Forteo denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Forteo for treatment of the enrollee’s low density for age. Findings: The physician reviewer found that the review of the submitted documentation and relevant literature demonstrate the medical necessity of the requested medication. According to the National Osteoporosis Foundation guidelines “for severe osteoporosis, sequential treatment with anabolic therapy followed by an antiresorptive agent is generally preferred to concomitant combination therapy” (Cosman, et al). Teriparatide is an anabolic agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of osteoporosis in postmenopausal women and men at high risk for fracture.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Forteo 20 mcg/dose pen injector. Buerba and colleagues compared the efficacy of the use of either bisphosphonates or Forteo on radiographic and functional outcomes of patients who underwent thoracolumbar spinal fusion. The authors concluded that Forteo was “associated with higher fusion rates than bisphosphonates.” In this patient’s case, there is a documented history of spinal fusion and a current indication for revision surgery. The patient’s provider has recommended treatment with Forteo to enhance the patient’s bone strength and increase of likelihood of hardware placement success during the planned surgery. Furthermore, treatment with Forteo is likely to health improve the patient’s bone mineral density.

Where the denial was upheld

The patient is a 48-year-old female who is perimenopausal and was referred for a DEXA scan because of a positive family history of osteoporosis. This scan of the left and right hips revealed T scores of -2.3 and -2.5. The etiology of the low bone density is unknown and a presumptive diagnosis of osteoporosis was suggested by the patient’s provider. Based on a history of multiple sclerosis, petit mal seizures and a family history of osteoporosis, the patient was considered to be at high risk for falls. She was fitted with a hip protector and instructed to return in a year for another DEXA scan. There is no history of fragility fractures and no additional risk factors beyond her T scores and the possibility that she might fall.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Forteo. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee who has a history of osteoporosis.Findings: Current peer reviewed literature supports the use of Forteo for the treatment of osteoporosis following failure of first line treatment. However, current prescribing information from the manufacturer and U.S. Food and Drug Administration (FDA) does not support the use of Forteo for more than two years throughout the life of the patient based on the risk of osteosarcoma. Jeremiah and colleagues recommend first line treatment of osteoporosis which consists of fall prevention, smoking cessation, moderation of alcohol intake, and bisphosphonate therapy.

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