Medicare Blog

medicare denied xiaflex for peyronies what can i do

by Petra Kutch Published 1 year ago Updated 1 year ago

Does Medicare cover Xiaflex for Peyronie’s?

Doctors prescribe FDA-approved Xiaflex for the treatment of Peyronie’s because the active ingredients break up collagen. If you have a penile curvature of more than 30 degrees when erect, your physician may recommend treatment with Xiaflex. If so, you may want to know more about how Xiaflex works and whether your Medicare benefits cover its cost.

What are the side effects of Xiaflex® for Peyronie's disease?

The most common side effects with XIAFLEX® for the treatment of Peyronie's disease include: a small collection of blood under the skin at the injection site (hematoma) swelling at the injection site or along your penis. pain or tenderness at the injection site, along your penis and above your penis.

How much does Xiaflex cost with Medicare?

Because Xiaflex is not a medication that you can take or inject at home by yourself, Medicare Part B covers 80 percent of the final approved cost. You pay the remaining 20 percent of that cost, and you are responsible for your Part B deductible of $185.00 (as of 2019).

Can Xiaflex help Dupuytren’s contracture and Peyronie's disease?

The cause of Peyronie’s disease may stem from trauma, likely due to injuries sustained during sexual activity, but genetic factors may also lead to the development of the disease. For both Dupuytren’s contracture and Peyronie’s disease, prescription medications like Xiaflex may help. What is Xiaflex?

Does Medicare pay for the treatment of Peyronie's disease?

Most insurances cover this therapy, including Medicare / Medicaid. Interferon $200 per injection. Typically 12 injections performed over 12 weeks. Insurance typically does not cover.

Is Xiaflex injection covered by Medicare?

To help support you and your patients, XIAFLEX ® is covered for the majority of both commercially insured and Medicare Part B patients.

Is Xiaflex covered under insurance?

This is considered a cosmetic use and therefore not covered under the medical benefit.

Is there a generic form of Xiaflex?

Xiaflex (collagenase Clostridium histolyticum) is a nonsurgical enzyme treatment derived from Clostridium histolyticum bacteria for adults with Dupuytren's contracture when a cord can be felt. Xiaflex is available in a generic form as collagenase Clostridium histolyticum.

How much does an injection of XIAFLEX cost?

Doctors who administer the drug will have to be specially trained and certified. Pain, swelling and bruising can develop in the injection area. Xiaflex costs $3,300 an injection, so a full course of eight injections would cost about $26,000, in addition to a doctor's fee.

Why was XIAFLEX discontinued?

The decision to withdraw is not based on safety or efficacy concerns. Despite best efforts to appropriately educate the government and the market on XIAFLEX® over the past several years, the product did not receive government reimbursement approval and demand for the product has remained unsustainably low.

How much does it cost to treat Peyronie's disease?

The mean annual, per-individual cost of Peyronie's disease treatment increased from $1,531 in 2007 to $10,339 in 2018. The cost increase was greatest for injectable therapies, which rose from $811 per individual in 2007 to $16,184 in 2018, a 19-fold increase.

Is collagenase covered by insurance?

Collagenase injection and Needle Aponeurotomy are the only nonsurgical treatments to help patients suffering from dupuytrens contracture....NEEDLE APONEUROTOMYCOLLAGENASE INJECTIONCovered by Insurance includes consult and procedure / injection / drugsYes*Yes*Cash price for consult$200Likely the same7 more rows

Does XIAFLEX cause erectile dysfunction?

After treatment, one of the tubes inside the penis could break during an erection, called penile fracture. This typically requires surgery. Damage to the penis may not get better after penile fracture, even with surgery. This could lead to permanent inability to have an erection.

Is Peyronie's disease covered by insurance?

Medicare and most insurance plans cover the procedure in most cases. Billing specialists in the physician's office can help confirm your coverage.

Why is XIAFLEX no longer available in Canada?

Notice : The Xiaflex was recently withdraw from the Canadian market by the US pharmaceutical company Endo for financial reasons. This drug is therefore no longer distributed in Canada. It is possible to obtain it through special permission from Health Canada.

What is the success rate of XIAFLEX?

Success rates vary but studies demonstrate an average 34% improvement in the curvature (or 17-degree decrease from baseline curvature). 60% of men getting Xiaflex experienced improvement compared to 30% with placebo.

What is Xiaflex used for?

Xiaflex (collagenase clostridium histolyticum) is a medication developed by Endo Pharmaceuticals and is an FDA-approved treatment for structural deformities that are caused by injury or genetic factors that lead to inflexibility in connective tissue.

Why does Peyronie's disease develop?

The cause of Peyronie’s disease may stem from trauma, likely due to injuries sustained during sexual activity, but genetic factors may also lead to the development of the disease. For both Dupuytren’s contracture and Peyronie’s disease, prescription medications like Xiaflex may help.

Do you need physical therapy for Xiaflex?

In most cases, people who receive Xiaflex injections will also need to add light physical therapy into a treatment routine in order to stretch affected areas as the medication breaks down a plaque or fibrous growth that is inhibiting normal range of motion .

Does Medicare Part B cover outpatient care?

For medications that are administered in a clinical setting, Medicare Part B benefits may help cover the costs. Medicare Part B helps cover outpatient needs, including doctor’s office visits and treatments that take place in a medical office setting.

Is Xiaflex covered by Medicare?

