Reimbursement: The True Bottleneck for Radioligand Therapies in Europe…?

Radioligand therapies (RLTs) represent a groundbreaking advancement in oncology, offering highly targeted treatment for various cancers, including prostate and neuroendocrine tumors. These innovative therapies hold immense promise, delivering precise radiation directly to cancer cells while minimizing harm to healthy tissue. A core innovation within RLT lies in the concept of theranostics, which combines diagnostic and therapeutic capabilities in a single molecular entity or paired agents. This allows for personalized treatment strategies tailored to individual patient responses and the specific molecular profile of their cancer, representing a significant advancement in precision medicine. The market for these therapies is experiencing substantial growth, with projections indicating global market size could reach over $35 billion by 2034. Companies like Telix Pharmaceuticals, ITM Isotope Technologies Munich, Curium Pharma, Eckert & Ziegler, SHINE Technologies, Novartis, Bayer, Cardinal Health, and Trasis are making significant investments in production capacity and infrastructure across Europe.

However, despite advancements in isotope supply, EMA approvals, and even hospital readiness, a critical bottleneck is severely limiting patient access to these life-saving treatments in Europe: reimbursement. As the EMA’s 2025 steering group highlighted, “Access to radiopharmaceuticals remains uneven across Member States due to fragmented reimbursement systems and the lack of harmonised regulatory pathways.”

This article will delve into the complexities of radiopharmaceutical reimbursement in the EU, contrasting it with the more centralized US system, and explore the multifaceted challenges faced by biotech companies and hospitals, ultimately proposing pathways forward.

The Inherent Complexity of Radioligand Therapies and its Impact on Reimbursement

RLTs, while clinically transformative, possess unique characteristics that inherently complicate their market access and reimbursement pathways, particularly within the EU’s diverse healthcare landscape.

Firstly, their high cost is a significant barrier. A single treatment episode for metastatic prostate cancer using RLT can range from approximately $95,000 in the EU to over $200,000 in the US. These costs are driven by sophisticated manufacturing processes and stringent regulatory requirements for radiopharmaceuticals.

Secondly, the manufacturing and supply chain for radiopharmaceuticals are exceptionally complex. The extremely short half-lives of the radionuclides involved (e.g., Fluorine-18 with a half-life of 1.8 hours, Gallium-68 with 68 minutes, Technetium-99m with 6 hours) often necessitate production just hours before patient administration. This demands a highly specialized, just-in-time infrastructure for handling, production, and distribution, making the supply chain vulnerable to even minor fluctuations or delays. Any protracted reimbursement process directly exacerbates this issue, as the product may literally decay before it can be widely distributed.

Lastly, the administration of RLTs is highly specialized, typically occurring in hospitals and dedicated oncology clinics that possess the requisite infrastructure and expert personnel. This concentration of expertise and facilities inherently limits the number of accessible treatment centers.

The “precision medicine” nature of RLTs, while a significant clinical advantage, paradoxically contributes to market access challenges. RLTs focus on personalized treatment, often implying smaller patient cohorts for clinical trials. This can lead to “highly limited data” for regulatory bodies and HTA agencies compared to traditional pharmaceuticals. This limited, yet highly specific, clinical evidence makes it challenging to fit RLTs into conventional HTA models that typically seek broad, generalizable cost-effectiveness data for large patient populations. Furthermore, RLTs are often associated with a “single upfront payment, despite benefits extending many years into the future,” fundamentally altering the value assessment framework. This creates a disconnect between the scientific innovation of personalized medicine and the existing market access infrastructure, resulting in friction and delays in reimbursement.

