In medicine, it has become increasingly common for physicians to encounter patients who we know we could help but can’t — at least not right away — without jumping through hoops created by their insurers.
These hoops extend time to treatment, interfere with clinic workflow, add to patient inconvenience and lead to treatment abandonment and adverse outcomes. It’s these kinds of cases that are extraordinarily frustrating because, as a physician trained in cancer care, I know the right thing to do, but I am limited in my ability to do it.
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Every day in medical practices around the country, more and more health care providers like me are finding ourselves hamstrung over what’s best for our patients — thanks to a new policy from the Centers for Medicare and Medicaid Services to allow Medicare Advantage plans to utilize “step therapy” for Part B drugs.
When this controversial policy was first announced, Department of Health and Human Services Secretary Alex Azar predicted step therapy wouldn’t be a significant issue for patients with cancer; however, that has proven to be far from the reality now that the policy is firmly in place.
Commonly called “fail first,” step therapy allows insurers to overrule physicians’ prescribing decisions — forcing patients to begin with the insurer-preferred therapies before advancing to the non-preferred ones. One of my partners refers to this as “cheap first,” because the payer almost invariably prefers a less-expensive and often-more toxic choice first. It’s sometimes required even when providers seriously doubt those substitute treatments will be as effective or even if they’ve been tried before when a patient was covered by a different insurance plan.
As a clinical oncologist, I’m the person who best understands my patients’ clinical needs. Step therapy removes my ability to make care decisions — putting that responsibility squarely in the hands of faceless bureaucrats at an insurance company who often have no direct knowledge, training or expertise in cancer care. It also muddies crucial care protocols while ignoring clear, evidenced-based clinical pathways established by physicians.
The variabilities in patient responses, especially among cancer patients, mean that treatments must be carefully considered and individualized for each patient. Some therapies, for example, may carry a higher risk of adverse side effects for some patients or interact poorly with other prescribed medications they are taking. Patients with cancer don’t have the luxury of failing an insurer-preferred drug first because failure can mean disease progression or an early death.
Since CMS began allowing step therapy in Medicare Advantage plans early last year, my oncology practice has seen insurers deny patient access to certain chemotherapy drugs despite physician recommendations. Just recently, I was considering options of treatment for a patient with metastatic breast cancer and a genetic mutation.
There are two drugs that uniquely treat her genetic mutation and are appropriate to treat her cancer, but only one of them appears to treat cancer that has spread to the brain. Because my patient has brain metastasis, I want to give her this therapy, but it is not approved by the insurance company.
This insurance tactic risks sequencing drugs with the less-effective drug first, which can have a negative impact on a patient’s outcome. In this case, if she has to fail the other drug first, she may have neurologic decline similar to stroke symptoms or even premature death because the insurance company will require that I first give her a drug that I know will not be effective before I can give one that may be.
CMS — and commercial plans — claim that step edits reduce costs by giving plans more ability to negotiate with drug manufacturers, but my oncology practice has seen insurers demand patients fail first on a more-expensive brand drug before they can try a less-expensive biosimilar version.
This is happening even though the list price is lower for the biosimilar, meaning patients with high deductibles or coinsurance based on the list price would pay less. Why would an insurer deny coverage of a cancer drug that has been prescribed by a patient’s oncologist in favor of a more expensive one?
Likely because they are receiving some form of a rebate from the drug manufacturer and not passing the savings directly on to the patient. In this case, not only are patients not receiving the drug prescribed to them by their physician, but they are paying more than they should.
I fear we will only see continued expansion of this policy — at the patient’s expense. In commercial plans, we are already seeing insurers requiring step edits with therapeutic agents for advanced cancer. For example, one insurer is requiring use of a brand-name drug or a specific biosimilar used to treat non-Hodgkin’s lymphoma when there are multiple biosimilar versions available.
As a physician with specialized training in cancer care, I make educated, sophisticated and nuanced decisions in treating my patients. Treatment decisions should be made by patients and their doctors. Insurance companies should not practice medicine and should allow doctors and their patients to make decisions about therapy choices.
It’s time for Azar and his colleagues at CMS to withdraw this policy and prohibit step therapy practices for Medicare Part B drugs altogether.
Dr. Debra Patt serves on the U.S. Oncology Research breast cancer committee and chairs the breast cancer subsection of the pathways task force for The U.S. Oncology Network, and she is also a practicing oncologist and breast cancer specialist in Austin, Texas, and a vice president of Texas Oncology, which has 420 physicians in 176 sites of service caring for over half of Texans with cancer.
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