Funding and Procurement Process

Access to radiopharmaceuticals, especially for positron emission tomography (PET), and supporting infrastructure across Europe is marked by considerable variation caused by regional funding mechanisms, procurement practices, and healthcare priorities. Differing approaches to reimbursement and cost-sharing reflect both local constraints and national healthcare strategies. These diverse models influence how radiopharmaceuticals are acquired and used in hospitals, affecting both availability and patient access.

EU4+UK (France, Germany, Italy, Spain, and the United Kingdom)

There are limitations and inequalities among regions and hospitals in access to PET radiopharmaceuticals and infrastructure in all EU4+UK countries. The cost of PET radiopharmaceuticals is covered through different approaches:

• Limited and nationally fixed tariffs for PET procedures (France, Italy, Germany)
• National Health Service (NHS) commissioning policy, sidecar to procedure tariff (UK)
• Healthcare budgets, usually under pressure (Spain)
• National drug list reimbursement for Class H and fixed national PET tariff for Class C (Italy)
• Patient-by-patient specialized contracts (Outpatient Specialist Care/ Ambulante spezialfachärztliche Versorgung) by statutory health insurance (Germany)

From the clinicians’ standpoint, diagnostic accuracy (e.g., specificity and sensitivity) together with the number and type of indications and experience with the product drives most decisions on radiopharmaceutical use. When it comes to radiopharmaceutical’s purchasing decisions, nuclear medicine physicians are the main stakeholders. In the case of hospitals with radiopharmacy departments, it is usually a joint decision. All public procurement is tender-based and normally organized on a regional basis. Cost is usually the main driver, followed by clinical guidelines and alignment with hospital protocols/formularies. One purchasing option is a top-down approach from procurement departments that are aware of cheaper radiopharmaceutical options and ask the nuclear medicine department to assess the comparable efficacy and safety. Another is a bottom-up approach from nuclear medicine physicians that propose a new procedure and radiopharmaceutical to be purchased.

France
France has two main relevant types of procurement performed either by public hospitals/Centre hospitalier universitaire (CHUs) or Unicancer centers/Centres de Lutte contre le Cancer, which are private not-for-profit specialized cancer centers with most of the activity.

CHUs purchase radiopharmaceuticals through a tendering process. Tenders can be awarded to different companies at different market shares depending on hospital preferences for products. Cost, supply reliability, clinical benefits, and hospital preferences are the main decision drivers for tendering awards.

Unicancer centers purchase radiopharmaceuticals through direct negotiations with manufacturers where cost is the most important factor followed by experience with the product.

In France, the price of radiopharmaceuticals, especially for PET, frequently surpasses the outpatient tariff, and the hospital must absorb the extra cost. If the number of patients using the radiopharmaceutical is low, there is less risk, but at some point, certain hospitals may limit its use. Hospitals tend to operate on a loss.

Germany
Funding in Germany is linked to cost, which is the top criteria for radiopharmaceutical purchasing. Both tenders and direct purchases are in place. The funding mechanism is funded via an inpatient DRG lump sum or specific outpatient German Uniform Evaluation Standard/Einheitlicher Bewertungsmaßstab code. Some centers follow the outpatient procedure and use ambulatory clinics within the hospital to perform diagnostic techniques. Some centers have different procurement mechanisms for inpatient (tenders) versus outpatient care (direct contracts). As with France, the radiopharmaceutical price often exceeds the tariff, and hospitals must bear the extra cost.

Italy
Tenders for public hospitals in Italy are generally organized at a regional level, and then the hospitals agree to purchase the radiopharmaceutical that wins the public tender. In some cases, there are still joint negotiations at a higher level and a common tender based on efficiency and cost, but the trend is towards regional tenders. Nuclear medicine physicians are involved in the tender committee’s decision-making process. In the case of private hospitals, companies approach the purchase managers and based on the radiopharmaceutical forecast provided by the hospital, the company gives a quotation. Cost is the most important driver.

