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Date Printed: October 20, 2017: 12:03 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-85

Original Effective Date: 09/15/17

Reviewed: 08/09/17

Revised: 00/00/00

Next Review: 08/08/18

Subject: Abaloparatide (Tymlos™)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/Administration: Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates    
           

DESCRIPTION:

Abaloparatide (Tymlos™) is a synthetic peptide analog of parathyroid hormone-related protein (PTHrP) that selectively binds to the parathyroid hormone type 1 receptor (PTH1R). Binding to PTH1R activates signaling pathways that cause an anabolic effect on bone. This results in increases in bone mineral density (BMD) and bone mineral content that correlate with increases in bone strength.

The Food and Drug Administration (FDA) approved abaloparatide in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture. High fracture risk is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. The cumulative use of abaloparatide and parathyroid hormone analogs such as teriparatide is not recommended for more than 2 years during a patient’s lifetime due to risk of osteosarcoma. Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma in rats.

Abaloparatide was evaluated in a randomized double-blind, placebo-controlled trial in postmenopausal women for 18 months. Subjects were required to have a BMD T score between or equal to - 2.5 and - 5.0 as measured at the lumbar spine or femoral neck with evidence of fracture. Women greater than 65 years of age were permitted with a T score between or equal to -3.0 and -5.0 without evidence or fracture or between or equal to -2.0 and -5.0 with fracture. The primary endpoint was the incidence of new vertebral fractures and secondary endpoints included change in BMD at the total hip, femoral neck, and lumbar spine and incident nonvertebral fractures. Abaloparatide significantly reduced the risk of new vertebral fractures as compared to placebo (0.6% vs 4.2% respectively, p<0.001), and also demonstrated significant improvement in BMD at all sites as compared to placebo (p<0.001). Abaloparatide also reduced the incidence of nonvertebral fractures as compared to placebo (p=0.049).

According to evidence based guidelines (e.g., American Academy of Clinical Endocrinologists/American College of Endocrinology guidelines for treatment of postmenopausal women with osteoporosis), oral bisphosphonate therapy, zoledronic acid, or denosumab are appropriate for most patients at high risk of fracture due to the broad spectrum antifracture efficacy.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

I. Initiation of abaloparatide (Tymlos™) meets the definition of medical necessity when ALL of the following criteria are met:

1. Postmenopausal Osteoporosis

a. Member meets ONE of the following:

i. Diagnosed with osteoporosis defined as a pre-treatment bone mineral density (BMD) T-score of -2.5 or lower*

ii. Member has a history of osteoporotic hip or vertebral fracture

b. The cumulative duration of abaloparatide (Tymlos™) or teriparatide (Forteo®) use has not exceeded a total of 2 years in the member’s lifetime

c. Abaloparatide will be used as a single agent

d. ONE of the following:

i. Member has an inadequate response to injectable antiresorptive therapy [zoledronic acid (Reclast®) or denosumab (Prolia®)]

ii. Member has a contraindication to BOTH zoledronic acid and denosumab

e. Dose does not exceed 80 mg daily

Approval duration: 1 year (maximum lifetime duration is 2 consecutive years)

*Measured at the femoral neck, total hip, lumbar spine, or 33% radius

Inadequate response is defined as a new fracture in a compliant member or significant loss of bone mineral density on follow-up scans.

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

Abaloparatide is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Because of the unknown relevance of the rodent osteosarcoma findings to humans, cumulative use of abaloparatide and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended.

The recommended dosage of abaloparatide is 80 mcg subcutaneously once daily. Cumulative use of abaloparatide and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended. Supplemental calcium and vitamin D is recommended if dietary intake is inadequate.

Dose Adjustments None

Drug Availability

Pre-filled pen for subcutaneous injection: 3120 mcg/1.56 mL (2000 mcg/mL). The prefilled pen delivers 30 doses, each containing 80 mcg of abaloparatide.

PRECAUTIONS:

Contraindications: None

Boxed warning:

• Risk of osteosarcoma - Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma in male and female rats after subcutaneous administration at exposures 4 to 28 times the human exposure at the clinical dose of 80 mcg. It is unknown whether abaloparatide will cause osteosarcoma in humans. The use of abaloparatide is not recommended in patients at increased risk of osteosarcoma including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external beam or implant radiation therapy involving the skeleton. Cumulative use of abaloparatide and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended.

Precautions/Warnings:

Orthostatic Hypotension - Orthostatic hypotension may occur, typically within 4 hours of injection.

For the first several doses, abaloparatide should be administered where the patient can sit or lie down if necessary.

