Decision to fund the bowel cleansing preparation Plenvu

24 April 2023

Medicines Decision

What we’re doing

In response to a global product discontinuation of Klean Prep, a bowel cleansing preparation supplied by Norgine Pty Limited (Norgine), Pharmac has made the decision to fund Plenvu as an alternative bowel cleansing preparation in the hospital setting.

Bowel cleansing preparations are medications taken to cleanse the bowel ahead of procedures such as a colonoscopy or colorectal surgery.

This decision will ensure that a range of suitable bowel cleansing preparations remain available following the discontinuation of Klean Prep. This will provide continuity of supply for people who need these products where other funded options may not be suitable. Further details about this decision can be found below.

What does this mean for people?

Norgine, the supplier of Klean Prep, has advised Pharmac that this product has been discontinued globally, with stock in New Zealand expected to be depleted by August 2023.

We have secured an alternative product, Plenvu, through our annual tender process to ensure that a range of suitable bowel preparation options(external link) remains available. This would provide continuity of supply for those individuals where the other funded options may not be suitable. Our clinical advisors (the Gastroenterology Advisory Committee(external link)), considered Plenvu would be a suitable alternative product.

Plenvu (macrogol 3350 with sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid powder) will be listed in Part II of Section H alongside other bowel cleansing preparations from 1 May 2023. Klean Prep will be delisted from Part II of Section H of the Pharmaceutical Schedule on 1 April 2024 to ensure sufficient time for remaining stock to be used.

Key differences between Klean Prep and Plenvu

There are some differences between Klean Prep and Plenvu. These are summarised in the table below. Full details about Plenvu and Klean Prep are available from the Medsafe datasheet.

Product name	Plenvu	Klean Prep
Ingredients	Macrogol 3350 + sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid	Macrogol 3350 with potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate
Medsafe Datasheet	Plenvu Datasheet(external link)	Klean-Prep Datasheet(external link)
Form	Powder for oral solution, 3 sachets	Powder for oral solution, 4 sachets
Active ingredients details	Dose 1 sachet: macrogol 3350 100 g potassium chloride 1 g sodium chloride 2 g sodium sulfate 9 g Dose 2 (sachet A and B) Sachet 2A: macrogol 3350 40 g potassium chloride 1.2 g sodium chloride 3.2 g Sachet 2B: ascorbic acid 7.54 g sodium ascorbate 48.11 g	4x sachets each containing: macrogol 3350 59 g potassium chloride 0.7425 g sodium bicarbonate 1.685 g sodium chloride 1.465 g sodium sulfate 5.685 g
Preparation instructions	The first dose is supplied in sachet 1. Dose 2 is supplied in two sachets, sachet A and sachet B. Each dose is made up by dissolving the sachet(s) with 500 mL of water. An additional 500 mL of clear fluid must be taken with each dose. Each 500 mL dose and 500 mL additional clear fluids should be taken over 60 minutes.	Each sachet is dissolved in 1 L of water. Usual dose is 4 sachets taken at a rate of 250 mL every 10 to 15 minutes.
Recommended dosing regimen	Two-day split dosing schedule with the first 500 mL dose of PLENVU (including additional 500 mL of clear fluid) taken in the evening before the clinical procedure and the second 500 mL dose (including an additional 500 mL of clear fluid) in the morning of the day of the clinical procedure (approximately 12 hours after the start of the first dose) Morning only dosing schedule with both doses taken in the morning of the day of the clinical procedure (including an additional 500 mL of clear fluid); the second dose should be taken a minimum of 2 hours after the start of the first dose Day before dosing schedule with both doses taken in the evening before the clinical procedure (including an additional 500 mL of clear fluid); the second dose should be taken a minimum of 2 hours after the start of the first dose.	All four sachets should be taken within 4-6 hours, or Administration may be divided, for example, taking 2 sachets during the evening before the examination, and the remaining 2 sachets on the morning of the examination.
Flavour	Mango and fruit punch	Vanilla
Excipients	Citric acid, mango flavour VA93382, sucralose, aspartame, fruit mix flavour (fruit punch) FV654 VA93402	Aspartame, vanilla
Reconstituted shelf life	24 hours reconstituted stored at or below 25^oC (or in a refrigerator).	24 hours reconstituted stored in the refrigerator (2-8 degrees).

Who we think will be interested

People undergoing investigational or surgical procedures involving their large bowel (such as colonoscopy or colorectal surgery) and their whānau
Endoscopy units at Te Whatu Ora hospitals
Te Whatu Ora Hospital Pharmacists
Pharmaceutical suppliers

Details about this decision

Plenvu will be listed in Part II of Section H of the Pharmaceutical Schedule from 1 May 2023 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Price and subsidy
Macrogol 3350 with potassium chloride and sodium chloride with/without sodium sulfate, sodium ascorbate and ascorbic acid	Powder for oral soln 100 g with potassium chloride 1 g, sodium chloride 2 g and sodium sulfate 9 g per sachet (1), powder for oral soln 40 g with potassium chloride 1.2 g and sodium chloride 3.2 g per sachet (1) and powder for oral soln ascorbic acid 7.54 g and sodium ascorbate 48.11 g per sachet (1)	Plenvu	3	$18.52

As a result of this tender decision, Plenvu will be the principal supply brand of macrogol 3350 with sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid powder for oral soln, in Te Whatu Ora Hospitals. A discretionary variance (DV) limit of 5% will apply to the chemical from 1 October 2023 until 30 June 2026.

If you have any questions about this decision, 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 660 050.