United Healthcare: Please Don't Jeopardize Patient Health. Stop Non-Medical Switching.

United Healthcare: Please Don't Jeopardize Patient Health. Stop Non-Medical Switching.

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Carol Lee Dunn started this petition to United Healthcare

My experience with non-medical switching:

Spondylitis is an inflammatory disease where your own immune system attacks your spine as well as other joints and systems of the body. I found out just two days before my scheduled infusion that my insurance company was refusing coverage of the medication that has kept my disease stable for over 10 years. Their new policy is that I must try and fail treatment with a biosimilar for at least 14 weeks before they will allow coverage of the medication my doctor originally prescribed. My doctor once explained to me that when treatment with a biological medication is started and is successful, they do not change to another medication unless it is a last resort because doing so can trigger immunogenicity (provocation of a severe immune response). The development of biosimilar medications is overall a positive for this field of medicine. However, if needless switching from the originator drug to its biosimilar triggers a severe enough allergic reaction, I can then also be allergic to the originator, removing one of the few treatment options available. So even though their policy states they will allow me to resume treatment of my original medication, they are ignoring the fact that an allergic reaction to the biosimilar would negate this possibility. My physician has begun the appeals process and I have already received numerous denials. I am currently 7 weeks without my treatments.

I wrote the following letter to United Healthcare to explain my situation and advocate for my treatment:

July 13, 2021

 

United Healthcare

Appeals Department

P.O. Box 30432

Salt Lake City, UT  84130-0432

 

To Whom It May Concern:

Today, it took me 30 minutes to get out of bed. 30 minutes of pushing through muscle spasms just to get to my feet. That’s not so bad. Before Remicade, it could take an hour or longer. The spasms could become so intense that all the core muscles would become involved. The pain of my muscles clenching down on the nerves of my spine was searing. I would have to wait for each spasm to ease up so that I could get just a small, struggled breath of air. I’d keep thinking to myself, “Relax the muscles. If you want to breathe, you have to relax.” Sometimes the muscles would stay contracted for so long, I wondered if I would suffocate. Would my body’s misguided attempt to protect my spine override my need for oxygen? I would tell myself that if I passed out, the muscles probably wouldn’t keep spasming and then I would breathe. I told myself that many times, never really knowing if it were true or not. I know it’s only a matter of time before it gets that bad again. Today, I am loading my dishwasher from my knees so that I can keep my spine straight and not trigger more spasms. When I use the bathroom, I walk to the kitchen sink to wash my hands because the faucet is closer. You know that little forward lean you do to reach the water of your bathroom sink? It’s such a small movement that you probably don’t even realize you do it. For me, it can be excruciating, even when it doesn’t trigger spasms. I fight to take full breaths of air so that my ribcage won’t become constricted, even though sometimes that triggers more spasms. My ribs are so sore from the muscles spasming throughout the day. The joints where my ribs connect to my spine and sternum ache. My shoulders ache. That’s a new one for me but a known joint that Spondylitis can affect. Apparently, my disease is progressing while I wait for this appeals process. I know that I could make this all go away if I just took the biosimilar. So why don’t I? Because there are only a handful of medications to treat this condition and not every medication works for every patient. You know that if the biosimilar triggers a significant enough allergic reaction, I will then likely be allergic to the medication that has kept me stable for over 10 years. Patients who rely on biologics face the reality that at any time their medication can just stop working or they can develop an allergy to it and have to move on to the next medication. The limited options we have are precious and have to last us to end of life. I endure this today because I don’t want to be 60 or 70 years old without any treatment options left. I rely heavily on the strength of my leg and arm muscles to get me through this. What will I do when my muscles are not so strong anymore? What will I do when I can no longer rely on my knees? How will I get out of bed? No one can help me. No one can touch me. The lightest touch triggers more spasms. What will I do then?

Spondylitis is a disease that eludes many doctors. The average time from onset to diagnosis is seven years. For some of us it is much longer. By the time I found the doctor who diagnosed me, he told me I was one of the worst cases he had seen. He told me my ribcage was so constricted with inflammation that I was barely breathing and it was a wonder that I didn’t have pneumonia. When I went in for my first infusion, after trying to sit in a chair for the roughly 3 hour duration, I went into muscle spasms almost as bad as what I described above. My doctor’s staff went into a panic. They had never seen anything like this and they thought I was having an allergic reaction to the infusion. The muscle spasms were putting pressure on my diaphragm so I could not even talk to tell them that I was going to be ok. My doctor entered the room and assured his staff that it was ok and that I was used to this. Then when the spasms calmed down he said to me, “How have you endured this all this time?” Have you ever had a doctor ask you how you have endured something? Doctors see it all. They see all manner of nightmares. But he asked ME how have I endured. Your policy is that I am no longer allowed to have the drug that has kept me stable for over a decade until I have tried and failed treatment with a biosimilar for at least 14 weeks. You know that treatment with biological medicines is a very delicate situation. You know that forcing me to switch from my medication to a biosimilar can cause an allergic reaction and if it is significant enough, I will then likely be allergic to the originator medication. You have been informed that I have already had one allergic reaction to my medication. As stringent as the manufacture process of biologics is, it is impossible to create exact duplicates so they create as close to duplicate as they can. The fact that I got a batch of my own medication that triggered an allergic reaction shows how sensitive my immune system is and shows that I am a good candidate for having an allergic reaction to the biosimilar. Spondylitis is a horrific disease with only a few treatment options. Jeopardizing one of those options in any patient but especially a patient whose disease has progressed to the degree that mine has, is unethical. This lengthy appeals process is cruel. Please do not jeopardize my health. Please allow me to stay on my current treatment.

