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Standard Medicare Drug Benefit, 2006

$386 average annual premium***$250 Deductible

$2,250 in Total Drug Costs*

$5,100 in Total Drug Costs**

25%

5%

$2,850 Gap: Beneficiary Pays 100%

Medicare Pays 75%

Medicare Pays 95%

No Coverage (the “doughnut hole”)

Catastrophic Coverage

Partial Coverageup to Limit

Beneficiary Out-of-PocketSpending

*Equivalent to $750 in out-of-pocket spending. **Equivalent to $3,600 in out-of-pocket spending. ***Based on $32.20 national average monthly beneficiary premium (CMS, 8/05).SOURCE: KFF analysis of standard drug benefit described in Medicare Modernization Act of 2003. www.kaisered.org

The “Doughnut Hole”

National Committee to Preserve Social Security and Medicare. http://www.ncpssm.org/news/archive/update_partd_2008/

Problem Statement

• The doughnut hole may influence prescription fulfillments since low co-payments will be replaced with high out-of-pocket costs.

• Medicare Part D members’ prescription fulfillment decisions, defined as filling, delaying, switching, or completely stopping the fulfillment of a prescription, might be affected by a sudden benefit design change (100 percent cash prescription responsibility) as defined as the doughnut hole.

• Studies need to be conducted to determine whether the doughnut hole affects prescription decisions of Medicare Part D enrollees.

Study Aim and Purpose

• The purpose of the study is to determine whether the doughnut hole has any effect on prescription medication utilization as measured by filling, delaying, switching or cessation of the purchase of a prescription medication.

• The specific aims of the study are as follows:

1. The first aim of the study is to determine the effect of the doughnut hole on the filling of prescription medication.

2. The second aim of the study is to determine the effect of the doughnut hole on delaying the purchase of prescription medication.

3. The third aim of the study is to determine the effect of the doughnut hole on switching of prescription medication.

4. The fourth aim is to determine the effect of the doughnut hole on prescription medication cessation.

5. The fifth aim is to determine the effect of utilization against the confounding effects of the following covariates: age, gender, number and type of medication.

Research Design

• A case control, pharmacy adjudication, prescription fulfillment study design coding prescription fulfillment decisions into the dependent variable nominal categories of filled, switched, delayed, and stopped.

• Each prescription of each Part D participant within the HMO will be followed monthly throughout 2006 via a Part D health plan’s pharmacy adjudication database.

• Statistical analysis of the prescription decisions by members over one full year of enrollment. Enrollees (n=500) will be analyzed for the effect of the independent variable, the doughnut hole, for 1 entire year.

• In addition, a group of enhanced members (n = 250) with doughnut hole coverage will provide a control group for the primary study group (members with standard Medicare PDP benefits - or non-coverage through the doughnut hole).

• In compliance with HIPAA regulations, patient information will be blinded. Thus, no patient names will be disclosed in this research ensuring full-protection of human subjects’ health information privacy.

Days Spent in the “doughnut hole”

0 50 100 150 200 250 300

Days Spent In Doughnut Hole

0

10

20

30

40

50

60

Freq

uen

cyDays Spent In Doughnut Hole

Mean = 144.68 SEM = 2.268 N = 500

Legend: Distribution of Days Spent by Members in the Doughnut Hole

The graph displays the distribution of days spent in the doughnut hole by the 500 members of the standard Part D prescription drug plan (standard PDP). The mean was 144.68 days +/- 2.268 SEM.

Rx Fulfillment Behaviors

Legend: Fulfillment Behaviors for Members Who Experienced the Doughnut Hole

This table shows the prescription fulfillment behaviors of standard PDP members. Data are expressed in terms of the frequency, percent, and cumulative percent. Total number of participants n = 500.

Legend: Fulfillment Behaviors for Members without a Doughnut Hole

This table shows the prescription fulfillment behaviors of enhanced members. Data are expressed in terms of the frequency, percent, and cumulative percent. Total number of participants n = 250.

