Now more than ever, we are working to ensure that patients have access to and can afford their critical Astellas medications. In the U.S., Astellas has implemented changes to its patient assistance programs as part of the company's ongoing commitment to ensuring that patients have access to our products. Astellas Pharma Support SolutionsSM offers support to patients needing access and reimbursement assistance. The changes were made to make the application and verification process easily accessible for patients who have lost their jobs or insurance coverage as a result of COVID-19, and increase customer service capacity in light of the influx of patients requiring assistance. Click here to read more.
- The supply, manufacturing and distribution of Astellas products in the U.S. are not impacted, and patients are able to receive all approved U.S. medicines, including our oncology and transplantation medicines, without interruption related to COVID-19. Click here for the latest updates on supply status.
- To help ensure patient safety and alleviate strain on healthcare resources, we are implementing changes to our clinical trial operations. In countries and regions with continuing spread of COVID-19, we temporarily suspended start-up activities involving study sites for new interventional clinical studies. But we have started to reactive clinical studies following the benefit-risk assessment of each study.
- Consistent with the issued guidance from regulatory bodies of each country, we are assessing protocols and implementing measures to reduce the burden on healthcare systems while ensuring the maintenance of patient safety.
- Furthermore, in order to prioritize patient safety, we are providing measures, when applicable, such as remotely monitoring the safety of patients via phone, conducting necessary medical exams at medical institutions close to the patient’s home outside of the trial site, and/or sending investigational drug to the patient’s home, in case a patient cannot visit the trial site designated in the protocol.
- We will frequently reassess this approach, which applies to all interventional clinical trials led by us and our group companies, with a continued focus on ensuring patient safety across our clinical development programs. However, a different approach may be implemented for some clinical trials led by our collaboration partners.
We remain focused on ensuring patient safety, while maintaining regulatory compliance and data integrity across clinical development programs.
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