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What’s the problem?

We have a real problem in health care today. Patients are increasingly seeing denials of care and having to fight with insurance companies to get what their doctors are ordering, both in tests and treatments. There have even been situations in the news that show that insurance companies are negligent in administering policies. [1]

The Inflammatory Myopathies (dermatomyositis, polymyositis, inclusion body myositis, orbital myositis, and necrotizing autoimmune myopathy) are considered Rare Diseases. [2] One of the unfortunate features of a rare or orphan disease is a lack of FDA-approved treatments; in fact, the only FDA-approved therapies for Myositis are corticosteroids and related medications. [3]

Myositis patients often face adversity in many areas of their lives in addition to the typical chronic illness challenges of finding accurate and timely diagnoses. They face the arduous tasks of finding medications that work, dealing with the pain, fatigue, weakness, weight fluctuations, required adaptations to homes, tough choices about possible career changes, the revolving doors of medical appointments, tests, and procedures, relationship difficulties, and so many other obstacles that even friends and family aren’t always aware of. Being sick can feel like a lonely, horrible, underpaid full-time job; with a terrible boss, no recognition, and no benefits. In the middle of all of these unwanted tasks, is a hidden additional chore some patients wrangle with…fighting with insurance companies to get their medications approved.

Often, rare diseases don’t have a large cohort of patients. In fact, there are only approximately 50,000-75,000 myositis patients in the United States. The FDA drug approval process is long, difficult, and very expensive. [4] Unfortunately, when you are dealing with a disease with such a relatively low number of patients it likely doesn’t seem as financially beneficial to drug companies to study medications for myositis as it would for a disease with higher numbers. As a consequence, many of the medications myositis specialists (rheumatologists, neurologists, and dermatologists) prescribe are drugs made for, and have only received FDA-approval for, other diseases. This is commonly referred to “Off-label use.” [5]

Dr. Lisa Christopher-Stine, the Director of Johns-Hopkins Myositis Clinic, along with Dr. Jemima Albayda, explain the use of non-approved drugs: “Treatment has largely been off-label based on clinical expertise and experiential reports. Traditional first-line medications remain to be corticosteroids, with second-line agents employed as steroid-sparing or due to a lack of durable effect. These second-line immunosuppressants include azathioprine, methotrexate, mycophenolate mofetil, leflunomide, cyclophosphamide, tacrolimus, cyclosporine, tumor necrosis factor (TNF) inhibitors, and intravenous immunoglobulin (IVIG).” [6]

The problem is, that some insurance companies, due to the rarity of myositis, do not appear to always understand that medications which are not FDA-approved are routinely prescribed for myositis. In fact, they have been clinically proven to work for myositis and are actually preferred over long-term steroid use; the problem is just that the studies that would give enough evidence for FDA-approval are not widely available: “…the treatment of inflammatory myopathies to date has been complicated by the rarity of the disease and the paucity of large randomized clinical trials.” [7]

Consequently, insurance companies are known to deny medications for being “out of contract” due to not being FDA-approved!

What to do?

Well, here is where patients can start to experience an enormous amount of stress. The implications of insurance companies applying a clause in an insurance contract, in which they enforce the FDA-approval requirement on patients with a rare disease when the majority of medications for the disease are not FDA-approved can be quite frightening.

But we want you to know that you have the right to fight. You have the right to argue. Your doctor should be advocating alongside you.

The following is a personal account of how one patient fought the insurance company trying to deny a medication.


In eight years with this plan, through my spouse’s employer, we’ve never had a problem with the insurance company denying any of my medications, even IVIG which was well over $10,000/month. To be clear, this has included FDA-approved corticosteroids and additionally, many of the other medications Dr. Lisa Christopher-Stine mentioned in the passage above, none of which are FDA-Approved for my Dermatomyositis (DM). In the past, they have asked for documentation on some of the drugs’ usage in DM, but in the end, everything my doctor has prescribed has been covered. My methotrexate has been working fairly well on my muscles, but my skin is completely non-responsive. A year ago, we tried Plaquenil, and I had a bad reaction. This February, my doctor decided to try Quinacrine, a very old medication which is no longer manufactured, but widely accepted to be used in DM for refractory skin presentation. Since it is a “formulary” drug, meaning it has to be mixed by a specialty pharmacy at the time of purchase, it also has to be pre-approved under my policy, rather than just filled and submitted for payment.

It was promptly denied as being “out of contract” for not being approved by the FDA for Dermatomyositis.

I called the insurance company and my doctor’s office to gather as much information as possible. I was told that it was denied purely because of the lack of FDA-approval for my disease. The more my husband and I discussed this, the more we got concerned. If the insurance company has decided to start enforcing the FDA-approval clause in our policy, what does that mean for my other medications for DM? It would seem, looking at it from an outsider standpoint, that if they denied Quinacrine for being off-label, they may start denying all off-label immune suppressants. This is no small fear, my insurance company beginning to deny my immune suppressants would be catastrophic for my health.

I, again, called the insurance company to ask if this was a new application of the policy, if they had an increased stricter enforcement of the policy, or if it just occurred because it was a formulary drug needing pre-approval. I was unable to get a clear answer. I had them escalate my concern to a pharmacy supervisor and was told it was not a new or stricter enforcement of the policy, it had been applied all along (even though I had never had a drug denied for this reason). I explained in very clear and explicit terms about DM being a rare/orphan disease, that there are no FDA-approved drugs other than steroids, and that all of the other meds (aside from steroids) they have given me for DM over the past eight years have been off-label use. I was told that they could not predict if my other medications would be denied until I tried to re-fill them, and they weren’t paid. WHAT KIND OF ANSWER IS THAT?

