|Don your fascinator and grab a cuppa, it’s time for The Week That Was. No, we haven’t lost the plot—we’re just basking in the glow of the Windsor nuptials. Harry and Meghan looked smashing, despite a stressful week of tittle-tattle about the Markle clan (#fakenews). While we could waffle on about the Royals, we bet some pharma news would be right up your street. Read on for The Week That Was...(U.K. style)
|►REGULATORS, STATES KEEN TO TAKE ACTION ON DRUG PRICES
We are gobsmacked at the amount of pharma pricing activity following the release of President Trump’s “Blueprint” to lower drug prices. In a speech last week, HHS Secretary Azar suggested that POTUS might tweet about pharmacos that pursue unwarranted price increases. And the threat of public scrutiny didn’t end there. CMS released its drug price increase database, which shows drug prices year over year, while the FDA released its list of Reference Listed Drug (RLD) Access Inquiries in an effort to stop drugmakers from “gaming” regulations to prevent generic drugs from coming to market. And if the three-pronged transparency push from HHS, CMS and FDA wasn’t enough, Paul Ryan is leading the charge on a compromise to the CREATES Act that would help speed generics to market.
And while DC policymakers focused on transparency, Vermont became the first state to pass legislation to import drugs from Canada. As goes Vermont so go…five other states that are already moving importation bills through their legislatures.
It seems like federal activities around drug price transparency are starting to align, giving a boost to recent legislative and regulatory efforts by states. While Massachusetts recently requested to exclude certain drugs from its Medicaid program and Maryland unsuccessfully tried to thwart price spikes on generic drugs, it can be ‘all mouth and (no) trousers’ for states without federal support. But what Vermont and others have succeeded in doing is building pressure at the federal level to take action.
With the advent of these new databases and an Administration focused on drug prices, pharmacos planning media in coming weeks (think ASCO, BIO) should prepare to address questions about company pricing philosophy, product lifecycle actions, and price increases. Developers with upcoming approvals need to seriously consider how to signal and, ultimately, share pricing relative to the U.S. market, but also in the context of therapies available overseas. If you’re concerned about communicating your medicine’s value approval and beyond, call us. We supported 20% of product approvals last year and medicines in more than 60% of the ICER reviews since 2016. We can help you translate you investments into the discovery, development, and ongoing delivery life-changing medicines into value messages that resonate across stakeholders.
|►LAWMAKERS HAVE A BUTCHER'S AT 340B INTENT
The Senate Health, Education, Labor and Pensions (HELP) Committee is looking for clarity about 340B, a program that requires drugmakers to provide additional discounts on outpatient drugs for safety net facilities. At issue is ‘intent’ of the program and its oversight. Regulators say that without more clarity into the prices that manufacturers charge 340B hospitals and how hospitals use the savings, there’s not a lot they can do to monitor the program, given its broad intent. In her testimony last Tuesday, OIG’s Ann Maxwell “stressed the necessity of a rule to implement the civil penalties on drug companies that overcharge on 340B drugs, as well as the need for transparency on the ceiling prices for those drugs.”
There’s been a lot of slagging off between pharma, insurers and PBMs. But hospitals and pharmas may find themselves in a row centered on 340B. Drug makers say the program has expanded far beyond safety net providers, with almost half of all hospitals now qualifying for the program while the amount of hospital charity care is appearing to decline. While much of the program’s criticism is falling on pharma, don’t go spare just yet. One of the biggest concerns here is system impact—are savings being used to provide more or better healthcare? Pharmacos can help answer that question by publishing health economics and outcomes research, validating a medicine’ benefit through direct system savings data whenever possible. If direct data is not available, point to indirect, qualitative savings.
|►SUSSING OUT PRE-CONFERENCE DATA
ASCO is still a couple of weeks away, so why are we already hearing about the big takeaways from the conference? For years, ASCO has been holding “presscasts” to highlight research that will be presented at the conference that year. But with thousands of abstracts and only six presented to media, how does this shape the story? ASCO is extremely responsible, and even releases the abstracts after markets close, but there can be unintended consequences.
Big conferences generate big announcements, so stakeholders (both professionals and lay-people) watch eagerly for data on innovation treatment breakthroughs. This increased visibility means that more mainstream outlets may be covering these announcements—heightening the importance for manufacturers to properly contextualize their data and messaging. Embargoed information can be invaluable to both reporters and developers, but beware. With a limited amount of information shared under embargo, reporters (or lay bloggers) can start to fill in the story with off beam assumptions. Consider providing additional sources and validators along with embargoed information to ensure that stories are full of facts, not perceptions.
|After celebrating the Duke and Duchess of Sussex all weekend, we are absolutely knackered. Good thing for us, we’re on holiday next weekend (Memorial Day) and will return in a fortnight!
Well, Bob’s your uncle. There’s nothing more to say except, “Cheerio!”
- The Reputation & Risk Management Practice @ Syneos Health Communications