Denosumab (ARCHIVED)

Policy ID: I-30-020

Section: Injections

Effective Date: January 01, 2021

Revised Date: October 16, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-30-020

Section: Injections

Effective Date: January 01, 2021

Revised Date: October 16, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Denosumab (Prolia®, Xgeva®) is a fully human monoclonal antibody against the receptor activator of nuclear factor kappa-B ligand (RANKL), a protein that is essential for the formation, function, and survival of osteoclasts. Denosumab (Prolia, Xgeva) prevents RANKL from activating its receptor, receptor activator of nuclear factor B (RANK), on the surface of the osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone. Jubbonti (denosumab-bbdz) is a biosimilar to Prolia. Wyost (denosumab-bbdz) is a biosimilar to Xgeva.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Denosumab (Prolia) or Prolia biosimilars

Denosumab (Prolia) or a Prolia biosimilar may be approved for ANY of the following:

As treatment to increase bone mass in men receiving androgen deprivation therapy (ADT) for non-metastatic prostate cancer at high risk for fracture as defined by EITHER of the following:
- Individual has T-score less than -1 in combination with multiple risk factors for fracture; or
- Previous history of osteoporotic fracture; or
As treatment to increase bone mass in women receiving adjuvant aromatase therapy for breast cancer at high risk for fracture as defined by EITHER of the following:
- Individual has T-score less than -1 in combination with multiple risk factors for fracture; or
- Previous history of osteoporotic fracture; or
As treatment for postmenopausal women and to increase bone mass in men with osteoporosis who have EITHER of the following:
- The individual has a history of fragility fractures; or
- T-score of -2.5 or less and EITHER of the following
  - The individual has had an adequate trial and failure of at least one (1) bisphosphonate:
    NOTE: Trial and failure defined as a decrease in bone mineral density (BMD) despite trial of bisphosphonate therapy (e.g., alendronate, ibandronate, risedronate, zoledronic acid); or
  - The individual has a contraindication to all bisphosphonates:
    NOTE: Contraindications to bisphosphonate therapy include but are not limited to hypocalcemia, esophageal ulcerations, esophageal stricture, Barrett's esophagus, active ulcers, renal impairment, and an inability to stand or sit upright for 30 minutes; or
As treatment to prevent fractures in men and postmenopausal women with T-score between -1 and -2.5, as treatment of glucocorticoid-induced osteoporosis in men and women 40 years of age or older on prednisone (or equivalent) five (5) mg or higher for at least three (3) months of use, or has a history of previous fragility fracture with the following:
- The individual is at high risk for an osteoporotic fracture as substantiated by EITHER of the following:
  - The individual has a history of previous osteoporotic fracture; or
  - The individual has a 10-year risk of a major osteoporotic fracture greater than or equal to 20%; or
  - The individual has a 10-year risk of hip fracture greater than or equal to 3%; and
- The individual has had an adequate trial and failure of at least one bisphosphonate
  NOTE: Trial and failure defined as a decrease in BMD despite trial of bisphosphonate therapy (e.g., alendronate, ibandronate, risedronate, zoledronic acid); or
- The individual has a contraindication to all bisphosphonates
  NOTE: Contraindications to bisphosphonate therapy include but are not limited to hypocalcemia, esophageal ulcerations, esophageal stricture, Barrett's esophagus, active ulcers, renal impairment, and an inability to stand or sit upright for 30 minutes; or
As treatment for an individual at high risk for an osteoporotic fracture defined as the following:
- The individual has a history of previous fracture or T-score less than -3.0; and
- The individual has a 10-year risk of a major osteoporotic fracture greater than or equal to 30%; or
- The individual has a 10-year risk of hip fracture greater than or equal to 4.5%; or
Information has been provided that indicates the individual has been treated with denosumab (Prolia) within the last 210 days; or
The prescriber states that the individual has been treated with denosumab (Prolia) within the past 210 days and is at risk if therapy is changed; or

Compendia Sources

Denosumab (Prolia) or a Prolia biosimilar may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of denosumab (Prolia) or a Prolia biosimilar for all other indications not listed in this policy is considered not medically necessary and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J0897

Q5136

Denosumab (Xgeva) or Xgeva biosimilars

Denosumab (Xgeva) or a Xgeva biosimilar may be considered medically necessary for ANY of the following:

