHealth
Moderator:
Fred Pane, RPh, BS Pharmacy, FASHP, Senior Director,
The Medicines Company
Adding Value to the
Medication Formulary
Process
Terri Corbo, PharmD, BCPS, FASHP
Christiana Care Health System
Newark, Delaware
The Concept of Value
 Can be defined as health outcomes achieved
per dollar spent
 Is not a synonym for cost reduction
 Defined around/by the customer
N Engl J Med 2010; 363:2477-2481
Criterion of Medication Value
Efficacy
Value =
Societal
Benefit
Risk
Cost
Efficacy
Four Factors within Efficacy
Outcome
Tolerability
Evidence
Duration
Cure or prevention is weighted more heavily
than Slows progression is weighted more
heavily than End of Life Care
Assessment based upon the percentage of
patients dropping out of the study
Modeled after the ‘strength/levels of
evidence’ used by well respected consensus
generating groups
Data showing benefit for > 3 years is
weighted the most heavily; benefit for < 3
months is weighted the least heavily
Efficacy
Efficacy
[(Outcome x Tolerability) + Duration] x Evidence Multiplier
Risk
Risk Assessment
• An internally developed score card
14 items containing both external and
internal items indicative of risk
Internal risk indicators generated from our
medication event and adverse drug reaction
reporting programs
Cost
Cost
An assessment of overall revenue relative
to cost
If the medication requires use of routine
labs or tests, those costs are included in
the assessment in addition to medication
cost
Societal
Benefit
Societal Benefit Team
Team members:
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professor of political science and health policy
professor of anthropology
high school teacher
pastor
community activist
Societal
Benefit
Societal Benefit Team
Primary principles of societal benefit as defined
by the team
1. societal benefit is linked to improving
quality of life
2. there should be sustained benefit to both
the community and the institution
Total Medication Value Score
High Score
Value =
Low
Score
Moderate
Score
Conclusion
The traditional process of evaluating
medications for formulary addition does not
provide the components necessary for a
value assessment
Institutions can move toward a value
assessment by adding patients as evaluators
and assessing outcomes relative to cost
Formulary Drug
Selection
Brian E. Sayre, PharmD
Health System Director of Pharmacy
Comprehensive Pharmacy Services
Charleston Area Medical Center
Learning Objectives
1. Understand various factors that are analyzed during the
drug selection process
2. Identify opportunities to assist systems in product
procurement
Charleston Area Medical Center
West Virginia’s Largest Medical Center
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Memorial Hospital
General Hospital
Women & Children’s Hospital
838 Licensed Beds
Special Designations
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Level I Trauma
Level I PICU
Level IV NICU
Patient Care
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600,000 outpatient visits
100,000 ED visits
38,000 discharges
70,000 surgeries
14,000 cath lab procedures
Healthgrades 2014 Distinguished Hospital Award
What is Value?
•Hard to define
•Varies by customer
•Not a one size fits all approach
Value Analysis for
Formulary Selection
1. Safety
2. Efficacy
3. Cost
4. Operations
Safety
1. Look-alike / sound-alike drugs (LASA)
2. Reported adverse event or mix-ups
3. REMS requirements
4. Ease of Use
5. Mechanism of safety device
Efficacy
1. Evidence Based Medicine
2. Advantages over current formulary items
3. Novel strategy
4. New delivery
Cost
1. Price of medication
2. Impact on labor resources
3. Impact of length of stay
4. Ancillary costs
Operations
1. Ease of integration with computer systems
2. Compatibility with automation
3. Education of hospital team
4. Special handling/preparation requirements
5. Waste
Brand versus Generic Drug
1. Branded products limit diversity of manufacturers
2. Generic drugs may have multiple manufacturers
available
3. Opportunity for added value
Selecting a Manufacturer
1.
2.
3.
4.
5.
Price
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Lowest cost item
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History of price increases
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340B price
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WAC price
Supply
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Drug shortages
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Failure to ship
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Guarantee supply?
Barcode
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Type
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Consistency in readability
Partnership
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Willingness to work with hospital
Others
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Vial size
Summary
1. Value depends on the customer
2. Safety, Efficacy, and Cost are considerations
3. Integration into operations should be considered
4. Manufacturers have an opportunity to work with
customers to determine how best to meet their needs
EHR-CPOESAFETY QUALITY
and Value
Martin Caponi, BS Pharm.
PeaceHealth-Pharmacy Champion
Objectives
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Brief Overview of CPOE (how we got here)
Error Reduction
HITECH & Meaningful Use
Clinical Decision Support
EHR-CPOE & Medication Safety Projects - Results
EHR Value and memes
Safety Technology Convergence
Martin’s Crystal Ball?
