|Summer hit the country hard this week, with temps on both coasts and most of the Midwest reaching near-triple digits. Last week’s headlines were nearly as extreme. From one biopharma’s Right-to-Try misstep to political shade thrown at BIO and PhRMA for the infamous PABNAB rager, the industry heated up with one controversy after another. Crank up the A/C and read on for The Week That Was…
|►ACCESS—EXPANDED THEN RETRACTED—IN ALS
BrainStorm Cell Therapeutics made headlines recently by promising broad access for its investigational ALS therapy—for a price of about $300K. When BrainStorm CEO Chaim Lebovits said the “right-to-try” program was a “semi-commercial enterprise,” critics hit the company hard, calling the plan potentially dangerous, exploitive and even illegal. After days of intense scrutiny, the company cancelled the program, stating that access to the medicine would only be available through a clinical trial it is currently enrolling. Lebovits blamed a Bloomberg reporter for taking his comments about profiting out of context, causing the controversy.
While the new Right-to-Try law has been heralded as expanding patient access, it really just removed the FDA from the petition process—causing confusion and consternation for patients and pharmacos alike. Patients, understandably, want access to potentially lifesaving therapies as soon as possible. But “right-to-try” doesn’t mean “right-to-try for free.” Drugmakers are absolutely within their rights to charge in order to recoup manufacturing and other costs associated with expanding access to investigational medicines. Moreover, pharma companies want to protect the integrity of their clinical development programs—an issue that gets complicated by granting access outside clinical trials. And while the FDA is not supposed to factor in expanded access data as part of an NDA, Wall Street and Main Street often interpret AEs in “right-to-try” patients as safety risks, stifling uptake in the indicated population.
As the dust settles in the post-RTT environment, pharma companies need to be mindful of patients’ perceptions of these rights versus the letter of the law. We advise our clients to get ahead of these questions: Be fully transparent with clearly communicated policies regarding expanded access—even if that policy is no access—readily accessible to the public. Prepare statements about the company’s rationale, should media or policymakers come calling. And never ever try to use expanded access as a press hook. Even the best intentions around RTT will seem disingenuous if the program doesn’t pan out as promised. Too much is on the line (for both patients and pharmacos) to treat expanded access as an afterthought.
|►IS TRUTH IN ADVERTISING WAC?
According to a Kaiser Family Foundation survey, 76 percent of people polled are in favor of requiring biopharmas to include list price in prescription drug ads—a notion floated by the Trump Administration in its “Blueprint to Lower Drug Prices.” KFF notes that this proposal received bipartisan support, with nearly equal numbers of Democrat, Republican and Independent participants in favor. Critics note that this effort to improve pricing transparency would be moot, since few patients don't actually pay list prices.
Overwhelming support for pricing disclosures in ads reflects continued populist angst over drug prices. However, this effort toward more transparency would actually provide less—or, at the very least, be very misleading for consumers. As those in industry know, list price is just a starting point. Consider weight-based or other individualized dosing, and then factor in discounts and rebates to payers and PBMs. In reality, there isn’t just “one” price for a drug—and making it appear otherwise may just add to the confusion for patients. How can pharmacos get ahead of this potentially distorted reality? Promote your patient support programs. Call centers that help patients understand their health plans—whether a drug is covered and what they will likely owe out-of-pocket—provide actual transparency, albeit on an individual level.
|We’re prepping the grill and mini-pool to get ready for Independence Day, but we’re giving our laptops a much-needed rest. TWTW will be on hiatus next week, but we’ll return to your inboxes on July 16th. Happy 4th!
- The Reputation & Risk Management Practice @ Syneos Health Communications