Transcript file (Asthma Project Presentation)

Impact of the Inhaled Corticosteriod
Formulary Initiative: Review of Asthma
Medication Utilization and Adherence,
Disease Control, and Prescribing Trends
Nicholas Wytiaz, Pharm.D. Candidate, University of Pittsburgh, Denise Rotella, Pharm.D. Clinical Drug
Evaluation Pharmacist Independent Health Association (IHA), Kelly Verrall R.Ph. Manager, Medication
Therapy Management (MTM) (IHA), Amy Nash Pharm.D. MTM Pharmacist (IHA) and Andrew W. Green,
M.D., Associate Medical Director (IHA)
Asthma: An Increasing Concern
• Prevalence
– 300 million people worldwide are afflicted with asthma
– Ranks among the most common chronic health conditions in the U.S.
– More than 16 million American adults and 7 million children diagnosed
– Leading chronic illness of children in the U.S.
• Cost
– Asthma costs the U.S. economy approximately $19.7 billion a year
– $6.2 billion on Rx drugs = largest single direct medical expenditure
– Resultant healthcare costs from non-adherence-related disease
exacerbations
• Quality of Life
– 2 million ER visits and 500,000 hospitalizations each year
– 13 million missed school days and 10 million missed workdays a year
Asthma and Adherence
• Asthmatics can live normal lives by controlling disease with
appropriate medications
• Research has shown poor adherence to preventive medications
– Adults average around 60% adherence rate
– Children adherence rates often fall below 50%
• Poor adherence with anti-inflammatory therapy directly associated
with increased asthma morbidity and mortality
– ER visits and hospitalizations linked to non-adherence
• Medication cost is a primary factor in patient non-adherence
Adherence: A Multifaceted Issue
www.adultmeducation.com/images/Figure2.png
Expected Results from Increased Adherence
• Improvement in…
– Quality of care
– Quality of life
– Work Productivity
• Cost impact
Pharmacy
– Increases for target drug(s)
– Decreases for other drugs (e.g. rescue medications)
Medical
– Short Term: increase when patients become more compliant with
care visits, screening, etc.
– Long term: decreased cost as a result of improved clinical status
(less hospitalizations, ER visits)
Goals of Asthma Management
"The goal of asthma therapy is to control asthma so
that patients can live active, full lives while
minimizing their risk of asthma exacerbations
and other problems"
– William W. Busse, M.D., chairman of the Expert
Panel on Guidelines for the Diagnosis and
Management of Asthma
History of Asthma Management Programs
Pitney Bowes: 2002
– Provides mail processing equipment and services related to
documents, packages, mailing, and shipping
– Reduced co-payments for drugs used to treat chronic diseases
– Onsite medical clinics and services, onsite health screenings, and
access to onsite or nearby fitness facilities at low or no cost
– Cafeterias provided financial incentive for healthier food choices
• Results
– Reportedly saved $1 million in cost offsets in 1 year
• Limitation
– Analysis conducted without an external control
– Unclear if the experience is replicable in other settings
History of Asthma Management Programs
Marriott International: 2005
– Waived employee co-pays on generic and halved co-pays
for brand diabetes, asthma, and heart disease drugs
– Contracted with data and disease management firm to
identify workers with drug compliance issues and notify
doctors when patients have a lapse in treatment
• Results
– Decrease in adverse events and overall healthcare cost trend
• Limitations
– Intervention of disease management program in addition to
co-payment reductions
History of Asthma Management Programs
ActiveHealth Management: 2005
– Health management service provider, offering disease management,
clinical decision support and personal health records
– Reduced co-payments for ACE inhibitors, ARBs, β-blockers, diabetes
medications, statins, and ICSs
– Access to comprehensive, telephonic, nurse-staffed, disease-state
management program for employees and dependents
– Compared results with other groups who did not have co-pay
reductions but still had access to the disease management program
• Improved on Pitney Bowes study via external control
• Results
– Reductions in drug co-payments increased overall medication
adherence, though a statistically significant effect was not seen for ICSs
• Limitations
– Control groups had higher adherence throughout the study period
– Intervention of disease management program in addition to co-pay
reductions
History of Asthma Management Programs
The Asheville Project : 2006
– 207 adult patients with asthma from two study groups followed for 5 years
– Two employers: City of Asheville and Mission-St. Joseph's Health System
– Categorized based on symptoms ("mild intermittent" to "severe persistent“)
– Co-payments for asthma medications waived
– Regular 1-on-1 meetings held with a certified asthma educator
• Results
– Total cost savings $584,307 for the 5-year study
– Significant decrease in annual ER visits, missed workdays, hospitalizations
• Limitations
– Selection bias due to voluntary participation
– Multiple interventions (asthma medication, long-term follow-up) in
addition to waived co-payments
IH Asthma Management Program
Key Differences
1) ICS co-payment reductions implemented as an automatic
benefit design for all eligible patients in an open
commercial formulary
• Not limited to disease management program patients
• Not limited to single employer group
2) Designed in accordance with established guidelines for
stepwise approach to disease management
• Provided tier 1 access for preferred first step of
therapy despite lack of generic medications
National Asthma Education and Prevention
Program (NAEPP) Guidelines: 2007 Report
Children <12 years of age:
Step 1 (intermittent)
SABA PRN is preferred
Step 3 (moderate persistent)
Step 2 (mild persistent)
Monotherapy with a low
dose ICS is preferred
Patients >12 years of age:
Step 1 (intermittent)
SABA PRN is preferred
Either a medium dose ICS
or a combination low dose
ICS + LABA, LTRA, or
theophylline is preferred
Step 3 (moderate persistent)
Step 2 (mild persistent)
Monotherapy with a low
dose ICS is preferred
Either a medium dose ICS
or a combination low dose
ICS + LABA is preferred
Inhaled Corticosteriods: Role in Therapy
• Majority of patients with
persistent asthma have
mild-moderate disease
Persistent Asthma Severity
Severe
23%
• Primary target to benefit
from ICS monotherapy
Moderate
48%
Mild
29%
Blaiss M, et al. Annual ACAAI Meeting.
