A View on Value
Reducing drug prices remains a top issue for American voters. Policymakers have hosted a variety of hearings lately as they barrel towards legislation to placate them - many often pointing fingers at specific drug companies and therapeutic classes. It’s a tough environment for drug makers, which is why communicating value has never been more important.
Now, we have a new tool in our toolbox: data on the investment in drug development over time. This week, Regulatory Focus dug into some recent IQVIA data we mentioned a few weeks ago, noting that while the number of clinical trials required for a drug to get approval has declined, the design of the clinical trials is becoming more rigorous and the duration of trials remains long. That’s especially the case for orphan drugs, where companies need to accumulate adequate safety, efficacy and durability over time data from smaller overall patient numbers. That’s in addition to comparing effectiveness to the current standard of care.
Highlights from the report:
- 42% of novel drugs approved in 2018 were approved on the basis of only one trial. And one out of eight approvals relied only on Phase 1 or 2 trials, with no Phase 3 trials. As in previous years, a large portion of the drugs relying on only one trial were new orphan and cancer drugs.
- Nearly 90% of drugs included randomized clinical trials in their regulatory packages.
- Nearly half of the new drugs (46%) were tested in trials with active control arms, versus only 20% a few years ago. This highlights the increasing importance of comparative effectiveness in disease indications where existing standards of care are in place.
- The cumulative years in the clinic and registration remains long at 12+ years. This average time holds true for both orphan drugs and non-orphans, interestingly.
- The average trial duration for orphan drugs is 12% longer than for non-orphans, based on the 4-year averages (7.6 years vs 6.7 years).
The nuances of development often get buried in conversations about a drug’s value. As pricing continues to be under the microscope, it is important to be upfront about everything that went into a drug’s development, including the details about how your trials were conducted, and how they’re unique. Greater understanding about the process, in addition to the impact a drug will make for patients and caregivers, is a key to acceptance. While we cannot darken the spotlight instantaneously, increasing transparency about what exactly goes into R&D could move us in the right direction.
Who wrote this? The managing editors of TWTW are Randi Kahn, who is happy she at least got to see the Who’s farewell tour, and Dana Davis, who is at a college graduation this weekend (not her own).
Syneos Health Communications' Reputation & Risk Management Practice is a team of healthcare communications consultants, policy-shapers and crisis response specialists. We provide unique solutions to the evolving communications challenges in today’s healthcare industry, using evidence-based approaches to help our clients successfully navigate the most sensitive of situations.
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