teriparatide subcutaneous injection — Medica

Preferred products

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

Initial criteria

• For Glucocorticoid-Induced Osteoporosis – Treatment: ALL of the following (A, B, and C) are met:
• A) Patient is either initiating or continuing systemic glucocorticoids; AND
• B) ONE of the following (i–iv):
• i. Patient has tried zoledronic acid intravenous infusion (Reclast); OR
• ii. Patient has tried at least one oral bisphosphonate or oral bisphosphonate-containing product (e.g., Fosamax, Fosamax Plus D, Actonel, Atelvia, Boniva) AND has either: (a) inadequate efficacy after a 12‑month trial, OR (b) significant intolerance; OR
• iii. Patient cannot take an oral bisphosphonate due to inability to swallow, inability to remain upright, or preexisting gastrointestinal medical condition; OR
• iv. Patient has severe renal impairment or chronic kidney disease OR has had an osteoporotic or fragility fracture; AND
• C) ONE of the following (i or ii):
• i. If prescriber confirms patient is at high risk for fracture, approve for (a) up to 2 years if initiating therapy or <1 year of prior teriparatide use, OR (b) 1 year if ≥1 year of prior use; OR
• ii. If not at high risk for fracture, approve only for duration needed to complete a lifetime maximum of 2 years total teriparatide therapy.
• For Osteoporosis Treatment in Postmenopausal Patients: ALL of the following (A, B, and C) are met:
• A) ONE of the following (i–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 −1.0 to −2.5) AND, per prescriber, high risk for fracture; AND
• B) ONE of the following bisphosphonate‑related criteria (i–iv):
• i. Tried ibandronate IV (Boniva) or zoledronic acid IV (Reclast); OR
• ii. Tried ≥1 oral bisphosphonate or oral bisphosphonate‑containing product and had inadequate efficacy after 12 months or significant intolerance; OR
• iii. Cannot take oral bisphosphonates due to inability to swallow, inability to remain upright, or preexisting gastrointestinal condition; OR
• iv. Has severe renal impairment/chronic kidney disease OR has had an osteoporotic or fragility fracture; AND
• C) One of the following approval durations:
• i. If at high risk for fracture: (a) up to 2 years if initiating or <1 year previous therapy, OR (b) 1 year if ≥1 year prior therapy; OR
• ii. If not at high risk: duration necessary to complete lifetime maximum 2 years.
• For Osteoporosis Treatment to Increase Bone Mass in Men with Primary or Hypogonadal Osteoporosis: ALL of the following (A, B, and C) are met:
• A) ONE of the following (i–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 −1.0 to −2.5) AND, per prescriber, high risk for fracture; AND
• B) ONE of the following (i–iv):
• i. Tried ibandronate IV (Boniva) or zoledronic acid IV (Reclast); OR
• ii. Tried at least one oral bisphosphonate or oral bisphosphonate‑containing product and had inadequate efficacy after 12 months or significant intolerance; OR
• iii. Cannot take an oral bisphosphonate because of inability to swallow, inability to remain upright, or preexisting gastrointestinal condition; OR
• iv. Severe renal impairment/chronic kidney disease OR had an osteoporotic or fragility fracture; AND
• C) Approval duration the same structure as above: if high risk, up to 2 years total (or 1 year reauthorization after ≥1 year prior use); if not high risk, only to complete a 2‑year lifetime total.

Reauthorization criteria

• If patient continues to be at high risk for fracture after prior teriparatide therapy and total lifetime use <2 years, may reauthorize up to 2 years total;
• If patient has already completed 2 years of therapy, continuation beyond 2 years requires prescriber documentation that patient remains or has returned to high risk for fracture (annual evaluation).

Approval duration

up to 2 years; continuation beyond 2 years evaluated annually for high fracture risk