Letters, Statements & Analysis

AMCP communicates the importance of managed care pharmacy by collaborating with members to provide comments, analysis, and testimony to Congress and federal and state agencies on the impact of proposed regulations and laws on managed care pharmacy and patients.

AMCP Sends A Letter to the Michigan House Health Policy Committee Expressing Concerns with Specific Provisions of House Bill 4472, Regarding the Regulation of Biological Products and the Substitution of Interchangeable Biological Products

The Academy of Managed Care Pharmacy (AMCP) is writing to express concerns with specific provisions of House Bill 4472 regarding the regulation of biological products and the substitution of interchangeable biological products when dispensed by pharmacists. We strongly support the language in the Bill that allows a pharmacist to substitute an FDA approved “interchangeable biological product.”
Legislation & Regulation

AMCP Comments on ISPOR Draft Special Task Force Report on Health Economics Approach to Value Assessment Frameworks

The Academy of Managed Care Pharmacy (AMCP) thanks the International Society for Pharmacoeonomics and Outcomes Research (ISPOR) for the opportunity to comment on the Draft Special Task Force Report “A Health Economics Approach to US Value Assessment Frameworks” issued on May 4, 2017 as part of its Initiative on US Value Assessment Frameworks.

AMCP Delivers Remarks on Biosimilars Position at FDA Oncologic Drug Advisory Committee Meeting

AMCP supports the implementation of a robust biosimilars pathway to ensure that Americans continue to receive access to safe, effective, and affordable biologics and biosimilars. AMCP has been working extensively with the Food and Drug Administration and other stakeholders on federal and state legislation and regulations that impact the biosimilars pathway.
Biosimilars

AMCP Submits Comments to the FDA on the Biosimilar Interchangeability Draft Guidance Seeking Additional Clarity Prior to Finalization

The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to “Considerations in Demonstrating Interchangeability With a Reference Product: Guidance for Industry [Docket No. FDA-2017-D-0154]” as published in the Federal Register on January 18, 2017.

AMCP Joins 10 Organizations in Joint Comment Letter to the FDA on Draft Interchangeability Guidance

All of the undersigned groups share the FDA's deep commitment to the development of a robust biosimilars market for patients, and greatly appreciate all the work the agency has done in creating certainty around the approval pathway created by the Biologics Price Competition and Innovation Act (BPCIA), including the long anticipated proposed guidance detailing the requirements of obtaining an interchangeability designation for a biosimilar.

AMCP Sends a Letter to Connecticut House Leadership Expressing Concerns with Specific Provisions of Substitute Bill No. 7118 Regarding the Regulation of Biological Products and the Substitution of Interchangeable Biological 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.

AMCP Submits Comments to Tennessee House Leadership Expressing Strong Support for House Bill No. 628 Which Would Establish a Medication Therapy Management (MTM) Pilot Program as a Component of the Tenncare Program

The Academy of Managed Care Pharmacy (AMCP) urges you to support House Bill No. 628, which would establish a Medication Therapy Management (MTM) pilot program as a component of the TennCare program. MTM services have demonstrated success for Medicare Part D beneficiaries by improving patient outcomes while decreasing overall health care costs, and AMCP strongly supports the expansion of MTM services for other patient groups including Medicaid beneficiaries.

AMCP Submits Comments to PQA on Three New Measures Under Consideration for Endorsement, Advocating for Measures with a Focus on Outcomes, Consideration for Clinical Appropriateness of Medications, and Avoidance of Duplication of Measures

The Academy of Managed Care Pharmacy (AMCP) thanks the Pharmacy Quality Alliance (PQA) for the opportunity to provide comments in response to the memo titled Endorsement Consideration by PQA Members of Three New Performance Measures.

AMCP Joins 17 Other Health Care Organizations and Consumer Groups in Support of the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 – H.R. 2212 and S. 974

As stakeholders firmly committed to fostering patient access to affordable medicines and pharmaceutical competition, we would like to thank you for introducing the bicameral and bipartisan Creating and Restoring Equal Access to Equivalent Samples (“CREATES”) Act.