What may have once seemed like it was ripped from the pages of science fiction was realized last week, when the FDA unanimously voted in support of CAR-T, a pioneering therapy that uses the body’s own immune cells to attack cancer. In contrast to this this giant step forward for patients and providers, the status of “Obamacare” stood steadfastly still after Senate Majority Leader McConnell (KY) again deferred the Chamber’s vote to repeal the Affordable Care Act, pending the return Sen. McCain (AZ) following emergency surgery. With two Republicans—with Sens. Collins (ME) and Paul (KY) refusing to support the bill, McConnell can’t afford to lose a single GOP vote and pass the repeal.
Despite the lack of action in Congress, we have plenty of other news for you, so read on for The Week That Was…
WHY THE FDA BECAME THE HOTTEST SHOW IN TOWN
On Wednesday, an FDA advisory committee voted unanimously to recommend Novartis’ CAR-T therapy for acute lymphoblastic leukemia—moving the U.S. a step closer to having an approved gene therapy. While media coverage of an FDA ad comm usually is proportionate to the novelty of the therapy, magnitude of the breakthrough for patients, and the significance of the decision to the industry, the CAR-T vote seemingly set a new record. Reporters tweeted throughout and STAT News featured a live blog of the meeting.
Live media streams traditionally reserved for car chases and celebrity concerts are not the norm for arcane governmental proceedings (with the exception of C-SPAN, perhaps). Yet, this application of digital media opens the formalities of the drug approval process to a much larger audiences. That means that biopharmaceuticals need to be prepared to showcase the value of a medicine—and to answer questions and concerns from a wide variety of stakeholders—long before commercial launch. When a product is highly anticipated, any public event, from medical meetings, to investor days, to regulatory milestones, can generate questions that are potentially “off topic” from event-specific talking points. Drugmakers need to ensure their company spokespeople have been properly briefed and that their communications team has developed message points on value, access, and topline pricing questions—including a few with 140 characters or less.
TRANSPARENCY: A FRESH START TO RIGHTING PRIOR WRONGS
As if opioids weren’t in the news enough lately, legal actions against Insys, maker of opioid Subsys, have dominated recent industry headlines. Last week, two former Insys Therapeutics sales reps pled guilty to violating anti-kickback laws by participating in a speaker program that claimed to educate medical providers about Subsys. Prosecutors however, argue the program was used to reward physicians for prescribing the drug. Other company executives, including the former CEO, were charged in relation to the program late last year. Rather than responding to press inquiries, the company has opted to communicate with the public through statements on its website, including details about the company’s CEO succession plan, its intent to cooperate with authorities during investigations, and its forward-looking transparency goals. But the Street doesn’t seem too reassured: Insys stock was down at the close of the week.
How much detail is appropriate for a statement responding to a lawsuit or judicial inquiry? The answer is: it’s tricky. If you divulge too many details, the content could wind up in court; but if you say too little, then you risk looking guilty in the court of public opinion. It’s certainly important for a company’s leadership to reassure stakeholders that they have a plan in place to move forward. The key question corporate communicators must ask is: what is the right channel and the appropriate content? Some nuanced updates may be better communicated directly to stakeholders via conference calls with employees, key opinion leaders and shareholders. Addressing inaccuracies and intent are appropriate for a public statement.
CAN A MEDICINE HAVE TOO MUCH POTENTIAL?
What happens when a company discovers that a drug marketed to treat a very rare disease also has medical benefits to a much more common one? The Wall Street Journal provides an in-depth look at questions manufacturers must address when a drug shifts from rare to chronic populations. The WSJ focuses on Novartis, which recently discovered that Ilaris, a drug it sells for a group of very rare inflammatory diseases, could be used to treat patients with heart conditions. At $16,000-per-dose—a modest price tag in the rare disease market— Novartis would have to reduce the cost be competitive with other cardiac drugs. The decision to enter the cardiovascular market could raise a range of pricing considerations to company executives, including: lowering the list price, considering indication-based pricing, and more.
Pricing decisions are not easy. Guessing how payers, providers and your competition will act requires a lot of (well) educated assumptions. If you’re a pharmaceutical executive who gets the price wrong, you’ll have to answer to your peers, the public, and potentially Congress. The WSJ’s feature signals mainstream audiences and investors are increasingly interested in the tensions between business decisions and ethical concerns. The lesson to pharmacos is to keep this tension top-of-mind. Stakeholders expect transparency and explanations of the nuances and challenges that manufacturers work through to help patients. Our advice: be ready to proactively explain, in clear terms, the factors that influence the price of your medicine.
Until next week,
– The Issues Management Practice @inVentiv Health Communications