Proposal to list various radiological contrast media

Medicines

Consultation Closed

PHARMAC is seeking feedback on proposals relating to provisional agreements with a number of suppliers for the supply of contrast media.

Summary of the proposals

Provisional agreements for listing contrast media have been reached with the following suppliers:

  • Bayer New Zealand Limited
    • gadotexate disodium (Primovist)
    • meglumine iotrexate (Biliscopin)
    • gadobutrol (Gadovist)
    • sodium and meglumine amidotrizoate (Gastrografin)
    • meglumine gadopentate (Magnevist)
  • GE Healthcare Limited
    • gadodiamide (Omniscan)
    • iohexol (Omnipaque)
    • iodixanol (Visipaque)
  • Global Medical Solutions (NZ) Limited
    • perflutren (Definity)
  • Obex Medical Limited
    • Gadoteric acid (Dotarem)
    • iodised oil (Lipiodol Ultra Fluid)
    • patent blue V (Patent Blue V)

Omnipaque, Visipaque and Definity would be awarded Hospital Sole Supply status for the non-ionic monomer, non-ionic dimer and ultrasound contrast media markets respectively from 1 September 2014.

The following products would be delisted from 1 September 2014:

  • all presentations of iomeprol;
  • all presentations of iopromide;
  • iotrolan inj 240 mg per ml, 10 ml vial;
  • diatrizoate meglumine with diatrizoate sodium inj 146 mg with sodium amidotrizoate 40 mg per ml, 250 ml bottle; and
  • diatrizoate meglumine with diatrizoate sodium inj 370 mg with sodium amidotrizoate 100 mg per ml, 50 ml bottle.

The background to and details of the proposal can be found on the following pages.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Friday, 16 May 2014 to:

Christine Chapman
Therapeutic Group Manager
PHARMAC
PO Box 10 254
Wellington 6143

Email: christine.chapman@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 withheld.  PHARMAC will give due consideration to any such request.

Background

In September 2013 PHARMAC released a Request for Proposals (RFP) for supply of radiological contrast media for the DHB Hospitals. The RFP document can be found on PHARMAC's website.

The timetable for the RFP was amended on 18 December 2013 [PDF, 137 KB].

The proposed listings and amendments are as a result of this RFOP process. 

Please note: PHARMAC is in discussion with Regional Healthcare for supply of gadobenic acid (Multihance), diatrizoate sodium (Ioscan) and various barium presentations following the RFP.

Details of the proposals

Bayer New Zealand Limited

A provisional agreement with Bayer New Zealand Ltd would result in the following listings and amendments.

  • new listings in Part II of Section H of the Pharmaceutical Schedule from 1 July 2014 (prices are ex-manufacturer and excluding GST):
Chemical Presentation Brand Pack size Price
Gadoxetate disodium Inj 181.43 mg per mL (equivalent to 0.25 mmol per ml), 10 ml syringe Primovist 1 $300.00
Meglumine iotrexate Inj 105 mg meglumine iotrextate, 100 ml bottle Biliscopin 1 $150.00
  • amended listings in Part II of Section H from 1 July 2014 as follows (prices are ex-manufacturer and excluding GST):
Chemical Presentation Brand Pack size Current price  Proposed price
Gadobutrol Inj 604.72 mg per ml (equivalent to 1 mmol per ml), 7.5 ml syringe Gadovist 5 $253.10 $180.00
Gadobutrol Inj 604.72 mg per ml (equivalent to 1 mmol per ml), 15 ml vial Gadovist 10   $700.00
Meglumine diatrizoate with sodium amidotrizoate Oral liq 660 mg per ml with 100 mg per ml sodium amidotrizoate, 100 ml bottle Gastrografin 1 $21.00 $22.50
Meglumine gadopentate Inj 469 mg per ml (equivalent to 0.5 mmol per ml), 10 ml syringe Magnevist 5 $92.00 $95.00
Meglumine gadopentate Inj 469 mg per ml (equivalent to 0.5 mmol per ml), 10 ml vial Magnevist 10 $184.00 $185.00
  • The following products would be delisted from Part II of Section H of the Pharmaceutical Schedule from 1 July 2014 as they are no longer available from the manufacturer:
Chemical Presentation Brand Pack size Price
Meglumine diatrizoate with sodium amidotrizoate Inj 370 mg with sodium amidotrizaote 100 mg per ml, 50 ml bottle      
Meglumine diatrizoate with sodium amidotrizoate Inj 146 mg per ml sodium amidotrizaote with 40 mg per ml, 250 ml bottle Gastrografin 10 $210.00
  • All pharmaceuticals supplied by Bayer New Zealand Limited under this provisional agreement would have delisting protection up to and including 30 June 2017.