Error Reduction - The Journey
 Harvard Medical Practice Study (1991) - 3.7% of hospitalized
patients experienced adverse events
 IOM Report (1999) - Systems of care cause 48k-98k deaths/yr.
 IOM AHRQ NQF Evidence Based Practice Center
Evidence Report 43 (2001)
 The EBP study focused on randomized clinical trials and biomedical (read technology) improvements in patient care…
not error reduction and CPOE represents a “clear
opportunity for research”
 Health systems implemented error reduction strategies based
on actual errors and not based on randomized clinical trials
Preventable Adverse Events3rd Leading Cause of Death
(210,000 - 400,00 death/yr. 2008 data)
Incentives to Change
HITECH & Meaningful Use
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2009 HITECH Act - $26B to providers and health care sys.
Aimed at increasing utilization of HIT to make care safer
Meaningful Use (incentives penalties) & Interoperability
Medication related MU measures
 Active allergy and medication lists
 Drug-Drug and Drug-Allergy checking
 E-prescribing (Note: C-II’s special case NY law)
 Drug formulary checking
 Implement medication reconciliation
 MU stage 2 - 60% of IP medication orders via CPOE
 Creates challenges for providers – takes more time to enter e-orders
 2005 study by Hillestad et al. on potential benefits of e-medical records, est.
saving of $142-$371 B via better safety and improved efficiency (over 14 years)
EHR-CPOE- Value & Safety
 Treatment, coding and safety measures built into ordersets
 Ordersets guide care and are pulled in automatically based
on patient diagnosis
 CDS is configurable for both soft stops and hard stops that
require input to proceed (forcing functions)
 Orderset can be suppressed based on facility specific
parameters (CAH vs. Community Hosp.)
 Integration allows for merging ordersets for patients with
complex care
 Order panels can be built to assure EBM and MU
Clinical Decision Support (CDS)
 Metric for HIT & Medication Safety (Journal of Hospital
Pharmacy)
 Literature review evaluated if “uniformity exist in
choosing metrics to assess the impact of HIT/EHRs on
medication safety-related outcomes”
 Results- 43 articles reviewed, 34 different measures use
and 60% of measures were utilized in 2 or fewer articles
 No standard metric and a lot of variance!
Measuring Medication Safety
 Measuring EHR-CPOE medication safety challenges
 Medication PAE’s are a small % of total orders, making it
nearly impossible to power a RCT
 Errors occur 1/1000, and 10% the errors cause harm
(1/10,000), means one would need to analyze 100,000
orders to be evidence of harm
 Safe Systems- TMIT EHR-CPOE flight simulator to test
the safety of the CDS & CPOE system design
 “Trust but verify” becomes ‘Test and verif
Medication Process Errors
Mediation Safety- Results
CPOE EHR- VBP & Benefits
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One e-chart that replaces inefficient paper charts
Eliminate transcription time/cost and errors
Integrated order workflow
CDS best practice alerts demonstrate 85% reduction in provider
order entry errors and duplicate therapy/test
Standardize evidence based order sets (limit variation)
Extend Bar-code meds to ED and Surgery pre/post-op
MU and Core Measures built in
The goal is to achieve the benefit metrics and not just complete the
technical install
Better patient care and several studies show improvement in
medication safety (results do vary based on IT system, level of
integration, and effective clinical decision support (CDS)
Health Care Memes of 2010 - TBD
 In 20??, XYZ health system recognized an opportunity
to increase EMR adoption while also meeting
Meaningful Use objectives by mandating computerized
provider order entry (CPOE). This presented a challenge
because it exposed significant deficiencies in how
clinicians…[insert issues here]
 Ambulatory provider productivity drops with the
implementation of a new enterprise EHR and it can take
more the 6 months to return to pre-implementation
productivity.
Martin’s Crystal Ball?
 Health care will utilized Mo-Sol-Clo strategy
 Big data future state- 70% ‘I’ and 30% ‘T’
 ACA includes 2% Medicare cut (if Medicare represents
50% of patients, than 6% of bottom line is at risk
 Organizations will not be able to continue commit 30% of
capital to HIT
 “Retalization” of health care (Part D, Exchanges, CVS)
 ACA- reduce cost for who?
 Some ACO will chose not to join exchanges
 Future of acute care pharmacy practice??
Questions?
Contact information
Martin Caponi
mcaponi@peacehealth.org