The Fragmented European Landscape: A “Postcode Lottery” for Patients

The core issue in Europe stems from the decentralized nature of healthcare decision-making. While the European Medicines Agency (EMA) grants a single marketing authorization valid across all EU Member States, the crucial step of reimbursement is determined at the national, and sometimes even regional or local, level. This creates a “centralized authorization, national reimbursement” paradox, forcing pharmaceutical manufacturers to navigate “multiple systems, increasing administrative burdens and costs.” This structural disconnect undermines the EU’s stated objectives of facilitating “faster and wider access to innovative health technologies” and ensuring “equity of access and solidarity across EU member states.” The consequence is a fragmented landscape where patient access is often determined by geographical location and national healthcare budgets, rather than by medical need.

This fragmentation leads to vast disparities in Health Technology Assessment (HTA) frameworks and pricing policies across member states. For example, while 98% of new cancer medicines were available in Germany between 2018 and 2021, only 2% were accessible in Malta, with the overall European average standing at a mere 50%. The time to market access after EMA authorization can range from a swift 86 days to a protracted nearly 1,000 days in some Member States.

Divergent HTA Frameworks and Value Perception

National HTA bodies, such as Germany’s Gemeinsamer Bundesausschuss (G-BA), France’s Haute Autorité de santé (HAS), Italy’s Agenzia Italiana del Farmaco (AIFA), and Spain’s Red de Agencias de Evaluación de Tecnologías Sanitarias (RedETS)/Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), retain significant autonomy over economic assessments and final reimbursement decisions, even with the new EU HTA Regulation (HTAR) applicable from January 12, 2025, for oncology products and Advanced Therapy Medicinal Products (ATMPs) that encompass RLTs. While the HTAR aims to streamline joint clinical assessments (JCAs), the deeper, more subjective national differences in value perception and economic evaluation remain critical for final reimbursement decisions.

• • Germany (G-BA): Focuses on determining an “additional benefit” (Zusatznutzen) based on efficacy, safety, or quality of life improvements. This assessment influences subsequent price negotiations. Crucially, Germany allows for initial 100% reimbursement from the day of launch, with price scrutiny and negotiation occurring after one year under the AMNOG process. This “no fourth hurdle” approach facilitates rapid initial market entry but shifts pricing pressure to post-launch negotiations. The recent “Medical Research Act” passed in July 2024 further introduces the concept of “confidential reimbursement prices” and offers pricing incentives for companies that conduct a “relevant part” of their clinical trials in Germany, subtly intertwining local R&D with pricing.

• • France (HAS): Assesses “Actual Benefit” (Service Médical Rendu – SMR) and “clinical added value” (Amélioration du Service Médical Rendu – ASMR). The ASMR level directly influences the reimbursement rate and the potential for a higher price, creating an upfront linkage of clinical value to price.

• • Italy (AIFA): Assesses “therapeutic need, added therapeutic value, and robustness of scientific evidence.” Despite recent reforms to streamline processes, Italy has historically experienced prolonged pricing and reimbursement negotiation times, averaging 395 days for centrally approved medicines.

• • Spain (RedETS/AEMPS): The HTA process has faced criticism for a perceived lack of transparency and a misalignment between HTA reports and final reimbursement decisions. Budget impact often overrides innovation criteria, and the innovation criterion has not been consistently used to support reimbursement decisions.

This divergence means biotech companies cannot simply rely on a single, EU-wide clinical dossier; they must tailor economic and societal value arguments to each national context, often requiring additional real-world evidence (RWE). The varying acceptance of RWE, with UK and Spanish HTA bodies generally more receptive than their French and German counterparts, adds another layer of complexity to evidence generation. This perpetuates fragmentation and uncertainty for RLTs, which often have high upfront costs and long-term benefits that current value frameworks struggle to capture adequately.

