  |
|
|
|
|
|||
| Journal of the New Zealand Medical Association,
28-October-2005, Vol 118 No 1224
|
|||
|
PHARMAC responds on long-acting insulin analogues
A Special Series article in August by Dr Jeremy Krebs
discussed the timing of funding of long-acting insulin analogues in glycaemic
control in diabetes (http://www.nzma.org.nz/journal/118-1221/1641/).
We respond to three issues raised by Dr Krebs: process; availability of
long-acting insulin analogues internationally; and cost-effectiveness.
Timeframes and PHARMAC’s processesPHARMAC aims to ensure fair allocation of funding across
competing new medicines, and must ensure appropriate targeting of medicines to
get best value for money. For this reason, our processes for assessing new
pharmaceutical funding applications are necessarily diligent. PHARMAC’s
process involves both expert clinical review, negotiation with suppliers,
consultation with the health sector, and then decision by PHARMAC’s Board.
The process is described in the Attachment to
this letter.
For insulin glargine, the most significant delays have been
caused elsewhere. Insulin glargine has been registered for use in New Zealand
since June 2001, following first application to Medsafe for registration in May
1999—some two years earlier. Insulin glargine was then registered for
three years before the supplier applied to PHARMAC for funding in July 2004.
We have had the application to list insulin glargine for
little over a year, during which time:
The next steps will be for
PHARMAC to negotiate with the suppliers of both insulin glargine and insulin
detemir for a commercial arrangement to list one or both long acting insulin
analogues; any agreed proposal(s) would then be consulted on and considered by
PHARMAC’s Board. Any proposals for the listing of any long-acting insulin
analogues would be subject to the standard decision criteria that all proposals
are weighed against, and prioritised alongside competing new medicines at the
time.
Timelines for the applications to PHARMAC for long acting
insulin analogues are detailed in the Attachment to this letter. Available relevant
minutes of PTAC and Diabetes subcommittee meetings are also included in the
Attachment.
Long-acting insulin analogues are not funded in Australia nor recommended for funding in CanadaNeither insulin glargine nor insulin detemir is funded in
Australia. The New Zealand application for insulin glargine coincided with an
application to the Pharmaceutical Benefits Advisory Committee (PBAC) in
Australia. The Pharmaceutical Benefits Advisory Committee (PBAC) has since
already rejected insulin glargine and deferred a decision for insulin detemir:
The Canadian Expert Drug Advisory Committee
(CEDAC) (https://www.ccohta.ca/CDR/cdr_pdf/cdr_submissions/Complete/cdr_complete_Lantus_2005Sept28.pdf)
has recently recommended that insulin glargine not be listed, citing
inter alia no significant differences
in 21 open-label RCTs between insulin glargine and NPH (or ultralente) insulin
in the incidence of severe symptomatic hypoglycaemia. CEDAC also did not feel
that the claimed differences in clinically important outcomes in favour of
insulin glargine over NPH insulin justified the three-fold difference in cost.
Cost-effectivenessLong-acting insulin analogues aim to achieve at least as
good glycaemic control as insulin isophane (insulin NPH) while reducing the
frequency and severity of hypoglycaemic episodes. At PTAC’s request,
PHARMAC staff performed a preliminary3 CUA, based on the supplier’s
original submission to PTAC for insulin glargine.4 Depending largely on the
impact of fear of further hypoglycaemic episodes, PHARMAC estimated a wide range
of cost/QALY values for insulin glargine treatment, ranging between
$17-18,000/QALY and $3.1-3.3 million/QALY.5
Guidance from the UK National Institute of Clinical
Excellence (NICE) on the use of long-acting insulin analogues6 was informed by a
comprehensive systematic review and analysis by ScHARR7 (http://www.ncchta.org/fullmono/mon845.pdf).
This analysis showed, similarly to PHARMAC’s CUA, a wide range of
cost-utility values, again driven by the degree of anxiety/fear of further
severe hypoglycaemia and this fear’s effects on quality of life.8 The
ScHARR authors commented that the supplier’s submission’s claimed
base case was based on the most favourable of a number of analyses. They also
concluded that further research was needed that on the quality of life issues
associated with the fear of hypoglycaemia, and also the economic impact of
balancing HbA1c control and the incidence of hypoglycaemia achieved in practice.
PHARMAC has since estimated a $34,500 to $58,000/QALY range
for long acting insulin analogues for the key group recommended by the Diabetes
subcommittee – being Type 1 diabetes patients using intensive insulin
regimes who had had an unexplained severe hypoglycaemic episode in the previous
12 months.9
The PHARMAC Board will use the above ranges of
cost-effectiveness estimates, alongside clinical advice from PTAC and the
Diabetes subcommittee and consultation feedback, when deciding whether to fund
long-acting insulin analogues and if so under what access arrangements.
Conflict of
interest: Scott Metcalfe is externally contracted to work with PHARMAC
for public health advice. Jackie Evans and Peter Moodie declare no
conflicts.
Scott Metcalfe
Public Health Physician Wellington Jackie Evans
Therapeutic Group Manager PHARMAC Wellington Peter Moodie
Medical Director PHARMAC| Wellington Footnotes and
references:
Using a New
Zealand-based EQ-5D disutility score for mild/moderate anxiety/depression
(11112) of 0.296 would have given lower cost/QALYs. (See Devlin N, Hansen P,
Kind P, Williams A. Logical inconsistencies in survey respondents’ health
state valuations – a methodological challenge for estimating social
tariffs. Health Economics 2003;12(7):529-544.)
Under the least
cost-effective scenario ($3.1-3.3 million/QALY), the fear of further
hypoglycaemic episodes was assumed to be lower-grade (0.5% disutility) and
lasting three months after each episode. The 0.5% disutility derived from a
patient-based survey commissioned by Aventis using the EQ-5D, used and cited by
the ScHARR analysis (Warren E, Weatherley-Jones E, Chilcott J, Beverley C.
Systematic review and economic evaluation of a long-acting insulin analogue,
insulin glargine. Health Technol Assess. 2004 Nov;8(45):iii, 1-57.)
Assuming a high disutility
from fear (but not continual disutility, rather lasting for three months) gave a
cost /QALY of $210-220,000.
The cost-effectiveness
estimates that assumed the fear of further hypoglycaemia to be both high and
continual imply a significant loss in quality of life – with continual
anxiety and moderate effects on the ability to perform usual activities (work,
recreation, etc). Using such values means that the fear of hypoglycaemia is
counted as being worse than the event itself (both day-to-day and as it affects
year-long quality of life). It is consistent with the impact of severe
hypoglycaemia on some patients and their families – where, for instance,
following hospitalisations for severe hypoglycaemia and knowledge of others who
have suffered perhaps crippling consequences, patients or parents consistently
test frequently during the day and then at night, and diabetes control and the
fear of hypoglycaemia in an individual dominate family life.
|
|
|
| | Current
issue | Search journal |
Archived issues | Classifieds
| Hotline (free ads) Subscribe | Contribute | Advertise | Contact Us | Copyright | Other Journals |
|