November 5-10, 2009; Miami, FL. Abstract 63.
Inhaled Corticosteriods: Availability
• FDA has not determined a standard for
bioequivalence for ICSs in multi-dose inhalers
(MDIs) or dry powder inhalers (DPIs)
• Generic availability may be significantly delayed
• There is no estimated date of generic approval
Objectives of IH Asthma Initiative
• To assess the effects of a value-based co-payment
reduction program on utilization and adherence to
controller medications in an open formulary setting
• To provide a Tier 1 drug choice for asthma patients
aligned with NIH guidelines for asthma management
• To determine if adherence rates for patients receiving
community counseling by healthcare professionals or
clinic visits differ from rates of patients with no recorded
counseling (future project)
Methods
Study Design
• Prospective observational cohort study comparing Independent Health’s
pharmacy claims data for 12 months prior to the intervention (4/1/083/31/09) versus 12 months after the intervention (4/1/09-3/31/10)
Inclusion Criteria
• Patients age 5-56 year old with “persistent asthma”
– 1+ ER visits with asthma as principal diagnosis OR
– 1+ acute inpatient discharge with asthma as principal diagnosis OR
– 4+ outpatient asthma visits and 2+ medication dispensing events OR
– 4+ asthma medication dispensing events
• Based on HEDIS Asthma Registry
• Emphysema and COPD patients excluded
Methods
Intervention
• On April 1, 2009 IH moved single agent ICS
medications to the lowest tier co-payment group
(Tier 1) of the commercial therapeutic formulary
for all lines of business
• Brands moved included Alvesco®, Asmanex®,
Flovent®, Pulmicort®, and QVar®
• The tier shift aligns with NIH Asthma
Management Guidelines, which consider ICS the
first step in chronic asthma management
Methods
Data Analysis
• Evaluated pharmacy claims and utilization data to
determine utilization, adherence, disease control, and
prescribing trends
• Reviewed medical data for pre and post intervention to
determine asthma-related ER visits and hospitalizations
• Data broken down quarterly to show prescribing trends
and yearly to show direct results of intervention
• Z-tests and T-tests compiled to determine statistical
significance
Methods
Primary Outcome Measures
1. Utilization
– ICS, SABA, and combination trends (claims per quarter)
2. Adherence
– Based on Proportion of Days Covered (PDC)
PDC = (number of claims x days supply per claim)
total days available
– 3 mo washout period at end of the year to avoid overestimation
– PDC capped at 1 and multiplied by 100 to obtain percent adherence value
– Mean of all participant PDC values provides overall study adherence value
2. Disease Control
– Rescue medication use
• Ratio of ICS to SABA
• Patients with > 6 SABA claims / year
Methods
Secondary Outcome Measures
1. Disease Control
– ER visits / hospitalizations
2. Prescribing Trends
– Percent of patients newly prescribed ICS vs. combo
• Initial 6 mo washout period to capture new starts
– Percent of patients stepping down from combination
inhalers to single agent ICS
Table 1. Asthma Medication Utilization, Adherence, and
Disease Control
P value
Measurement
Pre-Intervention
Post-Intervention
Claims
(n=19990)
(n=22179)
SABA
9346
10328
0.3594
ICS
3932
4512
0.0436
Combo
6712
7339
0.1454
Adherence
(n=7396)
(n=8133)
ICS
31.76%
34.79%
0.0003
Combo
48.08%
48.26%
0.4293
Control
(n=7396)
(n=8133)
ICS:SABA
0.42
0.44
0.0764
>6 SABA claims
348 (4.70%)
350 (4.30%)
0.1164
Results: Utilization
Yearly Data
• Significant increase in ICS
claims per member
(0.532 vs. 0.555, p<0.002)
Quarterly Data
Claims and Utilization Trends
SABA
ICS
Combination
Pre-Intervention
Post-Intervention
3,200
2,900
2,600
• Slight increase for SABA
(1.264 vs. 1.270, p=0.146)
TRx #
2,300
2,000
1,700
1,400
1,100
800
500
Q2 08
Apr-June
• Decrease for combination
(0.908 vs. 0.902, p=0.257)
Q3 08
July-Sept
Q4 08
Oct-Dec
Q1 09
Jan-Mar
Q2 09
Apr-June
Review Quarters
Q3 09
July-Sept
Q4 09
Oct-Dec
Q1 10
Jan-Mar
Results: Medical Data
• Slight increases in total ER visits and hospitalizations
(1729 vs. 1987 and 669 vs. 717)
90.00
80.00
70.00
60.00
50.00
40.00
30.00
20.00
10.00
0.00
Asthma-Related ER Utilization
Asthma-Related Inpatient Utilization
Members Age 5-54 Years Old
Members Age 5-54 Years Old
85.31
50.56
56.19
Commercial
Medicaid
6.66
8.64
9.93
Apr 07 - Mar 08 Apr 08 - Mar 09 Apr 09 - Mar 10
