The U.S. Justice Department has launched an investigation into Astellas Pharma Inc. relating to its financial assistance to charities that assist Medicare patients in covering out-of-pocket drug costs, Reuters reported Nov. 15.
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What is Astellas Pharma support solutions?
Astellas Pharma Support Solutions (APSS) offers access and reimbursement support to help patients overcome challenges to accessing Astellas medication. APSS provides information regarding patient healthcare coverage options and financial assistance options that may be available to help patients with financial needs.
What is the Astellas Patient Assistance Program (PAP)?
The Astellas Patient Assistance Program a (PAP) provides Myrbetriq ® (mirabegron extended-release tablets) at no cost to patients who meet the program eligibility requirements. The PAP is not available for patients prescribed Myrbetriq ® granules (mirabegron for extended-release oral suspension).
What is Astellas Xtandi support solutions?
b XTANDI Support Solutions is a component of Astellas Pharma Support Solutions SM. c Other insured patients may be eligible for the program if they meet certain eligibility criteria.
Did Astellas fund Ari drug copays for prostate cancer patients?
The government alleged that, in May 2013, Astellas asked two foundations about the creation of copay assistance funds to cover the copays for Medicare patients taking ARIs, but not for other types of prostate cancer drugs. In July 2013, both foundations opened ARI-only copay funds; Astellas was the sole donor to both funds.
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Astellas Patient Assistance Program
The Astellas Patient Assistance Program a provides XTANDI ® (enzalutamide) at no cost to patients who meet the program eligibility requirements.
Eligibility Requirements
XTANDI Support Solutions b can assess whether the patient meets the eligibility requirements. For more information, contact us at 1-855-898-2634. We are available Monday–Friday, 8:00 am–8:00 pm ET.
Application Process
Upon completion of the Patient Enrollment Process, we will evaluate and determine if the patient is eligible for this program. If the patient is eligible, we will notify you and the patient, and ship the XTANDI prescription directly to the patient's home.
What is the Astellas lawsuit?
Justice Department was conducting a joint criminal and civil investigation of the company, its officers and its employees.
Who was the first drugmaker to settle allegations?
In September, Aegerion Pharmaceuticals Inc became the first drugmaker to resolve such allegations, agreeing to pay $40.1 million to resolve probes related to various claims stemming from its marketing of cholesterol drug Juxtapid.
What is the Justice Department investigating?
Astellas said the Justice Department was investigating potential violations of healthcare fraud law and other criminal statutes, as well as potential civil claims under the False Claims Act.
Is Astellas Pharma a probe?
BOSTON (Reuters) - Astellas Pharma Inc has become the latest company to reveal it has become the subject of a U.S. probe into drugmakers’ financial support of charities offering assistance to Medicare patients seeking help to cover out-of-pocket drug costs.
What is Astellas Pharma Support Solutions?
Astellas Pharma Support Solutions is designed as a single point of contact to help patients understand their coverage and reimbursement options when they are prescribed an Astellas medication . We are here to answer questions about your insurance coverage or accessing your Astellas medication. Patients can find information online at http://www.astellaspharmasupportsolutions.com/patient/index.aspx. To speak with a dedicated access specialist, please call us at 1-800-477-6472. We are available Monday–Friday, 9:00 AM–8:00 PM ET.
How to contact Astellas Pharma?
To speak with a dedicated access specialist, please call us at 1-800-477-6472. We are available Monday–Friday, 9:00 AM–8:00 PM ET.
What is Astellas Pharma?
Astellas Pharma US helps patients, their family members, and care partners manage the health conditions treated by our products and therapies. We offer the following tools and resources to meet the unique medical needs of patients.
How to contact Astellas?
Call us with questions about safe and proper use of Astellas medicines. We are here to help. Please call us at 1 (800) 727-7003. We are available Monday–Friday, 8:00 AM–4:30 PM CT. For more information or to submit your questions online visit Astellas Medical Information. Close.
What is an adverse event in Astellas?
An adverse event is when a person has something unwanted happen to them when they have taken a medicine. This might include a side effect of medicine or that the medicine does not work as you expected. We encourage you to report any adverse events related to Astellas medicines.
What is the phone number for Astellas?
