Using Evidence to Make Prescription Drug Purchasing

DecisionsJOHN SANTA MD MPHGrant Administrator

Attorney Generals Consumer and Prescriber Grants ProgramCenter for Evidence-based Policy

Oregon Health & Science University

“More than any other time in history, mankind faces a crossroads. One path leads to despair and utter hopelessness. The other to total extinction. Let us pray we have the wisdom to choose correctly.”

Woody Allen

Wisdom to Choose

• There are more than these two options

• Act like a purchaser. Understand: • playing field/negotiating table• who you represent • who the “sellers” are.

• DON’T BLINK

Playing FieldAmerican Culture

• Tension between individual freedom and equality

• Individual freedom• Religion• Capitalism

• Equality of opportunity• Land of opportunity, not economic

security

Playing FieldEmployer based, FFS

• Unlimited access to the most sophisticated acute care in the world when desperately ill.

• Multiple tiers of care unless need acute care, desperately ill.

• Unlimited access to the most health care information in the world in every imaginable medium.

Playing Field“Perfect Competition”

• Homogeneity of product• Perfect information• Freedom of entry and exit• Numerous small firms and customers

Microeconomics Principles and Policy, Baumol, W.J., and Binder A.S.

Who you representSystems are perfectly designed to

get the results they achieve.

Who you represent

• Working people• Sick people—high % chronic

diseases• People 50-65 years old• You are negotiating a substantial %

of their income. Annual income of families at 100% of federal poverty level

Who you represent• Almost 2 million adults (almost 1%) file for

bankruptcy every year• 28% major factor = illness/injury• 27% leading factor = uncovered medical bills• 21% cite loss of income due to illness• 75% had health insurance• Average age in forties, over 90% middle

class• HEALTH CARE COSTS NOW THE MAJOR

CAUSE OF BANKRUPTCY

Archives of General PsychiatryJune 2006

• In 2002, antipsychotic drugs were prescribed to 1,438 children per 100,000, up from 275 children per 100,000 between 1993 and 1995 – five fold increase;

• One-third of children who received antipsychotic drugs had behavior disorders, one-third had psychotic symptoms or developmental problems and one-third had mood disorders;

• Overall, more than 40% of children who received an antipsychotic drug were taking at least one other antipsychotic medication;

• Between 2000 and 2002, more than 90% of prescriptions analyzed were for newer atypical antipsychotic drugs which were introduced in the early and mid-1990s;

• Caucasian boys are the most common recipients of antipsychotic medications.

New York Times, June 2006

"We are using these medications and don't know how they work, if they work or at what cost," John March, a professor of child and adolescent psychiatry at Duke University, said. He added, "It amounts to a huge experiment with the lives of American kids, and what it tells us is that we've got to do something other than [what] we're doing now."

SellersTransparency/Conflict of Interest

• 16 Billion on RX marketing---much more than spent on medical education or research

• Academic medical centers especially conflicted

• Gifts/relationships make a difference

SellersConflict of Interest

“The medical profession has sold its soul in exchange for what can only be described as bribes from manufacturers of drugs and medical devices”

NY Times Jan 2006

Is there hope?

“We can’t solve problems by using the same kind of thinking we used when we created them.”

Albert Einstein

VA

• Government administered and provided health care system

• Means tested• Provides a basic benefit for a fixed

amount• Integrated system

Who are VA Patients?Disadvantaged Populations

• Older ~49% over age 65

• Sicker~Compared to Age-Matched Americans

-3 additional Medical Diagnoses-1 Additional Mental Health Diagnosis

• Poorer~70% with annual incomes < $26,000~40% with annual incomes < $16,000

• Homelessness~1/3 of all homeless individuals are veterans approximately 200,000

More than 400,000 may experience homelessness in a given year

• Changing Demographics~4.5% female overall

Improved Efficiency: Enrollees, Patients & Resources/Patient

1996-2004

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Enrollees

Economies of Scale: VA’s PBM (Pharmacy Benefits Management Program)

