Nadroparin Calcium
Recommended CardiovascularRestrictedNot applicable line 💬 consumer voice
Prophylaxis against deep vein thrombosis (DVT) associated with general or orthopaedic surgery, treatment of DVT, and prevention of clotting during haemodialysis.
2
Submissions
2 resub
2015–16
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2016 Recommended Deep Vein Thrombosis (DVT) prophylaxis/ treatment Haemodialysis
- Meeting Jul 2015 Recommended Prevention of deep vein thrombosis
Access path
- Jul 2015Recommended · restricted
vs enoxaparin
- Nov 2016Recommended
Evidence: RCT → Cost-minimisation
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended a change to the PBS listing for nadroparin to increase its MQ and repeats across all strengths, such that the same number of syringes can be dispensed per script as the comparator enoxaparin for both the restricted and unrestricted listings.PSD · Nov 2016
6.2 The PBAC noted that the current practice and guidelines for prophylaxis recommend treatment for durations of more than four days in some cases, which cannot be met through one script with the current MQ for nadroparin.PSD · Nov 2016
Economic analysis
5.3 The submission presented an analysis of savings based on market share and the model presented in July 2015 submission. However, the evaluation of an economic model is out of scope for a minor submission.PSD · Nov 2016
Clinical claim
6.26 The submission described nadroparin as at least non-inferior in terms of comparative effectiveness and superior in terms of comparative safety over enoxaparin. The PBAC considered that this claim was reasonable in terms of comparative effectiveness, but not in terms of comparative safety.PSD · Jul 2015
For more detail on PBAC’s view, see section 7 “PBAC outcome”PSD · Jul 2015
Financial management – risk sharing
6.44 The sponsor did not state a willingness to undertake a risk sharing arrangement.PSD · Jul 2015
Cost-effectiveness
Minor submission; cost-minimisation basis; no economic model evaluation in scope.
The PBAC considered that the estimated financial implications presented in the submission were highly uncertain, but that as the nadroparin listing would have the same MQ and repeats as the comparator enoxaparin, utilisation was likely to be as a result of substitution, and as nadroparin was listed on a cost-minimisation basis to enoxaparin, should be cost neutral to the PBS. PBAC · 2016
ICER uncertainCost-effectiveness accepted
Decision context
PopulationPatients requiring prophylaxis against DVT associated with general or orthopaedic surgery, treatment of DVT, or prevention of clotting during haemodialysis.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Recommended | enoxaparin | — | Cost-minimisation · Cost-minimisation |
| Jul 2015 | Recommended · restricted | enoxaparin | — | RCT · DVT prevention / safety |
Consumer voice
No consumer comments were received for this item.
There were no consumer comments received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC excludes Fraxiparine Forte® (treatment of DVT), restricting to lower concentration formulation only.