High R&D isn't necessarily why drugs are so expensive ucsandiego jamanetworkopen
If the product was not granted an extension, we recorded the first patent expiry date in the FDA Orange Book. Second, we identified the statutory exclusivity period for each product. All products in the sample were eligible for a 5-year statutory period of regulatory exclusivity, except products that were granted an orphan designation, which were eligible for a minimum 7-year period of exclusivity. Third, we selected the later date between steps 1 and 2 as the date of loss of exclusivity.
We used data published by Haute Autorité de Santé, the French national health technology assessment agency, to assess whether each drug provided added benefit over existing treatment options at the time of launch. We used the assessment of the French agency because no equivalent assessment was available from a US organization. The agency gives all new products that launch in France a score ranging from 1 to 5 . Scores were available for 38 of the 60 products in the sample.
Because factors other than research and development investments may alter the prices set by drug companies, we also fitted multivariable regression models. In the primary analysis, we ran linear regression models with log-transformed treatment costs as the dependent variable. To select independent variables, we tested for associations between product characteristics and standardized treatment costs using univariate regressions.
In the secondary analysis, we repeated the same process using generalized linear models with γ distributions and log links. We again ran univariate regressions to identify the variables associated with treatment costs, and then we conducted independence tests to identify correlated variables. We built a fully adjusted model and a parsimonious model. Each model was run using treatment costs at launch and in 2021.< .05 considered to be statistically significant.
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