Country	Primary HTA Body	Key Assessment Concept	Key Criteria Considered	RWE Acceptance (General)	Impact on Price/Reimbursement	Initial Reimbursement Status
Germany	G-BA	Additional Benefit (Zusatznutzen)	Efficacy, Safety, Quality of Life, Comparator identification	Less accepting (for efficacy claims)	Price linked to benefit level (post-launch negotiation), influenced by local R&D	100% from launch
France	HAS	Actual Benefit (SMR) & Clinical Added Value (ASMR)	Disease severity, Clinical efficacy/safety, Drug aim, Therapeutic strategy, Public health interest, Comparator identification	Less accepting (for efficacy claims)	Reimbursement rate and price linked to ASMR level	Post-HTA decision
Italy	AIFA (CSE)	Therapeutic Need, Added Therapeutic Value, Robustness of Scientific Evidence	Efficacy, Safety, Therapeutic need, Added therapeutic value, Robustness of scientific evidence, Price negotiation	More receptive (for ATMPs generally)	Price negotiation based on innovation/evidence	Post-HTA decision
Spain	RedETS/AEMPS	Value, Budget Impact, Transparency	Severity, Therapeutic value (clinical & cost-effectiveness), Budget impact, Availability of cheaper alternatives, Innovation (not consistently used)	More receptive	Budget impact/cheaper alternatives often override HTA	Post-HTA decision

Pricing Mechanisms and Payer Negotiations

Beyond HTAs, national governments in the EU increasingly implement various pricing mechanisms, such as price caps and reference pricing systems, significantly limiting profit margins. The “no fourth hurdle” approach in Germany, while accelerating initial market entry, shifts pricing pressure to post-launch negotiations, creating uncertainty for long-term revenue. The AMNOG process can lead to substantial price reductions or discounts if the perceived benefit is not considered significant, or if local R&D activities are not adequately demonstrated, compelling companies to continuously demonstrate value. In contrast, France’s ASMR rating directly influences pricing upfront.

The Bottleneck Effect: Delays in Pricing and Tariff Approvals

One of the most impactful barriers to RLT reimbursement in the EU is the significant and often unpredictable delays in pricing and tariff approvals. The average time to reimbursement for innovative treatments across EU and EEA countries is a prolonged 504 days, meaning that even after EMA marketing authorization, actual patient availability can be delayed by well over a year. This contrasts sharply with a median time to reimbursement of just 3 days in Germany for new anticancer medicines, while France recorded 142 days and the UK 265 days. These extended timelines directly translate to prolonged patient suffering and missed opportunities for early intervention.

Multifactorial Causes of Delays

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has identified ten interrelated factors contributing to the unavailability and delays of innovative medicines in the EU, deeply rooted in national access systems:

• • Slow Regulatory Process: The European regulatory process for marketing authorization has been observed to be slower compared to some international counterparts, particularly the US.

• • Late Initiation of Market Access Assessment: In many countries, the reimbursement process does not automatically commence after EMA marketing authorization. Some member states wait for formal EMA decisions or even for reimbursement decisions in other countries before initiating their own national assessment.

• • Duplicative Evidence Requirements: Varying and often overlapping evidence requirements across countries necessitate the generation of country-specific evidence, prolonging discussions and decision-making processes for manufacturers.

• • Complex National Negotiation Procedures: Pricing negotiations are frequently protracted due to national budget limitations and intricate approval processes. The lack of a harmonized EU approach means manufacturers must navigate multiple, often opaque, systems.

• • Ineffective Transparency Directive: The EU Council Directive 89/105/EEC, intended to limit national pricing and reimbursement decision times to a maximum of 180 days, is largely ineffective in practice. The significant discrepancy between the mandated 180-day deadline and the actual average TTR of 504 days, with many countries far exceeding this limit, points to a systemic failure of EU-level policy to enforce timely national access. Member states frequently utilize “clock stops” and other mechanisms to extend timelines, driven by the complexity of national processes, duplicative evidence demands, and budget limitations.

This systemic failure to enforce timely access creates a significant disincentive for manufacturers to launch products in all EU markets, especially smaller or less affluent ones, exacerbating access inequalities.

