C(nn) and compassionate use: two approaches for early access. Proposals for a better management
Introduction: To ensure access to drugs prior to their marketing authorization and/or reimbursability, but outside of clinical trials, two modes of early drug access have been implemented: C(nn) and compassionate use (CU). The C(nn) class of drugs includes drugs in class C that have not yet been ne...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
AboutScience Srl
2025-06-01
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| Series: | Global & Regional Health Technology Assessment |
| Subjects: | |
| Online Access: | https://journals.aboutscience.eu/index.php/grhta/article/view/3464 |
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| Summary: | Introduction: To ensure access to drugs prior to their marketing authorization and/or reimbursability, but outside
of clinical trials, two modes of early drug access have been implemented: C(nn) and compassionate use (CU). The
C(nn) class of drugs includes drugs in class C that have not yet been negotiated (nn) and allows the company to
make available a drug that is authorized but whose Price & Reimbursement is still under negotiation with AIFA;
CU, on the other hand, is applied in the absence of viable therapeutic alternatives in life-threatening patients and
allows the use of drugs that have not yet been authorized.
Methods: This paper highlights some problematic aspects of regional pharmaceutical policies regarding early
access drugs, which emerged in the context of a multi-stakeholder working group and proposes resolving guidelines.
Results: Referring to C(nn) drugs, the absence of guidance at the central level is currently responsible for great
heterogeneity in commercial agreements, in the guidelines adopted by Regions and in the way prescribing centers
are selected. Regarding CU, although the regulations are better defined, critical issues were highlighted and
addressed, particularly that of therapeutic continuity. The discussion among experts led to the definition of: (i)
organizational guidelines, such as the need for common criteria for defining prescribing centers, (ii) contractual
guidelines between pharmaceutical and health care companies, and (iii) guidelines aimed at ensuring therapeutic
continuity, with the goal of ensuring rapid and equal access to medicines in each Region.
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| ISSN: | 2284-2403 2283-5733 |