Global impact of real world evidence: replacing discord with harmony - Graham Lewis, VP Global Pharma Strategy Stockholm: November 2011
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Global impact of real world evidence: replacing
discord with harmony
Graham Lewis, VP Global Pharma Strategy
Stockholm: November 2011
Image sourced from internet
The size of Pharma costs, the relentless ageing
process and budget pressures have collided
By 2015 Global pharma spend will have reached $1.1 trillions
1 compared to $300 billions in 2000
Payer cost containment is a global phenomenon but it is most
2 strongly focussed on mature markets where innovation was king
Payers and Regulators are insisting on demonstrable incremental
3 value in clearly defined patient cohorts: of which the elderly are an
increasingly critical and complex part
But Payers and regulators do not trust the industry to provide the
4 objective evidence they seek thus the desire for Real World
Evidence beyond that derived from Pharmaco sources
The cost of clinical development has doubled to $1.8Bn in 10 years:
5 investors believe Pharma is less innovative: proof of incremental
value is the aspiration to realise
Customers are not interested in the escalating costs of
R&D: they have more pressing issues
Patients Physicians Payers
Maximize
care/cost
efficiency and
ELECTRONIC
improve
MEDICAL CLAIMS operating
PATIENT
REPORTED
RECORDS DATA margins
OUTCOMES
Optimize patient
Monitor own treatment
care, self-
Hospitals
diagnose
conditions, and Optimize
understand Pharmacies outcomes/cost
treatment Ensure safe ADMISSIONS, efficiency and
PROCEDURES,
options utilization and MORTALITY
improve
compliance RECORDS operating
Rx
and improve margins
DISPENSING
DATA operating
margins
It‟s not surprising that the concept of efficient health
provision is challenged along many dimensions
Rising health
care costs
Inefficiency of Increasing R&D
care costs
Therapies failing Are we at a Increasing
to perform in tipping patient
practice point? awareness
Increasing
pipeline of
Medical errors undifferentiated
treatment
options
Conflicting data
…although stakeholders are energised by the
information revolution
“FDA Approves First Mobile Diagnostic
“Medicare Part D
Viewing App for iPads and iPhones”
requires drug plans
Cardiovascular Business, 2/3/2011
participating in the new
prescription benefit to
support electronic
prescribing” US HHS
“Intel and GE
form JV to Focus Using mobile technologies
on Telehealth and and smart networks to
Independent improve the quality of care,
Living in Effort to reduce costs, and contribute
Tackle Increasing to a healthier world
Global Burden of
Chronic Disease
and Age-Related Personal Wellness
Conditions” Intel Monitor tracks
Press Release, calories burned,
8/1/2011 steps taken, distance
traveled and sleep
quality
The pace and shape of enlightenment through RWE
will be determined by four key enablers
• Legal and Ethical • Systems Infrastructure
Framework • Facilitation of the
• Terms and conditions on logistics, data collection
how data can be used and linkages
(e.g. privacy)
Enablers
• Stakeholder • Alignment on Use
Acceptance • Common definitions
• Linkage across and standards to
stakeholders evaluate evidence
However, there are two key challenges in making
comparisons between RCT and RWE
Key Challenges to Traditional
RCT R&D Model
Impact of Adherence / Compliance on Genetic Variation & Differential Real-
Real-world outcomes world Treatment Responsiveness
Poor persistence across many chronic TAs Patients respond differently to the same drug
Source: Yeaw et al. (2009), J Manag Care Pharm % patient population for which a drug in a class is
effective, on average
*RCT: Randomised Control Trials
Adherence matters to the World Health Organization
Seven “Lessons Learned”
1. Patients need to be supported,
not blamed
2. The consequences of poor adherence to
long-term therapies are poor health
outcomes and increased health care costs
