Discussion
The present study was designed to compare, using a cost-effectiveness
analysis, the cost and the effectiveness of four surgical strategies
used for the treatment of AUB-O,E,N in France. It showed that
mini-invasive 2G and 1G procedures, which are recommended as preferred
solutions for the surgical treatment can also be considered as
cost-effective procedures, as they are associated with lower severe
complication rates and lower costs, when compared to curettage and
hysterectomy. Conversely, hysterectomy is the most expensive procedure,
because of the high cost of the initial surgery and the higher rate of
hospitalization for complications over time; curettage is the least
effective one with the highest rate of failures over time.
Our results are in accordance with previous cost-effectiveness studies,
confirming that 2G and 1G are cost-effective. Our study is the first and
the only one for which cost and effectiveness data are entirely
extracted from a unique source of data, i.e. the PMSI database.
Roberts15 and Garside16 both point
out that theirs models included hypothetical patients and they built
them with multiple sources and limited available data.
Miller18 also regrets the incorporation in his model
of data from older studies, some of which predate the advent 2G
endometrial ablation technologies. Only Fernandez13,
Bischoff-Everding17 and Cooper14performed their cost analysis using economic data collected on
individual patients. These studies are however based on small sample of
patients (147, 88 and 660 patients, respectively), which may not be
representative of AUB surgical management. Our study has the advantage
of being based on observed cost and efficiency data from patients in
real-life conditions, in the largest and exhaustive cohort of French
patients, over a long observation period. The analysis with KM curves
allows considering the time of occurrence of events since the initial
surgery in patients with heterogeneous follow-up time. Indeed, the
sensitivity analysis based on patients with 60 months of follow-up
confirmed the conclusions at 18 months, demonstrating the robustness of
our results.
The use of the PMSI database for performing a cost-effectiveness
analysis presents other advantages. Since it is the basis of prospective
hospital funding, hospitals have to produce standardized reports for
each stay performed. Data extracted from the PMSI then presented a high
exhaustiveness (all public and private hospitals are included and no
sampling is done) and a high level of quality, with limited coding
errors. The large number of cases documented allowed the study outcomes
to be determined with high precision. Bias due to sampling errors and to
loss to follow-up should be minimal. The economic burden of AUB is also
expected to be well documented, as the management of the initial surgery
and of severe complications occurred in hospital setting. At the time of
study completion, hospital external activity was not available in the
PMSI database: activity such as consultations or some procedures could
not be tracked. Therefore, failure and complications that would have
occurred out of hospital and that would not have led to hospitalization
shall not have been tracked as they are not reported in the PMSI
database. We might have an overestimation of failure/complications
avoided. A linkage is currently available between the PMSI and SNIIRAM
(French sick funds comprehensive reimbursement database). However,
SNIIRAM could not be used in this study, as its access was not possible
within the study delay. Other costs could therefore not be tracked, such
as sick leaves, leading to potential underestimation of associated
costs. However, the overestimation of effectiveness as well as the
underestimation of costs might not be different between the 4 groups.
1G and 2G appear to be the preferred techniques. The cost of the device
could be offset by its greater use with a logical reduction in the
purchase cost and by the economy of occupying operating theaters because
performing 2G surgery is twice as fast as for 1G.
In conclusion, this study based on the largest cohort of patients
surgically treated for AUB-O,E,N confirms that 1G and 2G techniques are
the most efficient strategies in real-life conditions. Despite the fact
that hysterectomy and curettage are not recommended as first line
strategies, that curettage is the least effective strategy and
hysterectomy the most expensive one, both strategies are still used in
more than half patients as first line surgical treatment. Switching to
2G techniques would not require a specific training for surgeons, when
compared to curettage or hysterectomy, and it would decrease the annual
AUB budget impact of about 65 millions \euro (as the extra-cost of
hysterectomy compared to 2G is 24,008 \euro and 3000 annual
hysterectomies are done in France with 90% of which are not justified
for this indication). Improving the 2G French tariffs could foster this
switch, allowing a more adapted treatment to these patients, with a
limited expected increase of costs for the National Health Insurance.
Moreover, most second-generation endometrial ablation are still
performed under general or epidural anaesthetic in an operating theatre.
However, the new small diameter devices should encourage movement of
minimal invasive surgery out of the traditional operating theatre and
this next development will accentuate the cost-effectiveness of the
treatment of heavy menstrual bleedings by 2G techniques.
Finally, we are at a turning point where we have to balance the superior
efficiency of radical surgeries (total or subtotal hysterectomy) and the
lesser efficiency of 2G or 1G techniques, but despite all, that being
significant with less than 20% reoperations, and their economic impact
for national health insurance.
Disclosure of interests : GD, JF, DT, PD, HF and IB received
personal fees from Hologic for their participation to Steering Committee
during the work. PD, HF and DT reports personal fees from HOLOGIC
France, outside the submitted work. HEVA works with all pharmaceutical
and medical devices industries like JANSSEN, BMS, PFIZER, NOVARTIS,
BSCI. JF reports personal fees from HEVA during the conduct of the study
and personal fees from Astellas Pharma outside the submitted work. IB
received personnel fees from Novartis, Allergan, CSL-Berhing, Merck
outside the submitted work.
Contributions of authorship : This study was initiated by LdL,
LL, IB and supported by Hologic. IB, LDL and LL elaborated the protocol.
TL and GC performed the PMSI data extraction, their data-management and
their statistical analysis under the control of LL and LDL. IB performed
the cost-effectiveness analysis. GD, HF, DT, PD and JF were members of
the Steering Committee which oversaw the implementation of the study and
contributed to the interpretation of the study. The authors were fully
responsible for all content and editorial decisions. All the authors
made substantial contributions during all the stages of the work,
including the conception and design of the work, acquisition, analysis
and interpretation of data, manuscript development, revision of the
manuscript and have approved its final version.
Details of ethics approval : The study was conducted in
accordance with relevant international and French regulatory
requirements. Since this was a retrospective study of an anonymized
database and had no influence on patient care, ethics committee approval
was not required. Use of the PMSI-MCO database for this type of study
has been approved by the French national data protection agency (CNIL;
annual authorization #1419102 v7 – 2015-111111-56-18 / order M14N056
and M14L056).
Funding : The study was funded by Hologic (no grant number), a
company that markets NovaSure®, a radiofrequency endometrial ablation
device. The funder had no role in study design, data collection and
analysis, decision to publish, or preparation of the manuscript.