ࡱ> vyu j+bjbj <!"3j j qqq4h !4:tUkkkk###M:O:O:O:O:O:O:$B=?Js:q####|##s:kk:7%7%7%#8kRkM:7%#M:7%7% 6O"9k,?$d8h9::0:59p.@$.@99.@q9##7%#####s:s:7%###:####.@#########j s:  8 March, 2010 Mr Mike Bignall, Therapeutic Group manager, Pharmac PO Box 10 254, Wellington 6143  HYPERLINK "mailto:mike.bignall@pharmac.govt.nz" mike.bignall@pharmac.govt.nz Dear Mr Bignall Re: Proposal for Funding of and Access to Special Foods I write on behalf of the Gastroenterology, Hepatology and Nutrition Special Interest Group of the 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 have reviewed the many sections of the document, and write in response to these, as a number have implications for our practice and for the infants and children we care for. We will make specific responses to each of the relevant sections. Who can authorise special foods Whilst we can see the sense in opening access of these products to infants and children in order to improve equity and access, this suggestion seems counter-intuitive to the concerns raised about rising costs for these products. We would suggest that there is consideration for wider access to some products, but ongoing more limited access to the higher-cost products, especially the amino acid (AA) based formulae. Elemental infant formulae We note the proposal to adopt elements of the guidelines to the use of formulae in infants with food allergy as developed in Australia. This guideline was developed for infants and was aimed to provide a framework for approaching the management of these infants in the primary care setting. The guideline does draw distinction between the different categories of food allergy (immediate versus delayed), with different paths depending on these presenting features as well as age. A second publication by the group has subsequently provided an additional perspective on this topic. We agree with the initial use of soy-based formulae in infants aged greater than 6 months. As noted in the referenced guideline document, there are concerns regarding the use of soy and soy-based products in the first 6 months of infancy. We note the other indications for the use of soy products (page 5 of the document), including that of congenital lactase deficiency. This format 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 two lines, the children are required to have a cows milk-based formula initially (and then soy formula in older infants). This inclusion may not apply directly to all children. 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 these infants to the proposed three steps. We feel that there must be an avenue available for infants with these significant features to have direct access to an AA formula (i.e. as a one step process). We would 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 this section and consequently would not have any access to modified protein formulae. A proportion of infants with symptoms such as significant irritability, poor feeding and growth faltering will have disease that is related to or exacerbated by cows milk protein. Exclusion of this protein (and hence consideration of modified protein formulae) can be an important aspect of the management of these children. We ask that the exclusion of this group of patients be reconsidered, perhaps with access for those 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 of fats (in particular differences in medium chain triglyceride content). These differences mean that these formulae have different applications and roles. The choice of only one of these potentially leads to a compromise in the management of selected children. We have no concerns about the delisting of goats milk formula, and would not expect this to impact adversely upon the management of infants and children. Removal of the distinction between supplementary oral feeds and feeds as a total diet We have reviewed this suggested change and agree that this would be advantageous and simplify the process for a number of children. Merging of the oral supplement and adult product standard sections We also agree that this suggestion would be advantageous and appropriate to consider for children aged up to 18 years of age, in addition to adults. Use of a malnutrition screening tool and other dietary measures prior to access to feeds We note that the recommendations in this section apply specifically to patients aged above 18 years of age. We concur with this consideration. The included criteria for children aged up to 18 yrs of age appear appropriate and reasonable. Reference pricing of liquid feeds to standard powder feeds We have reviewed this section and note several concerns. Firstly, we are unsure of the relevance of referencing 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 see and manage. A child requiring around 2500 kcals per day of Fortisip or Ensure will require the parents to pay at least $50 or $100 per week. This leads to a significant imposition upon the families. When provided in this manner the product is being supplied as a medication, not simply a nutritional product. One such group of children are those with Crohns disease who require at least 8 weeks of nutritional therapy 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 this purpose. Further, these children may need substantially more calories per day (greater than 120% of recommended requirements) than well healthy children. This indicates that the cost calculations are inadequate and inappropriate. These funding changes would lead to this superior therapy being expensive and difficult for some parents and families to afford. The costs involved would be a significant imposition in this use of a product as a medical therapy. There are two recent international studies illustrating that the costs associated with this therapy are one of the factors that leads to dissatisfaction with the therapy, or leads to the therapy being unsuccessful. In addition these additional costs will add to the already large direct and indirect costs associated with Crohns disease in children that impact adversely upon children, parents and their families. Gluten free foods We 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 disease can be diagnosed appropriately with non-invasive tests alone. New Zealand and international data supports this. Whilst we would like, in due course, to be able to offer this approach to children and their parents, the current gold standard for the diagnosis of Coeliac disease should still be a small bowel biopsy obtained endoscopically. This situation may alter in the coming years. Such changes in management should be based upon sound scientific evidence only, as the consequences could have profound implications. Whilst we are concerned about the cost of the provision of GFD to children and their families, we do appreciate the variations in access and product availability that currently exist. Regardless, the additional costs associated with a switch to a GFD from a standard gluten-containing diet are not insignificant. 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 to particular morbidity and likely mortality to the individuals involved, as well as additional costs to our health system and society. Thank you for the opportunity to comment on, and to write in regards to, this consultation document. Yours sincerely,  Andrew S Day For Gastroenterology, Hepatology and Nutrition SIG     THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  PSNZ Gastro SIG Feedback re Proposal for Funding of and Access to Special Foods Health of our children: Wealth of our nation >Eef  b>qa<##))* *!*÷ hgCCJh{/jh]UhHBh6 hw6 h;s5\ hw5\ hw5hwCJOJQJaJh;shwB*CJ^JaJph hw0JhwB*phjhwB*UphhFe    gdw !`ab<=>q_`agdwa<=>####i$j$&&\)])^))))))))))))gdHBgdw)*** *!*#*$*&*'*)***,*-*/*U*V*c*d*e*f*  !Sn#$If !Sn#$If$ x$Ifa$  $Ifd 0gdgCgdw!*"*$*%*'*(***+*-*.*/*T*U*V*m*n*******2+3+4+i+j+Ƿשו{wq hgCCJhGh''h]5CJaJjh$GUmHnHuh$Gh$G5B*CJOJQJphh$GB*CJOJQJphh$G5B*CJ(OJQJphh$G5B*CJ$OJQJphh$G5OJQJ%jh$G5OJQJUmHnHuhdfjhdfUf*g*n*~*********hb` !ekdxH$$If\u+#a  $If  $If !Sn#$If  !Sn#$If ***2+3+4+5+6+7+8+g+h+i+j+ 0gdgC $ !a$ !gdgC $ !n#a$ ,&P . A!"#$%n 9 0&P 1+:pw. A!8"8#$%n 9 0&P 1+:pw. A!8"8#$%n xHDdZ   s A.?6. 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Submissions

The Paediatric Society believes all children and youth should, by right, attain optimal physical, mental and social health and wellbeing.  By working as a coordinated national network of health professionals the Society dedicates its efforts and resources to making official submissions to both Government and Non-Government organisations on issues that will impact on the health and wellbeing of children and young people.

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