Protein Formula With Carbohydrate, Fat, Vitamins, Minerals And Transforming Growth Factor Beta-2
Dietary management of Crohn disease in the active or remission phases in adults and children over the age of 5 years, as enteral nutrition.
From the public summary
6.1 The PBAC did not recommend the PBS listing of protein formula with carbohydrate, fat, vitamins, minerals and transforming growth factor beta 2 (Modulen IBD) for the dietary management of Crohn Disease (CD), due to an uncertain clinical need on the PBS, inappropriate and uncertain comparators for the requested populations, and uncertain evidence of clinical benefit due to the nature and quality of the evidence presented.PSD · Mar 2020
6.2 The PBAC considered there was an uncertain and likely limited clinical need for enteral nutrition to be subsidised on the PBS for this population as there are a range of therapeutic alternatives on the PBS in which acceptable cost-effectiveness has been established.PSD · Mar 2020
5.6 The submission requested listing on a cost minimisation basis to Peptamen Junior and Fortisip, at an equivalent price per kcal of prepared formula.PSD · Mar 2020
5.7 The cost minimised price of Modulen IBD of $39.54 per can (containing 2,012kcal energy) in the paediatric population was calculated based on a price of $0.0197/kcal, derived from the approved ex-manufacturer price (AEMP) per pack of Peptamen Junior ($36.55) and energy content per pack (1,860 kcal), as shown in Table 1 below.PSD · Mar 2020
5.2 The PBAC noted and welcomed the input from Crohn’s and Colitis Australia that identified the cost of enteral nutrition as a barrier for patients, particularly for those for whom steroids are not optimal. The submission also described patient experiences of improved disease remission, reduced disease flares, reduced hospitalisations as well as improved mental health and quality of life while on and following treatment with Modulen IBD.PSD · Mar 2020
5.3 The submission provided a number of references to clinical and epidemiological studies to support the effectiveness of enteral nutrition in CD, as EEN, as partial enteral nutrition (PEN) in adults and paediatric patients, and for use in the perioperative setting (i.e. prior to surgery for CD). The included evidence consisted mostly of non-randomised, open label or single-arm studies.PSD · Mar 2020
Cost-effectiveness
Cost minimisation analysis on a cost-minimisation basis; no ICER calculated as this is a food for special medical purposes, not a medicine
Decision context
PopulationChildren aged 5-14 years and adolescents and adults aged 15 years and over with active or remission phase Crohn disease, including those unsuitable for or who have failed corticosteroid therapy
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2020 | Not recommended | mixed comparator: Peptamen Junior (paediatric); Fortisip (adult); standard enteral nutrition formulas | — | Single-arm · Remission induction |
Consumer voice
Crohn's and Colitis Australia reported that cost of enteral nutrition is a barrier for patients, particularly those for whom steroids are not optimal. Patients reported improved disease remission, reduced flares, reduced hospitalisations, and improved mental health and quality of life with Modulen IBD.
identified the cost of enteral nutrition as a barrier for patients, particularly for those for whom steroids are not optimal Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to Crohn disease management; TGA label covers all foods for special medical purposes without disease specification.