It’s Monday. It’s fall. And everything is far from certain in healthcare. But as Enzo Ferrari said, “The future is always in the hands of those who know how to preempt it.”
But, how do you predict American consumer and patient behavior when their own perspectives are split? Well, that’s the million dollar question. Whether its food, health insurance or drug prices, we seem to have conflicting thoughts – both as individuals and as a nation. While there are no easy answers; get ready to dissect our conflicting concerns in The Week That Was: The Cognitive Dissonance Issue.
►PUBLIC RELATIONS AWARD OF THE WEEK: REGENERON
Let’s be honest; when the CEOs of biopharmaceutical companies are covered in national media, the tone is typically less-than-complimentary. Some may even argue it’s UNFLATTERING. This is precisely why an article by The New York Times’ Gina Kolata stood out last week. In response to Kolata’s October 2nd story about two heart disease patients denied powerful, cholesterol-lowering PCSK9 inhibitors by their insurers, something unusual happened. The day the story ran, Kolata received an email from Len Schleifer and George Yancopoulos, the respective CEO and CSO of Regeneron, the company that makes one of two PCSK9 therapies. In a telling account, Kolata described how Yancopoulos, offered his personal cell phone number and encouraged the profiled patients to reach out to him. He offered to help liaise with their insurers, and if that didn’t work, give them the drug for free. Yancopoulos added that the barriers which insurers have placed on PCSK9’s are so challenging that even Regeneron’s own employees didn’t have covered access to their company’s own medicine.
It’s nearly impossible to read Regeneron’s response and not come away with the impression that this is a company that genuinely cares about patients. Regeneron has been known for speaking frankly (recall readers when Schleifer confronted Pfizer CEO last year). In this circumstance, frankness worked well. By giving access to the Times, Yancopoulos demonstrated Regeneron’s concern for patients; the challenges insurers are putting in place that can adversely affect patients and the steep investment the company invested in developing its PCSK9. There’s a message here for executives: while it’s nerve-wracking to give reporters deep access, sometimes it may be the only way to convey the facts and your intentions.
A new report by FirstWord Pharma finds that up to one in three biologic-prescribing physicians who participated in a recent survey recounted that they were exposed to negative word-of-mouth messages about biosimilars over the last six months. Physician respondents said that they were targeted with negative messages about biosimilars, including raising concerns about safety (cited by 58%), efficacy (55%) and efficacy related to extrapolated indications (55%). Nearly half of all physicians exposed to negative information said this had come from originator biologics companies. This news comes on the heels of Pfizer filing a Citizen’s Petition with the FDA last August. That petition accused rivals Amgen, Johnson & Johnson and Roche of disseminating “false and misleading” information about biosimilars in the U.S. (For more, see TWTW, Oct. 1, 2018).
Seven years after the passage of the Act outlining the regulatory pathway for biosimilars, the market remains stifled, potentially costing Americans billions annually. Legislative and regulatory gaps, coupled with legal murkiness, and patent dances, contribute to biosimilars being underutilized. In this opaque environment, competitors will seek to create boundaries on their own. But, the question is, if you manufacture branded biologics AND biologics, how do you engage? If you’re confident in your biosimilar (or biologic) post-marketing safety monitoring, interchangeability and differential naming should not be a threat. Ultimately, a good medicine is a good medicine. However with ~$293 billion in annual global biologic sales set to lose patent protection by 2023, we predict the fight will continue!
►ZEKE EMANUEL: PRESCRIPTION FOR THE FUTURE
Last week, the former head of the NIH Dr. Ezekiel Emanuel gave a lecture on the intersection between bioethics and drug prices, titled “When Is A Drug Price Unjust?” Dr. Emanuel critiqued the pharma industry’s commonly cited reasons for high drug prices; such as costs of research and development, risks associated with drug failure, investment into future medical innovations, and the desire for fair revenue. He argued a lack of regulation and monopolies enable expensive drugs to maintain exclusivity. His solution: value-based price standards relative to average lifetime earnings. He asserted that society should reward drugs that prolong and improve quality of life, but that doesn’t create a disproportionate burden relative to an individual’s average earnings over a lifetime. After some carefully calculated math on Americans lifetime spending, Emanuel concluded any drug priced over $70,015 is unjust.
Dr. Emanuel has long had sharp words about the cost of healthcare. In a Wall Street Journal op-ed about immune-oncology medicines, Emanuel cited a recommendation from the Institute for Clinical and Economic Review that argued drugs should be priced in such a way as to increase total drug spending by no more than GDP growth plus 1.5%. In 2018, that figure would be ~$15 billion, so if 30 new drugs were approved, no single one could add more than $500 million to the total GDP. Our take: that model is unlikely to occur – but concerns about the budget impact of new drugs on private and government payers are here to stay.
Okay, enough economics. Have a good week and see you next Monday.
The Week That Was Team