Prolia® (denosumab) injection
Financial Assistance
Financial Assistance
MEDICARE PART B

79% of Prolia® syringes cost Medicare Part B patients $0 OOP, according to benefit verification data1*†‡

OOP Costs for Medicare Part B Patients per Prolia® Syringe (% of Syringes)1*†

These data do not include medical benefit OOP costs related to office visits or administration of Prolia®. This sample includes Medicare patients with supplemental/ secondary coverage (eg, Medigap) that may require additional monthly premiums. Individual OOP costs will vary.

ProliaPLUS® can refer eligible Medicare Part B patients to independent co-pay foundations, which may be able to provide financial assistance. Click here to learn more.

MEDICARE PART D

Approximately 60% of Prolia® syringes cost Medicare Part D patients no more than $10 out of pocket (OOP)2*

OOP Costs for Medicare Part D Patients per Prolia® Syringe (% of Syringes)2*

These pharmacy claims data do not include deductibles or any other physician-related service fees associated with administration of Prolia® (eg, doctor visits). OOP costs may vary by patient and/or injection.

For 72% of Medicare Part D patients with a co-pay less than $100 per syringe, the approximate cost is $15 per month.

COMMERCIAL INSURANCE

With the Prolia® Co-pay Program, eligible patients with commercial insurance can pay $25 or less with the Prolia® Co-pay Card

To check a patient's eligibility and to activate the coupon online, go to www.ProliaSupport.com
  • No income eligibility requirement
  • Reduce OOP costs under the medical or pharmacy benefit
  • Applies to deductible, co-insurance, and/or co-pay for Prolia®*
FINANCIAL ASSISTANCE SERVICES

If your patients need help, Financial Assistance options are available

For your eligible patients, who are not insured or under-insured, there are other ways that you can help them afford their Prolia® treatment. See all the services available below.

The Safety Net Foundation
A nonprofit foundation supported by Amgen that provides Prolia® at no cost to qualifying patients. Eligibility requirements apply.
Visit www.safetynetfoundation.com or call 1-888-762-6436.

Independent Nonprofit Co-pay Foundations
Eligible patients, including those with Medicare, may qualify to receive assistance with out-of-pocket costs from independent, nonprofit co-pay foundations.

Availability of funds changes frequently. Increasing demand for co-pay foundation support cannot be met by one company alone and requires engagement from across the industry. Please contact each foundation directly for more information and to find out if you qualify for assistance.

Patient Access Network
Visit www.panfoundation.org for more information and to apply online or call 1-866-316-PANF (7263).

Patient Advocate Foundation (PAF) Co-Pay Relief
Visit www.copays.org for more information and to apply online or call 1-866-512-3861.

HealthWell Foundation
Visit www.healthwellfoundation.org for more information and to apply online or call 1-800-675-8416.

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. Data on file, Amgen. 2015. 2. Data on file, Amgen. 2015.