Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Relapsing Polychondritis and Inflammatory Arthritis.
Treatment: Resuvo, Pre-service.
The insurer denied the Resuvo, Pre-service.
The denial is overturned.

This patient is a female with history of relapsing polychondritis with inflammatory polyarthropathy.  The patient was started on methotrexate several years ago.  Initially, the patient was started on oral methotrexate but recently has developed symptoms of acid reflux necessitating is switch to injectable methotrexate.  Due to inflammatory polyarthropathy affecting pain, swelling and stiffness within her hands the provider feels that the patient would be unable to use generic injectable methotrexate.  

The request for Rasuvo was initially denied due to the patient not having a diagnosis of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis or psoriasis.  The reason the provider is appealing the determination is because the patient overall is doing well with methotrexate but having side effects to the oral formulation and is unable to do generic injectable methotrexate.

Yes, the proposed treatment with Resuvo is medically necessary.
Relapsing polychondritis is an immune-mediated condition associated with inflammation in cartilaginous structures and other tissues throughout the body, particularly the ears, nose, eyes, joints, and respiratory tract. The clinical features and course of relapsing polychondritis vary considerably from patient to patient. No known clinical or laboratory measures predict the expression of specific disease manifestations or the overall disease course.  

The relative rarity of relapsing polychondritis has prevented the systematic evaluation of potential drug therapies for their efficacy and safety in randomized trials. Thus, the approach to pharmacologic therapy is largely based upon observations in case series, multiple case reports, and clinical experience.  Initial treatments are typically glucocorticoids, dapsone and methotrexate.	This patient was started on methotrexate and clinically has responded well.  More recently, the patient is having more gastrointestinal side effects which can be a common side effect to oral methotrexate.  Studies have shown that the bioavailability can vary up to 30% with oral methotrexate and some experts do recommend injectable methotrexate over oral if patient can tolerate it.  There is also less documented side effects from injectable methotrexate versus oral methotrexate.  This patient has not previously tried and failed generic injectable methotrexate.  Given that this requires the drawing up of the medication from a small vial with a small syringe, it does require an amount of dexterity and sometimes those with significant inflammatory arthritis have difficulties performing this task.  The provider has commented that she feels the patient would be unable to correctly perform a self-injection with generic injectable methotrexate vial and syringe.  Rasuvo is methotrexate in a prefilled pen device.  It does not require any drawing up of the medication.  There is less risk of medication error with a prefilled device pen.  Therefore, at this time the proposed treatment is found to be medically necessary.

No, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient.
As mentioned above, methotrexate is commonly used in medical literature for the treatment of inflammatory polyarthropathy related to relapsing polychondritis.  The patient has tried and failed oral methotrexate.  The patient is unable to use generic injectable methotrexate due to concern for dexterity.  Therefore, an appropriate option for the patient would be Rasuvo.