As treatment for prevention of skeletal-related events in individuals:
- With EITHER:
  - Multiple myeloma; or
  - Bone metastases from solid tumors; and
- Prior treatment with an IV bisphosphonate (e.g. pamidronate or zoledronic acid) has been ineffective, contraindicated, or not tolerated; or
For the treatment of giant cell tumor of the bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity in both individuals 18 years of age and older and skeletally mature adolescents (e.g., at least one (1) mature long bone); or
As treatment of hypercalcemia of malignancy (HCM) refractory to intravenous bisphosphonate therapy when the following criteria are met:
- Prior treatment with an IV bisphosphonate (e.g., pamidronate or zoledronic acid) has been ineffective, contraindicated, or not tolerated; or
Information has been provided that indicates the individual has been treated with denosumab (Xgeva) within the last 210 days; or
The prescriber states that the individual has been treated with denosumab (Xgeva) within the past 210 days and is at risk if therapy is changed; or

Compendia Sources

Denosumab (Xgeva) or a Xgeva biosimilar may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of denosumab (Xgeva) of a Xgeva biosimilar for all other indications not listed in this policy is considered not medically necessary and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J0897

Q5136

Reauthorization Criteria (non-oncologic indications)

Continuation of therapy for denosumab (Prolia) or a Prolia biosimilar may be considered medically necessary when ALL the following criteria are met:
- Reauthorization is indicated for postmenopausal osteoporosis, or to increase bone mass in high-risk individuals; and
- Provider attestation of positive clinical response; and
- Reauthorization will be for a period of 12 months.

The use of denosumab (Prolia, Xgeva) or a denosumab biosimilar for all other indications not listed in this policy is considered not medically necessary and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J0897

Q5136

Note: NCCN recognizes that the use of a bisphosphonate (oral/IV) or denosumab is acceptable to maintain or improve bone mineral density and reduce risk of fractures in postmenopausal (natural or induced) individuals receiving adjuvant endocrine therapy.

Note: Therapy with denosumab (Prolia, Xgeva) is appropriate for continuation when an individual shows stability or improvement in their condition.

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Note: All individuals should be monitored for hypocalcemia. Denosumab (Prolia, Xgeva) is contraindicated for individuals with hypocalcemia.

Note: Denosumab (Prolia, Xgeva) is NOT to be used in combination with ANY of the following:

Parathyroid hormone analogs (e.g., Forteo, Tymlos); or
IgG2 monoclonal antibody and sclerostin inhibitor (Evenity).

Diagnosis Codes

Covered Diagnosis Codes for Denosumab (Prolia)

