Guide
Securing drug reimbursement in the United States
Karine Wittmer and Julie Bächtold, Switzerland Global Enterprise
Apr 2, 2026
Entering the United States market offers a major growth opportunity for Swiss and Liechtenstein-based pharmaceutical manufacturers, but it comes with a fundamentally different reimbursement reality. Our guide for Swiss pharmaceutical manufacturers provides an overview of how the system works.
Unlike Switzerland, where pricing and reimbursement conditions for mandatory health insurance are defined within a federally regulated framework, the United States does not operate under a single nationally coordinated reimbursement system.
In this environment, FDA approval is a critical milestone, not market access. Regulatory authorization does not automatically translate into coverage, formulary inclusion, or sustainable payment. Companies must secure three interdependent elements—coverage, coding, and payment—across a fragmented landscape of public and private payers. The Centers for Medicare & Medicaid Services shapes key federal frameworks, states play a central role in Medicaid, and Pharmacy Benefit Managers influence formulary placement and net pricing through contracting.
This fragmentation also means United States revenue rarely equals the public list price. While the wholesale acquisition cost is visible, realized revenue depends on the full gross-to-net dynamic, including rebates and statutory discount mechanisms. Pricing decisions therefore require early modeling of the expected net outcome not only the headline price.
Recent policy shifts further change long-term planning. The Inflation Reduction Act introduces a new timeline risk for high-spend branded products in Medicare, compressing the period in which manufacturers can rely on unconstrained pricing. At the same time, most-favored-nation-style external reference dynamics increase the strategic linkage between prices set in Switzerland (and other markets) and potential United States price ceilings, making global pricing governance part of the United States business case.
As formulary position and access conditions can shift quickly without sustained payer engagement, evidence generation, and contracting strategy, reimbursement is not a one-time hurdle but a lifecycle commitment. For Swiss small and medium-sized enterprises in particular, limited in-house policy and contracting capacity can create structural disadvantages making early, specialized market access support and coordinated industry engagement more important.
Experts recommend starting United States market access planning 24–36 months before anticipated FDA approval, so evidence, coding readiness, benefit classification, and payer strategy mature in parallel rather than becoming late-stage constraints.
Recent developments
The US pharmaceutical reimbursement environment has undergone profound changes since 2022. Swiss manufacturers entering the US market today face a fundamentally different regulatory, pricing, and trade landscape compared to even two or three years ago. Three structural shifts in particular demand immediate attention.
Shift 1
The Inflation Reduction Act (IRA) of 2022 has introduced direct Medicare drug price negotiations — a first in US history. Negotiated prices for the first 10 selected drugs take effect January 1, 2026. A further 15 drugs (including Ozempic and Wegovy) have been selected for 2027. Any manufacturer with a drug meeting IRA eligibility criterion must now treat negotiation exposure as a core element of their commercial strategy.
Shift 2
President Trump's May 2025 Executive Order on Most-Favored-Nation (MFN) pricing now requires manufacturers to align US prices with the lowest prices offered in OECD peer countries. Major companies have already signed voluntary pricing agreements. The implications for launch sequencing, Swiss pricing, and global revenue architecture are significant and still evolving.
Shift 3
Swiss pharmaceutical exports to the US represents approximately 50–60% of Switzerland's total US-bound exports. A November 2025 US–Swiss trade accord capped pharmaceutical import tariffs at 15%. However, the situation remains fluid. Smaller Swiss firms that lack dedicated US policy teams face structural disadvantages compared to large pharmaceutical companies.
The following four workstreams provide a structured framework for navigating US reimbursement framework. While they build on one another conceptually, in practice they evolve in parallel and are closely interdependent rather than strictly sequential.
Workstream 1: market environment assessment
1.1 Understanding the US payer ecosystem
The US does not operate under a single nationally coordinated reimbursement system. Coverage decisions are made independently by a fragmented set of payers and intermediaries. For a Swiss manufacturer accustomed to dealing with a single federal counterpart, this multiplicity requires a significant strategic adjustment.
The four primary payer categories
- Commercial/Private Insurance: Covers approximately 155 million Americans through employer-sponsored or individually purchased plans. Coverage decisions are managed by health plans and often delegated to PBMs. This segment is the most heterogeneous and requires plan-by-plan engagement strategies.
