The Impact of the Clinical Added Value Labels on Price Negotiation Duration

Speaker(s)

Rivière L1, Le Dissez C2, Monnier R1, Duteil E3
1PASS, Bègles, France, 2PASS, Bois d'Arcy, 78, France, 3PASS, Bègles, 33, France

Presentation Documents

OBJECTIVES: This study aims to analyze the influence of Clinical Added Value (CAV) labels issued by the Health Technology Assessments in France (HAS) on the duration of price negotiations with the French Healthcare Products Pricing Committee (CEPS).

METHODS: Opinions issued by the Transparency Committee between April 2021 and May 2024 were extracted from the HAS website. Only initial listings of products with a CAV rating were included. Generics, biosimilars, and products with prices published after June 23, 2024, were excluded. A total of 76 products with 79 indications met the criteria. Differences in negotiation duration across CAV labels were assessed using the Kruskal-Wallis H-test.

RESULTS:

  • Distribution of CAV Levels: 56.58% (43 products) were CAV V, 25.00% (19 products) were CAV IV, and 18.42% (14 products) were CAV III.
  • Distribution of CAV Labels: 76.32% (58 products) were labeled as "Therapeutic strategy”," 11.84% (9 products) as "Same as," 6.58% (5 products) as "Versus innovative product," and 5.26% (4 products) as "Versus generic/biosimilar."
  • Listing Categories: 59.21% (45 products) were listed as "retail," 27.63% (21 products) as "hospital," and 13.16% (10 products) as "liste en sus."
The Kruskal-Wallis H-test indicated no statistically significant difference on the duration of the negotiation among the CAV labels (p = 0.205).

The mean duration of negotiation was highest for "Versus generic/biosimilar" (335.75 days), followed by "Same as" (309.33 days), "Therapeutic strategy" (278.16 days), and "Versus innovative product" (128.00 days). Medians followed a similar trend, with 258.5, 216.0, 231.5, and 129.0 days, respectively. Although not statistically significant, there is a notable positive impact of the "Versus innovative product" label on reducing negotiation timelines. Low sample size likely explains the non-significance.

CONCLUSIONS: While statistical significance was not achieved, the "Versus innovative product" label showed a notable reduction in negotiation timelines. This suggests that CAV labels can influence price negotiation durations.

Code

HPR218

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Approval & Labeling, Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

Drugs