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Assessing Availability of New Drugs in Europe, Japan, and the U.S.
An analysis of drug approval and reimbursement trends and timelines
Dec 11, 2024
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The life sciences R&D ecosystem has brought more than 500 novel active substances (NASs) across a variety of therapeutic areas through regulatory approval in the United States, the European Union, and Japan from 2014-2022; however, patient access to these innovative treatments varies substantially across these regions, due to both regulatory approval processes and subsequent availability challenges. Understanding these dynamics is a crucial step in addressing these access disparities for public health policymakers, improving patient health outcomes, and fostering a more robust and competitive R&D environment worldwide.

This report aims to understand the current landscape of NAS approvals and availability across these regions and to identify areas where policy reforms can enhance patient access. The proportion of total NASs approved by each region and how quickly each region approved NASs is evaluated. Subsequently, the rate at which NASs achieve availability after approval and how long it takes to become available by country is assessed. By shedding light on the hurdles faced by drug developers and the impact of these challenges on patient outcomes, the findings intend to guide stakeholders in making informed decisions to bridge gaps in patient access and ensure that innovative treatments are available to those who need them most.

Key Findings:

  • A total of 545 NASs were approved by the U.S., EU, and/or Japan from 2014-2022, with nearly half (260) approved by all three regulatory bodies.
  • The U.S. approved the most NASs, approves NASs earlier on average than the EU and Japan, and has continued to increase its margin of exclusive approvals.
  • U.S. only NASs are concentrated in the oncology and neurology therapeutic areas, are most often developed by emerging biopharma (EBP) companies, and nearly half are first-in-class products.
  • Though Japan falls behind both the U.S. and EU in terms of total approved NASs (potentially due to drug developers not submitting their products), once approved they are almost always become available within a few months.
  • The EU countries vary in their rate of availability and time to availability, and the majority of the EU fall behind the U.S. in both metrics, highlighting potential unmet patient need in this region.

Other Findings:

  • Of the 545 NASs selected, 48% (260) have been approved by all three regulatory bodies (US, EU, and Japan).
  • Another 22% (121) have been approved by the U.S. and EU only (i.e., not approved in Japan), 6% (34) are approved by the U.S. and Japan only, and 1% (6) are approved by the EU and Japan only.
  • Of products only approved by one of the three regulatory bodies, 13% (69) have only been approved in the U.S., 2% (12) have only been approved in the EU, and 8% (43) have only been approved in Japan.
  • Between the U.S. and EU, a total of 502 NASs were approved by one or both regulatory bodies, and 85% (427) of these were approved by at least one of these two regions from 2014-2022.
  • Of the 329 NASs approved by both the FDA/EMA from 2014-2022, 79% (260) were approved in the U.S. first.
  • Across the 329 shared NASs, the mean and median time to approval is 0.4 years faster and 0.5 years faster in the U.S., respectively.
  • Between the U.S. and Japan, a total of 533 NASs were approved by one or both regulatory bodies, and 97% (519) of these were approved by at least one of these two regions from 2014-2022.
  • 53% (285) of NASs were approved in both the U.S. and Japan, while 35% (185) are U.S.-only and 9% (49) are Japan-only.
  • Across the 285 shared NASs, the mean and median time to approval is 2.8 years faster and 1.3 years faster in the U.S., respectively.
  • The U.S. has the highest absolute rate of availability, with its 318 available NASs constituting 58% of the full 545 NAS list.
  • Japan closely follows the U.S. in terms of available NASs at 55% (299); however, another 37% (202) out of all 545 NASs have never been approved in Japan.
  • When all 27 EU countries are considered, the proportion of NASs approved by EMA from 2014-2022 that achieved availability ranges from 52% down to only 2%.
  • Time to availability, which is the length of time from a NASs’ central approval date to the date which it achieves payer coverage within a given country, can vary by product, country, and (in the U.S.), by benefit type and payer channel.
  • 25 of the 27 EU countries have longer median delays to availability than the U.S., and 22 of the 27 EU countries have a median time to availability from approval of one year or longer for novel treatments.
  • The process of adding drugs to each country’s reimbursement list can be burdened by drawn out negotiations, budget limitations, and limited resources; for drug developers, this process can also prove challenging after receiving approval by the EMA due to the decentralized requirements and rules of each of the 27 EU countries.

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