|
Title: |
| Forteo |
Number: |
| OKRX 0307301 |
Effective Date: |
| 08/30/06 for Oklahoma |
Legislation: |
OK Clinical Policy Origination Date 03/14/03 Review / Revision Date: 07/22/03, 03/29/04, 09/01/04, 08/30/06 |
Contract: |
| Check all contract provisions. |
Coverage: |
Teriparatide (Forteo) is considered medically necessary for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture when all of the following criteria are met:
A. Women: Postmenopausal with osteoporosis and previous vertebral or non-vertebral fractures for at least 2 risk factors for fracture as listed below. Risk factors for fracture:
- Age 65 or older
- BMI 20 or less
- Current smoking
- Current excessive alcohol use
- Family history of osteoporosis with a hip, wrist or spine fracture in a first degree relative
- Recurrent falls
- Dementia
- Immobilization (i.e. wheelchair bound)
- Estrogen deficiency (menopause <45 or pre-menopausal amenorrhea >1 year)
- Organ transplant or pending transplant
- Endocrine and metabolic abnormalities (acromegaly, Cushing’s syndrome, hypercalciuria, hyperparathyroidism, hyperthyroidism, hypogonadism including anorexia nervosa, prolactinoma, renal tubular acidosis, type 1 diabetes mellitus, vitamin D deficiency)
- Hematologic disorders (Gaucher’s disease, hemophilia, homocysteinuria, leukemia, lymphoma, multiple myeloma, pernicious anemia, thalassemia)
- Gastrointestinal disease (celiac disease, chronic liver disease, gastrectomy, hemochromatosis, inflammatory bowel disease, parenteral nutrition, primary biliary cirrhosis)
- Connective tissue abnormalities (amyloidosis, Ehler-Danlos syndrome, Marfan’s syndrome, osteogenesis imperfecta)
- Rheumatologic disorders (ankylosing spondylitis, rheumatoid arthritis)
- Drugs (Adrenocorticotropin, anticonvulsants, cyclophosphamide, cyclosporine, glucocorticosteroids, heparin, lithium, methotrexate, premenopausal tamoxifen, thyroxine
B. Intolerant to two previous osteoporosis therapies (i.e. biphosphonates, estrogens, SERMs, calcitonin). C. No evidence of Padget’s disease, prior radiation treatment to the skeleton, bone cancer or metastases or hypercalcemia. D. Bone Mineral Density (BMD) testing T Score of –2.5 or lower prior to therapy
- BMD testing after 1 year to monitor drug efficacy.
E. Total length of therapy does not exceed 24 months.
|
|
|
Description: |
|
Teriparatide (Forteo) is a recombinant amino terminal fragment of parathyroid hormone (PTH). Endogenous PTH is the primary regulator of calcium and phosphate metabolism in the bone and kidney; it acts directly on the bone and kidney and also acts indirectly on the intestine to increase serum calcium concentrations. Teriparatide affects calcium and phosphorus metabolism in a pattern consistent with the known actions of endogenous PTH. Teriparatide binds to the same receptors as PTH and is known to exert effects identical to that of PTH on the bone and the kidney.
PTH and teriparatide stimulate bone formation and resorption and can increase or decrease bone mass, depending on the level of exposure. Teriparatide's anabolic effects manifest as in increase in skeletal mass, increase in the number of osteoblasts and osteoclasts allowing for an increase in bone remodeling, and an increase in bone strength. Osteoblasts have PTH receptors where teriparatide binds and stimulates bone-forming effects. Osteoclasts do not have PTH receptors, but appear to be activated by cytokines and other biochemical precursors that are released by stimulated osteoblasts. Teriparatide binds to the plasma-membrane receptors on osteoblasts and increases intracellular production of cyclic adenosine monophosphate (cAMP) and adenyl cyclase (AC). The release of cAMP and AC triggers osteogenesis and cAMP prompts the release of genes that drive the accumulation of osteoblasts and osteogenesis. The net result of increased number of osteoblasts and increased osteogenesis is increased bone mass and bone strength.
Teriparatide (Forteo) dosage: Subcutaneous dosage: Adults: 20 mcg SC once daily for up to 2 years.
The most commonly reported adverse events include- hypercalcemia, hypercalciuria, orthostatic hypotension, dizziness, leg muscle cramps, hypertension, angina, syncope, nausea, vomiting, constipation and dyspepsia.
Teriparatide (Forteo) is pregnancy category C. |
|
|
References: |
The North American Menopause Society. Management of osteoporosis in postmenopausal women: 2006 position statement of the North American Menopause Society. Menopause 2006; 13:340—67.
Liu H, Michaud K, Nayak S, Karpf DB, Owens DK, Garber AM. The cost-effectiveness of therapy with teriparatide and alendronate in women with severe osteoporosis. Arch Intern Med.
2006 Jun 12; 166(11):1209-17.
Delmas PD, Licata AA, Reginster JY, Crans GG, Chen P, Misurski DA, Wagman RB, Mitlak BH. Fracture risk reduction during treatment with teriparatide is independent of pretreatment bone turnover.
Bone. 2006 Aug; 39(2):237-43. Epub 2006 Mar 24.
McClung MR, San Martin J, Miller PD, Civitelli R, Bandeira F, Omizo M, Donley DW, Dalsky GP, Eriksen EF. Opposite bone remodeling effects of teriparatide and alendronate in increasing bone mass.
Arch Intern Med. 2005 Aug 8-22; 165(15):1762-8. Erratum in: Arch Intern Med. 2005 Oct 10;165(18):2120
Forteo™ (teriparatide) prescribing information | |
| CPT® only copyright 2003 American Medical Association. All Rights Reserved. |
|