Pharma & Biotech

Price and reimbursement are shaped long before the first payer meeting.

The outcome of an access negotiation depends on more than the case made at the table. Trial design, evidence generation, partnership terms and alignment between global and country teams all shape a company’s position and its room to move.

We work with pharmaceutical and biotech leaders on the negotiations that decide access: with payers and HTA bodies, between global headquarters and country teams, and increasingly in health policy. And we work on the decisions, many of them made years earlier in development, that determine how well prepared a company is for them: a clear value argument, an internal position that holds, and licensing or co-development terms that keep the path to patients open.

Access is negotiated on more than one level

Pricing and reimbursement systems were built for medicines that treat large, homogeneous populations and prove their benefit in conventional randomized trials. For cell and gene therapies, many biologics and targeted cancer medicines, the evidence comes from small patient groups and keeps developing after launch. The gap between how these medicines create value and how the systems assess it is where access negotiations get hard.

In most European countries, the reimbursed price is the outcome of a defined procedure: a benefit assessment, followed by a negotiation with a payer or an authority (e.g., the AMNOG process with the G-BA and the GKV-Spitzenverband in Germany, or the listing procedure of the Federal Office of Public Health, BAG, in Switzerland). What happens at that table is only part of the negotiation. A company’s position is shaped on three levels at once.

The product. The clinical evidence, the value argument and the price of a single medicine. This is the level market access teams usually focus on in their preparations.

The organization. Global headquarters decides on price expectations, decision rights and escalation for many markets at once. Where these are not agreed with the country team before the first meeting, the team negotiates without a clear mandate, and headquarters decides on the next step only once the payer’s first response is in. And when headquarters instructs the team to hold firm because a lower price in one country would put prices elsewhere at risk, a negotiation that was making progress on the evidence stalls, for reasons the payer cannot see.

The system. HTA methods, reimbursement rules and the health policy behind them determine which evidence counts and which payment arrangements are possible. A company proposes an outcome-based agreement for a gene therapy whose long-term benefit is not yet proven, an arrangement that would suit both sides. But many national rules make little or no provision for risk-sharing or flexible pricing, and sometimes the obstacle is as practical as how the payments would be tracked, settled and refunded.

These levels are becoming more connected. Since January 2025, joint clinical assessments at EU level have covered new cancer medicines and advanced therapies within scope, and orphan drugs follow in 2028. They inform national HTA procedures such as AMNOG, while pricing and reimbursement decisions remain national. In the US, the voluntary GENEROUS model uses international net prices, including those in Germany and Switzerland, to calculate Medicaid rebates for selected medicines. For some products, a concession in Berlin or Bern can now cost more in the US revenue than the European markets bring in, and some companies are reconsidering whether and when to launch in Europe at all. Meanwhile, national cost-containment measures turn access into a political negotiation, in which the industry’s arguments regularly land on the wrong level.

Value is shaped long before launch

Many of the choices that shape a medicine’s value are made during development: the patient population studied, the endpoints and comparators selected, the evidence generated and the manufacturing approach. Two gene therapies at comparable prices reached opposite outcomes in Europe. One gained broad reimbursement, the other was withdrawn from several markets. The price did not explain the difference. The choice of comparator, the handling of uncertainty and the timing of payer engagement did.

These choices are made in the development team, but they bind R&D, regulatory, medical and commercial alike, and each function weighs them differently. R&D and clinical development weigh feasibility and probability of success, regulatory the evidence needed for approval and the label, medical the clinical relevance, commercial the differentiation and the value proposition. Each function answers its own question, and nobody holds the mandate to weigh them against each other. The consequences surface years later: when the trial evidence cannot establish added benefit against the comparator the HTA body applies, or when the sequence of indications limits the room in a later price negotiation.

New technologies sharpen the question. Cell and gene therapies, platform technologies and AI-supported development bring data science, manufacturing, quality and external partners into development decisions earlier, while budgets, roles and approval paths still reflect the old way of working. Without agreed decision rights, a new approach stays a parallel initiative instead of becoming part of the development program. The same holds when a portfolio is reprioritized: the teams whose projects are stopped are usually the ones asked to carry out the decision, so the criteria have to be accepted before it is taken. And a company moving from research toward the market needs an organization it has never needed before.

Partnerships decide how risk, control and value are shared

Many pharmaceutical and biotech companies rely on partners for development, manufacturing or commercialization. Licensing and co-development agreements allocate development risk, decision rights, commercial rights and future economics. Manufacturing agreements settle capacity, cost, quality responsibilities and what happens when plans change. For a company based outside Europe, the partner question is also a market question: where to launch first, alone or with a partner, in markets whose procedures differ from country to country.

Friction typically arises at two points. Before the term sheet, founders, investors and functional leaders have not agreed on priorities, red lines and trade-offs. After signing, governance exists on paper and is hard to apply once assumptions change or priorities diverge. The negotiation starts before the term sheet and continues through the partnership.

What we hear from the industry

The dossier is written for the benefit assessment, and the arguments the price negotiation needs later are missing.
Global headquarters sets a price expectation that the national process cannot deliver, and the country team negotiates without room to move.
A new indication is coming, and the price agreed for the first one limits what is possible.
Most-favored-nation pricing in the US puts European prices under scrutiny at headquarters, and the launch sequence is up for debate.
A cost-containment law is under debate, and the industry’s arguments provoke the opposite of what they intend.
R&D, regulatory, medical and commercial hold different views on which evidence the program needs, and the trial design is due.
A licensing or co-development negotiation is coming, and founders, investors and functional leaders have not agreed on priorities, risks and acceptable terms.
The alliance is signed, its governance exists on paper, and it is unclear who decides when the partner’s priorities change.
A new platform or AI-supported approach is meant to change how development works, and nobody holds the mandate to change budgets, roles and decision rights.
A company from the US or Asia plans its first European launch and discovers that each country follows its own process.
A biotech company moves from research toward the market, and its roles and decision rights were designed for a much smaller organization.

What we work on with you

Which lever matters depends on where the friction comes from: the dossier, the organization, the system, or a decision taken earlier in development. We find that out first, then work on the level where the decision is actually made.

The dossier and the negotiation: a consistent line of argument from the evidence to the price agreement, a negotiating strategy that looks beyond the first indication, preparation for negotiations with payers and authorities (e.g., the GKV-Spitzenverband or the BAG) and, where needed, support at the table.
The organization: a negotiating mandate agreed between global headquarters and the country team, a launch and pricing sequence that accounts for international price referencing, one team across medical, market access, legal and commercial, and clear roles in each phase.
The system: positioning in health policy debates, alliances beyond the industry, and arguments built for the level at which they will be heard.
Development decisions: one agreed view across R&D, regulatory, medical and commercial before design choices are locked in, with criteria for the trade-offs, clear decision rights and an evidence plan carried by the functions that depend on it. The same applies to new technologies and to portfolio decisions.
Partnerships: internal alignment before the term sheet, preparation and negotiation of licensing, co-development and manufacturing agreements, governance after signing that still works when priorities diverge, and the sequence and setup of European market entry.
Growing organizations: the step from a research organization to one that brings a product to market, with roles and decision rights that fit the next stage.

Insights

Article: How Development Decisions Shape Market Access (April 2026) → Read

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