Bonsity (teriparatide) — Medica

Preferred products

• zoledronic acid intravenous infusion (Reclast)
• oral bisphosphonates (Fosamax, Fosamax Plus D, Actonel, Atelvia, Boniva)

Initial criteria

• Patient has tried zoledronic acid intravenous infusion (Reclast); OR
• Patient has tried at least one oral bisphosphonate or oral bisphosphonate-containing product AND meets one of the following:
• - According to the prescriber, patient has experienced inadequate efficacy to oral bisphosphonate therapy after a trial duration of 12 months; OR
• - Patient has experienced significant intolerance to an oral bisphosphonate; OR
• Patient cannot take an oral bisphosphonate due to ONE of the following: cannot swallow or has difficulty swallowing; cannot remain in an upright position post oral bisphosphonate administration; or has a preexisting gastrointestinal medical condition (e.g., esophageal lesions, esophageal ulcers, esophageal abnormalities); OR
• According to the prescriber, patient has severe renal impairment (e.g., creatinine clearance < 35 mL/minute) or chronic kidney disease; OR patient has had an osteoporotic fracture or a fragility fracture

Reauthorization criteria

• If patient is at high risk for fracture AND is initiating therapy or has received < 1 year of teriparatide product, approve for up to 2 years total; OR
• If patient is at high risk for fracture AND has already received ≥ 1 year of teriparatide product, approve for 1 year; OR
• If patient is not at high risk for fracture, approve only for the duration necessary to complete a maximum of 2 years total therapy during lifetime
• Use beyond 2 years is evaluated annually for continued high risk of fracture

Approval duration

up to 2 years; reauthorization 1 year or until completion of 2 total years of therapy