GE Healthcare Limited

A provisional agreement with GE Healthcare Limited would result in the following:

  • amendments to listings in Part II of Section H of the Pharmaceutical Schedule from 1 July 2014  (all prices are ex-manufacturer and exclusive of GST):
Chemical Presentation Brand Pack size Current price Proposed Price
Gadodiamide Inj 287 mg per ml, 5 ml vial Omniscan 10   $120.00
Gadodiamide Inj 287 mg per ml, 10 ml syringe Omniscan 10 $220.00 $200.00
Gadodiamide Inj 287 mg per ml, 10 ml vial Omniscan 10 $180.00 $170.00
Gadodiamide Inj 287 mg per ml, 15 ml syringe Omniscan 10 $330.00 $320.00
Iohexol Inj 240 mg per ml, 50 ml bottle Omnipaque 10 $77.80 $75.00
Iohexol Inj 300 mg per ml , 20 ml bottle Omnipaque 10   $57.00
Iohexol Inj 300 mg per ml , 50 ml bottle Omnipaque 10 $77.80 $75.00
Iohexol Inj 300 mg per ml , 100 ml bottle Omnipaque 10 $155.60 $150.00
Iohexol Inj 350 mg per ml , 20 ml bottle Omnipaque 10   $59.00
Iohexol Inj 350 mg per ml , 50 ml bottle Omnipaque 10 $77.80 $75.00
Iohexol Inj 350 mg per ml , 75 ml bottle Omnipaque 10 $116.70 $114.00
Iohexol Inj 350 mg per ml , 100 ml bottle Omnipaque 10 $155.60 $150.00
Iohexol Inj 350 mg per ml , 200 ml bottle Omnipaque 10 $311.16 $290.00
Iodixanol Inj 270 mg per ml , 50 ml bottle Visipaque 10 $223.50 $220.00
Iodixanol Inj 270 mg per ml , 100 ml bottle Iodixanol 10 $447.00 $430.00
Iodixanol Inj 320 mg per ml , 50 ml bottle Iodixanol 10 $223.50 $220.00
Iodixanol Inj 320 mg per ml , 100 ml bottle Iodixanol 10 $447.00 $430.00
Iodixanol Inj 320 mg per ml , 200 ml bottle Iodixanol 10 $894.00 $850.00
  • Visipaque and Omnipaque would have Hospital Sole Supply status from 1 July 2014 to 30 June 2017 in the non-ionic dimer and non-ionic monomer markets respectively. A 5% DV limit would apply to both.
  • All presentations of iomeprol and iopromide would be delisted from Part II of Section H of the Pharmaceutical Schedule from 1 July 2014 as a  result of awarding Hospital supply Status to Omnipaque and Visipaque.

Global Medical Solutions (NZ) Limited

  • A provisional agreement with Global Medical Solutions (NZ) Limited would result in the listing of perflutren (Definity) in Part II of Section H of the Pharmaceutical Schedule from 1 July 2014 as follows (prices are ex-manufacturer, excluding GST):
Chemical Presentation Brand Pack size Price
Perflutren Inj 1.1 mg per ml, 1.5 ml vial Definity 1 $180.00
Perflutren Inj 1.1 mg per ml, 1.5 ml vial Definity 4 $720.00
  • Definity would have Hospital Sole Supply status from 1 July 2014 to 30 June 2017 in the Ultrasound contrast media market.  A 5% DV limit would apply.

Obex Medical Limited

A provisional agreement with Obex Medical Limited would result in the following listings and amendments:

  • new listing of two new presentations of gadoteric acid in Part II of Section H of the Pharmaceutical Schedule (prices are ex-manufacturer excluding GST) from 1 July 2014 as follows:
Chemical Presentation Brand Pack size Price
Gadoteric acid Inj 279.32 mg per ml (0.5 mmol perml), 5 ml vial Dotarem 1 $12.50
Gadoteric acid Inj 279.32 mg per ml (0.5 mmol per ml), 15 ml vial Dotarem 1 $35.00
  • amendments in Part II of Section H of the Pharmaceutical Schedule from 1 July 2014 (prices are ex-manufacturer excluding GST):
Chemical Presentation Brand Pack size Price
Gadoteric acid Inj 279.32 mg/ml (0.5 mmol/ml), 10 ml vial Dotarem 1 $23.50
Gadoteric acid Inj 279.32 mg/ml (0.5 mmol/ml), 20 ml vial Dotarem 1 $47.00
Gadoteric acid Inj 279.32 mg/ml (0.5 mmol/ml), 10 ml syringe Dotarem 1 $25.00
Gadoteric acid Inj 279.32 mg/ml (0.5 mmol/ml), 15 ml syringe Dotarem 1 $41.00
Gadoteric acid Inj 279.32 mg/ml (0.5 mmol/ml), 20 ml syringe Dotarem 1 $55.00
Iodised Oil Inj 480 mg iodine per ml, 10 ml vial Lipiodol 1 $143.00
Patent blue V Inj 2.5%, 2 ml ampoule Patent Blue V 5 $440.00
  • All pharmaceuticals supplied by Obex Medical Limited under this provisional agreement would have delisting protection up to and including 30 June 2017.