Good morning folks. It’s Monday, we’re caffeinated and its one week away from Mother’s Day (you’re welcome). There were so many healthcare issues last week that we’re suffering a bit of whiplash. Hold on to your seats, for these healthcare headlines:

  • Poor performance, poor pay. Executive compensation seemingly rivals lottery winnings these days, but not if you’re the CEO of Acorda. Company CEO Ron Cohen recently saw his bonus withheld due to Acorda’s poor pipeline setbacks and patent challenges. But don’t cry for Cohen yet, he has a chance to win back the bonus. Still, in an era when many CEOs have “failed forward,” Acorda’s board prescribed an unusual dose of accountability.
  • Maine goes “transparent.” With no tangible solutions to drug pricing on the federal level, 27 state governments have taken the mantle and demanded greater transparency. Last week, Maine passed legislation, targeting the 25 costliest, most frequently prescribed drugs in the state, along with the medicines that result in the highest year-over-year cost increases. So far, the state bills have limited “teeth” but they reflect the public desire for action on the affordability of medicines just days before POTUS may deliver his long-rumored drug pricing policy. Stay tuned! 
  • ‘Biohacker’ dead at 28. On a sad note, Aaron Traywick, the Ascendance CEO, who injected himself with an experimental herpes medicine, was tragically found dead last week – seemingly for causes unrelated his biohacking exploits. The biohacking flame is unlikely to be extinguished with Traywick, though the FDA has cautioned about self-developed injections.

Now, read on for The Week That Was...

Wooooow. That’s about all we can say after reading a sweeping investigative expose inThe New York Times Magazine about the corrupt marketing practices taken by INSYS Pharmaceuticals, the maker of the potent opioid pain killer, SUBSYS. The NYT’s 8,000-word feature unravels INSYS’ extensive, blatant efforts to essentially bribe cancer and pain management physicians into writing scripts for SUBSYS. The account chronicles years of efforts by company sales representatives to enlist physicians into becoming key opinion leaders involved in paid “speaker” programs that were tantamount to a quid pro quo for writing SUBSYS prescriptions. Company efforts included hiring exotic dancers to entice divorcee physicians and encouraging doctors to abandon work with pharmaceutical wholesalers who applied mandatory caps on pain prescribing. The end result was the creation of independent “pill mills” that were harder for the DEA to track – and thousands of patients becoming dependent on opioids. It is alleged that INSYS even used its own staff to pose as physicians’ office staff to overcome insurer prior authorization barriers that would’ve limited scripts of SUBSYS to cancer patients experiencing pain, which is the official label for the therapy.
This is some serious, well, stuff. In a post-Sunshine era, INSYS took repeated and flagrant steps to push its therapy on patients for whom it was not approved, and enticed doctors with monetary incentives.  But those who suffer are responsible patients in pain and pain therapy developers. Last week, FDA Center for Drug Evaluation & Research Director Janet Woodcock said there has been a “desert of pain innovation.” The bad actions of companies like INSYS make pain management a less-attractive field for innovation – and create hazards to chronic pain patients who deserve better options.

With President Trump’s widely anticipated speech on drug pricing due on May 8th, there are varying opinions as to whether it will have a meaningful impact on actual prices that patients pay at the pharmacy counter. Citing the enormous appetite for drug pricing control among Americans, Wells Fargo analyst David Maris believes “a rebellion is coming.” Maris cautioned "we worry that some may be living in a bubble, a cozy patent-protected, high-margin bubble, mesmerized by the bubble's beautiful swirling iridescence." (The guy does get some PR points for having a flare for dramatic language!). Maris believes that pharmacos and Wall Street are myopic to the implications of price control and how it could impact business. However, other health policy experts at Johns Hopkins told STAT, BALONEY! They argue that without any regulatory or legislative changes, nothing is bound to change, noting that the need to generate revenues for shareholders remains paramount in driving pricing decisions.
It’s true that rhetoric alone is unlikely to create a tectonic shift in drug pricing; but, we believe bluster from Congress and 1600 Pennsylvania Avenue has made an impact. In 2017, net spending on drugs increased just .6% after rebates and discounts, the slowest rate of growth since 2012. Net prices for brand drugs grew by just 1.9%. And at least six companies made price pledges – and even more issued price transparency reports. Net/net: words matter. We’ll be tuned in to HHS Secretary Azar and President Trump’s words on Tuesday.

