Thalidomide denials in California external review

What the reviewers wrote

Where the denial was overturned

Physician 1The patient is a 56-year-old man who was diagnosed with myelodysplastic syndrome (MDS) in 1992. His specific form of MDS is refractory sideroblastic anemia. Over the years he has been on a variety of treatments, including Neupogen to stimulate his white blood cell count, and Epogen, to increase his hemoglobin. It appears that the patient’s hemoglobin has not been responding well to his current treatment and he has been on thalidomide for an unknown period of time. He requests continuation of thalidomide therapy. The Health Plan has denied the request on the basis that thalidomide is considered experimental for treatment of the patient’s medical condition.MDS encompasses a wide range of subtypes, but all are characterized by a bone marrow that is not functioning normally, such that one or the other of the formed elements of the blood is deficient.

The patient is a 74-year-old male with idiopathic myelofibrosis. He is dependent on blood transfusions for treatment of his anemia. The patient is also on Exjade for iron chelation secondary to transfusion-related iron overload, a potentially life threatening condition. The patient’s provider recommended treatment with thalidomide (and prednisone) and submitted a request for authorization. The Health Plan denied the request based upon a determination that the medication is not medically necessary.There is no treatment for myelofibrosis that is universally indicated or efficacious in all patients. Myelofibrosis is very heterogeneous and certain therapies work for some patients but not for others.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: an enrollee has requested authorization and coverage for Alkeran and Thalomid. Findings: the physician reviewer found that the requested medications were removed from the list of treatment options in the National Comprehensive Cancer Network (NCCN) guidelines. For non-transplant candidates, the regimens that are no longer recommended by the NCCN panel include all melphalan containing regimens, thalidomide/dexamethasone, and vincristine/doxorubicin/dexamethasone (VAD). As such, Alkeran and Thalomid are no longer considered the current standard-of-care for patients diagnosed with MM, either due to concerns for toxicity and/or the availability of more effective regimens. The literature reports that melphalan-based regimens can lead to significant cytopenias and may limit subsequent use of newer medications.

A 56-year-old male requested authorization and coverage of thalidomide for treatment of ocular melanoma with metastasis to the liver. The health plan denied the enrollee’s request indicating that treatment with thalidomide is considered experimental.Three physician reviewers performed an experimental/investigational Independent Medical Review. Two of the three-physician reviewers concluded that thalidomide is not likely to be more beneficial for treatment of the enrollee’s ocular melanoma with metastasis to the liver than any available standard therapy. Because two of the three physician reviewers concluded that the requested treatment is not likely to be more beneficial for treatment of the enrollee’s medical condition than any available standard therapy, the review organization upheld the health plan’s denial.

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 Thalidomide, then check the rights and deadlines that apply to your plan.