Big data expert Pam Baker says that for precision medicine to work, a new "data diagnostician" specialty will be needed—and formularies must be eradicated.
Precision medicine, aka personalized medicine, got a hefty boost when President Obama recently announced his US$215 million Precision Medicine Initiative. He called it “one of the greatest opportunities for new medical breakthroughs that we have ever seen,” and indeed it is. While there were many who applauded the Initiative, some proceeded with hand-wringing over the excitement outpacing the science.
But no, the science is there. It’s in full-bloom in some areas and budding in others, but it is there. What’s missing are the new professionals—data diagnosticians—needed to make it useable throughout the existing healthcare system; a major restructuring of public healthcare goals; and, the eradication or vast expansion of private and public insurer drug formularies.
Here is what needs to happen next for precision medicine to come to fruition in patient care.
Rise of the data diagnosticians
“For most people, genetic medicine is not yet delivering customized care,” writes Cynthia Graber in her post in The New Yorker. “As scientists continue to draw connections between DNA data and health outcomes, the problem of interpretability continues to grow. Many doctors are simply not qualified to make sense of genetic tests, or to communicate the results accurately to their patients.”
We can fix that with a new specialty.
I think of them as “data diagnosticians,” as their work would encompass both traditional medical data from myriad lab results and patient observations, as well as genetic data and big data. They would be part medical data analyst and part physician.
To produce this new line of specialists, medical schools will have to teach advanced statistics and other classes designed to increase data literacy and interpretation skills. Meanwhile, software developers can focus on making the “data scientist” part an embedded feature that will help these specialists use analytics with little computer knowledge.
Eventually, this new role will be fully automated wherein descriptive, predictive and prescriptive analytics will all come into play to diagnose the patient and deliver both a prognosis and prescription for optimal treatment or cure.
But the field of analytics today is not far enough along to do that work accurately. So we need these new specialists, and we need them in a hurry—if precision medicine is to be delivered accurately at the patient level. Otherwise, the science and the data will be in place, but patient delivery will fail—or worse—untrained doctors will continue to make mistakes from misinterpretations of the data.
There are also a number of other problems in the delivery of personalized medicine. To learn more about those, see my post “Gene Patents, Physician Mistakes, and Other Mishaps Shaping Personalized Medicine Outcomes,” in GenomeAlberta. While I wrote that report in 2013, many of those issues remain today. If the new specialists—the data diagnosticians—are to succeed, these issues must be addressed as well.
And that brings us to the next thing that is needed for precision medicine to come to fruition.
Major restructuring of public and private healthcare goals must occur or precision medicine will never happen.
As long as the focus within public and private healthcare insurers remains on immediate cost reduction, precision medicine has no chance of ever becoming common practice. It’s not wrong to try to curtail healthcare costs; what’s wrong is how we’re going about cutting those costs.
In short, the typical approach to cost-cutting is to reduce patient testing and care to the cheapest now available. This short-sighted approach actually drives up costs in the long run. As patients are increasingly herded through cheaper tests first, and treatments are likewise doled out, their diseases typically progress—as do the costs of treating and monitoring them.
The smarter and more cost-effective approach is to cut overall healthcare costs rather than single, in-the-now costs. You do that through precision medicine— which may cost more now but will be far cheaper in the long run.
It’s the difference between giving a patient cheap but ineffective treatments and medicines for years while their disease worsens to a far more costly level, and curing or stopping disease progression outright from the beginning.
“And ultimately, this has the possibility of not only helping us find new cures, but it also helps us create a genuine health care system as opposed to just a disease care system,” said U.S. President Obama.
And he is correct. The ultimate cost-savings will be found in entirely new healthcare systems.
“For an area of medicine that promises to be critical in delivering better healthcare to patients, the [President Obama’s precision medicine] plan should have been bigger and more ambitious,” writes Meredith Salisbury, co-founder and organizer of the Consumer Genetics Conference, in her Forbes post.
And she’s absolutely right.
We must stop being “penny-wise and pound-foolish” in all of healthcare and in our future planning—which brings us to the greatest obstacle yet for precision medicine.
Precision medicine cannot come to be until private and public insurer drug formularies are eradicated.
Public and private insurance drug formularies are the single biggest obstacle to precision medicine. Formularies are an antiquated way to cut drug costs. They are not tied in any way to patient outcomes, but solely to price or profit. It is past time to see these dangerous practices eradicated.
Consider this excerpt from a post by Robert Goldberg in The Hill:
A recent New England Journal of Medicine study found that health plans and PBMs are working together to discriminate against sick people. They are forcing people with HIV, cancer, psoriasis, multiple sclerosis and many other diseases to fail first on cheaper medicines before accessing precision medicines. And even when the precision medicines are made available, patients have to pay thousands of dollars to use them. The plans and PBMs know that such out of pocket costs will discourage people from starting new drugs.
Plans and PBMs have often required consumers to pay more for brand drugs when a generic version is available. But as the NEJM study found: the goal of this—“adverse tiering”— is not to influence enrollees’ drug utilization but rather to deter certain people from enrolling.
That’s bad enough. But health plans and PBMs are also profiting from these discriminatory tactics as well. The PBMs are also covering one new medicine for a disease and no other precision drugs to the drug company giving them the highest cash rebate.
For instance, PBMs are covering one hepatitis C drug and excluding others. As drug benefit expert Adam Fein points out, these pay to play schemes allow PBMs to rake in “as much as $2,600 to $3,100 per (hepatitis C) patient. “ That comes out to about $3 billion. When approach is extended to precision medicines for cancer the PBMs could make up to $15 billion by next year.
As more precision medicines are developed, PBMs and insurers work hand in glove to [make] it harder and more expensive to get them. Fein notes: “Express Scripts has 66 products on its 2015 formulary exclusion list, compared with 48 in 2014. CVS Caremark’s 2015 list has 95 products, including 72 carryovers from the 2014 formulary. “
However, public insurers also tend to have formularies complete with a list of drug exclusions. Those too must be eradicated—or at least greatly expanded—to encompass new and better drug discoveries and precision medicine prescriptions.
President Obama is aiming for exactly that in his new budget.
“President Barack Obama's new $3.99 trillion budget for fiscal-year 2016 proposes allowing the U.S. secretary for health and human services to negotiate prices for biotechnology treatments and other high-cost drugs in Part D ‘to ensure access to and affordability of these treatments,’" reports David Morgan in his Reuters article.
But there is already stiff opposition to that in Congress fueled primarily by pharmaceutical companies’ desire to protect their profits and patents.
“Biotechnology treatments, or biologics, are generally patented, genetically engineered drugs that can be more effective than traditional medicine,” writes Morgan in that same article. “But they can also be more expensive because they are more complex to manufacture. Some biologics play a role in precision medicine, which seeks to better tailor treatments to individual patients based on their genetic makeup and other influences.”
“The proposal to allow drug price negotiations follows a campaign by private insurers and pharmacy benefits companies against Gilead Sciences Inc's $84,000 hepatitis C drug, Sovaldi,” he continued. “U.S. payers argued that the drug, which cures nearly all patients of the liver-wasting disease, could cost $200 billion to cover the entire hepatitis C population, an unsustainable sum for society.”
The decision that must ultimately be made is whether profit and patent protections—or human life protection—is the ultimate goal in healthcare around the world.
In the U.S. it boils down to the age-old argument of whether healthcare is a privilege, or a human right. A barbaric argument, to be sure, but one that rages to this very day.
Unless that argument is resolved in the U.S. and elsewhere, and cost containment is more realistically reconfigured worldwide, precision medicine will die—and so will patients everywhere.