1996 - 2004

• $4.72 Billion in savings:• In drug acquisition costs from standardization contracting ($1.92B)• In labor/mail costs through CMOP prescription processing (>$2.3B)• In negative distribution fees (rebates) the Pharmaceutical Prime

Vendor contract (~$503M)*

• * Savings achieved in collaboration with VA’s National Acquisition Center

• Quality Improvements resulting in unmeasured cost savings:• CMOP error rate reduction (approaching six sigma)• Two-thirds reduction in reported medication errors through BCMA• Evidence-based prescribing guidance• Outcomes assessment to monitor/maintain safe prescribing

CLINICAL PERFORMANCE INDICATOR

Portland VA Medical

Center 2005

HEDIS Commercial

2004

HEDIS Medicare

2004

HEDIS Medicaid

2004

Breast cancer screening 72% 73% 74% 54%

Cervical cancer screening 89% 81%Not

Reported65%

Colorectal cancer screening 71% 49% 53%Not

Reported

LDL Cholesterol < 100 after AMI,

59% 51% 54% 29%

Diabetes: Poor control HbA1c > 9.0% PTCA, CABG(lower is better)

15% 31% 23% 49%

Diabetes: Cholesterol (LDL-C) controlled (<100)

61% 40% 48% 31%

Diabetes: Cholesterol (LDL-C) controlled (<130)

76% 65% 70% 41%

Diabetes: Eye Exam 79% 51% 67% 45%

Hypertension: BP <= 140/90 most recent visit 70% 67% 65% 61%

Follow-up after Hospitalization for Mental Illness (30 days)

77% 76% 61% 55%

Immunizations: influenza, (note patients age groups)

73%38.9%

(50-64)

74.8% (65 and older)

70%

(65 and older)

Immunizations: Pneumococcal, patients 65 and older

98%Not

ReportedNot

Reported65%

Balancing Access & ResourcesWaiting for Medically Non-Urgent Care

Numbers waiting over 30 days for elective care by region.

VA Patient Satisfaction:

• VA Inpatient – 83%

• Private Sector Inpatient -*73%

• VA Outpatient – 80%

• Private Sector Outpatient - *75

• *American Customer Satisfaction Index

Are there problems?

• FDA---recent IOM report---”sweeping” changes needed

• CMS---prohibited from using evidence funded by the Medicare Modernization Act that compares drugs

• Academic centers/pharma companies---growing concerns about corruption--- www.hcrenewal.blogspot.com

“We are drowning in information but starved for knowledge.”

John NaisbittMegatrends, 1982

Do you believe that the health care services you receive should be based on the best and most recent research

available?

Yes 95%No 4%Don’t know 1%

Source: National survey, 2005, Charlton Research Company for Research!America

The Ethics of Pharmaceutical Benefit Management

Burton S.L. et al, Health Affairs, 20, #5, Sept/Oct 2001

• Accept resource constraints• Help the sick• Protect the worst off• Respect autonomy• Sustain trust• Promote inclusive decision making

Major issues

• Effectiveness---especially comparative effectiveness. How does Drug A compare to Drug B??

• Safety---especially longer term safety• Off label uses---uses not approved of

by the FDA

Lets just focus on comparative effectiveness

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The Prescription Drug Purchasing Process

• Information• Price• Credibility/Transparency/Trust• Implementation• Evaluation

• Systematic drug class reviews focusing on comparative effectiveness and safety

• Focus on the most important 25 drug classes

• Update every 12-24 months (sooner if needed)

• Each participant uses local decision makers to draw conclusions from the evidence for their use

The Drug Effectiveness Review Project

Drug Classes 1. Proton Pump Inhibitors2. Long-acting Opioids3. Statins4. Non-steroidal Anti-

Inflammatory Drugs5. Estrogens6. Triptans7. Skeletal Muscle Relaxants8. Oral Hypoglycemics9. Over Active Bladder, Drugs

to treat10. ACE Inhibitors11. Beta Blockers12. Calcium Channel Blockers13. Angiotensin II Receptor