- Medicare: The federal insurance program for people aged 65+ and certain people with disabilities, covering approximately 67 million Americans. It is divided into: Part A (hospital); Part B (physician-administered drugs and outpatient services); Part D (prescription drugs, managed by private plan sponsors). Part B and Part D have distinct reimbursement mechanisms and require separate strategic approaches.
- Medicaid: Joint federal–state program for low-income populations, covering approximately 90 million Americans. Manufacturers must participate in the federal Medicaid Drug Rebate Program (MDRP) if they want Medicaid reimbursement. States retain discretion over preferred drug lists (PDLs) and utilization management.
- Veterans Affairs (VA) and other federal programs: The VA negotiates prices independently. Products sold to the VA establish Federal Ceiling Prices (FCPs), which affect other government pricing calculations.
Pharmacy Benefit Managers (PBMs): the hidden gatekeepers
PBMs are intermediaries that manage prescription drug benefits on behalf of insurers and employers. They are among the most consequential actors in the US reimbursement system — yet they are largely invisible in the reimbursement frameworks familiar to Swiss manufacturers. The three largest PBMs (CVS Caremark, Express Scripts/Cigna, and OptumRx/UnitedHealth) collectively administer benefits for the majority of commercially insured Americans.
PBMs exert leverage over: formulary design and drug tier placement; prior authorization and step therapy policies; rebate negotiations with manufacturers; and network pharmacy access. A drug that fails to secure PBM favor — particularly at the three largest — may find itself excluded from formularies covering the majority of commercially insured patients.
Swiss market entry risk
Swiss manufacturers must engage PBMs proactively and early. PBM formulary decisions are often made 6–12 months before a product is even available to patients. Late engagement is one of the most common and costly mistakes for European companies entering the US market.
1.2 Competitive and market landscape analysis
- Before initiating any US reimbursement activity, manufacturers should conduct a structured landscape assessment covering:
- Competitor and Comparator Research: Identify existing treatments (branded, generic, biosimilar) that payers will use as benchmarks. Map payer perceptions of clinical differentiation. Assess whether existing drugs are already subject to IRA price negotiations, which may reframe the competitive pricing environment.
- Addressable Patient Population: Quantify the total addressable population using US epidemiological data (not Swiss or European figures, which may differ substantially). Identify geographic concentration, as disease prevalence and payer mix vary significantly by US region.
- Payer Mix Modeling: Estimate the distribution of patients by payer type (Commercial, Medicare Part D, Medicare Part B, Medicaid). This shapes net revenue projections, rebate strategy, and government pricing compliance obligations.
- Care Setting Analysis: Determine whether the product will be administered in physician offices, infusion centers, hospital outpatient departments (HOPDs), or self-administered at home. The care setting directly determines the applicable reimbursement pathway (Part B vs. Part D vs. commercial pharmacy).
Manufacturers should also map the key stakeholders who influence formulary decisions within each payer type, including Pharmacy & Therapeutics (P&T) committee structures, medical director networks, and specialty pharmacy relationships.
1.3 Benefit classification — a foundational strategic decision
One of the earliest and most consequential decisions in US market access is determining whether a product falls under the pharmacy benefit or the medical benefit. This classification is not simply an administrative formality — it defines the entire reimbursement infrastructure, the relevant payer relationships, and the revenue realization mechanism.
| Dimension | Pharmacy Benefit vs. Medical Benefit |
| Product type | Self-administered drugs (oral tablets, self-injected) vs. Provider-administered (IV infusions, clinic-injected biologics) |
| Medicare pathway | Part D (managed by private plan sponsors) vs. Part B (direct CMS payment to providers) |
| Payment basis | Formulary tier and cost-sharing structure vs. ASP + 6% (Medicare Part B standard, though under political pressure in 2025) |
| Key relationships | PBMs, Part D plan sponsors, specialty pharmacies vs. Hospital/clinic purchasing departments, physicians, GPOs |
| NDC / coding | NDC code required for pharmacy dispensing vs. HCPCS/CPT J-code or Q-code for medical billing; may require new code creation |
| Rebate dynamics | Manufacturer rebates to PBMs/plans for formulary placement vs. No traditional rebate in Part B; pricing reported as ASP to CMS |
| Swiss analogy | Comparable to SL (Spezialitätenliste) pharmacy dispensed drugs vs. Comparable to hospital-billed drugs under AL tariffs |
Classification error risk
A misclassification of the benefit type — even if later corrected — can delay commercial launch by 12–18 months due to billing infrastructure and payer policy requirements. This decision should be confirmed with US reimbursement counsel before any payer engagement begins.
