Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Coronary Artery Disease.

Treatment: Brilinta 90 MG (milligram) tablet.

The insurer denied coverage for Brilinta 90 MG (milligram) tablet.

The denial is upheld.

 
This is an adult male with a past medical history that includes hypertension, hyperlipidemia, and gastro-esophageal reflux disease. He has a recent diagnosis of coronary artery disease (CAD), having undergone percutaneous coronary intervention (PCI) to the right coronary artery (RCA) with a drug-eluting stent (DES), in the setting of myocardial infarction (MI).

His cardiologist noted residual 90% stenosis in the 1st diagonal branch of the left anterior descending artery, with staged intervention potentially planned upon that artery, depending on the results of a stress test. The cardiologist planned to obtain prior authorization for Brilinta. There is minimal indication of the patient's response to therapy in that note. The cardiac review of systems (ROS) refers to the HPI (history of present illness), which makes no mention of symptoms or their absence. Shortness of breath is noted in the ROS.

Clopidogrel or prasugrel (the formulary alternatives) were not likely to cause the patient an adverse reaction. There is no indication in the submitted documentation that there was a history of intolerance to either medication. The patient is listed as having no known drug allergies (NKDA) in the clinical note by Dr. Choi. In terms of possible adverse reactions, they do have the potential to cause bleeding complications as antiplatelet medications, although that risk also exists with Brilinta. However, clopidogrel does offer significant benefit after myocardial infarction (MI) with PCI, and was the standard of care for many years. Evidence is supplied below, indicating the benefit of prasugrel after MI with PCI.

Clopidogrel or prasugrel had not been ineffective based on the patient's clinical history. There is no indication in the submitted records that either medication has been tried in the past. Additionally, as noted above, there is no indication in the submitted documentation that there was a history of intolerance to either medication. 

Ticagrelor (Brilinta) is more effective than one of the formulary drugs, clopidogrel, but less effective (and potentially more dangerous) than the other formulary drug, prasugrel. Additionally, the shortness of breath that the patient noted may have been a commonly reported side effect of the Brilinta, which he had been taking since his stent was placed two months earlier. Finally, there are now data that suggest that switching to clopidogrel, from Brilinta or prasugrel at one month, may result in better outcomes.

There now exist many studies demonstrating the potential benefits from switching from ticagrelor or prasugrel to monotherapy with clopidogrel. These are not yet guideline-based recommendations (although the guidelines do recommend a change towards monotherapy). However, in the setting of dyspnea, it is reasonable to stop ticagrelor and switch to an alternative antiplatelet regimen, such as one of the formulary-based options.

For these reasons, Brilinta was not necessary for treating the patient after his MI and stent placement.

This is consistent with the documentation submitted for review. 

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 not 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 Brilinta 90 MG (milligram) tablet upheld/reversed.