We live in an era of unprecedented innovation for people living with cancer. Yet, there is no value from innovation if patients for whom it is intended, cannot have access to it. The “Every Day Counts” report shows that tremendous differences exist in patient access to innovative oncology treatments across European countries. There are ten reasons explaining why many patients tend to have longer waiting times than needed to access new cancer medicines.
Behind the numbers are real people waiting for access to treatments that could improve, prolong or save their or their loved-ones’ lives. For them, every day counts. Accelerating time to patient access is critical if we are to beat cancer in Europe.
How can we improve time to patient access?
We share the goal of fast, equitable and sustainable access to treatments and recognise the disparities and delays in access for patients across Europe. Addressing these issues requires a shared, evidence-based understanding of the root causes of barriers and delays in access to treatments. All stakeholders have a role to play in realising these objectives and no one can solve these challenges alone.
We need a collaborative approach now. Because for patients, every day counts.
A once-in-a-generation opportunity to optimise regulatory timelines to improve time to patient access
“Every Day Counts: Improving Regulatory Timelines to Optimise Patient Access to Innovative Oncology Therapies in Europe” concentrates on the final stage of marketing authorisation: the administrative process between the final opinion of the Committee for Medicinal Products for Human Use (CHMP) and the final decision of the European Commission.
With a maximum official duration of 67 days (and a range of 33-198 days in practice), this administrative process represents only a small part of a medicine’s journey, but nevertheless an important opportunity for improvement. During the COVID-19 pandemic, it was expedited to less than one day for COVID-19-related vaccines. This suggests it is possible to shorten timelines for other approvals significantly, without affecting the quality and rigor of scientific review.
Three potential solutions to optimise regulatory timelines
Several strategic options and concrete solutions were considered to improve the process between CHMP opinion and EC decision. When considering the impact and feasibility of solutions, the following potential solutions were prioritised, noting that these could be used in combination:
- Conduct the decision-making phase in parallel to the linguistic phase, thereby allowing Marketing Authorisation to be granted 12 days earlier
- Increase the use of digital tools during the linguistic phase, which could shorten this phase by 10 days
- Provide an opportunity to shorten the written procedure in cases where Member States foresee no objections, thereby shortening the decision-making phase by 15 days
The COVID-19 pandemic has hit every aspect of cancer care, putting patients at higher risk of poor outcomes. Despite the challenges, there have been some positive features of Europe’s response to the pandemic, including the adoption of digital health and greater agility in the development and approval of innovative solutions.
Stakeholders have identified six recommendations which can make cancer care delivery more resilient to disruptions and more sustainable in the post-pandemic world.
6 ways to improve access to cancer care
- Clear the cancer backlog now, using innovative practices which emerged during the pandemic
- Maintain the proven agility of R&D and Marketing Authorisation processes
- Continue the intensified European collaboration in clinical assessment to use HTA resources more efficiently after the pandemic
- Continue the adoption of digital health to increase remote care and use healthcare resources more efficiently after the pandemic
- Maintain and build adaptive surge capacity to be ready for future disruptions to cancer care
- Safeguard cancer budgets as a critical enabler for improving continuity, efficiency, and sustainability of cancer care