Move over Felicity Huffman and Lori Loughlin, there are some other parents going to extraordinary measures to help their kids get into college. Seventeen South Korean academics have been caught naming children, mostly their own kids, as co-authors on their manuscripts when they did not contribute to their research.

The South Korean education ministry says the problem dates back to 2007 and involves at least 24 papers. Eek! While they broke the rules, the offenders will not be joining Huffman behind bars. The repercussions being considered include reprimands, a one-year limit on participating in national research activities, and dismissal from their jobs.

As we reminisce about the extra-curriculars listed on our college applications (shocker: managing editor of the school newspaper was among them), read on for the rest of the week’s news -- including an announcement from ICER and an update on the Trump Administration’s plans regarding drug pricing.   


THE WEEK THAT WAS

Monday

Fingers crossed that it’s “bye-bye” to Ebola! After two decades of research, the EU approved the world’s first vaccine for Ebola. A vaccine has been a top priority for the European Commission following the 2014 outbreak in West Africa, which infected over 28,000 and killed over 11,000 people. The FDA is slated to make a decision by March 2020.

Tuesday

Getting the hiccups may annoy you (Meg Alexander), but maybe you should be relieved it’s happening.  New data reveals hiccups play a big role in newborn brain development and are correlated to brain signals that activate involuntary breathing. The cause of hiccups in adults remains unknown, but scientists say stress, excitement or eating could be triggers.

Wednesday

While it’s still the leading cancer killer, survival rates for lung cancer are improving. A new report from the American Lung Association found the five year survival rate for lung cancer has increased 26% over the past decade. The report underscores the lifesaving potential of improved lung cancer screening, and the importance of advancements in lung cancer research and treatment options. On a state-by-state basis, Utah has the lowest lung cancer rate, while Kentucky has the highest. 

Thursday

Health literacy can be challenging enough without having to sift through deceiving information. Google is taking a stand against misleading insurance advertisers -- removing ads that blatantly use the term “healthcare.gov" and falsely claim to be the federal health insurance marketplace. Although this is an important step to ensure ACA users find the right website to purchase healthcare coverage, there are still plenty of ads targeted to those looking for the government marketplace that could confuse shoppers. Lawmakers and patient advocates urge ACA shoppers to go directly to healthcare.gov and not use a search engine to find it (good luck with that). 

Friday

In other healthcare shopping news…The Trump Administration will force hospitals to publicly disclose prices in an effort to help patients shop for better deals. Patients should theoretically receive clearer information on hospital costs negotiated with insurers for in-network care and out-of-network care, as well as the cost for those paying cash. The transparency rule will go into effect in 2021 but is likely to be challenged in court.   

Pulse on Pricing: IPI Insights  

By Randi Kahn and Michelle Leeds

This week we got a glimpse into the Trump administration’s latest thinking on reference pricing. Secretary of Health and Human Services, Alex Azar, said the agency will revise its International Pricing Index policy to be more aggressive. Recall readers, the initial IPI proposal aimed to reduce drug prices by tying payments for Medicare Part B drugs to the average of drug prices paid by other developed countries. Revisions now aim to deliver President Trump’s goal of getting the “best deal” for America by pushing for “most favored nation status.”

Another revelation from Azar: this policy will be proposed as a regulation from HHS, and not as an executive order, as President Trump had indicated in public statements last July. Taking that avenue means a longer road ahead for implementing the anxiously anticipated regulations, which will require a public comment period. It will also give the policy more permanence as Executive orders can be overturned by new administrations.

What’s next? The timing on the regulation is still vague. The Office of Management and Budget has been reviewing an IPI policy since June, but it is unclear if what’s in their inbox is the current version. The administration could also be waiting to see if Congress will be able to pass drug pricing legislation this year before considering more aggressive steps via executive action.