In order for Xiaflex to be covered under Medicare, there are some guidelines that must be followed. First, the patient must be diagnosed with Dupuytren’s contracture or Peyronie’s disease, and a physician must prescribe the medication as a medically necessary treatment.

How to contact Xiaflex?

For more information, call 1-800-743-2382. *Restrictions, Terms and Conditions. By accepting this offer, you agree to report the value received under this offer to any health insurer or other third party paying for any part of your XIAFLEX ® prescription if you are required to do so by benefit terms, contract, or law.

How many vials of Xiaflex are needed?

Eligible patients may save on their out-of-pocket costs for each vial of XIAFLEX ®. Each treatment cycle consists of 2 XIAFLEX ® injection procedures, requiring 2 vials of XIAFLEX ®, and patients may save on both vials. 1

Is Xiaflex uninsured?

They are uninsured or have insurance that is not provided by Medicare, Medicare Prescription Drug Benefit plans, Medicare Advantage, Veterans Affairs (VA), Medicaid, ...

What happens if you take Xiaflex?

Receiving an injection of XIAFLEX may cause damage to the tubes in your penis called the corpora. After treatment with XIAFLEX, one of these tubes may break during an erection. This is called a corporal rupture or penile fracture. This could require surgery to fix the damaged area.

What is Xiaflex used for?

XIAFLEX is a prescription medicine used to treat adult men with Peyronie's disease who have a "plaque" that can be felt and a curve in their penis greater than 30 degrees when treatment is started. It is not known if XIAFLEX is safe and effective in children under the age of 18.

How long after Xiaflex injection can you have sex?

Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with XIAFLEX and after any pain and swelling has gone away. XIAFLEX for the treatment of Peyronie's disease is only available through a restricted program called the XIAFLEX Risk Evaluation and Mitigation Strategy (REMS) Program.

What are the symptoms of a ruptured penis?

Symptoms of corporal rupture or other serious injury to your penis may include: a popping sound or sensation in an erect penis. sudden loss of the ability to maintain an erection. pain in your penis. purple bruising and swelling of your penis.

Is Xiaflex right for you?

XIAFLEX may not be right for you. The most common side effects with XIAFLEX for the treatment of Peyronie's disease include: Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with XIAFLEX.

Is Xiaflex clostridium histolyticum allergic to collagenase

you are allergic to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX.

How much does Xiaflex cover?

The XIAFLEX#N#®#N#Copay Assistance Program can cover up to $1200 of your out-of-pocket costs for each injection of XIAFLEX#N#®#N#(collagenase clostridium histolyticum). How much you pay for XIAFLEX#N#®#N#depends on your health benefits or insurance coverage.

How to contact Xiaflex?

For more information, call 1-800-743-2382. By accepting this offer, you agree to report the value received under this offer to any health insurer or other third party paying for any part of the XIAFLEX ® prescription if you are required to do so by benefit terms, contract, or law.

What is Xiaflex used for?

A prescription medicine used to treat adult men with Peyronie’s disease who have a “plaque” that can be felt and a curve in their penis greater than 30 degrees when treatment is started . Prescribing Information.

What is Xiaflex used for?

Treating Peyronie's disease - XIAFLEX®. A prescription medicine used to treat adult men with Peyronie’s disease who have a “plaque” that can be felt and a curve in their penis greater than 30 degrees when treatment is started. Prescribing Information.

How long after Xiaflex can you do penile modeling?

For 6 weeks after each treatment cycle with XIAFLEX#N#®#N#, you'll need to take a few minutes each day to do penile modeling—gentle stretching and straightening activities for your penis. When paired with injections of XIAFLEX#N#®#N#, these activities help to break down your Peyronie's plaque and help reduce the curve in your erection.

Can you wrap your penis after Xiaflex?

As with any medicine, there are important things to do and not do during treatment with XIAFLEX. ®. . Be sure to follow these instructions throughout your treatment: Your penis may be wrapped with a bandage after each injection Your HCP will tell you when to take the bandage off.

Alternative Treatments

You may have seen online forums discussing other injection therapies such as steroids, Verapamil or interferon, but there is far less data on these options and results are not consistent. Dr. Kapadia will be happy to discuss proven and unproven therapies with you, during your consultation.

Delving deeper into Xiaflex

Because Xiaflex is FDA approved, it is more often prescribed for PD. This medication, as with any, comes with both benefits and risks, which are discussed during your consultation with Dr. Kapadia. One of the most concerning risks is known as a penile fracture. This is when one of the tubes, running the length of the penis, breaks.

Making The Most of injections

To ensure that the injections like Xiaflex are most effective, patients will be asked to perform what is known as penile modeling – essentially traction exercises on the penis to stretch the softened plaque. This is performed daily, at home, after each injection.

Surgical Alternatives

Statistically, some patients will not receive a substantial benefit from penile injections. Other patients with severe deformity may need surgery for their Peyronie’s. Fortunately, there are a few procedures that can significantly improve both the discomfort and impediment to sex that Peyronie’s Disease causes.

Should urologists perform surgery for Peyronie's disease?

A debate among members of the International Society for Sexual Medicine is whether high cost is a potential knockout factor for CCH and urologists should instead perform surgery for Peyronie’s disease, according to Dr. Trost.

Is Xiaflex a viable treatment for Peyronie's disease?

With that group, the most cost-effective is traction alone, but Xiaflex is a viable option ,” Dr. Trost said. Dr. Trost said his current standard for treating Peyronie’s disease is combination therapy of CCH and traction therapy.

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