Iron infusions in the community

Hospital devices

Consultation Closed

What we’re proposing

PHARMAC is seeking feedback on a proposal to list ferric carboxymaltose (Ferinject) 50 mg per ml, 10 ml vial in Section B of the Pharmaceutical Schedule from 1 August 2017; funding would be subject to Special Authority criteria.

Consultation closes at 5 pm on Wednesday, 21 June 2017 and can be emailed to matthew.tyson@pharmac.govt.nz.

What would the effect of the proposal be?

Ferric carboxymaltose comes in a vial which is administered via an intravenous (IV) infusion.  It would be fully funded when dispensed from a community pharmacy for patients with a prescription and a valid Special Authority, and could be administered by community-based infusion services, such as general practice.

Patients would need to check with their prescriber about the availability of community-based infusion services and any related service charges.

Eligible prescribers would be able to prescribe ferric carboxymaltose and apply for Special Authority approval for their patients who meet the criteria.

General practices or other primary health providers wishing to offer iron infusion services would need to liaise with their DHB regarding service arrangements.

Who we think will be interested in this proposal

This proposal will be of interest to:

  • community and hospital clinicians, particularly haematologists, surgeons, and general practitioners.
  • hospital and community pharmacists, DHBs, suppliers and wholesalers.
  • patients who currently travel to hospital to have an iron infusion in an outpatient setting.

About ferric carboxymaltose (Ferrinject)

Ferric carboxymaltose(external link) is an IV iron preparation and up to 1000 mg can be administered as a single infusion given over 15 minutes. It provides well tolerated and quick reversal of iron deficiency anaemia for people in whom oral iron preparations are ineffective or cannot be used, and it can be administered in a non-hospital setting.

Ferinject 10 ml vial contains ferric carboxymaltose 180 mg per ml (1800 mg per 10 ml) which is equal to elemental iron 50 mg per ml (500 mg per 10 ml).

Delivery of an infusion of ferric carboxymaltose would require the provider to be appropriately trained, as well as to have a minimum standard of safety equipment including resuscitation equipment.

Why we’re proposing this

In July 2014 PHARMAC notified of its decision to list ferric carboxymaltose in Section H of the Pharmaceutical Schedule for use in DHB hospitals. This proposal was the subject of a consultation letter dated 16 May 2014. Following consultation, PHARMAC sought advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) and Haematology Subcommittee of PTAC regarding Special Authority criteria for community funding of ferric carboxymaltose.  More information, including links to PTAC and Subcommittee minutes, can be found in the Application Tracker record for ferric carboxymaltose.

Community infusion services

When making the hospital listing decision PHARMAC identified that provision of infusion services in a community setting were not nationally consistent and, since then, we have been discussing the impacts of listing ferric carboxymaltose in the community setting with stakeholders.

In October 2015 PHARMAC released a discussion document “Improving access to medicines and devices in primary care”. Feedback on this suggested that there were opportunities to improve patient outcomes by improving funded access to medicines and devices.

There was support from many respondents for development of a model that could help streamline supply and funding processes around medicines that require administration and oversight by a qualified health professional, such as a doctor or nurse.  Issues highlighted in feedback included:

  • administration charges & variation by practice/region creating access inequity
  • inconvenience for the patient having to collect medicines for administration in general practice, particularly around acute conditions
  • delays when pharmacy do not have stock on hand
  • having to make alternative supply arrangements for some medicines not available through community pharmacy

Some respondents noted that improving the availability of medicines could lead to an increase in the number and types of providers, therefore opening opportunities to better provide services in communities.

During 2016 and early 2017 PHARMAC has continued discussions with DHB and primary care providers about opportunities to develop a model for funding processes around medicines in primary care, including those that would involve infusion services.  Since 2016 a number of DHBs have expanded their community based infusion services.  Several DHBs have indicated they are keen for a community listing of ferric carboxymaltose to be progressed by PHARMAC to enable its use in these services.

To enable DHBs to make ferric carboxymaltose available in the community, we’re now proposing listing this medicine in Section B of the Pharmaceutical Schedule. With no reimbursement and claiming model in place for general practice, and PHARMAC now being in a budget position to advance a proposal to fund ferric carboxymaltose in the community, the only model available for progressing this is a listing in Section B with reimbursement claims submitted by pharmacies with community contracts.

We are keen to receive feedback on the on the proposed Special Authority criteria and the impact such a listing might have on community based infusion service availability across DHBs. 

Details about our proposal

Ferric carboxymaltose (Ferinject) would be listed in Section B of the Pharmaceutical Schedule from 1 August 2017 at the following price and subsidy (ex-manufacturer, excluding GST): 

Chemical

Presentation

Brand

Pack size

Price and subsidy

Ferric carboxymaltose

Inj 180 mg per ml (50 mg per ml elemental iron), 10 ml vial

Ferinject

1

$150.00

A confidential rebate would apply to Ferinject, reducing its net price to the Funder.

Ferric carboxymaltose (Ferinject) would be listed in Section B subject to the following Special Authority criteria:

Special Authority for Subsidy

Initial application – (serum ferritin 20 mcg/L) from any medical practitioner. Approval valid for 3 months for applications meeting the following criteria:

Both:

Renewal – (serum ferritin ≤ 20 mcg/L) from any medical practitioner. Approval valid for 3 months for applications meeting the following criteria:

Both:

  1. Patient continues to have iron-deficiency anaemia with a serum ferritin level of ≤ 20 mcg/L; and
  2. A re-trial with oral iron is clinically inappropriate.

Initial application – (serum ferritin >20 mcg/L) only from an internal medicine specialist, obstetrician, gynaecologist or anaesthetist or a medical practitioner on the recommendation of an internal medicine specialist, obstetrician, gynaecologist or anaesthetist. Approval valid for 3 months for applications meeting the following criteria:

Both:

Renewal – (serum ferritin >20 mcg/L) only from an internal medicine specialist, obstetrician, gynaecologist or anaesthetist or a medical practitioner on the recommendation of an internal medicine specialist, obstetrician, gynaecologist or anaesthetist. Approval valid for 3 months for applications meeting the following criteria:

Both:

  1. Patient continues to have iron-deficiency anaemia with a serum ferritin level of > 20 mcg/L; and
  2. A re-trial with oral iron is clinically inappropriate.

The listing of ferric carboxymaltose for use in the DHB hospital setting (Section H) would remain the same, as follows:

Restricted

Initiation

Treatment with oral iron has proven ineffective or is clinically inappropriate.

For the avoidance of doubt there would be no change to the listing of iron polymaltose or iron sucrose. Iron polymaltose would remain listed in both Section B and Section H of the Pharmaceutical Schedule and iron sucrose would remain listed in Section H. Therefore clinicians could continue to choose which iron preparation to prescribe, depending on the clinical situation. 

To provide your feedback to this proposal

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Wednesday, 21 June 2017 to:

Matthew Tyson
Therapeutic Group Manager
PHARMAC

Email: matthew.tyson@pharmac.govt.nz
Fax:     04 460 4995
Post:    PO Box 10 254, Wellington 6143

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, where 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.