THE PAEDIATRIC SOCIETY Secretariat: Denise Tringham P O Box 22 234 Wellington 6441 OF NEW ZEALAND Tel: (04) 938 4827 Fax: (04) 976 4827 Email: firstname.lastname@example.org March, 2010Mr Mike Bignall,Therapeutic Group manager,PharmacPO Box 10 254, Wellington email@example.comDear Mr BignallRe: Proposal for Funding of and Access to Special FoodsI write on behalf of the Gastroenterology, Hepatology and Nutrition Special Interest Group ofthe Paediatric Society of New Zealand in response to the above Consultation Document.We note the background and the concerns raised in this Consultation document. We havereviewed the many sections of the document, and write in response to these, as a numberhave implications for our practice and for the infants and children we care for. We will makespecific responses to each of the relevant sections.Who can authorise special foodsWhilst we can see the sense in opening access of these products to infants and children inorder to improve equity and access, this suggestion seems counter-intuitive to the concernsraised about rising costs for these products. We would suggest that there is consideration forwider access to some products, but ongoing more limited access to the higher-cost products,especially the amino acid (AA) based formulae.Elemental infant formulaeWe note the proposal to adopt elements of the guidelines to the use of formulae in infants withfood allergy as developed in Australia. This guideline was developed for infants and was aimedto provide a framework for approaching the management of these infants in the primary caresetting. The guideline does draw distinction between the different categories of food allergy(immediate versus delayed), with different paths depending on these presenting features aswell as age. A second publication by the group has subsequently provided an additionalperspective on this topic.We agree with the initial use of soy-based formulae in infants aged greater than 6 months. Asnoted in the referenced guideline document, there are concerns regarding the use of soy andsoy-based products in the first 6 months of infancy. We note the other indications for the use of “Health of our children: Wealth of our nation”
THE PAEDIATRIC SOCIETY Secretariat: Denise Tringham P O Box 22 234 Wellington 6441 OF NEW ZEALAND Tel: (04) 938 4827 Fax: (04) 976 4827 Email: firstname.lastname@example.org products (page 5 of the document), including that of congenital lactase deficiency. Thisformat does not however, include an age restriction.In regards to the access criteria for EHF (page 6), we note the proposed criteria. In the first twolines, the children are required to have a cow’s milk-based formula initially (and then soyformula in older infants). This inclusion may not apply directly to all children. “Health of our children: Wealth of our nation”
We feel that in addition to the criteria proposed there are infants presenting with severe symptoms,often complicated by malnutrition and other consequences. It would be inappropriate to restrict theseinfants to the proposed three steps. We feel that there must be an avenue available for infants withthese significant features to have direct access to an AA formula (i.e. as a one step process). Wewould propose that this could be limited to specialists (or even particular subspecialists).Some infants (listed as those with colic, constipation and reflux) will be expressly excluded from thissection and consequently would not have any access to modified protein formulae. A proportion ofinfants with symptoms such as significant irritability, poor feeding and growth faltering will havedisease that is related to or exacerbated by cow’s milk protein. Exclusion of this protein (and henceconsideration of modified protein formulae) can be an important aspect of the management of thesechildren. We ask that the exclusion of this group of patients be reconsidered, perhaps with access forthose with severe symptoms, or for those being seen in a secondary or tertiary care setting.One aspect of this suggested change is for only one extensively hydrolysed formula to be available.We feel that this would be inappropriate. Currently available EHF products (e.g. Alfare and Pepti-Junior) have clinically significant differences in protein formulation (especially size) and the balance offats (in particular differences in medium chain triglyceride content). These differences mean that theseformulae have different applications and roles. The choice of only one of these potentially leads to acompromise in the management of selected children.We have no concerns about the delisting of goats milk formula, and would not expect this to impactadversely upon the management of infants and children.Removal of the distinction between supplementary oral feeds and feeds as a total dietWe have reviewed this suggested change and agree that this would be advantageous and simplify theprocess for a number of children.Merging of the oral supplement and adult product standard sectionsWe also agree that this suggestion would be advantageous and appropriate to consider for childrenaged up to 18 years of age, in addition to adults.Use of a malnutrition screening tool and other dietary measures prior to access to feedsWe note that the recommendations in this section apply specifically to patients aged above 18 yearsof age. We concur with this consideration. The included criteria for children aged up to 18 yrs of ageappear appropriate and reasonable.Reference pricing of liquid feeds to standard powder feedsWe have reviewed this section and note several concerns. Firstly, we are unsure of the relevance ofreferencing liquid feeds to one particular product that is not directly comparable, and often inadequate.This is especially pertinent to a paediatric population.This proposed change will lead to a substantial cost increment for a number of the children we seeand manage. A child requiring around 2500 kcals per day of Fortisip or Ensure will require the parentsto pay at least $50 or $100 per week. This leads to a significant imposition upon the families. Whenprovided in this manner the product is being supplied as a medication, not simply a nutritional product.
One such group of children are those with Crohn’s disease who require at least 8 weeks of nutritionaltherapy to induce remission, as well as on supplementary feeds to assist in maintenance of remission.In the absence of dedicated products, the liquid feeds covered in this proposal may be used for thispurpose. Further, these children may need substantially more calories per day (greater than 120% ofrecommended requirements) than well healthy children. This indicates that the cost calculations areinadequate and inappropriate. These funding changes would lead to this superior therapy beingexpensive and difficult for some parents and families to afford. The costs involved would be asignificant imposition in this use of a product as a medical therapy. There are two recent internationalstudies illustrating that the costs associated with this therapy are one of the factors that leads todissatisfaction with the therapy, or leads to the therapy being unsuccessful. In addition theseadditional costs will add to the already large direct and indirect costs associated with Crohn’s diseasein children that impact adversely upon children, parents and their families.Gluten free foodsWe note the comments in this section. The text in the section is somewhat confused and unclear:some messages are unclear.We feel that is there is not yet sufficient data, especially in toddlers and children, that Coeliac diseasecan be diagnosed appropriately with non-invasive tests alone. New Zealand and international datasupports this. Whilst we would like, in due course, to be able to offer this approach to children andtheir parents, the current gold standard for the diagnosis of Coeliac disease should still be a smallbowel biopsy obtained endoscopically. This situation may alter in the coming years. Such changes inmanagement should be based upon sound scientific evidence only, as the consequences could haveprofound implications.Whilst we are concerned about the cost of the provision of GFD to children and their families, we doappreciate the variations in access and product availability that currently exist. Regardless, theadditional costs associated with a switch to a GFD from a standard gluten-containing diet are notinsignificant. In addition, the inadequate use of GFD in individuals with known Coeliac disease (i.e.ongoing gluten exposure) consequent to poor access to GFD or decreased affordability likely leads toparticular morbidity and likely mortality to the individuals involved, as well as additional costs to ourhealth system and society.Thank you for the opportunity to comment on, and to write in regards to, this consultation document.Yours sincerely,Andrew S DayFor Gastroenterology, Hepatology and Nutrition SIG