Medical Policy

Effective Date:10/04/2006 Title:Parathyroid Hormone Analogs (Forte & Tymlos)
Revision Date:09/01/2017 Document:BI163:00
CPT Code(s):J3110
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Forteo (teriparatide) and Tymlos (abaloparatide) require prior authorization.

2)    These products are used to treat osteoporosis.

3)    Forteo and Tymlos are specialty drugs that are generally covered under the pharmacy benefit.

Medical Statement
  1. The  daily injection of teriparatide (Forteo) or Tymlos (abaloparatide) is considered  medically necessary for the treatment of post-menopausal women with osteoporosis who are at high risk for fracture when both of the following criteria are met:
    • The T score of their bone mineral density is 2.5 or more standard deviations below the mean value (i.e., T score is less than -2.5) (a T score of -1.0 to -2.5 is classified as osteopenia, while a T score of -1.0 or higher is considered normal); and
    • Members had a previous osteoporotic vertebral compression fracture and who show continued bone loss after at least a 2 year treatment course with a bisphosphonate or a selective estrogen receptor modulator (SERM) or
       Are intolerant to the side effects of both bisphosphonates and SERMs.
  2. Forteo is considered  medically necessary for the treatment of men with primary or hypogonadal osteoporosis who are at high risk for fracture when both of the following criteria are met:
    • The T score of their bone mineral density is 2.5 or more standard deviations below the mean value (i.e., T score is less than -2.5); and
    • Members had a previous osteoporotic vertebral compression fracture and who show continued bone loss after at least a 2 year treatment course with a bisphosphonate, or are intolerant to the side effects of bisphosphonates.

Codes Used In This BI:

 

J3110 Teriparatide injection

Limits

Since the effects of long-term treatment with teriparatide (Forteo) or Tymlos (abaloparatide) are not known at this time, therapy for more than 2 years duration is not covered.

As specialty drugs covered under the pharmacy benefit, both Forteo and Tymlos are limited to a 30 day supply per fill.

Reference
  1. Orwoll ES, Scheele WH, Paul S, et al. The effect of teriparatide [human parathyroid hormone (1-34)] therapy on bone density in men with osteoporosis. J Bone Miner Res. 2003; 18(1):9-17.
  2. No authors listed. Forteo approved for osteoporosis treatment. FDA Consum. 2003; 37(2):4.
  3. World Health Organization (WHO). Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: Report of a WHO study group. WHO Technical Report Series 843. Geneva, Switzerland: WHO; 1994. Available at: http://whqlibdoc.who.int/trs/WHO_TRS_843.pdf .
  4. National Institute for Clinical Excellence (NICE). Technologies for the prevention and treatment of osteoporosis and prevention of osteoporotic fractures in postmenopausal women. Appraisal Consultation Document. London, UK: NICE; December 19, 2003. Available at: http://www.nice.org.uk/Docref.asp?d=100352. Accessed January 12, 2004.
  5. National Institute for Clinical Excellence (NICE). Bisphosphonates (alendronate, etidronate, risedronate), selective oestrogen receptor modulators (raloxifene), and parathyroid hormone (teriparatide) for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. Final Appraisal Determination. London, UK: NICE; July 2004. Available at: http://www.nice.org.uk/page.aspx?o=100352 .
  6. Aetna Clinical Policy Bulletins; Teriparatide (Forteo) at: http://www.aetna.com/cpb/data/CPBA0666.html

Addendum:

Effective 09/01/2017:  Changed name of policy and added Tymlos to coverage criteria.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.