Fulfillment Behaviors for Members Who Experienced the Doughnut Hole

Doughnut Hole = Y Frequency Percent

Filled 140 28.0

Switched 67 13.4

Delayed 110 22.0

Stopped 30 6.0

Switched and Delayed 49 9.8

Switched and Stopped 26 5.2

Delayed and Stopped 50 10.0

Switched, Stopped, and Delayed

28 5.6

Total 500 100.0

Fulfillment Behaviors for Members without a Doughnut Hole

Doughnut Hole = N Frequency Percent

Filled 135 54.0

Switched 25 10.0

Delayed 27 10.8

Stopped 21 8.4

Switched and Delayed 8 3.2

Switched and Stopped 10 4.0

Delayed and Stopped 21 8.4


3 1.2

Total 250 100.0

Rx Fulfillment Behaviors – Frequency graphs

Legend: Rx Fulfillment Behavior of Standard PDP Members

This figure shows the prescription fulfillment behavior of standard PDP members when experiencing the doughnut hole. Data are expressed as the mean of the number of participants who 1 = filled, 2 = switched, 3 =delayed, 4 = stopped, 5 = both switched and delayed, 6 = switched and stopped, 7 = delayed and stopped, or 8 = switched, stopped and delayed their prescription medication. Total number of participants n = 500.

Legend: Rx Fulfillment Behavior when NOT Experiencing the Doughnut Hole

This figure shows the prescription fulfillment behavior of enhanced members, who do NOT experience the doughnut hole. Data are expressed as the mean of the number of participants who 1 = filled, 2 = switched, 3 =delayed, 4 = stopped, 5 = both switched and delayed, 6 = switched and stopped, 7 = delayed and stopped, or 8 = switched, stopped and delayed their prescription medication. Total number of participants n = 250.

Fre

qu

ency

Fre

qu

ency

0 1 2 3 4 5 6 7 8

Rx Fulfillment Behavior

0

20

40

60

80

100

120

140

Rx Fulfillment Behaviors of Standard PDP Members (experienced the doughnut hole) n=500

0 1 2 3 4 5 6 7 8


0

20

40

60

80

100

120

140

Rx Fulfillment Behavior of Enhanced Members (experience no doughnut hole) n=250

Percentage of Classes Affected

Legend: Percentage of Classes Affected by Prescription Fulfillment Decisions of Standard PDP MembersThis pie chart shows the percentages for the classes which were impacted by prescription fulfillment behaviors of standard PDP members. Data are percent. Total number of participants n = 500.

28.0%

28.8%

26.2%

13.2%

3.8%

0 classes (n=140)

1 class (n=144)

2 classes (n=131)

3 classes (n=66)

4 classes (n=19)

Percentage of Classes Affected by Prescription Fulfillment Decisions of Standard PDP Members

Odd Ratios

Legend: Descriptive Cross Tabulation for Prescription Fulfillment Behaviors and the presence of a doughnut hole with Odds RatiosThe above table compares the prescription fulfillment behaviors identified for members experiencing and Not experiencing the doughnut hole. Prescription fulfillment frequencies are displayed for each type of prescription fulfillment behavior possible from a member; these are separated by group (those who experienced the doughnut hole compared with those who did NOT experience the hole. Odd ratios are displayed for each classification of finalized cumulative prescription decisions made by members (p<0.05).

Rx Fulfillment Behavior Cross Tabulation with Odds Ratios

Doughnut Hole Y or N

Total Odds Ratio

Yes – Experienced the

hole – no coverage

No hole exp – had full

coverage at all times


Filled 140 135 275 0.519

Switched 67 25 92 1.340

Delayed 110 27 137 2.037

Stopped 30 21 51 0.714

Switched and Delayed 49 8 57 3.063

Switched and Stopped 26 10 36 1.300

Delayed and Stopped 50 21 71 1.190


28 3 31 4.667

Total 500 250 750 750

Covariate Analysis

Legend: Multinomial Regression. This table displays the findings of a multinomial regression model. A stepwise method was used to introduce age, gender, type of class of medications, the number of medications, and days spent in the doughnut hole were reported. Reference category is filled. The odds ratios for each variable are displayed. (p<0.05)

Variables in the EquationMultinomial

Regression Results (n=750)

