## **Supplementary Online Content**

Kamat S, Ungar B, Agarwal A, Wan J, Ross JS, Gupta R. Innovation in development of dermatologic drugs approved by the US Food and Drug Administration between 2012 and 2022. *JAMA Dermatol.* Published online December 20, 2023. doi:10.1001/jamadermatol.2023.5036

**eMethods.** Drug Selection and Innovation

This supplementary material has been provided by the authors to give readers additional information about their work.

## **eMethods. Drug Selection and Innovation**

| | | | Drug Selection |
|---|---------------------------------------------------------------------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Approvals | Annual lists of FDA New Drug | - Identification of new prescription drugs (i.e., new molecular entities (NMEs)), including small-molecule drugs and biologics, approved by the FDA for an |
| | | | original dermatologic indication from 2012-2022 |
| 2 | Centers for Medicare & Medicaid Services (CMS) CenterWatch | | - Identification of drug approvals and confirmation of the list of new drugs |
| | | | approved by the FDA for dermatologic indications |
| | | | - Identification of additional drugs with new supplemental approvals for a dermatologic indication |
| 3 | Peer-reviewed articles (Boozalis 2018; Bell 2019; Lewis 2022; Mazmudar 2020) | | - Confirmation of the list of drugs by reviewing dermatologic drugs approved |
| | | | during our study's time period - Identification of additional drugs with new supplemental approvals for a |
| | | | dermatologic indication |
| 4 | Drugs@FDA database | | - Identification of new prescription drugs (i.e., new molecular entities (NMEs)), |
| | | | including small-molecule drugs and biologics, approved by the FDA for an |
| | | | original dermatologic indication from 2012-2022 |
| | | | - Confirmation of the list of drugs by manually reviewing supplemental drug |
| | | | application approval documents |
| 5 | (BU/JK) | Board-certified dermatologists | - Ensure accuracy and completeness |
| | | | Drug Characteristics |
| 1 | At least one FDA expedited review or | | - FDA approval letters and summary documents: to identify whether each drug |
| | regulatory development program | | was granted accelerated approval by the FDA, an indicator for whether a drug |
| | | (accelerated approval, fast track, | meets a serious unmet need |
| | breakthrough, or priority review) | | - FDA website: to identify drugs that received fast track and breakthrough drug |
| | | | status, indicators for a drug's promise |
| | | | - Drugs@FDA database: to determine whether each drug received standard FDA review or priority review |
| 2 | | Orphan Drug Product designation | Orphan drug status: drugs for treatment of a rare disease, defined as affecting - |
| | database | | fewer than 200,000 people in the US annually |
| 3 | WHO | Lists of Essential Medicines | Includes drugs that address a population's priority health needs - |
| | | | Innovation |
| 1 | Innovation | Schematic developed | Drugs that were first-in-class were categorized as such - |
| | designation | by FDA research and | First-in-indication: not first-in-class but approved as the first treatment for a - |
| | | modified based on | dermatologic indication |
| | | Chen et al | Advance-in-class: received priority review but not first-in-class or first-in - |
| | | | indication |
| | | | Addition-to-class: meeting none of the above categorizations - |
| 2 | Clinical | Prescrire, the French | Clinically useful (possibly helpful, offers an advantage, a real advance, bravo) - |
| | usefulness | drug industry watchdog | Clinically not useful (nothing new, not acceptable) - |
| | | | "Judgment reserved" if further data were necessary or the drugs were not - |
| 3 | Canada | Human Drug Advisory | evaluated High: if they present breakthrough, substantial, or moderate improvement - |
| | | Panel | Low: if they present slight or no improvement - |
| | | | N/A: if ratings were not provided - |
| 4 | Germany | Federal Joint | High: major or considerable added benefit - |
| | | Committee | Low: minor, nonquantifiable, no, or less (i.e., additional harm potential) added - |
| | | | benefit |
| | | | N/A: if ratings were not provided - |
| 5 | France | National Authority for | High: major, moderate, or considerable added benefit - |
| | | Health | Low: minor, or no added benefit - |
| | | | |

Ratings from Prescrire, Canada, France, and Germany have been used extensively in existing literature to understand a drug's therapeutic value because the ratings are determined independent of a drug's price and relative to existing therapeutic options for an indication. Moreover, by many measures, including income and population health, these countries are similar to the U.S. Of note, we utilized the most favorable rating for a particular indication disease setting across multiple ratings (e.g. for subpopulations), with an overall rating of high if any one country provided a high rating.

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