This is the text extract for Proposal to amend the restrictions applying to azithromycin and list Apotex's brand of azithromycin 250 mg tablets; Closing Date: Closed; Contact: Greg Williams, browse documents here.

30 August 2012

Proposal to amend the restrictions applying to azithromycin and list Apotex’s brand of azithromycin 250 mg tablets

PHARMAC is seeking feedback on a proposal to fund azithromycin 250 mg tablets (ApoAzithromycin) through a provisional agreement with Apotex NZ Limited. PHARMAC is also seeking feedback on a revised proposal to amend the restrictions applying to the prescribing of azithromycin tablets in the community. The restriction on azithromycin was the subject of a consultation earlier this year. We have amended this proposal following feedback received in that consultation. This proposal would result in azithromycin 250 mg tablets (Apo-Azithromycin) being funded with a restriction in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 December 2012 as follows (prices ex-man, ex-GST):

Chemical Azithromycin Presentation Tablet 250 mg Brand Apo-Azithromycin Pack size 30 Price and subsidy $10.00

Further information on the proposal can be found below. Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Friday, 14 September 2012 to: Greg Williams Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 Email: Greg.Williams@pharmac.govt.nz Fax: 04 460 4995

All feedback received before the closing date will be considered by PHARMAC’s Board (or Chief Executive acting under delegated authority) prior to making a decision on this proposal. Details of the proposal In July 2012 PHARMAC consulted upon removing the restrictions relating to the prescribing of azithromycin tablets http://pharmac.govt.nz/2012/07/04. Responses to consultation noted concerns that azithromycin would be used for its antiinflammatory properties or as a prophylactic in chronic obstructive pulmonary disease with the impact that such use could have on resistance. PHARMAC now proposes to include a treatment length restriction on the prescribing of azithromycin tablets. Responders also

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noted concerns regarding inappropriate prescribing of azithromycin if the restrictions were removed. If the proposal is accepted PHARMAC intends to provide prescriber education relating to appropriate prescribing of azithromycin through the use of the Best Practice Journal as appropriate, to ensure prescribers are aware of New Zealand specific prescribing advice for azithromycin prior to any changes occurring. The following amended restriction would apply to the prescribing of azithromycin 250 and 500 mg tablets from 1 December 2012 (additions in bold, deletions in strikethrough):

a) Maximum one pack (two 500mg tablets) per prescription.

Maximum of 5 days treatment per prescription; can be waived by endorsement for the following patients: Patient has either: i. ii. Received a lung transplant and requires treatment or prophylaxis for bronchiolitis obliterans syndrome*; or Cystic fibrosis and has chronic infection with Pseudomonas aeruginosa or Pseudomonas related gram negative organisms*.

b) Maximum of 8 available on PSO Indications marked with * are Unapproved Indications c) subsidised only if prescribed for patients with uncomplicated urethritis or cervicitis proven or presumed to be due to Chlamydia trachomatis and their sexual contacts and prescription or PSO is endorsed accordingly. Special Authority for waiver of rule Initial application - (cystic fibrosis) only from a respiratory specialist or paediatrician. Approvals valid without further renewal unless notified for applications meeting the following criteria: All of the following: 1 The applicant is part of multidisciplinary team experienced in the management of cystic fibrosis; and 2 The patient has been definitively diagnosed with cystic fibrosis*; and 3 The patient has chronic infection with Pseudomonas aeruginosa or Pseudomonas related gram negative organisms as defined by two positive respiratory tract cultures at least three months apart*; and 4 The patient has negative cultures for non-tuberculous mycobacteria. Note: Caution is advised if using azithromycin as an antibiotic in the treatment of cystic fibrosis patients with pneumonia. Testing for non-tuberculosis mycobacteria should occur annually. Initial application - (bronchiolitis obliterans syndrome) only from a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria: All of the following: 1. Patient has received a lung transplant; and 2. Azithromycin is to be used for prophylaxis of bronchiolitis obliterans syndrome*; and 3. The applicant is experienced in managing patients who have received a lung transplant. Renewal - (bronchiolitis obliterans syndrome*) only from a relevant specialist. Application valid without further renewal, unless notified, for applications meeting the following criteria: Both 1. The patient remains well and free from bronchiolits obliterans syndrome*; and 2. The applicant is experienced in managing patients who have received a lung transplant. Indications marked with * are Unapproved Indications.

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