Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual
Policy #:	2019009
Category:	Pharmacy
Initiated:	September 2019
Last Review:	September 2023

Romosozumab-aqqg (e.g., Evenity®)

Description:

Romosozumab is an IgG2 humanized monoclonal antibody that binds and inhibits sclerostin. Sclerostin inhibitors are a new therapeutic class of osteoporosis therapies and romosozumab is first in the class. Sclerostin is the protein product of the SOST gene and is secreted by the osteocyte. Sclerostin is thought to act by binding to low-density lipoprotein receptor-related proteins 4, 5, and 6 (LRP4, LRP5, and LRP6). Romosozumab is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, or multiple risk factors for fracture, and for those individuals who have failed or are intolerant to other available osteoporosis therapy.

In 2020, the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE, 2020) osteoporosis treatment guidelines added a category of “very-high-risk” to the risk stratification for postmenopausal women with osteoporosis. Alendronate, denosumab, risedronate, and zoledronate are appropriate as initial therapy for most osteoporotic individuals with high fracture risk. Abaloparatide, denosumab, romosozumab, teriparatide, and zoledronate should be considered for individuals unable to use oral therapy and as initial therapy for individuals at very high fracture risk. The AACE/ACE further state that, “Romosozumab will likely be viewed as a ‘rescue drug’ for individuals at very high fracture risk” in the near term. It is an option for individuals previously treated with teriparatide or abaloparatide, and future retreatment with romosozumab may be possible.

Very High Fracture Risk for postmenopausal women with osteoporosis may be defined as having at least ONE of the following (AACE/ACE, 2020):

a recent fracture (e.g., within the past 12 months),
fractures while on approved osteoporosis therapy,
multiple fractures,
fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids),
very low T-score (e.g., less than −3.0),
high risk for falls or history of injurious falls,
very high fracture probability by FRAX® (fracture risk assessment tool) (e.g., major osteoporosis fracture >30%, hip fracture >4.5%) or other validated fracture risk algorithm

A fragility fracture is defined as those fractures occurring spontaneously or from minor trauma, such as a fall from a standing height or less. Fragility fractures result from mechanical forces that would not ordinarily result in fracture. Reduced bone density is a major risk factor for fragility fractures.

The original FDA submission of romosozumab was denied based on cardiovascular safety findings in the pivotal studies. In response, the indication was narrowed to women at high risk for fracture and a black box warning was added. In addition, there is a lack of long-term safety and efficacy data with romosozumab; therefore, the label limits treatment duration to one year (12 monthly doses).

The black box warning for Evenity indicates the potential risk of myocardial infarction (MI), stroke, and cardiovascular death. It should not be initiated in individuals who have had an MI or stroke within the preceding year and should be discontinued if a individual experiences an MI or stroke during therapy.

Regulatory status

On April 9, 2019, Evenity® was approved by the FDA for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

Coding

See CPT/HCPCS Code section below.

Policy/
Coverage:

Effective February 1, 2020, Prior Approval is required for romosozumab-aqqg.

The initial use of this drug requires documentation of direct involvement of a physician with advanced training in the treatment of osteoporosis (e.g., endocrinologist, mineral metabolism expert, or rheumatologist) in both the ordering and evaluation as well as a signature in the medical records submitted for prior approval.

The Step Therapy Medication Act is applicable to fully insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart, Tyson or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.

Effective September 1, 2023

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

INITIAL APPROVAL STANDARD REVIEW for up to 12 months:

The use of romosozumab-aqqg meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL of the below criteria are met:

1. Individual is a postmenopausal female with the following (FDA, 2020; AACE/ACE, 2020):

a. A diagnosis of severe osteoporosis defined as a bone mineral density (BMD) T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of <-3.5 in the absence of a fragility fracture, or T-score < -3.0 with a fragility fracture OR

b. A clinical diagnosis based on history of multiple fragility fractures, multiple vertebral fractures, hip fracture etc; AND

