Bonsity (teriparatide subcutaneous injection – Alvogen) — Cigna

Preferred products

• ibandronate intravenous injection (Boniva)
• zoledronic acid intravenous infusion (Reclast)
• oral bisphosphonate products (Fosamax, Fosamax Plus D, Actonel, Atelvia, Boniva)

Initial criteria

• For Osteoporosis Treatment for a Postmenopausal Patient, patient meets ALL of the following (A, B, and C):
• A) Patient meets ONE of the following (i, ii, or iii): i) T-score ≤ -2.5 at lumbar spine, femoral neck, total hip, or 33% radius; OR ii) Osteoporotic or fragility fracture; OR iii) Low bone mass (T-score between -1.0 and -2.5) AND patient at high risk for fracture.
• B) Patient meets ONE of the following (i, ii, iii, or iv): i) Tried ibandronate IV (Boniva) or zoledronic acid IV (Reclast); OR ii) Tried at least one oral bisphosphonate and had inadequate efficacy after ≥ 12 months or intolerance; OR iii) Cannot take oral bisphosphonate due to difficulty swallowing, unable to remain upright, or GI condition; OR iv) Has severe renal impairment/chronic kidney disease or osteoporotic/fragility fracture.
• C) Duration: If high risk for fracture, approve for 2 years total (if <1 year prior therapy, up to 2 years total; if ≥1 year prior therapy, 1 year approval; use beyond 2 years evaluated annually). If not high risk, approve up to total of 2 years of therapy lifetime.
• For Osteoporosis Treatment (to Increase Bone Mass) for Men with Primary or Hypogonadal Osteoporosis, patient meets ALL of the following (A, B, and C):
• A) Patient meets ONE of the following (i, ii, or iii): i) T-score ≤ -2.5 at lumbar spine, femoral neck, total hip, or 33% radius; OR ii) Osteoporotic or fragility fracture; OR iii) Low bone mass (T-score between -1.0 and -2.5) AND patient at high risk for fracture.
• B) Patient meets ONE of the following (i, ii, iii, or iv): i) Tried zoledronic acid IV (Reclast); OR ii) Tried at least one oral bisphosphonate and had inadequate efficacy after ≥ 12 months or intolerance; OR iii) Cannot take oral bisphosphonate due to inability to swallow, remain upright, or GI condition; OR iv) Has severe renal impairment/chronic kidney disease or osteoporotic/fragility fracture.
• C) Duration: If high risk for fracture, approve for up to 2 years total or 1 year if already received ≥1 year; use beyond 2 years evaluated annually. If not high risk, approve up to total of 2 years lifetime.

Reauthorization criteria

• If high risk for fracture and already received ≥ 1 year of teriparatide therapy, approve for 1 year; continued use beyond 2 years evaluated annually for continued high risk of fracture.

Approval duration

up to 2 years; or 1 year if ≥ 1 year prior therapy