Antagonists

14. 2nd Generation Antidepressants

15. Antiepileptic Drugs in Bipolar Mood Disorder and Neuropathic Pain

16. 2nd Generation Antihistamines

17. Atypical Antipsychotics18. Inhaled Corticosteroids19. ADHD and ADD, Drugs to

treat20. Alzheimers, Drugs to treat21. Anti-platelet Drugs22. Thiazolidinedione23. Newer Antemetics24. Sedative Hypnotics25. Targeted Immune Modulators26. Inhaled Beta Agonists

Overview of Project

PRIVATE NON PROFITS AND STATES

CENTER FOR EVIDENCE-BASED POLICY

COORDINATING EVIDENCE BASED PRACTICE CENTER

OHSU EPC UNC EPC CALIF RAND EPC

Governance Group

• 17 Organizations• State Medicaid organizations• State employee plans• Private organizations

• Decisions to be made• Key policy decisions• Drug classes to be reviewed• Key questions• Timelines

Currently AnnouncedParticipating Organizations

• Alaska• Arkansas• California• Oregon• Washington• Idaho• Wyoming• Kansas• New York

• Michigan• Missouri• Minnesota• North Carolina• Wisconsin• CHCF• CCOHTA• Montana

Center for Evidence-based Policy

• MISSION: To address policy challenges by applying the best available evidence through self-governing communities of interest.

• Department of Public Health and Preventive Medicine, Oregon Health & Science University

• Supports collaboration, facilitates communication

OHSU Evidence-based Practice Center

• Designated an EPC by AHRQ • Department of Medical Informatics

and Clinical Epidemiology, OHSU • Agreement with Center for drug

class reviews.• Credible, experienced (10 years)

source of comprehensive information.

Evidence-based Practice Center

• Emphasize getting questions right• State of art methods for conducting

systematic reviews• Multiple reviewers• Accustomed to timelines, deliverables• Extensive, external peer review• Many EPC products available for the

world to evaluate

Expert Strategy

• Experts may underplay controversy or select only supportive evidence

• Without systematic approach bias may be introduced

• Experts may ask good research questions but the wrong questions for patients and providers

• Experts may not be aware of all evidence• Experts may or may not disclose conflicts

Systematic Review Process

• Problem formulation/key questions• Find evidence• Select evidence• Synthesize and present• Peer review and revision• Maintain and update

Key Questions• EPC drafts initial KQ using standard

comparative review approach• Three questions

• Comparative effectiveness• Comparative safety profile• Subpopulations

• Multiple discussions• Multiple inputs• Consensus process

Key Questions

• Drugs to be included in class• Indications• Outcomes of interest• Types of studies

Possible Results

• No good quality comparative studies done.

• Good studies done. No differences.• Good studies done. Small

differences.• Good studies done. Significant

differences.

Some examples

• COX 2s/NSAIDs—never more effective, risks were suppressed

• Heartburn medicines---No differences in effectiveness for vast majority of patients

• Long acting narcotics---little comparative evidence

• Antidepressants---all effective at similar levels, different side effect profiles

Subpopulations• All reports include evidence focused on

subpopulations• Gender, race, ethnicity, age, income

• Evidence frequently not found• General population evidence vs no

evidence• Strive for studies that meet rigorous

standards for all populations.• If we don’t make decisions based on

evidence can we ever hope to get it?

Update Reports

• Every 12-24 months — some continuously updated every 7 months

• Start with key questions from previous final report

• Integrate input from local discussions• New drugs, new studies, additional

issues added• Chance to improve reports

Final Comments

• Credible, transparent, explicit, trustworthy• Good information, reasonably current• Consumers/patients have access to info• Insist practitioners disclose financial

relationships to purchasers and patients• Don’t blink• Shift market share

More Information

• Project website at www.ohsu.edu/drugeffectiveness.

• Email comments/questions regarding the Center to santaj@ohsu.edu.

• Call John Santa at 503-494-2691 if questions regarding the Center or Project.