Workstream 2: pricing and revenue architechture
2.1 From list price to net revenue
Switzerland's drug pricing system produces a single, nationally applicable price (the SL price) from which manufacturers can predict revenue. The US system is structurally different: manufacturers set a list price (Wholesale Acquisition Cost — WAC) which is a publicly available reference point, but net revenue is determined by a complex web of rebates, discounts, and mandatory government obligations that can reduce realized revenue to a fraction of WAC.
Understanding this full revenue architecture — not just the list price — is essential for Swiss companies building their business case for US entry.
Price reduction layers: the revenue waterfall
- Gross-to-net adjustments for commercial payers: Manufacturers negotiate rebates with PBMs and commercial insurers in exchange for formulary placement. These rebates — which are confidential — can range from 10–60% of WAC depending on the therapeutic category and competitive landscape.
- Medicaid rebates and best price: The Medicaid Drug Rebate Program (MDRP) requires manufacturers to pay a base rebate of at least 23.1% of Average Manufacturer Price (AMP) for branded drugs. Additionally, when a manufacturer's AMP increases faster than inflation, additional rebates are owed. Critically, the 'Best Price' rule requires manufacturers to report their lowest available commercial price; this price then becomes the floor for Medicaid rebate calculations, creating a link between commercial rebate negotiations and Medicaid obligations.
- 340B discounts: The 340B Drug Pricing Program requires manufacturers to sell covered outpatient drugs at a ceiling price (approximately 23.1% below AMP) to qualifying 'covered entities', including federally qualified health centers, disproportionate share hospitals, and others. The program has grown substantially: in 2023, covered entities purchased $66.3 billion in drugs under 340B, making it the second-largest federal drug program after Medicare Part D.
- Inflation-related penalties (IRA): Under the IRA, manufacturers must pay rebates back to Medicare if drug prices increase faster than the rate of inflation. This provision is effective for Medicare Part B and Part D drugs and was first applied beginning in 2023.
- ASP reporting (Medicare Part B): Manufacturers of Part B drugs must report Average Sales Price (ASP) to CMS quarterly. The ASP includes all price concessions, rebates, and discounts. Medicare then reimburses providers at ASP + 6%. Failure to report accurately - or misclassifying products under the MDRP - exposes manufacturers to False Claims Act liability.
2.2 The IRA Medicare price negotiation program — critical for Swiss manufacturers
The Inflation Reduction Act of 2022 introduced, for the first time in US history, the authority for the federal government to negotiate directly with drug manufacturers on Medicare drug prices. This program has major implications for any Swiss company with a product that could qualify for negotiation.
How the program works
- CMS selects drugs based on high Medicare spending and absence of generic or biosimilar competition. Qualifying small-molecule drugs must have been FDA-approved for at least 7 years; biologics, for at least 11 years.
- Selected manufacturers must either participate in negotiations or face a punitive excise tax (up to 95% of US sales of the selected drug). No manufacturer has declined to participate.
- Negotiated Maximum Fair Prices (MFPs) for the first 10 selected Part D drugs take effect January 1, 2026, representing an average 38% reduction from 2023 list prices.
- 15 additional drugs — including Ozempic and Wegovy — were selected in January 2025 for negotiation, with prices effective January 1, 2027. CMS signed agreements with these manufacturers by March 2026.
- The program is expanding: 15 drugs per year for 2028, then 20 per year from 2029 onward, extending to Part B drugs (physician-administered) beginning in 2028.
IRA negotiation exposure
Swiss manufacturers launching high-spend biologics or specialty small molecules in the US should model IRA negotiation risk from day one. Even drugs not yet on the market may qualify for future negotiation cycles. The 7-year (small molecule) and 11-year (biologic) post-approval clocks begin at FDA approval - not at commercial launch.
IRA 'small biotech exception' — relevant for Swiss SMEs
The IRA provides a temporary exception for drugs manufactured by companies meeting the 'small biotech' definition - broadly, companies where the selected drug accounts for a very high proportion of total Medicare revenue. This exception delays (not eliminates) negotiation eligibility for qualifying firms. Swiss SMEs with a single key product should assess small biotech exception eligibility as part of their US market access planning. The exception must be re-applied for each negotiation cycle.
