Nutritional products (Special Foods) supplied by Nutricia

Transcription

1 2 April 2012 Nutritional products (Special Foods) supplied by Nutricia PHARMAC is pleased to announce the funding of a number of nutritional products (Special Foods) supplied by Nutricia. These products will be funded from 1 April 2012 and were the subject of a consultation letter dated 16 February Summary of the decision From 1 April the following products will be funded for eligible patients: Indication / Product Type Phenylketonuria (PKU) Ketogenic diet Paediatric enteral feeds New Product to be funded as a replacement for Minaphlex KetoCal for patients requiring a ketogenic diet Nutrini Low Energy Multi Fibre (0.75 kcal/ml with fibre) for children with low energy requirements Nutrini Energy Multi Fibre (1.5 kcal/ml with fibre) as an alternative to non-fibre products Standard (adult) enteral feeds Nutrison Energy (1.5 kcal/ml) as an alternative to fibre containing products Nutrison Concentrated (2 kcal/ml) for patients with high energy requirements it will be moved from the Renal Products category to the Adults Products High Calorie category Amino acid based infant formula Neocate Gold as a replacement for Neocate Neocate Advance vanilla as a replacement for Neocate Advance tropical Oral feeds Fortisip powder as an alternative to current powders Implementation Patients being dispensed funded Nutrison Concentrated before 1 April 2012 via a Renal Products Special Authority approval number will automatically be issued with a Special Authority approval number for Adult Products High Calorie. This will enable them to continue to receive Nutrison Concentrated fully funded. DHB Hospital Purchase The above products will be listed in Section H of the Pharmaceutical Schedule making them available for DHB hospital purchase (at each hospital s discretion). A Page 1 of 5

2 Details of the decision From 1 April 2012, the following products will be listed fully funded in the Community (Section D of the Pharmaceutical Schedule) subject to the following Special Authority Forms, prices and subsidies: Special Food Brand Form Flavour Pack Size Price/Subsidy Special Authority Form Liquid Orange 125 ml $13.10 Liquid Berry 125 ml $13.10 Liquid Unflavoured 125 ml $13.10 Foods and for Inborn Errors of Metabolism High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate KetoCal Powder Vanilla 300 g $35.50 Paediatric enteral feed with fibre 0.75 kcal/ml Nutrini Low Energy Multi Fibre Liquid Not applicable 500 ml $4.00 Paediatric enteral feed with fibre 1.5 kcal/ml Nutrini Energy Multi Fibre Liquid Not applicable 500 ml $6.00 Paediatric Products Enteral feed 1.5 kcal/ml Nutrison Energy Liquid Not applicable 1000 ml $7.00 Standard Enteral feed 2 kcal/ml Nutrison Concentrated Liquid Not applicable 500 ml $5.50 Neocate Gold Powder Unflavoured 400 g $56.00 Amino Acid Formula Neocate Advance Powder Vanilla 400 g $56.00 Amino Acid Formula Oral feed (powder) Fortisip Powder Vanilla 900 g $9.50 Standard The above products will be listed in Section H of the Pharmaceutical Schedule at the above prices making them available for DHB hospital purchase at the DHB hospital s discretion. The following products will be discontinued once stock is depleted: Minaphlex it would be replaced by Neocate alternatives would include Neocate LCP and Neocate Gold Neocate Advance tropical it would be replaced by Neocate Advance vanilla A Page 2 of 5