Yes – Experienced the hole, no coverage

No –No hole exp – had full coverage at all times Odds Ratio

Significance of Age p=.355

Age 74 23 15 .767

Age 77 14 13 .538

Significance of Gender p=.848

Male 214 109 .982

Female 286 141 1.014

Significance of Classes of Medication p=.712

Asthma/Allergy (1) 4 0 -

Analgesic (2) 5 8 .313

Anti-infective (3) 34 13 1.308

Cardiovascular (4) 44 32 .688

Central Nervous System (5) 110 46 1.196

Endocrine & Metabolic (6) 108 51 1.059

Gastrointestinal (7) 117 58 1.009

Cancer (8) 68 36 .944

Other (Skin, Stroke, Dental) (9) 10 6 .833

Significance of Number of Medications p=.000

Odd Ratios greater than 1.5 times

7 Different Medications 11 3 1.833




32 different Medications 6 2 1.500

Significance of Days Spent in the Hole P=.000 -

Results

• Each of the 750 members averages 17.5 different medications +/- .253 SEM encompassing an average of 5.9 classes of medications +/- .058 SEM. (SEM - standard error of the mean)

• 54 percent of enhanced members chose to fill all of their prescriptions at regular intervals compared to only 28 percent of members experiencing the doughnut hole.

• The mean distribution of days spent in the doughnut hole by the 500 members of the standard Part D prescription drug plan was 144.68 days +/- 2.268 SEM.

• Medicaid Part D members who experienced the doughnut hole are 1.3 times more likely to switch, 2 times more likely to delay, 3 times more likely to switch and delay, and 4.7 times more likely to switch, stop, and delay their prescription medications.

• “Multi-layering” refers to prescription fulfillment decision making that alters the prescription fulfillment process by means of more than two fulfillment behaviors.

Results Continued…

• 22 percent of the standard PDP members delayed their prescriptions, 13.4 percent switched medications, 10 percent delayed and stopped some medications, and over 9 percent switched and delayed their medications.

• In comparison, the enhanced group had 10.8 percent delayed prescriptions, while 10 percent of members switched prescriptions.

• In the standard PDP group, the fulfillment decisions in regards to 1 or more group of medications was altered 70 percent versus 46 percent with the enhanced group.

• 28.2 percent of doughnut hole members affected one class of medications by making a decision other than filling their prescription.

• Alarmingly, 43.2 percent of the time standard PDP members’ prescription fulfillment decisions affected two or more classes of therapy.

Results Continued…

• It was also noted that 17 percent of the time, three or more classes were impacted by their prescription fulfillment decisions.

• In comparison, the enhanced group showed prescription fulfillment decisions impact three or more medication classes 8.8 percent of the time.

• Multinomial Regression demonstrated that the Number of Different Medications and the Number of Days Spent in the Hole are significant (p=.000; p=.000) contributors to a prescription being switched, delayed, or stopped.

Conclusions

• The doughnut hole is a factor in altering prescription fulfillment decisions by Medicare Part D members.

• Alternative designs of PDPs, which limit excessive financial burden, may increase patient compliance with medications.

• Further research is warranted to adequately determine the total heath care costs, as well as clinical outcomes associated with the current Medicare Part D PDP doughnut hole design.

ISPOR POSTER

• INDIVIDUAL’S HEALTH - Health Care Use & Policy Studies • PIH48 RELATIONSHIP BETWEEN DRUG COST COVERAGE AND

PRESCRIPTION DECISION MAKING IN MEDICARE PART D ENROLLEES Hales J1, Dudley S2, Hegamin A1, Poulios N3, Mills K1

• Here is the written response:• RELATIONSHIP BETWEEN DRUG COST COVERAGE AND PRESCRIPTION

DECISION MAKINGIN MEDICARE PART D ENROLLEES

for presentation at the ISPOR 14th Annual International Meeting to beheld May 16-20, 2009 at the Renaissance Orlando Resort at SeaWorld inOrlando, FL, USA. Congratulations, your abstract has been accepted as aPOSTER PRESENTATION during the following session:

POSTER SESSION IIIWednesday, May 20, 20098:00 AM - 3:00 PM

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