Decision to fund dexamethasone implants (Ozurdex)

Medicines

Decision

What we’re doing

PHARMAC is pleased to announce the approval of an agreement with Allergan Australia Limited (Allergan) for the listing of dexamethasone ocular implants in Section B (Community) and in Part II of Section H (Hospital) of the Pharmaceutical Schedule.

This was the subject of a consultation letter dated 15 September 2017.

The funding of dexamethasone ocular implants means that from 1 November 2017, a new long-acting pharmaceutical, with a different mechanism of action to currently-available treatments, will be available and funded for eligible people with diabetic macular oedema (DMO).

Any changes to the original proposal?

The proposal was broadly approved as was consulted on, except for small changes to the funding criteria in that:

  • criterion 3.3 of the initiation criteria (which referred to the residential location of the patient) was removed, as it was considered that criterion 3.2 (which refers to anti-VEGF inhibitor treatment being unsuitable) was sufficient to keep the overall intent unchanged.

Details of this decision

Dexamethasone ocular implant

Dexamethasone ocular implant (Ozurdex) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 November at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Price and subsidy

Dexamethasone

Ocular implant 700 mcg

Ozurdex

1

$1,444.50

A confidential rebate would apply to Ozdurex which would reduce the net price to the Funder.

Dexamethasone ocular implant will be listed in Section B of the Pharmaceutical Schedule, subject to the following Special Authority Criteria:

Special Authority for Subsidy

Initial application – (Diabetic macular oedema) only from an ophthalmologist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. Patients have diabetic macular oedema with pseudophakic lens; and
  2. Patient has reduced visual acuity of between 6/9 – 6/48 with functional awareness of reduction in vision; and
  3. Either:

3.1   Patient’s disease has progressed despite 3 injections with bevacizumab; or
3.2   Patient is unsuitable or contraindicated to treatment with anti-VEGF inhibitors; and

  1. Dexamethasone implants are to be administered not more frequently than once every 4 months, and up to a maximum of 3 implants per year.

Renewal – (Diabetic macular oedema) only from an ophthalmologist.  Approvals valid for 12 months for applications meeting the following criteria:

Both:

  1. Patient’s vision is stable or has improved (prescriber determined)
  2. Dexamethasone implants are to be administered not more frequently than once every 4 months, and up to a maximum of 3 implants per year.

Initial application – (Women of child bearing age with diabetic macular oedema) only from an ophthalmologist.  Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. Patients have diabetic macular oedema; and
  2. Patient has reduced visual acuity of between 6/9 – 6/48 with functional awareness of reduction in vision; and
  3. Patient is of child bearing potential and has not yet completed a family
  4. Dexamethasone implants are to be administered not more frequently than once every 4 months, and up to a maximum of 3 implants per year.

Renewal – (Women of child bearing age with diabetic macular oedema) Only from an ophthalmologist.  Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. Patient’s vision is stable or has improved (prescriber determined)
  2. Patient is of child bearing potential and has not yet completed a family
  3. Dexamethasone implants are to be administered not more frequently than once every 4 months, and up to a maximum of 3 implants per year.

Dexamethasone ocular implant be listed in Part II of Section H of the Pharmaceutical Schedule, subject to the following restrictions:

Restricted

Initiation – Diabetic macular oedema

Ophthalmologist

Limited to 12 months treatment

All of the following:

1. Patients have diabetic macular oedema with pseudophakic lens; and

2. Patient has reduced visual acuity of between 6/9 – 6/48 with functional awareness of reduction in vision; and

3. Any of the following:

3.1    Patient’s disease has progressed despite 3 injections with bevacizumab; or
3.2    Patient is unsuitable or contraindicated to treatment with anti-VEGF inhibitors; and

4. Dexamethasone implants are to be administered not more frequently than once every 4 months, and up to a maximum of 3 implants per year.

Continuation – Diabetic macular oedema

Ophthalmologist

Limited to 12 months treatment

Both:

  1. Patient’s vision is stable or has improved (prescriber determined); and
  2. Dexamethasone implants are to be administered not more frequently than once every 4 months, and up to a maximum of 3 implants per year.

