Decision to award sole supply of propofol in DHB hospitals

Medicines

Decision

PHARMAC is pleased to announce that a decision has been made to award Hospital Supply Status from 1 June until 30 June 2019 for propofol in DHB hospitals.

  • AFT Pharmaceuticals Limited for its brand Provive MCT-LCT 1% inj 10 mg per ml, 20 ml vial ; and
  • Fresenius Kabi New Zealand Limited for its brand Fresofol 1% MCT/LCT inj 10 mg per ml, 50 ml vial and inj 10 mg per ml, 100 ml vial.

A 10% discretionary variance (DV) limit will apply.

This decision has been made following a Request for Tender (RFT) for the supply of propofol to DHB hospitals, issued on 14 October 2015, and was the subject of a consultation letter dated 15 December 2015.

The proposal was approved as consulted on. In summary, the effect of the decision is:  

  • All currently listed presentations of propofol other than Provive MCT-LCT 1% 20 ml vial will be delisted from 1 June 2016;
  • The 50 ml and 100 ml presentations of Fresenius Kabi’s Fresofol 1% MCT/LCT brand will be listed from 1 April 2016;
  • A reduction in price across all three presentations of propofol;
  • All listed presentations of propofol will be:
    • in a vial presentation;
    • of the MCT-LCT formulation;
    • subject to a 10% DV limit.

Details of the decision follow.

Details of the decision

  • AFT’s Provive MCT-LCT 1% (propofol) 20 ml vial will remain listed, and Fresenius Kabi’s Fresofol 1% MCT/LCT (propofol) 50 ml and 100 ml vials will be listed in pack sizes of 10 vials, in Part II of Section H of the Pharmaceutical Schedule at the following prices from 1 April 2016: 

Chemical

Presentation

Brand

Pack size

Current price per pack (ex-man, ex GST)

New price per pack (ex-man, ex GST)

Propofol

Inj 10 mg per ml, 20 ml vial

Provive MCT-LCT 1%

5

$7.60

$5.27

Propofol

Inj 10 mg per ml, 50 ml vial

Fresofol 1% MCT/LCT

10

N/A

$24.50

Propofol

Inj 10 mg per ml, 100 ml vial

Fresofol 1% MCT/LCT

10

N/A

$49.00

  • Provive MCT-LCT 1% inj 10 mg per ml, 20 ml vial will be awarded Hospital Supply Status from 1 June 2016 until 30 June 2019 with a 10% DV limit.
  • Fresofol 1% MCT/LCT inj 10 mg per ml, 50 ml and 100 ml vials will be awarded Hospital Supply Status from 1 June 2016 until 30 June 2019 with a 10% DV limit.
  • The following currently listed presentations will be delisted from Part II of Section H of the Pharmaceutical Schedule from 1 June 2016:
Chemical Presentation Brand Supplier Pack size
Propofol Inj 10 mg per ml, 20 ml ampoule Fresofol 1% Fresenius Kabi 5
Propofol Inj 10 mg per ml, 20 ml vial Diprivan AstraZeneca 5
Propofol Inj 10 mg per ml, 50 ml vial Diprivan AstraZeneca 1
Propofol Inj 10 mg per ml, 50 ml vial Fresofol 1% Fresenius Kabi 1
Propofol Inj 10 mg per ml, 50 ml vial Provive MCT-LCT 1% AFT 1
Propofol Inj 10 mg per ml, 50 ml syringe Diprivan AstraZeneca 1
Propofol Inj 10 mg per ml, 100 ml vial Fresofol 1% Fresenius Kabi 1
Propofol Inj 10 mg per ml, 100 ml vial Provive MCT-LCT 1% AFT 1
  • This will mean that from 1 June 2016 the following presentations will be delisted from Part II of Section H of the Pharmaceutical Schedule:
    • the syringe presentation
    • all non MCT-LCT propofol formulations (LCT and EDTA containing)
  • PHARMAC notes that:
    • usage of the syringe presentation is very low, at less than 1% of the current 50 ml propofol market in terms of units,
    • usage of the EDTA containing formulation is low, at less than 2% of the current market in terms of units,
    • limited use of the syringe presentation and EDTA formulation would be possible (i.e. volumes would need to fall under the 10% DV limit). 

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 15 January 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:

Theme Comment
There was general agreement that vials were preferable to ampoules.Some responders did not think that the benefit of the vial was great enough to justify the removal of the LCT formulation. This feedback was carefully considered. Clinical advice obtained by PHARMAC specified a clear preference for vial presentations and did not identify any evidence of clinical need for both LCT and MCT-LCT formulations.
PHARMAC received responses regarding the proposed 10% DV limit and how, in particular, use of the propofol with EDTA formulation in Intensive Care Units may be affected.Concern was expressed regarding the use of preservative free propofol, due to the risk of the lipid vehicle becoming contaminated. The risk is greater during prolonged use, such as that typical of propofol use in the ICU.Responses noted that an advantage of the EDTA formulation is that it is sulphite free and therefore the preferred option for use with patients who have sulphite allergies. The 10% Discretionary Variance (DV) limit will allow some use of other formulations outside of the Hospital Supply Status brand. This could include use of the EDTA containing formulation.
Clarification was sought on the availability of a 2% propofol solution.The respondent highlighted the benefit of a 2% product for prolonged use being it reduced the burden of the intravenous lipid load by 50%. During the development of the Hospital Medicines List in 2012, PHARMAC’s clinical advisors considered 2% propofol and recommended against its use.“The Subcommittee noted that there was little use of propofol 20 mg per ml injections in DHB hospitals. The Subcommittee considered that there was a safety risk associated with having this higher strength product available but no significant clinical benefit. The Subcommittee recommended that this not be included in a national PML.”The decision does not prevent PHARMAC from considering a 2% propofol for listing at a later stage, should an application be submitted.
Clarification was sought that all of the products in the proposal were licensed for use in paediatrics. All products are licensed for use in paediatrics.
Sought confirmation that the prosed vials were latex free. Both suppliers have confirmed that their products are all latex free.

More information

If you have any questions about this decision, you can email enquiry@pharmac.govt.nz.