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The Massachusetts, Maine and New Hampshire Rheumatology Association believes that the standard of care for the administration of biologic agents for rheumatic diseases and autoimmune conditions requires rheumatologic recommendations for the choice of medication as well as the rheumatologist’s approval of the handling, delivery, storage and administration of intravenous, subcutaneous and intramuscular administered medications when performed in their offices.

In the last decade there have been numerous discoveries that have led to a better understanding of the pathogenesis of rheumatoid arthritis, psoriatic arthritis and other autoimmune disease. As a result of these discoveries, agents that modify specific abnormalities of the immune system, termed biologic modifying agents, have been developed. The use of these agents in the treatment of rheumatoid arthritis and other autoimmune diseases has resulted in marked improvement of the overall condition of people with these illnesses. According to some studies, it is now possible to even prevent deformities that result in disabilities in illnesses like rheumatoid arthritis.

Biologic agents target interleukins and cytokines, which are involved in disease pathogenesis and inflammation, for the treatment of rheumatoid arthritis. In the United States, the FDA has approved the use of infliximab, etanercept, anakinra, adalimumab, abatacept and rituxan. Etanercept has been approved for the treatment of rheumatoid arthritis, psoriatic arthritis, psoriasis, and ankylosling spondylitis. Infliximab has been approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Humira has been approved for rheumatoid arthritis and psoriatic arthritis. Orencia and Rituxan have recently been approved for rheumatoid arthritis. With this in mind the A.C.R. unequivocally states that rheumatologists have a responsibility to provide what they consider to be the safest and most effective treatment option for the patient’s illness, even where full FDA approval may never be obtained. It is not justifiable for third party payers to attempt to influence these medication selections by preauthorizing requirements, “preferred drug status” (such as cost discounts negotiated by third party payers) or tiered levels of co-pays. There are many therapeutic alternatives for the treatment of rheumatoid arthritis. Failure to respond to at least one or two disease modifying drugs in the case of rheumatoid arthritis (often methotrexate and or leflunomide), separately or in combination, have been used as a criterion by the insurance industry to warrant consideration of biologic modifying drugs. We do not feel that this is appropriate, as many rheumatologists feel that failure on only one disease modifying agent should be sufficient to warrant consideration of a biologic drug. Patients with ankylosing spondylitis do not generally respond well to disease modifying drugs, and it is our position that biologic agents should be offered as a first choice alternative after the appropriate usage of only nonsteroidal anti-inflammatory drugs. Dosage flexibility is important with infliximab, etanercept and humira.

Patients on biologic therapies may concomitantly receive methotrexate, However, not all patients can tolerate methotrexate. Leflonomide is an acceptable alternative with biologic therapies. Biologic drugs may also be given as monotherapy. The rheumatologists together with their patients determine what is best for the total functional well being of each individual. Selection of therapy considers: age, gender, length and severity of illness and comorbid medical history.

The Massachusetts, Maine and New Hampshire Association believes that the choice of biologic and non-biologic drugs for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and other autoimmune disease is the responsibility of the treating rheumatologist with collaboration of the patient based on standard of care. In at least 40% of patients with active rheumatoid arthritis, laboratory studies for inflammation may be normal. The H.A.Q. score is felt to be more predictive of patient morbidity and mortality in research studies than predictive on how well the patient feels. Limiting treatment decisions to objective and not subjective parameters would not optimize patient care.

In office administration of intravenous biologic agents is considered safe and cost effective in the hands of rheumatologists. In office administration of subcutaneous and intramuscular drugs allows for closer monitoring and better compliance of the patient. Furthermore, patients may not be willing or able to inject themselves. The delivery of all of these medications should be consistent with the parameters to minimize denaturing or damaging the medicines for acceptable standard of care.

Over the past several years we have witnessed a true revolution in the care of patients with diseases such as rheumatoid arthritis, psoriatic arthritis, crohn’s disease, ankylosing spondylitis and other autoimmune disorders. The cost of the new agents adds greater responsibility to the rheumatologist in selecting appropriate treatment. The direct cost is only one of the financial considerations. Loss of present and future earning capacity if treatment is omitted or comorbid illnesses related to continued progression of the disease also have a cost. The optimum management for a given patient may be complex. Decisions are best made within the patient/physician relationship. It is our hope that these medications will continue to be available to all patients who need them.

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