ph-9991065
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Parathyroid Hormone Analog for Osteoporosis Prior Authorization through Preferred with Quantity Limit Program Summary

Policy Number: PH-9991065

This program program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

Parathyroid Hormone Analog for Osteoporosis Prior Authorization through Preferred with Quantity Limit

TARGET PREFERRED AGENT

Tymlos® (abaloparatide)

TARGET NON-PREFERRED AGENT

Forteo® (teriparatide)

Bonsity™/Teriparatide

Brand (generic)

GPI

Multisource Code

Quantity Limit (per day or as listed)

Bonsity™/Teriparatide

250 mcg/ml injection

3004407000D221

M, N, O, or Y

2.48 mL / 28 days

Forteo® (teriparatide)

250 mcg/mL injection

3004407000D221

M, N, O, or Y

2.48 mL / 28 days

Tymlos™ (abaloparatide)

2000 mcg/mL injection

3004400500D230

M, N, O, or Y

1.56 mL / 30 days

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Preferred Agent (Tymlos) will be approved when ALL of the following are met:

  1. ONE of the following:
    1. ONE of the following:
      1. The patient is currently being treated with the requested agent within the past 90 days

OR

      1. The prescriber states that the patient is currently being treated with the requested agent within the past 90 days AND is at risk if therapy is changed

OR

      1. The patient has a diagnosis of osteoporosis AND ALL of the following:
        1. ONE of the following:
          1. The patient is a postmenopausal female

OR

          1. The prescriber has provided information that the requested agent is medically appropriate for the patient’s gender

         AND

        1. The patient’s diagnosis was confirmed by ONE of the following:
          1. A fragility fracture in the hip or spine

OR

          1. A T-score of -2.5 or lower

OR

          1. A T-score of -1.0 to -2.5 and ONE of the following:
            1. a FRAX 10-year probability for major osteoporotic fracture of ≥20%

OR

            1. a FRAX 10-year probability of hip fracture of ≥3%

AND

        1. ONE of the following:
          1. The patient is at a very high fracture risk as defined by ONE of the following:
            1. Patient had a recent fracture (within the past 12 months)

OR

            1. Patient had fractures while on FDA approved osteoporosis therapy

OR

            1. Patient has had multiple fractures

OR

            1. Patient had fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids)

OR

            1. Patient a very low T-score (less than -3.0)

OR

            1. Patient is at high risk for falls or has a history of injurious falls

OR

            1. Patient has a very high fracture probability by FRAX (e.g., major osteoporosis fracture >30%, hip fracture >4.5%) or by other validated fracture risk algorithm

OR

          1. ONE of the following:
            1. The patient has tried and had an inadequate response to a bisphosphonate

OR

            1. The patient has an intolerance or hypersensitivity to a bisphosphonate

OR

            1. The patient has an FDA labeled contraindication to ALL bisphosphonates

AND

  1. The patient does NOT have an increased baseline risk for osteosarcoma

AND

  1. The patient will NOT be using the requested agent in combination with a bisphosphonate, SERM, denosumab (Xgeva), denosumab, romosozumab, or another parathyroid hormone analog (i.e., teriparatide, abaloparatide) therapy 

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. The total duration of treatment with Forteo (teriparatide), Bonsity/Teriparatide, and Tymlos (abaloparatide) has NOT exceeded 2 years in lifetime

OR

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

Length of approval:  For those who have had less than 2 years of treatment in lifetime between Bonsity/Teriparatide, and Tymlos (abaloparatide), approve for the remainder of the 2 years of therapy remaining.  Only one parathyroid hormone analog will be approved for use at a time.

Non-Preferred Agent (Forteo, Bonsity/Teriparatide) will be approved when ALL of the following are met:

  1. ONE of the following:
    1. The patient is currently being treated with the requested agent within the past 90 days

OR

    1. The prescriber states that the patient is currently being treated with the requested agent within the past 90 days AND is at risk if therapy is changed

OR

    1. The patient has a diagnosis of osteoporosis AND ALL of the following:
      1. ONE of the following:
        1. The patient is a male

OR

        1. The patient is a postmenopausal female AND ONE of the following:
          1. The patient’s medication history includes a preferred agent (Tymlos) in the past 90 days

OR

          1. The patient has an intolerance or hypersensitivity to the preferred agent (Tymlos) that is not expected to occur with the requested agent

