Proposal to fund a number of Nutritional products (Special Foods) supplied by Nutricia

Transcription

1 16 February 2012 Proposal to fund a number of Nutritional products (Special Foods) supplied by Nutricia PHARMAC is seeking feedback on a proposal to fund a number of nutritional products (Special Foods) supplied by Nutricia from 1 April In summary, it is proposed that: Phenylketonuria (PKU) PKU Anamix Junior LQ is funded as a replacement for Minaphlex. Ketogenic diet KetoCal (a high fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate) is funded for patients requiring a ketogenic diet. Paediatric enteral feeds Nutrini Low Energy Multi Fibre (0.75 kcal/ml with fibre) is funded for children with low energy requirements but normal protein and micronutrient requirements. Nutrini Energy Multi Fibre (1.5 kcal/ml with fibre) is funded as an alternative to nonfibre products. Standard (adult) enteral feeds Nutrison Energy (1.5 kcal/ml) is funded as an alternative to fibre containing products. The listing and access criteria of Nutrison Concentrated (2 kcal/ml) is changed from Renal Products to Adults Products High Calorie allowing wider access. Amino acid based infant formula Neocate Gold is funded as a replacement for Neocate. Neocate Advance vanilla is funded as a replacement for Neocate Advance tropical. Oral feeds Fortisip powder is funded (from 1 May 2012).. DHB Hospital Purchase The above products would be listed in Section H of the Pharmaceutical Schedule making them available for DHB hospital purchase (at each hospital s discretion). Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Thursday, 1 March 2012 to: Stephen Woodruffe Therapeutic Group Manager PHARMAC stephen.woodruffe@pharmac.govt.nz Phone: All feedback received before the closing date will be considered by PHARMAC s Board (or Chief Executive acting under delegated authority) when making a decision on this proposal. A Page 1 of 6

2 Details of the proposals From 1 April 2012, the following products would be listed fully funded in the Community (Section D of the Pharmaceutical Schedule) subject to the following Special Authority Forms, prices and subsidies (with the exception of Fortisip which would be listed on 1 May 2012). Special Food Brand Form Flavour Pack Size Price/Subsidy Special Authority Form Aminoacid formula without phenylalanine Aminoacid formula without phenylalanine Aminoacid formula without phenylalanine PKU Anamix Junior LQ PKU Anamix Junior LQ PKU Anamix Junior LQ Liquid Orange 125 ml $13.10 Liquid Berry 125 ml $13.10 Liquid Unflavoured 125 ml $13.10 Foods and Supplements 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 New Special Authority Details below Paediatric enteral feed with fibre 0.75 kcal/ml Nutrini Low Energy Multi Fibre Liquid Not applicable 500 ml $4.00 New Special Authority Details below 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 Supplements Enteral feed 2 kcal/ml Nutrison Concentrated Liquid Not applicable 500 ml $5.50 New Special Authority Details below Amino acid formula Neocate Gold Powder Unflavoured 400 g $56.00 Amino Acid Formula Amino acid formula Neocate Advance Powder Vanilla 400 g $56.00 Amino Acid Formula Oral feed 1 kcal/ml Fortisip Powder Vanilla 900 g $9.50 Standard Supplements The above products would be available for DHB hospital purchase at their discretion at the same prices and would be listed in Section H of the Pharmaceutical Schedule. The following products would be discontinued once stock is depleted: Minaphlex it would be replaced by PKU Anamix Junior LQ Neocate alternatives would include Neocate LCP and Neocate Gold Neocate Advance tropical it would be replaced by Neocate Advance vanilla A Page 2 of 6

3 The following Special Authorities would 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 who require 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 ten years; and 2 Any of the following: 2.1 Any condition causing malabsorption; or 2.2 Failure to thrive; or 2.3 Increased nutritional requirements; and, 3 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 form would change from the Renal Products Special Authority criteria to the Adults Products High Calorie Special Authority criteria as follows: Current Special Authority Criteria Initial application - only from a dietitian, relevant specialist or vocationally registered general practitioner. Approvals valid for 3 years where the patient has acute or chronic renal failure. Proposed Special Authority Criteria 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 2 Other lower calorie products have been tried; and 3 Patient has substantially increased metabolic requirements. A Page 3 of 6

