Table 49: Osteoporosis and Bone Metabolism Agents
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Bone
Medication Class/Individual Agents: Osteoporosis and Bone Metabolism Agents
I. Prior-Authorization Requirements
Osteoporosis and Bone Metabolism Agents – Bisphosphonates |
Clinical Notes |
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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.
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Osteoporosis and Bone Metabolism Agents – Not Otherwise Classified |
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# | This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent. |
BP | Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent. |
MB | This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable. |
M90 | Mandatory 90-day supply. After dispensing up to a 30-day supply initial fill, dispensing in a 90-day supply is required. May not include all strengths or formulations. Quantity limits and other restrictions may also apply. |
II. Therapeutic Uses
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 moderate-to-severe vasomotor symptoms associated with menopause
- treatment of X-Linked hypophosphatemia
- treatment/prevention of glucocorticoid-induced osteoporosis
- 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.
III. Evaluation Criteria for Approval
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.
- Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
- 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.
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)
- Documentation of all of the following is required:
- appropriate diagnosis; and
- inadequate response to an adequate trial or adverse reaction to alendronate.
Prevention of postmenopausal osteoporosis (Duavee)
- Documentation of all of the following is required:
- indication of prevention of postmenopausal osteoporosis; and
- one of the following:
- inadequate response to an adequate trial or adverse reaction to one oral bisphosphonate; or
- contraindication to all oral bisphosphonates; and
- inadequate response, adverse reaction, or contraindication to all of the following: one menopausal hormonal agent available without PA, raloxifene, zoledronic acid 5 mg; and
- requested quantity is ≤ one unit/day.
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 of 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 consult notes from an oncologist, hematologist, or orthopedic specialist are provided; and
- appropriate dosing.
- diagnosis of one of the following:
Primary or hypogonadal osteoporosis with a high risk for fracture or postmenopausal osteoporosis with a high risk for fracture (teriparatide 600 mcg/2.4 mL, teriparatide 620 mcg/2.48 mL)
- 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
- inadequate response or adverse reaction to one or contraindication to all of the following: ibandronate injection, Prolia, zoledronic acid 5 mg; and
- diagnosis of severe osteoporosis defined as at least one of the following:
- for teriparatide 620 mcg/2.48 mL, medical necessity for the requested formulation instead of teriparatide 600 mcg/2.4 mL.
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
- inadequate response or adverse reaction to one or contraindication to all of the following: ibandronate injection, Prolia, zoledronic acid 5 mg; and
- diagnosis of severe osteoporosis defined as at least one of the following:
- inadequate response to an adequate trial, adverse reaction, or contraindication to teriparatide 600 mcg/2.4 mL; and
- for calcitonin salmon injection, inadequate response, adverse reaction, or contraindication to calcitonin nasal spray.
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
- phosphaturic mesenchymal tumor cannot be resected or localized; and
- appropriate dosing.
- For recertification, documentation of positive response to therapy (defined as either improved member 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
- appropriate dose and frequency 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 moderate-to-severe vasomotor symptoms associated with menopause (Duavee)
- Documentation of all of the following is required:
- appropriate diagnosis; and
- inadequate response, adverse reaction to one or contraindication to all menopausal hormonal agents available without PA; and
- requested quantity is ≤ one unit/day.
Treatment of osteoporosis (Fosamax Plus D)
- Documentation of all of the following is required:
- appropriate diagnosis; and
- medical necessity for the combination product instead of 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
- member's current weight; and
- appropriate dosing.
- For recertification, documentation of positive response to therapy (defined as either improved member serum phosphorus concentration and/or radiographic improvement) is required.
Treatment/prevention of glucocorticoid-induced osteoporosis (teriparatide 600 mcg/2.4 mL, teriparatide 620 mcg/2.48 mL)
- Documentation of all of the following is required:
- appropriate diagnosis or chronic glucocorticoid use for at least three months in duration; 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
- inadequate response or adverse reaction to one or contraindication to all of the following: ibandronate injection, Prolia, zoledronic acid 5 mg; and
- diagnosis of severe osteoporosis defined as at least one of the following:
- for teriparatide 620 mcg/2.48 mL, medical necessity for the requested formulation instead of teriparatide 600 mcg/2.4 mL.
Treatment/prevention of glucocorticoid-induced osteoporosis (risedronate, risedronate delayed-release)
- Documentation of all of the following is required:
- appropriate diagnosis or chronic glucocorticoid use for at least three months in duration; and
- inadequate response to an adequate trial or adverse reaction to an oral bisphosphonate.
Treatment/prevention of glucocorticoid-induced osteoporosis (Prolia)
- Documentation of all of the following is required:
- appropriate diagnosis or chronic glucocorticoid use for at least three months in duration; and
- one of the following:
- inadequate response to an adequate trial or adverse reaction to one 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 (alendronate solution, Binosto)
- Documentation of all of the following is required:
- appropriate diagnosis; and
- medical necessity for requested formulation as noted by one of the following:
- member utilizes tube feeding (G-tube/J-tube); or
- member has a swallowing disorder or condition affecting ability to swallow; or
- member is < 13 years of age.
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.
Original Effective Date: 05/2010
Last Revised Date: 08/2024
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Last updated 08/12/24