Nancy Daley has lived with the pain and embarrassment of psoriasis for nearly 40 years. Like many patients with a severe case, she has tried just about every kind of treatment: topical creams, systemic medications, coal tar products, even tanning beds. "That worked wonderful, except that after six or seven months my neck looked like a piece of leather," says Daley, 56.
She finally found some relief with Enbrel, an injectable biologic medication, but in 2003, after a year on the drug, it stopped working (as biologics sometimes do). Her doctor switched her to another then-new biologic, Humira, which all but cured her plaques and pains. "It was the only thing that helped me," she says.
Then, two years ago, Daley moved from Minnesota to Nevada. She has switched jobsand insurance carrierstwice since then, and in the process her Humira co-pay has skyrocketed from $7.75 to $316 per month, an outlay she can no longer afford. Even as a state employee with health insuranceshes now a licensed nurse at a state prisonDaley has effectively been priced out of the only medication that works for her.
Shes not alone. Between 2000 and 2008, the average wholesale price of five popular psoriasis drugs increased at a rate nearly five times that of inflation, according to a study published earlier this year in the Archives of Dermatology. During that period, the price of a dose of Enbrel increased by nearly 50%, to about $208; a dose of Humira increased to $831. (Although its a useful indicator for pricing trends, a drugs wholesale price is often higher than the eventual sales price, the study notes.)
"Insurance costs are going up higher than inflation as well," says one of the studys authors, Stephen E. Wolverton, MD, a professor of clinical dermatology at the Indiana University School of Medicine, in Indianapolis. "Most of us say this rate of increase of insurance and drug costs just cant be sustained. To the great majority of the country, $500 a month [for a biologic] is a great big chunk of change."
In recent years, rising drug costs and insurance difficulties have combined to make biologics and other psoriasis treatments too expensive for a growing number of people. Since 2006, the National Psoriasis Foundation, the leading advocacy organization for psoriasis patients, has seen almost a four-fold increase in the number of people seeking help paying for psoriasis medication.
If you find yourself in a similar predicament, resources are available that can help make psoriasis drugs more affordable. The manufacturers of biologics and other high-priced psoriasis drugs offer assistance programs that help patients cover the cost of treatment.
Why are some psoriasis drugs so expensive?
Its unclear whats behind the rapid increase in the price of psoriasis drugs, says Dr. Wolverton. Nor is it clear why the price of some drugs has increased more quickly than others, he says.
Newness doesnt appear to be a factor. For instance, acitretin (Soriatane), an oral systemic medication that has been on the market for more than a decade, increased by 158% between 2000 and 2008, while Humirawhich is far more expensive to produce and newer, having received FDA approval for psoriasis in 2008has only increased 27% since 2003. (The drug is also used for rheumatoid arthritis.)
Although drug manufacturers set prices to recoup the drugs research and development costs, their prices are also intended to maximize revenue, Dr. Wolverton suggests. "My theory is that the cost of generating the drug is already a done deal, and the rest is market driven," he says. "But the logic of letting [drugs like acitretin] continue to increase sort of suggests [the manufacturers] are charging to help generate new drugs."
Unfortunately for people like Daley who rely on biologic drugs such as Humira, their treatment is likely to be expensive if it isnt fully covered by insurance. Biologics, which are genetically engineered versions of human proteins or other organic materials, are very costly to research, develop, and manufacture, says Mark G. Lebwohl, MD, the chair of the department of dermatology at the Mount Sinai School of Medicine, in New York City.
"The bottom line is that these drugs are too expensive, and that price is putting them out of reach for a lot of people," Dr. Lebwohl says. "Ive visited these plants. If someone there goes to the bathroom, they have to change out of two sets of disposable clothing. Theyre working with very expensive raw materials in a medium thats very easily contaminated."
And unlike with older systemic medications, generic versions of biologic medications, or "biosimilars," wont be available to psoriasis patients anytime soon. The new health-care legislation contains a provision that gives the makers of biologics 12 years of patent protection before other companies can produce biosimilars.