2. The individual has been refractory to, is intolerant of, or has a contraindication to bisphosphonate agents (FDA, 2020; AACE/ACE, 2020):

a. Has been refractory to a prior trial of an oral and an IV bisphosphonate (i.e zoledronic acid; alendronate; etidronate; risedronate; ibandronate; pamidronate; tiludronate) OR

b. Is intolerant to or has a contraindication to oral bisphosphonates as defined by:

i. Hypersensitivity to TWO oral bisphosphonates (one of which must be alendronate); OR

ii. Inability to stand or sit upright for at least 30 minutes; OR

iii. Pre-existing gastrointestinal disorders (Barrett's esophagus, hypersecretory disorders, delayed esophageal emptying, atrophic gastritis, etc.); OR

iv. Uncorrected hypocalcemia; OR

v. Severe renal insufficiency as defined by creatinine clearance less than 35 mL/min for alendronate agents or creatinine clearance less than 30 mL/min for risedronate and ibandronate; AND

3. Individual has been refractory to, is intolerant of, or has a contraindication to one of the following:

a. Teriparatide (e.g., Forteo) - has completed a two-year course, and osteoporosis persists [(T-score < -3.0) or a history of a fragility fracture after completion of therapy], OR

b. Abaloparatide (e.g., Tymlos) - has completed a two-year course, and osteoporosis persists [(T-score < -3.0) or a history of a fragility fracture after the above therapy], AND

4. Individual has failed a trial of denosumab (e.g., Prolia), and osteoporosis persists [(T-score < -3.0) or a history of a fragility fracture after completion of therapy], (AACE/ACE, 2020) AND

5. Individual has not had a stroke or MI in the past 12 months (FDA, 2020) AND

6. Individual is not using romosozumab-aqqg (e.g., Evenity) in combination with ANY of the following AACE/ACE, 2020):

a. Denosumab (e.g., Prolia) OR

b. Bisphosphonates (i.e zoledronic acid; alendronate; etidronate; risedronate; ibandronate; pamidronate; tiludronate) OR

c. Raloxifene (e.g., Evista) OR

d. Calcitonin nasal spray (e.g., Miacalcin/Fortical) OR

e. Zoledronic acid (e.g., Reclast) OR

f. Teriparatide (e.g., Forteo) OR

g. Abaloparatide (e.g., Tymlos); AND

7. Individual will utilize Romosozumab-aqqg (e.g., Evenity®) for a total duration of 12 months (AACE/ACE, 2020) in their lifetime AND

8. Must be dosed in accordance with the FDA label.

Dosage and Administration

Dosing per FDA Guidelines

The recommended dose of Romosozumab-aqqg is a total dose of 210 mg (two 105 mg injections) subcutaneous once a month for no more than 12 doses lifetime. Adequately supplement calcium and vitamin D during treatment.

Romosozumab-aqqg is available as 105 mg/1.17 mL solution in a single-use prefilled syringe. A full dose of romosozumab-aqqg requires two single-use prefilled syringes.

Romosozumab should be administered by a healthcare provider.

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Romosozumab-aqqg for any indication or circumstance other than those described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria, romosozumab-aqqg for any indication or circumstance than those described above is considered investigational.

Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective February 1, 2020 Prior Approval is required for romosozumab-aqqg.

The initial use of this drug requires documentation of direct involvement of a physician with advanced training in the treatment of osteoporosis (e.g. endocrinologist, mineral metabolism expert, or rheumatologist) in both the ordering and evaluation as well as a signature in the medical records submitted for prior approval.

The Step Therapy Medication Act is applicable to fully-insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart, Tyson or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.

