Skip to content
  • About
  • Contact
  • Contribute
  • Book
  • Careers
  • Podcast
  • Recommended
  • Speaking
  • All
  • Physician
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
  • Video
    • All
    • Physician
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • Video
    • About
    • Contact
    • Contribute
    • Book
    • Careers
    • Podcast
    • Recommended
    • Speaking

Practical barriers for comparative effectiveness studies

David Williams
Policy
July 10, 2010
Share
Tweet
Share

Writing in the New England Journal of Medicine three authors share their experience in running a head-to-head trial of Avastin (bevacizumab) versus Lucentis (ranibizumab) for wet age-related macular degeneration (AMD).

They describe the barriers they faced and suggest that the barriers will need to be removed for comparative effectiveness research to succeed. They make good points and may well be correct in their policy recommendations.

However the case of Avastin and Lucentis is unusual. The products are made by the same manufacturer and are essentially identical. Avastin and Lucentis are marketed separately by Genentech mainly to allow the company to capture a return on investment from its R&D.

The issue is that a regular dose of Avastin can be divided up into many doses for the eye. Since the products are sold by volume it turns out that Avastin is cheap when used for wet AMD, even though it’s pricey when used for cancer. As I’ve suggested previously, Genentech should be able to charge Lucentis prices for Avastin when it’s used in the eye. So there are quite a lot of people — starting with the manufacturer itself — who didn’t really want this study to go forward. That’s less likely to be the case with other studies.

With those caveats, here are the issues that were encountered:

* Initially CMS did not want to pay for routine Lucentis use by the study population. This policy was changed in 2007 to provide coverage of drugs under investigation if they were normally covered outside the trial. So this should no longer be an issue.

* Some patients were responsible for co-pays, and the differentials could be large because of the difference in the prices for the drugs. That could discourage participation or bias the results. NIH was able to make an exception to its policy and cover the difference. Ordinarily the differences won’t be so stark, but this could come up again.

* The most significant issue from my standpoint is how to mask the drugs so study participants don’t know which drug they’re getting. That’s actually harder to accomplish than it may sound when a trial population is mixed in with a clinical population. For example, how do you bill for a drug that is not identified? And how do you prevent an Explanation of Benefits from being printed that contains the name of the drug? It sounds as though a couple of attempts have been made to address this issue but that they have come to naught.

The authors rightly point out that studies in non-Medicare populations will be even more complex, because of all the private insurers involved. I agree this is an important area to address.

There are plenty of political barriers to the conduct and use of comparative effectiveness research. I’m glad to see people thinking about the practical barriers, even if I don’t agree that they are completely generalizable.

David E. Williams is co-founder of MedPharma Partners and blogs at the Health Business Blog.

Submit a guest post and be heard.

Prev

How to treat slouching in children

July 9, 2010 Kevin 2
…
Next

Linezolid resistant Staphylococcus aureus (LRSA) emerging

July 10, 2010 Kevin 2
…

ADVERTISEMENT

Tagged as: Public Health & Policy

Post navigation

< Previous Post
How to treat slouching in children
Next Post >
Linezolid resistant Staphylococcus aureus (LRSA) emerging

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

More by David Williams

  • The dialysis industry is a microcosm of what ails the health care system

    David Williams
  • Should patients be responsible for physician handwashing?

    David Williams
  • a desk with keyboard and ipad with the kevinmd logo

    The state of online doctor ratings: It’s still early

    David Williams

More in Policy

  • The silent toll of ICE raids on U.S. patient care

    Carlin Lockwood
  • What Adam Smith would say about America’s for-profit health care

    M. Bennet Broner, PhD
  • The lab behind the lens: Equity begins with diagnosis

    Michael Misialek, MD
  • Conflicts of interest are eroding trust in U.S. health agencies

    Martha Rosenberg
  • When America sneezes, the world catches a cold: Trump’s freeze on HIV/AIDS funding

    Koketso Masenya
  • A surgeon’s late-night crisis reveals the cost confusion in health care

    Christine Ward, MD
  • Most Popular

  • Past Week

    • The silent toll of ICE raids on U.S. patient care

      Carlin Lockwood | Policy
    • Why recovery after illness demands dignity, not suspicion

      Trisza Leann Ray, DO | Physician
    • Addressing the physician shortage: How AI can help, not replace

      Amelia Mercado | Tech
    • Why medical students are trading empathy for publications

      Vijay Rajput, MD | Education
    • Why does rifaximin cost 95 percent more in the U.S. than in Asia?

