Cholangiocarcinoma denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient is a 63-year-old female who has been diagnosed with a hepatocellular mass and chronic hepatitis B. The provider noted that the patient underwent hepatocellular mass resection in 2009. She was treated with transarterial chemoembolization (TACE). The provider noted the patient did well until 2018 when a computed tomography (CT) scan showed a two cm right upper lobe mass, a lytic lesion, and multiple enlarged mediastinal lymph nodes. The provider noted a positron emission tomography (PET) scan obtained in July 2019 confirmed metastatic disease. She was found to have an epidermal growth factor receptor (EGFR) exon 19 mutation and was started on gefitinib in September 2019. An esophagogastroduodenoscopy (EGD) with biopsies of a duodenal mass obtained revealed a poorly differentiated adenocarcinoma.

Physician 1: The patient was a 36-years old male with widely metastatic cholangiocarcinoma. He failed conventional systemic chemotherapy and transcatheter arterial chemoembolization (TACE) was utilized as a salvage regimen. The patient survived seven more months, albeit with pain and illness, and succumbed to advanced disease. The patient’s widow requested reimbursement for the chemoembolization, but her request was denied based upon the Health Plan’s determination that the therapy was experimental/investigational.Considering all of the circumstances, TACE appears to be a reasonable option in this clinical context. The patient had already failed conventional chemotherapy. Although the bulk of the literature deals with hepatoma, there is some data that suggests chemoembolization may be beneficial in cholangiocarcinoma.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for positron emission tomography (PET) scan (with concurrent acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; skull base to mid-thigh) provided 9/14/20.National Comprehensive Cancer Network suggests that patients should “consider multiphasic abdominal/pelvic computed tomography/magnetic resonance imaging (CT/MRI) with intravenous (IV) contrast and chest CT with contrast every three to six months for two years, then every six to twelve months for up to five years, or as clinically indicated.” In this case, the patient was diagnosed with cholangiocarcinoma in 2014. The recommended 5-year follow-up period had been completed. Based on the records, there were no clinical signs that he had a recurrence.

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for irinotecan liposome (Onivyde) injection. The U.S. Food and Drug Administration (FDA) does not approve liposomal irinotecan for the treatment of cholangiocarcinoma. While it may be used off-label for biliary cancers, the National Comprehensive Cancer Network (NCCN) guidelines for the management of biliary tract cancers list liposomal irinotecan in combination with fluorouracil and leucovorin as a category 2B recommendation, and notes that folinic acid, fluorouracil, and oxaliplatin (FOLFOX) is preferred. Per the medical records, the patient's ctDNA began to rise more than six months after surgery, indicating platinum sensitivity, and biomarker testing, which may guide treatment decision making, is pending.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving cholangiocarcinoma, then check the rights and deadlines that apply to your plan.