91 Acting early on NCDs The Partnership for Health System Sustainability and ResilienceJapan’s experience illustrates that whilst achieving remarkably efficient drug approval timelines averaging 73 days from approval to reimbursement compared to 120 days in Germany, and 527 days in France, 72.4% of medications approved in the US and Europe remained unavailable to Japanese patients between 2016–2020 (Yoshida, 2022; Bujar & McAuslane, 2020). Moreover, the number of unapproved anticancer drugs doubled, from 21 to 44, during this period, directly limiting cancer treatment options (Yoshida et al., 2022). This stems from Japan’s stringent regulatory requirements for Japan-specific clinical data, aggressive price reduction policies including annual revisions since 2021, and market expansion re- evaluation mechanisms that reduce predictability for pharmaceutical companies, effectively deterring them from launching products despite fast reimbursement processes once submitted. The requirement for Japanese clinical trials adds years and millions in costs, whilst the certainty of price reductions undermines business cases for market entry. Greece experiences extreme delays, with over 600 days from regulatory approval to formal public reimbursement for new cancer medicines (Hofmarcher et al., 2024), despite achieving over 75% reimbursement coverage for oncology precision medicines once they become available. These delays mean that Greek patients may wait nearly two years to access treatments already standard in other European countries, during which time disease progression may eliminate treatment options. Spain reports below-average access to innovative oncology medicines compared to other EU countries, with additional waiting times of 5–17 months varying by region for the same medications. Even after national approval, regional budget processes and local formulary decisions create additional delays. Patients in Madrid may access innovative therapies months before those in Extremadura, creating inequality within a supposedly universal system (Muñoz-Sanjuan & Arce- Martínez, 2007). Canada demonstrates how multi-layered approval processes compound delays, with an average of 29.8 months from regulatory approval to public formulary listing for all new drugs, nearly half of which is attributable to late manufacturer submissions (Gaudette et al., 2025). Fragmented funding models further create inequities between oral and intravenous medications, as take-home cancer drugs are often excluded from public cancer agency budgets, leaving patients to rely on hospital- based therapies despite the advantages of oral alternatives (Glennie et al., 2023; PDCI Market Access, 2021; Pott et al., 2025). These alarming trends illustrating deteriorating access to innovative medicines are a cause of concern in most countries examined. Fast and concerted action to remove market barriers for access to novel effective technologies is crucial to safeguarding improvements in patient outcomes and economic growth. Innovative funding mechanisms Despite these challenges, some countries have developed innovative mechanisms to improve access to high-value therapies, demonstrating that creative financing can accelerate patient access whilst managing budget impact. Italy established dual Innovative Drugs Funds with €500 million each for oncology and non-oncology medications, providing dedicated resources for breakthrough therapies. Currently, 37 products (47 indications) are designated as therapeutic innovations, with 95% targeting NCDs (Agenzia italiana del farmaco, 2025). This ring-fenced funding removes innovative therapies from regular budget competition, ensuring that breakthrough treatments reach patients without displacing existing services. The fund operates through performance-based agreements, with companies refunding costs for patients who do not respond, sharing financial risk between payers and manufacturers.

PHSSR Policy Roadmaps for Acting Early on NCDs Synthesis Report 2025