Meanwhile on Capitol Hill, two bills were blocked in the Senate that would have required price transparency in advertising as well as patent reforms. Democratic presidential candidates Senators Bernie Sanders and Corey Booker teamed up on a new proposal to create a bureau that would review drug costs and price increases. Under the bill, drug makers would have to submit: their costs of research and development, the amount of government investment that contributed to the development, and the product’s US price, along with the prices charged in 11 countries with market controls.

How much is a Cure Worth?

By Ché Knight and Miriam Kalnicki

With more than 20 gene therapies in Phase III, the Institute for Clinical and Economic Review (ICER) released a set of adaptations to their methodology for evaluating the value of “high impact, single short-term transformative therapies” (SSTs).

So how will ICER reconcile the tug-of-war between the promise and uncertainty in valuing potential cures? Well, we got the start of an answer. Check out ICER’s five adaptations to their value assessment framework for SSTs, which was developed in close collaboration with England’s National Institute for Health and Care Excellence (NICE) and the Canadian Agency for Drugs and Technologies in Health (CADTH).

  1. Defining what qualifies as an SST: Simply put, ICER defines SSTs as therapies delivered through a single intervention or short-term course of treatment (less than one year) and offer substantial or sustained benefits (i.e., potentially curative, produce major health gains, or halt the progression of significant illnesses).
     
  2. Addressing uncertainty and potential benefit: ICER will use different models to account for the potentially curative impact of SSTs by introducing both optimistic and conservative scenarios to determine a possible range of treatment benefit. It will create a dedicated section of its reviews to expand discussion around uncertainties and controversies. This section may include a discussion on the number of years a treatment will need to be sustained to reach cost-effectiveness thresholds (think on it as an ROI measure of sorts) and commentary around the uncertainties of the modeling.
     
  3. Additional domains of “value” added to ALL ICER reviews (not just SSTs): To consider benefits and disadvantages of new treatment options, an independent appraisal committee will vote to determine value based on three new metrics. These include the therapy’s potential: 1) advantages versus risks, 2) ability to increase access to future treatments, and 3) risk of precluding future treatments, if it is unsuccessful (imagine a scenario in which a gene therapy doesn’t work and a patient couldn’t take another intervention).
     
  4. ICER will apply the 3% discount to both health outcomes and costs: ICER isn’t changing its reference case applying the standard discount rate to all drugs, including SSTs.
     
  5. Hypothetical “shared savings” scenarios to model cost-offsets: If curative, SSTs may hold great potential to “bend the healthcare cost curve” by offsetting traditional costs of care. And, ICER is putting two scenarios in place to model these potential cost offsets. The first scenario will model 50% of the lifetime health system cost offsets back to the health system (insurers). The second scenario will assign cost offsets entirely to the new treatment, but cap them at $150,000 per year. Both scenarios could potentially undervalue the long-term savings and value of new treatments.


OUR TAKE

Much of the adapted methodology – including whether to use the adapted framework in the first place -- points to the need for increased engagement from manufacturers. Developers who are working on candidates beyond gene therapies and CAR-Ts, should pay attention to the new “domains of value.” These are what ICER is calling “the value of choice among treatments”, the value of options to additional treatment, and the benefit/disadvantage of not being able to receive additional treatment if the therapy is unsuccessful (as is a concern in some potential therapies).

The new methodology also raises the profile of discussions on health system cost-offsets, which have traditionally been a less visible part of the public discourse on drug pricing. Manufacturers will need to refine and clearly delineate how they differentiate against alternative treatment options with health economics arguments at the ready.

Who wrote this? The managing editor of TWTW is Randi Kahn, who desperately wants llama therapy. 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: injection by Jordan Alfarishy from the Noun Project, hiccup by priyanka from the Noun Project, Lungs by karina from the Noun Project, television ads by Nhor from the Noun Project, Hospital by supalerk laipawat from the Noun Project, dollar sign by Musmellow from the Noun Project, dollar sign by Musmellow from the Noun Project DNA by Lloyd Humphreys from the Noun Project
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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.