Doctors, patients struggle with new drug coverage.
The recent approval of a new drug to treat psoriatic arthritis (PsA) was a welcome development for people living with this painful condition and the doctors who treat them. But those enthusiastic to try Bimzelx (bimekizumab) have run into a common problem associated with many types of new medications—getting health insurance carriers to readily cover them.
Bimekizumab is an IL-17 inhibitor, a class of biologic drugs used to treat PsA, axial spondyloarthritis, and other autoimmune diseases. The FDA approved Bimzelx in September 2024. But a June 2025 report by Spherix Global Insights, a pharmaceutical marketing service, notes that while physicians are largely encouraged by the safety and effectiveness of the new drug, access to the anti-inflammatory medication remains difficult for many patients months after its FDA approval.
Simply having FDA approval isn’t always enough for a drug to be covered by insurance.
Shailendra Singh, M.D., a rheumatologist with Unity Health in Searcy, AR, says that while Medicare often (but not always) covers medications once they have FDA approval, other insurers typically rely on their formularies when approving or denying prescription coverage. A formulary is essentially a list of drugs that are covered by a particular health plan.
In many cases, insurance companies want doctors to employ step therapy, in which a patient tries established medications first. If they fail to provide adequate symptom control, then new medications may be covered.
“The insurance companies still call the shots,” says Christopher Morris, M.D., a rheumatologist in Kingsport, TN. “They want us to use the medications that they prefer. With PsA they usually like us to try methotrexate first.”
Methotrexate is a medication that tamps down the activity of your immune system and is often prescribed for the treatment of rheumatoid arthritis and psoriasis, among other conditions. Dr. Singh says only about 20% of PsA patients respond well to methotrexate. “If they don’t do well, then we look at biologics,” Dr. Singh says.
Trial and Fail
One of the more frustrating aspects of this “trial and fail” process, the doctors say, is that it takes time to see if a medication or a few different medications will provide adequate symptom relief—and time is something people living with a progressive chronic disease don’t have. If a preferred drug could be initiated earlier, it might slow disease progression and prevent unnecessary pain and disability, as well as a reduction in a patient’s quality of life.
In some instances, insurance companies require a prior authorization from the doctor’s office, explaining why a particular treatment is medically necessary. “They want to see good documentation for why we need a patient on one medication vs. another,” Dr. Morris says. But even by providing that type of information, doctors aren’t always successful in convincing insurance providers to cover newer drugs.
In addition to providing patient information and other documentation, a doctor or someone working in the doctor’s office can get on the phone and make a case for why a patient should receive a medication sooner rather than going through a lengthy process of trying other treatments first. These conversations can sometimes take an hour or more, and even then they don’t always lead to approval from the insurance company.
One way to get a new drug like Bimzelx into the hands of patients faster is through a bridge program, Dr. Singh says. Pharmaceutical companies sometimes provide a medication for free or at a reduced cost on a temporary basis. A bridge program is sometimes used when insurance approvals are delayed or a prior authorization has expired.
Drug companies also sometimes offer discount programs, such as co-pay cards, to reduce the cost to consumers for brand-name medications. To qualify, you must meet certain criteria established by the drug manufacturer.
Even with various programs and processes in place, patients all too often find themselves having to wait before getting what could be a life-changing medication or they get into endless back-and-forths with their insurance providers.
Dr. Morris, Dr. Singh, and organizations such as the American Medical Association, agree that much of the problem is due to the increasingly influential role of pharmacy benefit managers (PBMs).
Who Are Pharmacy Benefit Managers?
In the 1960s, as health insurance companies started including prescription drug coverage in their plans, pharmacy benefit managers (PBMs) emerged mainly to help insurance companies set reimbursement rates, process claims, and pay pharmacies. Over time, however, the influence of these third-party administrators has grown. They now negotiate with drug manufacturers and pharmacies to set prices, contract with pharmacies to participate in certain healthcare networks, and, perhaps most significantly, they determine patients’ access to specific medications.
As part of the negotiation process between PBMs and pharmaceutical companies the drug companies offer rebates to PBMs for such things as preferred formulary placement. Some rebates are then passed along to the health plans and their members. PBMs also may keep a portion of the rebates as revenue.
Many physicians are critical of this arrangement for its lack of transparency and because the decision about drug coverage isn’t made by doctors. “The decision isn’t made based on science,” Dr. Singh says. “The decision is made based on how much of a discount or rebate the PBM gets on the medication.”
State legislatures and Congress have gotten involved in recent years with efforts to better regulate the activities of PBMs and improve patient access to newer medications. But Dr. Singh notes that the states have far less authority over the PBMs and insurance rules than the federal government. The key, he says, is for Congress to step in and establish laws that will protect patients and make it easier for doctors to have a greater say in treatment decisions.
What Can You Do?
In addition to reaching out to your representatives and senators in Congress for greater oversight of PBMs, drug coverage and price controls, and other health insurance matters, you can try other steps to get on the treatment plan your doctor recommends.
You can ask your insurance provider for a tier exception, in which the insurer covers an expensive medication at a lower co-pay due to medical necessity and financial challenges.
And if your insurance company initially refuses to cover a particular drug (or test or procedure) you can file an appeal with your insurance company. It may require further documentation from your doctor and may go through several levels of appeal, but your patience and efforts may pay off. “Patients can be their own advocates,” Dr. Morris says. “That can sometimes make a big difference.”
Your pharmacist also may have some ideas. It could be something as simple as a generic version of an expensive brand-name drug or some other discount program or organization that helps patients navigate insurance problems and financial challenges associated with certain drugs.
And if you run into coverage obstacles frequently with your provider, look into switching insurance plans during open enrollment periods. If you have specific coverage questions, you may find the answer you want or need with a different provider.
And as for Bimzelx, if you’re eager to try what doctors suggest could be a game-changing medication for people with psoriatic arthritis, Dr. Morris recommends starting as early as possible with a treatment that will be covered. The sooner you can start step therapy, the sooner you will know if you need a biologic like Bimzelx or whether methotrexate or other treatment may do the job.
“Getting a patient in early can make a big difference,” Dr. Morris says. “The more a patient tries and fails with certain drugs, the more likely they are to eventually get the medication that will really help.” It can be a frustrating and difficult process, but it’s one that can be worth it in the end.
