Proposal for colecalciferol (vitamin D) oral liquid

Medicines

Consultation Closed

We propose to list colecalciferol (vitamin D) oral liquid (brand name Puria) from 1 January 2019.

What we’re proposing

We propose to list colecalciferol (vitamin D) oral liquid (brand name Puria) from 1 January 2019.

Consultation closes at 5 pm on Monday, 19 November 2018 and feedback can be emailed to alexander.rodgers@pharmac.govt.nz.

What would the effect be?

This proposal would list colecalciferol oral liquid in the community and hospital setting from 1 January 2019. This product would be supplied by Douglas Nutrition. Colecalciferol is one form of vitamin D (specifically, vitamin D3) and is used to treat vitamin D deficiency, which can cause rickets and other conditions.

Who we think will be interested

Pediatricians, dietitians, general practitioners, and other clinicians involved in treating vitamin deficiencies; patients with vitamin deficiencies or their caregivers; suppliers of vitamins, pharmacists; DHBs.

About colecalciferol oral liquid

This product (brand name Puria) is an oral liquid containing 188 mcg of colecalciferol per ml (7,500 iu of vitamin D per ml). This is about 10 mcg (400 iu) of colecalciferol per drop.

Puria is presented in a dropper bottle. Drops of the liquid can be administered straight into the mouth, or can be added to food or drink. One bottle of Puria provides one drop per day for three months.

Why we’re proposing this

Vitadol C, an oral liquid that contains vitamin D, will be delisted from the Pharmaceutical Schedule from 1 August 2019. This is due to a supplier discontinuation notified in 2017. This proposal would ensure continuous supply of an oral liquid containing vitamin D.

We have also received advice that there is a need for a vitamin D-only oral liquid; that is, one that does not contain other vitamins. Vitadol C also contains vitamins A and C, and we understand that this can cause issues when trying to administer one vitamin.

PHARMAC is aware that the discontinuation of Vitadol C would result in there being no funded oral liquid presentation that contains vitamin A. Separate to this proposal, PHARMAC is considering its options to secure a supply of vitamin A-only oral liquid.

Details about our proposal

From 1 January 2019, colecalciferol oral liquid 188 mcg per ml (7,500 iu per ml) (Puria) would be listed in both Section B (community) and Part II of Section H (hospital) of the Pharmaceutical Schedule, at a price of $9.00 per 4.8 ml OP bottle.

Colecalciferol oral liquid would be subject to the following restrictions: 

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Both:

  1. Patient is a child; and
  2. Patient has proven vitamin D deficiency and requires supplementation. 

Renewal from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Both:

  1. Patient is a child; and
  2. Patient has proven vitamin D deficiency and requires supplementation. 

These criteria are in line with the criteria recommended by the Gastrointestinal Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) at its March 2017 meeting.  [PDF, 405 KB]

To provide feedback

Send us an email: alexander.rodgers@pharmac.govt.nz by 5 pm, 19 November 2018.

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.