"Step therapy" insurance rules for biologics not always fair to psoriasis patients
The high cost of biologics and other specialty drugs, and insurers' efforts to rein in their costs, was the subject of a Wall St. Journal article the other day (paid registration may be required to view article), but the article only told part of the story.
Specialty drugs include biotech and other drugs for serious diseases such as cancer, multiple sclerosis and inflammatory maladies such as rheumatoid arthritis. The average prescription for these medicines runs more than $1,500 and some top $100,000 a year. By contrast, conventional brand-name pills for problems such as high blood pressure, high cholesterol, and depression run roughly $90 to $120 a month.
The article also included a chart indicating that the average monthly prescription cost for specialty drugs to treat "inflammatory conditions" (of which psoriasis is one) rose 4.6% last year to $1,547.97--and that increase was actually much smaller than the increase in prices for specialty cancer and MS treatments.
To combat this trend, Express Scripts and Medco say they are tightly managing their formularies with rules governing drug selection, usage and dose. Medco is enforcing what it calls step therapy rules, says Tim Wentworth, president of its Accredo unit. Patients are required to start treatment on the lowest-priced drug first, advancing to more expensive alternatives only if and when the cheaper drug fails to work.
We have several complaints, not with what the article says but with what it does not address. The article totally ignores another strategy used by some insurers--increasing co-pays on specialty drugs to make these treatments prohibitively expensive for patients. It ignores the great health benefits many patients have enjoyed with these therapies. And it ignores the "dark side" of so-called "step therapy." Here is part of what we wrote to the author and WSJ Editor about this:
With some insurers, step therapy in practice means requiring less effective and more dangerous drugs based solely on price, rather than on any balance of cost and benefit or safety to the patient. In psoriasis treatment, this can mean forcing patients to use the Korean War-era chemotherapy drug methotrexate, despite its known risks to the liver and, for women of child-bearing age, abortion-inducing properties. The biologics are finding a market precisely because past treatment options for many diseases were so inadequate.
The article closes with a very interesting concept:
Aetna Inc., the big Hartford, Conn., health insurer, is exploring a "pay-for-performance" strategy in which a drug's price would be tied to efficacy. "Some people have spectacular results" taking pricey biotech drugs while "others have no results," says Edmund Pezalla, national medical director of Aetna Pharmacy Management. The idea, already being tried in Europe, is to negotiate drug prices based on whether a patient responds to a treatment. While details are scarce, some companies provide rebates in cash for product if patients don't achieve the desired therapeutic benefit.
Over two decades, she tried virtually everything, like so many of us, and time and time again she had to look again for another option. Now on her second biologic, she is, at the moment, winning her psoriasis battle. Let's hope it continues for her.
A new study confirming an association between psoriasis and diabetes has been released. The study looked at a large group of psoriasis patients and a large group of patients without psoriasis, and found "diabetes was significantly higher in psoriasis patients as compared to the control group...."
But the summary of the study (we have not yet seen the full text) does not indicate if the psoriasis group and control group had similar average body weights or other diabetes risk factors. Other studies have shown that psoriasis patients tend to be heavier than non-psoriasis patients. What would be most useful would be studies that tell us if it is the extra pounds on many psoriasis patients that bring about more diabetes, or something inherent in psoriasis (inflammation, genetics, etc.) that leads to more diabetes.
Until that's cleared up, the fact remains that the medical community seems pretty confident that psoriasis patients could improve their overall health (and perhaps their psoriasis symptoms) by reducing obesity, smoking and excessive alcohol consumption.
An article in the New York Times (free registration may be required) makes several note-worthy points. The article talks about how extremely difficult it is for medical students to be selected to study dermatology--difficult because so many very smart people want the same few training spots available. It turns out relatively humane hours, and the riches from cosmetic procedures, are driving much of this demand. But it's still nice to know that many of the brightest people in the country may be treating psoriasis patients in between delivering Botox injections. Some excerpts follow. The article begins:
March Madness has a different meaning for Thomas Hocker and Meena Singh, a married couple in their final year at the Harvard Medical School, who are waiting to learn Thursday if they have been accepted into their residency programs of choice.
Already saddled with about $330,000 in education loans, they borrowed $20,000 more so they could fly around the country this winter for about two dozen residency interviews each. All told, each applied to 90 such training programs. ...
The search has been difficult not because they are mediocre students; indeed, each has a brand-name education, academic honors and published research on disease. No, it has been hard because they aspire to be dermatologists.
Then we get some statistics:
Only 61 percent of seniors at American medical schools whose first choice was dermatology received a residency in that field last year, compared with 98 percent for those whose first choice was internal medicine and 99 percent for those seeking family medicine, according to a report by the Association of American Medical Colleges and the National Resident Matching Program, which pairs candidates and programs. Although there are far fewer positions in dermatology (320 residencies in 2007) than in internal medicine (5,517) and family medicine (2,603), the field is attracting some of the best and brightest future doctors.
