Clin Trial (I) denials: what the review data shows

Where the denial was overturned

SummaryThe patient is a 51 year old woman with advanced pancreatic cancer and has received multiple courses of chemotherapy without benefit. She is asking for authorization to participate in a multi-modality Phase I clinical trial. The Health Plan denied authorization on the basis that it is experimental and therefore, not a covered benefit. Two of the three physician reviewers concluded that the proposed trial is clinically appropriate and that the Health Plan denial should be overturned. The third reviewer determined that the denial should be upheld.Analysis and FindingsClinical Facts: The patient has metastic pancreatic cancer and received multiple courses of chemotherapy. A CT scan performed in April 2006 showed metastasis to the liver. The patient’s CA 19-9 was 12,000. She is status post gemcitabine and Cisplatin, and then gemcitabine, Xeloda and Avastin treatments.

Nature of Statutory Criteria/Case Summary: An enrollee has requested the medication combination Yervoy (ipilimumab) 300 mg and Opdivo (nivolumab) 92 mg, for three weeks, refills for one year, nine cycles for treatment of the enrollee’s medical condition. Findings: Two physician reviewers found that Opdivo, Yervoy, and Keytruda are new monoclonal antibodies that bind with tumor antigens responsible for blocking immune attack from circulating lymphocytes. The current U.S. Food and drug Administration (FDA) label for Opdivo does not state that prior treatment with Keytruda is a contraindication. Progressive disease on Keytruda can be treated with Yervoy and Opdivo combination therapy if it has not been used before. The combination therapy is supported by the medical literature where certain patients were treated with the combination after monotherapy.

Where the denial was upheld

Physician 1: This patient is a 51-year-old male diagnosed with malignant melanoma of the scalp in June 2002, treated surgically. In July 2003 he was found to have involvement of the lymph nodes in his neck, which were resected. This was followed by one year of interferon therapy. In May 2005 the patient was found to have involvement of his spleen and left hilar area; he was treated with biochemotherapy, including Temodar, platinol vinblastine, interleukin-2 (IL-2), and interferon. There was no response. He was then treated with an experimental agent, MDX-010, with again, no response. He next was treated with chemotherapy including carboplatinum, Taxol, and sorafenib, again with progression of disease.It is now proposed that the patient be treated with high dose IL-2 along with taurolidine. This treatment is the subject of a clinical trial in Dublin, Ireland.

This patient a 60-year-old woman with a history of nasopharyngeal carcinoma first diagnosed when she was 15 years of age. She was treated with external beam radiotherapy. The patient had a remission of her cancer. She developed cervical schwannoma and sarcoma of the scalp in 1995, which was probably radiation induced. The patient presented with worsening difficulty with swallowing. An MRI of the brain was ordered in early 2002 and she was first diagnosed with advanced meningioma of foramen magnum in late 2002. A repeat MRI in May 2003 showed some progression. Another MRI performed in January 2004 showed the growth had increased by 33%. The patient was referred to a provider who recommended the patient participate in a clinical trial involving Avastin.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Clin Trial (I)when you appeal: reviewers routinely find that denials like yours didn’t hold up.