Proposal to fund paediatric oral/enteral feed (Infatrini)

Hospital devices

Consultation Closed

What we’re proposing

PHARMAC is seeking feedback on a proposal to list paediatric oral / enteral feed 1 kcal / ml (Infatrini) 125 ml bottle in Section D and amend Part II of Section H of the Pharmaceutical Schedule from 1 February 2018; funding would be subject to Special Authority criteria and HML restrictions.

Consultation closes at 5 pm on Wednesday, 22 November 2017 and can be emailed to matthew.tyson@pharmac.govt.nz.

What would the effect of the proposal be?

From 1 February 2018 Infatrini would be fully funded when dispensed from a community pharmacy to patients with a prescription and a valid Special Authority.

Infatrini is currently listed as an example brand in Part II of Section H of the Pharmaceutical Schedule in a 100 ml bottle (which, we are advised, has been discontinued); this proposal is to list Infatrini in a 125 ml bottle and its use would be subject to restrictions.

Who we think will be interested

  • Community and hospital dietitians, paediatricians, paediatric gastroenterologists and general practitioners.
  • Hospital and community pharmacists, DHBs, suppliers and wholesalers.

About Infatrini

Infatrini is an energy and nutrient dense, nutritionally complete, ready to feed infant formula. It is suitable for babies that have fluid restrictions and/or poor oral intake with faltering growth who require increased nutrition. Infatrini is suitable for administration via bottle, naso-enteric tube, gastrostomy or jejunostomy and can be used from birth to 18 months or 8kg in weight.

PHARMAC consider there are two patient groups with faltering growth that would be eligible for funded treatment via the proposed Special Authority.

  • ‘Fluid restricted’ patients are those that, due to co-morbidities, are restricted in their permitted fluid volume per day.
  • ‘Volume intolerant’ patients are those that are unable to tolerate an adequate volume of infant formula to maintain growth. These patients should have first trialled all funded alternative treatments including concentrating, fortifying and adjusting frequency of feeding.

A diagnosis of ‘fluid restricted’ or ‘volume intolerant’ needs to be made by a paediatrician or a dietitian and the hydration of these patients on an energy dense formula should be closely monitored.

Why we’re proposing this

A funding application for Infatrini was reviewed by the Special Foods Subcommittee of PTAC in April 2010 [PDF, 87 KB] and again in February 2014 [PDF, 125 KB]. Funding was recommended in the community and DHB hospitals with a medium/high priority, subject to restrictions limiting its use to fluid restricted infants and faltering growth.

PHARMAC has entered into a provisional agreement with Nutricia Limited for the supply of Infatrini, and feedback to this consultation will help us decide if this agreement should be confirmed.

Details about our proposal

Paediatric oral / enteral feed 1 kcal / ml (Infatrini) would be listed in Section D of the Pharmaceutical Schedule from 1 February 2018 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical Presentation Brand Pack size Price and subsidy
Paediatric oral / enteral feed 1 kcal / ml Liquid Infatrini 125 ml OP $2.35

The following Special Authority criteria would apply:

Special Authority for Subsidy – Hospital pharmacy [HP3]

Initial application only from a paediatrician or dietitian, or medical practitioner on the recommendation of a paediatrician or dietitian. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. Patient is fluid restricted or volume intolerant and has been diagnosed with faltering growth; and
  2. Patient is under the care of a paediatrician or dietitian who has recommended treatment with a high energy infant formula; and
  3. Patient is under 18 months of age or 8kg.

Renewal only from a paediatrician or dietitian, or medical practitioner on the recommendation of a paediatrician or dietitian. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Patient continues to be fluid restricted or volume intolerant and has faltering growth; and
  2. Patient is under the care of a hospital paediatrician or dietitian who has recommended treatment with a high energy infant formula; and
  3. Patient is under 18 months of age or 8kg.

The paediatric oral / enteral feed 1 kcal / ml listing in Part II of Section H of the Pharmaceutical Schedule (for use in the DHB hospitals) would be amended from 1 February 2018 to list Infatrini at the following price (ex-manufacturer, excluding GST):

Chemical Presentation Brand Pack size Price
Paediatric oral / enteral feed 1 kcal/ml Liquid 2.6 g protein, 10.3 g carbohydrate, 5.4 g fat and 0.6 g fibre per 100 ml Infatrini 125 ml bottle $2.35

The current restrictions for use in DHB hospitals would be amended as follows (additions in bold) and would be slightly different to the community Special Authority to allow more clinical flexibility for inpatient treatment:

Restricted

Initiation – Fluid restricted or volume intolerance with faltering growth

To provide feedback

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Wednesday, 22 November 2017 to:

Matthew Tyson
Therapeutic Group Manager
PHARMAC

Email: matthew.tyson@pharmac.govt.nz

Fax:     04 460 4995
Post:    PO Box 10 254, Wellington 6143

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.