3. Improving adherence also enhances patient
safety
4. Adherence is an important modifier of
health system effectiveness
5. Improving adherence might be the
best investment for tackling chronic
conditions effectively
6. Health systems must evolve to meet new
challenges
7. A multidisciplinary approach towards
adherence is needed
Sabate, WHO, 2003
Case Study: Adherence
Adherence can disrupt conventional thinking on
effectiveness of therapeutic classes
Based on RCT evidence, inhaled
corticosteroids (ICS) were preferred for
asthma patients over leukotriene
modifiers (LM)
ICS
HealthCore analyzed claims from LM
>55,000 asthma patients in 8
WellPoint plans
Adherence ER Risk - All ER Risk -Adherent
Patients taking LM (vs ICS) showed
significantly higher adherence and days on
therapy
OUTCOME:
ICS patients only showed reduced
WellPoint kept preferred tier status for LM
Emergency Room (ER) / Inpatient
and removed prior authorization
admission risk among adherent patients;
requirement
LM patients had lower ER risk overall
Source: HealthCore Case Study; http://www.mayoclinicproceedings.com/content/84/8/675.full
Case Study: Risk Profiling
And „partial‟ decision making can be flawed
EMEA and FDA removed marketing
authorization of an oral treatment due to
cardiovascular (CV) risk concerns
Users
Non-Users
LifeLink™ EMR-EU analysis of UK and
German patients, matched to non-users
with similar diagnosis 1999-2009
Stroke Risk - MI Risk - DE Stroke Risk - MI Risk - UK
DE UK
Showed that Body Mass Index and
Manufacturer sees opportunity for
prior CV risk were higher among
validation in additional countries
patients selecting suspect product
Earlier access to RWE may have
Matching users and non-users of
spared adverse regulatory
equal risk, product actually showed
decisions
lower risk of CV events
Source: IMS Health anonymised study; EMR = Electronic medical record; MI = Myocardial Infarction
10Market RWE Evolution
Importantly, RWE will develop to include a richer
range of metrics for all Stakeholders
RWE expansion will likely impact PMA, clinical, and R&D
decision making Evidence Utilisation
FUTURE
Conceptual Pricing & Market Access
• Justify launch price & access
Pre-launch Post-launch
FUTURE
• Lifecycle pricing
• Increasingly • MNF safety • Conditional reimbursement
sophisticated surveillance
Volume of Evidence
and extensive • MNF phase IV trials Clinical Decision Making
clinical trial • Non-pharma use of • Secure regulatory label & uptake
program wide range of • Post-launch label changes
metrics
• Justify appropriate use / safety
• Drive usage
R&D Strategy
• Inform trial endpoint design and
protocol feasibility
• Identify and segment indications,
Product‟s Lifecycle patients, areas by level of unmet need
Pharma RCT Pharma RWE Non Pharma RWEMarket RWE Evolution
Markets are at different stages in the adoption of
RWE evidence in payer & provider decision making
Geographical Examples: Label Price Access Use
• AMNOG ruling specifies that
prices are to be reassessed post-
launch
• Observational data used in post-
launch decision making
• Drug utilisation & safety studies
specified as a condition of
market access
• Phase IV studies potentially
influencing regional payer
decisions
• Value Based Pricing consultation
is considering RWE evidence and
post-launch P&MA reassessment
Limited Application
ApplicationCase Study: RWE Partnerships
Pharma is increasingly open to collaborations
Recent RWE Partnerships
“Collaboration seeking to answer a
fundamental question how can AZ we
improve overall patient health while lowering
the total cost of care – especially in the
treatment of chronic diseases”
We are seeking to answer a fundamental question with this
“Global agreement to help Sanofi better
research: How can we improve overall patient health while
leverage the real-world evidence generated
lowering the total cost of careduring
– especially in the treatment
product development of
and throughout
chronicthediseases?”
