HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-30-012
Topic:
Denosumab (Prolia, Xgeva)
Section:
Injections
Effective Date:
July 27, 2020
Issued Date:
July 27, 2020
Last Revision Date:
July 2020
Annual Review:
September 2019
 
 

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 κ 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.

Policy Position

Denosumab (Prolia)

Denosumab (Prolia) may be considered medically necessary for ANY of the following indications:

  • 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 a 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 bisphosphonate:
      • 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:
      • 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, or as treatment of glucocorticoid-induced osteoporosis in men and women 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:
      • 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:
      • 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.

Denosumab (Prolia) is considered experimental/investigational when all of the criteria specified above are not met, or for the treatment of all other indications, and therefore non-covered. There is a lack of evidence based literature to confirm the efficacy and safety for any other indication.

J0897

 

 

 

 

 

 




Denosumab (Xgeva)

Food and Drug Administration (FDA) Indications

Denosumab (Xgeva) may be considered medically necessary for ANY of the following indications:

  • 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.

National Comprehensive Cancer Network (NCCN) Indications

Denosumab (Xgeva) may be considered medically necessary for ANY of the following indications:

  • For the prevention of skeletal-related events in men with castration resistant prostate cancer who have documented bone metastases and creatinine clearance greater than 30 mL/min; or
  • For the prevention or treatment of osteoporosis during ADT for individuals with prostate cancer who have a high fracture risk; or
  • For use as second-line therapy for osteopenia or osteoporosis in individuals with systemic mastocytosis with bone pain not responding to bisphosphonates, or for individuals who are not candidates for bisphosphonates due to renal insufficiency; or
  • As treatment for bone metastases of papillary carcinoma, follicular carcinoma, Hürthle cell carcinoma, or medullary carcinoma of the thyroid; or
  • As palliative care for bone metastases for anaplastic carcinoma of the thyroid; or
  • As supportive therapy in individuals with bone metastases for non-small cell lung cancer; or
  • As a component of best supportive care for bony metastases for kidney cancer; or
  • For treatment of GCTB when therapy is used as a:
    • Single agent or combined with interferon alfa or radiation therapy for localized disease; or
    • Single agent for metastatic disease; or
  • As treatment to maintain or improve BMD, and reduce the risk of fractures in natural or induced postmenopausal women receiving adjuvant endocrine therapy for invasive breast cancer along with calcium and vitamin D supplementation; or
  • As treatment in combination with calcium and vitamin D supplementation in addition to chemotherapy or endocrine therapy for bone metastasis in individuals with invasive breast cancer with expected survival of 3 months or greater and adequate renal function;
  • For the treatment of multiple myeloma when used in combination with primary myeloma therapy.

Denosumab (Xgeva) is considered experimental/investigational when all of the criteria specified above are not met, or for the treatment of all other indications, and therefore non-covered. There is a lack of evidence based literature to confirm the efficacy and safety for any other indication.

J0897

 

 

 

 

 

 




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 U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

***

All individuals should be monitored for hypocalcemia and denosumab (Prolia, Xgeva) is contraindicated for individuals with hypocalcemia. 


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

M80.80XA

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

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

 



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of Denosumab (Prolia, Xgeva) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract, and subject to the applicable laws of your state.


Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as: 
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as: 
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator. 

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you. 

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: 

U.S. Department of Health and Human Services 
200 Independence Avenue, SW 
Room 509F, HHH Building 
Washington, D.C. 20201 
1-800-368-1019, 800-537-7697 (TDD) 

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. 

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. 





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.