Dabigatran
Dabigatran (Pradaxa) was listed with no Special Authority or prescriber type restrictions from 1 July 2011. Three doses (75mg, 110mg and 150mg capsules) are listed on the Pharmaceutical Schedule.
Dabigatran is an oral anticoagulant approved for use in atrial fibrillation and prevention of venous thromboembolism post major orthopedic surgery. Direct thrombin and Factor Xa inhibitors are new classes of oral anticoagulants that do not require regular blood monitoring. Use of these new classes of medicines could promote better anticoagulation management, with less monitoring burden on the patient.
Documents related to PHARMAC's decision
PHARMAC has released a number of documents, provided below, regarding its decision to fund dabigatran. The documents outline the rationale behind its decision, the advice it received from clinical advisory committees and feedback received during consultation on the funding proposal. The below media release and Q&A document provide more background regarding PHARMAC's decision:
- PHARMAC releases papers on its consideration of funding dabigatran (2 pages, 26 KB)
- Dabigatran: questions and answers (5 pages, 97 KB)
Some information has been withheld from the documents we have released in order to:
- protect the privacy of natural persons
- protect information where the making available of the information would be likely to unreasonably prejudice the commercial position of the person who supplied or who is the subject of the information
- protect information which is subject to an obligation of confidence or which any person has been or could be compelled to provide under the authority of any enactment, where the making available of the information would be likely to prejudice the supply of similar information, or information from the same source, and it is in the public interest that such information should continue to be supplied
- maintain legal professional privilege
- enable PHARMAC to carry out, without prejudice or disadvantage, commercial activities, and
- enable PHARMAC to carry on, without prejudice or disadvantage, negotiations, including commercial negotiations.
Released documents
- Cardiovascular Subcommittee dabigatran paper (15 pages, 699 KB)
- PTAC dabigatran paper (16 pages, 704 KB)
- PTAC and Cardiovascular Subcommittee minutes (9 pages, 627 KB)
- Review of CUA of dabigatran (13 pages, 647 KB)
- Dabigatran TAR (49 pages, 2598 KB)
- Dabigatran consultation responses (57 pages, 2366 KB)
- PHARMAC Board paper for dabigatran (29 pages, 725 KB)
- PHARMAC Board minutes for dabigatran (1 page, 549 KB)
Additional information
To read a question and answer information sheet from Medsafe about dabigatran click here (5 pages, 81 KB) or visit 
Medsafe's website.
- Dabigatran notification letter (3 pages, 117 KB)
- Dabigatran bleeding management (1 page, 86 KB)
- Dabigatran testing and perioperative management (2 pages, 178 KB)
- Dabigatran - information for clinicians (2 pages, 438 KB)
- Dabigatran - New Zealand Consumer Medicine Information (9 pages, 86 KB)
- Dabigatran - New Zealand Datasheet (23 pages, 255 KB)
Page updated on 31 Oct 2011
Linked documents
PHARMAC releases papers on decision to fund dabigatran (2 pages, 26 KB)
31 October 2011 Media release Papers reveal PHARMAC’s cautious approach with new anticoagulant drug Papers released by PHARMAC today outline the careful consideration given before funding was approved for the new-generation anticoagulant drug dabigatran (Pradaxa). Dabigatran, which belongs to a…
Dabigatran: questions and answers (5 pages, 97 KB)
Background on PHARMAC’s decision to fund dabigatran What was the rationale for PHARMAC's decision to fund dabigatran? Doctors have long sought an effective alternative to warfarin to treat patients needing anticoagulant therapy. Warfarin is a drug that is difficult…
Cardiovascular Subcommittee dabigatran paper (15 pages, 699 KB)
PHARMACEUTICAL SCHEDULE APPLICATION From: Date: September 2010 Dabigatran for atrial fibrillation SUMMARY OF PHARMACEUTICAL Brand Name Indications Therapeutic Group Supplier MOH Restrictions Proposed Subsidy Pradaxa Atrial Fibrillation Sub-group (group) Boehringer Ingelheim Prescription medicine pack of 60 (110mg and 150mg capsules)…
