ORA Policy on Biological Anti-TNF Medication developed in consultation with the ORA Board of Directors
Summary: We believe that the 5 anti-TNF medications now available, etanercept, infliximab, adalimimab, certolizumab pegol, and golimumab and the T-cell modulator abatacept should be equally available for use in rheumatic disease patients. So called step-wise therapy or fail-first therapy restrictions placed by insurance providers are not appropriate for patients in need of biologicals. Because of the individual and complex nature of these patients, the patient's physician must be free to select the most clinically appropriate available medication. Global clinical guidelines cannot address the needs of individual patients.
Detailed Analysis: Rheumatic disease patients who need biological medications such as those mentioned above are complex patients and their treatment does not lend itself to simplification. Each patient is a detailed mix of multiple factors and multiple diseases (co-morbidities). The rheumatic conditions are also pleomorphic and have many levels of severity in many multiple organ systems. In addition the medications, because of their different biologic characteristics, cannot be easily compared. These differing characteristics include half-life, method of delivery, binding coefficients, lymphocyctoxicity, and other cytokine interaction differences and complex side-effect profiles including effects on granuloma formation, nerve growth factors, and specific organ toxicities which are poorly understood but well recognized (such as Enbrel's specific tendency to cause iritis) make any specific general guidelines impossible. Add to this all the multiple patient factors such as congestive heart failure, neurological disease and previous cancer and infectious history and you have a multi factorial situation which can only be decided medically by the attending sub specialist. The home situation of the patient and their medical sophistication are important factors and home injection may not be appropriate for certain individuals due to physical handicaps or compliance issues. To provide the most complete care in these complex patients the therapeutic options must be left open and used at the discretion of the attending physician.
The Oregon Rheumatology Alliance (ORA) today announced its support for the American Medical Associations (AMA) recommended Health Insurance Code of Conduct, to be considered at the AMA's annual meeting. The Code was affirmed and passed through the AMA's House of Delegates on November 10, 2008.
"We are very pleased with the AMA delegate's decision to adopt this code of conduct for the health insurance industry," said Dr. Cody Wasner, a Eugene, Oregon rheumatologists and ORA president.. "It is the first step in preserving the doctor-patient relationship without insurers interfering in therapeutic decisions and medical evaluation."
In 2008, ORA filed formal complaints with the Oregon Board of Pharmacy, the Oregon Medical Board and the Oregon Insurance Division, to address insurer interference. Dr. Wasner and the ORA is encouraging patients and providers to sign an online petition supporting the Code of Conduct at www.insurepatientaccess.org.
The new code of conduct would benefit patients, physicians and other health care providers by challenging health plans to modify their restrictive policies without the need for legislative or judicial intervention. In addition, this date could provide consumers with additional tools for comparing health plans during enrollment periods and stimulate health plans to modify unacceptable practicies.
"As rheumatology physicians, we continue to be gravely concerned about the ongoing interference by insurance companies into the doctor-patient relationship," Dr. Wasner said. "We believe that often, insurance companies operate outside their scope of responsibility and restrict patient access to proper therapeutic options. They are also trying to influence the patient's choice of medication without knowledge of the patient's individual history, without licensing appropriate to the scope of practice, and without the knowledge of a medical examination.
According to Dr. Wasner, he and other providers agree that such policies implemented by local health insurers restrict and obfuscate patient medication prescriptions. Specifically, at least one Oregon insurer refuses to authorize the use of FDA-approved treatments for diseases such as arthritis and fibromyalgia. Insurers routinely require that patients first fail on other non-approved but cheaper medications. In many cases, these alternate medications are off-label or not indicated as treatment for that particular disease.
Dr. Wasner added: "The requirement that one must fail first before using the FDA-approved medication seems to be a clear violation of pharmacy practice and good medical practice. The evidence-based date used to support the use of any of these classes of medications certainly does not meet the standard applied by the FDA."
The Oregon Rheumatology Alliance joins the National Minority Quality Forum, the Alliance for Patient Access, the Los Angeles County Medical Association, Alliance for Better Medicine and many other organizations in lauding the AMA's resolution.