Prior Auth Protocol

FDA Approved Indications:

Treatment and prevention of osteoporosis in postmenopausal women
Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis
Reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer

Health Net Approved Indications and Usage Guidelines:

Treatment and prevention of osteoporosis or high risk of osteoporosis

OR

Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis

OR

Reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer

High Risk of Breast Cancer is defined as:

Five- year predicted risk of breast cancer (calculated using Breast Cancer Risk Assessment) at least 1.66%

OR

At least one breast biopsy with lobular carcinoma in situ (LCIS) or atypical hyperplasia

OR

One or more first-degree relatives with breast cancer

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

According to the National Osteoporosis Foundation, sequential treatment with anabolic therapy followed by an antiresorptive is generally preferred to concomitant combination therapy. However, combination therapy with teriparatide and an antiresorptive can be considered in a few clinical settings in patients with very severe osteoporosis. There are few indications for combining two antiresorptive treatments, but such options could be considered in the short-term in women who are experiencing active bone loss while on low dose hormone therapy for menopausal symptoms or raloxifene for breast cancer prevention.
Evista is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer.
There is insufficient data on the use of Evista for treatment of menopausal symptoms, i.e. hot flashes (an increased incidence of hot flashes has been observed with Evista in clinical trials).
If a patient has a history of non-vertebral (i.e. hip) fractures, the prescribing physician will be advised that:

The reduction of non-vertebral fracture risk has not been substantiated with calcitonin or Evista.
Bisphosphonates (Actonel and Fosamax) have demonstrated clinical efficacy in reducing the risk of non-vertebral fractures in controlled trials.

The Breast Cancer Risk Assessment Profile (BCRP) available at www.cancer.gov/bcrisktool/ is based on the Gail model that includes the following factors: current age, age at menarche, nulliparity or age at first live birth, number of first-degree relatives with breast cancer, number of breast biopsies and other factors. Healthcare professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-545-5979.
Evista has a black box warning for in increased risk of venous thromboembolism and death from stroke. Increased risk of deep vein thrombosis and pulmonary embolism have been reported with Evista. Women with active or past history of venous thromboembolism should not take Evista Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary artery disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
alendronate(Fosamax^R)	Post menopausal Osteoporosis (PMO) prevention 5 mg PO QD or 35 mg PO once weekly PMO treatment 10 mg PO QD or 70 mg PO once weekly	10 mg/day or 70 mg/week
Fosamax Plus D^R(alendronate/ cholecalciferol)*	PMO treatment 70 mg alendronate/ 2,800 units cholecalciferol or 70 mg alendronate /5,600 units cholecalciferol PO once weekly	70 mg alendronate/5,600 units cholecalciferol/week
risedronate (Actonel^R)*	PMO prevention & treatment 5 mg PO QD or 35 mg PO once weekly or 150 mg PO once monthly	5 mg/day 35 mg/week 150 mg/month
calcitonin-salmon nasal spray (Miacalcin^RNasal Spray, Fortical^R Nasal Spray)	PMO treatment 200 IU spray in one nostril QD	Nasal Spray: 200 IU/day
Miacalcin^R Injection (calcitonin-salmon)*	PMO treatment 100 IU SC/IM QOD	Injection: 100 IU/day
ibandronate (Boniva^R)*	PMO prevention & treatment (tablets) 150 mg PO once monthly PMO treatment (injection) 3 mg IV every 3 months over 15 to 30 seconds	PO: 150 mg /month IV: 3 mg per dose

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Evista	60 mg PO QD	Length of benefit

Product Availability:

Evista 60 mg tablets

References:

1. Evista [Prescribing Information] Indianapolis, IN: Eli Lilly and Company; January 2011.
2. National Osteoporosis Foundation. The Clinician`s Guide to Prevention and Treatment of Osteoporosis. Available at: http://nof.org/files/nof/public/content/file/2791/upload/919.pdf. Accessed February 27, 2016.
3. The North American Menopause Society. Management of postmenopausal Osteoporosis: 2010 position statement of the North American Menopause Society. Menopause 2010;17(1): 22-54.
4. Watts NB, Bilezikian JP, Camacho PM, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of postmenopausal osteoporosis. Endocr Pract 2010;16(Suppl 3):1-37.
5. National Cancer Institute. www.cancer.gov/bcrisktool/. Accessed February 27, 2016.
6. Raloxifene. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed February 27, 2016.
7. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed February 27, 2016
8. Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed February 27, 2016.