While members of Congress debate healthcare legislation, rheumatologists say many of their patients struggle to afford everything from generic drugs to insurance copayments for physical therapy.
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Explore This IssueJune 2017
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“It’s a mess. The cost of prescriptions and the rationale for those rising costs in the U.S. right now—it’s just a mess,” says James R. O’Dell, MD, Stokes-Shackleford Professor of Medicine, vice chair of internal medicine, and chief of the Division of Rheumatology at the University of Nebraska Medical Center in Omaha. “There are several areas where it is problematic and makes no sense at all.”
Soaring Ever Higher
Healthcare costs keep rising. The Centers for Medicare and Medicaid Services (CMS) estimates that U.S. prescription drug spending grew 9% in 2015 to $324.6 billion, and out-of-pocket spending by patients for healthcare costs grew 2.6% to $338.1 billion in the same year. The CMS projects that total national health expenditures will soar 5.6% each year between 2016 and 2025.1
While acknowledging that biologics—an essential treatment for many patients with inflammatory diseases, such as rheumatoid arthritis (RA)—are expensive to produce compared with synthetic drugs, their costs seem to be rising dramatically, says Dr. O’Dell.
“My patients used to be able to use a TNF [tumor necrosis factor] inhibitor for about $8,000–10,000 a year, but the cost is now $50,000 a year—less than 20 years later,” he says. Drug pricing is often murky, but one retail drug price comparison website, www.goodrx.com, lists prices for one carton of four self-injectable doses of etanercept (Enbrel) ranging from $4,539–4,788. The recommended dosage for adults with RA generally is one injection per week, so the retail price for a year’s supply of this drug is approximately $54,468. What patients actually pay out of pocket for their medications depends on their individual insurance plans, as well as potential discounts, coupons and copay assistance programs that some manufacturers offer. “There is not much transparency in what the costs really are—or what the drugs even cost to produce—and that is another part of the issue.”
Will Biosimilars Help?
Biosimilars, biologic products designed to be highly similar to an approved reference biologic according to the Food and Drug Administration (FDA), are coming on the market, but they do not yet offer much savings. The FDA has approved biosimilars to etanercept, infliximab and adalimumab.
“Prices for biosimilars are not nearly as aggressive as we had hoped: about 10–15% lower than the reference product,” says Sheila Arquette, RPH, executive director of the National Association of Specialty Pharmacists in Alexandria, Va. Some reference biologics manufacturers are increasing rebates to pharmacy benefit managers and large health insurance plans to keep their costs down, but this strategy may preclude them from including the biosimilar on their formularies. Rebates may not be passed along as savings to the patient at the point of sale, she says.
High-deductible plans, which require policyholders to pay out of pocket up to a coverage limit for their drugs or other costs of care, seem to be on the rise too. According to a survey by the Henry J. Kaiser Family Foundation in 2016, 29% of covered workers were enrolled in a high-deductible health plan in the U.S., up from 24% the year before.2 Medicare beneficiaries may incur high out-of-pocket costs for biosimilars based on current regulatory manufacturer brand discount program requirements if they are in the coverage gap phase of their Medicare Part D prescription drug benefit and have not entered the catastrophic benefit phase, says Ms. Arquette.
Some patients may try to switch to a biosimilar for possible cost savings, says Ms. Arquette, but “if a patient has been on a drug like infliximab, one of the first biologics, for a long time, and has had active disease that has gone into remission, does the physician want to risk how this patient is doing? Would switching really be that effective?” she says. “You have to consider the total cost of care. If you increase overall medical costs, where are the real savings?”
Some rheumatologists are optimistic about the cost-saving potential for biosimilars, although regulatory problems still need to be worked out. Spiking biologic prices makes the successful acclimation of biosimilars to the marketplace an urgent priority, says Angus B. Worthing, MD, FACP, a rheumatologist at Arthritis and Rheumatism Associates in Washington, D.C., and chair of the ACR’s Government Affairs Committee.
“From 2010, when Congress authorized the FDA to approve biosimilars, to 2016, the price of infliximab (Remicade) increased 70%. The first biosimilar in rheumatology, Inflectra, a biosimilar to Remicade, launched at just a 15% discount to Remicade,” he says. “Similar price hikes prior to patent expiration are common for small-molecule [drugs] before generics compete to drive prices back down. In contrast to generic pricing, biosimilars are not expected to drive prices down quickly. Indeed, at this time of large biologic price hikes and subtle biosimilars discounts, it seems the biosimilar marketplace has cost the U.S. a lot of money, and it will take multiple biosimilars per reference product, or maybe the emergence of interchangeable biosimilars, to compete enough to lower the price significantly.”
Interchangeables are biologic products that are expected to produce the same clinical result as the reference drug in any given patient, according to the FDA. No drug manufacturer has applied for this status yet.
More competition and lower prices in this class of treatments is greatly needed, says Dr. Worthing.
“Specialty drugs, such as biologics, are only 1% of prescriptions in the U.S., but they constitute about a quarter of the U.S. drug spend. High drug prices in rheumatology are likely driving a lot of the administrative hassles and barriers to care, such as prior authorization and step therapy. This is why it’s critical to get biosimilars to market efficiently,” says Dr. Worthing.
In a March 21, 2017, address to Congress, FDA Director Janet Woodcock, announced the hiring of additional staff to manage biosimilar approvals. Dr. Worthing says, “I am thrilled to see that the FDA can start hiring the experts needed to approve the backlog of 60+ biosimilars currently in the pipeline.”
Until biosimilars come down in price—if they do—other rheumatologists are skeptical about the benefit to arthritis patients already strapped with high costs for other medications and areas of care.
