Epidyolex Spending in Portugal Exceeds €3 Million Amid Regulatory Delays

Portugal’s Epidyolex spending has topped €3 million since 2021, fueling debates on access to this CBD-based epilepsy drug through the National Health Service (SNS). If you’re wondering how this impacts patient care and healthcare costs, the answer lies in Infarmed’s nearly four-year evaluation for public reimbursement. This spending highlights growing hospital use via a special Early Access Program (PAP), yet community pharmacy access remains stalled, affecting families with rare epilepsies like Lennox-Gastaut or Dravet syndromes. Drawing from public data, we’ll break down the costs, trends, and implications.

Hospital CBD Outlay Snapshot: €3M+ Since 2021

Portugal’s SNS has invested over €3 million in Epidyolex, the EMA-approved CBD medication for severe pediatric epilepsy, covering hospital purchases from 2021 onward under Infarmed’s PAP. While the program provides limited access as regulators assess broader funding, usage is rising, but the four-year delay in reimbursement decisions raises questions about equity and efficiency in cannabis-derived treatments.

Cost Surge, Regional Spread, and Safety Gaps in CBD Epilepsy Therapy

Epidyolex spending in Portugal reveals key patterns in CBD epilepsy therapy, including rising demand, and pharmacovigilance gaps.

• Rising Costs Over Time: Expenditures started small at €14,383 in 2021 with two contracts. They ballooned to €2.08 million in 2025 across 10 contracts. This doubled prior years’ totals. Contract sizes grew from €7,000 to over €200,000. Each 100ml bottle holds 10 grams of purified CBD and costs the state more than €1,000.
• Usage Across Regions: Adoption varies by area but is widespread. Coimbra’s ULS leads with over €1 million spent. Porto’s ULS Santo António follows at €900,000. Lisbon’s ULS Santa Maria totals €550,000. Santo António has the most contracts (11), with others like São João (10) and Alentejo Central (7) showing steady demand beyond main epilepsy centers.
• Safety Monitoring Issues: Global EudraVigilance data lists 4,476 adverse reaction cases as of January 2026. About 1,000 occurred in the EU. Professionals reported 93.6% of them. Over 50% involved children aged 3-17. Yet Portugal has no reported cases, pointing to possible local tracking shortfalls that may sway Infarmed’s reviews.

Four-Year Delay: Budget Strain and Rare Epilepsy Care Gaps

How does Portugal’s Epidyolex spending delay affect rare epilepsy care and budgets? The €3+ million hospital focus strains SNS funds and may pull resources from other options, while patients outside hospitals face barriers, worsening gaps in cannabis medicine access.

This could shape Portugal’s CBD policies, with questions arising such as “How will Infarmed’s pause raise long-term epilepsy costs?”; meanwhile, local options from other suppliers under 2018 cannabis laws offer domestic full-spectrum CBD, where reimbursement for these might cut import needs. Delays risk unregulated hemp oils harming patient safety.

Epidyolex Spend Drivers, Reimbursement Roadblocks, and CBD Alternatives

What drives the surge in Epidyolex spending in Portugal?
Hospital demand for pediatric epilepsy treatment has grown, with spending rising from €14,383 in 2021 to €2.08 million in 2025, reflecting more contracts and use in key ULS regions like Coimbra and Porto for adjunct CBD therapy.

Why is public reimbursement for Epidyolex taking so long in Portugal?
Infarmed’s PAP evaluation since 2021 weighs funding by reviewing safety data and results, but no decision yet, and Jazz’s potential no-launch adds uncertainty in this spending saga.

What other CBD options help epilepsy patients in Portugal?
Hospital Epidyolex is key, but approved full-spectrum products from Portocanna and Tilray exist without funding, and many use hemp oils though quality varies—prompting calls for broader, safer access.

Key Sources

• CannaReporter. (2026, January 9). Portugal já gastou mais de 3 milhões de euros em Epidyolex: Infarmed está a avaliar comparticipação há quase 4 anos. https://cannareporter.eu/2026/01/09/portugal-ja-gastou-mais-de-3-milhoes-de-euros-em-epidyolex-infarmed-esta-a-avaliar-comparticipacao-ha-quase-4-anos/
• European Medicines Agency (EMA). (2019). Epidyolex: EPAR summary. https://www.ema.europa.eu/en/medicines/human/EPAR/epidyolex