Mohit Manrao Talks Small-Molecule Penalty, Eliminating Cancer as a Cause of Death, and More
The small-molecule penalty "doesn't create the right incentives for where we want to go with the Cancer Moonshot or driving cures," Mohit reflected.
09.15.2023
President Biden’s Cancer Cabinet convened this week and announced new actions to advance the White House Cancer Moonshot, including a $240 million additional investment in efforts to “accelerate new ways to prevent, detect, treat, and survive cancer.”[1]
The Cancer Moonshot aims “to end cancer as we know it” by cutting the U.S. cancer death rate by at least half by 2047 and improving quality of life for people battling the disease.[2]
Unfortunately, unintended consequences of recent legislation will work directly against this ambitious goal.
Incubate executive director John Stanford recently sat down with Mohit Manrao, senior vice president and head of U.S. oncology at AstraZeneca, for a very special episode of the Making Medicine podcast. Over the course of their conversation, Mohit explained how current legislative hurdles will make it harder to achieve the Cancer Moonshot’s goals.
One example is the small-molecule penalty. Recent legislation affords newly approved small-molecule drugs just nine years of exemption from Medicare price controls, while granting thirteen years of exemption to a class of drugs known as biologics.
This harmful disparity will not only discourage firms from developing new small-molecule drugs, but also from finding innovative new uses — or “indications” — for existing ones.
Mohit pointed out that it can take years to get an existing drug approved for a new indication. AstraZeneca’s small-molecule cancer drug olaparib, for example, was initially approved to treat late-line ovarian cancer in 2014.[3] But it wasn’t until last year that the FDA approved olaparib to treat high-risk early breast cancer.[4]
It took AstraZeneca eight years of expensive clinical trials to demonstrate olaparib’s effectiveness against breast cancer. Unfortunately, the small-molecule penalty will make it harder for life sciences firms to make similar time and money investments in the future.
Because of the small-molecule penalty, a firm that spends 8 years and hundreds of millions of dollars developing a drug for a new indication would have only a year to earn back their up-front investments before steep price controls kick in. That’s simply not practical.
These distorted incentives threaten to undermine the Cancer Moonshot. Reducing the cancer death rate as quickly as possible doesn’t just mean inventing novel therapies; it also means making the most of the life-saving medicines we already have.
The small-molecule penalty “doesn’t create the right incentives for where we want to go with the Cancer Moonshot or driving cures,” Mohit reflected.
Mohit also spoke with John about AstraZeneca’s goal of releasing 15 new drugs by 2030, and the concept of patient centricity, which he described as working to transform “science into practice into care for all patients, regardless of zip code.”
To hear John and Mohit’s full conversation, be sure to check out the latest episode of the Making Medicine podcast on our website, Spotify, Apple Podcasts, or Google Podcasts!
[1]https://www.whitehouse.gov/briefing-room/statements-releases/2023/09/13/fact-sheet-as-part-of-president-bidens-unity-agenda-white-house-cancer-moonshot-announces-new-actions-and-commitments-to-end-cancer-as-we-know-it/
2]https://www.whitehouse.gov/cancermoonshot/
[3]https://www.astrazeneca.com/media-centre/press-releases/2014/lynparza-approved-us-fda-brca-mutated-ovarian-cancer-treatment-19122014.html#![4]https://ascopost.com/issues/april-10-2022/fda-approves-olaparib-for-adjuvant-treatment-of-high-risk-early-breast-cancer/#:~:text=On%20March%2011%2C%20the%20U.S.,with%20neoadjuvant%20or%20adjuvant%20chemotherapy.