Decision to list Multichem cholecalciferol (Vit. D3) capsules
Due to the expiration of Medsafe provisional consent for Cal-d-Forte 1.25 mg (50,000 iu) tablets (supplied by API Consumer Brands), PHARMAC has approved an agreement with Multichem NZ Limited relating to the supply of an alternative cholecalciferol product (Vit. D3 capsules). This was the subject of a consultation letter dated 26 January 2016.
The proposal was approved as consulted on. In summary, from 1 March 2016, the effect of the decision is that:
- There will be a cholecalciferol 1.25 mg product listed, fully funded on the Pharmaceutical Schedule, that is Medsafe approved; and
- Patients who currently use funded Cal-d-Forte tablets will need to switch to the Multichem Vit.D3 capsules.
Details of the decision
From 1 March 2016, Multichem’s Vit.D3 capsules will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following subsidy and price (ex-manufacturer and excluding GST):
|Chemical||Form and strength||Brand||Pack size||Price and subsidy
(ex-man., ex. GST)
|cholecalciferol||Cap 1.25 mg (50,000 iu)||Vit. D3||12||$3.85|
- Vit.D3 will have subsidy and delisting protection until 30 June 2017.
- Prescriptions for Vit.D3 capsules will be limited to subsidy of a maximum of 12 capsules per prescription.
- The STAT dispensing rule applies to dispensings of prescriptions for cholecalciferol.
We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 10 February 2016 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:
|Request for a liquid formulation for paediatric patients who are unable to swallow capsules.||PHARMAC is actively seeking an oral liquid formulation for listing.|
Approximately 230,000 patients’ access funded cholecalciferol tablets per year. Cholecalciferol 1.25mg (50,000 iu) tablets (Cal-d-Forte) are currently listed in the Pharmaceutical Schedule in the Alimentary Tract and Metabolism therapeutic group. Medsafe provisional consent for Cal-d-Forte expires on 12 February 2016. We understand that the supplier of Cal-d-Forte has notified all pharmacies about this and that stock levels are low.
This decision ensures a high strength cholecalciferol preparation will continue to be supplied and funded for people requiring vitamin D supplementation.
The Multichem Vit.D3 capsule is an oval shaped soft gelatin capsule containing pale yellow colored oil. The capsule fill contains refined soya oil. Further details are provided in the Medsafe datasheet: http://www.medsafe.govt.nz/profs/datasheet/v/VitD3cap.pdf(external link).
PHARMAC is aware there is a clinical need for a suitable preparation for young children and people unable to swallow a soft gelatin capsule. PHARMAC is actively working to secure supply of an oral liquid formulation of cholecalciferol.
PHARMAC is developing patient information to help support patients with the brand change. This information will be available to download from the PHARMAC website soon.
If you have any questions about this decision, you can email us at firstname.lastname@example.org.