OR

          1. The patient has an FDA labeled contraindication to the preferred agent (Tymlos)

OR

        1. The prescriber has provided information that the requested agent is medically appropriate for the patient’s gender

AND

      1. The patient’s diagnosis was confirmed by ONE of the following:
        1. A fragility fracture in the hip or spine

OR

        1. A T-score of -2.5 or lower

OR

        1. A T-score of -1.0 to -2.5 and ONE of the following:
          1. A FRAX 10-year probability for major osteoporotic fracture of ≥20%

OR

          1. A FRAX 10-year probability of hip fracture of ≥3%

AND

      1. ONE of the following:
        1. The patient is at a very high fracture risk as defined by ONE of the following:
          1. Patient had a recent fracture (within the past 12 months)

OR

          1. Patient had fractures while on FDA approved osteoporosis therapy

OR

          1. Patient has had multiple fractures

OR

          1. Patient had fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids)

OR

          1. Patient has a very low T-score (less than -3.0)

OR

          1. Patient is at high risk for falls or has a history of injurious falls

OR

          1. Patient has a very high fracture probability by FRAX (e.g., major osteoporosis fracture >30%, hip fracture >4.5%) or by other validated fracture risk algorithm

OR  

        1. ONE of the following:
          1. The patient has tried and had an inadequate response to a bisphosphonate

OR

          1. The patient has an intolerance or hypersensitivity to a bisphosphonate

OR

          1. The patient has an FDA labeled contraindication to ALL bisphosphonates

OR

    1. The patient has a diagnosis of glucocorticoid-induced osteoporosis AND ALL of the following:
      1. The patient is either initiating or currently taking glucocorticoids in a daily dosage equivalent to 5 mg or higher of prednisone

AND

      1. The patient’s expected current course of therapy of glucocorticoids is for a period of at least 3 months

AND

      1. The patient is at a very high fracture risk as defined by ONE of the following:
        1. A fragility fracture in the hip or spine

OR

        1. A T-score of -2.5 or lower

OR

        1. A T-score of -1.0 to -2.5 and ONE of the following:
          1. A FRAX 10-year probability for major osteoporotic fracture of ≥20%

OR

          1. A FRAX 10-year probability of hip fracture of ≥3%

AND

      1. ONE of the following:
        1. The patient is at a very high fracture risk as defined by ONE of the following:
          1. Patient had a recent fracture (within the past 12 months)

OR

          1. Patient had fractures while on FDA approved osteoporosis therapy

OR

          1. Patient has had multiple fractures

OR

          1. Patient had fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids)

OR

          1. Patient has a very low T-score (less than -3.0)

OR

          1. Patient is at high risk for falls or has a history of injurious falls

OR

          1. Patient has a very high fracture probability by FRAX (e.g., major osteoporosis fracture >30%, hip fracture >4.5%) or by other validated fracture risk algorithm

OR

        1. ONE of the following:
          1. The patient has tried and had an inadequate response to a bisphosphonate

OR

          1. The patient has an intolerance or hypersensitivity to a bisphosphonate

OR

          1. The patient has an FDA labeled contraindication to ALL bisphosphonates

AND

  1. The patient does NOT have an increased baseline risk for osteosarcoma

AND

  1. The patient will NOT be using the requested agent in combination with a bisphosphonate, SERM, denosumab (Xgeva), denosumab, romosozumab or another parathyroid hormone analog (i.e., teriparatide, abaloparatide)   

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
    1. The patient has never received treatment with a parathyroid hormone analog (Bonsity/teriparatide, Forteo, and Tymlos)

OR

    1. The patient has been previously treated with parathyroid hormone analog(s) and ONE of the following:
      1. The total duration of treatment with Forteo (teriparatide), Bonsity/Teriparatide, and Tymlos (abaloparatide) has NOT exceeded 24 months in lifetime

            OR

      1. ALL of the following:
        1. The patient has received 24 months or more of parathyroid hormone analog treatment in their lifetime, and is at high risk for fracture (e.g., shown by T-score, FRAX score, continued use of glucocorticoids at a daily equivalent of 5 mg of prednisone or higher) 

AND

        1. The requested agent is Forteo

            AND

        1. The patient was previously treated with Forteo

AND

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

Length of approval:  up to a total of 2 years of treatment in lifetime between Bonsity/Teriparatide and Tymlos (abaloparatide); Approve for up to 2 years for new Forteo starts or patients new to the plan’s Prior Authorization process.  Approve for 1 year if patient has already had 2 years of Forteo in lifetime and is at high risk.  Only one parathyroid hormone analog will be approved for use at a time.

