Before Using This Medicine
You should not use Prolia if you are allergic to denosumab, or if you have low levels of calcium in your blood .
While you are using Prolia, you should not use Xgeva, another brand of denosumab.
To make sure Prolia is safe for you, tell your doctor if you have:
a weak immune system
a history of hypoparathyroidism
a history of thyroid surgery
a history of surgery to remove part of your intestine
any condition that makes it hard for your body to absorb nutrients from food or
if you are allergic to latex.
Prolia may cause bone loss in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, gum infection, or slow healing after dental work.
Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia , and a pre-existing dental problem.
Prolia can harm an unborn baby or cause birth defects. Do not use Prolia if you are pregnant. Tell your doctor right away if you become pregnant during treatment.
It is not known whether denosumab passes into breast milk or if it could harm a nursing baby. This medicine may also slow the production of breast milk. You should not breast-feed while using this medicine.
Refractory Rash Denied For Ivig
Hi Michelle, thank you in advance for your help. My 22 year old son was diagnosed with amyopathic dermatomyositis 12/17, after a year of misdiagnosis. All antibodies are negative. He has elevated CK and the distinctive shawl rash, heliotrope rash,gottron’s papules and nailbed findings. His scans and MRI’s were negative for any muscle disease. Our insurance has denied his IVIG treatment 4 times, stating he needs a muscle biopsy. His physician states the muscle biopsy isn’t necessary because he has no signs/symptoms of muscle disease. Meanwhile his rash is worsening and he is becoming increasingly depressed and isolated. He is using all sun precautions, including black out curtains on his windows, high SPF, hat, and sun avoidance. How can we get his IVIG approved?Thanks again,
Does Your Medicare Insurance Plan Cover Prolia
Osteoporosis is a common condition in the United States. Over 10 million people have osteoporosis, and 44 million have bone density levels that are well below normal. People with osteoporosis live with limited mobility, pain, loss of height, and fear of bone fractures daily.
What Is Osteoporosis, and Are You At Risk?
Taken from the Greek language, osteoporosis means porous bones. It is a condition that promotes bone tissue deterioration and leads to brittle, fragile bones that are at greater than normal risk of cracking, breaking, or compressing under pressure. While there is no cure for osteoporosis, there are treatments that can help by slowing bone deterioration. They can help protect and strengthen bones, and even in some cases, stimulate new bone growth.
Osteoporosis is called a silent disease because there are typically no symptoms until you get a broken bone. The most common fractures occur in the hip, wrist, spine and shoulder.
The human body contains specific cells that are bone producing cells, and other cells that are bone removing cells. When this process is working normally, there is a continuous process of breaking down and building up of bone tissue, resulting in strong, healthy bones. In post-menopausal osteoporosis, the bone removing cells are more active which means the rate of bone loss is greater than the rate of bone building, resulting in brittle bones.
- Kidney disease
- Sedentary lifestyle
- Taking certain medications
Medicare Part D Coverage for Prolia
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How Is Prolia Given
Prolia is injected under the skin of your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.
Prolia is usually given once every 6 months.
Your doctor may have you take extra calcium and vitamin D while you are being treated with Prolia. Take only the amount of calcium and vitamin D that your doctor has prescribed.
If you need to have any dental work , tell the dentist ahead of time that you are using Prolia.
Pay special attention to your dental hygiene. Brush and floss your teeth regularly while using this medication. You may need to have a dental exam before you begin treatment with Prolia. Follow your doctor’s instructions.
Your risk of bone fractures can increase when you stop using Prolia. Do not stop using this medicine without first talking to your doctor.
If you keep this medicine at home, store it in the original container in a refrigerator. Protect from light and do not freeze.
You may take Prolia syringe out of the refrigerator and allow it to reach room temperature before the injection is given. Do not heat the medicine before using.
Do not shake the the prefilled syringe or you may ruin the medicine. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for a new prescription.
Each prefilled syringe of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
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Vaccines Covered By Medicare Part D
Medicare Part D covers all commercially available vaccines needed to prevent illness. You can get Part D coverage through a stand-alone Medicare prescription drug plan or a Medicare Advantage plan that includes drug coverage.
Vaccines covered by Part D include the following:
- Shingles vaccine: One-time vaccine given in two shots over two to six months
- Tdap vaccine : One shot if youve never been vaccinated, and a booster every ten years
- Other vaccines covered: Vaccines that are “reasonable and necessary” to prevent illness and are not covered by Part B
Part D may also cover vaccines you may need if you are traveling internationally. Talk with your doctor about your travel plans and ask what vaccines are recommended.
