Chronic Kidney Disease is when the kidneys gradually get damaged over time and the kidneys are unable to complete functions such as removing wastes from your body, maintain blood pressure, and keeping your bones healthy.
AMCP submits letter to Connecticut Senate General Law Committee on Senate Bill 197 regarding Interchangeable Biologic Products
The Academy of Managed Care Pharmacy (AMCP) is writing to express concerns with specific provisions of Substitute Bill No.7118 regarding the regulation of biological products and the substitution of interchangeable biological products when dispensed by pharmacists. We strongly support the language in the Substitute Bill that allows a pharmacist to substitute an FDA approved “interchangeable biological product”. That language is consistent with the Biologics Competition and Innovation Act (BPCIA) definition of “interchangeable biologic product” which allows a pharmacist to substitute an interchangeable biologic product without the intervention of the health care provider who prescribed the “reference product”. However, we oppose the language that defines an interchangeable biological product as therapeutically equivalent and imposes administrative requirements to dispense an interchangeable biological product that are different from existing requirements for all other classes of medications. We also are concerned about enacting requirements prior to the FDA finalizing guidance on interchangeable biological products.
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Prescription Digital Therapeutics (PDTs) offer vast opportunities but require careful consideration for coverage and reimbursement. At the direction of the AMCP Board of Directors we have developed definitions and principles to simplify your decision-making and provide digital health innovators with essential insights for evaluating safety and efficacy.
The United States Pharmacopeia Convention (USP) and the United States Food and Drug Administration (FDA) have updated an educational resource on biosimilars to help healthcare practitioners improve patient confidence in the quality and effectiveness of these treatment options. The following are recommended social media, website, and email content you can use to share this resource with your network.
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