2.3 The Most-Favored-Nation (MFN) pricing policy — a new strategic variable
On May 12, 2025, President Trump signed an Executive Order titled 'Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.' The order represents the most ambitious US government attempt to align domestic drug prices with international benchmarks and has direct and immediate implications for Swiss manufacturers.
Key provisions of the MFN executive order
- Scope: Covers all branded products across Commercial, Medicare, and Medicaid channels — a significantly broader scope than prior MFN proposals, which focused only on Medicare Part B.
- Benchmark: HHS set the MFN target price as the lowest price in any OECD country with a GDP per capita of at least 60% of the US GDP per capita. Switzerland — given its high per-capita income — is among the OECD peer countries referenced.
- Implementation timeline: CMS communicated MFN price targets to manufacturers by June 11, 2025. Manufacturers had until November 8, 2025 to negotiate voluntarily. Those that did not comply faced the prospect of formal rulemaking to impose prices.
- Voluntary agreements signed: By December 2025, the Trump administration announced nine MFN pricing agreements, including with Novartis, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Genentech, Gilead Sciences, GSK, Merck, and Sanofi. Each agreement includes price reductions delivered through direct-to-consumer (DTC) channels (the 'TrumpRx' platform).
- GENEROUS Model: On November 6, 2025, CMS announced a Medicaid supplemental rebate model designed to extend MFN-level prices to state Medicaid programs through voluntary manufacturer agreements.
MFN impact on Swiss launch strategy
Swiss pricing decisions are now directly visible to the US government. If a product is sold at a lower net price in Switzerland — or in any OECD peer country — that price can become the basis for MFN pricing targets in the US. This creates a fundamentally new linkage between Swiss domestic pricing (under the FOPH/BAG framework) and US revenue realization. Companies must model global launch sequences and pricing decisions with this linkage explicitly in view.
Strategic implications for Swiss manufacturers — MFN
The MFN policy introduces several strategic imperatives for Swiss companies:
- Launch sequence reconsideration: The conventional approach — launching in the US first, then in European markets — may need to be re-evaluated. Early launches in low-price OECD markets could establish a low MFN benchmark that undermines US pricing.
- Swiss price visibility: The Swiss SL price, while not the lowest globally, is visible and publicly accessible. Swiss manufacturers must assess whether their FOPH-negotiated price could be used as an MFN reference.
- Net price opacity is limited: The MFN framework focuses on net prices. Confidential rebate arrangements that produce low effective prices in other markets could be surfaced through US trade and pricing investigations.
- Existing products on market: For products already commercialized, manufacturers may face a choice between accepting MFN pricing margins or withdrawing from lower-price reference markets — a decision with significant legal, regulatory, and ethical dimensions in the affected markets.
Workstream 3: evidence and value demonstration
3.1 The US evidence landscape: no single HTA authority
Unlike Switzerland, where the FOPH (BAG) conducts a unified reimbursement review based on therapeutic value (Wirksamkeit, Zweckmässigkeit, Wirtschaftlichkeit — effectiveness, appropriateness, economy), the US has no single national Health Technology Assessment (HTA) body. Payers independently assess clinical and economic value, using their own evidence standards.
This fragmentation means manufacturers must prepare evidence packages capable of satisfying multiple different audiences simultaneously — each with different methodological preferences, clinical priorities, and budget impact perspectives.
The iCER framework — de facto HTA in the US
While the US lacks a formal national HTA body, the Institute for Clinical and Economic Review (ICER) — an independent nonprofit — has become the most influential external body shaping US payer evidence assessments. ICER publishes formal cost-effectiveness analyses (CEAs) for many new drugs, using a cost-per-QALY (quality-adjusted life year) framework similar to that used by NICE in the UK or HAS in France.
ICER reports are not binding, but payers — particularly PBMs and large commercial health plans — frequently cite them in formulary decisions and rebate negotiations. A negative or equivocal ICER review can materially impair a product's commercial access, particularly in the first 12–18 months post-launch. Swiss manufacturers should engage proactively with ICER's review timeline and consider submitting manufacturer evidence dossiers to ICER reviews that affect their products.
The AMCP dossier — standard format for US payer submissions
Manufacturers are expected to prepare an evidence dossier in accordance with AMCP (Academy of Managed Care Pharmacy) Format guidelines. This format — widely used by US insurers, PBMs, and Pharmacy & Therapeutics committees — structures the submission of clinical, economic, and outcomes data for formulary consideration.
