U.S. Pharmaceutical Reimbursement, Market Access and Regulatory Strategy
Lanton Strategies International advises European and international companies entering or expanding in the United States. We work with pharmaceutical and biotechnology businesses, healthcare organizations, and investors on U.S. reimbursement policy, market access, government affairs, and regulatory matters affecting commercial operations.
Entering the American market requires an understanding of how federal and state policies affect pricing, reimbursement, business agreements, and investment decisions. We help management teams evaluate these requirements before entering new markets, negotiating commercial arrangements, or committing capital.
U.S. Pharmaceutical Reimbursement and Market Access
For European pharmaceutical and biotechnology companies, U.S. reimbursement can be one of the more difficult parts of commercialization planning.
Medicare, Medicaid, commercial insurers, and pharmacy benefit managers (PBMs) operate under different payment and coverage requirements. A medicine may receive FDA approval but still face coverage restrictions, reimbursement limitations, or commercial barriers that affect its financial performance.
We advise companies on the business implications of U.S. pharmaceutical reimbursement policy, including:
Medicare and Medicaid: Federal reimbursement policy, drug pricing requirements, CMS initiatives, and changes affecting manufacturer payments and patient access.
Pharmacy Benefit Managers: PBM contracting practices, formulary access, reimbursement arrangements, and federal and state oversight.
340B Drug Pricing Program: Manufacturer obligations, contract pharmacy developments, program oversight, and related policy changes.
Drug Pricing Policy: Medicare drug price negotiations, Most-Favored-Nation (MFN) proposals, international pricing considerations, and pharmaceutical payment reforms.
Commercialization Planning: How reimbursement requirements affect U.S. market entry, licensing arrangements, commercial partnerships, and investment decisions.
Our advisory work focuses on the policy and commercial requirements affecting pharmaceutical market access. We work alongside companies' clinical, regulatory, and health economics and outcomes research (HEOR) teams when their work requires additional technical expertise.
Regulatory and Government Affairs Advisory
Federal and state legislation can affect how companies operate, invest, and expand in the United States.
LSI advises on the regulatory and legislative environment affecting healthcare, life sciences, technology, and other regulated industries.
Our work includes:
Federal and state regulatory assessment
FDA, CMS, and state agency policy analysis
Congressional and Executive Branch engagement strategy
Healthcare and pharmaceutical legislation
Technology and emerging innovation policy
Regulatory considerations affecting U.S. business expansion
We help companies identify relevant policymakers, understand proposed requirements, and evaluate whether direct government engagement is appropriate for their business objectives.
Trade, Investment and Cross-Border Policy
European companies expanding into the United States must also consider trade policy, foreign investment requirements, and restrictions affecting international business arrangements.
LSI advises management teams on the commercial implications of:
U.S. trade and tariff policy
National security and foreign investment review requirements
Cross-border biotechnology licensing and investment policy
Federal policy affecting manufacturing and capital investment
Regulatory requirements affecting international expansion
These considerations can affect where companies invest, how they structure partnerships, and whether planned commercial activities are practical under U.S. policy.
Advising European Companies on U.S. Business Decisions
Our work combines knowledge of the American healthcare and regulatory environment with an understanding of the commercial decisions facing European companies.
We help executives evaluate the policy requirements affecting market entry, assess reimbursement and regulatory exposure, and determine where government affairs or specialized advisory support may be warranted.
For pharmaceutical and biotechnology companies, these assessments can inform decisions about licensing, commercialization, reimbursement planning, and investment.
LSI provides senior-level strategic advice to companies operating across the United States and Europe, with particular attention to the financial and operational consequences of government policy.