About Endo Advantage™

Endo Advantage™ provides a single point of contact for healthcare professionals (HCP) and patients to help support patient access from start to finish.

Once the decision to prescribe XIAFLEX® is made, acquisition services through Endo Advantage™ can assist you and your patients with:

INSURANCE
BENEFITS
INVESTIGATION

PRIOR
AUTHORIZATION

PATIENT FINANCIAL
ASSISTANCE
for those who qualify

To contact Endo Advantage™

Acquiring XIAFLEX®: Quick tips for your practice

Learn how Endo can support your office staff to obtain XIAFLEX®.

Benefits Investigation

Endo Advantage™ can conduct a benefits investigation for your patient

Acquiring XIAFLEX®

Once REMS-certified, you can order XIAFLEX® through 1 of 3 channels

Only REMS-certified physicians and healthcare sites can acquire XIAFLEX®. For questions related to access, contact Endo Advantage™ for assistance.

Purchase the product from our Specialty Distributor (SD) and bill the patient’s insurance for both XIAFLEX® and your professional services.

SD CONTACT INFORMATION

Besse Medical
1-800-543-2111 (phone)
1-800-543-8695 (fax)
www.besse.com

The Specialty Pharmacy Provider (SPP) will fill a patient-specific prescription for XIAFLEX®, bill the patient’s insurance for the product, and then ship it.

SPP CONTACT INFORMATION

CVS Specialty
1-855-534-8323 (phone)
1-888-418-7246 (fax)
www.cvsspecialty.com

HCPs can acquire XIAFLEX® through normal ordering channels.

Patients can save with the Copay Assistance Program

With the XIAFLEX® Copay Assistance Program:

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

Restrictions for patients apply. See restrictions, terms and conditions below.*

More than 95 percent of eligible patients paid zero dollars out of pocket with the XIAFLEX® Copay Assistance Program

Patient eligibility

Patients qualify for assistance under this program if:

  • They are receiving or have received XIAFLEX® for an approved indication and in a manner consistent with the instructions for administration of XIAFLEX®
  • They are uninsured or have insurance that is not provided by Medicare, Medicare Prescription Drug Benefit plans, Medicare Advantage, Veterans Affairs (VA), Medicaid, or similar federal or state programs, and this program is not otherwise prohibited by law
  • They are 18 years of age or older
  • They have paid or are obligated to pay out-of-pocket costs for a prescription of XIAFLEX®

No other purchase is necessary to receive this offer.

For more information, call 1-800-743-2382.

*Restrictions, Terms and Conditions

  1. 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.

  2. This offer is not valid for prescriptions reimbursed in whole or in part by Medicare, Medicare Prescription Drug Benefit plans, Medicare Advantage, VA, Medicaid, or similar federal or state programs, or where otherwise prohibited by law.

  3. By accepting this offer, you agree that Endo Pharmaceuticals Inc. or those working on its behalf may contact your doctor to verify information about treatment that is relevant to verifying your eligibility for this offer.

  4. This offer is only valid for doses of XIAFLEX® administered in the US.

  5. This offer is valid for the out-of-pocket cost for a dose of XIAFLEX® only. Offer is not valid for any other products or other out-of-pocket costs (for example, office visit charges, office visit copays, or injection/administration costs), even if those costs are associated with the administration of a dose of XIAFLEX®.

  6. This offer is valid only if you have not used this program within the last 30 days.

  7. The selling, purchasing, trading, or counterfeiting of this offer is prohibited.

  8. Endo Pharmaceuticals Inc. reserves the right to rescind, revoke, or amend this offer without notice.

  9. By participating, you understand and agree to comply with the terms and conditions of this offer as set forth above.

†Most eligible patients with commercial insurance plans paid $0 copay for XIAFLEX®. Based on analysis of claims filed November 2017 through April 2020.

LEARN ABOUT TREATMENT WITH XIAFLEX®

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INDICATION

XIAFLEX® is indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.


Important Safety
Information for XIAFLEX

WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE'S DISEASE

Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX‑treated patients in clinical studies. In other XIAFLEX‑treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile "popping" sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) XIAFLEX‑treated patients.

Signs or symptoms that may reflect serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention.

Because of the risks of corporal rupture or other serious penile injury, XIAFLEX is available for the treatment of Peyronie's disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XIAFLEX REMS Program.

