Statements

Astellas Quote and Statement on the Bayh-Dole Act and XTANDI | February 9, 2022

Quote

“Astellas has invested years and more than $1.4 billion to research and develop XTANDI and successfully bring this innovative cancer treatment to market for patients with advanced prostate cancer. XTANDI is priced in line with other oral therapies for advanced prostate cancer available in the U.S. today and is widely available for patients across the health insurance marketplace. Based on an analysis of third-party claims data from January to November of 2021, 71% of US patients paid less than $100 in out-of-pocket costs for their XTANDI prescription regardless of insurance type.”
- Company Spokesperson, Astellas Pharma U.S., Inc.

Statement

Astellas has invested years and more than $1.4 billion to research and develop XTANDI and successfully bring this innovative cancer treatment to market for patients with advanced prostate cancer. At Astellas, we believe the price of medicines should reflect the value they bring to patients, healthcare systems, and society. Astellas is dedicated to working with policymakers and stakeholders across the healthcare system to find solutions that balance the need to foster medical innovation and ensure affordable access to medicines for patients.

XTANDI (enzalutamide) is widely available among U.S. patients and is the most prescribed branded drug for those living with advanced prostate cancer. XTANDI is the first and only novel hormone therapy (NHT) approved by the U.S. Food and Drug Administration (FDA) in three types of advanced prostate cancer: non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). In all three types for which it is approved, data has shown that XTANDI helped slow advanced prostate cancer progression, demonstrating a significant reduction in the risk of disease progression or death.

The Bayh-Dole Act – enacted in 1980 – incentivizes public-private collaborations that expand consumer access to new and potentially groundbreaking products and supports America’s global leadership in medical innovation and biopharmaceutical manufacturing. The National Institutes of Health (NIH) has consistently held the position that invoking the Bayh-Dole Act’s “march-in” rights authority is not an appropriate means to control prescription drug prices.

XTANDI is a prime example of how collaboration between early-stage public research and private development can benefit American consumers, as the Bayh-Dole Act envisioned.

In 2016, the NIH concluded that XTANDI is broadly available as a prescription drug and declined to exercise its “march-in” rights under the Bayh-Dole Act.

Invoking “march-in” rights as a means of controlling prescription drug prices could undercut the purpose of the Bayh-Dole Act to encourage the commercialization of Subject Inventions and could discourage the development of future innovations and medical breakthroughs by deterring future public-private collaborations.

While the U.S. government contributed approximately $500,000 to the initial discovery of the molecule that eventually became XTANDI, Astellas has invested more than $1.4 billion to date in research and development efforts for XTANDI on behalf of the patients we serve in the U.S. and around the world. Astellas and its partners supported extensive clinical trials and research necessary to demonstrate that XTANDI is safe and efficacious for patients, support the application that led to FDA approval, and further understand which patients will benefit from treatment.

Astellas is dedicated to improving access and affordability for patients who rely on our medications and working collaboratively with stakeholders across the healthcare system to find avenues that meet the dual imperatives of encouraging drug development and innovation while ensuring access to and affordability of medicines.

XTANDI is priced in line with other oral therapies for advanced prostate cancer available in the U.S. today. Recent references to the average wholesale price (AWP) of XTANDI are misleading reflections of what most purchasers and patients actually pay for XTANDI. It is important to note that a drug’s list price does not account for rebates that manufacturers individually negotiate with insurance companies, and the AWP does not reflect the amount most patients will pay for their prescription medications at the pharmacy counter. The facts demonstrate what patients actually pay. For instance, based on an analysis of third-party claims data from January 2021 through November 2021:

  • XTANDI is widely available to the majority of America’s seniors. 64% of Medicare patients paid $20 or less in out-of-pocket costs per month for their XTANDI prescription.
  • XTANDI is widely available to patients with private insurance. 62% of privately insured patients paid $25 or less out-of-pocket per month for XTANDI.
  • XTANDI is widely available for patients across the health insurance marketplace. 71% of US patients paid less than $100 in out-of-pocket costs for their XTANDI prescription regardless of insurance type.*

On the whole, the average out-of-pocket cost a patient with commercial insurance or Medicare Part D would pay for XTANDI is $254.88 or $226.40 per month, respectively.

Additionally, active-duty TRICARE patients have a $0 co-pay for XTANDI, and non-active-duty TRICARE patients can access XTANDI by mail-order supply, in the retail setting or a military treatment facility for co-pays ranging from $0 to $14.

Astellas offers assistance to patients through XTANDI Support Solutions, such as information about healthcare coverage options and financial assistance options – including co-pay assistance to eligible commercially insured patients. Astellas also provides XTANDI at no cost to eligible patients who do not have insurance or who are underinsured through the Astellas Patient Assistance Program.

However, Astellas recognizes that such patient assistance programs are not a long-term solution to outdated benefit designs that create access and affordability challenges for the patients we serve and others. Astellas is committed to working with policymakers and stakeholders across the healthcare system to find durable policy solutions that ensure patients can afford and access the medicines they need, while preserving an environment that enables U.S. biopharmaceutical companies to continue to invest in innovative research on behalf of patients.

* Source: Symphony Health, IDV®, January 1, 2021 – November 30, 2021.

Stay Connected

Get only the email alerts you want.

Subscribe

Media Contacts

corporate.communications@astellas.com

800-888-7704
(press menu option 5, then option 2)
This line is monitored between 8:00am-4:30-pm Central Time M-F

For inquiries during non-business hours, please contact us

 

Astellas on Twitter
Download Fact Sheet
Sustainability
Investors
Explore U.S. Products