Named Patient Supply (NPS) in the GCC

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Named Patient Supply (NPS) in the GCC

Across the GCC, Named Patient Supply (NPS) has evolved from a limited humanitarian exception into a widely used early access mechanism, particularly for rare diseases, oncology, biologics, and advanced therapies.

For manufacturers entering the region, NPS often appears straightforward: physician request, regulatory approval, and patient import. In reality, it operates within a structured and increasingly maturing ecosystem. Understanding how it truly functions is critical to sustainable market entry.

What is NPS?

Named Patient Supply is a regulated exceptional pathway that allows access to unregistered medicines for individual patients under defined circumstances, typically when:[1,2,3,4]

The patient’s condition is serious or life-threatening
No registered alternative exists locally, or available registered options have failed
The expected clinical benefit of the medication outweighs the potential risks
A treating physician provides documented clinical justification based on the individual patient’s medical condition, prior treatment history, and risk-benefit assessment

This process is formally governed by established regulatory frameworks across GCC markets, which define the clinical justification, approval, and import requirements for patient-specific access to unregistered medicines.[1,2,3,4]

Drivers Behind the Growing Use of Named Patient Supply (NPS) in the GCC

NPS is a growing access mechanism in the GCC. Its expanding role is closely linked to how healthcare delivery, regulatory frameworks, and funding decisions are structured within the region.

Two underlying factors explain its widespread use:

Timing Gaps Between Global Approval and Local Registration

Innovative therapies, particularly in rare diseases, oncology, biologics, and advanced therapy medicinal products (ATMPs), often receive approval from major reference authorities such as the FDA and EMA before completing registration processes in GCC markets – and even though this trend is changing quite quickly, NPS still provides a path to access before formal authorization.

While regulators across the GCC, particularly the Saudi Food & Drug Authority (SFDA) and the UAE Emirates Drug Establishment (EDE), have introduced accelerated review pathways, full market authorization still necessitates local dossier submission, pricing evaluation, and, increasingly, economic evaluation studies.[5,6]

NPS acts as a regulated bridge, enabling timely access while registration and pricing are finalized, consistent with national health transformation goals to expand access while maintaining oversight and sustainability.[7]

Physician-Centric Decision-Making Models

GCC healthcare systems, particularly within tertiary public institutions, are highly specialist-driven. Clinical leaders often play a central role in initiating access for complex or rare conditions. NPS applications are physician-led and require documented clinical justification. This framework places specialist advocacy at the core of early access decisions.

How NPS Typically Works

Although procedural requirements vary by country, the operational pathway follows a broadly consistent structure:[1,2,3,4]

Clinical Identification
A treating physician determines that a patient meets the criteria for exceptional access.

Institutional Review
The request is evaluated at the hospital level, often through a Pharmacy & Therapeutics (P&T) committee.

NPS Regulatory Approval
The relevant health authority grants approval for patient-specific import under defined conditions and quantities.

Funding Decision
Financial responsibility is determined, whether through hospital budgets, ministry allocation, or case-by-case approval mechanisms.

Successful NPS access depends on alignment between clinical justification, institutional approval and funding, and regulatory approval of special access.

Products supplied under NPS are typically freely priced, as they fall outside standard registered pricing frameworks.

Sustainability of NPS[8]

In the GCC markets, there are no strict legal time limits on how long a product can remain under NPS. In practice, expectations gradually shift toward pursuing formal registration, particularly when:[8]

Patient numbers increase
Overall spending becomes noticeable within hospital or ministry budgets

At this point, the focus typically moves from the needs of an individual patient to broader system sustainability, leading regulators and payers to steer the product toward formal registration.

Strategic Implications[8]

For innovative biopharmaceutical and rare disease companies, NPS is most effective when positioned as a structured early access phase within a broader market entry strategy. In this context, it can serve as:

A transitional step prior to formal registration
A mechanism to build physician familiarity and clinical confidence
An opportunity to generate early local clinical experience
A practical platform to gather preliminary real-world data, supporting the GCC’s increasing emphasis on localization and locally relevant evidence
A pathway that supports eventual formulary inclusion and sustainable funding discussions

Conversely, NPS becomes vulnerable when it is approached as:

A substitute for registration
A mechanism to scale patient volumes without formal evaluation

Conclusion

Named Patient Supply is a structured access mechanism operating within regulatory systems that are becoming progressively more rigorous, data-driven, and economically focused.

When deployed thoughtfully, NPS can facilitate early patient access, strengthen clinical engagement, and generate locally relevant experience aligned with regional localization priorities.

When extended without progression toward registration, however, it may lead to pricing friction, regulatory pressure, and delayed sustainable access.

As regulatory frameworks mature and expectations around economic evaluation and locally generated evidence intensify across the GCC, NPS is expected to remain part of the access landscape but with clearer boundaries and greater regulations.

For manufacturers, the strategic consideration is not simply whether NPS is feasible, but how it is embedded within a defined market entry roadmap for market success.

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