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Source: Pharmac

What we’re proposing

PHARMAC is seeking feedback on a proposal to fund two new enteral liquid peptide formulas (Nutrini Peptisorb and Nutrini Peptisorb Energy), for use in paediatric patients with impaired gastrointestinal (GI) function, from 1 September 2020 through a provisional agreement with Nutricia Limited (Nutricia). 

Listing would be in Section D and Part II of Section H of the Pharmaceutical Schedule and would be subject to Special Authority criteria and Hospital restrictions.  

Further details on this proposal, including how to provide feedback, can be found below.

Consultation closes at 5pm Tuesday 4 August 2020 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

From 1 September 2020, Nutrini Peptisorb and Nutrini Peptisorb Energy would be fully funded for paediatric patients who meet the Special Authority criteria (or Hospital restrictions). This would mean that paediatric patients who are tube fed and require a semi-elemental formula would have access to a liquid product.

Currently there are a number of funded semi-elemental and partially hydrolysed formulas available; however, these are powdered formulas which require constitution and do not fully meet the micronutrient needs for all patients. Nutrini Peptisorb and Nutrini Peptisorb Energy are nutritionally complete ready-to-hang formulas suitable for paediatric patients (between the ages of 1 – 14 years) who are unable to tolerate polymeric feeds and alternative semi-elemental or partially hydrolysed formulas (or for whom these feeds are not suitable).

We estimate that approximately 12 paediatric patients per year could benefit from the listing of Nutrini Peptisorb and Nutrini Peptisorb Energy.

Who we think will be interested

  • Paediatric patients and their whānau
  • Community and hospital dietitians
  • Paediatricians, paediatric gastroenterologists, paediatric surgeons, general practitioners, pharmacists and other clinicians and health professionals involved in the management of paediatric patients with impaired gastrointestinal function
  • Pharmaceutical suppliers and wholesalers

About Nutrini Peptisorb and Nutrini Peptisorb Energy

Impaired GI function can occur as a result of intestinal failure from a variety of causes such as: extensive small bowel mucosal disease, short bowel syndrome, inflammatory bowel disease, pancreatic enzyme deficiency (e.g. secondary to cystic fibrosis), chemotherapy induced enteritis and chronic liver disease. For these patients, impaired digestion and reduced absorption of proteins and lipids can result in inadequate nutritional intake and failure to thrive (poor growth), increasing the risk of malnourishment and impeding overall growth and development.  

Nutrini Peptisorb and Nutrini Peptisorb Energy are nutritionally complete liquid peptide (semi-elemental) enteral feeds, designed for paediatric patients with impaired GI function such as maldigestion or malabsorption, who do not tolerate a polymeric feed or for whom a polymeric feed may not be suitable. Both Nutrini Peptisorb and Nutrini Peptisorb Energy can be administered via naso-enteric tube, gastrostomy or jejunostomy.

Nutrini Peptisorb 500 ml is equivalent to a total energy of 500 calories, or 2092kJ, and is indicated for children aged between 1 – 6 years (8-20 kg in weight). Nutrini Peptisorb Energy 500 ml is equivalent to a total energy of 750 calories, or 3138kJ, and is indicated for children up to 45 kg in weight (approximately 12 – 14 years).  The volume of Nutrini Peptisorb and Nutrini Peptisorb Energy administered varies based on a patient’s individual energy and protein requirements.

Why we’re proposing this

A funding application for Nutrini Peptisorb and Nutrini Peptisorb Energy was reviewed by the Special Foods Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) in December 2017 [PDF, 564 KB]and was recommended for funding with a high priority for paediatric patients with impaired gastrointestinal function who do not tolerate polymeric feeds, or for whom polymeric feeds are not suitable.

This recommendation was noted by PTAC in May 2018 [PDF, 267 KB].

PHARMAC has reached a provisional agreement with the supplier, Nutricia, to fund Nutrini Peptisorb and Nutrini Peptisorb Energy.

