April 17, 2000 (San Francisco, Calif.) -- Five years ago, Suzanne F. was diagnosed with myelodysplastic syndrome, a potentially fatal blood disorder that she knew would require expensive and difficult treatment, possibly even a bone marrow transplant.
Then came this added insult: As if the diagnosis of this leukemia-like disease weren't enough, Suzanne now faced another problem: how to pay for Epogen, an extremely expensive biotech drug that her doctor said she needed to stimulate the production of red blood cells.
Unfortunately, Suzanne's health insurance wouldn't cover the drug, and she didn't have the resources to pay for it herself. Epogen costs about $8,000 per year for the average kidney dialysis patient. For her treatment, the amount she needed would cost six times that much.
What to do? At medical conferences concerning her disease, Suzanne learned that drug companies sometimes helped people in her situation. On her own, she went to Amgen, the Thousand Oaks, Calif., company that manufactures the drug, and to her great surprise and relief they agreed to supply it to her at no cost.
Using the drug stabilized Suzanne's condition so that she could continue working; it also bought her time to search for a bone marrow donor, says her attending physician Bradley Lewis, MD, director of hematology for the Alta Bates/Salick Comprehensive Cancer Center.
A Little-Known Secret
The fact that many drug companies will help patients get access to drugs -- sometimes for free -- is not widely known.
Drug companies don't like to talk about such programs, possibly because they fear opening themselves up to a potential flood of calls, says Gerald Hinckley, partner at Davis Wright Tremaine, who specializes in health care law. But a number of leading manufacturers will either offer drugs or lobby on behalf of patients whose requests for reimbursement are caught up in red tape.
Hoffman LaRoche, which operates four different assistance programs, tries to support doctors' efforts to get coverage. "We'll work with the doctors, but the physicians will have to be the true advocate, because they are the most familiar with the patient's condition and medical history," explains Abby Lessig, senior program associate with the LaRoche medical needs programs.
Biotechnology giant Amgen will, in some cases, take a more direct approach. "We do have people who try to help [patients] work through their insurance reimbursement challenges, which includes contacting payers on behalf of those patients," says an Amgen spokesman. And in the case of Epogen, Amgen will give patients who qualify subsidies, or sometimes even provide the drug at no cost.
The aim of such assistance programs is to provide the estimated 44 million U.S. residents without sufficient health care coverage a way to receive treatment for chronic illnesses -- with the drug company absorbing most or all of the cost of a medication.
Why Insurance Companies Refuse Drug Requests
There are a variety of reasons why a patient may be refused coverage for a drug. These include ambiguity in the prescription for a medication that has multiple uses. For instance, the skin cream Retin-A can be used cosmetically to treat wrinkles and medically to treat acne, but it may also have other "medically necessary" uses. A health plan may need clarification that the use is not a cosmetic one. In this case, the question of coverage can be resolved without a drug company's help.
Advocacy often comes into play when drugs are new or are being prescribed for new uses. In these cases, a health plan may regard the drug as experimental -- not part of mainstream medicine -- and decline coverage based on policy exclusions.
When a patient is refused coverage for a medication, the drug maker often will help in the appeals process by making phone calls to determine what a patient's policy will and will not cover, and by working with the doctor to write a letter of medical necessity. In the latter situation, the drug company may provide additional information about how a medication works and its effectiveness, including sending the physician journal articles to help support the appeal.
Programs Support Those in Need
Chief among those who must turn to these patient assistance programs are professionals on the frontlines of medical care for the financially needy -- pharmacists in free clinics, who give the programs glowing reviews.
"Medications would be prohibitive for us to purchase; we're the largest free clinic in the country with 16,000 to 20,000 patients a year," explains Ruth Smarinsky, PharmD, director of pharmacy services for the Venice (Calif.) Family Clinic.
Pharmacies at these clinics, which serve the working poor, do not have a ready supply of drugs to fill prescriptions immediately. Medications are obtained on a patient-by-patient basis, and patients must often wait three to four weeks to receive them. The majority of the programs give a patient enough medication to last three months.
To fill the gap, Smarinsky says the clinic relies on free samples that drug company representatives bring with them when they visit the clinic. The reps make these visits fairly often, because the Venice clinic sponsors a residency program that includes 500 volunteer physicians. "[The drug rep visit] is inexpensive marketing for [the company]," says Smarinsky. Although obviously beneficial for clinics and patients in some situations, such close collaboration between health professionals and drug companies remains controversial. (See A Prescription for Trouble)
In return for the drug rep's one-stop office visit, Smarinsky gets what her clinic needs -- a way to help bring relief to clinic patients while they wait for their prescription drugs to arrive. "We wouldn't have a pharmacy without the samples or the [patient assistance] programs," she says.
When You're On Your Own
But those who do not have a clinic operating on their behalf may have to take the initiative and go directly to the company themselves. (For more information, see Cracking the Secret.) If, like Suzanne, they are unable to get insurance coverage, they may be fortunate enough to receive the drug from the company.
This work by the drug companies has obvious benefits for the patients, says Lewis, but it also has perks for the drug companies as well. The Berkeley hematologist recalls a case 16 years ago when he wanted to give Alpha Interferon to a patient with myeloma, but the patient had been refused coverage. At the time, two companies were making the drug, but only one would help Lewis' patient by giving the drug for free.
"For many years I only used that company's brand [of Alpha Interferon], and most of my colleagues followed in my footsteps. It was four or five years before I would use the other company's drugs," he says.
Kristi Coale is a San Francisco-based freelance journalist who specializes in science and medical issues. Her work has appeared in Salon, Wired, and The Nation.