Authorization duration

Prior authorization is required for denosumab and will be issued initially for 12 months (365 days); renewals may be approved every 12 months (365 days) thereafter.

Prior authorization required when universal and indication criteria met

Submit a prior authorization request when the member meets the universal criteria and the indication‑specific medical necessity criteria (including documentation of calcium 1,000 mg and vitamin D ≥400 IU supplementation, absence of FDA‑labeled contraindications, and avoidance of concurrent denosumab/bisphosphonate/romosozumab/parathyroid hormone analog therapy).

Prior authorization considered (NQTL assessment)

The NQTL Factor Checklist was used to design utilization management for denosumab; prior authorization is considered based on indication, safety/efficacy, and drug cost per that assessment.

PA applied per NQTL assessment

Prior authorization is applied taking into account the NQTL assessment factors — indication, safety/efficacy, and cost — and may be required for coverage decisions per the checklist.

Bisphosphonate trial (12 months) required for many osteoporosis indications

For many osteoporosis indications, document a trial and inadequate response or intolerance to BOTH oral and IV bisphosphonates after a minimum 12‑month trial unless the member meets very high fracture‑risk exemptions or has documented contraindications.

• Minimum 12‑month trial on oral or IV bisphosphonates (e.g., alendronate, risedronate, ibandronate, zoledronic acid) or documented contraindication/intolerance to BOTH forms.
• Members with very high fracture risk are exempt from the bisphosphonate trial requirement.

Consider switching to oral/IV bisphosphonate after specified durations

For osteoporosis and glucocorticoid‑induced osteoporosis, the policy directs that after specified treatment durations clinicians should consider changing therapy to an oral or IV bisphosphonate for members with low‑to‑moderate risk unless contraindicated or intolerant.

• Osteoporosis: after 5 years obtain repeat DXA and consider change to oral/IV bisphosphonate for low‑to‑moderate risk unless contraindicated.
• Glucocorticoid‑induced osteoporosis: after 2 years obtain repeat DXA and consider change to oral/IV bisphosphonate for low‑to‑moderate risk unless contraindicated.

Step therapy may be considered per NQTL checklist

The NQTL assessment indicates utilization management strategies such as step therapy may be considered when designing PA rules due to indication, safety/efficacy, and drug cost.

No explicit step therapy requirements in these sections

No explicit step therapy rules are specified in this portion of the policy; the document notes consideration of utilization management but does not list specific step therapy requirements here.

Clinical documentation required for osteoporosis indications

Provide clinical documentation to support osteoporosis indications: DXA T‑score results (≤‑2.5 or specified ranges), history of fragility or other qualifying fractures, FRAX 10‑year probabilities, and evidence of prior bisphosphonate treatment and response.

• DXA T‑score by site (lumbar spine, femoral neck, total hip, or 33% radius) per policy thresholds.
• History of fragility fracture (hip, spine) or fracture types specified for T‑score between ‑1.0 and ‑2.5.
• FRAX 10‑year probability for major fracture ≥20% or hip ≥3%.
• Documentation of prior bisphosphonate trial and effectiveness or ineffective response (see definition of ineffective response).

Document glucocorticoid dose and duration for GIOP

For glucocorticoid‑induced osteoporosis, document the current or planned systemic glucocorticoid dose (prednisone equivalent) and expected duration (≥2.5 mg/day and expected ≥3 months) plus fracture‑risk evidence as required.

• Document daily prednisone‑equivalent dose (≥2.5 mg) and planned duration ≥3 months.
• Provide fracture risk factors or FRAX adjustments as applicable (see glucocorticoid dose adjustments in policy).

Document prior trial and inadequate response/contraindication to zoledronic acid or bisphosphonates

When prior bisphosphonate use or zoledronic acid is required (e.g., SRE prevention or prior therapy requirements), include documentation of the prior trial and inadequate response, contraindication, or intolerance — for SRE prevention a trial of zoledronic acid ≥3 months is expected; for hypercalcemia of malignancy a ≥7‑day IV bisphosphonate trial is referenced.

