French health technology assessment of antineoplastic drugs indicated in the treatment of solid tumours: perspective for future trends

Supplementary file

Fig. S1: Extraction grid items

Drug brand name
International Non Proprietary Name (INN)
Marketing authorization holder
Marketing authorization date
Conditional approval (Yes/No)
Approval under exceptional circumstances(Yes/No)
Indication (s) of the marketing authorization
ATC code
Pharmacological class (Targeted therapy/Radiopharmaceutical/Hormonotherapy/Immunotherapy/Cytotoxic drug/Other)
Route of administration
Mechanism of action
First-in-class (Yes/No)
Orphan drug status (Yes/No)
ATU in the considered indication(s) (Yes/No) (If Yes, start date/end date)
Prescription conditions
Appropriate comparator as reported by the Transparency Committee
Clinical data submitted to the Transparency Committee / Types of studies / Blinded randomised clinical studies vs comparator / Number of studies
Active comparator for each study
Sample size for each study
Blinded Randomized clinical studies vs placebo / Number of studies
Sample size for each study
Open (randomized or not) label studies / Number of studies
Sample size for each study
Other types of study / Number of studies
Sample size of each study
Studies submitted but not taken into account by the Transparency Committee / Number of studies
Reasons
Main study results (pivotal trials) / Primary endpoint
Result on primary endpoint
Median Overall Survival (OS)
Median Progression-Free Survival (PFS)
Other endpoint of interest and result
Assessment of the Transparency Committee / Type of assessment (initial assessment/assessment of extension of indication)
Date of assessment
Indication (s) evaluated
SMR rating
ASMR rating
Transparency Committee conclusions / Disease severity
Efficacy/safety ratio and drivers
Status as curative/preventive/symptomatic treatment
Alternative therapies
Treatment line
Public health impact and drivers
Target population
Place in therapeutic strategy
Decision (recommended/not recommended)
Additional request for data (if applicable)
Price of drug and of one selected appropriate comparator

Fig. S2: Profile of experts

Expert 1 / MD, clinician and expert advisor in HTA and drug development. Ex-member of Transparency Committee
Expert 2 / PharmD, Health Economist in specialized Cancer Hospital
Expert 3 / MD, PhD, specialist in oncology and in health economics. Coordination of several trials on oncology. Expertise on the field of health technology assessment for academics as well commercial projects
Expert 4 / MD, PhD Clinician and methodologist. Ex-member of Transparency Committee
Expert 5 / MD, PhD, Professor of health economics and market access, participation to numerous advisory boards as French expert in health economics and market access. He did act as HTA experts for various bodies including the EU commission