Prolia® (denosumab) injection
Medicare Insurance
Medicare Insurance
MEDICARE PART B

For your Medicare Part B patients

You can administer Prolia® in your office or refer them to an injection center

100% Medicare Part B beneficiaries have coverage for Prolia® with no prior authorization required1*

  • All Medicare Administrative Contractors cover Prolia®
  • There are no prior authorizations under Medicare Part B2**
  • PA may be required under Medicare Part C (Medicare Advantage)

On average, Prolia® claims are paid by Medicare within 15 days3‡
The permanent J-code for Prolia® for Medicare claim processing:
J0897 (Injection, denosumab, 1 mg)4

MEDICARE PART D

Your Medicare Part D patients can fulfill a Prolia® prescription through specialty or retail pharmacies

95% of Medicare Part D beneficiaries have coverage for Prolia®, over half with no prior authorization (PA) required5*†

PROLIA® IS COVERED BY THE FOLLOWING
TOP MEDICARE PART D PLANS5-7
Aetna/Coventry NO PA REQUIRED
Anthem/Blue Cross Blue Shield affiliates
Cigna-HealthSpring NO PA REQUIRED
CVS Caremark/SilverScript/Health Net NO PA REQUIRED
Express Scripts PA MAY BE REQUIRED§
Humana NO PA REQUIRED
Prime Therapeutics/MedicareBlue Rx/Blue Cross MedicareRx PA MAY BE REQUIRED
Rite Aid/EnvisionRx NO PA REQUIRED
UnitedHealthcare/AARP/OptumRx
WellCare NO PA REQUIRED

Specialty pharmacies in the Prolia® network can help your appropriate patients start and stay on track with their Prolia® therapy. They can:

  • Investigate benefits and support your office with PA process
  • Connect patients with financial assistance programs
  • Ship on demand directly to your office or your patient's home
  • Remind your office and patients when the next Prolia® injection is due
INSURANCE VERIFICATION

Verify your patients' insurance coverage with ProliaPLUS®

ProliaPLUS® can work directly with insurers to help verify patient coverage and out-of-pocket costs for Prolia®. ProliaPLUS® communicates insurance verification results directly to your office in near real time.

To request ProliaPLUS® assistance for an individual patient, either complete the Insurance Verification Request form and fax it to ProliaPLUS ® at 877-877-6542 or register for ProliaPLUS® online to submit requests through the internet.

Verify your patient's
insurance online:

Download the Insurance
Verification Request form:

Install Acrobat Reader:

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Important Safety Information

Contraindications: Prolia® is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Prolia®. Prolia® is contraindicated in women who are pregnant and may cause fetal harm. Prolia® is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling and urticaria.

Same Active Ingredient: Prolia® contains the same active ingredient (denosumab) found in XGEVA®. Patients receiving Prolia® should not receive XGEVA®.

Hypersensitivity: Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia®. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of Prolia®.

Hypocalcemia: Hypocalcemia may worsen with the use of Prolia®, especially in patients with severe renal impairment. In patients predisposed to hypocalcemia and disturbances of mineral metabolism, clinical monitoring of calcium and mineral levels is highly recommended within 14 days of Prolia® injection. Adequately supplement all patients with calcium and vitamin D.

Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving Prolia®. An oral exam should be performed by the prescriber prior to initiation of Prolia®. A dental examination with appropriate preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ such as invasive dental procedures, diagnosis of cancer, concomitant therapies (e.g. chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders. Good oral hygiene practices should be maintained during treatment with Prolia®. The risk of ONJ may increase with duration of exposure to Prolia®.

For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. Extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of Prolia® should be considered based on individual benefit-risk assessment.

Atypical Femoral Fractures: Atypical low-energy, or low trauma fractures of the shaft have been reported in patients receiving Prolia®. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with anti-resorptive agents.

During Prolia® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of Prolia® therapy should be considered, pending a risk/benefit assessment, on an individual basis.

Serious Infections: In a clinical trial (N = 7808) in women with postmenopausal osteoporosis, serious infections leading to hospitalization were reported more frequently in the Prolia® group than in the placebo group. Serious skin infections, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated with Prolia®.

Endocarditis was also reported more frequently in Prolia®-treated patients. The incidence of opportunistic infections and the overall incidence of infections were similar between the treatment groups. Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis.

Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections. In patients who develop serious infections while on Prolia®, prescribers should assess the need for continued Prolia® therapy.

Dermatologic Adverse Reactions: In the same clinical trial in women with postmenopausal osteoporosis, epidermal and dermal adverse events such as dermatitis, eczema and rashes occurred at a significantly higher rate with Prolia® compared to placebo. Most of these events were not specific to the injection site. Consider discontinuing Prolia® if severe symptoms develop.

Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Prolia®. Consider discontinuing use if severe symptoms develop.

Suppression of Bone Turnover: In clinical trials in women with postmenopausal osteoporosis, Prolia® resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. The significance of these findings and the effect of long-term treatment are unknown. Monitor patients for consequences, including ONJ, atypical fractures, and delayed fracture healing.

Adverse Reactions: The most common adverse reactions (>5% and more common than placebo) in women with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.

The most common adverse reactions (>5% and more common than placebo) in men with osteoporosis are back pain, arthralgia, and nasopharyngitis. Pancreatitis has been reported with Prolia®.

In women with postmenopausal osteoporosis, the overall incidence of new malignancies was 4.3% in the placebo group and 4.8% in the Prolia® group. In men with osteoporosis, new malignancies were reported in no patients in the placebo group and 4 (3.3%) patients in the Prolia® group. A causal relationship to drug exposure has not been established. Denosumab is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

Prolia® Postmarketing Active Safety Surveillance Program: The surveillance program is available to collect information from prescribers on specific adverse events. Please see www.proliasafety.com or call 1-800-772-6436 for more information.

Indications

Prolia® is indicated 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.

Prolia® is indicated for 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.

References

1. CMS Coverage Database Search Results for Denosumab. February 2016. 2. Garber AM. Commentary: the impact of Medicare coverage policies on health care utilization. Health Serv Res. 2008;43(4):1302-1307. 3. Data on file, Amgen. 2015. 4. Centers for Medicare & Medicaid Services. Alpha-Numeric Drug Table for 2014. http://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html. Accessed June 24, 2015. 5. Data on file, Amgen. 2016. 6. Medicare Plan Finder available at https://www.medicare.gov/find-a-plan/questions/home.aspx. Accessed February 25, 2016. 7. 2016 Cigna-HealthSpring Comprehensive Drug List (Formulary). Available at: http://www.cigna.com/iwov-resources/medicare-2016/docs/formulary-ea-mapd.pdf?WT.z_nav=medicare%2Fpart-d%2Fdrug-list-formulary%3BBody%3BEnglish. Accessed February 23, 2016.