The Specialty Medication Process Can Be Messy. It Doesn’t Have to Be.

The journey begins in the exam room, where the first major decisions are made between the patient and her doctor.   

In the Exam Room 

The doctor’s examination of the patient and her clinical history reveals a prior diagnosis of rheumatoid arthritis, which up until now has been successfully managed with non-specialty medication. But the medication isn’t working anymore. The joints of the patient’s hands and feet are swollen and painful, and she feels tired all the time.

So, her doctor writes a prescription for a specialty medication.  

As a rheumatologist who specializes in arthritis and autoimmune disease, Dr. Elana Oberstein has seen firsthand the evolution of therapy for the treatment of chronic conditions. On a panel with Mellin at a specialty medication symposium, Oberstein said, “I would almost attribute specialty medication to why I became a rheumatologist.” She noted that there has been “a complete overhaul” of therapy in rheumatology—the study and treatment of inflammatory disease—with improved outcomes for patients. 

“It’s a very exciting time,” Oberstein said.  

Innovative specialty medication is exciting, and bodes well for patient outcomes, but this also means that what happens in the exam room is not the end of the journey. It’s just the beginning.  

Decisions, Decisions, Decisions  

Mellin said that early in his career as a physician, decisions were easier and more straightforward. He would diagnose and then write a prescription. He wouldn’t think about it afterward, and that was it. Now, he said, there’s so much for a physician to consider at the point of care. 

At this point in the journey—still in the exam room—we see only the top layers of paint on the canvas. There are many layers underneath. Some are barely visible. Others are entirely obscured. In cases that don’t involve specialty medication, like a prescription for antibiotics to treat strep throat, the journey ends when the patient or caregiver picks up the medication at the pharmacy that same day.  

This is not the case for specialty medication.  

“We need to look at any prior interventions,” Oberstein said, “and if the patient failed those therapies.” The patient on this journey has failed those therapies. She has used the traditional anti-rheumatic drugs, which aren’t working. Specialty medication is the next tier, which means finding answers to many questions and making decisions based on those answers. 

What kind of insurance does the patient have? What medications are on formulary and might be covered? What are the patient’s potential out-of-pocket costs? Is there any financial assistance available? How often is the medication administered? Every day? Once a week? Can the patient tolerate a new method of administration, like infusion or injection?      

The patient will understandably want to start therapy as soon as possible, but it’s tough to know when that will be, because the answers to these questions are buried in layers of paint. But physicians like Oberstein remain optimistic. We’ll figure it out, she tells her patients, and promises to keep them informed along the way. 

Nurturing the Prescription  

The patient leaves the clinic for home. Her doctor has already sent the prescription to the specialty pharmacy, and in this case the pharmacy receives the prescription before the patient gets through her front door.  

But as we’ve seen, the medication probably won’t be ready that same day.  

It could take up to three or four weeks, and that’s because patient information isn’t easy to come by—and the pharmacy needs it to safely dispense the medication. The pharmacy cannot rely on outdated information, which might mean another visit to the clinic for the patient, and the prescription itself may need updating once the most up-to-date information comes in. 

This will take yet more time. The back-and-forth adds up.   

Getting Authorized  

With the prescription matched to accurate patient information, we move to the prior authorization stage of the journey.  

Before the patient’s specialty medication can be filled, dispensed and delivered, the pharmacy often needs the medication to be approved by the PBM and health plan. The patient’s doctor may—or may not—have already started the prior authorization process. Either way, prior authorization requires plenty of back-and-forth among the stakeholders. 

Meanwhile, the patient hangs in limbo. 

There is no guarantee that a given medication will be approved and authorized. The patient may be required to try a preferred lower-cost alternative before the higher-cost medication will be authorized (step therapy). Or authorization may be denied altogether, even after appeal. In that case, the patient and her doctor will have to start over with more decisions and a new or changed prescription.  

This, of course, adds more time: one week, two weeks, three weeks, four.    

Making Medication Accessible  

Specialty medication for rheumatoid arthritis has the potential to transform the patient’s life for the better. But the medication must be financially accessible to make that happen. Assuming the patient is covered by health benefits and the prior authorization is approved, out-of-pocket costs could still put the preferred medication out of reach. 

Now the abstract painting might start to feel a bit overwhelming (if it didn’t feel that way already).   

A drug manufacturer’s coupon might help the patient afford the medication for a few months or longer, but (like prior authorization) there are no guarantees. Coupons may not always be available. Or the patient may lose or change insurance coverage. The patient may suddenly find herself with no way to pay for the medication.   

What then? 

In general, high costs have a range of downstream effects. The patient might skip doses to make the medication last, even when rheumatoid arthritis causes a painful flareup. She might delay having her medication refilled (and delay going to the doctor for a checkup and lab test updates). She might stop taking the medication altogether and become non-adherent. This can lead to a poor health outcome and increased costs.     

All stakeholders can help find financial assistance: the doctor, the pharmacist, patient access vendors and life sciences companies. Even the patient or the patient’s caregiver might play a role. Ultimately, financial assistance can put specialty medication within reach and make the journey a success.  

Success! Medication Delivered 

The patient has insurance coverage. Prior authorization has been approved. Financial assistance is in place. The patient’s medication can now be dispensed and delivered.  

Not so fast, though. 

Specialty medication is “special” because it can transform the patient’s life for the better, but that’s not the only reason. Specialty medications can require special training, care and handling. For specialty medication to treat rheumatoid arthritis, the patient or her caregiver must learn how to administer an injection, or travel to a location onsite for administration. The pharmacy must follow up with the patient and arrange this. 

This adds yet another layer of paint to the canvas, another layer of time and complexity.  

As treatment progresses, the doctor and pharmacist need to know how the patient is responding. Are there any side effects from the medication? Are these side effects tolerable or dangerous? How can they be managed? In general, is the medication working as intended? Is the patient adherent? 

These questions can all be answered with open lines of communication, which is just as important now as it is throughout the journey.    

In the Exam Room Once Again  

For now, it seems, the medication is working. The patient just came home from a few rounds of pickleball—which she hasn’t enjoyed for weeks until now. But the care team must continually assess her health.  

Has the patient lost or gained weight? Is the medication causing unintended side effects? Is the medication still on formulary? Can the patient continue to afford it? This information must be kept up to date to achieve the best health outcome possible. 

For this patient, her rheumatoid arthritis has been successfully managed and controlled—so far—but a new year brought a new job and a new benefits plan. When she needs to take her medication, she finds that it’s no longer covered. The medication is not on formulary. Plus, plenty of pickleball has led to weight loss. This may affect dosing, and the pharmacy will need to get updated lab values from the doctor before the medication can be refilled. This likely means an entirely new prescription.   

And that means it’s back to square one. It’s back to the exam room.