Country	Median Time to Reimbursement (Days)	Compliance with EU Transparency Directive (180 days) [% of medicines meeting deadline]
Germany	3	100%
France	142	51%
United Kingdom	265	29%
The Netherlands	345	29%
Norway	628	6%
Switzerland	689	14%
Belgium	742	3%
Poland	>823	Not specified, but implied low
Romania	>883	Not specified, but implied low

Navigating the Labyrinth: Challenges for Biotech Companies

Biotech companies developing and commercializing RLTs face a unique set of challenges in the EU, stemming from the high costs of these advanced therapies, the complexities of their manufacturing, and the fragmented market access landscape.

High Treatment Costs and Limited Reimbursement Coverage

The inherently high cost of RLTs represents a formidable barrier to their widespread adoption. Consequently, limited reimbursement coverage in certain regions directly restricts market access, as payers and HTA bodies demand robust cost-effectiveness data. This creates a “chicken-and-egg” problem: widespread adoption is necessary to potentially drive down unit costs through economies of scale, but limited reimbursement coverage hinders this adoption. The high upfront costs make payers hesitant, leading to lower patient uptake and smaller market volumes, making it difficult for biotech companies to recoup their significant R&D and manufacturing investments. This in turn creates a difficult investment environment, potentially leading companies to prioritize markets with more favorable and predictable reimbursement landscapes, such as the US.

Complex Manufacturing and Supply Chain Hurdles

Radiopharmaceuticals are characterized by exceptionally complex manufacturing processes. A critical and unique challenge is the extremely short half-life of the radionuclides, which often necessitates their production just hours before patient administration, demanding a highly specialized infrastructure and exceptionally precise logistics. The supply chain is inherently complex and vulnerable, relying heavily on stable isotopes and materials often sourced from third countries, leading to dependencies and occasional shortages. A protracted reimbursement process means the product may literally decay before it can be widely distributed and administered. This places immense pressure on biotech companies, necessitating significant upfront investment in a supply chain that may not be immediately profitable due to reimbursement delays.

Evidence Generation and HTA Submission Strategies

Biotech companies are required to submit extensive comparative evidence to HTA bodies. While the new HTAR aims to streamline this through Joint Clinical Assessments (JCAs), national HTA bodies still retain significant autonomy over final economic assessments and reimbursement decisions. A significant challenge for RLTs, particularly as Advanced Therapy Medicinal Products (ATMPs), lies in demonstrating their long-term value. Existing value frameworks often focus on traditional metrics, potentially overlooking broader societal benefits. Real-world evidence (RWE) is increasingly accepted, but its acceptance criteria are often unclear, necessitating significant investment in health economics and outcomes research (HEOR) capabilities, further delaying market access and increasing costs.

Market Access Strategies and Innovative Payment Models

To address high upfront costs, biotech companies are exploring innovative payment models like outcomes-based agreements (where payment is linked to patient outcomes) and annuity payments (spreading costs over time). These aim to share financial risk. However, their successful implementation is hampered by the lack of harmonized legal and accounting frameworks across the EU, forcing bespoke, country-by-country negotiations. This fragmentation hinders the scalability of innovative payment models, which are otherwise vital for high-cost, single-administration therapies like RLTs. The growing interest in RLTs is also evident in the pharmaceutical industry, with large pharmaceutical companies increasingly acquiring smaller biotechs specializing in this field, suggesting a strategic move to leverage greater resources to navigate complex market access pathways and scale production.

On the Frontline: Challenges Faced by Hospitals

Hospitals, as the primary points of administration for RLTs, face their own set of operational and financial challenges that directly impede consistent patient access to these therapies across the EU.