Effective December 15, 2021

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

The use of romosozumab-aqqg meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when ALL of the below criteria (#1- #7) are met:

INITIAL APPROVAL STANDARD REVIEW for up to 12 months:

Individual is a postmenopausal female with the following (FDA, 2020; AACE/ACE, 2020):

A diagnosis of severe osteoporosis defined as a bone mineral density (BMD) T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of <-3.5 in the absence of a fragility fracture, or T-score < -3.0 with a fragility fracture OR
A clinical diagnosis based on history of multiple fragility fractures, multiple vertebral fractures, hip fracture etc; AND

2. The individual has been refractory to, is intolerant of, or has a contraindication to bisphosphonate agents (FDA, 2020; AACE/ACE, 2020):

Has been refractory to a prior trial of an oral and an IV bisphosphonate (i.e zoledronic acid; alendronate; etidronate; risedronate; ibandronate; pamidronate; tiludronate) OR
Is intolerant to or has a contraindication to oral bisphosphonates as defined by:

Hypersensitivity to TWO oral bisphosphonates (one of which must be alendronate); OR
Inability to stand or sit upright for at least 30 minutes; OR
Pre-existing gastrointestinal disorders (Barrett's esophagus, hypersecretory disorders, delayed esophageal emptying, atrophic gastritis, etc.); OR
Uncorrected hypocalcemia; OR
Severe renal insufficiency as defined by creatinine clearance less than 35 mL/min for alendronate agents or creatinine clearance less than 30 mL/min for risedronate and ibandronate; AND

3. Individual has been refractory to, is intolerant of, or has a contraindication to one of the following:

Teriparatide (e.g., Forteo) - has completed a two-year course, and osteoporosis persists [(T-score < -3.0) or a history of a fragility fracture after completion of therapy], OR
Abaloparatide (e.g., Tymlos) - has completed a two-year course, and osteoporosis persists [(T-score < -3.0) or a history of a fragility fracture after the above therapy], AND

4. Individual has failed a trial of denosumab (e.g., Prolia), and osteoporosis persists [(T-score < -3.0) or a history of a fragility fracture after completion of therapy], (AACE/ACE, 2020) AND

5. Individual has not had a stroke or MI in the past 12 months (FDA, 2020) AND

6. Individual is not using romosozumab-aqqg (e.g., Evenity) in combination with ANY of the following AACE/ACE, 2020):

Denosumab (e.g., Prolia);
Bisphosphonates (i.e zoledronic acid; alendronate; etidronate; risedronate; ibandronate; pamidronate; tiludronate);
Raloxifene (e.g., Evista);
Calcitonin nasal spray (e.g., Miacalcin/Fortical);
Zoledronic acid (e.g., Reclast);
Teriparatide (e.g., Forteo);
Abaloparatide (e.g., Tymlos); AND

7. Individual will utilize Romosozumab-aqqg e.g., (Evenity®) for a total duration of 12 months (AACE/ACE, 2020) in their lifetime.

Dosage and Administration

Romosozumab-aqqg is given in a total dose of 210 mg (two 105 mg injections) sub Q once a month for no more than 12 doses lifetime.
Should be administered by a healthcare provider.
Adequately supplement calcium and vitamin D during treatment

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Romosozumab-aqqg for any other circumstance not specified above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, romosozumab-aqqg for any other circumstance not specified above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective Prior to December 15, 2021

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Effective February 1, 2020 prior authorization is required for romosozumab-aqqg

The initial use of this drug requires documentation of direct physician (MD/OD) involvement in the ordering and evaluation as well as a signature in the medical records submitted for prior approval.

The use of romosozumab-aqqg meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when ALL of the below criteria are met:

Individual is a postmenopausal female with the following:

A. A diagnosis of severe osteoporosis defined as a bone mineral density (BMD) T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of <-3.5 in the absence of a fragility fracture, or T-score < -2.5 with a fragility fracture OR

B. A clinical diagnosis based on history of multiple fragility fractures, multiple vertebral fractures, hip fracture etc; AND

2. The individual meets one of the following:

A. Has been refractory to a prior trial of an oral and IV bisphosphonate (i.e zoledronic acid; alendronate; etidronate; risedronate; ibandronate; pamidronate; tiludronate) OR

