TAKEDA PHARMACEUTICALS AMERICA INC

BUD · Budget/Appropriations

FY 2025 Budget Resolution - Pharmaceutical Related Provisions

HCR · Health Issues

Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues H.R. 2214, DRUG Act

Literal federal measure citations: H.R. 2214

MMM · Medicare/Medicaid

Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act

Literal federal measure citations: H.R.1, S. 832, H.R. 946, HR 4229

TAX · Taxation/Internal Revenue Code

Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits Administration's Global Tax Proposal General issues around 2025 Reconciliation/Inbound Concerns

TRD · Trade (domestic/foreign)

General intellectual property policy issues Issues related to proposed Tariffs - all pharmaceutical related provisions

DEF · Defense

Discussions around Supply Chain implications