Insulin Degludec With Insulin AspartRyzodeg 70/30
Treatment of adult patients with diabetes mellitus where insulin treatment is necessary. IDegAsp is indicated for improvement of glycaemic control in adult patients with diabetes mellitus requiring basal and prandial insulin.
Decisions on record
- Meeting Mar 2018 Recommended Diabetes mellitus
- Meeting Nov 2017 Not recommended Diabetes mellitus
Access path
- TGA registered · Ryzodeg 70/30
TGA label equal than the PBS population
- Nov 2017Not recommended
vs biphasic insulin aspart 30 (T2DM); insulin detemir (T1DM)
- ↻ resubmittedMar 2018Recommended
Comparator changed: biphasic insulin aspart 30 (T2DM); insulin detemir (T1DM) → biphasic…
- PBS listing · Unrestricted
From the public summary
6.1 The PBAC recommended the listing of insulin degludec with insulin aspart (IDegAsp) as an unrestricted benefit on the basis of cost-minimisation to biphasic insulin aspart 30 (BIAsp 30) for the treatment of diabetes mellitus.PSD · Mar 2018
6.2 The PBAC considered an unrestricted listing was appropriate for IDegAsp as it would be consistent with other insulins on the PBS, with the exception of IDet and insulin bovine.PSD · Mar 2018
5.6 The following economic issues were addressed in the minor resubmission: In the previous submission, a CMA against BIAsp 30 (T2DM) and IDet (T1DM) was presented. As the PBAC did not accept IDet an appropriate comparator, the resubmission removed IDet as a comparator in the CMA and proposed a price weighted across T1DM and T2DM in comparison to BIAsp 30.PSD · Mar 2018
5.7 The resubmission did not alter the economic model structure, population weight, or equi-effective doses from that considered by the PBAC in November 2017. 5PSD · Mar 2018
T1DM: IDegAsp is noninferior in terms of effectiveness (change in HbA1c) and superior in terms of safety (confirmed nocturnal hypoglycaemia) compared with IDet.PSD · Nov 2017
6.3 The PBAC noted and welcomed the input from one organisation, the Australian Diabetes Society, via the Consumer Comments facility on the PBS website. The Australian Diabetes Society supported the use of IDegAsp in clinical practice.PSD · Nov 2017
5.16 While not a matter for the PBAC to consider, in addition to the SPA proposed, the minor resubmission proposed that the Sponsor was willing to work with the Department to offer a condition to rebate the Government up-front (subject to appropriate reconciliation measures); thus instead of paying the rebate after all 8PSD · Mar 2018
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. The submission claimed IDegAsp is cost-neutral to BIAsp 30 in T2DM population.
The minor resubmission claimed that IDegAsp is cost neutral to BIAsp 30 in the T2DM population with a calculated cost-minimising price AEMP $''''''''''''''/maximum quantity. PSD · 2018
Decision context
PopulationAdult patients with type 1 diabetes mellitus (T1DM), insulin-naïve type 2 diabetes mellitus (T2DM), and insulin-experienced type 2 diabetes mellitus (T2DM) requiring basal and prandial insulin treatment.
Risk sharingSpecial pricing arrangement (SPA) proposed with willingness to work with the Department to offer a condition to rebate the Government up-front (subject to appropriate reconciliation measures).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2018 | Recommended | biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes mellitus; biphasic insulin aspart 30 (BIAsp 30) in type 1 diabe | — | Cost-minimisation · Cost-minimisation |
| Nov 2017 | Not recommended | biphasic insulin aspart 30 (T2DM); insulin detemir (T1DM) | — | RCT · HbA1c |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — PBAC population (T1DM and T2DM requiring basal and prandial insulin) matches TGA label scope of adult diabetes patients requiring basal and prandial insulin.