The positioning paper follows a report published by the Alliance for Regenerative Medicine (ARM) in July 2019, titled ‘Getting ready: Recommendations for Timely Access to Advanced Therapy Medicinal Products (ATMPs) in Europe’.
With that initial report, the organization called on stakeholders to take action towards four objectives, in order “to create a fair and equitable environment for patient access to ATMPs.”
These actions included adaptation of Health Technology Assessment (HTA) frameworks to ATMPs; encouragement of conditional reimbursement schemes; development of pan-European initiatives; and use of ‘innovative’ payment schemes, such as pay-for-performance, annuity payments, and special funds for transformative treatments.
Later in 2019, Annie Hubert, senior director of European Public Policy for ARM, attended the UK Bioscience forum to talk about ‘Overcoming the barriers to cell and gene therapies’.
At the time, Hubert told BioPharma-Reporter that ATMPs ‘form a new ground’ for all stakeholders and the European healthcare systems, due to the complexity of manufacturing and administration.
The current landscape
In its latest report, ARM highlights the main challenges that the European market has yet to overcome in order “to ensure all European patients can secure access to ATMPs, irrespective of their country or region of origin.”
These challenges include:
- Not all approved ATMPs are expected to be made available to all countries in Europe or to all regions of a given country
- The legal frameworks that grant the right to cross-border healthcare for patients in Europe are not optimal for ATMP treatments
- The lack of HTA/pricing assessment in the patient’s country of origin and regional budgets or multiple payers/insurers in some countries can constitute barriers to cross-border or cross-region treatment with ATMPs
- Subsequently, the organization cites three key recommendations addressed, respectively to all stakeholders involved, including marketing authorization holders, payers and treatment centers.
The first recommendation is the establishment of a ‘one-stop shop’ ATMP coordination body at European Union/European Economic Area level. This body would act as a ‘broker’ between the different stakeholders and facilitate cross-border patient treatment and funding.
Additionally, ARM suggests the creation of ‘one-stop shop’ coordination bodies in countries with regional funding or with multiple payers/insurers to ensure authorities in the regions of treatment are compensated for the costs of treating patients from other regions.
Finally, the organization highlights the importance of fostering more effective coordination of HTA activities to “ensure greater alignment within Europe on product value assessment measures.”
As additional recommended measures to facilitate industry engagement in existing initiatives, ARM also cites the improvement of opportunities for cross-country collaboration, removing duplicative processes at national level, and adopting policy principles to enhance cross-country collaboration.