An AMCP dossier typically includes : product overview and indication summary; clinical evidence summary (pivotal trials, real-world data); comparative effectiveness versus standard of care; health economic analyses (cost-effectiveness, budget impact); and supporting references. Swiss manufacturers accustomed to HTA submissions for the FOPH will find some familiarity with this format but should note that US payers apply different economic thresholds and may place greater weight on US-specific budget impact analysis.
Key evidence generation priorities for the US
- Head-to-head comparative effectiveness data: US payers place significant weight on direct comparisons to existing standard-of-care treatments. Trials designed against active comparators - rather than placebo - are strongly preferred for formulary submissions.
- Real-World Evidence (RWE): US payers increasingly value real-world data in formulary decisions. Building a US real-world evidence strategy post-launch is now standard market access practice, not an optional add-on.
- US-specific budget impact models: Generic cost-effectiveness analyses derived from European or Swiss market assumptions may not be accepted by US payers. Models must use US-specific cost inputs, epidemiological data, and payer perspectives.
- Patient-reported outcomes (PROs): The FDA and US payers place growing emphasis on PROs, particularly for specialty products in oncology, rare disease, and CNS. These should be integrated into clinical trial design and US evidence strategy from the earliest development stages.
Workstream 4: stakeholder alignment and access execution
4.1 Payer engagement strategy
Successful US market access depends on coordinated engagement across a complex stakeholder ecosystem. For Swiss manufacturers, this requires both a national payer strategy and a regional strategy — a level of geographic differentiation rarely required in the Swiss market.
Priority stakeholder groups
- National PBMs (CVS Caremark, Express Scripts/Cigna, OptumRx): These three organizations collectively manage benefits for the majority of commercially insured Americans. Formulary decisions at the national level cascade into hundreds of regional health plan decisions. Pre-launch engagement — including AMCP dossier submission and rebate negotiation preparation — should begin 12–18 months before anticipated FDA approval.
- Medicare Part D Plan Sponsors: More than 700 Part D plan sponsors administer Medicare drug benefits. Manufacturers should prioritize the largest national plans and engage Part D medical directors and pharmacy directors with evidence packages tailored to the Medicare patient population.
- P&T (Pharmacy & Therapeutics) Committees: P&T committees at major health plans, PBMs, and hospital systems make formulary inclusion decisions. These committees evaluate clinical evidence — not commercial relationships. Preparation of strong, peer-reviewed evidence packages is the primary mechanism for influencing P&T outcomes.
- Specialty Pharmacy Partners: For specialty drugs (oncology, rare disease, immunology, gene therapy), specialty pharmacies are critical distribution and patient support partners. The three largest specialty pharmacies are owned by the three largest PBMs — creating complex alignment dynamics. Manufacturers should negotiate specialty pharmacy agreements and hub services early.
- Hospital and Integrated Delivery Network (IDN) Pharmacies: For provider-administered products (medical benefit), hospital pharmacy committees and group purchasing organization (GPO) contracts are key access levers. Swiss manufacturers unfamiliar with the GPO system should be aware that most hospital drug purchasing is conducted through GPO agreements.
- Patient Advocacy Organizations: In specialty and rare disease markets, patient advocacy groups (PAGs) can play an important role in formulary advocacy, access appeals, and real-world evidence generation. Engagement with PAGs should be conducted carefully in compliance with applicable US anti-kickback regulations.
Compliance critical
All engagement, contracting, and patient support program activities in the US must be reviewed for compliance with the Anti-Kickback Statute (AKS) and False Claims Act (FCA). Patient co-pay assistance programs — commonly used by Swiss manufacturers in other markets — are subject to strict limitations in federal programs (Medicare and Medicaid). Non-compliance can result in criminal liability and exclusion from federal healthcare programs.
4.2 Patient support and co-pay assistance
In the commercial market (privately insured patients), manufacturers commonly offer co-pay assistance programs that reduce patient out-of-pocket costs, supporting adherence and access. However, these programs are tightly regulated in the US:
- For commercially insured patients: Co-pay cards and patient assistance programs are generally permitted but must be structured carefully. If the co-pay assistance effectively lowers a drug's net price, this may need to be reported under Best Price calculations for Medicaid — creating a linkage between commercial patient support programs and government pricing obligations.
