2/52 MPNE on access to cross-border healthcare and clinical trials
We wrote this as submission on 10th February 2021 as feed-back to the EU Roadmap on Cross-border health
Under Directive 2011/24, EU nationals have the right to seek planned healthcare in another EU country. They can also claim reimbursement for treatment from their national health system or health insurance provider. This evaluation will assess how the EU rules are working, in particular as regards:
giving patients access to safe and high-quality healthcare in another EU country
encouraging cooperation between national healthcare providers, also on rare diseases and European Reference Networks.
This submission reflects our experiences with access to cross-border healthcare within the Melanoma Patient Network Europe as a European Cancer Patient Community, notably access to a) drugs b) medical devices/ procedures c) clinical trials/ CU/ EAP and d) particular challenges for patients with rare Melanomas.
Access to drugs: Since 2011, the approval of 10 new therapies has dramatically improved the survival in advanced Melanoma from 5% at 5 years to a situation where about half of all patients survive long-term. The high price of the products and new modes of actions with unexpected patterns of response with which HTAs struggled led to a high variability in the introduction of these products between countries, with an additional delay for CEE.
Access to medical devices and procedures: Uveal Melanoma predominantly metastasises to the liver, this is the main driver of mortality. Liver-directed treatments (involving medical devices) are not consistently available across Europe, patients pay privately for cross-border access.
Clinical trials and Compassionate Usage: Most countries explicitly exclude clinical trials from their S2 programs. Even those who do offer the possibility (some of the Nordics) have in our experience established administrative hurdles to effectively impede access, such as refusing a trial ‘for lack of evidence’. Due to the common mixed financing model, with the trial sponsor paying for the experimental treatment and all additional procedures and the healthcare system paying the standard procedures, a patient will be liable to pay for the latter, even if these procedures were reimbursed in his home country, in addition to costs for travel and accommodation abroad as most trials only cover limited travel costs. As Compassionate Usage and Early Access Programs are: in strange contrast to a common market authorisation- not centrally regulated, patients are normally unable to access these cross-border, increasing the disparities in access to novel therapies.
Particular challenges for rare cancers: ERNs currently do not show geographic representativeness and resulting in an overall limited access for EU patients. Despite their existence, accessing their services for patients outside their system is difficult to impossible. Rare and ultra-rare conditions, such as spitzoid Melanoma, where already the expertise for a correct diagnosis is rare, would benefit from a European-wide approach.
In our experience, it is only educated and proactive patients with sufficient financial means who are able to access healthcare abroad. Treating oncologists are often unaware of options abroad and actively discourage patients from exploring these. Administrative procedures for pre-planned healthcare are in our experience designed to prevent access as time lines are incompatible with a progressing cancer or require approval/ recommendations by those very physicians whose opinion a patient wants to validate abroad or whose local budgets will be impacted by the decision. Clinical trials represent treatment options for patients who have exhausted all available lines of treatments or for those where no effective standard of care exists, such as most rare Melanomas. Each clinical trial is only ever available in a certain number of countries, in particular if the cancer is rare, making cross-border access to clinical trials particularly important for those patients out of options.
Treatment abroad often requires a considerable upfront deposit that can already be prohibitive for some patients. Only patients who are persistent enough to take on the often deliberately cumbersome administrative procedures have a chance of claiming those costs back from their home country’s insurance, often many months later (and should they still be alive). Cross-border health as it currently stands has no effect on inequality in access to drugs and limited effect on access to medical devices.
To note: we are a network of volunteers, not employees.
Written by BR
Reviewed by GS and VA