Decision to widen access to ciprofloxacin eye drops

Medicines

Decision

From 1 October 2017, eligible people will be able to receive funded access to ciprofloxacin 0.3% eye drops for use in ears for the second line treatment of chronic suppurative otitis media (middle ear infection with perforated membrane).

What we’re doing

We’re pleased to inform you about our decision to widen funded access to ciprofloxacin 0.3% eye drops in Section B (Community) of the Pharmaceutical Schedule.

Any changes to the original proposal?

This was the subject of an amended consultation letter dated 14 August 2017.

We have since made minor changes to the wording of the restriction for administrative purposes, however the intent remains unchanged.

Detail of this decision

The funding criteria in Section B of the Pharmaceutical Schedule (Community Schedule) will be changed from 1 October 2017 as follows:

Subsidy by endorsement

When prescribed for the treatment of bacterial keratitis or severe bacterial conjunctivitis resistant to chloramphenicol; or for the second line treatment of chronic suppurative otitis media (CSOM)*; and the prescription is endorsed accordingly.

Notes: Indication marked with a * is an Unapproved Indication.

This decision will not change the listing in Section H of the Pharmaceutical Schedule for ciprofloxacin 0.3% eye drops.

We note that ciprofloxacin 0.3% eye drops are not registered by Medsafe for the second line treatment of CSOM; therefore, in this setting it would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981.

Who we think will be most interested

This decision will be of interest to:

  • Patients
  • Prescribers, specifically General Practitioners, Ear, Nose, and Throat Specialists and Paediatricians
  • Community Pharmacists

What will the effect of this decision be?

For patients

From 1 October 2017, eligible patients will be able to access funded ciprofloxacin 0.3% eye drops, for use in ears for the 2nd line treatment of chronic suppurative otitis media (CSOM), via a doctor’s prescription with the appropriate endorsements.

Eligible patients will be able to access this medicine by paying the normal applicable pharmaceutical co-payment (usually $5 per new prescription item, or no charge for children under 13 years of age for a subsidised medicine).

This decision to widen funded access to ciprofloxacin 0.3% eye drops is likely to benefit and improve access to this important antibiotic for a large number of New Zealanders, especially children.

For prescribers

From 1 October 2017, your patients will be eligible to receive funded access to ciprofloxacin 0.3% eye drops for the second line treatment of CSOM, when you endorse the prescription accordingly.

Our response to what you told us

We’re really grateful for the time people took to respond to the 14 August 2017 consultation. All consultation responses received by 28 August 2017 were considered in their entirety when making a decision, as well as 2 responses received after the closing date. The table below summarises the main themes raised in feedback, any changes we have made after listening to you, and other comments on the feedback.

If you have any questions, you can email us at enquiry@pharmac.govt.nz or call our toll-free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.

Theme

PHARMAC Comment

Supportive of proposal, noting current costs of accessing treatment. Considered that proposal may help to reduce disparities, improve access to treatment, and reduce hospitalisations.

Noted.

The Medicines Adverse Reactions Committee (MARC) noted in June 2017 that ciprofloxacin is less ototoxic than other antibiotic containing ear drops.

Noted.

Requested community funding of a combined ciprofloxacin with hydrocortisone (HC) ear drop, noting it was the standard of care for patients post-grommet surgery.

Ciprofloxacin with HC is currently listed in Section H for use in DHB hospitals, who can give it to a patient for use in the community provided that the quantity does not exceed that sufficient for up to 30 days' treatment (Rule 8, Section H of the Pharmaceutical Schedule). This medicine has been placed in the 2017/18 Invitation to Tender with the hope of achieving a listing in Section B to enable funded community use.

Requested funding of 10 mL bottles of the eye drop instead of 5 mL bottles.

There are no ciprofloxacin eye drops in 10 mL bottles registered in New Zealand.

Requested funding of ciprofloxacin 0.3% eye drops for the treatment of otitis externa.

PHARMAC is open to considering a funding application for this indication.

Noted that use of quinolones second line would reduce risk of antibacterial resistance.

Noted.

Considered that widening access to ciprofloxacin eye drops could lead to inappropriate use with consequences of increased antimicrobial resistance.

PHARMAC aims to support the health sector to combat the rise of antimicrobial resistance. We consider that endorsement criteria will require the prescriber to make active decisions during the prescribing process and that this is likely to reduce the frequency of inappropriate antibiotic prescribing and use.

A DHB Antimicrobial Stewardship Committee requested that access should be only with specialist recommendation.

PHARMAC consider that the endorsement criteria is sufficient to target treatment only to those patients with CSOM.

Questioned need of ciprofloxacin eye drops for treatment of CSOM as there are currently other funded/partially funded ear drops that are registered for this indication.

PHARMAC notes that PTAC, MARC, and the NZ Society of Otolaryngology, Head, and Neck surgery all consider most currently available ear drops to be potentially ototoxic.

Ciprofloxacin eye drops is not registered for use in ears.

Noted.

Comments on subsidy restriction mechanism:

  • Concerned that subsidy by endorsement creates extra work for prescribers and that the medicine’s use should be controlled through prescribing guidelines rather than endorsements.
  • Considered that ciprofloxacin eye drops should be listed for this indication using special authority (SA) rather than subsidy by endorsement.

PHARMAC note that SA criteria are generally used to target funding for expensive treatments to patients who would most benefit.  In the case of antibiotics, a number of SA criteria and endorsements aim to support the health sector to avoid anti-microbial resistance.  PHARMAC considers that the process, administrative burden, and time delays of applying for a special authority approval for a medicine used to treat acute infections is neither palatable nor appropriate, while an endorsement is considered sufficient to address AMR concerns.