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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Drugs
Policy Number:194
Effective Date: 07/13/2020
Original Policy Date:06/25/2019
Last Review Date:06/09/2020
Date Published to Web: 07/01/2019
Subject:
Romosozumab-aqqg (Evenity)

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

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Evenity (romosozumab-aqqg) is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Evenity (romosozumab-aqqg) is an anabolic agent and the first product with the dual effect of increasing bone formation and reducing bone resorption.

The efficacy of Evenity (romosozumab-aqqg) was demonstrated in three clinical trials. Study 1 was a randomized, double-blind, placebo-controlled study in women aged 55-90 years with bone mineral density (BMD) T-scores of -2.5 or less at the total hip or femoral neck. Women were randomized to receive subcutaneous injections of either Evenity (romosozumab-aqqg) (N = 3589) or placebo (N = 3591) for 12 months. At baseline, 18% of women had a vertebral fracture. After the 12-month treatment period, women in both arms transitioned to open-label anti-resorptive therapy (denosumab) for 12 months while remaining blinded to their initial treatment. Women received 500 to 1000 mg calcium and 600 to 800 international units vitamin D supplementation daily. The coprimary efficacy endpoints were new vertebral fracture at month 12 and month 24. Evenity (romosozumab-aqqg) reduced the incidence of clinical fracture (a composite endpoint of symptomatic vertebral fracture and nonvertebral fracture) at 12 months. At 12 months, new vertebral fractures had occurred in 16 of 3321 patients (0.5%) in the romosozumab group as compared to 59 of 3322 (1.8%) in the placebo group. This represented a 73% lower risk with romosozumab;P<0.001). Clinical fractures occurred in 58 of 3589 patients(1.6%) in the romosozumab group as compared to 90 of the 3591 (2.5%0 in the placebo group. This represented a 36% lower risk with romosozumab;P=0.008). At 24 monthsm the rates of vertebral fractures we lower in the romosozumab group than placebo after each group transitioned to denosumab , 0.6% in the romosozumab group vs. 25% in the placebo group, representing a 75% lower risk with romosozumab, P<0.001) An increase in BMD by 12.7% at the lumbar spine, 5.8% at the total hip, and 5.2% at the femoral neck was also observed.

Study 2, was a randomized, double-blind, alendronate-controlled study of postmenopausal women aged 55 to 90 years (mean age of 74 years) with BMD T-score less than or equal to −2.5 at the total hip or femoral neck and either one moderate or severe vertebral fracture or two mild vertebral fractures, or BMD T-score less than or equal to -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 randomized (1:1) to receive either monthly subcutaneous injections of Evenity (N = 2046) or oral alendronate 70 mg weekly (N = 2047) for 12 months, with 500 to 1000 mg calcium and 600 to 800 international units vitamin D supplementation daily. After the 12-month treatment period, women in both arms transitioned to open-label alendronate 70 mg weekly while remaining blinded to their initial treatment. This was an event driven trial. The coprimary efficacy endpoints were the incidence of morphometric vertebral fracture at 24 months and time to the first clinical fracture through the primary analysis period, which ended when at least 330 subjects had a clinical fracture and all subjects had completed the 24-month visit. Clinical fracture was a composite endpoint of nonvertebral fracture and symptomatic vertebral fractures. Over the 24 month period a 48% lower risk of new vertebral fractures was observed in the romosozumab-to-alendronate group; P<0.001) Clinical features occurred in 198 of 2046 patients (9.7%) in the romosozumab-to-alendronate group versus 266 of the 2047 paitents (13%) in the alendronate –to-alendronate group, representing a 27% lower risk with romosozumab;(P<0.001)

Study 3 was a randomized, open label study of 436 postmenopausal women aged 55 to 90 years with osteoporosis and a history of nonvertebral fracture after age 50 or vertebral fracture at any time. The primary efficacy endpoint evaluated was percentage change from baseline in BMD at the total hip through month 12 (mean of months 6 and 12). 436 patients were randomly assigned to romosozumab (n=218) or teriparatide (n=218). 206 patients in the romosozumab group and 209 in the teriparatide group were included in the primary efficacy analysis. Through 12 months, the mean percentage change from baseline in total hip areal BMD was 2·6% (95% CI 2·2 to 3·0) in the romosozumab group and −0·6% (−1·0 to −0·2) in the teriparatide group; difference 3·2% (95% CI 2·7 to 3·8; p<0·0001). The frequency of adverse events was generally balanced between treatment groups. The most frequently reported adverse events were nasopharyngitis (28 {13%} of 218 in the romosozumab group vs 22 {10%} of 214 in the teriparatide group), hypercalcaemia (two {<1%} vs 22 {10%}), and arthralgia (22 {10%} vs 13 {6%}). Serious adverse events were reported in 17 (8%) patients on romosozumab and in 23 (11%) on teriparatide; none were judged treatment related. There were six (3%) patients in the romosozumab group compared with 12 (6%) in the teriparatide group with adverse events leading to investigational product withdrawal.

