TORONTO - Billed as a first in the psychiatric field, a pharmaceutical company is offering a money-back guarantee on a drug for treatment-resistant schizophrenia.
Sandoz Canada Inc. promises to reimburse individuals, hospitals and government drug plans in cases where patients with treatment-resistant schizophrenia must be taken off clozapine within six months.
Sandoz is not the first pharmaceutical company to launch such a marketing scheme. Merck-Frost is already offering to reimburse provincial governments for the cost of finasteride (Proscar) if patients prescribed the drug require surgery for benign prostatic hyperplasia after one year of medical therapy. Some urologists have criticized the plan as a marketing ploy to direct attention away from other treatments.
The Sandoz reimbursement plan covers the costs of the drug, dispensing fees and pharmacy mark-ups.
One of the problems with clozapine is that while studies show it's extremely effective, its high cost - sometimes $15 or more per day - makes it relatively inaccessible. Cost is a major reason it's not included on most, if not all, provincial drug formularies although it's available with restrictions through special budgets.
There's also lots of bureaucracy surrounding the prescribing of and dispensing of clozapine. Doctors have to "go through all kinds of hoops and paper work" to get patients on the drug, said Dr. Duncan MacCrimmon, a psychiatrist at Hamilton Psychiatric Hospital and an associate professor at McMaster University in Hamilton.
Physicians must fill out government forms for funding purposes as well as additional forms for the pharmaceutical company, which keeps tabs on blood testing. Up to 2% of patients on clozapine develop agranulocytosis, a sudden and severe drop in white blood cells, so they're required to undergo weekly tests.
"The guy out in practice two hours away from a major centre, who has a person who might benefit from the drug, might not be bothered getting all the forms organized," said Dr. Barry Jones, schizophrenia research co-ordinator at Hamilton Psychiatric Hospital.
While limits set by governments on the number of patients who are supposed to be covered for this drug at any one time are being quietly ignored, at least in Ontario, restrictions on its use appear to be enforced in some hospitals. This, said Dr. Jones, may be because of "hassles" involved with the blood testing and manpower needed for pharmacy dispensing.
Because of all these perceived or real barriers to accessing the drug, some experts believe the drug's manufacturer is using its new marketing plan to try to tip the balance in favor of the drug.
Currently, its closest rival is risperidone, sold under the name Risperdeal by Janssen Pharmaceutica. It is expensive but has less paper work associated with its prescription.
Dr. William McCormick, a Dartmouth, N.S. psychiatrist and president of the Canadian Psychiatric Association (CPA), agreed Sandoz's new money-back guarantee may help break down existing barriers to prescribing clozapine.
"If I commit the patient to spend money and it doesn't help, the money will come back; but if I commit the patient and the money stays, at least the patient is getting the benefit."
Dr. McCormick said the marketing plan is a "potentially ticklish issue" that may be discussed in future by the CPA.
Dr. Jones believes clozapine and risperidone are different enough that competition is not a motivating factor behind the plan.
Both drugs have the potential to work where all the older generation antipsychotic drugs have failed. But unlike clozapine, risperidone can be used as a first line treatment and is not reserved for treatment-resistant cases.
For these refractory cases, clozapine is extremely effective, said Dr. MacCrimmon. Studies show it's 'head and shoulders' above other schizophrenia treatments and that the difference is "like black and white," he said.
Side effects reduced
"It's a relevant, important, major improvement in treatment," said Dr. MacCrimmon, adding that it has none of the Parkinson-like side effects such as tremors and stiffness that are common with other antipsychotic drugs.
Dr. McCrimmon has been prescribing clozapine on a limited basis since the late 1970s. The drug was approved for more widespread use by the Health Protection Branch of Health Canada in 1991.
Clozapine, said Dr. Jones, has a "niche" of its own. He therefore doesn't have a problem with the intent of the new marketing plan.
"If I personally felt they (the manufacturers) were trying to soak up someone else's market share with this strategy then I think people could get angry, but I don't see it that way.
"I see it more as Sandoz trying to reinvigorate clozapine in terms of publicity and in the minds of clinicians."
Dr. Paul Posner, a senior psychiatrist at the Queen Street Mental Health Centre here, agrees. "For real treatment-resistant schizophrenia cases, their treatment is really restricted these days to clozapine and clozapine."
"... I'm inclined to think this is Sandoz's way of saying this is an excellent drug and we're willing to stand by it. It's a bit of gesture or a statement. Economically I don't think it's going to make a huge lot of difference." Dr. MacCrimmon does not believe this new program will markedly alter physician prescribing habits.
"It's not a simple medication to use safely; it's complicated and cumbersome... This drug isn't for every patient. It's specifically for treatment-resistant patients who have not done well - and it takes awhile for that phenomenon to become clear."
Copyright © 1995 Maclean Hunter Publishing Limited
Reprinted with permission.
Internet Mental Health (www.mentalhealth.com) copyright © 1995-2011 by Phillip W. Long, M.D.