Infrastructure and Capacity Deficiencies

European healthcare systems are currently “not yet prepared” for the anticipated significant increase in RLT patient numbers, particularly for prostate cancer, which has a much higher incidence. There is a demonstrable insufficiency of treatment capacity in nuclear medicine therapy wards, necessitating substantial investments in radio-protected facilities and waste management. Furthermore, limited access to essential diagnostic imaging, such as Gallium-68 (Ga-68) PSMA PET-CT scans, creates critical bottlenecks. The rapid clinical advancement and EMA approval of RLTs are outpacing the physical and financial capacity of EU hospital infrastructure, creating a significant “readiness gap.” This infrastructure deficit directly translates into limited patient access, regional disparities, and longer waiting times.

Workforce Shortages and Training Gaps

A critical human capital bottleneck exists due to the highly specialized nature of RLTs. There is a significant shortage of specialized healthcare professionals, including medical doctors (PET/CT, PET/MRI, radiopharmaceutical administration), skilled nursing staff, medical physicists, and radiation protection operators. The lack of standardized training and curricula across the EU further exacerbates this issue. This directly restricts the number of patients that can be treated and the overall expansion of RLT services, even in hospitals with adequate physical infrastructure, contributing to regional disparities and prolonged treatment initiation.

Reimbursement for Administration and Associated Costs

Hospitals face a significant challenge in securing comprehensive and consistent reimbursement for the entire RLT care pathway, which extends beyond the cost of the radiopharmaceutical itself to include administration, imaging, dosimetry, and waste management. In some cases, current healthcare insurance claims do not fully cover these associated costs. For example, a study in the Netherlands found that hospitals had to cover a portion of the costs for 177Lu-PSMA-I&T treatment from their own budgets. Without a clear pathway to recoup the investment into new infrastructure and ongoing operational costs, hospitals may be reluctant to expand or initiate RLT programs.

Cross-Border Access Challenges for Patients

Despite the EU’s foundational principle of freedom of movement and directives aimed at facilitating cross-border healthcare (e.g., Cross-border Healthcare Directive 2011/24/EU), consistent patient access to RLTs across borders remains a significant practical challenge.

• • Prior Authorization Requirements: While the Directive aims to avoid prior authorization, Member States may subject reimbursement of costs for care involving overnight hospital stays or highly specialized, costly infrastructure to prior authorization. Such requirements, though intended to be proportionate, can act as restrictions and lead to delays or refusals.

• • Upfront Payment Burden: For high-cost therapies like RLTs, patients are often required to pay for the treatment upfront and then seek reimbursement from their home country. This is often not feasible for the substantial costs associated with ATMPs and RLTs.

• • Reimbursement Discrepancies: Reimbursement is typically capped at the cost that would have been assumed by the patient’s home Member State, which can lead to reduced reimbursement if the cost in the treatment country is higher, or if the therapy is not included in the “basket of care” in the home country.

• • Administrative Complexity and Information Gaps: Patients face significant administrative burdens in navigating different reimbursement mechanisms and documentation requirements, despite National Contact Points.

• • Logistical and Language Barriers: Travel and accommodation costs are generally not reimbursed, and language differences can be crucial factors.

• • Limited Data Sharing: Cross-border data sharing is complicated by varying privacy laws and the lack of interoperable digital health systems.

These challenges mean that while cross-border access to RLTs is theoretically possible, it is often complex, financially burdensome, and administratively demanding, limiting equitable access.

The US vs. EU Reimbursement Landscape: A Tale of Two Systems

The United States and the European Union present fundamentally different approaches to healthcare funding and market access for radiopharmaceuticals.

United States: Centralized Influence, Evolving Payment Models

The US operates a more market-driven healthcare system, where the Centers for Medicare & Medicaid Services (CMS) significantly influences reimbursement policies for its beneficiaries, often setting precedents for private payers. CMS’s decisions effectively serve as a market shaper.

A notable recent development, effective January 1, 2025, is CMS’s pivotal shift in the Hospital Outpatient Prospective Payment System (HOPPS) to unbundle and separately pay for high-cost diagnostic radiopharmaceuticals (those exceeding $630 per day). This policy aims to mitigate historical financial disincentives that hindered the adoption of innovative diagnostic agents. Previously, these were “packaged” within the payment for the associated procedure, making expensive diagnostics unprofitable. This unbundling is a direct response to longstanding advocacy and is expected to expand patient access and encourage R&D.

