HydrocortisoneCIPLA HYDROCORTISONE
Replacement therapy of adrenal insufficiency in patients aged six years or younger, or patients aged six years or older with swallowing difficulties or tablet phobia where treatment compliance is an ongoing issue.
Decisions on record
- Meeting Nov 2024 Noted Adrenal insufficiency no PSD
- Meeting Sep 2023 Recommended Adrenal insufficiency in children aged 6 or younger no PSD
- Meeting Jul 2021 Recommended Adrenal insufficiency
Access path
- TGA registered · CIPLA HYDROCORTISONE
TGA label narrower than the PBS population
- Jul 2021Recommended · restricted
vs hydrocortisone 4 mg and 20 mg tablets
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the Authority Required (STREAMLINED) listing of Alkindi for replacement therapy of adrenal insufficiency in patients aged 6 years or under. The PBAC made its recommendation on the basis that Alkindi would be acceptably cost- effective if listed with a modest price advantage over the currently listed hydrocortisone 4 mg tablets for this population.PSD · Jul 2021
6.2 The PBAC acknowledged there was a high demand for a formulation of hydrocortisone more suitable for paediatric dosing than the currently listed 4 mg and 20 mg tablets. 9PSD · Jul 2021
5.7 The submission claimed that Alkindi is therapeutically equivalent to hydrocortisone tablets but superior in effectiveness in usual clinical practice due to more precise dosing which should reduce the risk of under or overdosing in paediatric patients with the currently listed 4 mg and 20 mg hydrocortisone tablets. No bioequivalence data to Australian hydrocortisone products was presented to support this claim.PSD · Jul 2021
Overall, there is a lack of comparative data to support these claims.PSD · Jul 2021
5.2 The PBAC noted and welcomed the input from individuals (20), health care professionals (6) and organisations (4) via the Consumer Comments facility on the PBS website. The comments noted that many parents and carers find measuring lower doses with the existing tablets to be difficult and that the uncertainty around whether correct dosing has been administered causes significant stress.PSD · Jul 2021
5.3 The Congenital Adrenal Hyperplasia (CAH) Support Group UK, Australasian Paediatric Endocrine Group, Endocrine Nurses Society of Australia and the CAH Support Group Australia supported listing Alkindi on the PBS, noting the lower doses required for paediatric patients would be more easily and accurately prepared from the available strengths for Alkindi.PSD · Jul 2021
Cost-effectiveness
No economic analysis was presented in the submission. The submission stated that cost-effectiveness modelling versus hydrocortisone tablets would be inappropriate given the lack of comparative studies and the highly uncertain results from single-arm studies.
Decision context
PopulationPatients aged six years or younger with adrenal insufficiency, or patients aged six years or older with swallowing difficulties or tablet phobia resulting in poor treatment compliance.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2021 | Recommended · restricted | hydrocortisone 4 mg and 20 mg tablets | — | Single-arm · Safety |
Consumer voice
Consumer input from 20 individuals, 6 healthcare professionals, and 4 organisations highlighted that parents and carers struggle with measuring lower doses of existing hydrocortisone tablets, causing significant stress, and that the bitter taste makes administration to young children difficult. Support groups emphasised that Alkindi would enable more accurate dosing and reduce the burden on carers
many parents and carers find measuring lower doses with the existing tablets to be difficult and that the uncertainty around whether correct dosing has been administered causes significant stress Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to age ≤6 years or age ≥6 with swallowing difficulties/tablet phobia affecting compliance.