Spain
Public hospitals in Spain purchase radiopharmaceuticals through a tendering process. Generally, tenders are awarded to a single company. Tenders are awarded based on two main criteria: cost, which is the most critical aspect, weighted at 60%, and technical criteria, weighted at 40%. The technical committee can set different criteria to evaluate products, including diagnostic accuracy, number of indications, and supply reliability. Private hospitals purchase through direct negotiations with manufacturers, and cost is the main driver. Price elasticity per vial is limited by this purchasing procedure, but there is no cost ceiling when externalized radiopharmacy services for radiolabeling are needed (i.e., when radiopharmacies provide ready-to-use products).

UK
Public tenders are regionally performed based on integrated care systems distribution. The decision drivers for radiopharmaceutical purchase in the UK are changing. Now, cost accounts for 20-25%, user experience and clinical 30%, and National Institute of Health and Care Excellence guidelines and clinical regulations are the remaining drivers, as prices are similar across radiopharmaceuticals. Decisions are made by a committee normally composed of a radiopharmacist and clinicians that give their perspective on the different products available on the market. Financial agreements, i.e., price-volume agreements, are widely established across the centers that purchase radiopharmaceuticals. The British Nuclear Medicine Society believes that the commissioning and use of radiopharmaceutical in the NHS should be aligned with recently published RCR/RCP PET-CT guidance (2023).⁴

Nordics (Sweden, Norway, and Denmark)

Across the Nordic countries, the funding process is generally related to a national DRG, but in Sweden it is regional. Procurement for all three countries is primarily through tenders. Quality and price are the main drivers for the purchase of radiopharmaceuticals. Other considerations are logistics, image quality, and long half-life.

In Denmark, companies producing commercial products need to meet or exceed the quality and price benchmarks for in-house products, while also providing flexible and efficient delivery solutions. In Norway, better pricing conditions than in-house products are necessary for success. In Sweden, high prices may hamper the adoption of commercial products, so a parity price with other competitors would shift adoption towards innovations.

Baltics (specifically Latvia and Lithuania)

In the Baltics, as with the Nordics, quality and price are the most important factors in funding and purchasing. In general, funding is related to a national DRG. In Lithuania, procurement is primarily through tenders. Commercial products must offer at least the same quality and price as in-house products, and flexible and efficient delivery solutions are key to success. In Latvia, procurement is mainly through direct purchase because the center with nuclear medicine capacity is private. The main driver for commercial products is better pricing conditions than in-house production.

Belgium

Belgium follows many of the same guidelines as the EU4+UK countries with both tender and direct purchase processes. The price of radiopharmaceuticals often surpasses the DRG/tariff, meaning that hospitals must absorb the extra cost and often operate at a loss.

Switzerland

In Switzerland as in Belgium, funding and procurement are similar to the EU4+UK countries. However, the cost of the radiopharmaceutical is billed to insurance companies on top of the tariff established for nuclear medicine techniques.

Conclusion

The procurement of in-house and commercial radiopharmaceuticals differs in several key ways, primarily related to sourcing, costs, regulatory oversight, and supply chain dynamics. In-house production offers lower unit costs (without considering the huge investment in infrastructure and specialized equipment like cyclotrons) but comes with higher operational complexity and potential production constraints (e.g., local production schedule, raw material supply, operational capacity of the facility, cyclotron downtime). Meanwhile, commercial products are more readily available and tend to be more convenient as long as health distributors or direct manufacturers offer efficient customer service, including flexibility on supply guarantee.

Radiopharmaceutical manufacturers need to navigate diverse procurement and funding landscapes across Europe while ensuring consistent supply and competitive pricing. Because the key to competition with in-house production is at the hospital level, they must also build robust relationships with hospitals and procurement bodies to foster the adoption of innovative radiopharmaceutical solutions.

How Can Alira Health Help?

Our team can provide insight into the complex market access issues surrounding radiopharmaceuticals. With a deep understanding of the challenges at national, regional, and hospital levels, we offer vital guidance to companies seeking to bring radiopharmaceutical products to the market. We can accompany you on each step of this complicated development journey.