Seniors accepted in 2007 as residents in dermatology and two other appearance-related fields -- plastic surgery and otolaryngology (ear, nose and throat doctors, some of whom perform facial cosmetic surgery) -- had the highest median medical-board scores and the highest percentage of members in the medical honor society among 18 specialties, the report said. ...
For an idea of the competition facing dermatology aspirants, consider the application numbers. Last fall, 383 people applied for 6 places -- an average of about 64 applicants per spot -- in Harvard's dermatology program. By comparison, Harvard College received an average of 11 applications per offer of admission in the class of 2010.
The article also recognizes the profound impact psoriasis can have on patients.
"People greatly value the skin because it is what is on the outside that is the face you present to the world," Mr. Hocker said one evening last month after coming off a hospital shift in which he dealt with afflictions like heart failure and kidney failure. "Most dermatological diseases won't kill you, but they can greatly affect your quality of life."
[... Ms. Singh said:] "Having something on your skin is not life or death for people, but it can be equally important for them emotionally as a life-threatening disease."
Indeed, dermatology can be a psychological lifeline for people with severe skin problems. At pools or the beach, some people shun those with psoriasis who have scaly skin, fearing the condition is contagious, doctors said. ...
Dermatologists say they enjoy the variety of a specialty that encompasses serious illnesses like skin cancer and psoriasis as well as conditions like uncombable hair syndrome.
And we'll close with an excerpt that reminds us all that we should have paid more attention in science class:
But students interested in such work also often factor in personal benefits. Internists, for example, worked an average of 50 hours a week in 2006 while dermatologists worked about 40 hours, according to an annual survey by Medical Economics magazine. Dermatology also offers more independence from the bureaucracy of managed care, because patients pay up front for cosmetic procedures not covered by health insurance.
And while an internist earns an average of $191,525, a dermatologist earns an average of $390,274, according to an annual survey conducted by the Medical Group Management Association, whose membership includes more than 21,000 managers of medical practices. Dermatologists who specialize in cosmetic treatments or in skin-cancer operations can earn much more.
Golimumab, an anti-TNF-alpha monoclonal antibody, demonstrated strong efficacy in Phase Three clinical trials, improving both joint and skin symptoms for significant proportions of patients. For example, at week 14, roughly forty percent of patients achieved a 20% improvement in arthritic symptoms. And at week 24, one-fifth of patients had achieved a 70% improvement. In addition, thirty percent of patients achieved a 90% improvement in skin symptoms. The treatment was similarly effective for nail psoriasis.
In U.S. and Canadian clinical trials, the rate of tuberculosis infection has been roughly 0.007% of patients, or about 1 in 14,000 cases; but in actual practice, rare cases of tuberculosis have been seen in patients using tumor necrosis factor (TNF) inhibitors like Enbrel, Remicade and Humira.
It's a good reminder that patients should be screened for active and latent TB before beginning anti-TNF psoriasis treatments and periodically during treatment.
Save the Dates: Short Sleeve Days 2008 set for Sept. 12-14
Last year, hundreds of people from 32 states participated in Short Sleeve Day--educating the public about psoriasis while raising thousands of dollars for psoriasis research and education efforts. Public events were held in four cities; in other places, people simply wore the official Short Sleeve Day t-shirt or handed out our Psoriasis Info Cards to their friends and neighbors.
This year, the celebration will be bigger and better, and one day is not enough. So we will celebrate Short Sleeve Days on September 12-14, 2008, with goals of major events in 10 cities, participants from all 50 states, and $25,000 raised for psoriasis research and education.
New anti-TNF (ART621) being tested on psoriasis abroad
"Arana Therapeutics Limited (AAH) has commenced recruitment for a Phase II trial in psoriasis for its lead anti-TNF drug candidate ART621." Other anti-TNF's are already on the market, including Enbrel, Humira and Remicade. The psoriasis trial, to be conducted in Australia, is designed to help the company get the product approved one day for rheumatoid arthritis: "Arana chief executive John Chiplin said the strategy was to use information from the psoriasis trials to push along trials for the treatment of rheumatoid arthritis -- a significantly larger market."
XTRAC excimer laser effective for some moderate to severe psoriasis patients
A small pilot study has found the XTRAC excimer laser effective in treating certain cases of moderate to severe psoriasis, the company reported this week. The laser uses targeted ultraviolet (UV) light to treat psoriasis patches, while leaving unaffected skin alone.
This report should not come as a surprise. UV light--whether from the sun, special boxes designed for psoriasis treatment, or the lasers used in this pilot study--is very effective and safe for treating most psoriasis. What's odd is that some insurers' foolish reimbursement and co-pay policies are making UV treatments less attractive to their patients and physicians.
[The XTRAC study was done by a leading psoriasis researcher, but the sample was tiny (about 10 patients) and did not have a comparable placebo group, nor has it been peer-reviewed or published in an academic journal, so we would not make too much of the specific statistics cited.]
