Decision to fund paediatric oral / enteral feed (Infatrini)

Hospital devices

Decision

What we’re doing

We’re pleased to announce the approval of an agreement with Nutricia Limited for the listing of paediatric oral / enteral feed 1 kcal / ml (Infatrini) 125 ml in Section D (Community) and amending the listing in Part II of Section H (Hospital) of the Pharmaceutical Schedule from 1 February 2018. Funding is subject to Special Authority criteria and DHB Hospital Restrictions.

Any changes to the original proposal?

This was the subject of a consultation letter dated 8 November 2017. A few changes to the funding criteria were made following consultation as follows:

  • ‘Medical Practitioner’ was changed to ‘General Practitioner’ to more accurately reflect the intended applicant group.
  • A note was added to the Special Authority criteria and DHB Hospital Restrictions to define ‘volume intolerance’.
  • The Section H (Part II) Restriction regarding age and weight was amended to align with the Section D Special Authority criteria to ‘under 18 months of age or weighs less than 8kg’.

Who we think will be most interested

This decision will be of interest to:

  • Community and hospital prescribers, particularly paediatricians, dietitians, and general practitioners.
  • Hospital and community pharmacists, DHBs, suppliers and wholesalers.
  • Consumer advocacy groups.

What will the effect of this decision be?

From 1 February 2018 Infatrini will be funded via the Combined Pharmaceutical Budget for infants with faltering growth who are fluid restricted or volume intolerant. DHB Hospital Restrictions allow for use of Infatrini for fluid restricted or volume intolerant infants, or infants with increased nutritional requirements due to faltering growth.

Paediatricians, dietitians or general practitioners on the recommendation of a paediatrician or a dietitian will be able to apply for Special Authority approval for patients who meet the criteria.

Detail of this decision

Paediatric oral / enteral feed 1 kcal / ml (Infatrini) will be listed in Section D and Part II of Section H 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

Paediatric oral / enteral feed 1 kcal / ml (Infatrini) will be listed in Section D subject to the following Special Authority criteria (differences from consultation indicated with additions in bold, deletions in strikethrough):

Special Authority for Subsidy – Hospital pharmacy [HP3]

Initial application only from a paediatrician, dietitian, or medical practitioner general 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 weighs less than 8 kg.

Note: ‘Volume intolerant’ patients are those who are unable to tolerate an adequate volume of infant formula to achieve expected growth rate. These patients should have first trialled appropriate clinical alternative treatments such as concentrating, fortifying and adjusting the frequency of feeding.

Renewal only from a paediatrician, dietitian, or medical practitioner general 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 weighs less than 8 kg.

Note: ‘Volume intolerant’ patients are those who are unable to tolerate an adequate volume of infant formula to achieve expected growth rate. These patients should have first trialled appropriate clinical alternative treatments such as concentrating, fortifying and adjusting the frequency of feeding.

The listing of paediatric oral / enteral feed 1 kcal / ml (Infatrini) will be amended in Part II Section H as follows (differences from consultation indicated with additions in bold, deletions in strikethrough):

Restricted

Initiation – Fluid restricted or volume intolerance with faltering growth

Both:

  1. Either:
    1. The patient is fluid restricted or volume intolerant; or
    2. The patient has increased nutritional requirements due to faltering growth; and
    3. Patient is under 18 months old andor weighs less than 8kg.

Note: ‘Volume intolerant’ patients are those who are unable to tolerate an adequate volume of infant formula to achieve expected growth rate. These patients should have first trialled appropriate clinical alternative treatments such as concentrating, fortifying and adjusting the frequency of feeding.

Our response to what you told us

We’re very grateful for the time people took to respond to this consultation. All consultation responses received by 22 November 2017 were considered in their entirety when making the decision. The table below summarises the main themes raised in feedback, any changes we have made after listening to you, and other comments on the feedback.

If you have any questions, you can email us at enquiry@pharmac.govt.nz or call our toll-free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.

Theme PHARMAC comment

Respondents supported the proposal to fund Infatrini for fluid restricted and volume intolerant infants with failure to thrive.

Respondents considered that the proposed indications and restrictions were appropriate and noted that families are currently mixing two or more funded products at home which they are not trained to do.

Noted.

One respondent considered that metabolic paediatricians and paediatric nephrologists should be able to prescribe Infatrini.

Both these prescriber types are included in the ‘paediatrician’ definition and will therefore be able to seek Special Authority approval for funding of Infatrini.

One respondent suggested a small amendment to the wording of the ‘volume intolerant’ definition as follows (additions in bold deletions in strikethrough):

“‘Volume intolerant’ patients are those who are unable to tolerate an adequate volume of infant formula to maintain weight. These patients should have first trialled all funded appropriate clinical alternative treatments such as concentrating, fortifying and adjusting the frequency of feeding”

The Note in the Schedule has been amended following consideration of this feedback.

One respondent considered that currently this product is provided to DHB hospitals as an outer pack of 24 units as an ordering SKU. Infatrini is packaged and shrink wrapped, and this proposal is for the listing on an individual item which might increase the risk of breakage and cost more as handling cost would be multiplied by 24.

The respondent requested that this product be listed as 1 pack of 24 x 125 ml bottles.

PHARMAC notes that prescribed quantities depend on the patient’s weight. On average, patients are prescribed 6 bottles per day (180 bottles per month) which means that pharmacies will frequently need to split outer packs for dispensing purposes.

PHARMAC notes that listing Infatrini as an outer pack of 24 units would not be consistent with other pharmaceuticals in the Schedule, such as antibiotic vials and vaccines which are listed (and reimbursed) as single units.

One respondent considers that the financial impact of supplying Special Foods in the community should be addressed, as these items are bulky and attract additional costs of distribution that pharmacies are not reimbursed for.

Noted. This issue relates to the Community Pharmacy Services Agreement (CPSA) negotiated between pharmacies and their DHB.