B. Is intolerant to or has a contraindication to an oral bisphosphonate as defined by:

Hypersensitivity to TWO oral bisphosphonates (one of which must be alendronate); OR
Inability to stand or sit upright for at least 30 minutes; OR
Pre-existing gastrointestinal disorders (Barrett's esophagus, hypersecretory disorders, delayed esophageal emptying, atrophic gastritis, etc.); OR
Uncorrected hypocalcemia; OR
Severe renal insufficiency as defined by creatinine clearance less than 35 mL/min for alendronate agents or creatinine clearance less than 30 mL/min for risedronate and ibandronate; AND
Has failed a trial of denosumab (Prolia) AND

3. Individual has been refractory to, is intolerant of, or has a contraindication to one of the following:

A. Teriparatide (Forteo) has completed a two-year course, OR

B. Abaloparatide (Tymlos) has completed a two-year course, AND has persistent osteoporosis (BMD < -0.25) OR

C. A history of a fragility fracture after the above therapy; OR

D. Individual is refractory to, intolerant of, or has contraindication to the above. AND

4. Has not had a stroke or MI in the past 12 months

5. Individual is not using romosozumab-aqqg (Evenity) in combination with any of the following:

Denosumab (Prolia);
Bisphosphonates (i.e zoledronic acid; alendronate; etidronate; risedronate; ibandronate; pamidronate; tiludronate);
Raloxifene (Evista);
Calcitonin nasal spray (Miacalcin/Fortical);
Zoledronic acid (Reclast);
Teriparatide (Forteo);
Abaloparatide (Tymlos); AND

6. Individual will utilize Evenity (romosozumab-aqqg) for a total duration of 12 months in their lifetime.

Dosage and Administration

Romosozumab-aqqg is given in a total dose of 210 mg (two 105 mg injections) sub Q once a month for no more than 12 doses lifetime.
Should be administered by a healthcare provider.
Adequately supplement calcium and vitamin D during treatment

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Romosozumab-aqqg does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, Romosozumab-aqqg is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:

The FRAME study (Study 1; NCT01575834) was a randomized, double-blind, placebo controlled, parallel-group clinical trial assessing postmenopausal women aged 55 to 90 years (mean age of 70.9 years) with a BMD T-score of _ -2.5 at the total hip or femoral neck. Women were excluded from the trial who had a history of hip fracture, any severe or more than 2

moderate vertebral fractures, recent use of agents affecting bone metabolism, a history of metabolic bone disease, osteonecrosis of the jaw, current hypercalcemia or hypocalcemia, or vitamin D insufficiency. At baseline, a total of 1317 patients (18.3%) had a prevalent vertebral fracture. Women in the trial were randomized (1:1) to receive subcutaneous injections of either romosozumab at a dose of 210 mg (n=3589) or placebo (n=3591) once monthly for 12 months,

followed by open-label anti-resorptive therapy (denosumab) at a dose of 60 mg administered subcutaneously every 6 months for an additional 12 months. All patients received daily calcium and vitamin D supplementation. The co-primary efficacy endpoints were the cumulative incidences of new vertebral fractures at 12 months and 24 months. At 12 months, new vertebral fractures had occurred in 16/3321 patients (0.5%) in the romosozumab group versus 59/3322 (1.8%) in the placebo group (representing a 73% lower risk with romosozumab; p<0.001). At 24 months, the rates of vertebral fractures were significantly lower in the romosozumab group compared to the placebo group following transition to denosumab (0.6% in the romosozumab group vs. 2.5% in the placebo group, a 75% lower risk with romosozumab; p<0.001). The study authors concluded that romosozumab significantly lowered the incidence of new vertebral fractures compared to placebo in postmenopausal women with osteoporosis at 12 months, and also following the transition to denosumab at 24 months.