FDA APPROVED INDICATIONS AND DOSAGE1,2,12,13

Agent(s)

Indication(s)

Dosage

Bonsity™/Teriparatide, Forteo®

Injection solution

Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy

Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy

Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy

Recommended dose is 20 mcg subcutaneously once a day

Use for more than 2 years during a patient's lifetime should only be considered if a patient remains at or has returned to having a high risk of fracture

Tymlos® (abaloparatide)

Injection solution

Treatment of postmenopausal women with osteoporosis at high risk for fracture.

Recommended dose is 80 mcg subcutaneously once daily; patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

Limitation of use: 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

CLINICAL RATIONALE

Diagnosis of Osteoporosis

The National Osteoporosis Foundation states that the diagnosis of osteoporosis (OP) can be established by either measurement of bone mineral density (BMD) or by the occurrence of adulthood hip or vertebral fracture in the absence of major trauma (such as a motor vehicle accident or multiple story fall).  For evaluation, BMD measurement should be taken by central dual-energy X-ray absorptiometry at the lumbar spine and femoral neck (hip).  A BMD taken at the one-third (33%) radius site can be used for diagnosing osteoporosis when the hip and lumbar spine cannot be measured or are unusable or uninterpretable.  In postmenopausal women and men age 50 and older, WHO diagnostic T-score criteria is applied to the BMD measurement.  For those patients that are not postmenopausal women and not men age 50 and older, WHO BMD classification should not be applied, and the diagnosis of osteoporosis should not be made on densitometric criteria alone.3 

                                        WHO Definitions of bone density3

Normal                                                 T-score ≥ -1.0

Low bone mass (osteopenia)                  T-score between -1.0 and -2.5

Osteoporosis                                         T-score ≤ -2.5

The WHO absolute fracture risk model (Fracture Risk Algorithm, FRAX) was developed to calculate the 10-year probability of a hip fracture and the 10-year probability of a major osteoporotic fracture, taking into account femoral neck BMD and clinical risk factors.   

Treatment

According to the National Osteoporosis Foundation, postmenopausal women and men age 50 and older presenting with the following should be considered for treatment:

  • A hip or vertebral fracture
  • T-score of -2.5 or lower at the femoral neck, total hip, or lumbar spine (or at the 33% radius site if necessary)
  • Low bone mass (T-score between -1 and -2.5) and a 10-year probability of a hip fracture ≥ 3% or a 10-year probability of a major osteoporosis-related fracture ≥ 20% based on the US-adapted WHO algorithm3

The American Association of Clinical Endocrinologists (AACE)4, the Endocrine Society5, and the North American Menopause Society (NAMS)6 all agree with these treatment thresholds for postmenopausal women.  The Endocrine Society also agrees with these treatment thresholds for men with increased fracture risk.7

Postmenopausal women

The 2020 AACE Guidelines created a ‘very high’ risk category for post-menopausal women with osteoporosis.  The following patients are considered to be a very high fracture risk:

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

Patients who have been diagnosed with osteoporosis but do not meet the above definition of very high fracture risk are to be considered to be at high risk.4 

The AACE recommends alendronate, denosumab, risedronate, and zoledronate as appropriate initial therapy for most osteoporotic patients with high fracture risk.  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.4 

Men

The Endocrine Society recommends pharmacological therapy for men at high risk of fracture

including, but not limited to:

  • Men who have had a hip or vertebral fracture without major trauma
  • Men who have not experienced a spine or hip fracture, but whose BMD of the spine, femoral neck, and/or total hip is 2.5 standard deviations below the mean of normal young white males
  • In the US, men who have a T-score between -1.0 and -2.5 in the spine, femoral neck, or total hip plus a 10-year risk of hip fracture ≥ 3% using FRAX.  For men outside the US, region-specific guidelines should be considered
  • Men who are receiving long-term glucocorticoid therapy in pharmacological doses

Men at high risk of fracture can be treated with medication approved by regulatory agencies such as the U.S. FDA or the European Medicines Agency (EMA) (at the time of this writing, alendronate, risedronate, zoledronic acid, and teriparatide.  Denosumab can also be used for men receiving ADT [androgen deprivation therapy] for prostate cancer).  The selection of therapeutic agent should be individualized based on factors including fracture history, severity of osteoporosis (T-scores), the risk for hip fracture, patterns of BMD, comorbid conditions, cost, and other factors.8

The ACP recommends bisphosphonates to reduce the risk for vertebral fracture in men who have clinically recognized osteoporosis.9

