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Volume 39, Issue 1
Highlighting a few topics that just missed the cut for our annual Industry Outlook-but are worth keeping a close eye on.
This month we feature our annual Industry Outlook, culled by discussions with our illustrious Editorial Advisory Board experts. We had a long, long list of topics, but cut it down to the eight. But what about those trends that didn’t make the cut? Are they just not hot? Not the case. What makes the cut is when we think the trend is going to have significant impact this year. As an example, let’s look at the list we projected for 2018: Patient vs. Consumer, Pricing, FDA Commissioner, Emerging Markets, EMA on Move, Biosimilars,
Diagnostics, and eEnablement. Clearly, Commissioner Scott Gottlieb is still a force to reckon with at the FDA, but last year we weren’t sure where he was coming from or what he intended to do, so his appointment was very important to last year. EMA moving because of Brexit definitely had impact last year and continues into 2019 (Brexit does make this year’s list). Patient vs. consumer was very much a hot topic last year, and to a degree, certain influencers still press pharma to “get with the consumer times,” but the newness of that term and urgency is gone. Let’s look at the trends that did not make our list this year.
In late January 2018, Amazon, Berkshire Hathaway, and JPMorgan Chase & Co. announced a partnership on ways to address healthcare for their US employees, with the aim of improving employee satisfaction and reducing costs. Since that time, little headway had been disclosed until late in November, when the partners named insurance executive Dana Gelb Safran, senior vice president of enterprise analytics at Blue Cross Blue Shield of Massachusetts, as head of measurement for the initiative. Our EAB said, ultimately, since there is no movement by any of the players for the immediate future, it was being tabled until more progress is made.
The Institute for Clinical and Economic Review (ICER) was founded in 2006 as an independent and non-partisan research organization that evaluates the clinical and economic value of prescription drugs, medical tests, and other healthcare and healthcare delivery innovations. In the intervening 13 years, the institute has gained in exposure and influence, and this past August, CVS announced it would allow health plans and insurers using Caremark to refuse to cover drugs that didn’t pass ICER review. The resulting response was that ICER was trying to be the “NICE” of the US, but there aren’t more recent news reports about ICER. The EAB ultimately decided that ICER is but one of many influencers on pricing and market access that pharma executives need to be aware of and it didn’t merit its own separate category.
There is a widening gap of what regulatory approval looks like and what payers will pay for. This speaks to the trend where regulatory authorities are asking for and providing pathways of approval for more innovative and patient-centric therapies. But that these same therapies, in the end, may not be supported by payers or governments. Ultimately, this was decided to be an ongoing tension among the stakeholders and will likely not be any more impactful in 2019 than it will be in 2021.
And our final example is the bifurcation of the pharmaceutical industry. On one hand, there is the trend that pharma targets therapies that are very personalized and tailored, usually feature a population with unmet needs or caused by a gene variant, are delivered in a complex way, and have high prices. This group of biopharma doesn’t need extensive launch strategies because they are targeting very small populations. They don’t need a wealth of added wearables or IoT technology because the therapy itself is the patient engagement tool.
The other side of the divide relies more on prevention and large population healthcare issues, for example, diabetes. These therapies feature extensive launches with direct-to-consumer advertising; they rely on digital therapeutics to engage patients in their care, including their drugs and adherence; and they also feature extensive patient education and patient access programs. Much of the new developments around technology and services are geared more specifically to these larger population therapies. The EAB decided that this bifurcation is only beginning, and the subsequent changes to third-party providers who serve both markets will become more fine-tuned and not imply that all technologies and services are the same for all manufacturers.
Send us an email or tweet at @PharmExec and let us know what you think of this year’s Industry Outlook. All of us here at Pharmaceutical Executive wish you the best for a very Happy 2019!