Proposal to delist heparin sodium injection 1,000 iu per ml, 35 ml vial

Medicines

Consultation Closed

What we’re proposing

Following assessment of bids in PHARMAC’s 2017/18 annual Invitation to Tender, PHARMAC is proposing to delist one presentation of heparin sodium injection (1,000 iu per ml, 35 ml vial) from both the community and hospital settings from 1 December 2018.

Other presentations of heparin (1,000 iu per ml, 5 ml ampoule and 5,000 iu per ml, 5 ml ampoule) would remain listed.

PHARMAC is seeking your feedback on the proposed delisting of the 35 ml vial, including any information you can provide on the impacts of changing usage to an alternative presentation, such as the 1,000 iu per ml, 5 ml ampoule.

Consultation closes at 5 pm on Wednesday, 25 July 2018 and feedback can be emailed to Andrew Park, Senior Therapeutic Group Manager at andrew.park@pharmac.govt.nz.

Why we’re proposing this

Tender bids for heparin sodium (1,000 iu per ml, 5 ml ampoule) and a higher strength (5,000 iu per ml, 5 ml ampoule) were recently awarded Sole Subsidised Supply Status and Hospital Supply Status as part of 2017/18 annual Invitation to Tender.

If this proposal is approved, we expect that there would be significant savings to the pharmaceutical budget as a result of a usage shift to less expensive presentations of the same pharmaceutical.

What would the effect be?

For DHB hospitals

Heparin sodium in the 1,000 iu per ml, 35 ml vial presentation would no longer be able to be purchased from 1 December 2018. DHB hospitals would need to change usage to an alternative presentation of heparin sodium, such as the same strength (but smaller volume) 1,000 iu per ml, 5 ml ampoule.

For community based patients and pharmacies

Heparin sodium in the 1,000 iu per ml, 35 ml vial presentation would no longer be funded on prescription from 1 December 2018. Patients would need to change to an alternative presentation of heparin sodium, such as the same strength (but smaller volume) 1,000 iu per ml, 5 ml ampoule to remain on a funded product.

Who we think will be interested

  • Hospital and community pharmacists
  • DHB cardiothoracic surgical services
  • DHB renal services
  • Patients on home haemodialysis

About heparin sodium and use of the 35 ml injection presentation

Heparin is an anti-coagulant, indicated for the prophylaxis and treatment of thromboembolic disorders. We understand that the large volume (35 ml) presentation of heparin sodium has been used in the hospital setting as an anticoagulant in dialysis circuits for patients receiving haemodialysis and for anticoagulation during cardiopulmonary bypass. It is also used by patients receiving haemodialysis at home.

The presentations heparin sodium injection currently listed are:

  • Inj 100 iu per ml, 250 ml bag (hospital only)
  • Inj 1,000 iu per ml, 1 ml ampoule (hospital only)
  • Inj 1,000 iu per ml, 35 ml vial
  • Inj 1,000 iu per ml, 5 ml ampoule
  • Inj 5,000 iu in 0.2 ml ampoule (hospital only)
  • Inj 5,000 iu per ml, 1 ml ampoule
  • Inj 5,000 iu per ml, 5 ml ampoule
  • Inj 25,000 iu per ml, 0.2 ml (community only)

Although not universally recommended for use as a multi-dose vial, the 35 ml does contain benzyl alcohol as a preservative, and we have received advice that it is commonly used across 2-3 dialysis sessions over a week or so. The rationale for the historic use of the 35 ml as a multi-dose vial over the 5 ml ampoules is not clear. 

A manufacturing delay in late 2017 resulted in an interruption to supply of the 35 ml vial. Alternatives have been available and in use.

Clinical advice from the Nephrology Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) is that most haemodialysis centres have been using the 1,000 iu per ml, 5 ml ampoule without issue during the shortage of the 35 ml vial. The Subcommittee considered that there was no ongoing clinical need for the 1,000 iu per ml, 35 ml vials if the 1,000 iu per ml, 5 ml ampoules of heparin sodium remained available. This proposal would move usage of the 35 ml heparin vials to the alternatives on a permanent basis. 

The Subcommittee also noted concerns from an infection control perspective associated with the practice of vial sharing the 35 ml vials.

Details about our proposal

Following assessment of bids in PHARMAC’s 2017/18 annual Invitation to Tender, PHARMAC is proposing to delist one presentation of heparin sodium (1,000 iu per ml, 35 ml vial).

Tender bids for significantly less expensive presentations of heparin sodium were recently awarded

Summarised details of that notification are:  

Chemical and presentation

Brand

Pack Size

Current price

New price

Heparin sodium inj 1,000 iu per ml, 5 ml ampoule

Pfizer

50

$99.50

$58.57
(from 1 September 2018)

Heparin sodium inj 5,000 iu per ml, 5 ml ampoule

Pfizer

50

$341.89

$203.68
(from 1 September 2018)

A decision has not yet been made on tender line item “Inj 1,000 iu per ml, 20 - 35 ml vial”, so the details of any bid(s) received remain confidential.

From 1 December 2018, the Hospira brand of heparin sodium inj 1,000 iu per ml, 35 ml vial would be delisted from Section B (community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows (prices ex-man., ex. GST):

Chemical and presentation

Brand

Pack Size

Current price

 

Heparin sodium inj 1,000 iu per ml, 35 ml vial

Hospira

1

$24.15

Delist from 1 December 2018

To provide feedback

Send us an email: andrew.park@pharmac.govt.nz by 5pm on Wednesday 25 July 2018.

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.