LEDDEGIGT – - Sundhedsstyrelsen

ment period of approximately two months due to accelerated diagnosis
and treatment. The extra costs and manpower consumption are relatively
modest. Expected savings due to a better treatment effect and a
reduced morbidity are not included in the calculations.
Treatment with slowly-acting anti-rheumatic drugs can reduce disease
activity in most rheumatoid arthritis patients, and the efficacy is improved
by both early and intensive treatment. Some of the substances
can inhibit but not prevent the progressive joint damage.
In severe active rheumatoid arthritis that does not respond to conventional
treatment with slowly-acting anti-rheumatic drugs, which, based
on current treatment standards, encompasses an estimated 10-20% of
the population of rheumatoid arthritis patients attended by rheumatologists,
the TNF-alpha antagonists have proven to have a rapid and
marked effect on symptoms with only few side effects. Furthermore
TNF-alfa antagonists are able to significantly deminish or arrest the development
of joint damage. The beneficial effects of early treatment
with these new drugs remain to be adequately evaluated.
The additional costs of introducing treatment with the new biological
anti-rheumatic drugs are considerable and increase over a five-year period
depending on the indication criteria. With a treatment model entailing
less widespread use of TNF-alpha antagonists, the additional costs will
amount to DKK 57-71 million in the first year of treatment, increasing
to DKK 126-240 million annually by the fifth year. With more widespread
use in which all newly diagnosed patients are offered the treatment,
the additional costs will amount to DKK 136-169 million in the
first year, increasing to DKK 505-942 million annually by the fifth
year. Probable savings as a consequence of the reduction in morbidity,
loss of ability to work, etc. are not incorporated in the calculations.
It is recommended that all patients treated with TNF-alpha antagonists
should be registered in a central database to clarify treatment efficacy,
side effects, drug consumption and future indications for use of these
new, costly biological drugs.
Physiotherapy and occupational therapy have no fundamental effect on
the course of the disease, but training, instruction and the use of aids
are effective methods to improve the functional status and reduce pain
during the activities of daily life. Surgical treatment is most effective if
it is carried out before the loss of function becomes too great.
Based on an overall evaluation, the project group recommends that the new
drugs should be offered to the group of patients with severe active rheumatoid
arthritis who have not benefited from slowly-acting anti-rheumatic drugs,
an estimated 10-20% of the population of rheumatoid arthritis patients attended
by rheumatologists 1 . This limitation is in good accordance with what
can be justified from the documentation presently available, and corresponds
to international recommendations. It is further recommended that treatment
with these substances should be centralized at one single rheumatology department
in each of the 14 Danish counties.
In addition it is recommended that early referral and diagnosis should be
strengthened through establishment of formal collaboration between general
practitioners, specialists and the rheumatology clinics such that patients are
referred, diagnosed and treated as rapidly as possible since the likelihood of a
satisfactory treatment outcome is greatest in the earliest phase of the disease.
This should be aimed at irrespective of where the patients live. Similarly, all
patients should have equal access to relevant physiotherapy and occupational
therapy, as well as to surgical evaluation.
Background for the report and the key issues
The TNF-alpha antagonists currently available are infliximab and etanercept.
Both preparations have a pronounced inhibitory effect on the disease activity,
but are also able to slow down or completely stop the progressive joint damage
in rheumatoid arthritis.
The use of TNF-alpha antagonists has been initiated in several parts of the
country. In collabora-tion with the Danish Society of Rheumatology, The
Institute for Rational Pharmacotherapy drew up the first clinical guidelines
for the use of the new drugs as early as 1999. The efficacy, price and role of
the substances relative to the other treatments available had not yet been systematically
clarified at that time, however. Based on discussions between the
Danish Society of Rheumatology and the former Danish Institute for Health
Technology Assessment, the decision was made to initiate a broad health
technology assessment. This was to encompass all methods of treating rheumatoid
arthritis with special focus on both the new TNF-alpha antagonists
seen in relation to traditional pharmacotherapy, and the significance of early
referral, diagnosis and treatment.
A cross-disciplinary project group was established in early 2000 with the task
of assessing:
The evidence that early diagnosis and early initiation of treatment improve
the course of the disease and reduce progressive joint damage.
1 This corresponds to the above-mentioned treatment model with less widespread use of
TNF-alpha antagonists.
24 LEDDEGIGT – medicinsk teknologivurdering af diagnostik og behandling
LEDDEGIGT – medicinsk teknologivurdering af diagnostik og behandling 25