ArticlePharmacoEconomics - open2023
The Evaluation of Drug Innovativeness in Italy: Key Determinants and Internal Consistency.
Article in PharmacoEconomics - open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed.
- Closing the first wave of drug innovativeness in italy: final evidence from 2017 to 2025.The European journal of health economics : HEPAC : health economics in prevention and care · 2026Article
- Assessment and Appraisal of Drug Innovativeness in Italy: Ultimate Evidence on Key Drivers and Consistency.Journal of market access & health policy · 2026Article
- The Italian Assessment System for Innovative Medicines: An 8-Year Retrospective Analysis of Outcomes, Criteria, Timelines and Funding Dynamics.Applied health economics and health policy · 2026Article
- Access in all areas? A round-up of developments in market access and health technology assessment: part 10.Journal of comparative effectiveness research · 2025Article
- Pivotal Studies for Drugs About to Be Launched for Rare Diseases: Will They Better Support Health Technology Assessment and Market Access than in the Past?Journal of market access & health policy · 2025Article
- Pricing, Procurement and Reimbursement Policies for Incentivizing Market Entry of Novel Antibiotics and Diagnostics: Learnings from 10 Countries Globally.Applied health economics and health policy · 2024Review
- From Indication-Based Pricing to Blended Approach: Evidence on the Price and Reimbursement Negotiation in Italy.PharmacoEconomics - open · 2024Article
- Scoping Review of International Experience of a Dedicated Fund to Support Patient Access to Cancer Drugs: Policy Implications for Thailand.International journal of health policy and management · 2024Article
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- More and earlier data from AIFA: do they impact on the regional policies? Results from an exploratory analysis.Global & regional health technology assessmentArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
backgroundInnovative medicines are provided with dedicated funds and immediate market access in Italy. Innovativeness evaluation considers unmet need, added therapeutic value, and quality of the evidence.
objectiveWe aimed to evaluate the internal consistency and drivers of the innovativeness appraisal process.
methodsAppraisal reports on innovativeness refer to 1997-2021. We used both a descriptive approach and probabilistic multivariate analysis, using logistic regression models to compute odds ratios and 95% confidence intervals. The dependent variable is innovativeness status (innovative vs. non-innovative; full innovativeness vs. conditional innovativeness). Explanatory variables, besides the three above-mentioned domains, are the year of evaluation, drug type, target disease and population, and the number and type of available studies.
resultsAmong the 141 medicines scrutinized, 31.9%, 29.8%, and 38.3% were evaluated as fully innovative, conditionally innovative, and non-innovative, respectively. Added therapeutic value and the quality of the evidence were associated with the odds of receiving innovative status, and full compared with conditional innovativeness; unmet need was not a predictive variable. Other factors played a minor role: medicines for both solid tumours and rare diseases are more likely to be judged innovative; conditional innovativeness is more probable for medicines for rare diseases.
conclusionsInnovativeness status is driven by the added therapeutic value and quality of evidence. The appraisal process is internally consistent and predictable. This provides industry with a clear indication of what is needed to ensure that access to their medicines is prioritized.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.