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“The National Institutes of Health’s (NIH) decision on March 21, 2023, will protect public-private partnerships as incubators of technological innovation, as intended by the Bayh-Dole Act. This decision reinforces NIH’s consistently held position that invoking the Bayh-Dole Act’s “march-in” rights authority is not an appropriate means to control prescription drug prices. XTANDI is widely available among advanced prostate cancer patients in the U.S. and is a good example of how innovation and collaboration between early-stage public research and private development can benefit American consumers. Astellas is dedicated to working with policymakers and stakeholders across the healthcare system to find durable policy solutions that help 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 research and development to bring new innovative treatments to patients.”
- Company Spokesperson, Astellas Pharma US, Inc.
XTANDI® -- A Widely Available & Effective Treatment for Patients 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 these three types of advanced prostate cancer, data have shown Xtandi significantly reduced the risk of disease progression or death.
Commitment to Patients: XTANDI Has Benefited Hundreds of Thousands of Prostate Cancer Patients
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997,000 Patients Worldwide
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have been prescribed XTANDI since August 2012.
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272,700 U.S. Patients
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have been prescribed XTANDI since August 2012.
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Commitment to Affordability: XTANDI is Widely Available to U.S. Patients
The facts help to demonstrate what most patients pay out-of-pocket for XTANDI.
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Medicare and Commercial Insurance
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Medicare
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Commercial Insurance
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TRICARE
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In 2022, 80% of XTANDI prescriptions cost patients $50 or less – regardless of insurance type (Medicare and commercial insurance).*
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In 2022, 74% of XTANDI prescriptions cost Medicare patients $20 or less.*
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In 2022, 73% of XTANDI prescriptions cost commercially insured patients $20 or less.*
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Active-duty TRICARE patients have a
$0 co-pay for XTANDI, and non-active-duty TRICARE patients have copays ranging from
$0 to $14.
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*Symphony Health, IDV®, January 1, 2022 – December 31, 2022
A drug’s list price does not reflect the amount most patients will pay for their prescription medication. References to the wholesale acquisition cost (WAC) and average wholesale price (AWP) are misleading reflections of what most purchasers and patients pay for XTANDI. WAC and AWP also do not account for rebates that manufacturers individually negotiate with insurance companies.
Astellas believes reform of the system is needed to require pharmacy benefit managers (PBMs) and insurers to share directly with patients the savings PBMs and insurers receive from the rebates and discounts biopharmaceutical companies pay them.
Commitment to Access: Astellas Provides Eligible U.S. Patients with XTANDI at No Cost and with Financial Assistance
Through the Astellas Patient Assistance Program, Astellas provides XTANDI at no cost to eligible patients who are unable to afford their medication. Astellas also provides co-pay assistance through the XTANDI co-pay card program to eligible commercially insured patients.
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XTANDI Co-Pay Card Program
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XTANDI Patient Assistance Program
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Since XTANDI was first approved by the FDA in 2012, Astellas has provided patients with more than $100 million in co-pay assistance for their XTANDI prescription costs.
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Since XTANDI was launched in 2012, Astellas has provided more than 25% of all U.S. XTANDI prescriptions for free through our patient assistance program - at no cost to the patient, U.S. government, and insurers. Astellas has helped tens of thousands of patients access XTANDI at no cost, representing more than 18.7 million days of XTANDI therapy for patients with advanced prostate cancer.
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Commitment to Bringing New Value to Patients: Our Continued Research and Development of XTANDI
Through 2022, Astellas and its partners have invested years and more than $2.3 billion to support the extensive clinical trials and research necessary to demonstrate that XTANDI is safe and effective for patients, to support the applications that led to multiple FDA approvals, and to further understand how the medicine may be able to benefit more prostate cancer patients.
Astellas alone has invested nearly $1.5 billion to research and further develop XTANDI to make it available to more patients who need it.
The Bayh-Dole Act and XTANDI
The Bayh-Dole Act – enacted in 1980 – incentivizes public-private collaborations that help 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 good example of how collaboration between early-stage public research and private development can benefit American consumers, as the Bayh-Dole Act envisioned.
In 2016 and again in 2023, 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 innovations and could discourage the development of future innovations and medical breakthroughs by deterring future public-private collaborations.
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Astellas is dedicated to improving access and affordability for patients who rely on our medications. We work with policymakers and stakeholders across the healthcare system to find durable policy solutions that help 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 research and development to bring new innovative treatments to patients.
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