The National Centre for Pharmacoeconomics (NCPE) has completed a health technology assessment (HTA) for Omeprazole (Appizped) and recommended that the Health Service Executive (HSE) consider its reimbursement only if cost-effectiveness can be improved relative to existing treatments. The guidance highlights the product’s clinical comparability but raises concerns about its pricing.

  • The NCPE advises HSE to reimburse Omeprazole (Appizped) only with improved cost-effectiveness versus comparators.
  • More than 50% of recent Irish drug applications advance with only Rapid Review, avoiding full HTA.
  • Reimbursement timelines can extend beyond two years, mainly due to lengthy post-assessmentnegotiation phases.

The National Centre for Pharmacoeconomics (NCPE) recommends that omeprazole (Appizped) be considered for reimbursement by the Health Service Executive (HSE) only if cost-effectiveness is improved relative to current therapies. This NCPE recommendation underscores the intense focus. Payers are placing value on both clinical and economic factors as pharmaceutical companies seek Irish market access.

NCPE recommendations serve as a pivotal step in Ireland’s complex drug reimbursement process. When a new product such as omeprazole advances to HTA, the NCPE evaluates its incremental clinical benefit and cost-effectiveness, primarily using the incremental cost-effectiveness ratio (ICER) per QALY and potential budget impact. The guidance for omeprazole confirms clinical comparability but signals that its price does not represent sufficient value versus alternatives, triggering the need for further price negotiations or managed entry agreements.

Policy moves, such as the recent implementation of a reimbursement application tracker and a government commitment to accelerate rare disease drug reviews, highlight the continuing evolution of Irish pricing and reimbursement (P&R) frameworks. Still, the NCPE retains a clear standard that products must demonstrate compelling value or face delayed or restricted access.

“NCPE recommendations, though expert-driven, are increasingly setting the tone for value-based access in Ireland. For any new entrant, robust cost-effectiveness, paired with adaptive pricing strategies, will remain the key determinant of timely reimbursement.”

– Jane Nolan, VP Market Access, Axis Healthcare Consulting

Omeprazole’s conditional recommendation is emblematic of broader trends in Irish market access. Over half of new drug applications have advanced with a rapid review only, avoiding a full HTA and often achieving faster reimbursement. However, products failing initial cost-effectiveness thresholds, like Omeprazole (Appizped), are increasingly subject to drawn-out post-HTA negotiations, sometimes exceeding two years before final HSE decisions. This mirrors similar outcomes for drugs addressing high-prevalence chronic diseases, where modest clinical innovation without a significant pricing advantage is insufficient for unconditional recommendation.

For example, recent NCPE positions on other proton pump inhibitors and generics have reinforced the message that reimbursement will be withheld unless manufacturers align prices with established standards of value. Comparable scrutiny was observed in decisions for new oral anticoagulants and diabetes therapies, both of which required either significant price concessions or additional outcomes data to progress.

Meanwhile, the imminent adoption of Joint Clinical Assessment (JCA) for oncology medicines in 2025 is poised to introduce additional harmonization and potential hurdles for products entering the Irish market, especially when compounded by pan-European health technology assessment procedures.

The NCPE recommends a strategy that underlines the imperative for manufacturers to present locally relevant cost-effectiveness data and to proactively prepare flexible pricing or managed entry solutions. HSE can still approve products outside NCPE guidance, but rarely does so without demonstrable value advances. Market access teams must prioritize early payer engagement and scenario planning for post-HTA negotiation phases.

With new policy tools such as public reimbursement application trackers and enhanced transparency, there is increasing pressure for both manufacturers and payers to reduce reimbursement timelines, especially for products already available in peer EU markets.

The omeprazole case epitomizes the tightening interplay between clinical evidence, health economics, and market access in Ireland. For both innovators and generics, the bar for reimbursement set by NCPE recommendations continues to rise, necessitating a sophisticated, data-driven approach to launch planning and pricing in this highly scrutinized market.