Proposal to widen access to ciprofloxacin eye drops - AMENDED 14 AUGUST 2017

Medicines

Consultation Closed

We have received early feedback questioning the proposed funding criteria for the consultation released on Friday 11 August 2017.

Amendment to consultation

The concerns from respondents were around its proposed use in otitis externa, and suggesting that use in chronic suppurative otitis media (CSOM), a more severe form of otitis media with a perforated tympanic membrane and entrenched infection, would be more appropriate.

Following consideration of this feedback, we can confirm that we made an error in the proposed restriction for ciprofloxacin eye drops. In addition, the estimates for patient numbers have also subsequently been updated. 

 In summary, the proposal is to:

  • Widen funded access to ciprofloxacin eye drops for the second-line treatment of chronic suppurative otitis media (CSOM).

For the avoidance of doubt, please note that the proposal is not to widen access of ciprofloxacin 0.3% eye drops to treat otitis externa. The use of ciprofloxacin 0.3% eye drops in this indication would remain unfunded.

Below is the corrected proposal, which we seek your feedback on.

What we’re proposing

As part of PHARMAC’s 2016/2017 annual Invitation to Tender we are proposing to widen access to funded ciprofloxacin 0.3% eye drops for the second line treatment of chronic suppurative otitis media (CSOM), a severe form of middle ear infection with perforated membrane and entrenched infection, and we are seeking your feedback on this proposal.

A decision has not been made on the presentations in the tender so the brand names, pricing and timing for these changes, if they were to be implemented, is still to be determined.

What would the effect be?

Currently, ciprofloxacin 0.3% eye drops are not funded for use in ears and we understand that patients pay around $35 to the pharmacy per dispensing for private purchase of this medicine.

The proposed change would mean that ciprofloxacin 0.3% eye drops would be funded for use in the ear, when prescribed for the second line treatment of CSOM  bacterial ear infections, and patients would pay 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).

We estimate that this proposed change would benefit approximately 960 350 patients in the first year. 

Who we think will be interested 

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

About ciprofloxacin 0.3% eye drops

Ciprofloxacin is a broad spectrum antibacterial agent with in vitro activity against a wide range of gram-negative and gram-positive organisms, possessing the greatest antibacterial activity of all quinolones.

The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.

Ciprofloxacin 0.3% eye drops are currently fully funded in the community (Section B of the Pharmaceutical Schedule) for the treatment of bacterial keratitis or severe bacterial conjunctivitis resistant to chloramphenicol, and they are listed without restriction for use in DHB Hospitals (Part II of Section H of the Pharmaceutical Schedule).

About chronic suppurative otitis media (middle ear infections with perforated membrane)

Otitis media is the inflammation of the middle ear and the tympanic membrane, which often occurs as a result of an acute upper respiratory tract infection.

Otitis media is very common in children and there is a high rate of spontaneous recovery. It has been suggested that it is an unavoidable illness of childhood and part of the natural maturation of a child's immune system. Children living in communities where overcrowding is common are at increased risk of developing otitis media.

Studies have shown that Māori and Pacific children are more likely to be affected by otitis media and have higher rates of medical admissions than European children in New Zealand. [PDF, 644 KB]

Untreated or undertreated otitis media can result in chronic supurative otitis media, which can result in hearing loss and tympanosclerosis.

Why we’re proposing this

A funding application from the New Zealand Society of Otolaryngology Head and Neck Surgery for the funding of ciprofloxacin 0.3% eye drops for the treatment of CSOM otitis media has been reviewed by Pharmaceutical and Therapeutics and Advisory Committee (PTAC) and the Anti-infective Subcommittee.

In summary PTAC recommended ciprofloxacin 0.3% eye drops be funded for the second line treatment of CSOM otitis media with a high priority.  Following further analysis and consideration of the advice we received, PHARMAC included ciprofloxacin 0.3% eye drops in the 2016/17 annual Invitation to Tender issued in November 2016.  Once we have considered feedback on this proposal to widen access we would identify a preferred bid in the Tender and negotiate with the relevant supplier to list their product in Section B of the Pharmaceutical Schedule with widened access.

The proposed criteria (set out below) are in line with the advice we have received.

More information, including links to PTAC and the Anti-infective Subcommittee minutes, can be found in the Application Tracker.(external link)

This includes PTAC’s minutes of November 2013 including the use of ciprofloxacin eye drops for the treatment of CSOM.

Details about our proposal

PHARMAC is seeking feedback on a proposal to make the changes outlined below in conjunction with the awarding of ciprofloxacin 0.3% eye drops tender bids as part of PHARMAC’s 2016/17 annual Invitation to Tender. The proposed changes would widen funded access to ciprofloxacin 0.3% eye drops for the 2nd line treatment of CSOM (middle ear infections with perforated membrane) otitis media (middle ear infections) in Section B of the Pharmaceutical Schedule.

As any amendment to the current Section B listing would be implemented through the tender process, the brands to be listed, the pricing and subsidy, and the dates for listing changes are still to be confirmed. 

The proposed changes to the funding criteria are as follows (additions in bold, deletions in strikethrough):

For the treatment of bacterial keratitis or severe bacterial conjunctivitis resistant to chloramphenicol.

Subsidy by endorsement

Notes: Indication marked with a * is an Unapproved Indication

The proposal would not change the Hospital Medicines List (HML) listing for ciprofloxacin 0.3% eye drops.

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

To provide your feedback to this proposal

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Monday 28 August 2017 to:

Tony Wang
Therapeutic Group Manager
PHARMAC
PO Box 10254
Wellington 6143 

Email: tony.wang@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.