Average length of coverage: ​

Coverage will be provided for 12 months and may be renewed

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Dosing limits: 

A. Quantity Limit (max daily dose) [NDC Unit]:

-Prolia 60 mg/1 mL single-use prefilled syringe: 1 syringe every 6 months

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B. Max Units (per dose and over time) [HCPCS Unit]:

-Prolia: 

All indications: 60 billable units every 6 months 

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Initial Approval Criteria for Prolia

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Universal Criteria

• Patient must be supplementing with 1,000 mg of calcium and at least 400 IU of vitamin D daily; AND

• Patient must not have hypocalcemia; AND

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Coverage is provided in the following conditions: 

• Patient is at least 18 years of age; AND

• Patient must be at a high risk for fracture**; AND

• Pregnancy ruled out prior to starting therapy in women of child-bearing potential; AND

 

Osteoporosis in Men and Women †

• Women only: Patient must be post-menopausal; AND

• Patient has a documented diagnosis of osteoporosis indicated by one or more of the following:

  • Hip DXA (femoral neck or total hip) or lumbar spine T-score ≤-2.5 and/or forearm DXA 33% (one-third) of the radius; OR

  • T-score ≤-1 or low bone mass and a history of fragility fracture to the hip or spine; OR

  • T-score between -1 and -2.5 with a FRAX 10-year probability for major fracture ≥20% or hip fracture ≥3%; AND

• Documented treatment failure or ineffective response± to a minimum (12) month trial on previous therapy with bisphosphonates (oral or IV) such as alendronate, risedronate, ibandronate, or zoledronic acid; OR

• Patient has a documented contraindication* or intolerance to BOTH oral bisphosphonates AND intravenous (IV) bisphosphonates such as alendronate, risedronate, ibandronate, or zoledronic acid

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Glucocorticoid-Induced Osteoporosis †

• Patient will be initiating or is continuing systemic glucocorticoid therapy at a daily dosage equivalent to ≥ 7.5 mg of prednisone and is expected to remain on glucocorticoid therapy for at least 6 months; AND

  • Documented treatment failure or ineffective response± to a minimum (12) month trial on previous therapy with bisphosphonates (oral or IV) such as alendronate, risedronate, ibandronate, or zoledronic acid; OR

  • Patient has a documented contraindication* or intolerance to BOTH oral bisphosphonates AND intravenous (IV) bisphosphonates such as alendronate, risedronate, ibandronate, or zoledronic acid

 

Osteoporosis treatment and prevention in prostate cancer patients †

• Documented Hip DXA (femoral neck or total hip) or lumbar spine T-score ≤-1 (or patient meets the diagnostic criteria for osteoporosis above); AND

• Patient must be receiving androgen deprivation therapy for non-metastatic prostate cancer

 

Osteoporosis treatment and prevention in breast cancer patients †

• Patient must be receiving adjuvant aromatase inhibitor therapy for breast cancer

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±Ineffective response is defined as one or more of the following:

• Decrease in T-score in comparison with baseline T-score from DXA scan

• Patient has a new fracture while on bisphosphonate therapy Moda Health Plan, Inc. Medical Necessity Criteria Page 3/10 **High risk for fractures include, but are not limited to, one or more of the following:

• History of an osteoporotic fracture as an adult

• Parental history of hip fracture

• Low BMI

• Rheumatoid arthritis

• Alcohol intake (3 or more drinks per day)

• Current smoking

• History of oral glucocorticoids ≥5 mg/d of prednisone (or equivalent) for >3 months (ever) *Examples of contraindications to oral bisphosphonate therapy include the following:

• Documented inability to sit or stand upright for at least 30 minutes

• Documented pre-existing gastrointestinal disorder such as inability to swallow, Barrett’s esophagus, esophageal stricture, dysmotility, or achalasia

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Renewal Criteria

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Coverage can be renewed based on the following criteria: 

• Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND

• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: severe symptomatic hypocalcemia, osteonecrosis of the jaw, atypical femoral fractures, dermatological adverse reactions, severe infection, severe hypersensitivity/anaphylaxis, musculoskeletal pain, etc.; AND

 

Prolia

• Disease response as indicated by one or more of the following:

  • Absence of fractures

  • Increase in bone mineral density compared to pretreatment baseline; AND

• Osteoporosis in Men and Women ONLY:

  • After 5 years of treatment, patient will have a repeat DXA performed; AND

    • Patients with low-to moderate risk disease will have therapy changed to an oral or IV bisphosphonate unless there is a contraindication or intolerance to both dosage forms

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Dosage/Administration

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Prolia Indication Dose

All indications 60 mg subcutaneously by a health care provider every 6 months

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Billing Code/Availability Information 

HCPCS Code:

J0897 – Injection, denosumab, 1 mg; 1 mg = 1 billable unit

NDC:

Prolia 60 mg/1 mL single-use prefilled syringe: 55513-0710-XX