Proposal to list various radiological contrast media
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.