Teriparatide (non-preferred) — Blue Cross Blue Shield of New Mexico
osteoporosis
Preferred products
- FORTEO generic equivalent
- Tymlos (abaloparatide)
Initial criteria
- 1. ONE of the following: A. The patient has a diagnosis of osteoporosis and ALL of the following: 1. ONE of the following: A. The patient’s sex is male and ONE of the following: 1. The patient’s age ≥ 50 years OR 2. The requested agent is medically appropriate for the patient’s age and sex OR B. The patient's sex is female and ONE of the following: 1. The patient is postmenopausal OR 2. The requested agent is medically appropriate for the patient’s sex and menopause status AND 2. The patient’s diagnosis was confirmed by ONE of the following: A. A fragility fracture in the hip or spine OR B. A T-score ≤ -2.5 OR C. A T-score between -1.0 and -2.5 AND ONE of the following: 1. A fragility fracture of the proximal humerus, pelvis, or distal forearm OR 2. A FRAX 10-year probability for major osteoporotic fracture ≥ 20% OR 3. A FRAX 10-year probability of hip fracture ≥ 3% AND 3. ONE of the following: A. The patient is at very high fracture risk as defined by one or more of the following criteria: recent fracture (within the past 12 months); fractures while on FDA labeled osteoporosis therapy; multiple fractures; fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids); very low T-score (< -3.0); high risk for falls or history of injurious falls; very high fracture probability by FRAX (e.g., major osteoporosis fracture >30%, hip fracture >4.5%) or by other validated fracture risk algorithm OR B. ONE of the following: 1. The patient has been diagnosed with stage four advanced metastatic cancer and the requested agent is being used to treat or an associated condition based on peer-reviewed evidence AND the use is FDA approved OR 2. The patient has tried and had an inadequate response to a bisphosphonate (medical records required) OR 3. The patient has intolerance or hypersensitivity to a bisphosphonate OR 4. The patient has an FDA labeled contraindication to ALL bisphosphonates (medical records required)
- 2. ONE of the following: A. The requested agent is FORTEO generic equivalent OR B. The patient is currently being treated with the requested agent and is stable on therapy [chart notes required] OR C. The patient has tried and had an inadequate response to BOTH preferred agents (FORTEO generic equivalent AND Tymlos (abaloparatide)) OR D. BOTH preferred agents were discontinued due to lack of efficacy, diminished effect, or an adverse event [chart notes required] OR E. The patient has intolerance or hypersensitivity to BOTH preferred agents (FORTEO generic equivalent AND Tymlos (abaloparatide)) that is NOT expected with the requested agent OR F. The patient has an FDA labeled contraindication to BOTH preferred agents (FORTEO generic equivalent AND Tymlos (abaloparatide)) that is NOT expected with the requested agent OR G. BOTH preferred agents are expected to be ineffective based on known clinical characteristics; OR cause significant barrier to adherence; OR worsen comorbid condition; OR decrease ability to achieve or maintain daily function; OR cause adverse reaction or physical/mental harm [chart notes required] OR H. BOTH preferred agents are not in the best interest of the patient based on medical necessity [chart notes required] OR I. The patient has tried another drug in the same pharmacologic class as BOTH preferred agents that was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required]
- 3. The patient will NOT be using the requested agent in combination with a bisphosphonate, denosumab (e.g., Prolia, Xgeva), romosozumab-aqqg, or another parathyroid hormone analog (e.g., abaloparatide)
- 4. The patient does NOT have any FDA labeled contraindications to the requested agent
- 5. ONE of the following: A. The total duration of treatment with parathyroid hormone analog(s) for osteoporosis has NOT exceeded 2 years in a lifetime OR B. If >2 years, the patient is at high fracture risk (e.g., high FRAX score, T-score, or continued glucocorticoid use at prednisone ≥5 mg/day)
- For glucocorticoid-induced osteoporosis: The patient is either initiating or currently taking glucocorticoids equivalent to prednisone ≥5 mg/day AND expected therapy duration ≥3 months AND ONE of the following: A. Age <40 years with one of the following: prior fracture OR glucocorticoid dose ≥30 mg/day OR cumulative prednisone dose ≥5 g/year OR B. Age ≥40 years with one of the following: prior osteoporotic fracture OR T-score ≤ -2.5 OR FRAX 10-year probability major osteoporotic fracture ≥20% OR hip fracture ≥3% OR prednisone ≥30 mg/day for >30 days OR cumulative prednisone dose ≥5 g/year
Approval duration
up to remaining 2 years lifetime; if >2 years and high fracture risk: 1 year (minimum 3 months for BCBSNM/BCBSMT)