202303-159863
2023
Healthfirst Inc.
Medicaid
Orthopedic/ Musculoskeletal
Pharmacy/ Prescription Drugs
Formulary Exception
Upheld
Case Summary
Diagnosis: Osteoporosis
Treatment: Forteo
The insurer denied coverage for Forteo
The denial is upheld
According to the records, the patient is an adult with osteoporosis who has severe spinal disease and history of prior fracture. Her Endocrinologist recommends either Forteo or Tymlos to help increase her bone density.
According to the insurer, an alternative on the formulary list is Tymlos. The patient must try one alternative if there is only one covered alternative. The requested medication is denied based on the plan approved criteria Forteo, Teriparatide, Bonsity Marketplace.
The formulary drug is not likely to cause the patient an adverse reaction. The patient can use Tymlos.
The formulary drug has not been ineffective based on the patient's clinical history.
The requested drug is not more effective than the formulary drug.
According to the Tymlos Prescribing Information, "TYMLOS is a human parathyroid hormone related peptide analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture."
According to the Medical Letter (2017), "The Food and Drug Administration (FDA) has approved abaloparatide (Tymlos Radius Health), a synthetic analog of human parathyroid hormone related peptide, for treatment of postmenopausal women with osteoporosis who are at high risk for fracture. Abaloparatide is the second parathyroid hormone receptor agonist to be approved for this indication; teriparatide (Forteo Lilly), a recombinant parathyroid hormone analog, was the first. They are the only drugs approved for treatment of osteoporosis that stimulate bone formation. Other drugs used for this indication inhibit bone resorption".
Lastly, Shirley et al (2017) states, "Abaloparatide (Tymlos) is a synthetic peptide analogue of human parathyroid hormone-related protein that was developed by Radius Health as an osteoanabolic agent for the treatment of postmenopausal osteoporosis. Abaloparatide acts through selective activation of the parathyroid hormone type 1 receptor signaling pathway. In April 2017, subcutaneous abaloparatide received its first global approval, in the USA (United States of America), for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy."
The formulary drugs are not expected to cause adverse effects.
The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.
The formulary drug is not expected to be ineffective.
The not formulary drug is not expected to be more effective that the formulary alternatives.
The carrier's denial of Request for Formulary Exception for Forteo to treat osteoporosis is upheld.