Training Example: Prolia (Amgen) – Review the Data, Give Your Score & Compare to the Real AI Evaluation

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[H3] Important Safety Information

What is the most important information I should know about Prolia®?
If you receive Prolia, you should not receive other denosumab products at the same time.

Prolia® can cause serious side effects (including):

Increased risk of severe low calcium levels in your blood (hypocalcemia). Prolia may lower the calcium levels in your blood. If you have low blood calcium
before you start receiving Prolia, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia. Talk to your doctor before
starting Prolia. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Prolia. Take calcium and vitamin
D as your doctor tells you to.
If you have advanced chronic kidney disease (may or may not be on kidney dialysis), Prolia may increase your risk for severe low calcium levels in your blood,
which could result in hospitalization, life-threatening events and death. A mineral and bone disorder associated with kidney disease called chronic kidney
disease mineral bone disorder (CKD-MBD) may increase your risk for severe low calcium levels in blood. Before you start PROLIA and during treatment, your
doctor may need to do certain blood tests to check for CKD-MBD.
Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low
blood calcium such as:

spasms, twitches, or cramps in your muscles
numbness or tingling in your fingers, toes, or around your mouth

Serious allergic reactions have happened in people who take Prolia®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives.

Severe jaw bone problems (osteonecrosis) may occur. Your doctor should examine your mouth before you start Prolia® and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with Prolia®.
Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.
Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Prolia®. Talk with your doctor before starting Prolia® treatment. After your treatment with Prolia® is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop, skip or delay taking Prolia® without first talking with your doctor. If your Prolia® treatment is stopped, talk to your doctor about other medicine that
you can take.
Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take Prolia®. You may need to go to the hospital for treatment.
Prolia® is a medicine that may affect the ability of your body to fight infections. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.
Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.
Bone, joint, or muscle pain. Some people who take Prolia® develop severe bone, joint, or muscle pain.

Do not take Prolia® if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®.
Before taking Prolia®, tell your doctor about all of your medical conditions, including if you:
are taking other denosumab products
Have low blood calcium
Cannot take daily calcium and vitamin D
Had parathyroid or thyroid surgery (glands located in your neck)
Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
Have kidney problems or are on kidney dialysis
Are taking medicine that can lower your blood calcium levels
Plan to have dental surgery or teeth removed
Are pregnant or plan to become pregnant
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with Prolia®.
You should use an effective method of birth control (contraception) during treatment with Prolia® and for at least 5 months after your last dose of Prolia®.
Tell your doctor right away if you become pregnant while taking Prolia®.

Are breast-feeding or plan to breast-feed

What are the possible side effects of Prolia®?
It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® in women being
treated for osteoporosis after menopause are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.
The most common side effects of Prolia® in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat).
The most common side effects of Prolia® in patients with corticosteroid-induced osteoporosis are back pain, high blood pressure, lung infection (bronchitis), and
headache.
The most common side effects of Prolia® in patients receiving certain treatments for prostate or breast cancer are joint pain, back pain, pain in your arms and
legs, and muscle pain. Additionally, in Prolia®-treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.
These are not all the possible side effects of Prolia®. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Prolia® full

Prescribing Information and
Medication Guide.
Approved Uses
Prolia® is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.
Prolia® is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture.
Prolia® is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six months and are at high risk for fracture.
Prolia® is a prescription medicine used to treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.
Prolia® is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.

Prolia® is an injection administered by a healthcare professional and is
covered by both Medicare Part B and Medicare Part D
What you pay will depend on your Medicare plan and whether your doctor orders
Prolia® from a distributor (medical benefit) or gets it from a
pharmacy (pharmacy benefit).
Ask your doctor how you can get Prolia®

[IMG: Example of Medicare Health Insurance card]

If you are a Medicare Part B patient

100%

of Medicare Part B patients
have access to Prolia® as
initial therapy*

No step edit required
No prior authorization required

Most Medicare Part B patients have additional insurance and could pay
$0 per syringe of Prolia after meeting deductible†,‡

After you meet your deductible, Medicare Part B covers 80% of therapies
you receive in your doctor’s office

You can obtain an additional insurance (e.g., Medicare Supplement Plan
or Medigap, commercial, TRICARE) to pick up the additional 20%§
- You may need to pay additional monthly premiums with
these additional insurances.