Sincerely,

Carol Lee Dunn

You can help right now by signing my petition to amplify my story and show the damage that non-medical switching can cause patients like me!!! Want to learn more? Please keep reading!

AMERICAN COLLEGE OF RHEUMATOLOGY POSITION STATEMENT: PATIENT ACCESS TO BIOLOGICS

“This class of drugs is complex, the rheumatic diseases are complex, and the choice of treatment may be complex. Of note, the complex medical decision making and subsequent risks associated with these medications fall on the physician and the patient. Therefore, insurance plans must leave the clinical decision making for medical necessity to the rheumatologist and rheumatology professional and should not determine the treatment of the patient, nor should they mandate use of one therapy over another based on cost alone.” “Forcing a stable patient to switch to another biologic medication for the sake of cost control needlessly disrupts continuity of care and puts patients at significant risk for loss of disease control (see Reggia et al.) and potentially life-threatening complications.” (https://www.rheumatology.org/Portals/0/Files/Patient%20Access%20to%20Biologics%20aka%20Model%20Biologics.pdf

 

STATEMENT FROM THE ALLIANCE FOR SAFE BIOLOGIC MEDICINES:

Biologics are advanced prescription medicines to treat cancer, rheumatoid arthritis, and other debilitating diseases. In March of 2010, the Affordable Care Act granted the FDA the authority to establish a pathway for the introduction of biosimilars in the U.S.       

 In contrast to most medicines that are chemically synthesized and have structures that are known, biologics are complex compounds made from living cells and have highly complex structures that are not easily understood, characterized or replicated. That is why the attempts to replicate biologics are called biosimilar and not generics. Biosimilars are “similar to” but not exact copies of biologics and small differences can have unexpected or harmful clinical outcomes for patients. The introduction of biosimilars offers great promise to patients through broader access to lifesaving medicines, however patient safety must remain paramount.   

The physician-patient relationship and decision-making process must be preserved. Insurers or other third parties must not be empowered to dictate what therapies physicians can prescribe and patients can access. Only physicians have the medical education and understanding of their patients’ individual needs necessary to safely prescribe these powerful therapies.(https://safebiologics.org/wp-content/uploads/2015/02/ASBM-Onepager-REV.pdf

 

Letter from American College of Rheumatology to United Healthcare, speaking out against non-medical switching: (https://www.rheumatology.org/Portals/0/Files/UHC-Infliximab-Coverage-Changes.pdf?ver=2021-02-09-154413-683

Letter from National Infusion Center Association to United Healthcare, speaking out against non-medical switching: (https://infusioncenter.org/wp-content/uploads/2019/10/NICA-Letter-to-UHC-NMS-FINAL.pdf

 

Non-Medical Switching Can Actually Increase Costs

American College of Rheumatology

Press Releases:  People with Rheumatoid Arthritis Who Change Anti-TNF Inhibitors for Non-Medical Reasons at Increased Risk for More Symptoms and Disease Activity (Controlled Study)

“People with well-controlled rheumatoid arthritis who change anti-TNF inhibitors due to non-medical reasons — such as increased copay, change of insurance, job loss, or other economic factors — are at a higher risk to develop increased symptoms and higher disease activity as well as an increased utilization of health care resource use, according to new research findings presented this week at the American College of Rheumatology Annual Meeting in San Francisco.” ““These real-world results suggest that switching well-controlled patients from their therapy for a cost-related reason may have a negative impact on their outcomes,” says Dr. Wolf of the findings. “We saw that non-medical switching or discontinuation was associated with significantly worse clinical outcomes and increased use of medical services; to that end, physicians may want to consider the potential negative effects of non-medical discontinuation or switching in clinical practice.”” (https://www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/713

 

ALLIANCE FOR PATIENT ACCESS

A Study of the Qualitative Impact of Non-Medical Switching

“Nearly 40 percent of (survey) patients said the new medicine was not as effective as their original, and almost 60 percent experienced a complication from the new medication. Nearly one in 10 reported being hospitalized for complications after the switch.” (https://admin.allianceforpatientaccess.org/wp-content/uploads/2020/02/AfPA_Qualitative-Impact-of-Non-Medical-Switching_Report_Feb-2019.pdf

 

US PAIN FOUNDATION, The True Costs of Non-Medical Switching

“Rheumatoid arthritis patients who incurred non-medical switching experienced the following over six months: 42% more ER visits, 12% more outpatient visits. Patients with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis or Crohn’s disease who switch treatment due to a formulary change incur 37% higher all-cause medical costs (which include hospitalizations, ER visits, and outpatient visits) and 26 percent higher total costs than patients who are not switched.” (https://uspainfoundation.org/wp-content/uploads/2016/01/costs-of-non-medical-switching-infographic.pdf

 

Additional Health Organizations Speak Out Against Non-Medical Switching

https://safebiologics.org/2020/06/biosimilar-working-group-sends-letter-to-manitoba-opposing-forced-substitution/

https://safebiologics.org/2020/05/gastroenterologists-more-evidence-needed-before-non-medical-switching-of-ibd-patients/

https://safebiologics.org/2019/09/asbm-raises-concerns-for-patients-as-bc-govt-expands-biologics-forced-switching-policy/

https://safebiologics.org/2019/06/patients-physicians-raise-concerns-with-bc-biosimilar-non-medical-switching-policy/

https://admin.allianceforpatientaccess.org/wp-content/uploads/2020/02/AfPA-Position-Statement-Non-Medical_Switching_July-2019.pdf

 

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