Introduction to ORA Position Statements
Oregon Rheumatology Alliance (ORA) is a non-profit organization representing rheumatologists throughout the state of Oregon. Our membership includes over 90 % of all rheumatologists in the state. Our mission is to advocate for optimal care for our patients and educate insurers, agencies, employers, and other organizations on the current state of the art in clinical rheumatologic practice. It is with this in mind that we have formulated position statements on various treatments which are pertinent to our field of expertise. We intend these position statements to be used by physicians, patients, employers, and healthcare related organizations to ensure that appropriate treatments are available to patients with rheumatic diseases.
It is not our intent to provide practice guidelines nor to mandate any specific treatment algorithms for individual patients. The selection of the best treatment must be determined by the treating physician - taking into account all of the individual aspects of a particular patient, as well as the expertise and experience of the physician. This is then moderated by discussion and mutual consent of the patient and the physician. It is our belief that no other party should intercede in this relationship and decision as long as a reasonable standard of care is met. No therapy should be withheld as long as it meets the standard of care for rheumatologists at that time. This may include non-FDA approved indications for many treatments since in many rheumatic diseases there are no FDA approved treatments available. Failure to treat such patients would constitute less than adequate care or even potential malpractice. It is therefore inappropriate and unethical to withhold treatment considered by the rheumatologic community to be reasonable and appropriate. The term "experimental," therefore, is not contingent upon FDA approval but upon the current consensus of the experts in the field - clinical rheumatologists. It is inappropriate for any other group to presume the expertise and experience to override that judgment.
The concept of drug equivalency must be supported by direct head-to-head studies evaluating efficacy as well as adverse effects. This cannot be assumed in the absence of such studies or be deduced by comparing separate studies where patient demographics, selection criteria, methodology, analysis, or other factors may differ. Equivalency presumes comparable route of administration, pharmacokinetics, side effect profile, and efficacy. Only after all of these criteria are met can two treatments be considered to be equivalent. Cost should only be a factor in selecting treatment after equivalency has been considered. Cost should include not only acquisition cost of the treatment but indirect costs of adverse effects, ancillary costs, as well as the costs of failed or incomplete response.
Furthermore it should be accepted that a patient has a right to refuse a specific type of therapy and that this should not preclude them from receiving the next most preferred treatment option.