C61

M80.00XA

M80.00XD

M80.00XG

M80.00XK

M80.00XP

M80.00XS

M80.011A

M80.011D

M80.011G

M80.011K

M80.011P

M80.011S

M80.012A

M80.012D

M80.012G

M80.012K

M80.012P

M80.012S

M80.019A

M80.019D

M80.019G

M80.019K

M80.019P

M80.019S

M80.021A

M80.021D

M80.021G

M80.021K

M80.021P

M80.021S

M80.022A

M80.022D

M80.022G

M80.022K

M80.022P

M80.022S

M80.029A

M80.029D

M80.029G

M80.029K

M80.029P

M80.029S

M80.031A

M80.031D

M80.031G

M80.031K

M80.031P

M80.031S

M80.032A

M80.032D

M80.032G

M80.032K

M80.032P

M80.032S

M80.039A

M80.039D

M80.039G

M80.039K

M80.039P

M80.039S

M80.041A

M80.041D

M80.041G

M80.041K

M80.041P

M80.041S

M80.042A

M80.042D

M80.042G

M80.042K

M80.042P

M80.042S

M80.049A

M80.049D

M80.049G

M80.049K

M80.049P

M80.049S

M80.051A

M80.051D

M80.051G

M80.051K

M80.051P

M80.051S

M80.052A

M80.052D

M80.052G

M80.052K

M80.052P

M80.052S

M80.059A

M80.059D

M80.059G

M80.059K

M80.059P

M80.059S

M80.061A

M80.061D

M80.061G

M80.061K

M80.061P

M80.061S

M80.062A

M80.062D

M80.062G

M80.062K

M80.062P

M80.062S

M80.069A

M80.069D

M80.069G

M80.069K

M80.069P

M80.069S

M80.071A

M80.071D

M80.071G

M80.071K

M80.071P

M80.071S

M80.072A

M80.072D

M80.072G

M80.072K

M80.072P

M80.072S

M80.079A

M80.079D

M80.079G

M80.079K

M80.079P

M80.079S

M80.08XA

M80.08XD

M80.08XG

M80.08XK

M80.08XP

M80.08XS

M80.0AXA

M80.0AXD

M80.0AXG

M80.0AXK

M80.0AXP

M80.0AXS

M80.80XA

M80.80XD

M80.80XG

M80.80XK

M80.80XP

M80.80XS

M80.811A

M80.811D

M80.811G

M80.811K

M80.811P

M80.811S

M80.812A

M80.812D

M80.812G

M80.812K

M80.812P

M80.812S

M80.819A

M80.819D

M80.819G

M80.819K

M80.819P

M80.819S

M80.821A

M80.821D

M80.821G

M80.821K

M80.821P

M80.821S

M80.822A

M80.822D

M80.822G

M80.822K

M80.822P

M80.822S

M80.829A

M80.829D

M80.829G

M80.829K

M80.829P

M80.829S

M80.831A

M80.831D

M80.831G

M80.831K

M80.831P

M80.831S

M80.832A

M80.832D

M80.832G

M80.832K

M80.832P

M80.832S

M80.839A

M80.839D

M80.839G

M80.839K

M80.839P

M80.839S

M80.841A

M80.841D

M80.841G

M80.841K

M80.841P

M80.841S

M80.842A

M80.842D

M80.842G

M80.842K

M80.842P

M80.842S

M80.849A

M80.849D

M80.849G

M80.849K

M80.849P

M80.849S

M80.851A

M80.851D

M80.851G

M80.851K

M80.851P

M80.851S

M80.852A

M80.852D

M80.852G

M80.852K

M80.852P

M80.852S

M80.859A

M80.859D

M80.859G

M80.859K

M80.859P

M80.859S

M80.861A

M80.861D

M80.861G

M80.861K

M80.861P

M80.861S

M80.862A

M80.862D

M80.862G

M80.862K

M80.862P

M80.862S

M80.869A

M80.869D

M80.869G

M80.869K

M80.869P

M80.869S

M80.871A

M80.871D

M80.871G

M80.871K

M80.871P

M80.871S

M80.872A

M80.872D

M80.872G

M80.872K

M80.872P

M80.872S

M80.879A

M80.879D

M80.879G

M80.879K

M80.879P

M80.879S

M80.88XA

M80.88XD

M80.88XG

M80.88XK

M80.88XP

M80.88XS

M80.8AXA

M80.8AXD

M80.8AXG

M80.8AXK

M80.8AXP

M80.8AXS

M81.0

M81.6

M81.8

M85.9

M89.9

M94.9

Z79.811

Z87.310

Z87.311

Z87.312

Z87.81

Covered Diagnosis Codes for Denosumab (Xgeva)

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C40.00

C40.01

C40.02

C40.10

C40.11

C40.12

C40.20

C40.21

C40.22

C40.30

C40.31

C40.32

C40.80

C40.81

C40.82

C40.90

C40.91

C40.92

C41.0

C41.1

C41.2

C41.3

C41.4

C41.9

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

C61

C64.1

C64.2

C64.9

C65.1

C65.2

C65.9

C73

C79.51

C79.52

C90.00

C90.01

C90.02

C90.10

C90.11

C90.12

C90.20

C90.21

C90.22

C90.30

C90.31

C90.32

C96.20

C96.21

C96.22

C96.29

D47.02

D48.0

E83.52

Z85.528

Professional Statements and Societal Positions Guidelines

ND Committee Review

Internal Medical Policy Committee 11-19-2020 Adopted new pre-certification policy

Internal Medical Policy Committee 1-19-2021

Updated FDA indications for Prolia, and
Updated NCCN recommendations for Prolia and Xgeva

Internal Medical Policy Committee 3-23-2022 Added reauthorization criteria

Internal Medical Policy Committee 3-23-2023 Effective May 01, 2023

Removed NCCN recommendations and added this statement ' Drug may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'
Updated experimental/investigational statement

Internal Medical Policy Committee 3-19-2024 Effective May 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 7-16-2024 Effective September 01, 2024

Updated denosumab (Prolia) criteria; and
Changed policy title to Denosumab; and
Added denosumab biosimilar language

Internal Medical Policy Committee 9-17-2024 Effective October 01, 2024

Added new code, Q5136, for denosumab-bbdz (Jubbonti/Wyost) to the policy

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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Medical Policies Quick Search

Denosumab (ARCHIVED)

This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.

Description

Policy Application

Criteria

Procedure Codes

Procedure Codes

Procedure Codes

Diagnosis Codes

Covered Diagnosis Codes for Denosumab (Prolia)

Covered Diagnosis Codes for Denosumab (Xgeva)

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**