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Table 49: Osteoporosis and Bone Metabolism Agents


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Drug Category: Bone

Medication Class/Individual Agents: Osteoporosis and Bone Metabolism Agents

I. Prior-Authorization Requirements

 Osteoporosis and Bone Metabolism Agents – Bisphosphonates

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

alendronate / cholecalciferol Fosamax Plus D PA  
alendronate solution test  
alendronate tablet Fosamax test   #
etidronate test  
ibandronate IV Boniva PA  
ibandronate tablet Boniva test   #
pamidronate Aredia test   #
risedronate Actonel PA  
risedronate delayed-release Atelvia PA  
zoledronic acid 4 mg Zometa test   #
zoledronic acid 5 mg Reclast PA  

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.

  • Pharmacologic treatment should be offered to men and women who have known osteoporosis and to those who have experienced fragility fractures.
  • Pharmacologic treatment should be considered for men and women who are at risk for developing osteoporosis (patients with a T-score from –1.5 to –2.5, are receiving glucocorticoids, or are ≥ 62 years of age). 
  • The FDA recommends considering nonestrogen treatments prior to estrogen and/or hormone therapy for prevention of osteoporosis.
  • While combination therapy may produce small increases in bone mineral density (BMD) compared to monotherapy, the impact of combination therapy on fracture rates is unknown. The potential side effects and additional costs should be weighed against potential gains.
 

 Osteoporosis and Bone Metabolism Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

abaloparatide Tymlos PA  
burosumab-twza Crysvita PA  
calcitonin salmon injection Miacalcin PA  
calcitonin salmon nasal spray-Fortical Fortical test  
calcitonin salmon nasal spray-Miacalcin Miacalcin test   #
denosumab-Prolia Prolia PA  
denosumab-Xgeva Xgeva PA  
parathyroid hormone Natpara PA  
raloxifene Evista test   #
romosozumab-aqqg Evenity PA  
teriparatide PA  
teriparatide-Forteo Forteo PA   BP
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization 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.
 

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 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.

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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.
  • 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 (zoledronic acid 5 mg)

  • Documentation of the following is required:
    • appropriate diagnosis.


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

  • Documentation of all of the following is required:
    • appropriate diagnosis; 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 ibandronate IV; or
      • inadequate response to an adequate trial or adverse reaction to zoledronic acid 5 mg; or
      • inadequate response to an adequate trial or adverse reaction to Prolia; or
      • contraindication to intravenous bisphosphonates and Prolia; 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 
    • 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 ibandronate IV; or
      • inadequate response to an adequate trial or adverse reaction to zoledronic acid 5 mg; or
      • inadequate response to an adequate trial or adverse reaction to Prolia; or
      • contraindication to intravenous bisphosphonates and Prolia; 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:
      • 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 old; 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 old; 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)

  • 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 ibandronate IV; or
      • inadequate response to an adequate trial or adverse reaction to zoledronic acid 5 mg; or
      • inadequate response to an adequate trial or adverse reaction to Prolia; or
      • contraindication to intravenous bisphosphonates and Prolia; 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
    • For teriparatide:
      • medical necessity for the requested formulation instead of Forteo.

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, zoledronic acid 5 mg)

  • 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 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 (ibandronate IV, Prolia, zoledronic acid 5 mg)

  • 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: 08/2021


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Last updated 10/25/21

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