Cost and Co-pay Support for XTANDI® (enzalutamide) capsules
Find the right support solutions for patients regardless of coverage
99% of commercially insured patients enrolled in the XTANDI Patient Savings Program pay $20 per prescription†3
Medicare Part D
XTANDI Support Solutions can provide information about other resources that might be able to help‡
100% of eligible patients enrolled in the Astellas Patient Assistance Program receive their XTANDI prescription at no cost§
XTANDI Patient Savings Program†
Allows eligible patients with commercial insurance to pay as little as $20 per prescription
Astellas Patient Assistance Program§
The Astellas Patient Assistance Program provides XTANDI at no cost to patients who meet the program eligibility requirements
XTANDI Quick Start+™ Program
The XTANDI Quick Start+ Program provides a free, one-time, 14-day supply of XTANDI to new patients who experience a delay in insurance coverage
*32.7 million represents the number of covered lives for Humana, CVS SilverScript, WellCare and Cigna-HealthSpring Medicare plans, as well as Express Scripts commercial plans.
†The XTANDI Patient Savings Program ("Program") is for eligible patients with commercial prescription insurance for XTANDI. The Program is not valid for patients whose prescription claims are reimbursed, in whole or in part, by any state or federal government program, including, but not limited to, Medicaid, Medicare, Medigap, Department of Defense (DoD), Veterans Affairs (VA), TRICARE, Puerto Rico Government Insurance, or any state patient or pharmaceutical assistance program. This program is void where prohibited by law. Certain rules and restrictions apply. Astellas reserves the right to revoke, rescind, or amend this offer without notice.
‡XTANDI Support Solutions has no control over the decisions of, and does not guarantee support from independent third parties.
§Subject to eligibility. Restrictions may apply. Void where prohibited by law.
XTANDI Support Solutions℠ can help your patients obtain XTANDI through our network of specialty pharmacies, help problem-solve financial assistance, and provide educational resources included with prescription delivery.
Patient enrollment form for XTANDI Support SolutionsDownload Patient Enrollment Form
Appeals: XTANDI Support Solutions provides assistance with denial appeals and shows that insurers will approve an initially denied prior authorization for XTANDI 88% of the time upon submission of a denial appeal4
XTANDI (enzalutamide) capsules is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
Important Safety Information
XTANDI is not indicated for women. XTANDI can cause fetal harm and potential loss of pregnancy.
Warnings and Precautions
Seizure occurred in 0.5% of patients receiving XTANDI in clinical studies. In a study of patients with predisposing factors, seizures were reported in 2.2% of patients. See section 5.1 of the Prescribing Information for the list of predisposing factors. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Permanently discontinue XTANDI in patients who develop a seizure during treatment.
Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.
The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI patients from the two placebo-controlled clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. In the bicalutamide-controlled study of chemotherapy-naïve patients, the most common adverse reactions (≥ 10%) reported in XTANDI patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, upper respiratory tract infection, diarrhea, and weight loss.
In the placebo-controlled study of patients taking XTANDI who previously received docetaxel, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In the placebo-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups. In the bicalutamide-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients and 37.6% of bicalutamide patients. Discontinuations due to adverse events were reported for 7.6% of XTANDI patients and 6.3% of bicalutamide patients.
Lab Abnormalities: In the two placebo-controlled trials, Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).
Infections: In the study of patients taking XTANDI who previously received docetaxel, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In the study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death.
Falls (including fall-related injuries) occurred in 9% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.
Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of patients in each arm.
Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI.
Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.
Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.
Please see Full Prescribing Information for additional safety information.
FORMULARY STATUS DOES NOT IMPLY SAFETY OR EFFICACY.
A product’s placement on a plan formulary involves a variety of factors known only to the applicable plan and is subject to eligibility. Provider communication only—not approved for prescription drug plan member distribution. Formulary status is not a guarantee. Please verify copay, coinsurance, coverage, and updated information with the plan sponsors. Information subject to change without notice. Astellas does not endorse any individual plans.