Anthem Blue Cross California Human Parathyroid Hormone Agents Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of human parathyroid hormone agents for the treatment of osteoporosis. Agents included in this clinical guideline include: • Tymlos (abaloparatide) • Forteo (teriparatide) • Bonsity (teriparatide) Tymlos (abaloparatide), Forteo (teriparatide), and Bonsity (teriparatide) are approved for the treatment of postmenopausal osteoporosis in a select population of women considered at high risk for fracture. Forteo and Bonsity are also approved for glucocorticoid-induced osteoporosis and men with hypogonadal osteoporosis at high risk for fracture. Bonsity is a follow-on to Forteo and carries the same indications. Its approval, in part, was based on safety and efficacy data from Forteo. The American College of Endocrinology (AACE/ACE) (2020) osteoporosis treatment guidelines stratify initial treatment based on risk status. For those at high risk/no prior fractures, initial therapy options include bisphosphonates (alendronate, risedronate, or zoledronic acid) or denosumab. For those at very high risk, initial therapy options are denosumab, abaloparatide, teriparatide, romosozumab, or zoledronic acid. The Endocrine Society osteoporosis guideline update (2020) recommends initial therapy with bisphosphonates (alendronate, risedronate, zoledronic acid, or ibandronate) or alternatively denosumab for those at high risk. Teriparatide and abaloparatide are recommended for very high risk of fracture such as those with severe or multiple vertebral fractures. Osteoporosis may be diagnosed by bone mineral density (BMD) testing indicating a T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of less than or equal to -2.5 as compared to a young-adult reference population. It also may be clinically diagnosed based on a history of a fragility fracture (low trauma fracture). High risk for fracture is defined in the FDA label as history of osteoporotic fracture; or multiple risk factors for fractures; or a failure or intolerance to other osteoporosis therapies. Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Tymlos (abaloparatide) Initial requests for Tymlos (abaloparatide) may be approved for the following: I. Individual has one of the following: A. B. Individual is a postmenopausal female with the following a diagnosis of osteoporosis (defined as a bone mineral density (BMD) T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of less than or equal to -2.5 as compared to a young-adult reference population OR a clinical diagnosis based on history of a low trauma fracture (fragility fracture)) at high risk for fracture; OR Individual is a male diagnosed with osteoporosis (defined as BMD T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of less than or equal to -2.5 as compared to young-adult reference population OR a clinical diagnosis based on history of a low trauma fracture (fragility fracture)) at high risk for fracture using to increase bone mass; B. AND II. The individual meets one of the following: 1 A. Individual is at very high risk for fracture as defined by one or more of the following (AACE/ACE 2020): 1. Recent fracture (within the past 12 months) 2. Fractures while on approved osteoporosis therapy 3. Multiple fractures 4. Fractures while on drugs causing skeletal harm (e.g. long-term glucocorticoids) 5. Very low T-score (less than -3.0) 6. High risk for falls or history of injurious falls 7. Very high fracture probability by FRAX (fracture risk assessment tool) (e.g. major osteoporosis fracture >30%, hip fracture >4.5%) or other validated fracture risk algorithm; B. C. OR Individual has been refractory to a prior trial of a bisphosphonate; OR Individual is intolerant to or has a contraindication to a bisphosphonate as defined by: 1. Hypersensitivity to TWO bisphosphonates (one of which must be alendronate); OR 2. 3. Pre-existing gastrointestinal disorders (Barrett's esophagus, hypersecretory disorders, delayed esophageal emptying, Inability to stand or sit upright for at least 30 minutes; OR atrophic gastritis, etc.); OR 4. Uncorrected hypocalcemia; OR 5. Severe renal insufficiency as defined by creatinine clearance less than 35 mL/min for alendronate agents and zoledronic acid or creatinine clearance less than 30 mL/min for risedronate and ibandronate; AND III. Individual is not using Tymlos (abaloparatide) in combination with any of the following: A. Prolia (denosumab); B. Bisphosphonates; C. Evista (raloxifene); D. Miacalcin/Fortical (calcitonin nasal spray); E. Reclast (zoledronic acid); F. Forteo (teriparatide) or Bonsity (teriparatide); G. Evenity (romosozumab-aqqg). Continuation of therapy with Tymlos (abaloparatide) may be approved if the following criteria are met: I. II. There is clinically significant response to therapy (including but not limited to no new fractures or reduction of fractures, or no worsening vertebral fractures, or no clinically significant adverse reaction); AND If individual has been on therapy ≥ 24 months of treatment, a repeat BMD demonstrates a stable or