Transcript Rationing - I.U. School of Law

Patient-Centered Outcomes
Research Institute (§ 6301)
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Created to promote comparativeeffectiveness research (CER)
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Research that evaluates and compares the
patient health outcomes and benefits of two or
more medical treatments or services
Responsibilities include

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Setting priorities for CER and funding CER
studies
Analyzing data from CER studies and reporting
to the public on the significance of the study
results
Patient-Centered Outcomes
Research Institute (§ 6301)

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The Institute may not recommend coverage
changes or other policies based on its
analyses, but
Medicare and Medicaid may consider the
Institute’s analyses in determining
coverage policies as long as:
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No denial of coverage “solely on the basis of”
CER
Coverage decisions do not treat the lives of
elderly, disabled or terminally ill persons as
having lower value
Can the CER institute become our NICE?
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NICE evaluates the cost-effectiveness of medical
therapies and approves those that are sufficiently
cost-effective for Britain’s National Health Service
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Treatments are cost-effective if they provide 1 QALY for no
more than £20,000 (now $31,250)
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Sometime, NICE approves treatments up to £30,000
($46,900) per QALY
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Rarely, NICE approves treatments beyond £30,000 per QALY
NICE has approval authority, while the CER institute
can only issue reports (though NICE authority
supposed to be eliminated)
CER institute “shall not develop or employ a dollarsper-quality adjusted life year . . . as a threshold” nor
shall HHS employ such a measure as a threshold for
coverage.
What’s a “good” buy?
“Expensive”
more than $100,000/QALY
“Reasonable” $50,000/QALY
(UK upper limit ~ $47,000)
“Very Efficient” less than $25,000/QALY
Most writers use $50-100,000 as upper limit
of good value, but public preferences suggest
upper limit over $200,000
Hirth RA, et al., Medical Decision Making. 2000;20:332-342
Some sample QALYs (2002 dollars)
Harvard Public Health Review (Fall 2004)
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< $0 (If the cost per QALY is less than zero, the intervention
actually saves money)
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Under $10,000
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Antihypertensive medications in adults age 35-64 with high blood pressure
but no coronary heart disease
Lung transplant in UK (Anyanwu AC et al. J Thorac Cardiovasc Surg
2002;123:411-420)
$50,000-$100,000
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Colonoscopy every five to 10 years for women age 50 and up
$20,000 to $50,000
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Combination antiretroviral therapy for certain HIV patients
$15,000 to $20,000
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Beta-blocker drugs post-heart attack in high-risk patients
$10,000 to $20,000
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Flu vaccine for the elderly
Dialysis for patients with end-stage kidney disease
Antibiotic prophylaxis during dental procedures for persons at moderate to
high risk of bacterial endocarditis ($88,000) (Med Decis Making.
2005;25(3):308-20)
Over $500,000
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CT and MRI scans for kids with headache and an intermediate risk of brain
tumor
COST/QALY: Selected Medicare services
Condition/Treatment
Cost per QALY
Treatment for Erectile Dysfunction
$6,400/QALY
*Physician Counseling for Smoking
$7,200/QALY
Total Hip Replacement
$9,900/QALY
*Outreach for Flu and Pneumonia
$13,000/QALY
Treatment of Major Depression
$20,000/QALY
Gastric Bypass Surgery
$20,000/QALY
Treatment for Osteoporosis
$38,000/QALY
*Screening For Colon Cancer
$40,000/QALY
Implantable Cardioverter Defibrillator
$75,000/QALY
Lung-Volume Reduction Surgery
$98,000/QALY
Tight Control of Diabetes
$154,000/QALY
*Treating Elevated Cholesterol ( + 1 risk factor)
$200,000/QALY
Resuscitation After Cardiac Arrest
$270,000/QALY
Left Ventricular Assist Device
$900,000/QALY
Cost of treatment for metastatic colon
cancer
(Schrag D. NEJM. 2004;351:317-319)
Examining the cost and cost-effectiveness
of adding bevacizumab (Avastin) to chemo
in metastatic colon cancer
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Randomized trial compared chemotherapy
alone vs. chemotherapy + bevacizumab
Bevacizumab regimen prolonged median
survival from 15.6 to 20.3 months (p<0.001)
Cost of extra 4.7 months?
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$101,500 (assuming $5,000 per month for
bevacizumab)
$259,149 per year of life gained (not quality
adjusted)
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NICE decided not to recommend for NHS coverage
Examining the cost and cost-effectiveness of
adding bevacizumab (Avastin) to chemo in
advanced non-small cell lung cancer
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Randomized trial compared
chemotherapy alone vs. chemotherapy +
bevacizumab
Bevacizumab regimen prolonged median
survival from 10.2 to 12.5 months
(p=0.007)
Cost of extra 2.3 months?
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$66,270-$80,343
$345,762 per year of life gained (assuming
$66,270 cost)
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Grusenmeyer PA, Gralla RJ. J. Clin. Oncology.
2006;24(18S):6057.
Can we make QALY-based decisions?
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Cost-effectiveness decisions are
controversial
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Prohibited under PPACA from being used as sole
basis for denying coverage in federal programs
(§6301)
Oregon Health Care Plan
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Mammography screening guidelines in 2009
(even though cost wasn’t a factor)
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Ended up with fairly generous “basic” coverage
US Preventive Services Task Force recommended that
routine screening begin at age 50 instead of age 40
The “tragic choices” problem
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It’s difficult to make life-and-death decisions openly
Cost containment strategies
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If main drivers of high costs are physician
incentives to provide excessive care and patient
incentives to demand excessive care, we should
employ policy changes to remove these incentives
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Changes in physician incentives
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Salary or capitation for physicians (combined with quality
measures to avoid under-provision of care)—could increase
physician pay and still lower overall costs
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Capitation would address problem of too many prescriptions
for expensive drugs—CER institute important here too
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Limits on hospital beds, surgical suites, MRI scanners and
other facilities
Financial incentives for patients?
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If people are not sufficiently sensitive to
costs because of insurance, should we use
health savings accounts or other
mechanisms to give patients more skin in
the game?
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Raising out-of-pocket costs reduces patient
demand for care, but
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Patients do not always distinguish between
necessary and unnecessary care
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Caps on out-of-pocket costs prevent patient
sensitivity to costs of high-cost services
(e.g., heart surgery, cancer chemotherapy)
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Buntin et al. 2006
What is a QALY?
Major
stroke
0
1
Perfect
health
Dead
Recurrent
stroke
Studying for a
law school exam