3 The following Special Authorities will apply: High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate (KetoCal) Initial application only from a metabolic physician or paediatric neurologist. Approvals valid for 3 months for patients with intractable epilepsy, pyruvate dehydrogenase deficiency or glucose transported type-1 deficiency and other conditions requiring a ketogenic diet. Renewal only from a metabolic physician or paediatric neurologist. Approvals valid for 2 years for patients on a ketogenic diet and the patient is benefiting from the diet. Paediatric enteral feed with fibre 0.75 kcal/ml (Nutrini Low Energy Multi Fibre) Initial application only from a dietitian, relevant specialist or vocationally registered general practitioner. Approvals valid for 1 year for applications meeting the following criteria: Both: 1 Child aged one to eight years; and 2 The child has a low energy requirement but normal protein and micronutrient requirements. Renewal 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 1 year for applications meeting the following criteria: Both: 1 The treatment remains appropriate and the patient is benefiting from treatment; and 2 General Practitioners must include the name of the dietitian, relevant specialist or vocationally registered general practitioner and date contacted. Enteral feed 2 kcal/ml (Nutrison Concentrated) The Nutrison Concentrated Special Authority criteria would change from the Renal Products Special Authority criteria (the patient has acute or chronic renal failure) to the Adults Products High Calorie Special Authority criteria which has been amended to account for fluid restricted patients as follows (changes in bold): Initial application (Cystic fibrosis) only from a dietitian, relevant specialist or vocationally registered general practitioner. Approvals valid for 3 years for applications meeting the following criteria: All of the following: 1 Cystic fibrosis; and 2 other lower calorie products have been tried; and 3 patient has substantially increased metabolic requirements. Initial application (Indications other than cystic fibrosis) only from a dietitian, relevant specialist or vocationally registered general practitioner. Approvals valid for 1 year for applications meeting the following criteria: All of the following: 1 Any of the following: 1.1 any condition causing malabsorption; or 1.2 failure to thrive; or 1.3 increased nutritional requirements; and or 1.4 fluid restricted; and 2 other lower calorie products have been tried; and 3 patient has substantially increased metabolic requirements or is fluid restricted. Renewals would be provided for both of the above patient groups where the patient is benefiting from treatment. A Page 3 of 5

4 Feedback received We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 1 March 2012 were considered in their entirety in making a decision on the proposed changes. All responses were supportive of the proposals with the following issues being raised in relation to specific aspects of the proposals: Issue KetoCal / Ketogenic Diet While the funding of KetoCal 4:1 was supported for use in a ketogenic diet it was requested that KetoCal 3:1 is also considered for funding. The Special Authority criteria should include pyruvate dehydrogenase deficiency and glucose transporter type-1 deficiency - metabolic conditions where a ketogenic diet is used. The Special Authority criteria should exclude patients under 1 year of age. Paediatric Feeds Clarification was sought as to whether the proposal would raise the upper age limit for eligibility to oral and enteral paediatric feeds from the current eight years of age to ten years of age with support being for ten years of age. PHARMAC Comment Nutricia has indicated that KetoCal 3:1 is not currently available in either Australia or New Zealand (it is relatively new on the market in the USA and UK) but that it is open to considering whether it can be made available. PHARMAC would consider an application for KetoCal 3:1. Authority criteria as suggested to make it clearer that these patients groups are included. An age restriction has not been included as this would prevent clinicians from making early applications and therefore could delay funding for appropriate patients. The age of eligibility for paediatric feeds is currently eight years of age. We have however been considering whether to raise this to ten years of age and may be issuing a proposal with respect to this in the near future. The Special Authority for Nutrini Low Energy Multi Fibre (a low energy paediatric enteral feed) should not require malabsorption, failure to thrive, or increased nutritional requirements. It should be available for children with a low energy requirement but normal protein and micronutrient requirements. Standard (Adult) Enteral Feeds There is a clinical need for the adult version of Nutrini Low Energy Multifibre (eg Nutrison 1000 Complete or Nutrison 1200 Complete). The current products (eg Nutrison Multifibre) can require a patient to have around 1500 mls per day to obtain an adequate protein, vitamin and mineral intake. This equates to 1500kcals which can results in large weight gains in bedbound inactive patients who may only require 1000kcals. Authority criteria as suggested. We note the support for Nutrison 1000 Complete and Nutrison 1200 Complete and would be happy to consider an application for funding should the supplier be able to supply it. A Page 4 of 5

5 Issue Moving Nutrison Concentrated into the Adult Products High Calorie category may not enable it to be used for fluid restricted patients where they are volume sensitive but have normal metabolic/nutritional requirements. Standard Supplement Powders While feedback was positive regarding the listing of Fortisip powder (as it provides more choice for patients) it was hoped that this would not occur at the risk of the two currently funded powders ie Ensure powder and Sustagen Hospital Formula. Clarification is required as to whether the standard supplement powders are funded for preparations/dilutions other than 1.0 kcal/ml. PHARMAC Comment Authority criteria as suggested to clarify the eligibility of fluid restricted patients who are volume sensitive. The listing of an additional product may impact on the usage of products currently in the market. We can not guarantee the feasibility of all products. We had never intended that the standard supplement powders only be used to make up a 1.0 kcal/ml dilution. Our view is that they can be used to make up any dilution that is considered clinically appropriate for a patient. To clarify this issue we have replaced the Oral feed 1kcal/ml listing with "Oral feed (powder). More information If you have any questions about this decision, you can call our toll free number (9 am to 5 pm, Monday to Friday) on A Page 5 of 5