      Jai Kumar, MD, Brian Nohomovich, DO, PhD and Leonid Shamban, DO | Meds
    • How conflicts of interest are eroding trust in U.S. health agencies [PODCAST]

      The Podcast by KevinMD | Podcast
  • Past 6 Months

    • What’s driving medical students away from primary care?

      ​​Vineeth Amba, MPH, Archita Goyal, and Wayne Altman, MD | Education
    • Make cognitive testing as routine as a blood pressure check

      Joshua Baker and James Jackson, PsyD | Conditions
    • The hidden bias in how we treat chronic pain

      Richard A. Lawhern, PhD | Meds
    • A faster path to becoming a doctor is possible—here’s how

      Ankit Jain | Education
    • Residency as rehearsal: the new pediatric hospitalist fellowship requirement scam

      Anonymous | Physician
    • The broken health care system doesn’t have to break you

      Jessie Mahoney, MD | Physician
  • Recent Posts

    • How conflicts of interest are eroding trust in U.S. health agencies [PODCAST]

      The Podcast by KevinMD | Podcast
    • Why young doctors in South Korea feel broken before they even begin

      Anonymous | Education
    • Measles is back: Why vaccination is more vital than ever

      American College of Physicians | Conditions
    • When errors of nature are treated as medical negligence

      Howard Smith, MD | Physician
    • Physician job change: Navigating your 457 plan and avoiding tax traps [PODCAST]

      The Podcast by KevinMD | Podcast
    • The hidden chains holding doctors back

      Neil Baum, MD | Physician

Subscribe to KevinMD and never miss a story!

Get free updates delivered free to your inbox.


Find jobs at
Careers by KevinMD.com

Search thousands of physician, PA, NP, and CRNA jobs now.

Learn more

View 1 Comments >

Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories.

Social

  • Like on Facebook
  • Follow on Twitter
  • Connect on Linkedin
  • Subscribe on Youtube
  • Instagram

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

  • Most Popular

  • Past Week

    • The silent toll of ICE raids on U.S. patient care

      Carlin Lockwood | Policy
    • Why recovery after illness demands dignity, not suspicion

      Trisza Leann Ray, DO | Physician
    • Addressing the physician shortage: How AI can help, not replace

      Amelia Mercado | Tech
    • Why medical students are trading empathy for publications

      Vijay Rajput, MD | Education
    • Why does rifaximin cost 95 percent more in the U.S. than in Asia?

      Jai Kumar, MD, Brian Nohomovich, DO, PhD and Leonid Shamban, DO | Meds
    • How conflicts of interest are eroding trust in U.S. health agencies [PODCAST]

      The Podcast by KevinMD | Podcast
  • Past 6 Months

    • What’s driving medical students away from primary care?

      ​​Vineeth Amba, MPH, Archita Goyal, and Wayne Altman, MD | Education
    • Make cognitive testing as routine as a blood pressure check

      Joshua Baker and James Jackson, PsyD | Conditions
    • The hidden bias in how we treat chronic pain

      Richard A. Lawhern, PhD | Meds
    • A faster path to becoming a doctor is possible—here’s how

      Ankit Jain | Education
    • Residency as rehearsal: the new pediatric hospitalist fellowship requirement scam

      Anonymous | Physician
    • The broken health care system doesn’t have to break you

      Jessie Mahoney, MD | Physician
  • Recent Posts

    • How conflicts of interest are eroding trust in U.S. health agencies [PODCAST]

      The Podcast by KevinMD | Podcast
    • Why young doctors in South Korea feel broken before they even begin

      Anonymous | Education
    • Measles is back: Why vaccination is more vital than ever

      American College of Physicians | Conditions
    • When errors of nature are treated as medical negligence

      Howard Smith, MD | Physician
    • Physician job change: Navigating your 457 plan and avoiding tax traps [PODCAST]

      The Podcast by KevinMD | Podcast
    • The hidden chains holding doctors back

      Neil Baum, MD | Physician

MedPage Today Professional

An Everyday Health Property Medpage Today
  • Terms of Use | Disclaimer
  • Privacy Policy
  • DMCA Policy
All Content © KevinMD, LLC
Site by Outthink Group

Practical barriers for comparative effectiveness studies
1 comments

Comments are moderated before they are published. Please read the comment policy.

Loading Comments...