Cost of MS medication may go unspoken in the clinic
By Jake Remaly
credit: PLG/Getty Images
The cost of treatment for multiple sclerosis (MS) has been the subject of GoFundMe campaigns, an investigation by members of Congress, and recent studies in Neurology and JAMA Neurology. In October, a presidential candidate even mentioned the high cost of medications for MS and other diseases during a debate. In day-to-day clinical practice, however, concerns or questions about cost may often go unspoken by neurologists and patients with MS.
“Costs are much less of an issue for patients than one might expect since companies very commonly pay their copays,” said Ilya Kister, MD, an associate professor of neurology at NYU Langone Health in New York. In 2016, Dr. Kister coauthored an article about approaches to treating to MS that could reduce costs, such as the use of off-label therapies and alternative dosing schedules. “They all have patient assistance programs for the newer drugs. It is rare for patients not to be on drug because they can’t afford it.”
Caption: Trend over time shows increases in the annual cost of treatment for a selection of multiple sclerosis drugs. Related study: San-Juan-Rodriguez A et al. JAMA Neurol. 2019 Aug 26 [Epub ahead of print].
Credit: Alvaro San-Juan-Rodriguez
“In general, at present, it is less of an issue” at the individual patient level, said Alexander D. Rae-Grant, MD, a neurologist at Cleveland Clinic. “Our population seems to have access to the medicines in a reasonable way. Most Food and Drug Administration–approved [treatments] have some kind of copay assistance program.”
Still, neurologists may encounter cost-related obstacles when caring for patients.
Perhaps once a week, Joseph R. Berger, MD, professor of neurology at the Hospital of the University of Pennsylvania in Philadelphia, wants to start a patient on an infusion therapy, but encounters difficulty in having the treatment covered by insurance providers who want the patient to try other medications first. Sometimes, the other medications are ones that Dr. Berger considers close to adequate but not ideal for the patient, he said.
Another problem can occur when patients on Medicare “have to come up with a substantial amount of money … before Medicare payments kick in,” he said. In a forthcoming manuscript, Dr. Berger and colleagues analyzed Medicare databases and found that patients “miss the medications for long periods of time, and doctors are unaware of it,” he said.
Dr. Alexander D. Rae-Grant
Dr. Joseph R. Berger
Dr. Berger said he has had people with MS tell him that “the expense of the drugs [is] something that they can’t bear.” Some of these patients are ineligible for assistance from pharmaceutical companies because of their income levels or other restrictions.
Typically, social workers and pharmacists in Dr. Berger’s MS clinic ensure that patients receive their medication. This model has “proven to be enormously helpful for us,” he said. “I as the physician don’t have to interface terribly much on matters of cost.”
“In large measure, pharmaceutical companies have themselves to blame for this,” Dr. Berger said. “They price these drugs so high that it has gotten out of hand.”
Guideline touches on cost
Dr. Rae-Grant was the lead author of the American Academy of Neurology’s 2018 practice guideline on selecting disease-modifying therapies for MS. The guideline advises that neurologists should consider patient preferences regarding the cost of treatment, along with route of administration, safety, lifestyle, efficacy, and tolerability. The guideline mentions that patients might be able to obtain financial assistance from groups such as the National Organization for Rare Disorders and that the off-label use of medications may be an option when other treatments are not available. Nonetheless, the guideline provides “an incomplete answer” as to how cost may factor into treatment decisions, Dr. Rae-Grant said.
“Cost in medicine is a very difficult topic to get your hands around because there are all sorts of different ways to portray costs,” he said. When the authors created the guidelines, many of the available studies about cost-effectiveness had originated from pharmaceutical companies, which made them ineligible for their review, Dr. Rae-Grant said. Cost analyses may be a larger part of future publications, he said.
In practice, cost-related issues may come up when trying to work within the patients’ insurance policies.
“What does your insurance cover? Can we responsibly treat within those boundaries?” Sometimes, Dr. Rae-Grant needs to negotiate with insurance companies to obtain a medication that is outside of the insurance company’s typical formulary. After a patient tries one or two drugs unsuccessfully, usually “we will want to get to higher effectiveness, and sometimes that becomes a negotiation on the phone,” which can be “a little tricky,” he said.
“I’ve been doing MS work for more years than I care to count,” said Dr. Rae-Grant. Having to convince a physician with the insurance company “that I know what I’m doing is not a very effective process in terms of getting the patient care.”
While the cost of drugs may be less of an issue for individual patients, the implications for the broader health system are another matter. If medication costs “keep increasingly taking money out of the healthcare pot, where does that end?” he said. “I don’t know the answer to that.”