Initiation – Women of child bearing age with diabetic macular oedema

Ophthalmologist

Limited to 12 months treatment

All of the following:

  1. Patients have diabetic macular oedema; and
  2. Patient has reduced visual acuity of between 6/9 – 6/48 with functional awareness of reduction in vision; and
  3. Patient is of child bearing potential and has not yet completed a family; and
  4. Dexamethasone implants are to be administered not more frequently than once every 4 months, and up to a maximum of 3 implants per year.

Continuation – Women of child bearing age with diabetic macular oedema

Ophthalmologist

Limited to 12 months treatment

All of the following:

  1. Patient’s vision is stable or has improved (prescriber determined); and
  2. Patient is of child bearing potential and has not yet completed a family; and
  3. Dexamethasone implants are to be administered not more frequently than once every 4 months, and up to a maximum of 3 implants per year.

Who we think will be most interested

This decision will be of interest to:

  • Patients with DMO who have had cataract surgery and for whom the currently available treatments are either ineffective or inappropriate.
  • Public and private ophthalmologists
  • DHB ophthalmology departments
  •  Community and hospital pharmacies and pharmacists
  • Suppliers and wholesalers

What will the effect of this decision be?

For patients

From 1 November 2017, patients (who meet the funding criteria) will be able to access funded dexamethasone implants for the treatment of their DMO. This medicine is administered by an ophthalmologist and is an implant into the eye; it provides long term management of diabetic macular oedema.

If you meet the funding criteria for dexamethasone implants, your ophthalmologist will be able to prescribe you this medicine and it will be dispensed by a community or hospital pharmacy when you present your prescription. You may need to collect this medicine from the pharmacy prior to the administration date, store it at home, and take it with you to your ophthalmology appointment. Your clinician will tell you how to get the medicine.

If the medicine is dispensed to you from a community pharmacy, the standard $5 or $15 pharmaceutical co-payment (depending on whether the medicine is prescribed by a DHB Hospital ophthalmologist or a private ophthalmologist) will apply.

Each dexamethasone implant is sealed, and packaged in an original pack containing the implant and the applicator device. The dexamethasone implant can be safely stored at room temperature.

For Ophthalmologists

From 1 November 2017, you will be able to prescribe fully funded dexamethasone implants to eligible patients with DMO.

To access funding from the Combined Pharmaceutical Budget you will need to apply for a Special Authority in advance of treating your patient; this can be applied for electronically or manually, and you should make sure the approval number is printed on the prescription.

Pharmacies will be able to dispense funded dexamethasone implants on presentation of a prescription. You might ask patients to collect the implant from the pharmacy and bring it with them to the administration appointment, or you might yourself arrange for the collection of the product.

For Community and Hospital Pharmacies

From 1 November 2017, dexamethasone implants will be listed in both Section B and Part II of Section H of the Pharmaceutical Schedule.

This means that patients could bring a prescription from their ophthalmologist to a community pharmacy to access funded dexamethasone implants or reimbursement, claims could be made (electronically or manually) by hospital pharmacies with a community pharmacy contract claimant number.

Each dexamethasone implant is sealed, and packaged in an original pack containing the implant and the applicator device. The dexamethasone implant can be safely stored at room temperature.

Our response to what you told us

PHARMAC is grateful for the time people took to respond to the consultation. All consultation responses received by 3 October 2017 were considered in their entirety when making a decision. 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. 

Theme

PHARMAC Comment

Supportive of listing dexamethasone ocular implants.

Noted.

One respondent considered that visual acuity criteria should be widened from 6/9 – 6/48 to 6/9 – 6/60 as the Snellen visual acuity charts in many hospitals jump from 6/36 to 6/60, and do not have the 6/48 step.

PHARMAC notes that the funding criteria are in line with recommendations from our Ophthalmology Subcommittee and do not require a specific visual acuity measurement tool to be used.  We consider that clinicians experienced in using the Snellen visual acuity chart will be able to assess and judge patient’s eligibility to dexamethasone implants.

One respondent considered that Ozurdex should be made available as second line treatment to all patients with DMO, and not limited to patients with pseudophakic lens.

PHARMAC’s Ophthalmology Subcommittee recommended that Ozurdex be listed for the second line treatment of DMO, with strict initiation criteria. The funding criteria are in line with the Subcommittee’s recommendations.

The respondent also considered that Ozurdex should be available for patients with macular oedema of all underlying aetiology (rather than just diabetes).

PHARMAC is open to receiving a funding application for widening access to Ozurdex for other indications.

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.