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| Journal of the New Zealand Medical Association,
16-December-2005, Vol 118 No 1227
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PHARMAC’s response on temozolomide and funding costly
medicines that prolong life shortly
Dr David Hamilton (http://www.nzma.org.nz/journal/118-1227/1774)
accurately describes the clinical benefits of temozolomide and PHARMAC’s
consideration of funding; and how this relates to what price to pay to prolong
survival in incurable illnesses. We update progress with the funding of
temozolomide, and agree there are dilemmas around the funding of high-cost
medicines that give definite if limited survival gains.
TemozolomideWe have moved as quickly as possible to assess temozolomide.
It is not usual to carry out a clinical review by PTAC and an economic analysis
before a drug is registered by Medsafe and the supplier has made an application
to PHARMAC; however this is what was done for temozolomide. Details of timelines
can be seen in the Appendix to this letter. Our
approach with temozolomide recognised the limited life expectancy for patients
diagnosed with glioblastoma multiforme, and their particular needs.
Temozolomide is unfortunately a costly treatment, currently
in the region of $40,000 to $50,000 per patient per year, and even with only 50
treated new patients per year this would result in an overall annual cost of
around $2 million. For that sort of expenditure our analysis must be robust and
the expenditure compared with other areas of need.
We consider that there are a number of reasons to support
the funding of temozolomide when considered under PHARMAC’s decision
criteria.1 We have also had constructive discussions with the supplier and have
sent them a proposal for funding, and anticipate a decision early in 2006.
What value does society place on limited survival gains in incurable disease?Currently, PHARMAC has funding available for medicines such
as temozolomide and has a programme of new investments. However, that funding
would not cover all the applications for new medicines that we have received,
and funding for out-years is uncertain, so choices between medicines need to be
made.
There will always be difficult decisions to make when
funding pharmaceuticals within a constrained budget, and these decisions are not
going to get any easier. This prioritisation will be particularly tested in
coming years, as on the horizon are a number of new oncology drugs and other
beneficial high-cost medicines.
Spending on cancer drugs funded from the community
pharmaceutical budget has grown from just over $1 million three years ago to
nearly $12 million in 2004/05. This makes it one of the fastest-growing areas of
expenditure, and some new and expensive treatments are also being considered.
Although difficult to obtain reliable data on hospital use of cancer
pharmaceutical treatments, our best estimate is that hospitals spent $35 million
in the 2004/05 financial year. Growth in cancer treatment has outstripped growth
in spending on other treatments.
Newer oncology drugs are often extremely expensive, often in
the range (and sometimes greater than) $50,000 per year per
patient—temozolomide and trastuzumab (for breast cancer) being good
examples. These drugs will mean that we will all need to continue to make
decisions about where New Zealand’s priorities lie. At the moment,
expensive treatments, which may offer significant benefits to a small number of
people, must compete for limited funds with less expensive medicines that treat
large numbers and achieve greater putative population health gains2 for the same
total costs. The growing number of costly new treatments makes such decisions
both more common and more difficult.
Relevant to these issues, there has been recent debate in
the Journal whether PHARMAC should
lower the discount rate used in its economic analyses (affecting how medicines
are prioritised).3–5 Such issues are important to the funding of medicines
that give short-term survival gains, as lower discount rates tend to advantage
long-term gains at the expense of short-term.
PHARMAC is currently reviewing its decision-making process
for high-cost medicines—driven in part by having to turn down treatments
for small numbers of people, who then miss out. PHARMAC’s Board should be
considering the outcome of the review process next year; prior to that, any
proposed changes to our decision making processes would undergo public
consultation.
PHARMAC’s prioritisation process tries to allocate
scarce resources in a fair and transparent way—consistent from year to
year and medicine to medicine.6 Transparency in the decision-making is
important, so that people understand the decision even if they don’t agree
with it. While we have a fixed, albeit increasing, pharmaceutical budget, the
issue of rationing—making explicit choices to fund and not fund particular
medicines—remains something that New Zealand must keep doing.
Scott Metcalfe
Public Health Physician Wellington Steffan
Crausaz
Therapeutic Group Manager PHARMAC Wellington Peter Moodie
Medical Director PHARMAC Wellington Wayne McNee
Chief Executive PHARMAC Wellington Conflict
of interest: Scott Metcalfe is externally
contracted to work with PHARMAC for public health advice. Steffan Crausaz, Peter
Moodie and Wayne McNee declare no conflicts.
References and endnotes:
PTAC
considered that the available evidence demonstrated that some patients obtain a
considerable benefit, with an additional 15% of patients surviving at 2 years
compared with radiotherapy alone (median survival benefit 2.5-5.7 months).
However, PTAC considered the majority of patients would obtain little benefit
from treatment with temozolomide, and that it was appropriate to examine
targeting of treatment to those patients likely to benefit from treatment with
temozolomide. PTAC considered that, from the data provided, patients with higher
performance status (Karnofsky score >80, WHO score 0 or 1) obtained
significant benefit with temozolomide treatment; tumour resection (rather than
biopsy with no resection) was also predictive of a response.
PTAC recommended that
temozolomide should be listed on the Pharmaceutical Schedule for the adjuvant
treatment of newly diagnosed glioblastoma multiforme in combination with
radiotherapy. PTAC recommended that subsidy should be targeted to this patient
group possibly by means of a Special Authority. PTAC considered that patients
should have a good performance status (Karnofsky score >80 or WHO score 0 or
1) at diagnosis, and preferably a resectable or partially resectable tumour.
PTAC gave a high priority to this recommendation. PTAC considered that CaTSoP
should review any criteria. PTAC considered that a low priority should be given
to funding under criteria that included a poor performance score (Karnofsky
score <80 or WHO score 2). PTAC also recommended that approvals for funding
should be restricted to the initial treatment in combination with radiotherapy
followed by a maximum of six cycles of temozolomide.
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