Time to reimbursement of novel anticancer drugs in Europe: a case study of seven European countries

Post, H. C.; Schutte, Tim; Oijen, Martijn G.H. van; Laarhoven, Hanneke W.M. van; Hollak, C.E.M.

doi:10.1016/j.esmoop.2023.101208

Cited by 7 publications

(3 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Similar results regarding the Bulgarian market were revealed in previous periods [63,64]. In contrast, Post et al demonstrated a significantly shorter median time for the reimbursement of innovative cancer drugs in Germany, France, the UK, the Netherlands, Belgium, Norway, and Switzerland (407 days) [65]. Parallel to our findings, the authors observed that orphan status was not statistically associated with accelerated access.…”

Section: Discussionsupporting

confidence: 90%

Availability and Access to Orphan Drugs for Rare Cancers in Bulgaria: Analysis of Delays and Public Expenditures

Kostadinov,

Popova-Sotirova,

Marinova

et al. 2024

Cancers

View full text Add to dashboard Cite

Rare cancers are defined by an annual incidence of fewer than 6 per 100,000. Bearing similarities to rare diseases, they are associated with substantial health inequalities due to diagnostic complexity and delayed access to innovative therapies. This situation is further aggravated in Southeastern European countries like Bulgaria, where limited public resources and expertise underscore the need for additional policy and translational research on rare cancers. This study aimed to explore the availability and access to orphan drugs for rare cancers in Bulgaria for the period of 2020–2023. We cross-compared data from both the European Union and national public sources to evaluate the number of available and accessible orphan drugs for rare cancers, the delay from market authorization to reimbursement, the dynamics of public expenditures, and regional disparities in access across the country. We juxtaposed the main characteristics of oncological and non-oncological orphan drugs as well. Only 15 out of 50 oncological orphan drugs that were authorized by the European Medicine Agency were accessible for rare cancer patients in Bulgaria. The median delay between market authorization and inclusion in the Bulgarian Positive Drug List was 760 days. The total expenditures for all orphan drugs for rare cancers amounted to EUR 74,353,493 from 2020 to 2023. The budgetary impact of this group rose from 0.24% to 3.77% of total public medicinal product expenditures for the study period. Rare cancer patients represent a vulnerable population that often faces limited to no access to treatment. We call for targeted European and national policies to address this major inequality.

show abstract

Section: Discussionsupporting

confidence: 90%

Availability and Access to Orphan Drugs for Rare Cancers in Bulgaria: Analysis of Delays and Public Expenditures

Kostadinov,

Popova-Sotirova,

Marinova

et al. 2024

Cancers

View full text Add to dashboard Cite

show abstract

“…However, R&D costs are not transparent and traceable enough, there are no clear rules on how to consider the amount of effort done up to the P&R decision (especially in early approvals) nor on how different countries must bear and share the burden of such investment returns. Consequently, a variation in pricing, funding decisions, and time to reimbursement for innovative medicines, which encompasses OMPs, ATPMs, and anticancer drugs, across European countries has been described ( Martinalbo et al, 2016 ; Szegedi et al, 2018 ; Cufer et al, 2020 ; Iglesias-Lopez et al, 2022 ; Post et al, 2023 ). This fuels disparities in patient access to these medicines throughout the diverse European countries.…”

Section: Uncertainty and Consequences Of Access To Innovative Medicin...mentioning

confidence: 99%

The challenges of access to innovative medicines with limited evidence in the European Union

Vallano,

Pontes,

Agustí

2023

Front. Pharmacol.

View full text Add to dashboard Cite

The European Medicines Agency (EMA) fosters access to innovative medicines through accelerated procedures and flexibility in the authorization requirements for diseases with unmet medical needs, such as many rare diseases as well as oncological diseases. However, the resulting increase of medicines being marketed with conditional authorizations and in exceptional circumstances has lead to higher clinical uncertainty about their efficacy and safety than when the standard authorizations are applied. This uncertainty has significant implications for clinical practice and the negotiation of pricing and reimbursement, particularly as high prices are based on assumptions of high value, supported by regulatory prioritization. The burden of clinical development is often shifted towards public healthcare systems, resulting in increased spending budgets and opportunity costs. Effective management of uncertainty, through appropriate testing and evaluation, and fair reflection of costs and risks in prices, is crucial. However, it is important not to sacrifice essential elements of evidence-based healthcare for the sake of access to new treatments. Balancing sensitive and rational access to new treatments, ensuring their safety, efficacy, and affordability to healthcare systems requires thoughtful decision-making. Ultimately, a responsible approach to timely access to innovative medicines that balances the needs of patients with healthcare systems’ concerns is necessary. This approach emphasizes the importance of evidence-based decision-making and fair pricing and reimbursement.

show abstract

“…This reflects variations in reimbursement rates, with 64% of indications being reimbursed in Czechia, 40% in Hungary, 51% in Poland, and 19% in Slovakia. The increasing expenditure on cancer drugs in Europe has made it progressively challenging to provide access where resources are low, necessitating a prioritized approach to ensure access [13][14][15].…”

Section: Introductionmentioning

confidence: 99%

Demographic Analysis of Cancer Research Priorities and Treatment Correlations

Horgan,

Van den Bulcke,

Malapelle

et al. 2024

Current Oncology

View full text Add to dashboard Cite

Understanding the diversity in cancer research priorities and the correlations among different treatment modalities is essential to address the evolving landscape of oncology. This study, conducted in collaboration with the European Cancer Patient Coalition (ECPC) and Childhood Cancer International-Europe (CCI-E) as part of the “UNCAN.eu” initiative, analyzed data from a comprehensive survey to explore the complex interplay of demographics, time since cancer diagnosis, and types of treatments received. Demographic analysis revealed intriguing trends, highlighting the importance of tailoring cancer research efforts to specific age groups and genders. Individuals aged 45–69 exhibited highly aligned research priorities, emphasizing the need to address the unique concerns of middle-aged and older populations. In contrast, patients over 70 years demonstrated a divergence in research priorities, underscoring the importance of recognising the distinct needs of older individuals in cancer research. The analysis of correlations among different types of cancer treatments underscored the multidisciplinary approach to cancer care, with surgery, radiotherapy, chemotherapy, precision therapy, and biological therapies playing integral roles. These findings support the need for personalized and combined treatment strategies to achieve optimal outcomes. In conclusion, this study provides valuable insights into the complexity of cancer research priorities and treatment correlations in a European context. It emphasizes the importance of a multifaceted, patient-centred approach to cancer research and treatment, highlighting the need for ongoing support, adaptation, and collaboration to address the ever-changing landscape of oncology.

show abstract

Time to reimbursement of novel anticancer drugs in Europe: a case study of seven European countries

Cited by 7 publications

References 31 publications

Availability and Access to Orphan Drugs for Rare Cancers in Bulgaria: Analysis of Delays and Public Expenditures

Availability and Access to Orphan Drugs for Rare Cancers in Bulgaria: Analysis of Delays and Public Expenditures

The challenges of access to innovative medicines with limited evidence in the European Union

Demographic Analysis of Cancer Research Priorities and Treatment Correlations

Contact Info

Product

Resources

About