Utilization / 1000
Utilization / 1000
• Similar rate increases seen in patient population not
affected by intervention
17.00
15.00
13.00
11.00
9.00
7.00
5.00
3.00
1.00
15.76
16.35
14.43
Commercial
Medicaid
3.25
3.13
3.58
Apr 07 - Mar 08 Apr 08 - Mar 09 Apr 09 - Mar 10
Results: Prescribing Trends
• More patients stepped-down to ICS after the tier change
• Percent of patients newly prescribed ICS vs. combination
medications actually decreased
Discussion: Utilization and Adherence
Utilization
• Quarterly trends difficult to analyze based on total claims
– Confounding variables (CFC ban, H1N1 outbreak)
– Seasonal fluctuation (increase in spring-summer)
Adherence
• Statistically significant increase in ICS adherence and claims
– Patients refilling controllers and using more regularly
• No effect on adherence to other controller medications
• PDC does not guarantee medication was used as prescribed, only
that the patient filled the prescription
• Could not control for other non-financial factors affecting adherence
such as patient treatment perceptions and beliefs.
• Causal inference cannot be made between adherence and utilization
based on study design (prospective, observational)
Discussion: Disease Control
• SABA utilization, asthma-related ER visits, and asthmarelated hospitalizations measured to evaluate control
• Overuse of rescue inhalers determined by number of
patients with 6 or more SABA claims per year and ICS to
SABA ratio
– Both measurements shown to be useful determinants
of quality of asthma care and control of the disease
• Positive changes were seen in both measurements
Discussion: Confounding Variables
FDA Chlorofluorocarbon (CFC) Ban
“Effective January 1, 2009, the FDA will ban the sale of chlorofluorocarbon
(CFC)-propelled albuterol inhalers, products used to treat asthma and COPD,
because they are harmful to the environment.”
– Initiated switch to hydrofluoroalkane (HFA) propelled albuterol
– HFA only available as brand name inhalers
– Initial SABA utilization decrease (Q4 08 to Q1 09) coincides with ban
Pandemic H1N1 Virus
• U.S. peak: April 2009 to Feb 2010 – nearly entire post intervention year
• SABA claim increase from Q2 09 to Q4 09 coincides with H1N1 outbreak
• 30% adults and 33% children hospitalized for H1N1 also had asthma
• May have been largely responsible for increase in asthma-related ER
visits and hospitalizations in post-intervention year
Discussion: Prescribing Trends
•
•
Tier change did not seem to affect the initial prescribing trends
Percent of patients newly prescribed combination inhalers actually increased in the
post intervention year
Limitations
1. Lack of clinical, patient-specific information
– Only reviewed claims data
– Not able to evaluate severity of a patient’s asthma
– Initial combination therapy is appropriate for moderate persistent asthma
2. Advertising of combination products (Advair® and Symbicort®)
– May have predisposed physicians to prescribe these agents
– Advertising for ICS monotherapy is limited
3. Lack of Educational Component
– Physicians only informed of tier change via a newsletter
– Financial barrier may not be the only problem in prescribing ICS medications
– Educational component may also be necessary
Conclusions: Effects of ICS Initiative
• Effective means for increasing medication adherence
– Significant increase in ICS adherence rates
– Significant increase in ICS utilization / claims
• Favorable trends toward improved asthma control
– Decreased rescue medication overuse
– Difficult to analyze medical outcomes
• Mixed results on physician prescribing
– Increased members stepping down to ICS monotherapy
– No effect on initial therapy decision
Conclusions: Going Forward
• Educational component
– Promote appropriate prescribing in line with NIH guidelines
– Ensure patients receive best possible care at the lowest cost
• “Touched” population
– Collaboration of IH case managers, Buffalo Medical Group and Catholic
Health Systems
– Identify population of patients who received asthma specific counseling
– Compare “touched” to general (control) asthma population
• Continued data collection
– More time needed to assess full effects of intervention
– Medical outcomes, Cost analysis/Return on investment
• Additional studies
– Needed before definitive conclusions can be reached as to the full effects of
the initiative on IH and its members