Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Arthropathic Psoriasis. 
Treatment: Humira 40mg, Pre-service. 

The insurer denied the Humira 40mg. 
The denial is overturned. 

This patient is a male with history of psoriatic arthritis.  He was diagnosed and has previously tried and failed conventional disease modifying anti-rheumatic drug (DMARD) methotrexate and biologic DMARD (disease modifying anti-rheumatic drug) Humira 40mg subcutaneous injection every 2 weeks.  He was started on Humira but only had a partial response.  The patient was increased to weekly Humira over the last year and has been in remission on this dosing.  Humira was initially denied due to policy not allowing coverage of Humira if the prescribed dosing frequency exceeds the Food and Drug Administration's (FDA's) recommended dosing frequency for the patient's diagnosis and if it is not known if the patient has any risk factors for tuberculosis or if the patient has been tested for tuberculosis within the previous 12 months.  The reason the physician is appealing the decision is because the patient has a negative tuberculosis test and the patient has been taking Humira weekly for the last year with good clinical remission. 

The proposed treatment is medically necessary. 

Humira was initially denied due to policy not allowing coverage of Humira if the prescribed dosing frequency exceeds the Food and Drug Administration's (FDA's) recommended dosing frequency for the patient's diagnosis and if it is not known if the patient has any risk factors for tuberculosis or if the patient has been tested for tuberculosis within the previous 12 months.  The patient has a history of psoriatic arthritis. The patient was diagnosed approximately two years ago. The patient was started on Humira but the medication was not effective enough so the patient was increased to weekly Humira last year and since then has overall been doing very well. There have been  studies indicating that weekly Humira is safe without an increased risk of side effects. The Food and Drug Administration (FDA) has approved weekly Humira dosing escalation in those with incomplete response to every other week dosing in rheumatoid arthritis. While weekly dosing has not yet been approved by the FDA for the treatment of psoriatic arthritis, there have been studies in which they have shown that patients can have improvement in symptoms when the dose is increased to weekly Humira. This patient has personally demonstrated an improvement in patient's symptoms with Humira weekly dosing.  While many of these studies do not analyze for statistically significant differences between every other week and every week dosing of Humira, they do find that both treatment options are a viable treatment option. This patient has personally demonstrated that every other week dosing is not efficacious enough however weekly dosing is efficacious for this patient. Requiring the patient to try an alternative treatment option at this time may cause worsening flaring of the patient's disease leading to potential disability.  Clinical studies do show that non-medical switching was more often associated with negative or neutral effects than positive effects on an array of important outcomes. Among patients with stable/well controlled disease, non-medical switching was associated with mostly negative effects.   The patient has a negative tuberculosis test.  Therefore the proposed treatment is medically necessary. 

The best interest of this patient is to continue on the treatment plan in which he is overall doing clinically well.  This would be to allow him to continue on weekly Humira in which he has clinically been doing well.