CurrentAvMedPolicy N/A

Parathyroid Hormone Analogs

Policy Summary

PayerAvMed

PolicyParathyroid Hormone Analogs

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrescribing physician must sign and print name on the prior authorization form and submit required documentation (BMD, radiographs, FRAX, chart notes, lab results) via fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

3Products covered

24Maximum lifetime therapy (months)

2.24 / 1.56 mLQuantity limits (teriparatide / abaloparatide)

Coverage Summary

Defines prior authorization and step-edit clinical criteria, documentation requirements, quantity limits, and therapy duration limits for Forteo (teriparatide), generic teriparatide, and Tymlos (abaloparatide) for treatment of osteoporosis and glucocorticoid-induced osteoporosis. Approval requires meeting the clinical diagnosis criteria and prerequisite therapy or documented contraindication/intolerance, submission of supporting documentation (BMD, radiographs, FRAX, chart notes, lab results), adherence to quantity limits of 2.24 mL per 28 days for teriparatide and 1.56 mL per 28 days for abaloparatide, and a maximum cumulative lifetime therapy limit of 24 months for all parathyroid analog products.

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Thresholds

Quantity Limit (teriparatide)Maximum 2.24 mL per 28 days

Quantity Limit (abaloparatide)Maximum 1.56 mL per 28 days

Duration LimitMaximum 24-month approval (total cumulative lifetime therapy) for ALL parathyroid analog products

FRAX thresholds10-year major osteoporotic fracture risk ≥ 20% OR hip fracture risk ≥ 3%

T-score thresholdsT-score ≤ -2.5; T-score -1 to > -2.5 with high FRAX; Very high risk defined as T-score ≤ -3.0 or T-score ≤ -2.5 with fragility fractures or severe/multiple vertebral fractures

Renal insufficiency thresholdsCrCL < 35 mL/min for alendronate agents and zoledronic acid; CrCL < 30 mL/min for risedronate and ibandronate

Initial Therapy Criteria

Overall Approval Requirement

All criteria must be met for approval. To support each line checked, documentation including lab results, diagnostics, and/or chart notes must be provided.

ONE of: Requested drug is one of: Forteo (teriparatide) injection, generic teriparatide, or Tymlos (abaloparatide) injection
ONE of
- Female with post-menopausal osteoporosis
- Male with primary or hypogonadal osteoporosis
- Systemic glucocorticoid-induced osteoporosis
ONE of
- History of vertebral fracture(s), low trauma or fragility fracture(s) within the past 5 years
- T-score ≤ -2.5 in spine, femoral neck, total hip or 1/3 radius OR T-score between -1 and > -2.5 with high pre-treatment FRAX fracture probability (10-year major osteoporotic fracture risk ≥ 20% OR hip fracture risk ≥ 3%)
- Very high risk for fracture defined as T-score ≤ -3.0, OR T-score ≤ -2.5 with history of fragility fractures, OR severe or multiple vertebral fractures
  Members meeting 'very high risk' are NOT subject to prior trial and failure requirements with bisphosphonates
ONE of
- ANY of the following
  - alendronate (Fosamax®)
  - ibandronate (Boniva®)
  - risedronate (Actonel®)
  - zoledronic acid (Reclast®)
- ALL of the following
  - Hypersensitivity to TWO bisphosphonates (one must be alendronate)
For approval of Brand Forteo or Tymlos, member must have trial and failure of generic teriparatide injection (chart notes documenting therapy failure must be submitted)
Chart notes documenting therapy failure must be submitted
Contraindications and usage exclusions (see separate contraindications group) - Member must NOT be using or initiate specified agents and must NOT have listed contraindications

Continuation Therapy Criteria

Maximum cumulative lifetime therapy for all parathyroid analog products is limited to 24 months. Samples do not satisfy step-edit or prior authorization requirements and therefore do not count toward meeting trial requirements. Quantity limits must be followed on an ongoing basis (2.24 mL/28 days for teriparatide; 1.56 mL/28 days for abaloparatide).

Duration and Quantity Limits

Duration LimitMaximum 24-month approval

Quantity Limit (teriparatide)2.24 mL/28 days

Quantity Limit (abaloparatide)1.56 mL/28 days

Contraindications and Exclusions

Contraindications / Exclusions

Member is NOT currently using and will NOT initiate therapy with a bisphosphonate while using the requested medication
Member is NOT currently using and will NOT initiate therapy with a SERM while using the requested medication
Member is NOT currently using and will NOT initiate therapy with calcitonin (Miacalcin or Fortical) while using the requested medication
Member is NOT currently using and will NOT initiate therapy with denosumab (Prolia or Xgeva) while using the requested medication
Member is NOT currently using and will NOT initiate therapy with Evenity (romosozumab) while using the requested medication
History of skeletal irradiation
History of osteosarcoma
Open epiphyses
Paget's disease
Hypercalcemia
Hyperparathyroidism

Provider Actions

Prior Authorization

Prior Authorization Required

Prescribing physician must sign and print name on prior authorization request form; submit required documentation (BMD, radiographs, FRAX, chart notes, lab results) to support each checked criterion. Fax to 1-305-671-0200.

Documentation Required

Document Diagnosis and Prior Therapy

Submit documentation of diagnosis confirmation (BMD, radiographs, FRAX) and evidence of bisphosphonate trial/failure or documented contraindications/intolerance as specified.

Billing Rule

Quantity and Duration Limits

Adhere to quantity limits (2.24 mL/28 days for teriparatide; 1.56 mL/28 days for abaloparatide) and maximum 24-month cumulative lifetime therapy; samples do not satisfy step-edit/preauthorization.

Step Therapy

Step Therapy Requirement

Members must fail a 12-month trial of a bisphosphonate (or meet documented intolerance/contraindication criteria) before approval, unless documented "very high risk" applies which waives bisphosphonate trial requirement.

Documentation Required

Specialty Pharmacy

Medication to be provided by Specialty Pharmacy - Proprium Rx; if non-formulary on a Plan, documentation of medical necessity will be required.

Background

Parathyroid hormone analogs (teriparatide and abaloparatide) are anabolic agents indicated for treatment of osteoporosis. The policy requires a documented diagnosis of osteoporosis (e.g., post-menopausal, primary/hypogonadal, or systemic glucocorticoid-induced osteoporosis) and submission of confirming documentation (chart notes, radiographs, BMD or FRAX assessments). Approval also requires a prior 12-month trial and failure of a bisphosphonate or documentation of intolerance/contraindication to bisphosphonates before initiating teriparatide/abaloparatide, except when the patient meets criteria for very high fracture risk. For Brand Forteo or Tymlos, trial and failure of generic teriparatide is required prior to approval.

Very high risk for fracture is defined as T-score ≤ -3.0, OR T-score ≤ -2.5 with a history of fragility fractures, OR severe or multiple vertebral fractures; patients meeting this definition are exempt from the bisphosphonate trial requirement.