Table. Differences in Prices and Price Trends for Newly Marketed Drugs From 2008-2021, by Drug Characteristics.
| Drug characteristicsa | Drugs, No. (%) | Price per y, 2008-2021, median (IQR), $ | Adjusted relative differences in mean priceb | Adjusted absolute difference in % price increase per yc | ||
|---|---|---|---|---|---|---|
| Estimate (95% CI) | P value | Estimate (95% CI) | P value | |||
| All drugs | 548 | 20 657 (3929-138 509) | ||||
| Novelty | ||||||
| New active ingredient | 357 (65) | 68 596 (7276-184 065) | 1.7 (1.2-2.2) | .001 | 0.4 (–6.9 to 8.3) | .91 |
| Reformulationd | 191 (35) | 5429 (2105-18 782) | Reference | Reference | ||
| Ingredient type | ||||||
| Biologic | 139 (25) | 84 508 (18 861-288 759) | 2.2 (1.5-3.4) | <.001 | 13.7 (2.9 to 25.7) | .01 |
| Small molecule | 409 (75) | 10 580 (3076-98 516) | Reference | Reference | ||
| Approval pathway | ||||||
| Accelerated approvale | 64 (12) | 168 344 (115 609-240 302) | 0.9 (0.6-1.5) | .75 | –0.4 (–11.2 to 11.6) | .94 |
| Traditional approval | 484 (88) | 12 912 (3434-96 030) | Reference | Reference | ||
| Patient population | ||||||
| Raref | 182 (33) | 168 441 (78 291-338 379) | 6.8 (5.0-9.2) | <.001 | 8.1 (0.5 to 16.4) | .04 |
| Nonrare | 366 (67) | 6252 (2675-33 227) | Reference | Reference | ||
| Indication | ||||||
| Oncology | 119 (22) | 155 091 (109 832-233 916) | 3.7 (2.5-5.3) | <.001 | –10.3 (–18.3 to –1.5) | .02 |
| Nononcology | 429 (78) | 7783 (2963-52 483) | Reference | Reference | ||
| Route of administration | ||||||
| Oral | 282 (51) | 15 630 (3948-115 609) | Reference | Reference | ||
| Injected | 199 (36) | 72 875 (9908-236 164) | 0.9 (0.6-1.4) | .70 | –6.0 (–14.3 to 3.0) | .19 |
| Otherg | 67 (12) | 3545 (1542-6689) | 0.4 (0.3-0.6) | <.001 | –0.5 (–10.4 to 10.4) | .92 |
Drug characteristics were obtained from Drugs@FDA, linked to SSR Health data based on brand name.
Estimates are from a linear regression model of log-transformed price; the model included year of market entry (rounded to calendar quarter) plus all listed characteristics as independent variables. The results shown are exponentiated coefficients and reflect the relative difference in mean price, adjusting for all other characteristics and time. For example, mean prices for oncology drugs were 3.7 times higher than those for nononcology drugs.
Estimates are from a second linear regression model that additionally included interaction terms between year of market entry and each characteristic. The results shown are based on exponentiated coefficients and reflect the difference in the annual percent increase in price. For example, mean prices for oncology drugs increased by 10.3% per year less than those for nononcology drugs.
Reformulations included any product for which the US Food and Drug Administration had previously approved a different product with the same active ingredient. This included new formulations of existing drugs (eg, long-acting depot injections), new manufacturers, and new combination products.
The US Food and Drug Administration accelerated approval program allows approval of drugs that treat a serious condition or fill an unmet need to be approved based on evidence of efficacy using a surrogate end point that is only reasonably likely to predict a clinical end point.
Under the Orphan Drug Act, a drug is intended to treat a rare condition that affects fewer than 200 000 individuals in the US.
Includes 18 inhaled, 18 transdermal, 9 ophthalmic, 7 nasal, 5 vaginal, 4 implanted, 4 sublingual, 1 instilled, and 1 rectal.