Another Hurdle Explained
A quick reminder: Tomorrow is the teleconference about radioimmunotherapy (see the entry on May 14). It's not too late to register by phone and this is a wonderful opportunity to learn about RIT and to ask questions of some experts.
Now, for the heart of this entry....The recent articles that we've posted about RIT (in the Journal of the National Cancer Institute, the Lymphoma Research Foundation newsletter, and the AP story) have made reference to the role that licensing requirements play in the underutilization of the treatment. That role is more significant than most of us realize and it's a big reason why 90% to 95% of the patients who might benefit from RIT aren't getting it.
Because Bexxar and Zevalin contain minute radioactive components, the drugs are regulated by the Nuclear Regulatory Commission (NRC) which requires that oncologists take 700 hours of training in order to be licensed to prescribe the drugs. That's the equivalent of 17-1/2 forty-hour work weeks, and what oncologist has that amount of time to devote to obtaining a license to prescribe any drug?
Curiously, endocrinologists, who treat patients with thyroid disease, are required to take only 80 hours of training in order to prescribe radioactive iodine in much higher doses than that which is found in Bexxar.
NRC's requirement means that few oncologists are licensed to prescribe RIT. Combined with the reimbursement issues that preclude oncologists for billing for RIT, the restrictive licensing requirement further limits patient access to the treatment - despite the fact that numerous studies have shown RIT to be the most effective single agent available.
This requirement could change. There is a petition before the Nuclear Regulatory Commission which, if approved, would reduce the training time for oncologists to prescribe RIT to that which is required for endocrinologists. It would also allow oncologists to be reimbursed for prescribing RIT. If approved, this would undoubtedly give many more patients access to this effective treatment, but until it is, patients who may be candidates for RIT will have to find oncologists who are licensed to prescribe it.
You can view the petition at http://ruleforum.llnl.gov/cgi-bin/rulemake?source=prm3519&st=petitions-a. You can also submit a comment to the NRC. To date, comments are mostly from physicians but my husband submitted a letter because we believe that it is important to let the NRC hear from patients and their families as well. We must let the NRC know that regulatory oversight must be fair and consistent so that ALL patients will have equal access to ALL treatments, old and new. The NRC has verified receipt of his letter but has not yet posted it as of the time I am writing this entry.
It is disturbing to think that patients with any illness would not be offered every available treatment option, and as patients, we shouldn't have to consider the role that reimbursement and licensing plays, yet we must recognize these influences in order to make the best decisions for ourselves.
Betsy