Denosumab Prior Authorization with Quantity Limit

TARGET AGENT(S)

Prolia^® (denosumab) is FDA approved:

·        For the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, nonvertebral, and hip fractures.

·        For the treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy

·        For the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy

·        For the treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia also reduced the incidence of vertebral fractures

·        For the treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer  

Xgeva^® (denosumab) is FDA approved:

·        For the treatment of the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors

·        For the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity 

·        For the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.  

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Initial Evaluation

I. Prolia or biosimilar will be considered medically necessary when ALL of the following are met: 

A. The patient has diagnosis of osteopenia defined as femoral neck T-score of -1.0—2.5 and BOTH of the  following:

1. The patient is a postmenopausal woman, or male age 50 years or older; AND

2. The patient is considered at high fracture risk based on ONE of the following:

                            a. Previous fracture; OR

                            b. 10yr probability of hip fracture of ≥3% per FRAX score; OR

                            c. 10yr probability of major osteoporotic fracture of ≥20% per FRAX score.

OR

B. The patient is postmenopausal female; AND

              1. The diagnosis of osteoporosis is defined by ONE of the following:

                             a. Osteoporosis has been diagnosed based on presence of hip, vertebral, or fragility fracture; OR

                            b. Osteoporosis has been diagnosed based on documented BMD T-score of <-2.

OR

C. The patient is male and has diagnosis of osteoporosis based on ONE of the following:

             1. Osteoporosis has been diagnosed based on BMD T-score of -2.0 to -1.0; OR

             2. Osteoporosis has been diagnosed based on history of fragility fracture.

OR

    D. Prolia or biosimilar is being used to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic, hormone-sensitive prostate cancer and ONE of the following:

              1. The patient has a history of vertebral fracture(s), or low trauma or fragility fracture(s) [e.g., prior fracture from minor trauma such as falling from standing height or less] within the past 5 years; OR

              2. ONE of the following:

                            a. The patient is ≥70 years of age; OR

                            b. The  patient is <70 years of age AND has a T-score of -1 or lower OR a history of an osteoporotic fracture.

OR                      

E. Prolia or biosimilar is being used to treat a woman at high risk for fracture receiving adjuvant aromatase inhibitor therapy for hormone receptor-positive nonmetastatic breast cancer; AND

           1. The patient has low bone density as defined by T-scores less than -1.0.

AND

  F. ONE of the following:

             1. The patient has tried a bisphosphonate (IV or oral formulation); OR

             2. The patient has intolerance or FDA approved contraindication to use of bisphosphonates (IV or oral formulation); AND

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

H. The patient must have contraindication, intolerance or failure to preferred agents Bildyos AND Jubbonti AND Stoboclo.

Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence

Length of Approval:  36 months

I. Denosumab (Xgeva or biosimilar) will be considered medically necessary when ALL of the following are met: 

    A. The patient has a diagnosis of multiple myeloma and ALL of the following:

1. The request agent will be used for the prevention of skeletal-related events; AND

2. ONE of the following:

a. The patient has tried/failed zoledronic acid; OR

b. The patient has a documented intolerance, FDA labeled contraindication or hypersensitivity to zoledronic acid (documentation must be provided).

OR

   B. The patient has a solid tumor cancer diagnosis (e.g., thyroid, non-small cell lung, kidney cancer, prostate cancer, breast cancer) and ALL of the following:

1. The patient has documented bone metastases; AND

2. ONE of the following:

a. The patient has tried/failed zoledronic acid; OR

b. The patient has a documented intolerance, FDA labeled contraindication or hypersensitivity to zoledronic acid (documentation must be provided).

OR

   C. The patient has a diagnosis of hypercalcemia of malignancy and ONE of the following:

1. The patient has failed/is refractory to intravenous bisphosphonate therapy (i.e., albumin-corrected calcium of ≥ 12.5 mg/dL [3.1 mmol/L]); OR

2. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to intravenous bisphosphonate therapy.

OR

   D. The patient has a diagnosis of giant cell tumor of bone AND tumor is unresectable or surgical resection is likely to result in severe morbidity AND

   E. The patient must have contraindication, intolerance or failure to preferred agents Bilprevda AND Osenvelt AND Wyost

AND

   F. ONE of the following:

1. The patient is not receiving concomitant denosumab (Prolia or biosimilar) therapy; OR

2. The prescriber indicates that the patient will discontinue Prolia (or biosimilar) prior to beginning therapy with Xgeva (or biosimilar).

 Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence

 Length of Approval:  Prolia: 36 months; Xgeva: 12 months

 Renewal Evaluation

I. Target agent(s) will be considered medically necessary when ALL of the following are met:

   A. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process; AND

        1. The patient has had clinical benefit with the requested agent

AND

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

AND

         3. ONE of the following:

A.      The requested quantity (dose) does not exceed the program quantity limit

OR

B.      ALL of the following

                                                     i.     The requested quantity (dose) is greater than the program quantity limit

AND

                                                   ii.     The requested quantity (dose) does not exceed the maximum FDA labeled dose for the requested indication

AND

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

OR

C.      ALL of the following:

                                                     i.     The requested quantity (dose) is greater than the program quantity limit

AND

                                                   ii.     The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

                                                  iii.     Information has been provided in support of therapy with a higher dose for the requested indication.

Length of Approval:   Prolia: 36 months; Xgeva: 12 months 

FORMS 

To request preauthorization complete the form at:

https://www.nebraskablue.com/~/media/pdf/Provider/Pharmacy/Prolia%2089051%20072611.pdf

1. Other conditions that would exclude coverage include uncorrectable hypocalcemia.

2. Dosing: Denosumab (Prolia™) is FDA-approved at a dose of 60 mg administered subcutaneously by a healthcare professional every 6 months. Doses of denosumab (Prolia™) higher than the FDA-approved dose may increase the risk of malignancy.

3. Claims records will be reviewed to confirm consistent use of androgen deprivation therapy or adjuvant aromatase inhibitor therapy.

4. Denosumab will not be given along with bisphosphonates.

5. Initial authorization is for 36 months.