increase in BMD. AND III. Individual is not using Tymlos (abaloparatide) in combination with any of the following: A. Prolia (denosumab); B. Bisphosphonates; C. Evista (raloxifene); D. Miacalcin/Fortical (calcitonin nasal spray); E. Reclast (zoledronic acid); F. Forteo (teriparatide) or Bonsity (teriparatide); G. Evenity (romosozumab-aqqg). Forteo (teriparatide); Bonsity (teriparatide) Initial requests for Forteo (teriparatide) or Bonsity (teriparatide) may be approved for the following: I. Individual has one of the following: A. Individual is a postmenopausal female with diagnosis of osteoporosis (defined as bone mineral density (BMD) T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of less than or equal to -2.5 as compared to young-adult reference population OR a clinical diagnosis based on history of a low trauma fracture (fragility fracture)) at high risk for fracture; OR Individual is a male diagnosed with primary or hypogonadal osteoporosis (defined as BMD T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of less than or equal to -2.5 as compared to young-adult reference population OR a clinical diagnosis based on history of a low trauma fracture (fragility fracture)) at high risk for fracture using to increase bone mass; OR Individual has a diagnosis of osteoporosis (defined as BMD T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of less than or equal to -2.5 as compared to young-adult reference population OR a clinical diagnosis based on history of a low trauma fracture (fragility fracture)) associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone for at least 3 months) at high risk for fracture; B. C. 2 AND II. AND III. Individual meets one of the following: A. Individual is a postmenopausal female at very high risk for fracture as defined by one or more of the following (AACE/ACE 2020): 1. Recent fracture (within the past 12 months) 2. Fractures while on approved osteoporosis therapy 3. Multiple fractures 4. Fractures while on drugs causing skeletal harm (e.g. long-term glucocorticoids) 5. Very low T-score (less than -3.0) 6. High risk for falls or history of injurious falls 7. Very high fracture probability by FRAX (fracture risk assessment tool) (e.g. major osteoporosis fracture >30%, hip fracture >4.5%) or other validated fracture risk algorithm; B. C. OR Individual has been refractory to a prior trial of a bisphosphonate; OR Individulal is intolerant to or has a contraindication to a bisphosphonate as defined by: 1. Hypersensitivity to TWO bisphosphonates (one of which must be alendronate); OR 2. 3. Pre-existing gastrointestinal disorders (Barrett’s esophagus, hypersecretory disorders, delayed esophageal emptying, Inability to stand or sit upright for at least 30 minutes; OR atrophic gastritis, etc.); OR 4. Uncorrected hypocalcemia; OR 5. Severe renal insufficiency as defined by creatinine clearance less than 35 mL/min for alendronate agents and zoledronic acid or creatinine clearance less than 30 mL/min for risedronate and ibandronate; Individual is not using Forteo (teriparatide) in combination with any of the following: A. Prolia (denosumab) B. Bisphosphonates C. Evista (raloxifene) D. Miacalcin/Fortical (calcitonin nasal spray) E. Reclast (zoledronic acid) F. Tymlos (abaloparatide); G. Evenity (romosozumab-aqqg); H. Another teriparatide agent. Continuation of therapy with Forteo (teriparatide) or Bonsity (teriparatide) may be approved if the following criteria are met: I. II. There is clinically significant response to therapy (including but not limited to no new fractures reduction of fractures, or no worsening vertebral fractures, or no clinically significant adverse reaction); AND If individual has been on therapy ≥ 24 months of treatment, a repeat BMD demonstrates a stable or increase in BMD; AND III. Individual is not using Forteo (teriparatide) or Bonsity (teriparatide) in combination with any of the following: A. Prolia (denosumab) B. Bisphosphonates C. Evista (raloxifene) D. Miacalcin/Fortical (calcitonin nasal spray) E. Reclast (zoledronic acid) F. Tymlos (abaloparatide); G. Evenity (romosozumab-aqqg); H. Another teriparatide agent. Requests for Forteo (teriparatide), Bonsity (teriparatide), and Tymlos (abaloparatide) may not be approved when the above criteria are not met and for all other indications. Quantity Limits Miscellaneous Osteoporosis Agents Quantity Limit Drug Limit Tymlos (abaloparatide) Injection 3120 mcg/1.56 mL Forteo (teriparatide) Injection 600 mcg/2.4 mL Bonsity (teriparatide) Injection 620 mcg/ 2.48 mL 1 pen per 30 days 1 pen per 28 days 1 pen per 28 days 3 Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS C9399 J3490 J3110 Unclassified drugs or biologicals [when specified as abaloparatide (Tymlos)] Unclassified drugs [when specified as abaloparatide (Tymlos)] Injection, teriparatide, 10 mcg [Bonsity] [Forteo] ICD-10 Diagnosis Z78.0 Asymptomatic menopausal state M80.00XA-M80.88XS Osteoporosis with current pathological fracture M81.0-M81.8 Osteoporosis without current pathological fracture Document History Revised: 08/18/2023