FDA-approved, for example:

• Paget’s disease
• prevention of skeletal-related events secondary to bone metastases in cancer related to solid tumors and in multiple myeloma
• treatment of FGF23-related hypophosphatemia in tumor induced osteomalacia
• treatment of giant cell tumor of the bone
• treatment of hypercalcemia
• treatment of hypercalcemia of malignancy
• treatment of hypocalcemia with hypoparathyroidism
• treatment of X-Linked hypophosphatemia
• treatment/prevention of glucocorticoid-induced osteoporosis in men and women
• treatment/prevention of postmenopausal osteoporosis in women and osteoporosis in men
• treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer
• treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

Note: The above list may not include all FDA-approved indications.

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

• All PA requests must include clinical diagnosis, drug name, dose, and frequency.
• A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
• For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
• Additional criteria may apply, depending upon the member’s condition and requested medication (see below)

Paget’s Disease (calcitonin salmon injection)

• Documentation (including medical records) of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response to an adequate trial or adverse reaction to alendronate; or
    • contraindication to oral bisphosphonates; and
  • one of the following:
    • inadequate response to an adequate trial or adverse reaction to pamidronate; or
    • inadequate response to an adequate trial or adverse reaction to zoledronic acid 5 mg; or
    • contraindication to IV bisphosphonates.

Paget’s Disease (risedronate)

Prevention of skeletal-related events secondary to bone metastases in cancer related to solid tumors and in multiple myeloma, and treatment of hypercalcemia of malignancy (Xgeva) 

• Documentation of all of the following is required:
  • diagnosis is one of the following:
    • prevention of skeletal-related events secondary to bone metastases in cancer related to solid tumors; or
    • prevention of skeletal-related events secondary to multiple myeloma; or
    • treatment of hypercalcemia of malignancy; and
  • prescriber is an oncologist, hematologist, or orthopedic specialist or has provided consult notes from an oncologist, hematologist, or orthopedic specialist; and
  • appropriate dosing.

Primary or hypogonadal osteoporosis with a high risk for fracture or postmenopausal osteoporosis with a high risk for fracture (Forteo, teriparatide)

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • bone mineral density indicating osteoporosis; and
  • one of the following:
    • inadequate response to an adequate trial or adverse reaction to an oral bisphosphonate; or
    • member is at very high risk for fracture indicated by at least one of the following:
      • history of fracture within the past 12 months; or
      • history of fractures while on osteoporosis therapy; or
      • history of multiple fractures; or
      • history of fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids); or
      • T-score less than −3.0; or
      • high risk for falls; or
      • history of injurious falls; or
      • very high fracture probability by FRAX (fracture risk assessment tool) or other validated fracture risk algorithm; or
    • contraindication to oral bisphosphonates; and 
  • one of the following:
    • diagnosis of severe osteoporosis defined as at least one of the following:
      • history of fracture within the past 12 months; or
      • history of fractures while on osteoporosis therapy; or
      • T-score less than −3.0; or
      • T-score of -2.5 or below plus a fragility fracture; or
    • an inadequate response or adverse reaction to one of the following, or contraindication to all of the following: ibandronate injection, Prolia, zoledronic acid 5 mg; and 
  • For teriparatide: 
    • medical necessity for the requested formulation instead of Forteo.

Postmenopausal osteoporosis (calcitonin salmon injection), or postmenopausal osteoporosis with a high risk for fracture (Evenity, Tymlos)

• Documentation (including medical records) of all of the following is required:
  • appropriate diagnosis; and
  • bone mineral density indicating osteoporosis; and
  • one of the following:
    • inadequate response to an adequate trial or adverse reaction to an oral bisphosphonate; or
    • member is at very high risk for fracture indicated by at least one of the following:
      • history of fracture within the past 12 months; or
      • history of fractures while on osteoporosis therapy; or
      • history of multiple fractures; or
      • history of fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids); or
      • T-score less than −3.0; or
      • high risk for falls; or
      • history of injurious falls; or
      • very high fracture probability by FRAX (fracture risk assessment tool) or other validated fracture risk algorithm; or
    • contraindication to oral bisphosphonates; and
  • one of the following:
    • diagnosis of severe osteoporosis defined as at least one of the following:
      • history of fracture within the past 12 months; or
      • history of fractures while on osteoporosis therapy; or
      • T-score less than −3.0; or
      • T-score of -2.5 or below plus a fragility fracture; or 
    • an inadequate response or adverse reaction to one of the following, or contraindication to all of the following: ibandronate injection, Prolia, zoledronic acid 5 mg; and
  • one of the following:
  • inadequate response to an adequate trial or adverse reaction to Forteo; or
  • contraindication to Forteo.

Treatment of FDF23-related hypophosphatemia in tumor induced osteomalacia (Crysvita)

• Documentation of all of the following is required:   
  • appropriate diagnosis; and
  • member is ≥ two years of age; and
  • documentation that phosphaturic mesenchymal tumor cannot be resected or localized; and
  • appropriate dosing.
• For recertification, documentation of positive response to therapy (defined as either improved patient serum phosphorus concentration and/or radiographic improvement) is required.

Treatment of giant cell tumor of the bone (Xgeva)

• Documentation of all of the following is required:   
  • appropriate diagnosis; and
  • one of the following:
    • tumor or metastases are unresectable; or
    • surgical resection is likely to result in severe morbidity; or
    • surgery is not an option at this time; and
  • dose and frequency are appropriate for giant cell tumor of the bone.

Treatment of hypercalcemia (calcitonin salmon injection)

• Documentation (including medical records) of all of the following is required:
  • appropriate diagnosis; and
  • medical necessity for calcitonin salmon injection.

Treatment of hypocalcemia with hypoparathyroidism (Natpara)

• Documentation of all of the following is required:
  • medical records documenting appropriate diagnosis; and
  • medical records documenting inadequate response, adverse reaction, or contraindication to calcium and active vitamin D supplementation; and
  • prescriber is an endocrinologist or provides documentation of a consultation with an endocrinologist; and
  • quantity limit of one package per 28 days.

Treatment of osteoporosis (Fosamax Plus D)

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • compelling clinical rationale of why the combination product would offer a therapeutic advantage over the individual agents.

Treatment of X-Linked hypophosphatemia (Crysvita)

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ six months of age; and
  • appropriate dosing.
• For recertification, documentation of positive response to therapy (defined as either improved patient serum phosphorus concentration and/or radiographic improvement) is required.

Treatment/prevention of glucocorticoid-induced osteoporosis (Forteo, teriparatide)

Treatment/prevention of osteoporosis (ibandronate injection, Prolia)

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response to an adequate trial or adverse reaction to an oral bisphosphonate; or
    • member is at very high risk for fracture indicated by at least one of the following:
      • history of fracture within the past 12 months; or
      • history of fractures while on osteoporosis therapy; or
      • history of multiple fractures; or
      • history of fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids); or
      • T-score less than −3.0; or
      • high risk for falls; or
      • history of injurious falls; or
      • very high fracture probability by FRAX (fracture risk assessment tool) or other validated fracture risk algorithm; or
    • contraindication to oral bisphosphonates.

Treatment/prevention of osteoporosis (risedronate, risedronate delayed-release)

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • inadequate response to an adequate trial or adverse reaction to an oral bisphosphonate.

Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer or treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non metastatic prostate cancer (Prolia)

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • inadequate response to an adequate trial or adverse reaction to a bisphosphonate; or
  • contraindication to oral and injectable bisphosphonates.