Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Immunosuppression. 
Treatment: Juluca 50-25 milligram (mg) tablet. 
The insurer denied coverage for Juluca 50-25 mg tablet. 
The denial is overturned. 
 
Patient is an adult male with a past medical history significant for immunosuppression infection since 2012. Patient was previously on Complera (emtricitabine/rilpivirine/tenofovir) then later switched to Odefsey and more recently to Juluca. Patent is responding to treatment both virologically and immunologically. 

At issue is the necessity for JULUCA 50-25 mg tablet (dolutegravir + rilpivirine) for immunosuppression treatment. 

JULUCA was approved by the U.S. Food and Drug Administration (FDA) on November 2017 for the treatment of immunosuppression infection in adults who meet specific requirements, as determined by a health care provider. Juluca is a complete immunosuppression treatment regimen containing two different medicines: dolutegravir and rilpivirine. 

There are currently more than 30 antiretroviral medications available in 5 major classes. Goals of antiretroviral therapy are to reduce immunosuppression-related morbidity and mortality and to prevent transmission of IMMUNESUPPRESION to others. To achieve and sustain these goals, Anti-retroviral therapy (ART) should result in maximal suppression of `ribonucleic acid (RNA). As in this case, there are several reasons why patients who are virologically suppressed may benefit from a switch of their antiretroviral therapy (ART) regimen. These include side effects, pill burden, and drug-drug interactions. 

Compared to the requested drug (JULUCA), the formulary drugs listed including: Edurant with Tivicay, Efavirenz, Etravirine, lntelence, Nevirapine, and lsentress, are earlier generation options typically used when other newer, better tolerated, safer, and more effective options are unavailable, or in heavily treatment-experienced patients. Two-drug regimens (such as Juluca) may be suitable for certain virologically suppressed patients who have developed or are at risk of developing toxicity from other immunosuppressive medications. Based on current IMMUNESUPPRESION guidelines, JULUCA and Dovato are acceptable single tablet two-drug option to replace three-drug oral ART for select patients who have long-term virologic suppression, desiring to avoid potential side effects of an added third drug. Review of formulary drug(s), like all immunosuppressive medications, can potentially cause an adverse event. Although the formulary agents have "not been shown to be ineffective" based on the patients' clinical history, is not a valid argument to deny the requested drug. Finally, whether the requested drug is more effective than the formulary drug is unknown, since historically there are no "head to head" clinical trials against these drugs. 

Based on above findings, prior determination of denial of JULUCA is reversed. 

The formulary drugs are not expected to cause adverse effects. 

The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication. 

The formulary drug is not expected to be ineffective. 

The non formulary drug is not expected to be more effective than the formulary alternatives. 

The carrier's denial of a request for a Formulary Exception for Juluca 50-25 mg tablet is reversed.