Hypercalcemia - Use is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia.

• Hypercalciuria and Urolithiasis - If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

C9399

Unclassified drugs or biologicals

J3490

Unclassified drugs

ICD-10 Diagnoses Codes That Support Medical Necessity

E28.310

Symptomatic premature menopause

E28.319

Asymptomatic premature menopause

E28.39

Other primary ovarian failure

M80.00XA – M80.00XS
M80.011A – M80.011S
M80.012A – M80.012S
M80.019A – M80.019S
M80.021A – M80.021S
M80.022A – M80.022S
M80.029A – M80.029S
M80.031A – M80.031S
M80.032A – M80.032S
M80.039A – M80.039S
M80.041A
– M80.041S
M80.042A – M80.042S
M80.049A – M80.049S
M80.051A – M80.051S
M80.052A – M80.052S
M80.059A – M80.059S
M80.061A – M80.061S
M80.062A – M80.062S
M80.069A – M80.069S
M80.071A – M80.071S
M80.072A – M80.072S
M80.079A – M80.079S
M80.08XA – M80.08XS

Age-related osteoporosis with current pathological fracture

M80.80XA – M80.80XS
M80.811A – M80.811S
M80.812A – M80.812S
M80.819A – M80.819S
M80.821A – M80.821S
M80.822A – M80.822S
M80.829A – M80.829S
M80.831A – M80.831S
M80.832A – M80.832S
M80.839A – M80.839S

M80.841A – M80.841S
M80.842A – M80.842S
M80.849A – M80.849S
M80.851A – M80.851S
M80.852A – M80.852S
M80.859A – M80.859S
M80.861A – M80.861S
M80.862A – M80.862S
M80.869A – M80.869S
M80.871A – M80.871S
M80.872A – M80.872S
M80.879A – M80.879S
M80.88XA – M80.8
8XS

Other osteoporosis with current pathological fracture

M81.0

Age-related osteoporosis without current pathological fracture

M81.8

Other osteoporosis without current pathological fracture

N95.1

Menopausal and female climacteric states

Z78.0

Asymptomatic menopausal state

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the guideline creation.

DEFINITIONS:

Osteoporosis: reduction in the amount of bone mass, leading to fractures after minimal trauma. Osteoporosis is defined by the World Health Organization (WHO) as a bone mineral density (BMD) value for the hip, spine, or wrist of 2.5 standard deviations (SD) or more below the mean for healthy young white women, or a T-score of less than or equal to –2.5. The disease is characterized by an increased risk of fractures, which can result in pain, diminished quality of life, decreased physical mobility and independence, inability to work, and increased burden on caregivers.

Postmenopausal: occurring after menopause.

Risk Factors for Osteoporosis: For osteoporotic fractures, includes low BMD, parental history of hip fracture, low body weight, previous fracture, smoking, excess alcohol intake, glucocorticoid use, secondary osteoporosis (e.g., rheumatoid arthritis) and history of falls. These readily accessible and commonplace factors are associated with the risk of hip fracture and, in most cases, with that of vertebral and other types of fracture as well.

RELATED GUIDELINES:

Bone Mineral Density Studies, 04-70000-21

Denosumab (Prolia™, Xgeva™) Injection, 09-J1000-25

Ibandronate IV (Boniva®), 09-J0000-71

Teriparatide (Forteo®), 09-J0000-47

Zoledronic Acid IV (Reclast®, Zometa®), 09-J0000-72

OTHER:

None Applicable

REFERENCES:

  1. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 2017-07-17]. Available from: http://www.clinicalpharmacology.com/.
  2. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis. Endocr Pract. 2016; 22: Suppl 4;1-42.
  3. Cosman F, Miller PD, Williams GC et al. Eighteen months of treatment with subcutaneous abaloparatide followed by 6 months of treatment with alendronate in postmenopausal women with osteoporosis: results of the ACTIVExtend trial. Mayo Clin Proc. 2017; 92(2): 200-210.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2017-07-17]. Available from: http://www.thomsonhc.com/.
  5. Leder BZ, O’Dea L, Zanchetta JR et al. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015; 100: 697-706.
  6. Miller PD, Hattersley G, Riis BJ et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA. 2016; 316 (7): 722-733.
  7. Tymlos [prescribing information]. Radius Health, Inc. Waltham, MA. April 2017.
  8. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [cited 2017-07-17]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 08/09/17.

GUIDELINE UPDATE INFORMATION:

09/15/17

New Medical Coverage Guideline.

Date Printed: October 20, 2017: 12:03 PM