Proposal to list and delist some antibiotic products - clarithromycin

Medicines

Consultation Closed

PHARMAC is seeking feedback on a provisional agreement with BGP Products for the supply of the antibiotic clarithromycin 250 mg per 5 ml, 50 ml, grans for oral liquid (Klacid) in the community and to DHB hospitals.

In summary this proposal would result in:

  • Clarithromycin 250 mg per 5 ml, 50 ml, grans for oral liquid (Klacid) being fully funded, subject to restrictions, from 1 April 2016.
  • Clarithromycin 125 mg per 5 ml, 70 ml grans for oral liquid (Klacid) being delisted from Section B and Part II of Section H of the Pharmaceutical Schedule at some point in the future (date yet to be determined).

Funded access to clarithromycin 250 mg per 5 ml, 50 ml, grans for oral liquid would be subject to the same rules and restrictions that currently apply to clarithromycin 125 mg per 5 ml, 70 ml grans for oral liquid (see next page).

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 5:00 pm Friday, 26 February 2016 to:

Matthew Wolfenden
Procurement Manager
PHARMAC
PO Box 10 254
Wellington 6143

Email: procurement@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 it withheld.  PHARMAC will give due consideration to any such request. 

Details of the proposal

  • Clarithromycin 250 mg per 5 ml, 50 ml grans for oral liquid would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 April 2016 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Proposed price and subsidy

Clarithromycin

Grans for oral liquid250 mg per 5 ml

Klacid

50 ml

$23.12

  • Clarithromycin 250 mg per 5 ml, 50 ml grans for oral liquid would be listed in Section B of the Pharmaceutical Schedule subject to the following dispensing rule and Special Authority for Waiver of Rule:

Maximum of 500 mg per prescription; can be waived by Special Authority:

Special Authority for Waiver of Rule

Initial Application – (Mycobacterial infections) only from a respiratory specialist, infectious disease specialist or paediatrician. Approvals valid for 2 years for applications meeting the following criteria:

Either:

  1. Atypical mycobacterial infection; or
  2. Mycobacterium tuberculosis infection where there is drug-resistance or intolerance to standard pharmaceutical agents.

Renewal – (Mycobacterial infections) only from a respiratory specialist, infectious disease specialist or paediatrician. Approvals valid for 2 years where the treatment remains appropriate and the patient is benefiting from treatment.

  • Clarithromycin 250 mg per 5 ml, 50 ml is an antibiotic oral liquid and therefore the wastage rule would apply.
  • Clarithromycin 250 mg per 5 ml, 50 ml grans for oral liquid would be listed in Part II of Section H of the Pharmaceutical Schedule subject to the following restriction:
Restricted
  1. Atypical mycobacterial infection; or
  2. Mycobacterium tuberculosis infection where there is drug resistance or intolerance to standard pharmaceutical agents.
  • Clarithromycin 125 mg per 5 ml, 70 ml grans for oral liquid (Klacid), would be delisted from Section B, and clarithromycin 250 mg per ml, 70 ml grans for oral liquid (Klacid) would be delisted from Part II of Section H of the Pharmaceutical Schedule at some point in the future (date yet to be determined). We would notify the market prior to this occurring.

Background

Clarithromycin is a macrolide antibiotic commonly used to treat a variety of bacterial infections.

The current proposal to list a new strength presentation of clarithromycin, and delist the existing strength, has arisen from supplier changes related to harmonisation with Australian presentations.

PHARMAC staff sought clinical advice on this alternative presentation. The advice we received indicated that no clinical issues were expected to arise as a result of a change from a 125 mg per 5 ml formulation to a 250 mg per 5 ml formulation.

We note that this change of strength would result in a change in the volume of liquid dispensed per dose. Prescribers should continue to calculate the correct dosage based on the recommended dose in mg/kg. Further information on recommended dosages of clarithromycin can be found at http://www.nzfchildren.org.nz/nzf_3152(external link).