Various ways to look at cost
Formulary preferences may be based on rebates from pharmaceutical companies that patients and clinicians never see, said Mark Gudesblatt, MD. “Ultimately, a clinician chooses a drug that the clinician believes in their heart is the best drug for their patient,” said Dr. Gudesblatt, the medical director of the Comprehensive MS Care Center at South Shore Neurologic Associates in New York. “Because ultimately the costs are more disability, visible or invisible.” Patients may lose the ability to work or drive and may require nursing home care. “Those are the big costs,” he said.
Generally in the clinic, treatment cost does not come up because “so many companies give rebates and free drugs,” he said. Recently, one of his patients lost insurance coverage because of a job change, but the patient’s MS therapy had already shipped to a pharmacy. The pharmaceutical company agreed to provide the drug for free until the patient had insurance coverage again.
“I choose a medication, people get authorizations,” Dr. Gudesblatt said. A team in his office is able to help determine which therapies are approved and will be affordable for patients. He typically does not hear about costs “because the people in the office are able to advocate effectively for the patient,” he said.
Ideally, a neurologist would choose treatments based on biomarkers. “We haven’t figured that out yet,” he said. “We judge by our own personal preference.”
Dr. Gudesblatt heavily weighs medication adherence and whether a patient will take self-administered drugs. “Drugs not taken don’t work,” he said.
Another issue arises when neurologists start patients on a lower-potency drug and plan to use a more effective drug if the disease worsens. But that approach hinges on the patient being aware of the worsening, the neurologist’s ability to detect it, and the neurologist’s determination of whether the worsening is significant enough to warrant escalation in treatment, Dr. Gudesblatt said.
Proactive monitoring of brain atrophy and cognitive decline may be needed to detect disease worsening, but the cost of such monitoring may not be covered. “Payers should only want to use the best drugs,” and they should not waste time while patients accumulate disability, said Dr. Gudesblatt.
The parties involved “need to come to the table and bring a rational approach to health care,” Dr. Gudesblatt said.
Effects on patients
For a hearing in the House of Representatives in September on lowering drug prices, Bari Talente, JD, executive vice president of advocacy for the National MS Society, noted that a National MS Society survey of people with MS found that 40% “have altered their use of their [disease-modifying therapy] because of costs.”
“They may have stopped treatment for a period of time, they may skip or delay filling a prescription, maybe they skip or delay a treatment, or they don’t take the medication as prescribed to try and make it last longer,” she wrote.
“It’s very troubling to think that people are making decisions because of the cost of the medications,” Ms. Talente said in an interview. When patients’ out-of-pocket costs increase, they may put off getting an MRI, stretch time between appointments, or not fill medications for symptom management.
And while patients are grateful for assistance from pharmaceutical companies, “for many people, it is another sort of added burden to navigate through the process,” she said. “Every Band-Aid on the system is one more hurdle to get over.”
Dealing with doctors’ offices, insurance companies, specialty pharmacies, and financial-assistance programs can be time consuming. “I’ve had people describe it to me as it’s almost like having a full-time job,” said Ms. Talente.
The cost of medication may prompt patients to consider discontinuing therapy. Brian Howard, an editor at Philadelphia magazine, reached out to his neurologist when a change in his insurance coverage meant that he suddenly would be paying more for his MS medication. The insurance policy change meant that his out-of-pocket costs for generic glatiramer acetate would increase by more than $3,000 a year.
“I have been asymptomatic for 15 years now, and I have the luxury to think about the option of going off,” Mr. Howard said.
He likely will stay on treatment though. In an article about the cost of prescription drugs and his attempt to understand them, he described the calculus: “An extra $3,180 isn’t going to bankrupt me, but it’s also money I would have saved – tucked away for retirement or put into my daughters’ college funds. I’ve since reached out to my doctor to talk about maybe going off the meds. … But, as my wife points out, our equation has changed. It’s great for me and our family that I’ve remained healthy and that in the morning I get to walk my 2-year-old daughter to the preschool she adores without a second thought. Why would I do anything – anything at all – to put that at risk for daughter No. 2?”
Although medication costs affect patients, doctors and patients may not see a need to discuss them.
When Mr. Howard first was prescribed interferon beta-1a, he remembers “seeing a price tag and being sort of shocked, and my doctor basically saying something like, insurance will cover it and there are ways to make sure I got it.”
“My sense is my doctor is not thinking about cost, but what’s the best treatment,” he said. “Even if they are concerned, pricing is so opaque I don’t know what they could do about it.”