A disturbing if not deadly development is taking center stage in American health care, but can we see it? Because patients who need access to precision medications are starting to feel it.
The major crisis at hand for patients with chronic diseases has less to do with drug-pricing and more to do with insurance and regulatory practice that is, every day, overriding doctor treatment decisions and blocking patients from getting the treatments they need and deserve.
With all that we know is wrong in the system, this is truly health care’s secret scandal.
How widespread is this? Consider the 27 million American adults with heart disease and its common related condition of high cholesterol
Fewer than one in three adults with high LDL cholesterol has the condition under control, and it’s not merely a matter of better diet. Millions of these patients need specialized medicine because traditional treatments are ineffective or, worse, carry debilitating side effects.
In the midst of what looked to be a medical breakthrough in July and August of 2015, the FDA approved two new medications for treatment of advanced high cholesterol called PCSK9 inhibitors.
These medicines specifically target millions of patients diagnosed with a disease called Familial Hypercholesterolemia (FH), a life-threatening genetic disorder that causes high cholesterol starting at birth.
These people have a genetic disorder. We know what it is, how to detect it and we know how to treat it. The FDA supports the treatment potential and protocol. And yet, patients whose doctors believe they should try these new medications are being turned down and turned away in droves.
What is coming between patients and the therapies prescribed by their doctors? The increasingly frequent use of restrictive formularies, clinical pathways and value frameworks that focus on drug cost first and patient access far later.
These are the interesting priorities of an influential entity called the Institute for Clinical and Economic Review (ICER), which is busy developing suggested price controls on medicine – and the federal government seems very interested.
Just after approval of these advanced high cholesterol medications, ICER released a step-by-step manual on tactics insurers can deploy to deny patient access. These documents illustrate the preferred ways to deny patients and, revealingly, utilize guidelines released within weeks of FDA approval of PCSK9 inhibitors by some of the nation’s largest health insurers, including Anthem and United HealthCare.
The result is essentially an instruction manual for insurance denials, including sample language to limit patient access: “Use prior authorization criteria to limit use to populations with highest unmet need.”
It also outlines in even greater detail how to make patients prove they have undergone extensive trials of high-dose medications that don’t work in order to be considered for what their doctors wish to prescribe.
In this way, patients will increasingly conclude ICER and the insurance industry exist in a symbiotic relationship, feeding off each other and maintaining an equilibrium that serves both entities in the shared drive to control costs by, first and foremost, controlling patient treatment.
This turns on its head the entire concept of insurance design and our common belief that if we pay for health coverage, we will get coverage in return. Is an industry we look to for care instead conspiring against us?
There is a better way: Putting patients first isn’t only the moral choice, it would have the added tangible benefit of driving scientific innovation and making the drug delivery system more sustainable through creativity instead of cutting.
Finally, it would target the soft bigotry that looks at patients as a commoditized drain on public resources, rather than a community of human beings we know how to help.
FH patients in America might not number in the millions – yet. But like millions of other people, every one of them represents a patient at the crossroads, waiting to be discovered, diagnosed and treated with medicine that is at the ready.
Or, they and other patients – and perhaps one day all of us – could be designated too expensive to treat and too costly to save.
Which would you choose?