Levodopa with carbidopa (as monohydrate), intestinal gel, 20 mg – 5 mg (base) per mL, 100 mL, Duodopa®
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Product: Levodopa with carbidopa (as monohydrate),
intestinal gel, 20 mg – 5 mg (base) per mL, 100 mL,
Duodopa®
Sponsor: Abbott Australasia Pty Ltd
Date of PBAC Consideration: November 2010
1. Purpose of Application:
The re-submission sought a Section 100 (Highly Specialised Drugs
Program) Public and Private Hospital Authority Required PBS listing
for the initial management of advanced Parkinson disease (PD) in a
patient with severe disabling motor fluctuations not adequately
controlled by oral therapy.
Highly Specialised Drugs are medicines for the treatment of chronic
conditions, which, because of their clinical use or other special
features, are restricted to supply to public and
private hospitals having access to appropriate specialist
facilities.
The re-submission also sought a Section 85 Authority Required PBS
listing for maintenance therapy following treatment which was
commenced in a hospital based specialised movement disorder clinic,
of a patient with advanced PD with severe disabling motor
fluctuations not adequately controlled by oral therapy.
2. Background:
This was the third time the PBAC had considered levodopa with carbidopa intestinal
gel, for the treatment of advanced PD.
The PBAC rejected submissions requesting PBS-listing for levodopa with carbidopa on
two previous occasions (March 2008 and March 2009) on the basis of the unacceptably
high and uncertain incremental cost effectiveness ratio (ICER). Public Summary Documents
(PSDs) from these meetings are available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/public-summary-documents
3. Registration Status:
Levodopa with carbidopa intestinal gel was TGA registered on 27
February 2008 for the treatment of advanced idiopathic Parkinson's
disease with severe motor fluctuations despite optimised oral
treatment. A positive clinical response to levodopa with carbidopa
intestinal gel administered via a temporary nasoduodenal tube
should be confirmed before a permanent percutaneous endoscopic
gastrostomy (PEG) tube is inserted.
4. Listing Requested and PBAC’s View:
Section 100 (Highly Specialised Drugs Program)
Public and Private Hospital Authority Required
Management of advanced Parkinson disease in a patient with severe
disabling motor fluctuations not adequately controlled by oral
therapy. A positive clinical response to Duodopa administered via a
temporary nasoduodenal tube should be confirmed before a permanent
percutaneous endoscopic gastrostomy (PEG) tube is inserted.
Treatment must be commenced in a hospital based Movement Disorder
clinic.
NOTE:
Specialist Movement Disorder clinics are required to have the
following facilities for the provision of specialised clinical
support of advanced Parkinson’s patients:
a) a Neurologist or Geriatrician experienced in the management of
advanced Parkinson’s Disease
b) a Parkinson’s Disease Specialist nurse;
c) a Gastroenterologist experienced in PEG-J insertion and hospital
facility equipped for this procedure
d) 24 hour access by patients to medical advice
e) a hospital pharmacy with adequate cold chain storage
Section 85
Authority Required
Maintenance therapy with levodopa with carbidopa following
treatment which was commenced in a hospital based specialised
Movement Disorder clinic, of a patient with advanced Parkinson
disease with severe disabling motor fluctuations not adequately
controlled by oral therapy.
See Recommendations and Reasons for PBAC’s
view.
5. Clinical place for the proposed therapy:
Parkinson disease is a chronic, progressive neurological disease.
PD causes the neurons in the substantia nigra cells to die, leading
to a lack of dopamine in the brain, especially in the basal
ganglia. This results in loss of the ability to control the normal
body movements, with varying degrees of muscular control.
Patients with advanced PD experience daily changes in symptoms,
medication side effects that limit treatment options and the loss
of independence in activities of daily living.
Levodopa with carbidopa intestinal gel would provide a treatment
for advanced idiopathic PD in patients who are not adequately
controlled on oral treatment.
6. Comparator:
As in the previous submission, the re-submission nominated current
interventions including oral therapy, apomorphine and deep brain
stimulation as the main comparators. The PBAC considered these were
the appropriate comparators.
7. Clinical Trials
No new clinical data were presented in the re-submission. Published
trials presented in the previous submissions have been previously
reported in the March 2008 and March 2009 PSDs.
8. Results of Trials
Trial results have been previously reported in the March 2008 and
March 2009 PSDs.
9. Clinical Claim
No new clinical claim was made in the re-submission. The previous
submission claimed that levodopa-carbidopa intestinal gel has
statistically significant advantages in effectiveness over standard
medical management with regards to ‘on’ time (treatment
success), time spent in Parkinsonian health state
(‘off’ time), and health related quality of life as
measured by the 15D instrument.
For PBAC’s view, see Recommendations and
Reasons.