As per the FDA labeled package insert, Evenity (romosozumab-aqqg) has a Black Box Warning for Potential Risk of Myocardial Infarction, Stroke and Cardiovascular Death. Evenity (romosozumab-aqqg) may increase the risk of myocardial infarction, stroke and cardiovascular death. It should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, Evenity (romosozumab-aqqg) should be discontinued.


Policy:

    1. Evenity (romosozumab-aqqg) is medically necessary for the following FDA approved indications when ALL of the following criteria are met
      • For the treatment of osteoporosis in postmenopausal women at high risk for fracture with all of the following:
          • Patient is a postmenopausal woman (aged 18 years and older) with a diagnosis of osteoporosis defined as one of the following:
              • BMD T-score ≤-2.5 based on BMD measurements from lumbar spine (at least two vertebral bodies), hip (femoral neck, total hip), or radius (one-third radius site); OR
              • Low-trauma spine or hip fracture (regardless of BMD) OR
              • Osteopenia or low bone mass (T-score between –1 and –2.5) AND one of the following
                  • a 10-year probability of a hip fracture ≥3 % or a 10-year probability of a major osteoporosis-related fracture ≥20 %; OR
                  • b. History of low trauma or fragility fracture (e.g, prior fracture from minor trauma such as falling from standing height or less) of proximal humerus, pelvis, or distal forearm
          • Patient has tried and failed or had an inadequate response to a trial of 1 bisphosphonate OR patient is intolerant to or has a contraindication to other oral and IV osteoporosis therapy (e.g. alendronate, risedronate, ibandronate, and zoledronic acid). AND
          • Patient has no known contraindications to Evenity including hypocalcemia and known hypersensitivity to Evenity supported by the following documentation:
              • The member’s calcium level has been measured in the past 4 weeks and
                  • a. If the member is hypocalcemic, it will be corrected prior to use of the requested agent OR
                  • b. The patient is continuing therapy with the requested agent AND the prescriber has indicated that the patient is not at risk for hypocalcemia (not including risk associated with the requested agent)
          • Patient is not receiving Evenity in combination with any of the following:
              • Parathyroid hormone analogs (e.g., Forteo, Tymlos)
              • RANK ligand inhibitors (e.g., Prolia, Xgeva)
              • Bisphosphonates
          • Patient is receiving adequate supplementation with calcium and vitamin D during treatment
      [INFORMATIONAL NOTE: As per the FDA labeled package insert, the safety and efficacy of Evenity (romosozumab-aqqg) has not been studied in pediatric patients.

      As per the clinical trials for Evenity (romosozumab-aqqg) in the FDA labeled package insert, patients received Evenity (romosozumab-aqqg) as monotherapy and not in combination with any other osteoporosis medications. In addition, there are no published studies as per PubMed or Clinicaltrials.gov supporting the combination use of Evenity (romosozumab-aqqg) with other osteoporosis mediations.]


    2. When Evenity (romosozumab-aqqg) is medically necessary, therapy will be approved once per lifetime at the FDA recommended dosage of;
      • 210 mg once every month for 12 months, administered as two separate subcutaneous injections in the abdomen, thigh, or upper arm.
      [INFORMATIONAL NOTE: As per the FDA labeled package insert, limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered.]
    3. Other uses of Evenity (romosozumab-aqqg) are considered investigational.

    Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Romosozumab-aqqg (Evenity)
Evenity (Romosozumab-aqqg)

References:
1. Evenity [package insert]. Thousand Oaks, Ca: Amgen Inc ; April 2020

2. Evenity. Clinicaltrial.gov. Accessed on 4/26/19 . Available at: https://clinicaltrials.gov/ct2/show/NCT01631214

3. Eventiy. Clinicaltrial.gov. Accessed on 4/26/19 . Available at: https://clinicaltrials.gov/ct2/show/NCT01575834

4. Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med. 2016;375(16):1532-1543.

5. Saag, KG, Petersen J, Brandi ML, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med. 2017;377(15):1417-1427.

6. American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis. Endocrine Practice. September 2016;22(4):1-42.

7. Langdahl BL, Libanati C, Crittenden DB, et al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet. 2017 Sep 30;390(10102):1585-1594. doi: 10.1016/S0140-6736(17)31613-6. Epub 2017 Jul 26.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

    HCPCS
    J3111

    * CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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    Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

    The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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