Myositis patients, donate plasma

Next, I asked, “Who/what kind of doctor denied my medicine and on what grounds?” I asked this knowing that my doctor, a Mayo Clinic-Trained Rheumatologist, would have submitted everything needed to verify both my need for the medication and also its effectiveness and routine use in DM. They claimed there wasn’t enough evidence to support its use, and it was reviewed first by a pharmacist and in the first appeal by a medical doctor. My answer was to explain that even I know how to find the studies online to explain the off-label use of quinacrine, and I’m not medical. Surely, as medical professionals they should know how to read and interpret the documentation supplied by my doctor and/or search for the substantiation for off-label use in DM themselves. It turns out that their clinical pharmacist didn’t agree with the data my doctor submitted. I was left with the option to appeal again and ask for a peer-to-peer review. It would be at that time that my doctor could explain to their doctor all I had explained on the phone. I lamented that it should be incumbent on a clinical pharmacist, and the subsequent doctor who had also reviewed my file to know about my disease before making these decisions, and if they don’t know the answers, to do research to get up-to-speed. She said, “no, that’s your doctor’s job to tell them.” I said, “well I am PRETTY SURE he did in the information he submitted.”

All along I was in contact with my doctor’s office. They were steadily supplying information to the insurance company, and at some point, in the next stage of the appeal, were told that I was not, in fact, allowed to have a peer-to-peer review, which was in direct contradiction with what I was told on the phone.

In the meantime, I had called my husband’s Human Resources’ Benefits department. I told them the entire situation and asked if they could do anything to clarify/intervene on my behalf as any attempt to refuse to cover medications based on their being off-label use would be extremely dangerous, and certainly seemed to be outside of the intent and tenor of having an employer-provided healthcare policy.

So, now, between his employer, my doctor’s office, and me, we were each checking in on the status. I received a letter stating the date of my “Second Level Grievance Panel Appeal” but interestingly, it stated very plainly that they would not be considering if the medication was medically necessary, only if they had administered the policy correctly. Of note, they failed to notify my doctor of this date. Also, simultaneously, the doctor’s office was told they were not allowed to request a peer-to-peer review and my husband’s employer was informed that the insurance company had already conducted a peer-to-peer review with a certain date and name of the person from my doctor’s office (the pharmacist in my rheumatologist’s office, but not my doctor). I put all of this information together, sent it to my doctor’s office, and his pharmacist called the insurance company to ask them to prove to her they spoke with her on the specified day (because she had not), also to ask them why they had failed to inform my doctor of the appeal meeting, so his office could represent me.

Miraculously, the next day, we received a phone call that another clinical director, a doctor of family medicine, re-reviewed my case (rather than a pharmacist earlier in the process) and deemed my quinacrine medically necessary for my DM. They canceled my “appeal” and approved the medication. It’s unclear if they resubmitted it to the medical director, an actual physician instead of a pharmacist, because we caught them in multiple untruths…or if they finally looked at the record and realized they had messed up. But the bottom line is, that if it were not for me staying on top of all of the communications, seeing the discrepancies, and continuing to point each of the emails back and forth between all of my advocates; plus having such a proactive doctor’s office who held them accountable; I would not have had this outcome.


Being sick can feel like a lonely, horrible, underpaid full-time job; with a terrible boss, no recognition, and no benefits. In the middle of all of these unwanted tasks, is a hidden additional chore some patients wrangle with…fighting with insurance companies to get their medications approved.

We present this long story to you because we want you to know one way a patient fought back, in a long and very stressful, three-month process and won, getting approval for the medicine she needed.

Not every situation will go like this; and unfortunately, not every appeal will end favorably. But we want you to know that you have the right to fight. You have the right to argue. Your doctor should be advocating alongside you. If your insurance policy is through an employer, you can ask the benefits department to help you. Also, if you feel you are too tired of fighting, you can always give permission for a friend or family member to call and help you talk to the insurance company and fight for your treatments.


[1]https://edition.cnn.com/2018/02/11/health/aetna-california-investigation/index.html (Please note, the situation discussed in the current article does not involve Aetna.)

[2] https://rarediseases.org/rare-diseases/dermatomyositis/
https://rarediseases.org/rare-diseases/polymyositis/
https://rarediseases.org/rare-diseases/sporadic-inclusion-body-myositis/

[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5440004/
https://www.myositis.org/about-myositis/treatment-disease-management/medications/corticosteroids/
https://www.dermatologytimes.com/dermatology/dermatomyositis-requires-second-line-treatment

[4] https://www.fda.gov/drugs/development-approval-process-drugs

[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/

[6] Albayda, Jemima and Lisa Christopher-Stine, Novel approaches in the treatment of myositis and myopathies, Therapeutic Advances in Musculoskeletal Disease (prvided to NIH website by SAGE Publications). 2012 Oct; 4(5): 369–377. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3458613/ On May 12, 2019

[7] Ibid.


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Myositis Support

Myositis Support and Understanding Association (MSU) is a patient-led, patient-centered, all-volunteer 501(c)(3) nonprofit organization Empowering the Myositis Community! MSU was founded by myositis patients for myositis patients and caregivers and offers education, various support options, advocacy, clinical trial matching, financial assistance, and access to research. Visit our comprehensive myositis website at Understandingmyositis.org.

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