Do Medicare A And B Cover Prolia Injections
Medicare Part B may cover the cost of Prolia injections if you:
- Are a woman
- Are eligible for Medicare Part B and have paid your premium
- Have suffered a bone fracture related to osteoporosis
In addition, Medicare Part A may cover the cost of visits from a home health worker to administer the drug if your doctor writes a letter stating that you are unable to administer it yourself and any family members who reside with you are unable or unwilling to give you the injections.
Average Costs For Prolia With Medicare Drug Coverage1
Your copay and deductible costs for any prescription drug can vary depending on what coverage stage youre in.
|Deductible stage||Typical copay stage|
|Your deductible is the amount of money you must spend on covered drugs before your Medicare drug coverage starts paying its share of costs.In the deductible stage, youre responsible for the full cost of your prescription drugs.Some Medicare prescription drug plans have a $0 deductible. Medicare drug plans cannot have a deductible more than $415 in 2019.||After you meet your Part D deductible, you enter the initial coverage period.During this phase , you pay a copayment or coinsurance for your covered medications.|
Where Can I Get Vaccines I Need
You can get most vaccines at a pharmacy, doctors office, clinic or community health center. Talk with your doctor about what vaccines you may need. Your doctor or Part D plan provider can also help you understand whether your cost will be affected by where you go to get the vaccines that your doctor recommends.
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Medicare Part B Step Therapy Criteria
Xgeva, for the indication listed below:
- Hypercalcemia of Malignancy
Is not covered for new starts, unless the member meets ANY of the following:
Medicare Part C Inpatient Coverage
The inpatient coverage youll receive with Medicare Part C will at least match those of Medicare Part A. These services include:
- inpatient hospital care
Any additional coverage for these services will be outlined by the specific plan you choose. For example, some plans offer basic vision exams, while others include allowances for prescription eyeglasses or contact lenses.
The cost of a Medicare Part C plan will depend on a variety of factors. The most common costs within your plan will be:
- your Part B monthly premium, which may be covered by your Part C plan
- your Medicare Part C costs, which include a deductible and monthly premiums
- your out-of-pocket costs, which include copayments and coinsurance
Below are some cost comparisons for Medicare Part C plans in some major cities around the United States. All the plans listed below cover prescription drugs, vision, dental, hearing, and fitness benefits. However, they all differ in cost.
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Medical Equipment Used To Administer Medications
- Infusion pumps
- Nebulizer machines
* Oral chemotherapy and anti-nausea agents have to meet certain criteria to be covered by Part B. While the majority of injectable medications will be covered by Part B, keep in mind that some drugs may be excluded. The coverage requirements change on an annual basis.
** Hepatitis B risk factors for the purpose of Part B coverage include diabetes mellitus, ESRD, hemophilia, living with someone who has Hepatitis B, or being a healthcare worker who could be exposed to blood or other bodily fluid.
How Much Does Prolia Cost With Medicare
If you qualify for coverage for Prolia under Medicare Part B, your plan will typically pay 80% of the injection while you pay the remaining 20%. Based on the list price of the drug, the 20% coinsurance would amount to roughly $250. You’ll usually need to satisfy your Medicare Part B deductible before your plan will cover the drug.
Under Medicare Part D, the amount you’ll have to pay out of pocket depends on the terms of your plan, what tier your plan classifies the drug as and what stage of coverage you’re in.
- Deductible stage. Until you satisfy your plan’s deductible, you will usually need to pay the full price for Prolia.
- Post-deductible stage. After you have met your deductible, your plan will typically pay for some or most of the cost of the drug, leaving you responsible for a copay.
- Donut hole. Once your total drug spending reaches the threshold for your plan’s coverage gap or donut hole, you’ll generally be responsible for 25% of the cost of Prolia.
- Post-donut hole. After you and your plan have spent more than the upper limit for the donut hole, you’ll enter catastrophic coverage, with your plan likely paying most of the cost of the drug while you are responsible for only a copay or coinsurance.
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Compendial Uses For Xgeva
- Second line therapy for osteopenia or osteoporosis in patients with systemic mastocytosis
Denosumab is a fully human monoclonal antibody that inhibits osteoclastic bone resorption by binding to osteoblast-produced RANK ligand , a cytokine member of the tumor necrosis factor family. By reducing RANKL binding to the osteoclast receptor RANK, bone resorption and turnover decrease.
Denosumab is a novel, fully human, highly specific, monoclonal antibody to receptor activator of nuclear factor kappabeta ligand . The antibody is produced in genetically engineered mammalian cells. Use blocks osteoclast activation, thereby resulting in a decreased bone resorption . Three molecules, RANKL, receptor activator of nuclear factorkappabeta , and osteoprotegerin have been identified as essential factors in osteoclast generation and function the RANKLRANKosteoprotegerin pathway is responsible for osteoclast differentiation, activation, and survival. Denosumab, a monoclonal antibody to RANKL, mimics the actions of osteoprotegerin, and therefore, reduces bone resorption.
