Diagnosis: Nephrotoxicity
Treatment: Envarsus XR (extended release) 1 MG (milligram)
The insurer denied coverage for Envarsus XR 1 MG.
The denial is overturned.

The patient is an adult female who has received a heart and lung transplant. Other past medical history includes congestive heart failure (CHF), Amyloidosis, myocardial infarction, hypothyroidism, pulmonary hypertension, status post Tracheostomy and chronic kidney disease (Creatinine clearance 15 -29).

As per her physician's note, the patient's medical course was complicated by Tacrolimus induced Nephrotoxicity. Her doctor has requested Envarsus XR (extended release) 4 mg (milligrams) and 1 mg tablets.

Given the information that this patient suffered from Tacrolimus induced nephrotoxicity - acute kidney injury (AKI) during hospitalization and also has residual chronic kidney disease (CKD) Stage IV with impaired renal function (with Creatinine Clearance of 15-29), it was safer to prescribe the extended release form of the drug.

This patient has had prolonged use of Tacrolimus and prolonged exposure to high doses of Tacrolimus require further higher doses to maintain appropriate therapeutic levels. Envarsus XR has a narrow therapeutic index. Hence the drug on the formulary Tacrolimus is likely to cause further adverse reactions in this patient.

The extended release form of the drug which is Envarsus has a higher bio availability and lower peak concentrations and has a longer time to maximum concentration compared to the immediate release form.

This may be beneficial especially in a patient like this one who already had suffered from Tacrolimus induced AKI and now has Stage IV CKD.

Based on the above, Envarsus XR should be approved for this patient.

The formulary drugs are expected to cause adverse effects.

The formulary drugs were tried and the patient did have an adverse reaction or contraindication.

The formulary drug is not expected to be effective.

The non-formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a formulary exception for Envarsus XR 1 mg tablet is overturned.