# Presentation: 009405

## Pharmaceutical Promotion:  Perhaps Don’t Throw The Baby Out With The Bathwater

- September 22 2003

- Robert W. Dubois, M.D., Ph.D.

## Potential Impact of Pharmaceutical Promotion

- DTC increases the _**unnecessary use**_ of medications
- Promotion leads to greater disease awareness, broader understanding of treatment options, and _**reduced variation in care**_

## Research Questions

- Is there significant inappropriate use of statins, and has the rate of inappropriateness increased over time as DTC promotion has occurred?
- Is there greater geographic variation in the use of medications than in the use of surgical or medical procedures?

## Source: Estimated from Calfee JE, Winston C, Stempski R. Direct-to-Consumer Advertising and the Demand for Cholesterol-Reducing Drugs. Journal of Law and Economics. 2002; XLV;673-690.

## Statin Appropriateness Study

- _Research Design_
- Cardiovascular risk criteria developed based upon NCEP guidelines
- Administrative database of medical and pharmaceutical claims from managed care enrollees in 22 States
- Patients receiving statins  in 1997 and 1999 were assigned to 1 of 7 categories representing cardiovascular risk
- Odds calculated to determine if use changed during this time interval (adjusted for age, gender changes)

## Appropriateness of Lipid Therapy

- _Hierarchy_
- 1  Prior “event” (MI, CABS/PTCA)
- 2  Vascular Disease (Angina, PVD, CVD)
- 3  Diabetes
- 4  Multiple Risk Factors
- 5  Single Risk Factor
- 6  Hypercholesterolemia
- 7  No Reason

## Distribution of Patients by Appropriateness Level for Cholesterol-Lowering Therapy

- Source: Dubois, Alexander, Wade et al. Growth in Use of Lipid-lowering Therapies: Are We Targeting the Right Patients? *American Journal of Managed Care*. 2002;8(10):862-867.

## Changes In Use From 1997 To 1999

- 60% growth in the  number of patients using statins
- 5% of the population in 1997
- 8% of the population in 1999

## Distribution of Patients by Appropriateness Level for Cholesterol-Lowering Therapy*

- Source: Dubois, Alexander, Wade et al. Growth in Use of Lipid-lowering Therapies: Are We Targeting the Right Patients? *American Journal of Managed Care*. 2002;8(10):862-867.

- *no statistical difference

## Implications

- Significant growth in use of statins during a time of substantial pharmaceutical promotion
- 95% of statin users had existing heart disease or risk factors for its development
- No change from ’97 to ‘99 in the cardiovascular risk profile of patients on statins
- Despite DTC promotion, no apparent increase in the unnecessary use of this medication class
- Perhaps other temporal factors accounted for the increase in use
- Similar assessment of appropriateness is needed for other common drug classes

## Geographic Variation In Use Study

- _Background_
- Likelihood of receiving a surgical procedure varies based upon where you live (4-10 fold geographic variation in use of tonsillectomy, prostatectomy, GI endoscopy, and coronary angiography
- Reducing unexplained variation in care has been a key tenet of quality improvement efforts
- Little known about the geographic variation in use of medications

## Geographic Variation In Use Study

*Geographic Variation In Use Study*

- _Research Design_
- Administrative database of medical and pharmaceutical claims data from 3 Health Plans in California (Blue Cross, Blue Shield, PacifiCare)
- 638,188 patients in database (’98-’99)
- Variety of Plan Types (HMO, PPO, POS)
- Variety of pharmacy benefit structures (flat co-payment, 2-tier, 3-tier, open vs. closed formulary)
- Analyzed medication use in 11 California regions within condition and across population
- Analyzed use of surgical and medical procedures as comparison

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## Results

- Rather than 400%-1000% variation previously seen for procedures, medications varied by just 30-40%
- 49% of all asthmatics used an inhaled corticosteroid, ranging from 40% in the lowest use area to 59% in the highest use area

- Dubois RW, Batchlor E, Wade S. Geographic Variation in the use of medications:  is uniformity good news or bad?  *Health Affairs* 2002;21:240-250.

## Variation in Use of Medications and Procedures

- CABS

**        ****Medications****	**

**Coefficient of Variation **

*Variation in Use of Medications and Procedures*

**Procedures**

- Brand Antibiotics (URI)

-  ACE (CHF)

- ICS (Asthma)

- Lamin-ectomy

- CT/MRI Head

## Variation in Use of Medications and Procedures

- CABS

**        ****Medications****	**

**Coefficient of Variation **

*Variation in Use of Medications and Procedures*

**Procedures**

- Brand Antibiotics (URI)

-  ACE (CHF)

- ICS (Asthma)

- COX 2 (RA/OA)

- Lamin-ectomy

- CT/MRI Head

## Potential Explanations For Low Variation

- Unique California Managed Care phenomenon?
- Clinical areas studied had low amount of “uncertainty”?
- Required clinical trials for drugs provide more data for decision-making than is typically available for procedures?
- Less financial incentives for the use of medications than for the use of procedures?
- Pharmaceutical promotion more uniformly educates patients and providers?

## Summary	

- Despite significant pharmaceutical promotion in the latter ’90s, no change in the appropriateness of statin use
- Significantly less geographic variation in use of medications than procedures
- This research had limitations in the number of drug classes and areas of the country studied but found more evidence to support greater awareness than growing overuse