Patient-Centered Outcomes Research Institute (

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Patient-Centered OutcomesResearch Institute (
6301)

• Created to promote comparative-effectiveness
  research (CER)
• Research that evaluates and compares the patient
  health outcomes and benefits of two or more
  medical treatments or services
• Responsibilities include
• 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

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Patient-Centered OutcomesResearch Institute (
6301)

• The Institute may not recommend coverage changes
  or other policies based on its analyses, but
• Medicare and Medicaid may consider the
  Institutes analyses in determining coverage
  policies as long as
• 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

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Can the CER institute become our NICE?

• NICE evaluates the cost-effectiveness of medical
  therapies and approves those that are
  sufficiently cost-effective for Britains
  National Health Service
• Treatments are cost-effective if they provide 1
  QALY for no more than 20,000 (now 31,250)
• Sometime, NICE approves treatments up to 30,000
  (46,900) per QALY
• 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
  dollars-per-quality adjusted life year . . . as a
  threshold nor shall HHS employ such a measure as
  a threshold for coverage.

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Whats 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. 200020332-342
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Some sample QALYs (2002 dollars)Harvard Public
Health Review (Fall 2004)

• lt 0 (If the cost per QALY is less than zero, the
  intervention actually saves money)
• Flu vaccine for the elderly
• Under 10,000
• Beta-blocker drugs post-heart attack in high-risk
  patients
• 10,000 to 20,000
• Combination antiretroviral therapy for certain
  HIV patients
• 15,000 to 20,000
• Colonoscopy every five to 10 years for women age
  50 and up
• 20,000 to 50,000
• 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 2002123411-420)
• 50,000-100,000
• 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.
  200525(3)308-20)
• Over 500,000
• CT and MRI scans for kids with headache and an
  intermediate risk of brain tumor

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COST/QALY Selected Medicare services
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Cost of treatment for metastatic colon
cancer(Schrag D. NEJM. 2004351317-319)
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Examining the cost and cost-effectiveness of
adding bevacizumab (Avastin) to chemo in
metastatic colon cancer

• Randomized trial compared chemotherapy alone vs.
  chemotherapy bevacizumab
• Bevacizumab regimen prolonged median survival
  from 15.6 to 20.3 months (plt0.001)
• Cost of extra 4.7 months?
• 101,500 (assuming 5,000 per month for
  bevacizumab)
• 259,149 per year of life gained (not quality
  adjusted)
• NICE decided not to recommend for NHS coverage

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Examining the cost and cost-effectiveness of
adding bevacizumab (Avastin) to chemo in advanced
non-small cell lung cancer

• Randomized trial compared chemotherapy alone vs.
  chemotherapy bevacizumab
• Bevacizumab regimen prolonged median survival
  from 10.2 to 12.5 months (p0.007)
• Cost of extra 2.3 months?
• 66,270-80,343
• 345,762 per year of life gained (assuming
  66,270 cost)
• Grusenmeyer PA, Gralla RJ. J. Clin. Oncology.
  200624(18S)6057.

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Can we make QALY-based decisions?

• Cost-effectiveness decisions are controversial
• Prohibited under PPACA from being used as sole
  basis for denying coverage in federal programs
  (6301)
• Oregon Health Care Plan
• Ended up with fairly generous basic coverage
• Mammography screening guidelines in 2009 (even
  though cost wasnt a factor)
• US Preventive Services Task Force recommended
  that routine screening begin at age 50 instead of
  age 40
• The tragic choices problem
• Its difficult to make life-and-death decisions
  openly

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Cost containment strategies

• 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
• Changes in physician incentives
• Salary or capitation for physicians (combined
  with quality measures to avoid under-provision of
  care)could increase physician pay and still
  lower overall costs
• Capitation would address problem of too many
  prescriptions for expensive drugsCER institute
  important here too
• Limits on hospital beds, surgical suites, MRI
  scanners and other facilities

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Financial incentives for patients?

• 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?
• Raising out-of-pocket costs reduces patient
  demand for care, but
• Patients do not always distinguish between
  necessary and unnecessary care
• Caps on out-of-pocket costs prevent patient
  sensitivity to costs of high-cost services (e.g.,
  heart surgery, cancer chemotherapy)
• Buntin et al. 2006

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What is a QALY?
0
1
Perfect health
Dead