Details about our proposal

Nutrini Peptisorb and Nutrini Peptisorb Energy would be listed in Section D of the Pharmaceutical Schedule from 1 September 2020 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Proposed price and subsidy

Enteral liquid peptide formula 1kcal/ml  

Liquid

Nutrini Peptisorb

500 ml OP

$10.45

Enteral liquid peptide formula 1.5kcal/ml

Liquid

Nutrini Peptisorb Energy

500 ml OP

$15.68

The following Special Authority criteria would apply:

Special Authority for Subsidy

Initial application – (Paediatric exclusive enteral nutrition) only from a dietitian, relevant specialist or vocationally registered general practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Patient has impaired gastrointestinal function and either cannot tolerate polymeric feeds, or polymeric feeds are unsuitable; and
  2. Any of the following:

2.1 Severe malabsorption; or

2.2 Short bowel syndrome; or

2.3 Intractable diarrhoea; or

2.4 Biliary atresia; or

2.5 Cholestatic liver diseases causing malabsorption; or

2.6 Cystic fibrosis; or

2.7 Proven fat malabsorption; or

2.8 Severe intestinal motility disorders causing significant malabsorption; or

2.9 Intestinal failure; or

2.10 Both:

2.10.1 The patient is currently receiving funded amino acid formula; and

2.10.2 The patient is to be trialled on, or transitioned to, an enteral liquid peptide formula; and

  1. Either:

3.1 A semi-elemental or partially hydrolysed powdered feed has been reasonably trialled and considered unsuitable; or

3.2 For step down from intravenous nutrition.

Note: A reasonable trial is defined as a 2-4 week trial.

Renewal – (Paediatric exclusive enteral nutrition) only from a dietitian, relevant specialist, vocationally registered general practitioner or general practitioner on the recommendation of a dietitian, relevant specialist or vocationally registered general practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. An assessment as to whether the patient can be transitioned to a cows milk protein or soy infant formula or extensively hydrolysed formula has been undertaken; and
  2. The outcome of the assessment is that the patient continues to require an enteral liquid peptide formula; and
  3. General practitioners must include the name of the dietitian, relevant specialist or vocationally registered general practitioner and the date contacted.

Nutrini Peptisorb and Nutrini Peptisorb Energy would be listed in Part II of Section H of the Pharmaceutical Schedule from 1 September 2020 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Proposed price

Enteral liquid peptide formula 1kcal/ml  

Liquid 2.75 g protein, 13.7 g carbohydrate and 3.89 g fat per 100 ml, pack

Nutrini Peptisorb

500 ml

$10.45

Enteral liquid peptide formula 1.5kcal/ml

Liquid 4.2 g protein, 18.6 g carbohydrate and 6.58 g fat per 100 ml, pack

Nutrini Peptisorb Energy

500 ml

$15.68

The following Hospital restrictions would apply:

Restricted

Initiation – Paediatric exclusive enteral nutrition

All of the following:

  1. Patient has impaired gastrointestinal function and either cannot tolerate polymeric feeds, or polymeric feeds are unsuitable; and
  2. Any of the following:

2.1 Severe malabsorption; or

2.2 Short bowel syndrome; or

2.3 Intractable diarrhoea; or

2.4 Biliary atresia; or

2.5 Cholestatic liver diseases causing malabsorption; or

2.6 Cystic fibrosis; or

2.7 Proven fat malabsorption; or

2.8 Severe intestinal motility disorders causing significant malabsorption; or

2.9 Intestinal failure; or

2.10 Both:

2.10.1 The patient is currently receiving funded amino acid formula; and

2.10.2 The patient is to be trialled on, or transitioned to, an enteral liquid peptide formula; and

  1. Either:

3.1 A semi-elemental or partially hydrolysed powdered feed has been reasonably trialled and considered unsuitable; or

3.2 For step down from intravenous nutrition.

Note: A reasonable trial is defined as a 2-4 week trial.


Continuation –
Paediatric exclusive enteral nutrition

Both:

  1. An assessment as to whether the patient can be transitioned to a cows milk protein or soy infant formula or extensively hydrolysed formula has been undertaken; and
  2. The outcome of the assessment is that the patient continues to require an enteral liquid peptide formula.

To provide feedback

Send us an email:  consult@pharmac.govt.nz by 5pm Tuesday 4 August 2020.

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.

Last updated: 21 July 2020

MIL OSI