Parathyroid hormone analogs (Bonsity, Teriparatide (Alvogen), Tymlos)
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Prior authorization policy governing pharmacy benefit coverage for parathyroid hormone analog injections (Bonsity, teriparatide [Alvogen], Tymlos) for Commercial/Exchange members; defines coverage criteria, continuation, limits, and specialty dispensing requirements.
Added Bonsity (teriparatide) to the policy and designated teriparatide from Alvogen as preferred; removed Forteo and generic teriparatide.
Updated coverage criteria to align requirements across Bonsity, teriparatide (Alvogen), and Tymlos including diagnosis, BMD thresholds, fracture history, trial/failure of other osteoporosis therapies, and FRAX thresholds.
Reauthorization criteria updated to require that members treated 24 months or more must remain at or have returned to high fracture risk; approval length changed to 12 months.
New-member evidence provision added allowing current-treatment documentation for members new to the plan (<= 90 days).
Coverage Criteria
Initial Therapy Criteria
Initial authorization requires diagnosis plus disease severity or prior therapy requirements.
ALL of the following
- BMD osteoporosis: T-score ≤ -2.5 at lumbar spine, femoral neck, total hip, or radius (one-third radius site) AND ONE of: (a) history of low-trauma fracture of the hip, spine, proximal humerus, pelvis, or forearm; OR (b) trial and failure, contraindication, or intolerance to one osteoporosis treatment (e.g., alendronate, risedronate, zoledronic acid, denosumab).
- BMD osteopenia with risk: T-score between -1.0 and -2.5 at specified sites AND ONE of: (a) history of low-trauma fracture of the hip, spine, proximal humerus, pelvis, or forearm; OR (b) trial and failure, contraindication, or intolerance to one osteoporosis treatment AND a FRAX 10-year probability meeting thresholds (major osteoporotic fracture ≥20% or hip fracture ≥3% in the U.S.).
- Fragility fracture: History of fragility fracture (e.g., hip or spine) regardless of BMD qualifies.
Initial Therapy Criteria
Initial Therapy Criteria
Initial authorization requires diagnosis plus disease severity or prior therapy requirements.
ALL of the following
- BMD osteoporosis: T-score ≤ -2.5 at lumbar spine, femoral neck, total hip, or radius (one-third radius site) AND ONE of: (a) history of low-trauma fracture of the hip, spine, proximal humerus, pelvis, or forearm; OR (b) trial and failure, contraindication, or intolerance to one osteoporosis treatment (e.g., alendronate, risedronate, zoledronic acid, denosumab).
- BMD osteopenia with risk: T-score between -1.0 and -2.5 at specified sites AND ONE of: (a) history of low-trauma fracture of the hip, spine, proximal humerus, pelvis, or forearm; OR (b) trial and failure, contraindication, or intolerance to one osteoporosis treatment AND a FRAX 10-year probability meeting thresholds (major osteoporotic fracture ≥20% or hip fracture ≥3% in the U.S.).
- Fragility fracture: History of fragility fracture (e.g., hip or spine) regardless of BMD qualifies.
Continuation / Reauthorization Criteria
Continuation/ Reauthorization
Reauthorization (Continuation) criteria
ANY of the following
- Treatment < 24 months: Member treated for less than 24 months, has experienced clinical benefit (e.g., no new fractures on radiography, improvement or stabilization in T-score compared with the previous bone mass measurement) and has not experienced clinically significant adverse events during therapy.
- Treatment ≥ 24 months: Member treated for 24 months or more and remains at or has returned to being at high risk for fracture (attestation required).
Provider Actions and Requirements
Prior authorization and required documentation
Prior authorization is required for Bonsity, Teriparatide (Alvogen), and Tymlos under the pharmacy benefit for Commercial/Exchange members. These products are designated specialty medications and must be dispensed through a contracted specialty pharmacy. For members new to the plan (coverage effective date ≤ 90 days), submit medical records documenting current receipt of the requested drug (excluding samples or manufacturer patient assistance). Authorization may be granted when diagnosis and the coverage clinical criteria are met.
- Submit medical records for new members (coverage effective date ≤ 90 days) showing current receipt of therapy; exclude samples and manufacturer patient assistance.
- Ensure prescription is processed via a contracted specialty pharmacy per specialty designation.
- Include documentation that meets the coverage criteria (diagnosis and disease-severity/prior-therapy requirements) for approval.
Approval duration and quantity limits
Authorizations will be granted for 12 months. Quantity limits apply: Bonsity and Teriparatide (Alvogen) are limited to 1 pen per 28 days; Tymlos is limited to 1 pen per 30 days. Specialty pharmacy dispensing is required.
- Approval length: 12 months.
- Bonsity pen: 1 pen per 28 days.
- Teriparatide (Alvogen) pen: 1 pen per 28 days.
- Tymlos pen: 1 pen per 30 days.
- Medication must be filled at a contracted specialty pharmacy.
Coding and Clinical Thresholds
| Bonsity pen | Quantity Limit = 1 pen per 28 days |
| Teriparatide (Alvogen) pen | 1 pen per 28 days |
| Tymlos pen | 1 pen per 30 days |
| Approval length | Approvals will be granted for 12 months |
Definitions
Quantity Limits by Product
Site of Care and Dispensing
Specialty dispensing required (contracted specialty pharmacy)
These medications are designated specialty and must be dispensed through a contracted specialty pharmacy under the pharmacy benefit.
- Submit pharmacy claims through a contracted specialty pharmacy to comply with the specialty dispensing requirement.
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