Position Statement on Biologic Response Modifying Agents
The biologic response modifying agents comprise a new group of DMARDS (disease modifying anti-rheumatic drugs), which represent a significant advance in the treatment of rheumatic diseases. They offer the possibility of controlling rheumatic diseases to an extent not previously possible. They are the first agents considered by the FDA to inhibit the progression of structural damage and improve physical function in RA. The number of diseases in which these agents are useful continues to expand as do the number and types of agents available. At the present time there are two FDA approved medications directed against tumor necrosis factor (etanercept and infliximab) and soon there will be a third (adalimumab). Anakinra is the only FDA approved medication directed against interleukin-1.
While the medications available at this time have sufficient similarities to be considered as a group, the differences in ACR response rates, route and frequency of administration, antigen target, and possible side effect profiles prohibit any consideration of these drugs as equivalent agents. The choice for an individual patient cannot be based on population-based studies nor predetermined algorithms. The choice must be determined by a rheumatologist who takes into consideration the factors mentioned above as well as logistics, patient willingness or aversion, contraindications, comorbidities, concomitant medication, susceptibility to infection, and other factors - which can only be individualized on a patient-by-patient basis. Any attempt by a 3rd party to mandate the use of one agent over another should be strongly discouraged since this ignores the complexity of fitting a treatment to a patient, preempts the expertise of the physician, and blindly intrudes on the patient-physician relationship.
Issues of cost must be taken into consideration by all parties concerned due to the high cost of these medications at the present time. This places a greater burden and responsibility on the physician to use particular caution in the selection of patients and the timing of use in the course of a patient's disease. The optimal choice of medication should be the determinant for selection of a medication with cost consideration always playing a secondary role. Cost discounts negotiated by 3rd party payers should not be justification for selection of one agent over another. Overall cost considerations include, but are not limited to: loss of present and future earnings, psychological and social costs, costs of potential adverse effects of therapy. (A single excess hospitalization or surgery would likely cost more than any medication considered.)
The policy of increasing co-pays, to an extent that prohibits appropriate patient usage, should be strongly discouraged. This produces a two-tiered level of patient care, which will exclude patients from needed and optimal treatment.
Similarly physicians' offices and other institutions should not be asked to accept financial deficits due to inadequate reimbursement. Fees should reflect all of the factors inherent in CPT codes for other treatments and procedures: time, expertise, risk, overhead, work, etc.
Indications for the use of these medications should include, but not be limited to, all FDA-approved diagnoses. Non- FDA approved indications should be considered on a case-by-case basis using whatever evidence-based data is available at that time. It must be recognized that many rheumatic diseases have no FDA-approved therapies but it is nevertheless the moral and ethical responsibility of the treating physician to prescribe what he or she considers to be the safest and most effective treatment option that might be available.
October 3, 2002