Out-of-pocket costs do not include costs related to office visits or
administration of Prolia®.

What you pay for Prolia® will depend on the type of
Medicare plan you have. Talk to your insurance provider to find out what
you will pay for Prolia®.

*All Medical Lives associated with Coverage Restriction for Prolia in
MMIT coverage data snapshot as of January 2025 are included in this
analysis.

†Amgen's SupportPlus
insurance verification data for January 2024 to December 2024 was
analyzed to determine the OOP Distribution. Prolia prospective patients
are only included in the analysis.

‡The co-pay may depend
on coverage of additional insurance plan(s).

§You should be enrolled
in Medicare Part A and Part B. Medicare patients with supplemental
coverage (e.g., Medigap) may require additional premiums.

If you are a Medicare Advantage (Medicare Part C) patient

Medicare Advantage is another way to get Medicare services and is offered by private health
insurance companies.

Cost and coverage vary by plan so it’s important to verify your insurance benefits and
out-of-pocket costs for Prolia®

[IMG: Example of Medicare Advantage card]

If you are a Medicare Part D patient
96%
of Medicare Part D patients* have access* to
Prolia®†
[IMG: Prescription pad]
Pharmacy patients: Some Medicare Part D plans have a preferred specialty
pharmacy and some commercial plans require a specific specialty pharmacy for filling your
Prolia® prescription.
Preferred Specialty Pharmacies‡
[IMG: Pharmacies]
Some Medicare Part D plans have a preferred specialty pharmacy for
filling prescriptions

MEDICAL AND/OR PRESCRIPTION PLAN
PREFERRED SPECIALTY PHARMACY

Aetna
CVS Specialty

Express Scripts
Accredo Health Group

Cigna
Accredo Health Group

CVS Caremark
CVS Specialty

Highmark
Accredo Health Group

Humana
CenterWell Specialty Pharmacy

The pharmacies listed above are for information purposes only and may not be
comprehensive of all available mandated specialty pharmacies for a particular plan.
The information provided is not a guarantee of fulfillment. Information as of
01/20/2023. For the most up-to-date and complete information, please refer to a
patient’s health plan regarding specific policies, instructions, and
requirements.
[IMG: Example of Medicare Part D Prescription Drug Plans card]
If you have a limited income: Medicare beneficiaries may
qualify for Extra Help, a program to help pay for medication costs through Medicare Part D.
Visit the Medicare website to
learn more about Extra Help.
Dual eligibility: Medicare Part D is the primary source
of drug coverage for “dual eligible” beneficiaries covered under both Medicare
and Medicaid.
*Access is defined as the ability of a patient to obtain
Prolia®, although patient OOP cost and insurance requirements may vary.
†All Medicare Part D Pharmacy Lives associated with Coverage Restriction for Prolia in MMIT Coverage data snapshot as of February 2025 are used.
‡The information is provided as a courtesy only and Amgen does not guarantee
the accuracy of the information.
To learn more call 1-866-264-2778

[IMG: Amgen® SupportPlus]

[H1] Helping eligible commercially insured patients lower out-of-pocket costs

[IMG: Amgen® SupportPlus Card]

The Amgen® SupportPlus Co-Pay Program can help eligible commercially insured patients lower their out-of-pocket prescription costs, including deductible, co-insurance, and co-payment.

For Prolia®, you may pay as little as $0 out-of-pocket for each dose*
Can be applied to deductible, co-insurance, and co-payment

*Eligibility criteria and program maximums apply. See www.amgensupportplus.com/copay for full Terms and Conditions.
Help patients enroll online at www.amgensupportplus.com/copay or by phone at 1-866-264-2778

HOW TO GET STARTED

Please see Important Safety Information below.

[H3] Options to enroll in and how to use the Amgen SupportPlus
Co-Pay Program.

Option 1:
Direct Enrollment or Through your doctor’s office

Your doctor’s office can assist you with enrollment* or you can enroll yourself.

Online: AmgenSupportPlus.com/copay
Phone: (866) 264-2778

The co-pay card details can be accessed via the online portal or by calling (866) 264-2778
Submitting a Claim: You or your doctor’s
office can send in the itemized EOB† to the Amgen SupportPlus Co-Pay Program after each treatment using one of the options below.

