After having two infusions five years ago as part of a lupus phase III clinical trial, my lupus remained in a sustained near remission. Instead of needing more infusions every four to six months as initially expected, the first pair of were enough to last for years. My improvement was dramatic and my remission outlasted the clinical trial. Now that my lupus is acting up again, we need to find a new funding source for Rituxan.
The first stop? My insurance company. My rheumatologist has pursued insurance company approval of Rituxan infusions for my lupus, without success. For many weeks, my health insurance company continued to tell my rheumatologist “no” but would not issue a written denial letter.
Then, after many phone calls and conversations with the insurance company’s medical director, the company finally sent out a letter that said “no,” but denied that the letter was either a formal denial nor approval of coverage. After pursuing additional consideration based on medical necessity, the insurance company issued a second “denial” letter this week.
My insurance company strongly stated it would not cover Rituxan infusions for lupus, because it is considered experimental or investigational for treating lupus, and because the company has insufficient evidence to demonstrate these criteria:
- Scientifically show how Rituxan effects lupus
- Prove Rituxan improves lupus
- Prove Rituxan improves overall health more than standard lupus medications
- Support Rituxan is effective outside investigational settings
Further, my insurance company states that my policy does not cover investigational drugs, based on the company’s Medical Coverage Guidelines.
Here’s the catch and red-tape boondogle. The insurance company says we cannot appeal unless I get the infusions first. Then, after we submit a claim, they will officially deny coverage. After they deny coverage, we can then appeal their decision, but not until they issue a denial letter. Refusal to issue a pre-treatment claim denial is procedural block to our ability to appeal.
Frustrated by red tape and barriers, we continue to pray for approval of medications that will get my lupus back under control. Plaquenil and prednisone are no longer controlling the severity of my lupus, and it continues to escalate. We are reluctant to go back to using transplant and cancer chemotherapy drugs, after lupus began attacking my central nervous system and liver.
We are still determined to believe that an appropriate treatment will be available, even if that means going down a treatment path different than Rituxan. Perhaps this appeal process will end up taking longer than the pending FDA approval of Benlysta. This new biologic drug is on the verge of FDA approval for lupus, possibly as soon as March 2011. Benlysta may soon be available to help me and other lupus patients who have exhausted most of their other treatment options.
Somehow, the words of a foremost lupus expert seem appropriate to my situation:
“Remember, human beings are not ultimately in charge. As we struggle with our day to day lives, we always ask a higher power for help, too. Medicine isn’t going to do it all. But, some day, there is going to be a cure for lupus.”
Michelle Petri, M.D., M.P.H., Johns Hopkins Arthritis Center. See, http://www.hopkins-arthritis.org/arthritis-info/lupus/#treatment.