We may even be able to help you if you do not have insurance. We are here to help. Please call us at 1 (800) 477-6472.
What is clinical trial?
A clinical trial is a scientific study that helps determine if and how a medicine works in people. You can learn more about clinical trials by clicking here. We are here to help. For further information, please call us at 1 (800) 727-7003. We are available Monday–Friday, 8:00 AM–4:30 PM CT. Close.
How much did Amgen pay for False Claims Act?
(Astellas) and Amgen Inc. (Amgen) – have agreed to pay a total of $124.75 million to resolve allegations that they each violated the False Claims Act by illegally paying the Medicare copays for their own products, through purportedly independent foundations that the companies used as mere conduits.
Who conducted the Massachusetts investigation?
These investigations were conducted by the Department of Justice’s Civil Division and the U.S. Attorney’s Office for the District of Massachusetts, in conjunction with the Department of Health and Human Services, Office of Inspector General; and the FBI. The U.S. Postal Inspection Service also assisted with the investigation.
Did Astellas pay $100 million for Xtandi?
The government further alleged that, during the time that the ARI funds were open, Astellas promoted the existence of the ARI funds as an advantage for Xtandi over competing drugs in an effort to persuade medical providers to prescribe Xtandi. Astellas has agreed to pay $100 million to resolve the government’s allegations.
Is Astellas an ARI only fund?
In July 2013, both foundations opened ARI-only copay funds; Astellas was the sole donor to both funds. The government alleged that Astellas knew that Xtandi would likely account for the vast majority of utilization from each fund, and, in fact, Medicare patients taking Xtandi received nearly all of the copay assistance from the two ARI funds.
Does Astellas sell Xtandi?
Astellas : Astellas sells Xtandi, an androgen receptor inhibitor (ARI) used to treat certain prostate cancer; none of the other major drugs to treat the condition is an ARI. The government alleged that, in May 2013, Astellas asked two foundations about the creation of copay assistance funds to cover the copays for Medicare patients taking ARIs, but not for other types of prostate cancer drugs. In July 2013, both foundations opened ARI-only copay funds; Astellas was the sole donor to both funds. The government alleged that Astellas knew that Xtandi would likely account for the vast majority of utilization from each fund, and, in fact, Medicare patients taking Xtandi received nearly all of the copay assistance from the two ARI funds. The government further alleged that, during the time that the ARI funds were open, Astellas promoted the existence of the ARI funds as an advantage for Xtandi over competing drugs in an effort to persuade medical providers to prescribe Xtandi. Astellas has agreed to pay $100 million to resolve the government’s allegations.
What is the number to report healthcare fraud?
Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
Did Amgen donate to Onyx?
The government alleged that Onyx was the sole donor to this travel fund and that Amgen, after integrating Onyx into its operations in 2015, continued to donate to the fund. The foundation also operated a second fund that covered copays for multiple myeloma drugs, including Kyprolis.
How does Astellas help the medical community?
Astellas helps the medical community improve the overall safety and quality of patient care and treatment by supporting opportunities for high-quality, comprehensive independent medical education. In addition, Astellas provides funding to qualified nonprofit organizations working in our therapeutic areas of focus.
What is Astellas' mission?
Astellas believes that by building meaningful, trusted relationships with patient advocacy organizations, we can work together to understand and address patient and caregiver needs and achieve our shared vision of improving patients' overall healthcare outcomes and experiences. We work with organizations that share our commitment to innovation, increased disease awareness, and improving patient outcomes. By working with these organizations, we can produce evidence-based decisions that drive meaningful experiences and outcomes for those impacted by cancer.
What is an APSS?
Astellas Pharma Support Solutions (APSS) is designed as a single point of contact to help patients understand their coverage and reimbursement options when they are prescribed an Astellas medication. APSS is able to answer questions about your insurance coverage or accessing your Astellas medication. Patients can find information online here .
What is APSS in healthcare?
APSS provides information regarding patient healthcare coverage options and financial assistance information that may be available to help patients with financial needs.
Does Astellas endorse organizations?
Astellas is not affiliated with and does not endorse any of the listed organizations or resources. The information provided by Astellas is for informational purposes only and is not meant to replace the advice of your healthcare team.