Exceptional Access Program (EAP)

Osteoporosis Treatments

Romosozumab

• Brand(s): Evenity
• Dosage Form/Strength: 90 mg/mL
• Effective Date: October 11, 2023

Indications for Treatment

For the treatment of osteoporosis in postmenopausal women meeting ALL the following criteria:

1. History of osteoporotic fracture; AND
2. Is at a high risk for future fracture, defined as a 10-year fracture risk greater than or equal to 20% as defined by the Fracture Risk Assessment (FRAX) Tool; AND
3. Treatment naive to osteoporosis medications, except for calcium and/or vitamin D.

Exclusion Criteria

• Romosozumab will not be funded as combination therapy with other osteoporosis medications, except for calcium and/or vitamin D.

Approved Dose

• 210 mg subcutaneously once every month for 12 doses

Approval Duration

• 12 months (A maximum of 12 monthly doses will be reimbursed.)

Renewals

• Renewals will not be considered.

Note

• Requesting prescriber must include a copy of the FRAX assessment.

Teriparatide

• Brand(s): Forteo and generics (see formulary for funded OFIs)
• Dosage Form/Strength:
  • 250 mcg/mL – 3 mL prefilled pen
  • 250 mcg/mL – 2.4 mL prefilled pen

Please note:

• Patients who are treatment naïve to teriparatide at the time of the request will be required to access the biosimilar version of teriparatide.
• Forteo and its interchangeable generic versions will only be considered for those who have been stabilized on these formulations, who meet the below EAP funding criteria, and who have not reached 24 months of use since the starting dose was initiated.
• Refer to the ODB formulary for the limited use criteria

Indications for Treatment

For the treatment of osteoporosis in patients who meet the following criteria:

• 65 years of age or older who are mobile; AND
• Patient is at high risk of fragility fractures; AND
• Patient who has osteonecrosis of the jaw due to an anti-resorptive agent OR who has atypical femur fracture due to an anti-resorptive agent.
  • (Note: One of the two conditions must be present.)

High risk for fragility fractures is defined as:

• A bone mineral density (BMD) T-score less than or equal to -3; AND
• Prior fragility fracture

Note:

• Requesting physicians must include a copy of the BMD report with the EAP request.

Approved Dose

• Not specified in the provided text.

Approval Duration

• 24 months
  • Requests meeting criteria will be funded for 24 months.
  • Renewals are NOT considered.