If any of you have frequented a well-known San Francisco Bay-area hotel in recent months, you may have met Hazel, the new “hotel robot.” Hazel can help you out with your various travel needs – like bringing you a spare toothbrush or the newspaper.

And, if you stop at this Seattle hotel, she will even pop the question. As part of the “engagement package” guests can have Hazel do the anxiety-producing part of asking someone else to marry them. We don’t know what she does if the answer is “no, thank you…”

For now, we’ll stick with a strictly room-service-based relationship with Hazel, but you never know what the future will hold.  We do know what’s cooking in healthcare – and you will too – by enjoying this week’s edition of The Week That Was



 Funding for early-stage biotech startups has been revolutionized by the “venture creation model,” where startups are essentially incubated within a VC. The model has allowed more companies to start with less capital, creating a landscape that’s beginning to mirror the tech startup landscape of the early 2000s. In an analysis of this trend, Y Combinator predicted a potential future “explosion in the funding options for biotech companies.” We’ll see.


 The FDA issued a statement about Zolgensma, a recently-approved gene therapy for patients with spinal muscular atrophy. The statement, which was unusual for the FDA, publicly called into question the integrity of some of the data submitted as part of the therapy’s application. While the FDA “remains confident Zolgensma should remain on the market,” the manufacturer faces scrutiny for how this occurred, and how long the potential issue was known. Company leadership said they “are committed to rebuilding trust with society.”


 Adding to our list of “3,751 reasons we don’t envy Juul’s comms team” is the news that there have now been 127 reported incidents of people experiencing seizures after using e-cigarettes. The FDA has been investigating the incidents for months, but stressed they occurred over a ten-year period. Not the most reassuring statement from our view…


 We’ve heard the stories about genetic testing surprises. Long-lost siblings, unknown ethnicities, even a distant, famous relative. But as DIY genetic testing advances, it’s uncovering a lot of health information. When that information isn’t positive, it can make for a real communications challenge for the test manufacturer. For patients – such as the author of this STAT story – getting bad news in a brief, unemotional email can be incredibly jarring. And lawyers say the liability risk associated with genetic testing and failed/missed treatments is “gnarly.” Literally. It’s the word experts used to describe the increasing risk in this issue of Science magazine.


 TGIF, especially if you’re a woman looking to sit on a Lancet Group panel anytime soon. On Friday, the editors of the Lancet journals announced new commitments to diversity and gender equality. Taking a page out of NIH Director Francis Collin’s book, the editors made a pledge for no more ‘manels’ (aka. all-male-panels). Moving forward, the editors will not take part in any panel discussions where there are no female panelists, and will ensure a strong gender balance on any Lancet panels.

  Are we putting the CAR-T before the horse?

There are many things money can’t buy. But FDA-approved CAR-T cell therapies for patients on Medicare? That should be a different story. On Wednesday, the Center for Medicare and Medicaid Services (CMS) finalized rules for covering these potentially curative therapies. Yet, the decision received no applause from providers, pharmaceuticals or patients.

Some of the key points outlined in the CMS national coverage determination include:

  • Coverage will be given for the entire CAR-T process. As CMS Administrator Seema Verma outlined, coverage will extend to: “The administration of the drug. The collection of the cells. The manipulation of the cells and then putting it back into the patient. And then any of their outpatient or inpatient care as well."
  • Medicare will pay for CAR-Ts that are administered in “healthcare facilities” that adhere to the FDA’s safety rules. Notably, the distinction of “healthcare facilities” (vs. just hospitals) will allow for oncology clinics to also seek coverage.
  • The facilities don’t have to collect data on how patients are doing with the treatment, a concept that was present in previous draft rules.
  • CMS will only cover 65% of the payment costs, a rate that is 15% higher than previous proposals, but far short of what many hospital and provider groups sought.

This determination confirms the incredible potential of CAR-T therapies, but as we mentioned, not everyone is jumping for joy. Hospitals have serious concerns about whether they can break even by administering these therapies under these rates.

The bigger picture

Figuring out how to pay for CAR-Ts, and other similarly innovative and potentially curative treatments like gene therapies, has been an ongoing pressure point for the healthcare industry. Just days before the final determination, Seema Verma spoke with STAT about the challenges CMS encounters when considering payment for these treatments.

When it comes to pricing, the general consensus is that the current list prices for CAR-Ts are reasonable. ICER’s verdict, that the cost of current CAR-T therapies is aligned to their clinical benefit, has been particularly influential in fostering acceptance of current list prices. CMS even considered ICER’s analysis when developing their coverage rules.

Still, concerns about access and affordability persist, leading many eligible patients to continue to seek access to CAR-Ts through alternate pathways. A recent analysis found that as many as 25% of eligible patients opt for treatment through CAR-T clinical trials instead of approved, available therapies.

What does it mean?

When it comes to CAR-Ts, only time will tell. Many believe more efficacy and long-term data is still needed. Hospitals need to see how they will fare under the newest coverage rates. And, manufacturers need to assess the profitability and potential of CAR-Ts through commercial pathways – and whether deeper discounts are viable.

We’ll be keeping our eye on developments and sharing our perspectives with you along the way.

 Who wrote this? The managing editors of TWTW are Dana Davis, who, after 4 years at Syneos, is moving on to her next adventure, and Randi Kahn, who is sad her partner-in-crime is leaving, but simultaneously happy for her. The rest of the team may recover by 2020, but are still in a period of mourning.

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.

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Image credits: dollar sign by AlfredoCreates @ flaticondesign.com from the Noun Project, Data by Mat fine from the Noun Project, juul by Jake Tubbesing from the Noun Project, DNA by Lloyd Humphreys from the Noun Project, Female by Maurizio Fusillo from the Noun Project, IV Bag by Brandon Grant 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:

Dana Davis is a strategist in the Reputation & Risk Management Practice, where she helps biopharma clients communicate the value they bring to their stakeholders. Her expertise lies in issues of corporate activism; advising companies that must respond to activist tactics from patients, employees, or investors, as well as companies looking to take a proactive stance on social issues.

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.