LEDDEGIGT – - Sundhedsstyrelsen

Model B: TNF-alpha antagonists to all newly diagnosed patients plus
patients who fail to respond to slowly-acting anti-rheumatic drugs
In this model it is assumed that all newly diagnosed patients are started on
treatment with TNF-alpha antagonists (corresponding to approximately 1,700
patients annually). In addition, the treatment is to be given to the other patients
who are unresponsive to the slowly-acting anti-rheumatic drugs. This group is
expected to correspond to 10-20% of the population of rheumatoid arthritis
patients attended by rheumatologists, and is estimated to total 1,600-3,300 3 patients.
Including newly diagnosed patients a total of 10.100-11.800 4 patients will
be candidates for treatment with TNF-alfa antagonists during a five year period.
Due to the use of TNF-alpha antagonists, this model with infliximab entails a
first-year additional personnel requirement corresponding to approximately 8
full-time positions for physicians, 16 for nurses and 10 for secretaries, increasing
considerably by the fifth year to 29, 57 and 36 full-time positions,
respectively. The personnel resources are calculated assuming optimal organization
of the work burden and the gathering of patients in centralized units.
At the national level the annual additional costs when using infliximab will
increase from DKK 136 million in the first year to DKK 505 million by the
fifth year, of which expenses for medication account for 90%.
With etanercept the personnel requirements are more modest, corresponding
to 4 additional full-time positions for nurses in the first year, increasing to 6
in the fifth year. The associated additional costs amount to DKK 169 million
in the first year, increasing to DKK 942 million by the fifth year.
The above figures do not include additional costs and additional personnel
requirements associated with early referral and diagnosis.
Model C: TNF-alpha antagonists solely to patients who fail to
respond to slowly-acting anti-rheumatic drugs
In this model it is anticipated that due to the positive effects hereof, only
approximately 10% of the patients diagnosed after introduction of early
referral and diagnosis will need to start treatment with TNA-alpha antagonists
during the course of a five-year period. Among the remaining rheumatoid
arthritis patients attended by rheumatologists, approximately 10-20%, willstart
treatment over a five-year period. On this basis it is estimated that a total of
1,800-3,400 5 seriously affected rheumatoid arthritis patients will be candidates
for treatment with the biological drugs at the national level over a five-year period.
With Model C, patient recruitment is thus considerably lower than with Model
B because newly-diagnosed patients are not treated with TNF-alpha antagonists.
3 10–20% of (18,000 minus 1,700) patients equals 1,630-3,260 patients.
4 1.600-3.300 + (5x1.700) patients equals 10.100-11.800 patients.
5 10–20% of (18,000 minus 1,700) plus 10% of 1,700 equals 1,800-3,430 patients.
The additional personnel requirements entailed by the use of infliximab in
Model C correspond to 3 full-time positions for physicians, 7 for nurses and 4
for secretaries, increasing to 7, 14 and 9 full-time positions, respectively, by
the fifth year. The annual additional costs to the Counties associated with the
use of infliximab in this model are calculated to increase from DKK 57 million
in the first year to DKK 126 million by the fifth year, of which expenses
for medication account for 90%.
With the use of etanercept in this model the additional personnel requirements
decrease from 1.7 full-time positions for nurses in the first year to 1.2 by the
fifth year. The associated additional costs are calculated to increase from DKK
71 million in the first year to DKK 240 million by the fifth year.
Possible savings in connection with reduced need for medication, physiotherapy,
occupational therapy and surgical treatment and preserved ability to work
in models B and C are not included. The above figures do not include additional
costs and additional personnel requirements associated with early referral
and diagnosis.
Conclusion and recommendation concerning the models
It has been documented that patients who do not respond to conventional treatment
will benefit considerably from the TNF-alpha antagonists. At the same time, early
intensive use of the conventional slowly-acting anti-rheumatic drugs will be
beneficial for all patients with newly acquired rheumatoid arthritis.
Based on an overall assessment and taking into account not only the evidence
for the benefits and disadvantages but also the resource aspects, the project
group recommends Model C as the best foundation for the treatment of
rheumatoid arthritis at the present time.
Cost considerations and the unresolved long-term effects of the new drugs
also speak in favour of Model C at present. The recommendations of this report
should be re-evaluated within a few years as the results of a large number
of clinical trials of TNF-alpha antagonists and several new biological drugs are
underway. Among other things, these studies will help determine whether the
use of biological drugs entails treatment benefits in early rheumatoid arthritis
relative to the slowly-acting anti-rheumatic drugs. At the same time, the studies
will clarify any long-term effects of TNF-alpha antagonists.
According to the recommended model, Model C, it is estimated that over a
five-year period, 1,800-3,400 rheumatoid arthritis patients will be candidates
for TNF-alpha antagonist treatment in Denmark. In this connection, the
project group recommends that the practical implementation of treatment
with TNF-alpha antagonists should presently be centralized at a single rheumatology
hospital department in each of the 14 Danish counties for the following
reasons:
32 LEDDEGIGT – medicinsk teknologivurdering af diagnostik og behandling
LEDDEGIGT – medicinsk teknologivurdering af diagnostik og behandling 33