10. Economic Analysis
The re-submission used the same economic model as the March 2009
re-submission, to which a proposed price adjustment was
applied.
The base case ICER was in the range of $15,000 to $45,000, and
continued to include carer utilities and benefits, and did not
include deep brain stimulation in the comparator basket (as
previously recommended by the PBAC). When carer utilities were
excluded and the cost of DBS was included in the comparator basket,
the ICER was in the range of $45,000 to $75,000 (compared with
$75,000 to $105,000 in the previous submission).
11. Estimated PBS Usage and Financial Implications
The sponsor’s Pre-PBAC response estimated the likely number
of patients to be less than 2,000 in Year 5, at an estimated cost
to the PBS in the range of $10 to $30 million in Year 5.
12. Recommendation and Reasons:
The PBAC recommended the listing of levodopa with carbidopa
intestinal gel on the PBS as a Section 100 (Highly Specialised
Drug) for the management of advanced Parkinson disease in a patient
with severe disabling motor fluctuations not adequately controlled
by oral therapy and as a Section 85 listing for maintenance
therapy. Listing was recommended on the basis of a high but
acceptable cost-effectiveness ratio compared with standard medical
management including deep brain stimulation (DBS).
The PBAC considered that a high clinical need existed for the drug
in the requested patient population, given that levodopa with
carbidopa intestinal gel is likely to be reserved as last line
therapy for younger patients with advanced Parkinson disease and
severe symptoms that are not adequately controlled by oral therapy.
Although the PBAC had been concerned about mishaps associated with
drug delivery via a PEG tube, members were somewhat reassured by
improvements in PEG tube technology and insertion techniques.
No new clinical data were presented in the re-submission. The PBAC
noted that clinical trials were continuing and that two new trials
comparing the intestinal gel to oral levodopa/ carbidopa therapy
had begun. The results should be provided to the PBAC when
available.
The PBAC noted that the base case ICER was in the range of $15,000
to $45,000 and continued to include carer utilities and benefits,
and did not include deep brain stimulation in the comparator
basket. When carer utilities were excluded and the cost of DBS was
included as a comparator, the resultant base case ICER was in the
range of $45,000 to $75,000. Incorporating the price adjustment and
including both costs and outcomes of DBS also resulted in an ICER
in the range of $45,000 to $75,000, which the PBAC considered to be
high. However, the PBAC noted the difficulties in comparing the
intestinal gel to DBS arising from differing trial designs and the
limited availability of DBS. The PBAC acknowledged that there was
an impact on carers, taking this into account in their
recommendation, but reiterated that the inclusion of carer
utilities and benefits in the base case economic analysis was not
appropriate.
The PBAC noted that the number of patients was likely to be low.
Further, the method of drug administration would discourage
inappropriate drug use.
The PBAC noted the advice of the Highly Specialised Drugs Working
Party that levodopa with carbidopa intestinal gel meets the
criteria for listing under the Highly Specialised Drugs
Program.
Recommendation
LEVODOPA with CARBIDOPA (as MONOHYDRATE), intestinal gel, 20 mg
– 5 mg (base) per mL, 100 mL
Restriction: Section 100 (Highly Specialised Drugs Program)
Private Hospital Authority Required Public Hospital Authority Required (STREAMLINED)
Management of advanced Parkinson disease in a patient with severe disabling motor fluctuations not adequately controlled by oral therapy.
Treatment must be commenced in a hospital-based movement disorder clinic.
NOTE:
Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.
A positive clinical response to Duodopa administered via a temporary nasoduodenal tube should be confirmed before a permanent percutaneous endoscopic gastrostomy (PEG) tube is inserted.
Maximum quantity: 56
Repeats: 5
Section 85
Authority Required
Maintenance therapy following treatment which was commenced in a hospital-based movement disorder clinic, of a patient with advanced Parkinson disease with severe disabling motor fluctuations not adequately controlled by oral therapy.
NOTE:
Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.
NOTE:
Shared care model
For prescribing by nurse practitioners where care of a patient is shared between a nurse practitioner and medical practitioner in a formalised arrangement with an agreed management plan. Further information can be found in the Explanatory Notes for Nurse Practitioners.
Maximum quantity: 56
Repeats: 5
13. Context for Decision
The PBAC helps decide whether and, if so, how medicines should be
subsidised in Australia. It considers submissions in this context.
A PBAC decision not to recommend listing or not to recommend
changing a listing does not represent a final PBAC view about the
merits of the medicine. A company can resubmit to the PBAC or seek
independent review of the PBAC decision.
14. Sponsor’s Comment
Abbott is pleased to be able to provide a treatment for patients
with advanced Parkinson disease, given the high clinical need for
alternative therapies.