4 Background to the Proposals PKU Anamix Junior LQ PKU Anamix Junior LQ is an amino acid formula without phenylalanine for use in children with phenylketonuria aged 1 to 10 years. Currently Minaphlex is funded for these patients. PHARMAC received an application from Nutricia to replace Minaphlex with PKU Anamix Junior. The Special Foods Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that PKU Anamix Junior LQ be listed in the Pharmaceutical Schedule with a high priority. In reviewing the application the Subcommittee considered that: PKU Anamix Junior is clinically equivalent to Minaphlex powder. PKU Anamix Junior LQ has a number of advantages over Minaphlex including that it is a liquid rather than a powder and that it is a follow-on product to PKU Anamix Infant. PKU Anamix Junior LQ tastes better than Minaphlex powder and this may result in better compliance and therefore better clinical outcomes. KetoCal KetoCal is a nutritionally complete powdered ketogenic diet formula which has a 4:1 ratio (4 g fat for every 1 g carbohydrate and protein) which can be used as a supplement/meal replacement in the dietary management of intractable epilepsy and other conditions requiring a ketogenic diet. The Special Foods Subcommittee of PTAC recommended that KetoCal be listed in the Pharmaceutical Schedule with a high priority for use by patients requiring a ketogenic diet. In reviewing KetoCal the Subcommittee considered that: It would be useful for those with the need for tube feeding due to disability or for patients sick at home and who cannot eat. Patients who are able to eat would not use KetoCal as a full time diet replacement as they would prefer to eat solid food. It could be restricted by Special Authority to Metabolic Physicians or Paediatric Neurologists and patients over 1 year of age. The Subcommittee considered that an initial Special Authority approval of 3 months with 2 yearly renewals would be appropriate. Nutrini Low Energy Multi Fibre Nutrini Low Energy Multi Fibre is a 0.75 kcal/ml paediatric enteral feed with fibre for use in children (1 to 10 years of age) with a low energy requirement but normal protein and micronutritient requirements. There is currently no equivalent product funded. The Special Foods Subcommittee of the PTAC recommended that Nutrini Low Energy Multi Fibre is listed on the Pharmaceutical Schedule with a high priority for children with low energy requirements who have neurodevelopment disability. In reviewing the application the Subcommittee considered that: A Page 4 of 6

5 Currently the volume of a standard feed would be reduced (1 kcal/ml paediatric enteral and oral feeds - Nutrini RTH and Pediasure) and additional vitamins and minerals may be added. Most patients would be tube-feed and lifted by their carer and therefore the weight of the child can be an issue. There is a significant amount of evidence regarding child growth and micronutrients levels including an increased risk of oestopenia if load bearing does not occur. Nutrini Energy Multi-fibre Nutrini Energy Multi Fibre is a 1.5 kcal/ml paediatric enteral feed with fibre. Funding Nutrini Energy Multi Fibre would provide a fibre containing equivalent to Nutrini Energy and would provide an enteral feed alternative to Nutrini drink with fibre (1.5 kcal/ml sip feed with fibre). The Special Foods Subcommittee of PTAC recommended that Nutrini Energy Multi Fibre is listed in the Pharmaceutical Schedule with a high priority. The Subcommittee noted while there is no clinical trial evidence that the addition of fibre reduces constipation or diarrhoea, anecdotal evidence suggests that fibre products reduce constipation. Nutrison Energy Nutrison Energy is a 1.5 kcal/ml standard (adult) enteral feed which does not include fibre. Funding Nutrison Energy would provide a non-fibre equivalent to Nutrison Energy Multi Fibre (a 1.5 kcal/ml standard adult enteral feed with fibre). Nutrison Concentrated Nutrison Concentrated is a 2 kcal/ml standard (adult) enteral feed. It is currently listed under the Renal Products heading and Special Authority access criteria in the Pharmaceutical Schedule this limits funding to patients with acute or chronic renal failure. Moving Nutrison Concentrated from the Renal Products category to the Adults Products High Calorie category would widen access to include fluid restricted patients who require a 2 kcal/ml enteral feed, better align its composition to the product category, and still enable renal failure patients to access funding for it (although via different eligibility criteria). Neocate Neocate is an amino acid based infant formula. The currently funded brands of Neocate are: Brands Flavour(s) MCT component Neocate Unflavoured 5% Neocate LCP Unflavoured 5% Neocate Advance Unflavoured Tropical 5% In addition Elecare and Vivonex Paediatric are also funded. A Page 5 of 6

6 Neocate Gold has the same composition as Neocate LCP except that it contains 33% MCT (the same as Elecare). The Special Foods Subcommittee of the PTAC had no concerns with delisting Neocate and Neocate Advance tropical and listing Neocate Gold and Neocate Advance vanilla - it did note that while the change in MCT content for Neocate Gold would affect the osmolarity this would not be clinically significant (360 mosmol/kg versus 375 mosmol/kg). Fortisip Fortisip is a vanilla flavoured supplement powder. Funding Fortisip would provide an additional vanilla powder supplement option in addition to Ensure and Sustagen Hospital Formula (these come in vanilla and chocolate flavours). The following table illustrates the composition of these products when mixed to produce a 1 kcal/ml product: Ensure powder Sustagen Hospital Fortisip powder Formula Flavours Vanilla / chocolate Vanilla / chocolate Vanilla Mixing Instructions 6 scoops (52.3g) + 190ml of water 3 scoops (60g) + 200ml of water 7 scoops (57g) and make up to 260 ml Serving Volume 230 ml 240 ml 260 ml Kcal per ml Protein per serve 8.5 g 13.8 g 10.4 g Fat per serve 7.4 g 1.5 g 10.7 g Carbohydrate per serve 31.6 g 39 g 31.2 g Fibre per serve 2 g FOS 0 g 0 g Lactose No Yes Low (<0.16g per 100g) Gluten No No No Age Not intended for use in children unless recommended by a physician or health care professional Not recommended for under 3 years Use with caution in children aged 1-6 years Can size 900 g 900 g 900 g Serves per can A Page 6 of 6