Azithromycin longer treatment now requires Special Authority from 1 July 2017

Medicines

Decision

PHARMAC would like to remind you that the endorsement for long treatment periods of azithromycin for people with cystic fibrosis or having received a lung transplant has been replaced by Special Authority Criteria as of 1 July 2017.

For prescribers

Prescriptions written for azithromycin for greater than 5 days treatment via endorsement need a Special Authority number for patients to be able to collect funded repeat prescriptions.

This will require prescribers to complete a Special Authority application for azithromycin – this can be done via the Electronic Special Authority system or manually using the form which can be found on our website.

For pharmacy

Patients who have received a prescription for azithromycin for greater than 5 days treatment via endorsement will need a valid Special Authority number in order to be dispensed funded azithromycin.

There may be some patients who present at pharmacy with an endorsement prescription or who have repeats; so you may need to communicate the Special Authority requirements to relevant prescribers.

We do appreciate your help sharing this message with your colleagues and we apologise for any inconvenience this may cause.

If you have any questions about this, please contact PHARMAC on 0800 66 00 50.

Background

On 12 June 2017 PHARMAC notified of its decision to change funding access criteria for azithromycin tablets from 1 July 2017. This was the subject of a consultation letter issued on 8 May 2017 (updated on 12 May 2017).

In summary, the effect of the decision is that:

  • Azithromycin (Apo-Azithromycin, Zithromax) funding criteria was widened to include longer treatment periods for non-cystic fibrosis bronchiectasis in children and people with atypical mycobacterial infections.
  • The previous endorsement for long treatment periods with azithromycin for specified patient groups has been replaced by a Special Authority.

Details of the decision to change access to azithromycin

Azithromycin – for treatment of non-cystic fibrosis bronchiectasis in children

  • Funding criteria for azithromycin 250 mg and 500 mg tablets (Apo-Azithromycin) and granules for oral liquid 200 mg per 5 ml (40 mg per ml) (Zithromax) was widened in Section B (Community) and in Part II of Section H (Hospital) of the Pharmaceutical Schedule from 1 July 2017 to allow funding of more than 5 days’ treatment in children with non-CF bronchiectasis and people with atypical mycobacterial infections.
  • To effect this change, the current restrictions for azithromycin in Section B of the Pharmaceutical Schedule have been replaced by the following:

AZITHROMYCIN – Maximum of 5 days treatment per prescription; can be waived by endorsement Special Authority

For Endorsement, patient has either:

1) Received a lung transplant and requires treatment or prophylaxis for bronchiolitis obliterans syndrome*; or

2) Cystic fibrosis and has chronic infection with Pseudomonas aeruginosa or Pseudomonas related gram negative organisms*.

Indications marked with * are Unapproved Indications

Special Authority for Waiver of Rule

Initial application – (bronchiolitis obliterans syndrome, cystic fibrosis and atypical Mycobacterialinfections) from any relevant specialist. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Any of the following:

  1. Patient has received a lung transplant and requires treatment or prophylaxis for bronchiolitis obliterans syndrome*; or
  2. Patient has cystic fibrosis and has chronic infection with Pseudomonas aeruginosa or Pseudomonas-related gram negative organisms*; or
  3. Patient has an atypical mycobacterial infection.

Indications marked with * are Unapproved Indications

Initial application – (non-cystic fibrosis bronchiectasis*) only from a respiratory specialist or paediatrician. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. For prophylaxis of exacerbations of non-cystic fibrosis bronchiectasis*; and
  2. Patient is aged 18 and under; and
  3. Either:

3.1 Patient has had 3 or more exacerbations of their bronchiectasis, within a 12 month period; or
3.2 Patient has had 3 acute admissions to hospital for treatment of infective respiratory exacerbations within a 12 month period.

Indications marked with * are Unapproved Indications

Renewal – (non-cystic fibrosis bronchiectasis*) only from a respiratory specialist or paediatrician. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. The patient has completed 12 months of azithromycin treatment for non-cystic fibrosis bronchiectasis; and
  2. Following initial 12 months of treatment, the patient has not received any further azithromycin treatment for non-cystic fibrosis bronchiectasis for a further 12 months, unless considered clinically inappropriate to stop treatment; and
  3. The patient will not receive more than a total of 24 months’ azithromycin cumulative treatment (see note).

The patient must have had no more than 1 prior approval.

Note: no further renewals will be subsidised. A maximum of 24 months of azithromycin treatment for non-cystic fibrosis bronchiectasis will be subsidised.

Indications marked with * are Unapproved Indications

  • A similar restriction applies in Part II of Section H of the Pharmaceutical Schedule from 1 July 2017.

For the avoidance of doubt, there is no change to the maximum of 5 days funded treatment per prescription for any indication.

If you have any questions about this, please contact us on 0800 66 00 50 or you can email us at enquiry@pharmac.govt.nz