Position Statement
Subject:
New Agents
for Arthritis
Presented By:
Committee on Rheumatologic Care
For Distribution To:
Members of the American College of Rheumatology
Medical Societies
Members of Congress
Centers for Medicare and Medicaid Services
Managed Care organizations/Third-Party Carriers
Arthritis Foundation
Background
A new group of
DMARDS (disease modifying anti-rheumatic drugs) has been developed with the
purpose of interfering with inflammatory cytokine biology. They represent a
significant advance in the treatment of rheumatic diseases. These so called
"biologics" or biologic response modifying agents have proved to be
very effective and offer the possibility of controlling rheumatic diseases to
an extent not previously possible. Currently approved representatives are anakinra,
etanercept, infliximab and adalimumab. These agents are 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.
The clinical improvement with these
drugs is often quite dramatic and several years of data show that these responses
are long lasting. However, the production of these medications is significantly
more complicated than our previous treatments and their cost is significantly
higher. Because of cost, access to these medications has become increasingly
difficult for our patients and a clarification on the American College of Rheumatology's
policy on these medications is needed.
Policy:
We believe that all patients with
serious rheumatic disease must have these new "biologic" medications
available when clinically appropriate.
Access
Attempts to restrict their use by guidelines or criteria that are outside the
patient-physician relationship should be discouraged, and cost based substitutions
within this group are inappropriate. The differences in ACR response rates,
route and frequency of administration, antigen target and possible side effect
profiles prevent any consideration of these drugs as equivalent agents.
Decision Making
The choice for any individual patient should be determined by the treating rheumatologist
who, as an expert in the field, will take into consideration not only the above
medication differences but logistics, patient willingness or aversion to various
medication delivery systems, contraindications, co-morbidities, concomitant
medication, susceptibility to infection, and other factors which can only be
individualized on a patient-by-patient basis. Third party payers should not
attempt to mandate the use of one agent over another based on population-based
studies nor predetermined algorithms. To do so ignores the complexity of decision
making by the rheumatologist, preempts the expertise of the physician and blindly
intrudes on the patient-physician relationship.
Cost Considerations
Because these newer agents are costly, the rheumatologist has added responsibility
in selecting appropriate treatment for rheumatic patients. Financial considerations
are not limited to the direct cost of medication, however; they range from the
loss of present and future earning capacities if treatment is omitted to the
potential consequences of adverse effects of treatment. The optimal management
for a given patient may be complex, but these decisions are to be made within
the patient-physician relationship. It is not justifiable for third party payers
to attempt to influence these medication selections by pre-authorization requirements,
"preferred drug status" (such as cost discounts negotiated by third
party payers) or tiered levels of co-pays.
Spectrum of Use
Presently the new "biologic' medications are FDA approved for use in Rheumatoid
Arthritis. Etanercept is indicated for Psoriatic Arthritis as well. It must
be recognized however, that many rheumatic diseases, because of small numbers
or other factors, may never have FDA approval for biologic treatment, but have
adequate evidence-based data to justify such treatment. For example, at the
present time Ankylosing Spondylitis and other spondyloarthropathies and inflammatory
arthridities, such as reactive arthritis, Reiter’s Syndrome, and inflammatory
bowel disease arthritis meet this requirement. The fact that these are non-FDA
approved indications should not be justification of third party denial for this
treatment. 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.
Approved by Committee on Rheumatologic
Care: 01/11/03
Approved by the Board of Directors: 03/07/03