PTAC dabigatran paper (16 pages, 704 KB)
PHARMACEUTICAL SCHEDULE APPLICATION From: Date: September 2010 Dabigatran for atrial fibrillation SUMMARY OF PHARMACEUTICAL Brand Name Indications Therapeutic Group Supplier MOH Restrictions Proposed Subsidy Pradaxa Atrial Fibrillation Sub-group (group) Boehringer Ingelheim Prescription medicine pack of 60 (110mg and 150mg capsules)…
PTAC and Cardiovascular Subcommittee minutes on dabigatran (9 pages, 627 KB)
PTAC and Cardiovascular Subcommittee Minutes for Dabigatran in Orthopaedics and AF November 2008 PTAC minutes Dabigatran Etexilate for the Prevention of Venous Thromboembolic Events in Patients Undergoing Orthopaedic Surgery The Committee reviewed an application from Boehringer Ingelheim for the listing…
Review of CUA of dabigatran (13 pages, 647 KB)
Review of Supplier Economic Analysis Dabigatran Etexilate for the Prevention of Stroke, Systemic Embolism and Reduction of Vascular Mortality in Patients with Atrial Fibrillation To: From: Date: Subject: September 2010 Review of Cost-Utility Analysis of Dabigatran Exexilate for the prevention…
PHARMAC Board paper for dabigatran (29 pages, 725 KB)
MEMORANDUM FOR BOARD MEETING OF 27 MAY To: From: Date: May 2011 PHARMAC Directors ____________________________________________________________________ Listing of dabigatran for atrial fibrillation and VTE prophylaxis following orthopaedic surgery Recommendations It is recommended that having regard to the decision criteria set out…
PHARMAC Board minutes for dabigatran (1 page, 549 KB)
EXCERPT FROM THE MINUTES OF THE PHARMACEUTICAL MANAGEMENT AGENCY (PHARMAC) BOARD MEETING, 27 MAY 2011 Funding of dabigatran resolved to list Pradaxa (dabigatran) in the Oral Anticoagulants therapeutic subgroup, Blood and Blood Forming Organs therapeutic group of Section B and…
Medsafe information on dabigatran (Pradaxa) - updated (5 pages, 81 KB)
Media Releases Pradaxa (dabigatran etexilate): Questions and Answers 1. What is Pradaxa? Pradaxa is a medicine that contains the active substance dabigatran etexilate. It is available in strengths of 75mg, 110mg and 150mg per capsule. Pradaxa is only available on…
Dabigatran notification letter (3 pages, 117 KB)
10 June 2011 Dabigatran funding approved PHARMAC is pleased to announce the approval of an agreement with Boehringer Ingelheim (NZ) Limited to fund dabigatran (Pradaxa) without Special Authority restriction, from 1 July 2011. Dabigatran is an oral anticoagulant approved for…
Dabigatran bleeding management (1 page, 86 KB)
Guidelines for management of bleeding with dabigatran - for possible inclusion into local management protocols The following guidelines have been prepared by PHARMAC with the assistance of practicing specialists in response to requests for information. They are provided to assist…
Dabigatran testing and perioperative management (2 pages, 178 KB)
Guidelines for testing and perioperative management of dabigatran - for possible inclusion into local management protocols The following guidelines have been prepared by PHARMAC with the assistance of practicing specialists in response to requests for information. They are provided to…
Dabigatran - information for clinicians (2 pages, 438 KB)
DABIGATRAN Where can I find further information about dabigatran? Further information can be found: • In the Medsafe datasheet – www.medsafe.govt.nz; • In guidelines for management of Atrial Fibrillation on the NZGG website www.nzgg.org.nz and ESC website www.escardio.org. Information about…
Dabigatran - New Zealand Consumer Medicine Information (9 pages, 86 KB)
New Zealand Consumer Medicine Information PRADAXA® Capsules Dabigatran etexilate What is in this leaflet This leaflet answers some common questions about PRADAXA. It does not contain all available information. Nor does it take the place of talking to your doctor…
New Zealand Datasheet (23 pages, 255 KB)
New Zealand Datasheet Name of Medicine PRADAXA® Dabigatran etexilate Presentation 75 mg hard capsules: Imprinted hypromellose capsules with light blue, opaque cap and creamcoloured, opaque body of size 2 filled with yellowish pellets. The cap is imprinted in black ink…