Online: Submit a claim by
uploading it to your account on
AmgenSupportPlus.com/copay

Fax: 844-369-9961
Mail: Amgen SupportPlus Co-Pay Program 100 Passaic Avenue, Suite 245 Fairfield, NJ 07004

Once the claim is approved, the Amgen SupportPlus Co-Pay Card can be used to reduce your out-of-pocket cost

Option 2:
With participating pharmacies

After being prescribed an Amgen product, you can work with participating specialty or retail pharmacies to enroll* in the Amgen SupportPlus Co-Pay Program and also activate a virtual co-pay card.

The specialty pharmacy will process the claim with card information listed here:

Member ID
RxBIN
PCN
Group Number

The pharmacy will help coordinate the shipment of your medication directly to the site of care or to you so that it is available for administration

*A healthcare representative, including pharmacists, may not enroll you in the Co-Pay Card Program. However, they may assist you if you are commercially insured with enrollment. You will need to be physically present, or on the phone during the enrollment to (1) answer the eligibility questions; (2) indicate that you read, understood, and accepted the Terms and Conditions; and (3) indicate that you read and agreed to the Patient Authorization.
†An itemized EOB is an explanation of benefits from a health plan that typically indicates the amount of insurance coverage for each service and/or treatment at the doctor’s office, as well as the patient’s normal out-of-pocket costs.

[IMG: prolia_patient_logo_small]

Amgen® SupportPlus Representatives can provide information about independent nonprofit foundations that may be able to help.‡
Please contact Amgen SupportPlus for more information at 1-866-264-2778
‡Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofit’s criteria. Amgen has no control over these programs and provides information as a courtesy only.

See whether Prolia® is right for you by selecting an option below

[IMG: Learn more if you]
[H3] Starting with Prolia®
I’ve been diagnosed with postmenopausal osteoporosis at high risk for fracture and am exploring treatment options.+

[IMG: quote-icon]

I thought my bones were fine. I exercise, I eat right, I’m very healthy. But I found
out my bones weren’t as great as I thought.
—Rebecca,
taking Prolia®
since 2015
Individual results may vary.

[IMG: Rebecca, taking Prolia® (denosumab) since 2015]

1
[H1] Osteoporosis is progressive and bone loss will worsen if not treated.

[IMG: dot line]

Though exercise, calcium, and vitamin D are a good start, those
elements alone may not be enough to protect you from breaking a bone.
Talk to your doctor to see if you can start slowing down bone loss and help reduce your risk of fracture with Prolia®.

2
[H1] Over 26 million women have been treated with Prolia® worldwide.*

[IMG: dot line]

Gain perspective from real women who have experience with Prolia® here.
*Estimates of patients treated reflect global data since launch (June 2010-June 2024; US=approximately 25% of data). Patient counts are based on syringes sold and IQVIA prescription data.

3
[H1] Prolia® is proven to help strengthen bones and significantly reduce spine fracture risk with 1 shot every 6 months.

[IMG: dot line]

In a 3-year study, women not treated with Prolia® had more new spine fractures (7.2%) compared to women treated with Prolia® (2.3%). Study consisted of 7393 patients who received either Prolia® or a placebo (a treatment containing no medicine).

You should take calcium and vitamin D as your doctor tells you to while you receive Prolia®.

After your treatment with Prolia® is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. Do not stop, skip or delay taking Prolia® without first talking with your doctor.

[H3] Talk to your doctor about Prolia®

Download the personalized Doctor Discussion Guide to be proactive before your next doctor's visit.

DOWNLOAD THE GUIDE

CLOSE SECTION
-

[IMG: Learn more if you]
[H3] Switching to Prolia®
I have postmenopausal osteoporosis at high risk for fracture and I am
on an oral medication, but I’m not happy with my current treatment.+

I had tried other treatments before, but I wasn't seeing the great results I wanted. So, I
talked to my doctor about Prolia®.
My scan showed improvement within that first year.
—Anita,
taking Prolia®
since 2011
Individual results may vary.

1
[H1] Only Prolia® is proven to help strengthen and protect bones from fracture with 1 shot every 6 months.

[IMG: dot line]

That could mean fewer doses than most other osteoporosis treatments.
You should take calcium and vitamin D as your doctor tells you to while you receive Prolia®.

After your treatment with Prolia® is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. Do not stop, skip or delay taking Prolia® without first talking with your doctor.