Glucocorticoid-Induced Osteoporosis

Oral bisphosphonates are currently regarded as first line options on the grounds of their low cost.  However, teriparatide has shown its effects on BMD and vertebral fracture risk in glucocorticoid-treated individuals with osteoporosis and should be considered as an alternative first line option in patients at high risk of vertebral fracture.11   The American College of Rheumatology defines high risk of fracture as: adults aged ≥40 years, previous osteoporotic fracture, hip or spine BMD T-score ≤-2.5, or 10 year fracture risk of ≥20% (major osteoporotic fracture or ≥3% (hip fracture).10 

Due to the lack of evidence on the effect on fracture risk, concomitant use of osteoporosis agents is not recommended.  There are no head-to-head trials with a preplanned endpoint of reduced fractures comparing one drug with another for osteoporosis.4

Safety

Teriparatide carries the following black box warnings:1

  • In rats, teriparatide caused an increase in the incidence of osteosarcoma, a malignant bone tumor.
  • Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe teriparatide only for patients for whom potential benefits outweigh potential risk. 
  • Teriparatide should not be prescribed for patients at increased baseline risk for osteosarcoma (e.g., those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton).

Abaloparatide carries the following black box warning:2

  • Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma, a malignant bone tumor, in male and female rats. It is unknown whether abaloparatide will cause osteosarcoma in humans.
  • Use of abaloparatide is not recommended in patients at increased risk for osteosarcoma.
  • Cumulative use of abaloparatide and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended.

For additional clinical information see the Prime Therapeutics Formulary Chapter 4.9A Calcium Regulators/Osteoporosis Agents.

REFERENCES

  1. Forteo Prescribing Information. Eli Lilly & Co. Indianapolis, IN. November 2020.
  2. Tymlos Prescribing Information.  Radius Health, Inc.  October 2018.
  3. Cosman F, de Beur SJ, LeBoff MS, et. al. Clinician’s Guide to Prevention and Treatment of Osteoporosis.  National Osteoporosis Foundation, Osteoporosis Int 25:2359-2381, 2014.  https://my.nof.org/bone-source/education/clinicians-guide-to-the-prevention-and-treatment-of-osteoporosis  Accessed June 19, 2020
  4. 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 – 2020 Update. Available at https://www.aace.com/sites/default/files/2020-05/Vol%2026%20Supplement%201%20%28May%202020%29%20GL-2019-0524.pdf.  Accessed 6/19/2020.
  5. Eastell R, Rosen CL, Black DM, et. al.  Pharmacological Management of Osteoporosis in Postmenopausal Women:  An Endocrine Society Clinical Practice Guideline.  J ClinEndocrinol Metab 104: 1595-1622, 2019.  https://academic.oup.com/jcem/article/104/5/1595/5418884  Accessed 6/19/2020.
  6. North American Menopause Society. Management of osteoporosis in postmenopausal women: 2010 position statement of the North American Menopause Society. Menopause. 2010;17(1):25-54.  Available at http://www.menopause.org/docs/default-document-library/psosteo10.pdf  Accessed 6/19/2020.
  7. Miller PD, Hattersley G, Juel Riis B, et al. Effect of abaloparatide vs. placebo on new vertebral fractures in postmenopausal women with osteoporosis. JAMA. 2016;316(7):722-733.
  8. Endocrine Society Guideline: Osteoporosis in Men: An Endocrine Society Clinical Practice Guideline 2012. Available at: https://academic.oup.com/jcem/article/97/6/1802/2536476  Accessed 6/19/2020.
  9. Qaseem A, Forciea MA, McLean RM, et. al.  Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update from the American College of Physicians.  Ann Intern Med. 2017;166:818-839.  https://annals.org/aim/fullarticle/2625385/treatment-low-bone-density-osteoporosis-prevent-fractures-men-women-clinical  Accessed 6/19/2020.
  10. Buckley L, Guyatt G, Fink HA, et al. 2017 American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis.  Arthritis and Rheumatology Vol. 69, No. 8, August 2017, pp 1521–1537.  Available at: https://www.rheumatology.org/Portals/0/Files/Guideline-for-the-Prevention-and-Treatment-of-GIOP.pdf  Accessed 6/19/2020.
  11. Compston, J. Glucocorticoid-induced osteoporosis: an update.  Endocrine 2018; 61(1):7-16. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5997116/pdf/12020_2018_Article_1588.pdf  Accessed 6/26/2020.
  12. Bonsity Prescribing Information.  Pfenex, Inc.  October 2019.
  13. Teriparatide Prescribing Information.  Alvogen, Inc.  November 2019.

 

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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