U.S. Government-funded Study May Actually Save Money

The news lately is full of stories about government waste – from extravagant GSA trips to Las Vegas to the ‘Bridge to Nowhere’ to $300 hammers and $500 toilet seats.  Today’s Wall Street Journal reports on a study funded by our government that actually makes lots of sense and more than a few cents.

To understand the reason behind the study there is some history to cover.  Studies of pharmaceuticals are typically underwritten by drug companies.  They spend tons of money to develop a new medication or a new application for an existing medication.  Their incentive to study the effectiveness of this medication is the ability to promote and sell it for this purpose.  The FDA will not allow either to occur until it has passed trials that demonstrate that it is safe and effective.  Medications can be used off-label by physicians but most physicians are adverse to using off-label medications when an on-label medication is available primarily due to legal risk

The medication Avastin was accidentally discovered to be effective in treating macular degeneration.  An observant retinal specialist noticed that his patients that were taking this medication used to treat colon cancer had not only less progression of their macular degeneration but occasionally it even got better.  He started using Avastin off-label (in other words, there were no formal studies approving the use of this medication in this way) by injecting very small amounts of it directly into the eyes of his macular degeneration patients and found that it worked quite well.  The direct injection into the eye reduced the dose so much that side effects were minimal and the cost was quite low.

In 2006, Genentech, the maker of Avastin, launched Lucentis which they felt would be better for ocular use than a medication that was originally approved for cancer treatment.  Lucentis has a similar chemical structure to Avastin but is a smaller molecule that should have better availability within the retina.  Since Genentech was the manufacturer of both medications it had no incentive to do a study to prove that Lucentis was superior – it only had to prove that Lucentis was safe and effective for macular degeneration.  Once it had FDA approval for Lucentis for the treatment of wet macular degeneration it then took the step of asking the FDA to discourage the use of Avastin for macular degeneration.  In fact, it even went so far as attempting to block physicians from being able to purchase Avastin for the treatment of macular degeneration in 2007.

This left retinal surgeons in a dilemma.  Should they continue to use Avastin, which had been anecdotally proven to be safe and effective to treat macular degeneration or should they switch to Lucentis which was actually proven in a study to be safe and effective to use in the eye.  Since Avastin had not gone through a study process it was deemed experimental by insurance companies (including Medicare) so they were not interested in paying for it but Lucentis (by virtue of having the study data to back it up) was paid for by insurance companies.  If that were the end of the story it would be no dilemma at all.  Use the one that’s been officially studied and approved by the FDA as safe and effective.  Unfortunately, there is one more part of the story.  Cost.  Avastin costs about $50 per month and Lucentis costs about $2000 per month.

This brings us back to today’s article.  According to today’s Wall Street Journal, the results of the study find that “Avastin and Lucentis are roughly equal at preserving vision in elderly people” with macular degeneration.  It goes on to point out that this could save insurers (including Medicare) millions of dollars annually.  Given the 40x differential in price, the monthly doses required to be effective in treating macular degeneration, and the 200,000 Americans expected to develop macular degeneration annually the savings should be huge.

Avastin and Lucentis have been phenomenal in their abilities to limit the progression and  even potentially reverse the development of wet macular degeneration.  Thankfully now patients should have the option of choosing a less expensive alternative that appears it may be just as safe and effective.  To read more in today’s Wall Street Journal.

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