Insurance Verification and Prior Authorization Form Patient

Prolia

60 mg pre-lled syringe, 60 mg SC every 6 months

Rell: x1 x2 x3 x4

Prescriber Signature: (required for legal prescription triage)



____________________________________ Date: ___________

Patient’s Scheduled Injection Date: ��

 M81.0 (Age-related osteoporosis without current pathological fracture)

 M80.0 ______ (Age-related osteoporosis with current

pathological fracture...) Please provide complete code

 Other (specify ICD Code) ________________________________

Please provide secondary ICD Code, if applicable: ______________

Original Diagnostic T-Score: ______ T-Score Date: _______________

 History of osteoporotic fracture

Prior Osteoporosis Therapy (if any):

 Generic alendronate  Fosamax

(alendronate sodium)

 Actonel

(risedronate sodium)  Boniva

(ibandronate sodium)

 Other ________________________________________________

Reason for Discontinuing Previous Osteoporosis Therapy(ies):

_______________________________________________________

Contraindications (if any):

_______________________________________________________

Patient is currently taking calcium and vitamin D supplements: Yes No

Calcium level available: Yes No

Other pertinent information: ________________________________

†

The sample diagnosis codes are informational and not intended to be directive or

a guarantee of reimbursement and include potential codes that would include FDA

approved indications for Prolia

. Other codes may be more appropriate given internal

system guidelines, payer requirements, practice patterns, and the services rendered.

*Physician Name: ________________________________________

*NPI #: _____________________ Tax ID #: __________________

Specialty: ______________________________________________

*Enter Site ID: _________________OR Complete information below.

*Site Name: ______________________________________________

*Street Address: _________________________________________

*City: _________ *State: ________ *ZIP: _____________________

*Phone: _ ____________________ Fax: ______________________

Ofce Contact: __________________________________________

*Site Type: MD Ofce Hospital Outpatient

Insurance Verication and Prior Authorization Form

Fax with copies of insurance card(s), front and back, to Amgen Assist

: 1-877-877-6542

*Asterisk elds are required for processing. If you have any questions, please contact Amgen Assist

at 1-866-AMG-ASST (1-866-264-2778).

Please see Indications and Important Safety Information on page 2, and the accompanying Prolia

full Prescribing Information, including Medication Guide.

By completing and faxing this form, you represent that your patient is aware of the disclosure of their personal health information to Amgen and its agents for

Amgen’s patient support services, including reimbursement and verication services and the services provided by eld reimbursement professionals in your ofce,

as part of the patient’s treatment with this product and that you have obtained appropriate patient authorizations as needed.

Fax Completed Form and/or Copy of Insurance Card(s) to Amgen Assist

: 1-877-877-6542.

*Patient Name: __________________________________________

 Attach patient demographic sheet OR Complete information below:

*Street Address: _________________________________________

*City: _________ *State: ________ *ZIP: _____________________

*Phone: ________________________________________________

M  F  *Date of Birth: _________________________________

Patient Information

Physician Information

(Defaults to Medical Benet)

 Medical and Pharmacy Benet

 Medical Benet (Physician Purchase)

 Referral to treating site:

*Enter Site ID: _________________ OR Complete information below.

*Site Name: _____________________________________________

*Street Address: _________________________________________

*City: _________ *State: ________ *ZIP: _____________________

*Phone: _ ____________________ *Fax: _____________________

Ofce Contact: __________________________________________

*Site Type: MD Ofce Hospital Outpatient

Fulllment Method (Select only ONE)

 Attach a copy of insurance card, front AND back OR provide:

*Insurance Name: ________________________________________

*Insurance Phone: ________________________________________

Subscriber Name: ________________________________________

Subscriber Date of Birth: ___________________________________

Subscriber Relationship to Patient: ___________________________

Group #: _______________________________________________

*Policy #: _______________________________________________

Primary Insurance Information

 Attach a copy of insurance card, front AND back OR provide:

*Pharmacy Insurance Patient ID #: ___________________________

*Pharmacy Insurance Phone #: _____________________________

Pharmacy Insurance Information

Prescription Information

Injection Date

 Attach a copy of insurance card, front AND back OR provide:

*Insurance Name: ________________________________________

*Is this a Medigap policy?  Yes  No  Not Known

If yes, please indicate plan letter: ____________________________

*Insurance Phone: ________________________________________

Subscriber Name: ________________________________________

Subscriber Date of Birth: ___________________________________

Subscriber Relationship to Patient: ___________________________

Group #: _______________________________________________

*Policy #: _______________________________________________

Secondary Insurance Information

(If Applicable)

Patient Medical Information

†

Amgen Inc.

One Amgen Center Drive

Thousand Oaks, CA 91320-1799

www.amgen.com

USA-162-82122 04/20

Please see accompanying Prolia

full Prescribing

Information, including Medication Guide.

Indications

Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, dened 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.

Prolia is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, dened 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.

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. In women of reproductive potential, pregnancy

testing should be performed prior to initiating treatment with Prolia

. 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 signicant 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

signicant 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, including treatment with other calcium-lowering drugs, clinical monitoring

of calcium and mineral levels is highly recommended within 14 days of Prolia

injection. Concomitant use of calcimimetic drugs may worsen

hypocalcemia risk and serum calcium should be closely monitored. 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

antiresorptive 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/benet assessment, on an individual basis.

•

Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia

Treatment: Following discontinuation of Prolia

treatment,

fracture risk increases, including the risk of multiple vertebral fractures. New vertebral fractures occurred as early as 7 months (on average

19 months) after the last dose of Prolia

. Prior vertebral fracture was a predictor of multiple vertebral fractures after Prolia

discontinuation.

Evaluate an individual’s benet/risk before initiating treatment with Prolia

. If Prolia

treatment is discontinued, patients should be

transitioned to an alternative antiresorptive therapy.

•

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 signicantly higher rate with Prolia

compared to placebo.

Most of these events were not specic 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 signicant suppression

of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. The signicance of these ndings 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.