DESCRIPTION
Teriparatide is a recombinant fragment of the human parathyroid hormone (PTH). It has an identical amino acid sequence to the biologically active region of PTH. Like PTH, teriparatide binds to specific high-affinity cell-surface receptors and by preferential stimulation of osteoblastic activity over osteoclastic activity, teriparatide stimulates new bone formation on trabecular and cortical bone surfaces. Its anabolic effects are manifest as an increase in skeletal mass, an increase in markers of bone formation and resorption, and an increase in bone strength.
An example of a preparation of teriparatide is ForteoŽ.
REFER TO DECISION SUPPORT TREE
POLICY
Teriparatide for the treatment of osteoporosis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Teriparatide for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Teriparatide for the treatment of osteoporosis is considered medically appropriate if the individual is ANY ONE of the following:
Postmenopausal woman with a high risk of fracture defined as ANY ONE of the following:
History of osteoporotic fracture
Multiple risk factors for fracture
Failure of or intolerance to previous osteoporosis therapy, based upon physician assessment
A man with ALL of the following:
Osteoporosis is ANY ONE of the following:
Primary
Hypogonadal
High risk of fracture defined as ANY ONE of the following:
History of osteoporotic fracture
Multiple risk factors for fracture
Failure of or intolerance to previous osteoporosis therapy, based upon physician assessment
Diagnosed with glucocorticoid-induced osteoporosis with ALL of the following:
18 years of age or older
High risk for fracture defined as ANY ONE of the following:
History of osteoporotic fracture
Multiple risk factors for fracture
Failure of or intolerance to previous osteoporosis therapy, based upon physician
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validates the application of teriparatide, for the treatment of other conditions/diseases.
The safety and efficacy of teriparatide has not been established for pediatric individuals.
SOURCES
Lexi-Comp Online. (2009). AHFS DI. Teriparatide. Retrieved April 23, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations (2009). Teriparatide. Retrieved September 22, 2009 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2009, July) Center for Drug Evaluation and Research. ForteoŽ: Teriparatide (rDNA origin) injection approval letter. Retrieved September 22, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021318s012ltr.pdf.
U. S. Food and Drug Administration. (2009, July) Center for Drug Evaluation and Research. ForteoŽ: Teriparatide (rDNA origin) injection label. Retrieved September 22, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf.
ORIGINAL EFFECTIVE DATE: 2/1/2005
MOST RECENT REVIEW DATE: 12/1/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
Pharmaceutical Decision Support Tree
Teriparatide (ForteoŽ)
Does the individual have a diagnosis of osteoporosis?
If yes, go to question #2
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the individual a postmenopausal woman?
If yes, go to question #3
If no, go to question #4
Does the individual show a high risk of fracture defined as ANY ONE of the following?
History of osteoporotic fracture
Multiple risk factors for fracture
Failure of or intolerance to previous osteoporosis therapy, based upon physician assessment
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the individual a man with primary or hypogonadal osteoporosis?
If yes, go to question #5
If no, go to question #6
Does the individual show a high risk of fracture defined as ANY ONE of the following?
History of osteoporotic fracture
Multiple risk factors for fracture
Failure of or intolerance to previous osteoporosis therapy, based upon physician assessment
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the individual diagnosed with glucocorticoid-induced osteoporosis with ALL of the following?
18 years of age or older
High risk for fracture defined as ANY ONE of the following:
History of osteoporotic fracture
Multiple risk factors for fracture
Failure of or intolerance to previous osteoporosis therapy, based upon physician assessment
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.