Decision relating to idarucizumab and dabigatran

Medicines

Decision

PHARMAC is pleased to announce the approval of an agreement with Boehringer Ingelheim NZ Limited for the listing of idarucizumab for use in DHB hospitals, along with price reductions for dabigatran.

The funding of idarucizumab means that an antidote to dabigatran will be available for use in DHB hospitals from 1 September 2016. Idarucizumab can be used in situations where reversal of the anticoagulant effects of dabigatran is required for emergency surgery/urgent procedures, or situations of life-threatening or uncontrolled bleeding.

This was the subject of a consultation letter dated 23 June 2016.

In summary, the effect of the decision is that from 1 September 2016:

  • idarucizumab (Praxbind) will be listed in Part II of Section H of the Pharmaceutical Schedule; and
  • the price and subsidy for all strengths of dabigatran (Pradaxa) will be reduced.

Details of the decision

Idarucizumab (Praxbind)

  • Idarucizumab will be listed under a new Pharmaceutical Schedule subheading, Anticoagulant Reversal Agents in the Antifibrinolytics, Haemostatics and Local Sclerosants therapeutic subgroup of the 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 Price
Idarucizumab Inj 50 mg per ml; 50 ml vial Praxbind 2 $4,250.00
  • A confidential rebate will apply to Praxbind, reducing the net price.
  • Praxbind will have price and delisting protection until 30 December 2019.
  • Idarucizumab will be listed 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 will 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 New 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 will apply to Pradaxa, reducing the net price.
  • Pradaxa will have subsidy and delisting protection until 30 December 2019.
  • Dabigatran will 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, will continue to apply.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 8 July 2016 were considered in their entirety in making a decision on the proposed changes. All responses were supportive of the proposal:

Theme Comment
Supportive of idarucizumab listing, noting the lack of alternatives and likely health benefits. Noted.
One responder requested price support to minimise the potential for an out-of-stock situation. PHARMAC will work with wholesalers and suppliers as per our usual practice when implementing price changes.
One responder requested an alternative novel oral anticoagulant (NOAC) be listed for patients who have an intolerance to dabigatran.  This decision will not limit PHARMAC’s ability to list another NOAC. 
A responder noted that the DHB hospital expenditure on idarucizumab will be greater than the savings they make on the dabigatran component of this proposal. We acknowledge there will be a cost for DHB hospitals as a result of this proposal. Idarucizumab will likely provide improved health outcomes and is considered to be a cost-effective treatment at the agreed price. 
Several responders considered that the decision to use idarucizumab needs to be closely managed, as there is the potential for convenience usage. A gatekeeper role for haematologists and emergency medicine specialists was suggested by a responder, where sign-off in each case is required.One responder considered that overly prescriptive restrictions may not be desirable, as delaying certain non-life-threatening surgeries can put a patient at risk for a number of severe complications and prolong the patient’s hospital stay. We consider that prescriptive HML restrictions limiting the use of idarucizumab based on prescriber type, laboratory/radiology results or the timing to surgery are not justified at this time.The HML restriction will not prevent DHBs from developing their own protocols to further clarify the bleeding or urgent surgical situations where idarucizumab may be used.We consider that DHBs are best placed to develop these protocols, given the potential clinical urgency and complexities involved in some cases where treatment with idarucizumab may be indicated.PHARMAC will review the usage of idarucizumab though its normal clinical advisory process following the listing, and could consider changes to the restriction if required.

More information

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