Well folks, it’s officially summertime in the city…but the livin’ is not exactly easy for The Week That Was editorial team! There are just too many hot headlines to choose from.
We busted out summer wardrobes and endured the first of many less-than-comfortable subway rides, but it was other heated climate news that dominated headlines last week. President Trump decided to pull out of the Paris climate agreement; the New York Times turned up the temperature on industry lobbying on drug pricing; Ohio announced a downpour of suits on opioid makers; and ICER held an all-day summit on orphan drugs.
And we endeavored to decipher the secret meaning of covfefe — while also being grateful for the miracle that is spell check.
Without further delay, please enjoy The Week That Was.
SCOTUS RULING EASES PATH TO IMPORTATION
Last week we saw some serious sparring in the Supreme Court over the riveting topic of: printer cartridges. Before you flip to your next email, the ruling has some import! SCOTUS’s finding may have removed a tool that pharmaceutical companies use to stop unauthorized importation of medicines from ex-US markets. The case involved Lexmark toner refills and whether it controlled the patent rights to its cartridges after they were sold. A company called Impression had been buying old ink cartridges in the United States and refilled them abroad for resale back to U.S. consumers. The Court backed Impression and ruled that a company’s patent rights end after a product is sold the first time – even if the sale occurs outside the United States. For pharma, the potential implication is that medicines sold at lower prices overseas could be shipped to U.S. patients. The pharma industry’s two largest trade associations filed amicus briefs arguing that their members should be able to use their patents to thwart such imports.
So will we be importing drugs from Canada next week? Well, not exactly. The Court’s ruling may have eliminated one tool for life science companies to control their products, but it did not legalize the importation of medicines. FDA regulations still prohibit most sales, and industries with relatively few customers can control their products more easily through contracts than those that sell mass quantities directly to consumers (like printer cartridges). For communicators, the ruling means that the issue of less expensive list prices overseas is once again back in the headlines, and the industry’s “whack-a-mole” reality to dealing with pricing debates continues.
ICER & THE ORPHANS: VALUING RARITY OR SEVERITY?
Last week, our team as well as rare disease drug developers across the nation tuned into the Institute for Clinical and Economic Review’s (ICER) policy summit on value assessments for orphan drugs. Seven hours of value framework talk is enough to exhaust our most focused of colleagues – but no one can accuse ICER of shying away from the tough issues.
The panelists immediately tackled tough questions, such as:
While the subjects were amply provocative, consensus was absent among the economists, bioethicists and pharmacos in attendance. ICER concluded by comparing access and coverage of medicines in the U.S. to Europe. ICER’s President Steve Pearson noted that in countries like the U.K., the National Institute for Health and Care Excellence (NICE) uses assessments that enable the government to say “no” — arguing such a system becomes the starting point for price negotiations with drug makers. But whether European-style cost effectiveness analyses would be culturally palatable in the U.S. are yet to be seen. Coverage decisions and treatments denials in Europe can drag on for years – especially in rare medicines. Our prediction: ICER is making some changes to its framework to better capture the personal and social costs of disease, but its assessments are still framed with a payer lens.
Mark our words: orphan pricing pushback is coming! By 2020, orphan drugs will account for 1 in 5 prescription drug sales, and represent increasing portions of medical innovation. inVentiv’s own payer research shows that the day when orphans are covered are “coming to an end.” In this environment, believing in your therapy and science isn’t good enough—you need to show it. Bring in press and patients to see first-hand the complexity of rare development and integrate value messaging across external-facing channels like your website, policymaker meetings, and medical Congresses.
PRO-HELMET LOBBY WINS WITH POPULIST MESSAGE
Pro-helmet activists are making head-way in their quest to establish and protect state helmet laws. A coalition of doctors, accident survivors and insurance groups are fighting for legislation requiring motorcyclists, ATV and moped riders to wear helmets. But they face hard-headed opposition: motorcyclist groups are simultaneously waging a war to loosen existing helmet laws citing “freedom of choice.” Since 1995, seven states loosened or repealed their helmet-laws. So pro-helmet activists have their work cut out for them. These activists are pairing some tried-and-true advocacy tactics (citing data about lives saved by helmets, sharing the stories of crash victims) with some populist approaches. So what’s working? The cost argument. Yep, helmet activists are appealing to a wider spectrum of voters by explaining how “taxpayers would be on the hook for more health care costs if motorcyclists were allowed to go without helmets.”
While protecting your noggin seems like a no-brainer (sorry, we can’t help ourselves), the emotional appeal of crash victims alone was not doing the trick in protecting state laws. So pro-helmet activists steered toward an economic message to deliver success. Instead of trying to incentivize a small subset of individuals to wear helmets, they focused on galvanizing the larger community to make them do so. In a populist world where Americans are pinching pennies, the pro-helmet group is finding a way to make wearing helmets in everyone’s self-interest.
Until next time,
– The Reputation & Risk Management Practice @ inVentiv Health Communications