Standard of Care vs. FDA Approved – How We Choose a Treatment

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Standard of Care vs. FDA Approved – How We Choose a Treatment

Avastin is actually not FDA approved for the eye. How is it an acceptable treatment for wet macular degeneration?

Avastin® is not FDA (Food and Drug Administration) approved for treating wet macular degeneration, but it is the standard of care for treating the disease.   The FDA has given approval for Avastin to be used to treat a variety of cancers, but nothing about eyes.

What is Standard of Care? Standard of care is the treatment that another prudent healthcare professional, of similar backgrounds and training,  would give to the same patient.  As an example, if I choose to treat you with Lucentis for wet macular degeneration and I am complying with the local standard of care, another retina specialist practicing across the street, would choose the same treatment for you.

What About FDA Approval? Last post, we spoke about evidenced based medicine and the need for a new drug to gain FDA approval.  Once a drug gains FDA approval, it may be used “off-label.”  Off-label indicates that healthcare providers have found other uses for the drug, in addition to the FDA indication.

Avastin is used “off-label” for the treatment of wet macular degeneration.  Avastin has FDA approval for the treatment of certain colon, breast, lung, kidney and brain tumors.

What About Lucentis? Lucentis® is made by the same manufacturer as Avastin (Genentech/Roche).  That manufacturer did go through clinical trials, and costs, of getting FDA approved for wet macular degeneration.

Avastin and Lucentis are chemically very similar, they are cousins.  One is much more expensive than the other.  Both are anti-VEGF treatments.

On Becoming the Standard of Care In this case, several people receiving chemotherapy for colon cancer started reporting that their vision was improving.  Some smart docs paid attention to these comments.  In short, because of the similarities, Avastin was soon used for intraocular injection.

The doctors that pioneered this approach designed a few “randomized” studies and reported their results at our industry meetings.  Others repeated similar studies and were finding the same results.

This then becomes intriguing for community physicians (like yours truly) and we try it ourselves.  If it works, we embrace the new “off-label” treatment.

What Does This Mean? In the case of Lucentis and Avastin, this means that we use a similar drug, get similar (or perhaps even better) results, but significant cost savings.  From a healthcare point of view, while Avastin was never FDA approved, the industry provides its own proof.

This is still evidenced based medicine.  While the traditional FDA clinical trials were not performed, similar trials are usually performed by institutions or groups of doctors that feel a new use, or indication, for a treatment is possible.  The trials are usually shorter and focused on efficacy of the new treatment.  The best “studies” are those that are prospective, randomized and double blinded.  These ensure the accuracy of any results.  The results are presented at meetings and in so-called “peer reviewed” journals.  It is in this arena, that we decide, outside of government (i.e. FDA) sanction, if new treatments are worthwhile.

It is at this level, we read a plethora of “studies” making claims.  There are good and bad studies.  This is where we need to “read critically.”

“Randy”

Randall V. Wong, M.D.
Ophthalmologist, Retina Specialist
Fairfax, Virginia

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Comments
  • Dick Marquis January 14, 2010 at 6:26 am

    Randy,
    Can Avastin (or Lucentis) be used as a preventive treatment prior to the onset of W-AMD?

    • Randall V. Wong, M.D. January 14, 2010 at 9:54 am

      No, we don’t think so. While the VEGF molecules may be blocked, I don’t know how you would determine the timing of the injection, that is, when would you inject?

      Remember also that the medication leaves the eye in a matter of 1-2 days.

      r

  • Raghunath August 4, 2011 at 9:00 pm

    Dear Doctor
    I am a insulin dependent diabetic and is being treated for macular odema. I had foggy vision in the right eye 3 months back which after tests by a reputed eye hospital at Chennai, India, have given an Avastin injection and on review after a month has shown improved vision. The treating doctor suggested a laser surgery, however on tests within a month, the vision deteriorated and reverted back to the earlier stage.. Incidentally my left eye cataract was performed with a Avastin injection. I am left with a blurred vision in the right eye and doctors suggested further Avastin shots. I am totally confused. Kindly advise how many more Avastin shots are required for a clear vision and also let me know on chances of recurrence. I am not financially sound also, hence trying to find out from you whether any other treatment is available which is cheaper and effective. I shall appreciate and immediate reply. With kind regards – Raghunath

    • Randall V. Wong, M.D. August 7, 2011 at 10:33 am

      Dear Raghunath,

      In my opinion;

      1. There is no guarantee how well Avastin will work…if at all. In my experience, most patients get some improvement, but not necessarily complete return of the vision.
      2. In the U.S., I would think Avastin is the cheapest treatment available. It certainly is cheaper than laser treatment. I am not aware of the fee structure in India.

      Randy

  • Raghunath August 8, 2011 at 1:19 pm

    Dear Dr. Randy
    many thanks for your prompt reply for my query. In India for a single shot of Lucentis the charges are 75000 Indian Rupees and for Avastin it is 10000 Indian Rupees (however one com-pule of Avastin is shared by 6 patients) i.e. there is not much of cost difference between the two – by giving avastin, only the eye hospitals are benefited because it is shared by six patients each one is charged 10000 INR, thus total recovery for the hospital is 60000 INR.for avastine.
    Sir, kindly suggest whether I should go for Avastine or Lucentis (from the articles i could understand that both has the same effect). I am 62 year old and as such my right has cataract which has to be operated after the mucular odema is treated. Your earliest reply will help me immensely in deciding the further treatment.
    With kind regards
    Raghunath

  • Alyce September 1, 2011 at 2:43 pm

    Do you know of any cases where avastin caused an infection and subsequent retinal detachment?

    • Randall V. Wong, M.D. September 4, 2011 at 9:29 pm

      Dear Alyce,

      No, I have not. It could happen, but I am not aware of any.

      Stay tuned this week for my post about Avastin and infection.

      You might consider subscribing to get emails about my new posts….so you don’t miss anything. This may be a hot topic for awhile.

      Thanks for asking.

      r

  • kelly May 5, 2012 at 1:41 pm

    My brother has been diagnosed with Macular Degeneration and, tho I have not talked to him, I am told it is the worst kind – I am assuming “wet.” He is told he is going to get injections into the eyes, which doesn’t huts, but “flushing” afterwards can be painful. These injections are given monthly and he can not drive. These injections are also very expensive and aren’t covered by insurance. Do you know if there are any grants or discounts? He is retired and on a fixed income. The doctor did tell him that he will probably be blind in 5 years. I guess I am having a hard time understanding, and accepting, this but I do want to help. Any suggestions???

    • Randall V. Wong, M.D. May 13, 2012 at 3:22 pm

      Dear Kelly,

      What a dreadful situation! I think your brother needs to talk to someone else.

      1. He won’t be blind, per se. We ARMD affects central vision.
      2. Injections are absolutely covered by insurance.

      Encourage him to find someone who can better explain his situation in a way that your brother understands. Something is amiss.

      r

  • Vinayak R Chavan March 13, 2013 at 8:00 am

    Dear Randy,
    My Mother has got CNVM and doctor suggested for injection with 2 options.
    1) Avastin Inj which would cost Rs.15,000/- (INR) approx USD $278 for single Dosage a Month.
    2) Lucentis Inj which would cost Rs. 50,000/- (INR) approx USD $920 for single Dosage a Month.

    According to the studies and practicability what do you suggest i should go for her treatment. Financially, not strong but for Mom i will do what it need to make her feel better.

    Please suggest

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