Considerations for administering denosumab :
Denosumab should not be used in the following:
- Patients with hypersensitivity to denosumab or any of its excipients
- Women who are pregnant or lactating and have not been apprised of the potential hazard to the fetus
- Patients with a history of jaw necrosis due to bisphosphonate therapy
- Prolia is not indicated in pediatric patients < 18 years old.
What Areas Offer Tufts Medicare Advantage Plans
Tufts Medicare Advantage plans are open to Massachusetts residents in many counties throughout the state. You can search your ZIP code on Medicares plan finder tool to see if Tufts offers plans in your county and how much they will cost.
Tufts Medicare Advantage plans are set up like most Medicare Advantage plans. They cover all the services offered by original Medicare, like hospital and outpatient medical care, plus additional services like prescription drug coverage.
Each plan will include basic Medicare services, including:
- hospitalization and inpatient care, including short-term care at a skilled nursing facility
- hearing screening and hearing aids
- prescription drug coverage
The services covered in a particular plan depend on the options you choose. There are lower-premium options for people who dont use healthcare services very often and higher-premium options with lower copayments for more frequent users.
Tufts Medicare Advantage plans vary in cost based on how much you want to pay in premiums versus copayments and other out-of-pocket costs. Plan availability varies by county, but none of these plans have a medical deductible.
Here are examples of what three plan options offer and what they cost in two different locations:
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Is Prolia Covered By Medicare
- Is Prolia covered by Medicare?’ Learn about the cost of this osteoporosis drug and how much you can expect to pay for it if your doctor prescribes it for you.
The National Osteoporosis Foundation reports that roughly 10 million Americans have osteoporosis and that an additional 44 million people suffer from decreased bone density and may develop the disease in the future. Osteoporosis puts you at an increased risk for debilitating fractures, but there are treatments available to lower the likelihood of injury due to a fall or other accident. Prolia is approved by the U.S. Food and Drug Administration to treat bone loss and minimize fracture risk. In many cases, Medicare covers Prolia to make treatment more affordable.
What Is The Alternative To Taking Prolia
The FDA has approved another brand-name version of denosumab, called Xgeva. Your Medicare Part D plan might not cover the medication. If it does, your out-of-pocket price for Xgeva injections may cost more or less than Prolia, depending on where the drugs are classified on the formulary.
Instead of Prolia, doctors may prescribe other drugs for people at risk of suffering fractures due to osteoporosis, such as:
- Bisphosphonates like alendronate, ibandronate, risedronate and zoledronic acid
- Bone-building medications like teriparatide, abaloparatide and romosozumab
- Hormone-related therapy like raloxifene
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Getting Help Paying For Your Medications
If you have Medicare and limited income and resources, the Social Security Administration may be able to help you cover the cost of your Medicare prescription drug plan through their Extra Help program.
To see if you qualify, call the Social Security Administration at 1-800-772-1213 or visit the Social Security Administrations website to learn more and fill out an application.
Prepare for Medicare Open Enrollment
Medicare Coverage Of Osteoporosis Medications
Many medications available today can slow the rate of bone loss and, in some cases, even rebuild bone strength.
Osteoporosis medications include oral drugs such as tablets and liquids. You may also be prescribed injectable drugs that you receive at your doctors office or administer to yourself at home.
According to the Mayo Clinic, the most widely prescribed osteoporosis medications for both men and women are bisphosphonates.
There are several types of bisphosphonates, including the following:
- Pills such as alendronate , ibandronate or risedronate that are taken daily, weekly or monthly
- Injections of ibandronate that are given once every three months
- Intravenous infusions of zoledronic acid that are given once a year
Medicare Part D plans and Medicare Advantage plans with prescription drug coverage will cover a portion of the cost of most bisphosphonates.
How much you pay out-of-pocket for your prescription depends on your plans formulary, or the list of drugs covered by your plan either in part or in full. Brand-name drugs and specialty drugs will cost more than generic drugs.
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When Does Medicare Pay For Prolia
Original Medicare may cover injectable osteoporosis drugs such as Prolia for women who:
Are enrolled in Medicare Part B
Meet Medicares requirements for getting home health services
Have a bone fracture that is related to post-menopausal osteoporosis
Have received a doctors certification that they are unable to administer the injection
Medicare Part B also covers bone density measurements once every 24 months if you meet one of the following conditions:
You’re a woman determined to be estrogen deficient or at risk for osteoporosis by your doctor
X-rays show you have possible osteoporosis, osteopenia or fractured vertebrae.
You take prednisone or steroid-type drugs
You have primary hyperparathyroidism.
You’re currently taking an osteoporosis drug like Prolia