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| Journal of the New Zealand Medical Association,
07-July-2006, Vol 119 No 1237
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Roche responds to the ‘Herceptin or deception’
article
Roche acknowledges that independent evaluations are required
for fair and balanced consideration of the costs and benefits of Herceptin®
for New Zealand women.
First results of independent assessments overseas have
recently become public, with the National Institute for Health and Clinical
Excellence (NICE) in the UK and the Scottish Medicines Consortium (SMC)
recommending the use of Herceptin in early breast cancer on 9 June 2006.1
These evaluations are based on transparency and the ability
to ensure systematic critical appraisal of the results. However Martin
Rosevear’s article published in
NZMJ on 2 June 2006 (http://www.nzma.org.nz/journal/119-1235/2014)
is limited in the information it provides, and a number of its cost estimates
are based on inaccurate assumptions in regard to the funding review currently
underway in New Zealand.
The Medsafe-approved indication is specifically for the use
of the three-weekly administration regimen upon completion of chemotherapy2 as used in the HERA trial.3 It is this three-weekly regimen with
Piccart-Gebhart et al as the primary source of evidence, which PHARMAC has been
asked to consider for funding. Three other trials (NSABP N9831, NCCTG B-31,
BCIRG 0064) have been provided as
supportive evidence. The paper by Romond et al reported the two-year combined
results of NSABP N9831 and NCCTG B-31.5
The once-weekly administration schedule used in the NSABP
N9831 and NCCTG B-31 studies forms the basis for the author’s simplistic
evaluation. However the drug acquisition and administration costs are higher
when Herceptin is administered once-weekly with chemotherapy, as is the rate of
cardiotoxicity, (which will have associated treatment costs). The three-weekly
regimen, as per the New Zealand indication, was considered by the NICE appraisal
committee as better use of healthcare resource.1
Rosevear also used the NICE 2001 cost/QALY estimate of
£19–38k in metastatic breast cancer,6 which is not appropriate for early
breast cancer. In the adjuvant setting, treatment with Herceptin significantly
improves disease-free and overall survival.7 The costs associated with a patient
being disease-free are minimal.8,9
The quality of life values have also been inappropriately
adjusted by the author using the NICE metastatic breast cancer guidance, a
significant decrease of 30–50%. The MEDTAP study commissioned by Roche UK
and validated by the School of Health and Related Research (University of
Sheffield) on behalf of NICE, adjusted the quality of life for the disease-free
state after diagnosis of early breast cancer by 15%.10
Rosevear’s analysis over-estimates the costs for
patients treated with Herceptin for HER2 positive early breast cancer. This is
supported by the release of the draft NICE Guidance in the UK. Whereas the 2001
cost/QALY estimate for use of Herceptin in metastatic breast cancer was
£19–38,0006, the estimate in
early breast cancer is between £2,387 and £18,000, with the upper
limit assuming patients that go on to develop metastatic breast cancer would be
retreated with Herceptin.1
The public and medical support for the funding for Herceptin
has been generated by the strength of the clinical evidence and the significant
advance Herceptin offers women with HER2-positive early breast cancer.10
It is important that the real benefit adjuvant Herceptin
offers for women with HER2-positive early breast cancer does not get lost in the
debate over the costs of providing this treatment.
Svend Petersen
Managing Director Roche Products (New Zealand) Limited Auckland References:
Martin Rosevear’s responseMy article was one of a series which examined the
‘equity’ of PHARMAC’s funding for a range of new
pharmaceuticals. The intent of these articles is to encourage rational debate
and equity in our funding of health interventions, and we suggested that
Herceptin® is expensive and we questioned whether it is affordable.
In summary:
The letters from Breast Cancer
Advocacy Coalition and Roche raise valid issues on some technical
details.
However the letters are mute on what we understand is the
big issue of budgetary impact and our ability to fund such drugs. If new drugs
such as Herceptin provide better value for money than other health
interventions, then funding should be available to give patients access to these
drugs. We are aware of a number of interventions provided routinely by hospitals
where the $/QALY far exceed an agent such as Herceptin, according to our
understanding, and the mechanisms to re-prioritise DHB funding between these
‘competing’ interventions are very weak. If existing funding
mechanisms are getting in the road of good health governance, these structures
should be changed.
As the respondents point out, the NICE findings suggest
Herceptin is relatively affordable and our understanding of the final NICE
findings is that they quote a base-case of approximately £18k ($55k) per
QALY. However it should be noted that many of the assumptions in these findings
are subject to debate and other interpretations would lower this value to
£8k ($24k) per QALY.
As a result of new information received, I have revised the
cost/benefit analysis in my original article, the details of which are set out
in Figure 1:
Figure 1. Herceptin survival estimates; hypothetical
results
 The model above is simplistic and intended to capture the
major issues in the debate. As we understand them, these issues are:
The life years gained is the area between
the Chemotherapy arm and the options above (Herceptin with declining persistence
and Herceptin with 100% persistence). These results are shown in Figure 2:
Figure 2
*Quality adjusted life
year.
We have chosen to use the results over 20 years as our
base-line results (ignoring the avoidance of metastatic disease):
$31k per QALY (assuming persistent survival) to $58k
per QALY (assuming 10%/annum decline in survival)
This result is lower than our original study. Furthermore we
are aware of clinical developments which may lower these estimates
further:
We agree with the respondents that it is important
for the real benefit of adjuvant Herceptin to be aired. But we also suggest that
it is equally important to understand the challenges in funding these new
treatments, and the need to re-prioritise interventions provided by the wider
health system.
Martin
Rosevear
Director Outcome Management Services (a consultancy specialising in health and public sector economics) Wellington References and
endnotes:
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