World Mental Health Day was this week and celebrities shared personal stories and called for an end to stigma about mental health disorders. Our favorite commemoration came from Prince Harry and Ed Sheeran who jested about stigma against redheads. On a more serious note, “the Good Place” actress Jameela Jamil shared an emotional post about her suicide attempt.

These moments of observation remind us of the importance of helping people with mental illnesses – and – make us proud that 140 new therapies are in development by the pharmaceutical industry to treat mental health disorders.

With that in mind, on with the news, which gave us hope and a bit of anxiety this week.



California is the first state to authorize pharmacists to dispense pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) without a doctor’s prescription. The new law also prohibits insurers from requiring prior authorization for coverage of the medication. The Golden State is an HIV hotspot so it is no surprise it’s making bold advances in prevention policy.


New York is about to find out just how rare, rare diseases are. This spring, new parents giving birth at eight hospitals in NY will be allowed to opt into a pilot program to test their newborns for 13 rare genetic diseases along with standard screenings. This is in addition to another pilot program announced last week that will screen newborns for Duchenne’s Muscular Dystrophy. The programs could lead to babies and children getting earlier care for diseases that may not present symptoms until later in life.


The New York Times featured the story of a medicine designed for only one person: Mila. A doctor at Boston Children’s Hospital developed the personalized medicine, milasen, after identifying an anomaly in Mila’s Battens Disease, a rare, fatal, debilitating neurological disorder. The R&D was funded through crowdsourcing -- raising questions for the path forward for N-of-1 personalized medicine. 


Elmo has a new friend: a green muppet named Karli who was in foster care as her mom was treated for addiction. Karli has been featured on “Sesame Street in Communities,” a series of online videos and resources, since May in an effort to help children understand foster care, but only recently revealed her full backstory. What we want to know: Will there be a Sackler muppet? 


Men account for less than 1% of all breast cancer cases in the U.S., but male breast cancer patients have a 19% higher mortality rate than females. According to a recent study in JAMA Oncology, biological attributes, treatment compliance and lifestyle factors are likely to blame for the disparity and not access to treatment. Lead author Dr. Xiao-ou Shu of Vanderbilt, said the results reinforce the need for more research into the biological features of male breast cancer and tailored treatments.

Mo' Money, Mo' Problems

By Che Knight

Turns out, some blockbuster drugs are breaking the bank to the tune of $5.1 billion – at least according to independent watchdog group, Institute for Clinical and Economic Review (ICER). Earlier this week, ICER published a report on Unsupported Price Increases of Prescription Drugs in the US. The report identifies the “drugs whose price increases would have contributed to the largest net increase in drug spending in the US,” and determined that the US spending impact of these price increases in the period 2017-2018 was more than $5B.

The analysis identified and ranked 100 drugs whose price increases contributed the most to US drug spending. Within that list, ICER called out seven drugs, all blockbusters with large patient populations, that it said lacked evidence to support additional clinical benefit, and therefore could not justify the price increase. The report additionally names two drugs that did have important clinical evidence – although ICER is careful to caveat that this doesn’t mean the evidence is sufficient to justify their price increases.

Implications for manufacturers

Although a number of factors go into pricing a drug, and increases can be attributed to many causes from coverage issues to supply chain challenges, ICER’s interest remains singularly focused on drug price as it impacts patients and the larger system.

What you need to know:

  • Be on notice. We can expect policymakers to use these lists as a reference for who to “blame and shame.” This report is intended to be annual, so even companies not mentioned in this year’s iteration should be aware that future reports could include them. Value communications are no longer “one and done,” but require an ongoing commitment that continues long after approval – a fact that’s doubly true for blockbuster drugs and costly drugs with a large patient population.
  • Be proactive on value – and define it globally. While showing value to the patient is critical, manufacturers must satisfy ICER’s imperative to prove more. That means manufacturers must communicate how a drug will be a valuable contributor on a system-wide level, especially over time.
  • Be ready with data. The drugs ICER excluded from its list were supported by new evidence that, in their estimation, does not necessarily justify the full price increase, but could warrant some fraction thereof. As a result, ICER and other critical parties will look to manufacturers to provide data and evidence to support the key points in their value communications.

If you have questions, hit us up.

Pulse on Policy: Marching in 

By Michelle Leeds

As the debate over reigning in drug pricing continues to run hot in Washington and on the campaign trail, the proposals from Democratic candidates are ratcheting up the pressure on their favorite boogeyman. This week, South Bend, Indiana Mayor Pete Buttigieg released a proposal that would engage an obscure section of a 1980 law that allows the federal government to break a patent on a drug if it deems the price is too high.

The concept is called “march in rights” because, under the law, the government has the right to “march in” and take back a patent that originated in publicly-funded research if the public does not have sufficient access to the goods. The provision has never been exercised, but even the threat of ignoring the exclusivity of a patent can give the government leverage in negotiations.

Senators Bernie Sanders and Kamala Harris have also proposed this idea in their drug plans, while Senator Elizabeth Warren has otherwise endorsed the concept. The key takeaway here is that candidates are exploring tools the president has at his or her disposal that do not require a stymied Congress to pass legislation.

With all this heightened rhetoric, it’s no wonder PhRMA is reportedly now lobbying for a compromise on legislation this year – rather than take their chances with a less friendly administration in 2021.

We’re continuing to monitor the situation so stay tuned!

Who wrote this? The managing editor of TWTW is Randi Kahn, who is still deciding what to wear for an upcoming Halloween party. Please send creative suggestions. Syneos Health Communications' Reputation & Risk Management Practice is a team of healthcare communications consultants, policy-shapers and crisis response specialists. We provide unique solutions to the evolving communications challenges in today’s healthcare industry, using evidence-based approaches to help our clients successfully navigate the most sensitive of situations.

Got thoughts? Contact Randi Forward ThisblankSend to Linkedin

Did someone forward this to you? You’re so lucky! Sign up to receive TWTW every week.

Feeling nostalgic? We get it. Check out old TWTW issues here.

 Want to find us? 200 Vesey St., New York, NY 10285

Image credits: hiv ribbon by Beny Eka Saputra from the Noun Project, Blood Test by Becris from the Noun Project, DNA by Lloyd Humphreys from the Noun Project, Drug by Sakchai Ruankam from the Noun Project, Male torso by Andrejs Kirma from the Noun Project, dollar sign by Alfredo @ from the Noun Project, American Flag by Xinh Studio from the Noun Project, American Flag by Xinh Studio from the Noun Project

And now please enjoy this disclaimer that prevents our team from getting in a heap of trouble: This report may contain links to external or third party websites. These links are provided solely for your convenience. Links taken to other sites are done so at your own risk and Syneos Health accepts no liability for any linked sites or their content. Syneos Health makes no warranties or representations, express or implied about such linked websites, the third parties they are owned and operated by, the information contained on them or the suitability or quality of any of their products or services. Syneos Health does not authorize the infringement of any intellectual property rights contained in material offered through these linked sites. Please refer to the use agreement and/or copyright statements of any external site you visit, or the terms and conditions of any externally provided web site for instructions, restrictions, and guidelines. If you have a question, please contact the webmaster of the external site.

About the Author:

Randi Kahn is a Senior Media & Content Director in our Reputation & Risk Management Practice, where she helps clients build and protect their brand reputations through executive thought leadership, public affairs, and issues preparation and response. She has worked for clients throughout the healthcare ecosystem including payers, providers, patient groups and pharma.