• For SRE prevention: documentation of ≥3 month trial of zoledronic acid unless inadequate response or contraindication.
• For hypercalcemia of malignancy: evidence of ≥7 day trial of IV bisphosphonates or documented contraindication/intolerance.
• Document inadequate response per policy (decline in T‑score or new fracture while on bisphosphonate).

Document exact product name or NDC

Include the exact product identification (brand name and/or NDC) for the denosumab product requested to support medical necessity and correct billing (policy lists multiple NDCs and product names).

• Provide NDC or exact drug name (e.g., Prolia 60 mg syringe NDC 55513‑0710‑xx or Xgeva 120 mg vial NDC 55513‑0730‑xx) as applicable.

Use Appendix 1 ICD‑10 diagnosis codes to support medical necessity

Support the request with the appropriate ICD‑10 diagnosis code from Appendix 1 (examples include M80.*, M81.*, and relevant malignancy codes C00‑C99) to demonstrate medical necessity.

Document calcium and vitamin D supplementation and FDA contraindications

Document that the member is receiving calcium (1,000 mg) and vitamin D (at least 400 IU) daily, or document an FDA‑labeled contraindication (e.g., hypocalcemia); failure to document supplementation or contraindications may render the request incomplete or subject to denial.

• Document daily calcium 1,000 mg and vitamin D ≥400 IU supplementation, or record a documented contraindication to supplementation.
• Document absence of FDA‑labeled contraindications such as hypocalcemia and pregnancy status in biologic females of child‑bearing potential.

Risk of denial if supplementation, contraindication, or concurrent‑use documentation is missing

Requests missing documentation that the member is receiving calcium/vitamin D as necessary, or lacking documentation of FDA contraindications (e.g., hypocalcemia), or documenting concurrent use with excluded bone agents may be denied or considered incomplete.

Utilization review/PA may be applied per NQTL checklist

Utilization review or prior authorization may be applied based on the NQTL checklist conclusions; providers should expect PA and utilization management to be used where indicated by the checklist.

NQTL considerations inform prior authorization design

Prior authorization decisions and utilization management reflect NQTL considerations (indication, safety/efficacy, and drug cost); PA may limit duration or extent of benefit consistent with the checklist.

Meet Site of Care specialty infusion program requirements

Members in scope for the Site of Care specialty infusion program must meet all program requirements for coverage under that program.

Administer subcutaneously by a health care provider per dosing schedule

Denosumab administration must be given subcutaneously by a health care provider per the dosing schedule specified in the policy.

Follow CMS/NCD/LCD/LCA rules for Medicare Part B outpatient administration

For Medicare Part B outpatient administration, site‑specific CMS NCD/LCD/LCA rules apply and providers must follow applicable Medicare coverage determinations for Part B claims.

Policy lists covered branded and biosimilar denosumab products

The policy enumerates covered branded and biosimilar denosumab products (e.g., Prolia, Xgeva and multiple biosimilars listed in Appendix 1).

J0897 and biosimilar Q‑codes included as covered HCPCS codes

HCPCS/J‑code J0897 (denosumab) is listed along with biosimilar Q‑codes (e.g., Q5136, Q5157) as covered HCPCS codes for denosumab products.

Biosimilar Q‑codes listed alongside J0897 (supporting coverage)

The policy includes multiple references listing biosimilar HCPCS Q‑codes alongside J0897 to support coverage of biosimilar denosumab products.

Additional biosimilar Q‑codes and code change notes documented

Additional biosimilar Q‑codes and transitioning codes (including J3590 discontinuation) are documented to reflect covered billing options and upcoming code changes.

Multiple branded/biosimilar products listed; no preference order stated

The policy lists multiple branded and biosimilar denosumab products with associated Q‑codes and NDCs (e.g., Prolia / Xgeva family), and does not state any explicit preference order among them.

Many branded and biosimilar product names listed; no stated preferencing

Appendix 1 and coding sections list numerous brand and biosimilar product names (Prolia, Xgeva, Jubbonti, Ospomyv, Bomyntra, etc.) without an explicit preferencing rule in the policy text.