- For Medicare/Medicaid patients: Co-pay assistance from manufacturers is generally prohibited under federal anti-kickback regulations. Direct subsidies to Medicare beneficiaries are not permitted. Manufacturers may support independent charitable patient assistance programs (PAPs) under strict guidelines — but may not direct contributions to funds supporting their own products.
Swiss manufacturers who rely heavily on patient financial assistance programs in other markets must redesign these programs from scratch for the US, with specific attention to the federal program limitations.
Post-listing management: a lifecycle discipline
6.1 Reimbursement is not a one-time event
Swiss manufacturers often experience reimbursement as a single negotiation event — the FOPH/BAG review — followed by a stable, centrally maintained SL listing. In the US, reimbursement is a continuous process requiring active maintenance and ongoing investment.
Key post-launch reimbursement activities
- Annual formulary defense: Commercial plans and Medicare Part D plans review formularies annually. A product that achieved favorable formulary placement at launch may be moved to a higher tier, subjected to new step therapy requirements, or removed from the formulary in subsequent years — often due to new competitor entries or rebate renegotiation.
- Utilization management defense: Prior authorization, step therapy, and quantity limit policies can be tightened post-launch. Manufacturers must monitor these restrictions and engage payers with updated evidence when restrictions are applied inappropriately.
- Label expansion and lifecycle management: When a product receives a new indication or label update from the FDA, manufacturers must proactively engage payers to ensure the update is reflected in formulary coverage policies. Failure to do so can result in the new indication being covered at less favorable terms.
- ASP reporting compliance: For Part B products, quarterly ASP reporting to CMS is a continuous regulatory obligation. Pricing governance must be maintained throughout the product's commercial lifecycle.
- Inflation penalty monitoring (IRA): Manufacturers must track their WAC price increases relative to CPI-Urban inflation benchmarks to avoid triggering IRA inflation rebates on Medicare sales.
- State-level Medicaid changes: Medicaid programs operate with significant state-level autonomy. Preferred Drug List (PDL) decisions, supplemental rebate negotiations, and managed Medicaid plan policies can change frequently and affect access in specific states.
- Federal policy surveillance: The US legislative and regulatory environment for drug pricing remains highly active. Manufacturers should maintain ongoing monitoring of CMS guidance, Congressional action, and executive branch policy that could affect reimbursement, rebate obligations, or pricing constraints.
Practical guide: action checklist for Swiss SMEs entering the US market
7.1 Pre-launch planning (36–24 months before FDA approval)
- Confirm benefit classification (medical benefit vs. pharmacy benefit) with US legal and reimbursement counsel.
- Conduct US payer mix analysis and model gross-to-net revenue waterfall under realistic rebate and discount assumptions.
- Assess IRA eligibility: If the product is a single-source brand with anticipated high Medicare spending, build IRA negotiation into the 7–10 year commercial planning horizon.
- Model MFN pricing linkage: Map all markets where the product is or will be priced; identify which OECD prices could become MFN reference prices for the US.
- Design global launch sequence to protect US pricing: Consider whether launching in low-price reference markets before the US may establish MFN benchmarks that constrain US revenue.
- Begin AMCP dossier preparation: Engage a US health economics team to develop the evidence dossier in AMCP format.
- Confirm NDC code assignment (pharmacy benefit) or HCPCS/J-code pathway (medical benefit).
- Assess 340B exposure: Model the volume of sales through covered entities and the resulting revenue impact of mandatory 340B discounts.
7.2 Launch preparation (24 - 6 months before FDA approval)
- Initiate PBM pre-launch engagement with top 3 PBMs (for pharmacy benefit products).
- Engage Medicare Part D plan sponsors and medical directors with clinical evidence packages.
- Establish specialty pharmacy network agreements and hub services (for specialty products).
- Assess GPO contracting requirements (for medical benefit / hospital-administered products).
- Design US patient support programs in compliance with anti-kickback regulations; separate commercial and government program patient populations.
- Establish ASP reporting infrastructure and compliance controls (for medical benefit products).
- Engage Interpharma and Switzerland Global Enterprise for US market intelligence and collective advocacy.
- Monitor tariff developments: Track CBP country-of-origin rules and pharmaceutical-specific tariff actions as part of US market entry financial planning.
7.3 Post-launch (ongoing)
- Monitor formulary status across key payers quarterly; proactively engage payers ahead of annual formulary review cycles.
