This week, we developed the (hopefully) final game plan for seeking funding to cover a pair of new Rituxan infusions. After five years, my remission outlived the clinical trial, so we have new avenues to pursue to pay for this round of infusions.
My checking account doesn’t have the five-digits extra Rituxan will cost, and the medicine will clearly exceed the balance in meager medical savings! So, while riding out the lupus storm with some bursts of temporary steroids, we have a plan.
Here’s the three step process to seek funding for lupus Rituxan infusions:
- Rheumatologist’s written request for coverage for 2 – 1000 mg Rituxan infusions, 14 days apart to my insurance company, acting as third-party administrator for my self-insured government employer.Denial is anticipated due to verbal statements from them that “Rituxan is not FDA-approved for lupus.” Nothing is, since there has been no new FDA approved drug for lupus in over 50 years. Everything for lupus is pretty much off-label.
- After denial, written formal appeal to insurance company, followed by conversations between the insurance company approval physician and my rheumatologist.
- If insurance appeal is unsuccessful, application to drug company’s program to evaluate financial criteria for them to pay for the cost of the medication. While previously advised a few months ago that we made $600 too much (due to my husband’s recent overtime,) the drug company advised my rheumatologist they would consider our taxable vs. adjusted gross income, which should put us well into the approval income bracket.If drug company agrees to pay the cost of the medication, my insurance company will be asked to pay for the costs of the infusion procedures. They were agreeable to do that during the clinical trial 5 years ago, and are expected to do so again, if needed.
If all of the outlined approaches for obtaining funding for my lupus Rituxan infusions are unsuccessful, we will have to seek a new direction. This, too, is an adventure!
All too cognizant that there have been two deaths in lupus patients from progressive multifocal leukoencephalopathy (PML) , a usually fatal viral brain infection, since my Rituxan infusions five years ago, I am still willing to view the amazing remitting benefits of Rituxan received last time as outweighing the risks of my lupus progressing again into being uncontrolled without it. PML does give me some concerns.
PML has also occured in many cancer patients taking Rituxan, but the numbers of these patients is vastly greater than lupus patients. PML has also occurred in lupus and cancer patients not taking Rituxan. Only hundreds of lupus patients have used Rituxan, so there is some concern, and a temptation to have a little fear.
Information about any patients with RA, for which it is FDA approved, are unclear based on what I have been able to read. Genentech warns the physicians and patients about this, and some other risks before they take Rituxan.
Genetech’s statement in the full prescribing information they provide to physicians includes this information:
5.4 Progressive Multifocal Leukoencephalopathy (PML) JC virus infection resulting in PML and death can occur in Rituxan-treated patients with hematologic malignancies or with autoimmune diseases. The majority of patients with hematologic malignancies diagnosed with PML received Rituxan in combination with chemotherapy or as part of a hematopoietic stem cell transplant. The patients with autoimmune diseases had prior or concurrent immunosuppressive therapy. Most cases of PML were diagnosed within 12 months of their last infusion of Rituxan. Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Discontinue Rituxan and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML. [See Boxed Warning, Adverse Reactions (6.4).]
See, http://www.gene.com/gene/products/information/pdf/rituxan-prescribing.pdf , p. 5, ls. 130-140.
If all available avenues for Rituxan funding are exausted without success, this girl will be very willing to look at new options and a different game plan.
Perhaps we could look at failure to get funding as a success in determining I shouldn’t take it again.
Strong belief that God leads and directs in very important (and in the not so important) life decisions is part of my daily perspectives. Setbacks can indeed be critical steps in a new direction, and that is ever on my mind with my lupus. I don’t know what is ahead and best, but God does.
Knowing ultimately what is best for my medical situation is at best a guessing game. The educated guessing of my doctor is clearly filled with great treatment knowledge, experience and his wisdom as a rheumatologist, and requires me to have great faith in him and faith and hope God.
I choose faith, hope and prayer!
I am excited about the outcome of this chapter in my life and lupus adventure, and hopeful for some soon relief to my increasing lupus symptoms. The fourth step in the Rituxan approval process is prayer, and that is for me and those who love and care about me to do.
My guiding personal life philosophy comes from a statement made by a Hebrew prophet of God in the Bible, “the joy of the Lord is my strength.” (Neh. 8:10)