“I was a little disappointed when I saw the first pricing for the biosimilars. If you look at the costs, they are pretty comparable to the biologics, which was surprising,” says Piyush Poddar, MD, a rheumatologist with Sanford Health in Bismarck, N.D. “I have patients on Medicare who, if they don’t have supplemental, commercial policies too, they can’t afford biologics. Their monthly copay may be $1,000–2,000 a month. Some of my patients say they try to stretch the doses. They split their dose of some drugs. The drugs lose their efficacy.”
Pricey biologics are not the only source of rising costs that concern rheumatologists. Generic drugs for rheumatologic conditions are going up in price, too.
“The costs that concern me the most are the high cost for a number of common generic medications, such as colchicine for gout and metalazone (Skelaxin), a non-sedating muscle relaxer,” says Scott Zashin, MD, a rheumatologist in private practive in Dallas. “These medications carry inexplicably high costs and can be a barrier to effective treatment.”
At his Omaha clinic, Dr. O’Dell is concerned by the rising costs of generic colchicine and hydroxychloroquine (Plaquenil). According to GoodRx.com, the average retail price of 60 tablets of 200 mg hydroxychloroquine is $220.05.
“Hydroxychloroquine has been used for 60 years at least. It used to be pennies a pill, and now it’s dollars a pill,” says Dr. O’Dell. He believes rising prices for generics are due to market forces, not research or development costs. “Hydroxychloroquine is a necessary medication for every patient with lupus. They should be on it and be taking it forever. Yet my lupus patients come in and say, ‘Doc, I’m not taking my hydroxychloroquine,’ or maybe, ‘I am taking a half dose, because I can’t afford it.’ That’s tragic.”
Dr. Poddar also cites both generic hydroxychloroquine and colchicine, which sells for an average retail price of $162.65 for 30 capsules according to GoodRx.com, as concerns for his patients. “Despite the fact it’s generic, every patient’s insurance is different, and some of my patients may pay $200 for a month’s supply of colchicine. Sometimes, the drug companies give coupons to offset the cost, but some pharmacies won’t accept them. So patients may just go without their drug,” he says. “High uric acid levels can have cardiovascular manifestations, so there are long-term ramifications, not just one joint problem. You can’t just tell these patients to tough it out. It’s not just their joints. These are systemic diseases.”
In his Kingsport, Tenn., rheumatology clinic, Christopher Morris, MD, also cites both colchicine and hydroxychloroquine as “outlandishly expensive, and most of our lupus patients are on generic Plaquenil,” he says. “If they only price a generic a few dollars less than the brand-name drug, there’s really no savings.”
Patients may not understand how their drug coverage on Medicare supplemental plans work when they purchase these policies, says Dr. Morris. They may struggle to pay 20% of the cost of a year’s supply of a drug that costs $25,000. His practice must now devote one full-time staff person just to deal with prior authorizations and insurance company negotiations, he says.
“High-deductible plans may make patients reach a certain level of money spent before they cover the drugs. These patients may have to shell out several thousand dollars before their insurance kicks in,” says Dr. Morris.
Copays Add Up Quickly
Rheumatology health professionals also hear their patients express concerns about high insurance copays adding up quickly for physical therapy and other integrative treatments, says Christine Stamatos, DNP, ANP-C, director of the Fibromyalgia Wellness Center at Northwell Health in Babylon, N.Y.
“I have patients who have to pay $50 for each physical therapy session,” Dr. Stamatos says. “Some patients have insurance policies with a lower premium each month, but very high deductibles, so they may go without their therapy, and this is care that we know is so effective. So it’s frustrating and scary.”
In the rheumatology clinic at the University of Kentucky in Lexington, Associate Professor Elizabeth Salt, PhD, also observes patients delaying care due to higher out-of-pocket costs. “We see decreased healthcare utilization at the beginning of the year when deductibles have not been met, and an increase at the end of the year, trying to get in treatments before the year ends. I see delays in necessary procedures due to cost and patients unable to afford medications due to increased cost,” she says.
Cognitive/behavioral, physical and occupational therapy are very effective for patients with chronic pain conditions, such as fibromyalgia, says Afton Hassett, PsyD, associate research scientist at the University of Michigan Medical School.
‘There is not much transparency in what the costs really are, or what the drugs even cost to produce, & that is another part of the issue.’ —Dr. O’Dell
“For behavioral therapy, some insurance plans may allow only a few visits a month. Effective behavioral therapy takes time, but many patients can have a good response, and they can learn skills that will benefit them in the long term,” says Dr. Hassett. “Those skills and their benefits do not go away as they do when someone stops taking a drug. They may learn skills to help them sleep better or how to do daily activities in ways that are safer and less likely to aggravate their pain,” she says.
If patients skip therapy sessions because of high out-of-pocket costs, “we all end up paying more in the long run with hospital costs or someone being out of work due to pain,” says Dr. Hassett. “I think insurance companies are running around chasing the illness or the problem instead of focusing on preventive strategies that can be highly effective.”
Some of Dr. Poddar’s patients must travel six hours to his Bismarck clinic for an appointment and incur costs like fuel, an overnight motel stay, or time off work in addition to their medications, he says.
“Our patients need the best management at the earliest point in their disease that we can provide it. With the right care for our patients, we can control the morbidities that can happen,” Dr. Poddar says. “Ultimately, the cost of delayed treatment is their quality of life. They can’t get that back. Some of our diseases can cause blindness if patients are not treated. You can’t get your eyesight back.”
Susan Bernstein is a freelance medical journalist based in Atlanta.
Rheumatologists say many of their patients struggle to afford everything from generic drugs to insurance copayments for physical therapy. Our patients need the best management at the earliest point in their disease that we can provide it. With the right care for our patients, we can control the morbidities that can happen. Ultimately, the cost of delayed treatment is their quality of life.