For therapeutic radiopharmaceuticals, such as Pluvicto (Lutetium-177), the US has seen a transition from initial generic billing codes (e.g., A9699) to more specific ones (e.g., A9607). While Pluvicto currently benefits from Transitional Pass-Through status (expiring September 2025), ensuring separate payment, the long-term strategy beyond this period will be critical. The US market generally allows for higher list prices for pharmaceuticals, as direct national price negotiation is less common.

The US regulatory landscape also includes the dual oversight of the FDA for drug efficacy/safety and the Nuclear Regulatory Commission (NRC) for radiation safety and material handling. This adds an additional layer of complexity and can extend development timelines due to specialized facility requirements.

European Union: Fragmented National Systems, Cost Containment Focus

In contrast, the European Union is characterized by its mosaic of national health systems, each with its own HTA bodies and distinct reimbursement rules. This leads to significant fragmentation where access can vary hospital by hospital, even for EMA-approved therapies.

• • Decentralized Reimbursement: Despite a single EMA marketing authorization, each of the 27 EU Member States retains autonomy over crucial pricing, reimbursement, and health economic decisions. This results in wide disparities in HTA frameworks and pricing policies.

• • Managed Entry Agreements (MEAs): European payment models are characterized by a strong emphasis on value-based assessments and risk-sharing agreements to manage the high costs and inherent clinical uncertainties of innovative radiopharmaceuticals within constrained national budgets. MEAs, including Outcome-Based Spread Payments (OBSPs) where payments are linked to actual outcomes, are widely utilized. This contrasts with the US where direct price negotiation is less common. The significantly lower prices of RLTs in the EU compared to the US (e.g., a single dose of Pluvicto in Germany can be $10,000-$25,000, vs. $52,000 in the US) reflect this emphasis on cost control.

• • Early Access Programs: For established therapies like Lu-177 (Pluvicto), market entry often involved early access or compassionate use programs, followed by rigorous national HTA evaluations.

• • Diverse Coding Systems: The EU lacks a single, harmonized coding system. Countries like Germany (OPS), France (CCAM), and the UK (HRG) utilize their own national coding systems, which are deeply integrated into their respective funding mechanisms. This administrative burden complicates cross-border operations for manufacturers.

For next-gen isotopes like Actinium-225 (Ac-225) or Terbium-161 (Tb-161), the situation gets even murkier in both regions. While these emerging therapies are predominantly in clinical development, the global shortage and scalability of the radioisotope supply chain currently represent a more immediate challenge to widespread patient access than regulatory approval or reimbursement pathways themselves. However, in Europe, the fragmented reimbursement landscape exacerbates this issue, meaning that even once supply is stable, the national barriers will remain.

Overcoming Barriers: Emerging Solutions and Policy Initiatives

Addressing the multifaceted barriers to RLT reimbursement and access in the EU requires a concerted, multi-stakeholder effort.

The EU HTA Regulation (HTAR): A Step, Not a Solution

The EU HTA Regulation (HTAR), applicable from January 12, 2025, for oncology products and ATMPs, represents a significant step towards streamlining joint clinical assessments (JCAs) and joint scientific consultations (JSCs). This aims to reduce duplication of clinical evidence generation across Member States. However, the HTAR’s scope is primarily limited to clinical assessments, explicitly preserving the autonomy of national authorities concerning pricing, reimbursement, and other non-clinical dimensions of HTA. This means that while clinical evidence may be jointly assessed, the crucial decisions of “at what cost” and “how will we pay for it” remain fragmented, requiring continued national economic analyses.