The ARCH study (Study 2; NCT01631214) was a randomized, double-blind, alendronate controlled clinical trial evaluating postmenopausal women aged 55 to 90 years (mean age of 74 years) with a BMD T-score of _ -2.5 at the total hip or femoral neck and either one moderate or severe vertebral fracture or two mild vertebral fractures, or a BMD T-score _ -2.0 at the total hip or femoral neck and either two moderate or severe vertebral fractures or a history of a proximal femur fracture. Women were excluded from the trial as previously described in Study 1 and for intolerance or contraindication to oral alendronate. Women were randomized (1:1) to receive either monthly subcutaneous romosozumab at a dose of 210 mg (n=2046) or weekly oral alendronate at a dose of 70 mg (n=2047) for 12 months. All patients received daily calcium and vitamin D supplementation. After the 12-month double-blind treatment period, both groups transitioned to open-label weekly oral alendronate 70 mg until the end of the trial, while remaining blinded to the initial treatment assignment. The co-primary efficacy endpoints were the cumulative incidence of new vertebral fracture at 24 months and time to the first clinical fracture

(non-vertebral and symptomatic vertebral fracture) through the primary analysis period, which ended when _ 330 patients had a clinical fracture and all patients had completed the 24-month visit. Over a 24-month period, a 48% lower risk of new vertebral fractures was observed in the romosozumab-to-alendronate group (6.2% [127/2046 patients]) than in the alendronate-toalendronate group (11.9% [243/2047 patients]) (p<0.001). Clinical fractures occurred in 198/2046 patients (9.7%) in the romosozumab-to-alendronate group versus 266/2047 patients (13.0%) in the alendronate-to-alendronate group, representing a 27% lower risk with romosozumab (p<0.001). During the first 12 months, serious cardiovascular adverse events were observed more frequently in the romosozumab group than with alendronate (2.5% vs. 1.9%). The study authors concluded that, in postmenopausal women with osteoporosis at high risk for fracture, 12 months of romosozumab treatment followed by alendronate significantly lowered fracture risk compared to alendronate alone.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through August 2021.

In 2020, the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE, 2020) osteoporosis treatment guidelines with the following key updates:

“Postmenopausal women with osteoporosis can be stratified according to high-risk and very-high-risk features, which includes prior fractures. Stratification of the patient drives the choice of the initial agent as well as the duration of therapy.
The new anabolic agent romosozumab is included in the treatment algorithm.
Transitions from therapeutic agents, including denosumab, are further elucidated.”

AACE also made the following recommendations with regard to Pharmacologic Therapy:

R20. Pharmacologic therapy is strongly recommended for patients with osteopenia or low bone mass and a history of fragility fracture of the hip or spine (Grade A; BEL 1).

R21. Pharmacologic therapy is strongly recommended for patients with a T-score of −2.5 or lower in the spine, femoral neck, total hip, or 1/3 radius (Grade A; BEL 1).

R22. Pharmacologic therapy is strongly recommended for patients with a T-score between −1.0 and −2.5 if the FRAX® (fracture risk assessment tool) (or if available, trabecular bone score [TBS]-adjusted FRAX®) 10-year probability for major osteoporotic fracture is ≥20% or the 10-year probability of hip fracture is ≥3% in the U.S. or above the country-specific threshold in other countries or regions (Grade A; BEL 1).

R23. Consider patients with a recent fracture (e.g., within the past 12 months), fractures while on approved osteoporosis therapy, multiple fractures, fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids), very low T-score (e.g., less than −3.0), high risk for falls or history of injurious falls, and very high fracture probability by FRAX® (fracture risk assessment tool) (e.g., major osteoporosis fracture >30%, hip fracture >4.5%) or other validated fracture risk algorithm to be at very high fracture risk. Consider patients who have been diagnosed with osteoporosis but are not at very high fracture risk, as defined above, to be high risk (Grade B; BEL 1; downgraded due to limited evidence).

R24. Approved agents with efficacy to reduce hip, nonvertebral, and spine fractures including alendronate, denosumab, risedronate, and zoledronate are appropriate as initial therapy for most osteoporotic patients with high fracture risk, as defined in R23 (Grade A; BEL 1).

