The PCSK9 drugs are stirring up a lot of attention, primarily around how to restrict access. But, no one is talking about how to best manage the patient's needs.
The PCSK9 drugs continue to remain in the news, mainly because of their price. Last week, Reuters reported that while health plans and pharmacy benefit managers are hoping competition creates price concessions, other reports suggest that the primary management approach will be to use aggressive prior authorization to ensure that only the “most appropriate” patients receive these drugs.
Obviously, the biggest fear is that the drugs will become just one more arrow in the quiver that primary care physicians reach for to treat uncontrolled low-density lipoprotein levels. Having seen ads in primary care-focused journals, this does not appear to be an unfounded fear.
Given that nearly half of middle-aged Americans, and virtually all seniors, may qualify for statin therapy, and that an estimated 32 million Americans are taking statins, health plans not only need to develop an effective strategy for managing the PCSK9 inhibitor drugs, but they also need to create programs that are effective at preventing cardiovascular disease as well as other common chronic diseases that lead to cardiovascular disease.
However, also fueling concerns is the pipeline of targeted and biologic drugs aimed at large portions of our population with common chronic illness. Case in point: Entresto approved for chronic heart failure is priced at, approximately, $4500 per year.
Health plans should also take note of the article published by the CDC in Morbidity and Mortality Weekly Report (MMWR) just one day after the Reuters article.
It stated that over 1 in 3 adults in the United States should be involved with intensive behavioral counseling. Some states have such an unhealthy population that nearly half of the population should be given intensive counseling! The report went on to state that of those patients who had one of the targeted cardiovascular risk factors, only 1 in 8 had actually been counseled by his or her physician. My conclusion: physicians practice with their pen more than with “intensive counseling.”
Health plans faced with potentially massive increases in costs for PCSK9 drugs (as well as other expensive chronic medications) will instinctively move to a more restrictive prior authorization process. But, by focusing on time-consuming and onerous prior authorization processes, health plans may ignore one of the key moves they should be making—focusing on behavior modification.
Both the Reuters and MMWR articles point at the same problem, namely personal behavior. We have, as a nation, long been lulled into the sense that there are no consequences for being massively overweight and eating foods that have been stripped of their nutritive value and laced with too much sugar, fat, and salt. Our collective lifestyle has led to more than just hyperlipidemia, it is the cause of much of our pre-diabetes and diabetes, at least a portion of cancer, joint disease, inflammatory disorders, etc—the list goes on and on.
Modifying behavior is difficult, but, a recent article in Evidence-Based Diabetes Management discussed a remarkable clinician, Cheryl Marco, RD, LDN, CDE, from Jefferson Hospital in Philadelphia, (incidentally my alma mater). Cheryl has developed a very effective cognitive behavioral program that literally changes lives. And, of course, she is not alone. There are numerous programs popping up around the country that are focusing on our national scourge.
In a companion article, Joslin Diabetes Center’s Osama Hamdy, MD, PhD, provides follow up to an intensive behavioral modification program for diabetes that has exceeded expectations … for 5 years running!
But all of these efforts suffer from scalability. There is no way these efforts can handle the nearly one-third of Americans who currently need this counseling, behavior modification, and monitoring.
The Answer: Cognitive Technologies
A recent white paper by Deloitte outlined how health plans could start to use cognitive technologies—in particular, natural language processing. It is not a stretch to imagine how digital technologies in general and natural language specifically might work. A study in Obesity by Lora Burke, PhD, MPH, RN, FAAN, at the University of Pittsburg School of Nursing and colleagues, demonstrated that an earlier model of digital assistant could produce weight loss outcomes that exceeded those of traditional approaches.
Natural language processing, more accurately termed natural language understanding (NLU), is a giant leap in digital medicine. NLU combined with artificial intelligence is the foundation for the latest generation of a virtual health assistant (VHA)—one that can literally talk to people.
VHAs can perform the intensive behavioral counseling recommended by the CDC and measure the results. Not only can the VHA can educate, assist in motivation, track exercise and adherence, measure calories and content of food, coach, and answer tens of thousands of questions, but also perform the data gathering and other administrative tasks essential to the prior authorization process for the PCSK9 class of drugs. And, given the earlier discussion, the requirements health plans create will be (and should be) substantial.
If you believe the CDC, it is time to get serious about behavioral counseling. And this behavioral counseling can now be offered, at an affordable price, to the 1 in 3 Americans who need it to prevent illness.