Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: AIDS/HIV
Treatment: Juluca
The health plan denied: Juluca
The determination is: Upheld

The patient is a female with human immunodeficiency virus (HIV), aortic dissection and repair, automatic implantable cardioverter defibrillator (AICD), treated Hepatitis C with sustained virologic response (SVR), and chronic kidney disease (CKD). She was treated with Atripla and did well. She was then changed to Odefsy (the reason for the change was not stated). She had increasing serum creatinine on Odefsy and was changed to Juluca.
She had an HIV follow-up visit. She was noted to have had a recent renal ultrasound (US) due to worsening renal function and glomerular filtration rate (GFR), which showed atrophic left kidney due to atretic left renal artery arising from false lumen, but it was noted as stable. Labs from the prior year showed HIV viral load (VL) not detected, her CD4 T lymphocyte was 654/36 percent (%), and the creatinine was 2.5 with an estimated glomerular filtration rate (eGFR) of 21. The creatinine was noted to be slightly higher than the previous lab. Repeat labs were ordered at this visit. The labs showed her creatinine was 2.93 with an eGFR of 17. These labs were repeated again two weeks later and showed a creatinine of 2.8 with an eGFR of 18.
The patient's physician requested Juluca 50-25 milligrams (mg), a non-formulary antiretroviral, and the request was denied by the health plan, which stipulates the medication will be approved if the following criteria are met:
	Member has tried and failed the individual components AND
	Is unable to take the separate individual components due to an adverse event (rash, nausea, vomiting, anaphylaxis) that is thought to be due to an inactive ingredient.
The individual components of the drug are on formulary, and the records provided did not indicate that member had adverse reaction to an inactive ingredient when the separate individual drugs were used. Formulary alternatives include Edurant with Tivicay, Efavirenz, Etravirine, Intelence, Nevirapine, and Isentress.
At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug (Juluca), or would have adverse effects.
The health plan's determination is upheld in whole.
Based on the provided documentation, there is no indication that this member has tried and failed, or has adverse reaction to, the individual components of the requested non-formulary drug, Juluca. Both Edurant (Rilpivirine) and Tivicay (Dolutegravir) are formulary. The patient has been on Odefsy (Emtricitabine, Rilpivirine and tenofovir -alafenamide) but has had worsening renal function on that drug, most likely due to the tenofovir-alafenamide component, and this component not recommended for patients with creatinine clearance (CrCl) less than 30.
While rilpivirine and dolutegravir can cause a small increase in serum creatinine levels due to the effect on tubular creatinine transport, they have not been shown to have any renal toxicity.
There is nothing in the documentation provided to indicate that the formulary drugs have been or will be less effective than the non-formulary drug, or would have adverse effects.