The Intervention Program

THE MISSING LINK IN BIOPHARMACEUTICAL SCIENCESTM

A basic principle

“Help your doctor help you”

medAmigo intervention program

medAmigo

med=medicine, Amigo=Friend

medAmigo patient management model

Patient Starts

Screening vs.

Algorithms &

Interventions Plans

Intervention Plan

SelectedPhysician &

Patient Feedback

Monitoring & Data

Collection

Intervention

Physician & Patient

Feedback

Measurement-Guided Medication Management (MGMM) based intervention

Successful techniques for improving compliance require two key elements:

• Realistic measurement– the objective, continuous electronic recording of day by day

dosing times, which can be easily interpreted by most patients

• Scheduled appointments with feedback – continuing periodic review with the patient, by the prescribing

physician, pharmacist, or nurse of the patient’s ongoing dosing history.

Illustrative results of a medAmigo intervention

Beforeintervention

Dos

ing

Tim

e

Dosing Date

Do

sin

g T

ime

0 100 200 300

00:00

06:00

12:00

18:00

24:00

1926 / 42 RE+

Strata : USA

1

2

23

6

0

4

5 5

6

21 1

1

1 0

1234

4

2

45

6 0

3

123456 0123456 0

345

6 012345

6 0123456 0

12

3456 0123456 01

1

3456 0123

456 01

23

3

456 0123456 0123456 0123456 0123456 01

23456 01

23456 0123456 0123456 0123456 0123456 0123456 0123456 012456 012345

5

6 0123456 0123445

6

0123456 0123456 0123456 012

3456 01234556 0123456 0123445

6

0123456 0123455

6 0123456 01234

5

6 012345

5

6 01234566123456 01

2

2

25

VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV VV V V

2 3 4 5 6 7

Days on treatment

After intervention

Treatment of osteoporosis

V= a missed dose, 0= Sunday; 1= Monday; 2= Tuesday; 3= Wednesday;…

MGMM tested successfully in Hypertension

McKenney et al., 1992 J Clin Pharmacol

No Intervention (N = 34) Mean compliance = 78%

Intervention (N = 36) Mean compliance = 95%Difference = 17%

12 weeks data

MGMM tested successfully in Hypertension

McKenney et al., 1992 J Clin Pharmacol

MGMM tested successfully in Serious Mental Illness

Month 1 Month 6

Intervention 81 ± 22%

N=31

76 ± 22%

N=25

No Intervention 68 ± 27%

N=29

57 ± 30%

N=20

Difference 13% 19%

P-value 0.023 0.008

Cramer and Rosenheck, 1999 J of Nervous & Mental Diseases

Burnier et al., 2001 J of Hypertension

MGMM tested successfully in Resistant Hypertension

MGMM tested successfully in Smoking Cessation

* p<0.05 ** p<0.001

Week

**** * *

Dose compliance

Schmitz et al., 2005, Journal of Behavioral Medicine

No InterventionN = 46

InterventionN = 51

Difference of

± 30%

MGMM tested successfully in HIV

• N=26 experienced patients (>6 months on treatment)

De Bruin et al., 2005 Aids Patient Care

2 months 3 months

Intervention

82% 93%

Difference = 11%, p<0.05

Larger confirmatory trial is ongoing

MGMM tested successfully in Lipid Lowering

~86%

~71%

Vrijens, et al., Pharmacoepidemiology and Drug Safety, 2006

P<0.01

Daily Percentage of adherers

Days since inclusion

%

0 50 100 150 200 250 300

60

70

80

90

10

0

InterventionNo Intervention

Difference of 15%

Poor adherence/short persistence

Decreased drug efficacy

Increased care costs

Early dropouts; lost sales

Patients LOSE

Payors LOSE

Industry LOSES

Breaking the downward spiral

Decreased care costs

Payors WIN

IndustryWINS

Late dropouts; retained salesTimely detection, focused

Intervention

Robust adherence/long persistence

Increased drug efficacy

Patients WIN