Over the summer, we tend to eat healthy and exercise more to have that beach-ready bod. Bears, on the other hand, do the opposite – upping their intake in preparation for hibernation in cooler months. In honor of this tradition, Alaska’s Katmai National Park launched “Fat Bear Week,” a March Madness-style Facebook contest where people vote to determine which pooh bear has grown the greatest gut.
Some hibernation time of our own sounds awfully good this weekend. For those sitting on the couch or reading in bed: enjoy this helping of healthcare news from a busy week.
I've got 99 problems, but approval ain't one
By Ché Knight
Gene therapies. They’re one of the most popular classes in development right now with the FDA expecting to receive more than 200 investigational new drug applications (yes, 200 INDs!) per year for gene and cell therapies starting in 2020. While we know the challenges of conducting clinical trials and obtaining regulatory approval for innovative new classes of medicine, a new report highlights the challenges manufacturers face once these drugs hit the market.
There are currently four FDA approved gene therapies, but accessing them is a major issue. Only five U.S. zip codes offer access to all of them, and 13 states have no gene therapy facilities at all.
Developers already know that commercializing a new class of gene therapeutics requires unique measures for education, treatment administration, patient monitoring, and more. But there are other systemic challenges impacting uptake as well:
- Scaling out vs. scaling up: As gene therapies are more personalized, manufacturing will require “scaling out” to ensure patient-specific processes are established – not “scaling up” like traditional batch manufacturing.
- Responsive supply chains: Speed in manufacturing, distribution, and reimbursement is of the essence. Delays in treatment may be life or death, and can undermine outcomes-based contracts.
- Tailored reimbursement models: As applications of these therapies increase, payers’ ability to absorb costs over time may pose a considerable challenge.
So, what can life sciences companies do?
- Communication is key. In what is likely to be a highly competitive environment, manufacturers developing gene therapies should be prepared with messaging that addresses these issues while still in development, including: 1) competitive advantages in manufacturing and 2) company initiatives to overcome access challenges.
- Reframe approach to manufacturing. The process doesn’t end when the drug leaves the production facility. Some companies are already starting to include treatment centers where the drug is administered to patients to ensure proper collection, quality, and handling of the drug. It will be critical to build communications strategies that support educating clinicians and fielding complex questions.
- Take an active role in logistics and tracking. Due to the delicate nature of gene therapies, a single temperature failure could render a medication useless. Delaying delivery may rob the patient of a second chance. Supply chain companies are working with developers to create real-time tracking software that provides frequent updates on the conditions where the drug is stored, its whereabouts, and even the return process.
- Think outside the prescription box. When it comes to insurance coverage and provider reimbursement, companies are adapting to payer concerns by offering different payment models meant to spread costs out over time and guarantee outcomes. Transformational treatments with a one-time administration should consider communication early about their potential cost-effectiveness relative to chronic treatments.
And the final tip: You must address all these gaps before bringing a gene therapy to market to ensure their product’s value is delivered and patient’s lives are saved!
Not thaaat whistleblower...
By Amanda Eiber, JD
Whistleblowers made news in healthcare this week with a judge dismissing two lawsuits alleging pharmaceutical manufacturers violated the Anti-Kickback Statute – a law that’s been responsible in recent years for several eight- and nine-figure settlements between pharma and the Department of Justice (DOJ).
The plaintiff in both cases, Health Choice Alliance (HCA), asserted that certain manufacturers violated the statute by unlawfully inducing physicians to prescribe their drugs. Court filings include claims that manufacturers and contracted third-parties provided nurse educators as “undercover sales reps,” staffed doctors’ offices with free nursing services and helped physicians with reimbursement and other administrative support that reps presented as a selling point.
While the cases were dismissed, it’s important to note that the ruling did not actually touch on whether any of the manufacturers engaged in problematic behavior that violated the statute at issue. Instead, the DOJ’s argument hinges on characteristics of this particular plaintiff, HCA. While HCA represented itself as a data research firm, the government contended that it was in fact a shell company, set up by another shell company, which in turn comprised other companies set up by investors (not an easy story to untangle!). In short, the government argued that HCA was a professional whistleblower that used questionable methods to obtain information to support this, and other, “cloned” lawsuits.
What should you take-away? A whistleblower lawsuit never looks good, but shifting DOJ policy may spare companies from what the government deems “meritless” litigation. Still, that doesn’t mean companies are in the clear. As always, vigilance and compliance remain critical aspects of any programs manufacturers offer to help physicians and patients. And, as a leading provider of clinical field teams, compliance is the name of the game here at Syneos!
Who wrote this? The managing editor of TWTW is Randi Kahn, who had her first pumpkin spice latte of the season this week (mmm!)
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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