R25. Abaloparatide, denosumab, romosozumab, teriparatide, and zoledronate should be considered for patients unable to use oral therapy and as initial therapy for patients at very high fracture risk, as defined in R23 (Grade A; BEL 1).

R26. Ibandronate or raloxifene may be appropriate initial therapy in some cases for patients requiring drugs with spine-specific efficacy (Grade B; BEL 1, downgraded due to limited evidence).

AACE/ACE further comment that, “Romosozumab will likely be viewed as a “rescue drug” for patients at very high fracture risk” in the near term. It is an option for patients previously treated with teriparatide or abaloparatide, and future retreatment with romosozumab may be possible. Romosozumab can be used in patients with prior radiation exposure. In the smaller of the phase 3 trials (N = 4,093), serious cardiovascular events were significantly more common with romosozumab compared with the alendronate control group (213), but the increased risk did not persist and was small. Because of this, the black-box warning for romosozumab states that it should not be used in patients at high risk for cardiovascular events or who have had recent myocardial infarction or stroke.”

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through September 2022. No new literature was identified that would prompt a change in the coverage statement.

2023 Update

Fifty-one postmenopausal women were enrolled and randomized equally into two groups to receive either romosozumab or the denosumab. Changes (Δ) in the BMD (at lumbar spine, total hip, and femoral neck), disease activity score in 28 joints (DAS28)-erythrocyte sedimentation rate (ESR) and van der Heijde-modified Total Sharp Score (TSS) from baseline to 12 months after treatment were evaluated.

Results: The ΔBMD at 12 months in the romosozumab and denosumab groups were 10.2 ± 5.6% and 5.0 ± 3.1% (p = .002) for the lumbar spine, 3.7 ± 4.9% and 3.5 ± 3.0% (p = .902) for the total hip, and 3.6 ± 4.7% and 3.2 ± 4.9% (p = .817) for the femoral neck, respectively. The ΔDAS28-ESR and ΔTSS at 12 months did not differ between these two groups.

Conclusions: Our results suggest that romosozumab treatment was more effective in increasing the BMD at the lumbar spine than denosumab and may be selected for patients who require a significant increase in the lumbar spine BMD. (Mochizuki T, Yano K, Ikari K, et.al., 2023)

CPT/HCPCS:

References:

Barrionuevo P, Kapoor E, Asi N, et al.(2019) Efficacy of pharmacological therapies for the prevention of fractures in postmenopausal women: a network meta-analysis. J Clin Endocrinol Metab. 2019;104(5):1623-30.

Camacho PM, Petak SM, Binkley N et al.(2020) American Association of Clinical Endocrinologists/American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis – 2020 Update. Endocr Pract. 2020 May;26(Suppl 1):1-46. doi: 10.4158/GL-2020-0524SUPPL. PMID: 32427503.

Cosman F, Crittenden DB, Adachi JD, et al.(2016) Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med. 2016;375(16):1532-43.

Cosman F, de Beur SJ, LeBoff MS, et al.(2014) National Osteoporosis Foundation (NOF). Clinician’s guide to prevention and treatment of osteoporosis. Osteoporos Int. 2014;25(10):2359-81.

Eastell R, Rosen C.J., Black D.M., et al.(2019) Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, May 2019, 104(5):1595-1622.

package insert.(2019) EVENITY (Romosozumab-aqqg) injection, Thousand Oaks, CA: AMGEN Inc; 4/2019

Saag KG, Petersen J, Brandi ML, et al.(2017) Romosozumab or alendronte for fracture prevention in women with osteoporosis. N Engl J Med. 2017;377(15):1417-27.

Shoback D, Rosen CJ, Black DM, et al.(2020) Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update. J Clin Endocrinol Metab, March 2020, 105(3):587-594.

U.S. Food and Drug Administration (FDA).(2020) EVENITY® (romosozumab-aqqg) injection, for subcutaneous use. Prescribing Information. (2019 [Revised 04/2020]). Available from: https://www.accessdata.fda.gov/drugsatfda_docs

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association.