Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Talicia. 
The denial was overturned. 

This is a  male patient recommended for Talicia (omeprazole magnesium, amoxicillin and rifabutin delayed-release capsules) to treat Helicobacter (H.) Pylori infection. This patient has a H. pylori infection. He was treated with Prevpac (Lansoprazole + clarithromycin + amoxicillin) but has a persistent H. pylori infection as documented on a breath test. Therefore, the attending provider would like to use Talicia to treat his H. pylori infection.
At issue is whether the non-formulary drug would not be as effective as the non-formulary drug.

The health plan's determination is overturned in whole.

The formulary drug will not be as effective as the non-formulary drug.
The formulary alternative is also clarithromycin and amoxicillin with a proton pump inhibitor (PPI), which the patient has already tried and failed.
Helicobacter pylori (H. pylori) infection is a common worldwide infection that is an important cause of peptic ulcer disease. Additionally, the World Health Organization lists H. Pylori as a Class 1 Carcinogen. H. pylori infection is a major cause of gastric (stomach) cancer, specifically non-cardia gastric cancer (cancer in all areas of the stomach, except for the top portion near where it joins the esophagus). H. pylori infection also causes gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Therefore, H. Pylori needs to be eradicated when diagnosed. H. pylori may also have a role in un-investigated and functional dyspepsia, ulcer risk in patients taking low-dose aspirin or starting therapy with a non-steroidal anti-inflammatory medication, unexplained iron deficiency anemia, and idiopathic thrombocytopenic purpura. Prior antibiotic exposure and resistance patterns of H. pylori bacteria are key determinants in choosing the appropriate regimen to treat H. Pylori infection. Clarithromycin based triple therapy should be used only in patients with no previous history of macrolide exposure who reside in areas where clarithromycin resistance amongst H. pylori isolates is known to be low. According to current guidelines, most patients will be better served by first-line treatment with bismuth quadruple therapy or concomitant therapy consisting of a PPI, clarithromycin, amoxicillin, and metronidazole. When first-line therapy fails, a salvage regimen should avoid antibiotics that were previously used. Quadruple therapy should be considered for first-line treatment in view of the rising prevalence of clarithromycin-resistant H. pylori, especially since quadruple therapy provides superior eradication with similar safety and tolerability to standard therapy.
Talicia (omeprazole magnesium, amoxicillin and rifabutin) is the first and only United States Food and Drug Administration (FDA) approved rifabutin-based H. pylori therapy and is designed to address the high and growing bacterial resistance and diminished efficacy of clarithromycin-based standard-of-care therapy, which is estimated to have more than doubled between 2009-2013. Researchers evaluated the drug in a phase 3 study in patients with confirmed H. pylori infection. Participants received four capsules of either Talicia or the active comparator three times daily for 14 days. The trial demonstrated 84% eradication of H. pylori infection with Talicia compared with 58% in the active comparator arm in the intent to treat population. 
Therefore, the formulary drug will not be as effective as the requested non-formulary drug.