Even if they do eventually come to market, biosimilars would still be relatively expensive compared to most generic medications (some of which are sold at pharmacies for as little as $4 a prescription). Biosimilars would "cut some costs," says Dr. Lebwohl, but, he adds, producing one is "still overwhelmingly more expensive than making a pill."
Dr. Wolverton predicts that a biosimilar would be about 80% to 90% of the patented drugs price. "Eighty percent of $20,000 is only a $4,000 discount, but its a start," he says, referring to the annual cost of a typical biologic.
There is no cure for psoriasis, so treating the condition is by definition a long-term process. Insurance coverage, on the other hand, can vary from year to year and job to job. If a psoriasis patients insurance situation changes, an expensive treatment can suddenly become unaffordable.
Gary Firstenberg, 52, has suffered from severe psoriasis for more than 30 years. Like Daley, he achieved mostly clear skin with Enbrel after years of experimenting with other treatments; the drug cleared up 90% of his plaques.
But within a few years, his monthly insurance premiums increased from $180 to more than $500, and then, in 2008, his longtime insurance company dropped his coverage after he failed to send in his renewal form. (Firstenberg maintains that he did send it.) Losing his medication, he says, caused him to "flare up terribly." Then, despite a promise from his agent that his new carrier would cover Enbrel, he was later informed that the company didnt cover injectable drugs.
"They wont totally support what you need over the long term," says Firstenberg, a Florida-based greeting card photographer.
Firstenberg is currently managing with moderate plaque coverage on methotrexate. He says hed love to try phototherapy, but the regular visits to a dermatologists office that the treatment requires would cause his business to suffer. "I think the next step for me might be playing the lottery and winning. Then I could pay for my Enbrel," he says. "Its pretty sad. The solutions out there for me; I just cant afford it."
Psoriasis patients without any insurance coverage are sometimes even worse off, as Daley can attest. In 2009, she was without insurance for three months before landing her job at the prison. She called the Abbott Patient Assistance Foundation, a nonprofit that administers a program to help patients pay for drugs manufactured by Abbott Labs, including Humira. The foundation told her that her household income was too high to qualify, however.
"My insurance dropped August 31 and I did not have insurance again until December 1. All those months in between I tried to see if I could get help, and I called Abbott," she says. "Because I didnt have insurance [the Abbott Foundation] considered my [household] income too high for a program. Now that I have insurance I do qualify. Thats wrong. They wouldnt help because I didnt have insurance; now theyll help me because I have insurance. Theres something I dont understand there."
The fact that she qualified only after she had health insurance struck her as a catch-22, and she doesnt feel that the income threshold for uninsured people (four times the federal poverty guidelines, or $58,280 for her two-person household) is high enough. Despite her frustrations about the Abbott programs requirements, Daley still encourages other psoriasis patients to contact their drug manufacturers if they can no longer afford the costs. The company has now agreed to give her $500 every other month to help cover her Humira co-pays, which will knock her monthly out-of-pocket costs for the drug down to a still high but "doable" $66, she says.
Programs such as Abbotts that help patients pay for drugs are known as patient-assistance programs. Most manufacturers of biologic drugs for psoriasis have such a program. Although they do have some restrictionspeople on Medicare and Medicaid arent eligible, for instancethese programs are often the best option for people who cant afford their psoriasis drugs or co-pays.
"The co-pays have gone up," says Elizabeth Hoff, Abbotts senior manager of pharmaceutical public affairs. "Weve seen the data."
Daleys experience sounds unusual, Hoff says, adding that more than 95% of Humira patients who apply to the foundation will qualify.
"Were trying to help as many people as we can," she says. "What weve done since the beginning is just encourage any patient to call regardless of their financial situation. Just call and well figure something out. Were trying to take costs off the table so people are not looking at that. The whole goal is to make it so patients dont have to come off their therapy."
Even so, people like Firstenberg whose insurance doesnt cover the drugs they need may find themselves in a no-mans-land.
Firstenberg submitted financial statements to the nonprofit Encourage Foundation (the patient-assistance program that subsidizes Enbrel) and to the patient assistance program for Stelara, a new biologic. He was declined assistance from both.