Innovative Payment Models and Contracting

Innovative payment models like outcomes-based agreements and annuity payments are gaining traction to address high upfront costs. These aim to share risk between manufacturers and payers, linking payment to actual patient outcomes. However, the successful implementation of these models is hampered by a lack of harmonized legal and accounting frameworks across the EU, forcing bespoke, country-by-country negotiations. This absence of a unified EU framework for novel contracting mechanisms adds significant administrative burden, legal costs, and further delays market entry.

Supply Chain Resilience and Collaboration

Recognizing the critical importance of radiopharmaceuticals and their inherent vulnerabilities, the EMA and Heads of Medicines Agencies (HMA) have issued recommendations to bolster the radiopharmaceutical supply chain. These emphasize increasing the EU’s domestic production capabilities, improving aging infrastructure, and enhancing existing production facilities. Initiatives like the European Observatory on the Supply of Medical Radioisotopes and the European Radioisotopes Valley Initiative (ERVI) are crucial. This proactive approach, including the consideration of industrial policy measures like the Critical Medicines Act, acknowledges that regulatory tools alone are insufficient without a robust and secure supply chain.

Addressing Infrastructure and Workforce Gaps

To prepare European healthcare systems for the increasing uptake of RLTs, significant investment in hospital infrastructure (radio-protected facilities, waste management) and workforce development is essential. The EU’s “Europe’s Beating Cancer Plan” and “Cancer Mission” aim to integrate innovative treatments. EU funding instruments like the EU4Health Programme (€5+ billion for 2021-2027) and EU Cohesion Policy funds are available to support these structural reforms. Addressing workforce shortages requires long-term strategic planning, investment in education, and standardized training for specialized nuclear medicine professionals.

Enhancing Cross-Border Collaboration

While cross-border patient access faces significant practical and administrative hurdles, efforts are being made to enhance collaboration. European Reference Networks (ERNs) serve as hubs for research and expertise exchange, particularly for rare and complex diseases. Further measures include improving information provision through National Contact Points and streamlining administrative procedures for prior authorization and reimbursement requests. Discussions are also ongoing regarding the potential for EU joint procurement mechanisms for medical countermeasures, which could include radiopharmaceuticals, to improve security of supply and accessibility, though their routine application is currently limited.

Conclusion: Health System Readiness is the New Frontier

The economic imperative for radiopharmaceutical therapies in Europe is clear: while production capacity is expanding and innovative breakthroughs are on the horizon, reimbursement has emerged as the bigger threat to patient access. The fundamental disconnect between centralized EMA marketing authorization and decentralized national reimbursement decisions creates a “postcode lottery” for patients, where access is dictated by geography and national fiscal capacity rather than medical need.

The substantial delays in pricing and tariff approvals, rooted in slow regulatory processes, duplicative evidence requirements, and complex national negotiations, are a critical bottleneck. The ineffectiveness of the EU Transparency Directive in enforcing timely national decisions underscores a systemic policy gap. For biotech companies, the high costs, complex supply chains, and fragmented value assessment necessitate a resource-intensive, bespoke strategy for each market. Hospitals grapple with critical infrastructure and workforce deficiencies, and current reimbursement models often fail to comprehensively cover the full costs associated with RLT administration.

Ultimately, realizing the full potential of RLTs in the EU requires a paradigm shift towards greater harmonization and collaboration across all stakeholders. It isn’t just about isotope supply anymore; it is very much about health system readiness. Future efforts must focus on developing more flexible and harmonized pricing and reimbursement frameworks, investing strategically in healthcare infrastructure and specialized workforce development, and strengthening the resilience of the radiopharmaceutical supply chain. Only through coordinated policy reforms and sustained multi-stakeholder engagement can the EU ensure equitable and timely access to these life-saving therapies for all its citizens.

The question then becomes: What’s the fastest path forward? Is the issue being fixed? While steps are being taken, a fundamental and unified commitment to overcoming these reimbursement hurdles is paramount to ensure that the promise of radioligand therapies translates into tangible patient access across the entire European Union.

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