2
[H1] Prolia® has been studied in two head-to-head bone mineral density (BMD) studies against other common treatments.

[IMG: dot line]

See the data

3
[H1] Over 26 million women have been treated with Prolia® worldwide.*
[IMG: dot line]

Gain perspective from real women who have experience with Prolia® here.
*Estimates of patients treated reflect global data since launch (June 2010-June 2024; US=approximately 25% of data). Patient counts are based on syringes sold and IQVIA prescription data.

[H3] Talk to your doctor about Prolia®

Download the personalized Doctor Discussion Guide to be proactive before your next doctor's visit.

DOWNLOAD THE GUIDE

CLOSE SECTION
-

[H5] Nearly 500,000 women were included in the largest
Real-World study for postmenopausal osteoporosis.

[H2] Compare fracture results between Prolia® and alendronate (Fosamax®).

SEE THE EVIDENCE

Learn about another treatment option for people who’ve already had a fracture or who are at very high risk for fracture due to osteoporosis.

EXPLORE

Close

[H3] Important Safety Information

What is the most important information I should know about Prolia®?
If you receive Prolia, you should not receive other denosumab products at the same time.

Prolia® can cause serious side effects (including):

Increased risk of severe low calcium levels in your blood (hypocalcemia). Prolia may lower the calcium levels in your blood. If you have low blood calcium
before you start receiving Prolia, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia. Talk to your doctor before
starting Prolia. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Prolia. Take calcium and vitamin
D as your doctor tells you to.
If you have advanced chronic kidney disease (may or may not be on kidney dialysis), Prolia may increase your risk for severe low calcium levels in your blood,
which could result in hospitalization, life-threatening events and death. A mineral and bone disorder associated with kidney disease called chronic kidney
disease mineral bone disorder (CKD-MBD) may increase your risk for severe low calcium levels in blood. Before you start PROLIA and during treatment, your
doctor may need to do certain blood tests to check for CKD-MBD.
Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low
blood calcium such as:

spasms, twitches, or cramps in your muscles
numbness or tingling in your fingers, toes, or around your mouth

Serious allergic reactions have happened in people who take Prolia®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives.

Severe jaw bone problems (osteonecrosis) may occur. Your doctor should examine your mouth before you start Prolia® and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with Prolia®.
Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.
Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Prolia®. Talk with your doctor before starting Prolia® treatment. After your treatment with Prolia® is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop, skip or delay taking Prolia® without first talking with your doctor. If your Prolia® treatment is stopped, talk to your doctor about other medicine that
you can take.
Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take Prolia®. You may need to go to the hospital for treatment.
Prolia® is a medicine that may affect the ability of your body to fight infections. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.
Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.
Bone, joint, or muscle pain. Some people who take Prolia® develop severe bone, joint, or muscle pain.

Do not take Prolia® if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®.
Before taking Prolia®, tell your doctor about all of your medical conditions, including if you:
are taking other denosumab products
Have low blood calcium
Cannot take daily calcium and vitamin D
Had parathyroid or thyroid surgery (glands located in your neck)
Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
Have kidney problems or are on kidney dialysis
Are taking medicine that can lower your blood calcium levels
Plan to have dental surgery or teeth removed
Are pregnant or plan to become pregnant
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with Prolia®.
You should use an effective method of birth control (contraception) during treatment with Prolia® and for at least 5 months after your last dose of Prolia®.
Tell your doctor right away if you become pregnant while taking Prolia®.

Are breast-feeding or plan to breast-feed

What are the possible side effects of Prolia®?
It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® in women being
treated for osteoporosis after menopause are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.
The most common side effects of Prolia® in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat).
The most common side effects of Prolia® in patients with corticosteroid-induced osteoporosis are back pain, high blood pressure, lung infection (bronchitis), and
headache.
The most common side effects of Prolia® in patients receiving certain treatments for prostate or breast cancer are joint pain, back pain, pain in your arms and
legs, and muscle pain. Additionally, in Prolia®-treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.
These are not all the possible side effects of Prolia®. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Prolia® full

Prescribing Information and
Medication Guide.
Approved Uses
Prolia® is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.
Prolia® is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture.
Prolia® is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six months and are at high risk for fracture.
Prolia® is a prescription medicine used to treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.
Prolia® is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.