The answer may be “yes” according to FDA Commissioner Dr. Scott Gottlieb, who signaled that rebates given by drug companies to pharmacy benefit managers create murkiness about the real price of medicines, and hinder patient affordability and competition. Commissioner Gottlieb signaled that the financial rebates that PBMs receive from pharmaceutical companies to secure attractive status on payer formularies (a prioritized list of approved therapies for patients) could be removed. To do so, the federal government must re-examine the current interpretation of the federal law shielding these rebates from legal “kick back” scrutiny.
The debate about costs absorbed by “middle men” has been the intense focus of PhRMA public relations efforts of late. Due to increased scrutiny, some payers like United Healthcare even committed to pass pharmaceutical rebate savings down to patients. Whether PBM rebates will arise in the POTUS’s drug pricing policy is TBD. Should rebates go the way of the dodo, watch for competitive categories like MS, diabetes and inflammatory conditions to face formulary reshuffling.

Since 1910, the government has had the authority to invoke so called ‘march-in-rights’ that override pharmaceutical patent protections during national emergencies. The City of Baltimore and Public Citizen is now calling on the Trump Administration to exercise this rarely-used power to combat the opioid crisis. The duo is urging the White House to override current patent protections of Narcan, the widely-used antidote to opioid overdose. This would clear the way for generic forms of Narcan to be manufactured, something that Baltimore and Public Citizen say could lower the cost of these life-savers and increase their availability.
It is unlikely that the Trump Administration will act upon this recommendation. The last time an Administration threatened to invoke march-in rights was during a fear of biologic warfare. However, there remains a significant PR risk for the manufacturers of therapies that address sensitive public health crises, such as the opioid epidemic and addiction.

A few weeks ago, we reported that PCSK9 partners Sanofi and Regeneron made news by agreeing to lower the price of its cholesterol fighter Praluent by ~60%, in an effort to make the therapy more accessible to those who could benefit from it. The manufacturers cited data from the Institute for Clinical and Economic Review – that the new price was more in-line with societal value. Fast forwarding to last week, the companies struck an exclusive deal with the largest stand-alone PBM in the U.S., Express Scripts. As a result, Praluent will be singularly listed on the Express Scripts formulary – a move that may help shift the PCSK9 market in the companies’ favor. In turn, the PBM agreed to drop administrative barriers to accessing the drug (e.g., detailed patient histories and lab results) and to pass along rebates directly to patients.
While these new headlines boast about price reduction, what may be overlooked is that Sanofi and Regeneron relinquished pricing power to address a commercial need. The reality is that prior to lofty PR announcements about ‘responsible pricing’ and access, Praluent had significantly lower market share than its competitor, Amgen’s Repatha. By cutting the price and pursuing exclusive contracting, and smoothing out access obstacles, Praluent will now have a more guaranteed chunk of the PCSK9 market.

See you next week,
-  The Reputation & Risk Management Practice @ Syneos Health Communications

About the Author:

We are a team of healthcare communicators, policy-shapers and crisis response specialists. Drawing upon professional experiences from Congress, CMS, HHS, hospitals, and health technology—and our collective work in rare disease, oncology, diabetes, gene therapy, pain management and infectious disease—we provide unique solutions to the evolving messaging challenges in today’s healthcare industry. We support our clients with evidence-based approaches to preventing pricing pushback, protecting brands from modern activism, establishing and communicating clear policies surrounding expanded access to medicines, and a proactive approach to value frameworks. Our offerings also include product safety, litigation, regulatory risks, ex-U.S. considerations and policymaker investigations.