product lifecycle”
“Collaboration is intended to enhance
Pfizer’s R&D approach by integrating
(Humana) genomic and phenotypic information, to help
understand the underlying biology of
disease and identify patients likely to benefit
from a new drug”Case Study: Adverse Event Monitoring
Governments are also making strong initiatives to
collect, analyse, and report real-world events
Evidenced through the Uppsala group
Global Adverse Events Monitoring & Objectives
Coordination
• Identify type of adverse reactions
(Type A or Type B)
• Report lack of effect (Counterfeiting,
Resistance, Interaction)
• Identify quality problem
• Report dependence and abuse of
drugs
• Identify medical error(s)
Services
• Handle case report management
• Comparing experiences
National centres
Around the world • Information exchange
• Provide support to Governments and
Established based on agreement between National policy centres
WHO and Swedish Government
• Publication of periodical newsletters
IMS Patient Adherence Solutions Confidential 14Case Study: Market RWE Evolution
In Germany, recent reforms mean new products
must go through an early benefit assessment
AMNOG clearly state what information the GBA need for their
early assessment decision making
Therapeutic benefit & Additional
therapeutic benefit compared to the
standard of care or alternative
options GBA
Number of patients/patient groups Essential
who would derive additional data
therapeutic benefit
Therapy costs for the statutory health
insurance system (GKV)Case Study: Market RWE Evolution
As part of the benefit assessment, the GBA
acknowledge the potential value of RWE data
RWE data will complement
In general, the GBA rank evidence- RCTs and help fill-in gaps...
credibility based on study design from
high to medium as follows: Primary Data
Credibility
• Longitudinal studies
HIGH
• Cohort studies
• Systematic reviews of • Observational studies
randomised controlled trials • Surveys
(RCTs)
• RCTs
• Controlled observational
Secondary Data
studies - cohort and case
control studies • Disease Registries
• Hospital Registries
• Uncontrolled observational • Data from third party payers
studies - case reports. • Commercial databases
MEDIUM
RCT = Randomised controlled trial
RWE = Real world evidenceIn other industries it is recognised that „tolerance‟
has more than one meaning: without it better
healthcare will wither on the vine
Urban Cycle
Carried out in a lab on a
rolling road from a cold start.
The cycle consists of a series
of accelerations, steady Combined Fuel
speeds, decelerating and Consumption Figure
idling. Max speed is 50km/h,
avg. speed 19km/h and 4km The figure presented is for
covered. the urban and extra-urban
cycle together. It is therefore
Extra-Urban Cycle an avg. of the two parts of
Conducted immediately after the test, weighted by the
urban cycle and consists of distances covered in each
half steady-speed driving and part
then accelerations,
decelerations, and some
idling. Maxi speed is
120km/h, avg speed is 63
km/h & the 7km covered.
“My vehicle does not produce the same fuel consumption figures as shown in the 'New Car Fuel
Consumption and Emission Figures„?
Because of the need to maintain strict comparability of results achieved by the standard tests they cannot be fully
representative of real-life driving conditions.
Firstly, it is not practicable to test each individual new car; thus only one production car is tested as being
representative of the model and may therefore produce a better or worse result than another similar vehicle.
Secondly, there are infinite variations in driving styles and in road, car and weather conditions, all of which
can have a bearing on the results achieved. For these reasons the consumption achieved on the road will not necessarily
accord with the official test results.”
Source: http://www.dft.gov.uk/vca/fcb/faqs-fuel-consumptio.aspIMS is building capabilities to facilitate the expansion
of RWE
RWE Attractiveness vs Readiness
Market Barometer • US: Largest pharma market with
high availability of data and need to
High find cost efficiencies in the system
• IMS major data provider
Attractiveness for RWE
• Germany: Largest EU market with
high availability of data and payer
Analysis
willingness to use the data to inform
decision making. RWE increasingly
attractive due to AMNOG reforms
• IMS data from EMR and LRx
• Sweden: Mid-size European market
with comprehensive patient data
records and high potential for
Low
integration
Low High
Readiness from RWE Analysis • IMS focus is on building higher
availability of data within privacy
requirementsBut there is one rallying point all Stakeholders can agree upon “Drugs don‟t work in patients who don‟t take them” C. Everett Koop: former US Surgeon General
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