INDICATION

XIAFLEX® is indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.


Important Safety
Information for XIAFLEX

WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE'S DISEASE

Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX‑treated patients in clinical studies. In other XIAFLEX‑treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile "popping" sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) XIAFLEX‑treated patients.

Signs or symptoms that may reflect serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention.

Because of the risks of corporal rupture or other serious penile injury, XIAFLEX is available for the treatment of Peyronie's disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XIAFLEX REMS Program.

  • Contraindications: XIAFLEX is contraindicated in the treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure and in patients with a history of hypersensitivity to XIAFLEX or to collagenase used in any other therapeutic application or application method
  • Corporal Rupture or Other Serious Injury to the Penis: Injection of XIAFLEX into collagen‑containing structures such as the corpora cavernosa of the penis may result in damage to those structures and possible injury such as corporal rupture (penile fracture). Therefore, XIAFLEX should be injected only into the Peyronie's plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen‑containing structures of the penis. Cases of localized skin and soft tissue necrosis occurring as sequelae of penile hematoma, some requiring surgical intervention, have been reported post-marketing
  • Hypersensitivity Reactions, Including Anaphylaxis: In the double‑blind, placebo‑controlled portions of the clinical trials in Peyronie's disease, a greater proportion of XIAFLEX‑treated patients (4%) compared to placebo‑treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 XIAFLEX injection procedures). The incidence of XIAFLEX‑associated pruritus was similar after each injection regardless of the number of injections administered
  • Because XIAFLEX contains foreign proteins, severe allergic reactions to XIAFLEX can occur. Anaphylaxis was reported in a post‑marketing clinical trial in one patient who had previous exposure to XIAFLEX for the treatment of Dupuytren's contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections. The safety of more than one treatment course of XIAFLEX is not known
  • Risk of Bleeding in Patients with Abnormal Coagulation: In the XIAFLEX controlled trials in Peyronie’s disease, 65.5% of XIAFLEX‑treated patients developed penile hematoma, and 14.5% developed penile ecchymosis. Patients with abnormal coagulation (except for patients taking low‑dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX in patients receiving anticoagulant medications (other than low‑dose aspirin, eg, up to 150 mg per day) within 7 days prior to XIAFLEX administration is not known. In addition, it is recommended to avoid use of XIAFLEX in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low‑dose aspirin)
  • Acute Post-Injection Back Pain Reactions: Post-marketing reports of acute lower back pain reactions, sometimes accompanied by radiation to the lower extremities, chest and arms, muscle spasms, chest pain, paresthesias, headache, and dyspnea, have been received by patients treated with XIAFLEX for Peyronie's disease. These events can be mild to severe in intensity. The events typically lasted for 15 minutes and typically did not require intervention. Administer the smallest number of treatment cycles necessary to treat the patient's curvature deformity
  • Syncope and Presyncope: Most, but not all cases of syncope and presyncope in patients with Peyronie’s disease, occurred in association with post-injection penile pain and hematoma, penile pain with spontaneous erections, and pain during micturition. These potential triggers suggest a vasovagal mechanism. Make patients aware of the potential symptoms that could trigger syncope and presyncope after treatment with XIAFLEX.
    If presyncopal symptoms occur, patients should remain recumbent until symptoms resolve. Syncope may be associated with bodily injuries, including concussion, head abrasion, and other accidental injuries

Adverse Reactions

Clinical trials

  • In the XIAFLEX clinical trials for Peyronie's disease, the most frequently reported adverse drug reactions (≥25%) and at an incidence greater than placebo included: penile hematoma, penile swelling, and penile pain.

Post-marketing experience

  • Acute post-injection lower back pain reactions have occurred in close temporal proximity to XIAFLEX treatments
  • Cases of localized skin and soft tissue necrosis events as sequelae of penile hematoma, some of which required surgical intervention
  • Syncope and presyncope have been reported in men treated with XIAFLEX for Peyronie’s disease. Most, but not all cases occurred in the immediate treatment period or within 1-2 days following injection. Bodily injuries associated with the syncopal events have been reported

Click for full Prescribing Information, including Boxed Warning and Medication Guide.

Reference:

1.  Data on file. DOF-XPD-27. Endo Pharmaceuticals Inc.