Proposal for idarucizumab and dabigatran

Medicines

Consultation Closed

PHARMAC is seeking feedback on a proposal involving idarucizumab and dabigatran, resulting from a provisional agreement with Boehringer Ingelheim NZ Limited.

The proposal includes the listing of idarucizumab for use in DHB hospitals, and price reductions for dabigatran.

In summary, this proposal would result in:

  • listing of idarucizumab (Praxbind), the specific reversal agent for dabigatran, in Part II of Section H of the Pharmaceutical Schedule from 1 September 2016.
  • a price reduction for all strengths of dabigatran (Pradaxa) effective 1 September 2016.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Friday, 8 July 2016 to:

Andrew Park
Therapeutic Group Manager
PHARMAC
PO Box 10 254
Wellington 6143

Email: andrew.park@pharmac.govt.nz
Fax:     04 460 4995

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. 

Details of the proposal

Idarucizumab (Praxbind)

  • Idarucizumab (Praxbind) would be listed under a new Pharmaceutical Schedule Subheading in Antifibrinolytics, Haemostatics and Local Sclerosants (Blood and Blood Forming Organs therapeutic group), in Part II of Section H of the Pharmaceutical Schedule from 1 September 2016 as follows (ex-manufacturer, excluding GST): 
Chemical Formulation Brand Pack size Proposed price
Idarucizumab Inj 50 mg per ml; 50 ml vial Praxbind 2 $4,250.00
  • A confidential rebate would apply to Praxbind, reducing the net price.
  • Praxbind would have price and delisting protection until 30 December 2019.
  • Idarucizumab would be listed in Section H of the Pharmaceutical Schedule subject to the following restriction:

Restricted

Initiation

For the reversal of the anticoagulant effects of dabigatran when required in situations of life-threatening or uncontrolled bleeding, or for emergency surgery or urgent procedures.

Dabigatran (Pradaxa)

  • The price and subsidy for dabigatran (Pradaxa) capsules would be reduced in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 September 2016 as follows (ex-manufacturer, excluding GST): 

Chemical

Formulation

Brand

Pack size

Current price and subsidy

Proposed price and subsidy

Dabigatran

Cap 75 mg

Pradaxa

60

$148.00

$76.36

Dabigatran

Cap 110 mg

Pradaxa

60

$148.00

$76.36

Dabigatran

Cap 150 mg

Pradaxa

60

$148.00

$76.36

  • A new confidential rebate structure would apply to Pradaxa, reducing the net price.
  • Pradaxa would have subsidy and delisting protection until 30 December 2019.
  • Dabigatran would remain listed in Section B and Part II of Section H of the Pharmaceutical Schedule without restriction, except that the current restriction in Section B on the 75 mg capsule, limiting use to a maximum of two capsules per day, would continue to apply.

Background

Dabigatran is an oral anticoagulant that acts via direct inhibition of thrombin in the blood. It is used for prevention of stroke, systemic embolism and reduction of vascular mortality in patients with non-valvular atrial fibrillation, the prevention of venous thromboembolic events in patients who have undergone major orthopaedic surgery and the treatment and prevention of deep vein thrombosis and/or pulmonary embolism.

Dabigatran has been listed in Section B (community) and in Part II of Section H (DHB hospitals) of the Pharmaceutical Schedule since 1 July 2011. Dabigatran is now used regularly by more than 20,000 people in New Zealand.  

Idarucizumab is a specific reversal agent for dabigatran that was approved by Medsafe for use in New Zealand in December 2015. It is indicated in patients treated with dabigatran when rapid reversal of the anticoagulant effects of dabigatran is required for emergency surgery/urgent procedures, or situations of life-threatening or uncontrolled bleeding.

Previously, a specific dabigatran reversal agent has not been available. Measures to control bleeding relied largely on supportive measures and treatments that did not have their efficacy established in clinical trials. In response to the lack of alternatives, PHARMAC produced guidelines on the management of bleeding and perioperative management with expert clinical advice from the Heamatology Subcommittee of PTAC.

PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) considered idarucizumab at its meeting in November 2015. The Committee recommended that idarucizumab be listed for the specific reversal of the anticoagulant effects of dabigatran when required in situations of life-threatening or uncontrolled bleeding, or for emergency surgery or urgent procedures, with a medium priority. Further details of PTAC’s advice are in the relevant PTAC meeting minutes; these are available via the application tracker on our website here:

https://connect.pharmac.govt.nz/apptracker/s/global-search/idarucizumab(external link)