- Track IRA price inflation benchmarks monthly to avoid unintended inflation rebate obligations.
- Report ASP to CMS quarterly; maintain pricing governance controls.
- Monitor MFN policy implementation; assess whether voluntary pricing commitments are required to avoid regulatory enforcement actions.
- Maintain Medicaid Best Price records; ensure all price concessions in any market are appropriately captured in Best Price reporting.
- Monitor state Medicaid PDL decisions and managed Medicaid plan policies for access restrictions.
- Build real-world evidence from US patient data to support formulary defense and payer re-assessments.
Key takeaways for Swiss pharmaceutical manufacturers
| Takeaway | Implication |
| FDA approval ≠ market access | Regulatory authorization is the entry point, not the destination. Coverage, coding, and payment must each be secured independently — across dozens of independent payers. |
| US revenue ≠ list price | The WAC is a public number. Net revenue is determined by rebates, 340B discounts, Medicaid MDRP obligations, and MFN pricing commitments. Model the full gross-to-net waterfall before setting a US price. |
| IRA changes the long-term calculus | Any high-spend branded product in Medicare is exposed to IRA negotiation after 7 years (small molecules) or 11 years (biologics). This compression of effective exclusivity must be modeled in the business case. |
| MFN links Swiss pricing to US revenue | For the first time, prices set in Switzerland — or in any OECD peer country — can become the legal basis for maximum US drug prices. Global pricing strategy must be integrated with US pricing decisions. |
| Swiss SMEs face structural disadvantages | Without dedicated US policy teams, smaller Swiss companies cannot negotiate directly with the US government the way large pharmaceutical companies can. Collective advocacy through Interpharma and proactive engagement of specialist US market access advisers is essential. |
| Reimbursement is a lifecycle commitment | Unlike Switzerland's relatively stable SL listing environment, US reimbursement must be actively managed throughout the product's commercial life — formulary positions can deteriorate quickly without sustained payer engagement. |
| Tariff exposure is real but currently bounded | The November 2025 US–Swiss trade accord capped pharmaceutical tariffs at 15%. However, this agreement is subject to the broader US–Swiss trade relationship and ongoing geopolitical dynamics. Swiss manufacturers should not treat the 15% rate as permanently locked. |
Sources and methodology
This guide draws on publicly available sources consulted between 2024 and March 2026. All factual claims are sourced and verifiable. Key sources include:
- CMS (Centers for Medicare & Medicaid Services): IRA Medicare Drug Price Negotiation Program guidance documents, including Final Guidance for IPAY 2026, 2027, and 2028.
- KFF (Kaiser Family Foundation): 'FAQs on IRA Medicare Drug Price Negotiation', updated January 2025.
- Commonwealth Fund: 'Medicare Drug Price Negotiations: All You Need to Know', May 2025.
- GlobalLegalInsights: 'Pricing & Reimbursement Laws and Regulations 2025: USA', August 2025.
- Health Affairs Forefront: 'Prescription Drug Policy, 2024 and 2025', December 2024.
- SWI Swissinfo.ch: Multiple articles on Swiss pharma and US trade, 2025–2026.
- Interpharma: 'The Footprint of the Pharmaceutical Industry in Switzerland', August 2025. interpharma.ch
- Fierce Pharma: 'Trump Relents on Swiss Tariffs', November 2025.
- Avalere Health: 'Impact of US Drug Price Policy on Global Market Access', January 2026.
- Jones Day: 'Most Favored Nation Drug Pricing and Manufacturer Agreements', December 2025.
- White House: 'MFN Executive Order', May 12, 2025.
- PwC Switzerland: 'US Tariffs and Trade Deals: Impact on Pharma', 2025.
- Drug Channels Institute: 'New Drug Launches in a Self-Pay World', January 2026.
- Congress.gov CRS: Report R47872 on Medicare Drug Price Negotiation. Legal Sidebar LSB11319 on MFN pricing.
Disclaimer: The information presented on this page has been gathered and researched from sources believed to be reliable and is written in good faith. Switzerland Global Enterprise cannot be held liable for data that may not be complete, accurate or up-to-date, nor for data that originates from Internet sites/sources over which Switzerland Global Enterprise has no control. The information on this page does not have a legal or juridical character. For individual advice, please contact Switzerland Global Enterprise.
