would likely increase the stringency of efficacy and safety measurements required for a drug to get FDA approval (as companies would be more reticent to modulating an already-existing drug that does not add much additional value), overall revenues from prescription drug sales would decrease. This would no doubt lead to backlash from the pharmaceutical industry.
While by no means are my proposed set of reforms for regulating the prices of PROTACs a comprehensive plan developed for immediate implementation, it is my hope that it can be a useful first step towards regulation of the prescription drug market as a whole.
An additional counterargument against value-based pricing is the claim that measurements of value are hard to define and can vary not only due to the intrinsic efficacy of a drug, but also the administration of medicines and adherence to treatment regimens. Much of the criticism of these methods largely center around the infeasibility of implementing such a system due to imprecise metrics of “value.” How can one measure the value of a drug when so many factors that affect treatment efficacy lie beyond the control of the drug manufacturer and even the healthcare provider? The good news is that the goal of reducing prescription drug prices seems to be a bipartisan issue. Both political parties support experimenting with value-based prescription drug pricing.15 Republicans would like value-based pricing models, as it shifts the focus of health reforms to market-based solutions. Democrats would also support value-based pricing, as it protects patients and consumer interests in guaranteeing value from their healthcare investments.
With new drug candidates appearing regularly every year, it is difficult to claim that PROTACs can truly become a disruptive force in the arena of pharmaceutical drug pricing just based on its unique biochemical properties. At the end of the day, despite the differences in molecular mechanism of action, PROTACs will still be taken as an orally-ingestible pill. Therefore, most patients and payers—who find themselves degrees removed from the biology behind PROTACs—won’t consider the difference. Policymakers and drug pricing advocates should do the same, and preempt aggressive marketing strategies of pharmaceutical companies by implementing regulation on prescription drug prices, just as if PROTACs were your run-of-the-mill inhibitor. The regulation of the entry of PROTACs into the clinic is a prime opportunity for regulating prescription drug costs at large.
The Time Is Now
If there is a proper time for policy wonks and advocacy groups to lobby for prescription drug price capping, it is now. The public
distrusts the pharmaceutical industry more than ever before, especially with the opioid crisis’ saliency as a public health emergency and the nefarious role of the Sackler-owned Purdue Pharmaceuticals in seeding it.16 Furthermore, high-profile news cases have helped shift public opinion of the industry. Take for example, Martin Shkreli’s company Turing Pharmaceuticals hiking up the price of the life-saving drug Daraprim used to treat toxoplasmosis,17 or of Mylan Pharmaceuticals tripling the price of EpiPen,18 the emergency epinephrine auto-injector used by people with severe allergies. These cases have eroded the trust of the public, casting the pharmaceutical industry as less of a manufacturer of life-saving drugs and more of a profit-driven industry that often takes up price-gouging methods to maximize profits. In fact, a recent Gallup poll showed that only 28 percent of Americans have a positive view of drug makers, which is the lowest rating in the 16 years Gallup has recorded public opinion.19 In short, people are angry with the pharmaceutical industry. If PROTACs pass through clinical trials, they will soon flood drug markets for treatment towards some of the most high-profile and expensive diseases, such as prostate and breast cancer. If left to the devices of what is currently a relatively unregulated prescription drug pricing market, PROTACs could play a big role in driving up America’s overall healthcare expenditures. As a drug that fundamentally acts differently than traditional pharmaceutical agents, bigger biopharmaceutical companies and PhRMA can market PROTACs as a disruptive “miracle drug.” If we are to prevent the unfair and exorbitant accumulation of profit by pharmaceutical companies on life-saving treatments, we must be careful to introduce regulation to make that purported miracle available to more patients. Price caps, which will indubitably be unpopular with major stakeholders in the pharmaceutical industry, ultimately will decrease prohibitive costs for therapy and increase access to PROTAC-based therapies, and lead to better patient health. It is a hard battle to fight but is one that must be undertaken, if only to chase after the dream of more equitable outcomes in American healthcare. www Stephen Wang '19 is a Molecular Biophysics & Biochemistry major from Houston, Texas. He is interested in drug discovery research and pharmaceutical reform.
PROTAC mechanism.
VOLUME 6, NO. 1
U.S. Department of Defense
You can reach him at stephen.wang@yale.edu
10