Proposal to fund dexamethasone ocular implants for DMO

Medicines

Consultation Closed

PHARMAC is seeking feedback on a proposal to list dexamethasone 700 mcg ocular implants (Ozurdex) through a provisional agreement with Allergan Australia Limited.

What we’re proposing

We are proposing to list dexamethasone 700 mcg ocular implants in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 November 2017, subject to restrictions, for the treatment of diabetic macular oedema (DMO).

Consultation closes at 5pm on Tuesday, 3 October 2017 and feedback can be emailed to: tony.wang@pharmac.govt.nz.

Please share this information with other groups you think may be interested in providing feedback.

What would the effect be?

For Patients

The proposal would mean that, from 1 November 2017, patients (who meet the funding criteria) would be able to access funded dexamethasone implants for the treatment of diabetic macular oedema.

This medicine is administered by an ophthalmologist and is an implant into the eye; it provides long term management of diabetic macular oedema. This medicine is particularly suitable for patients who have previously had cataract surgery, and are no longer benefiting from bevacizumab injections or those who live in geographically isolated areas.

If you meet the funding criteria for dexamethasone implants, your ophthalmologist would be able to prescribe you this medicine and it would be dispensed by a community or hospital pharmacy on presentation of a prescription.

In some cases you might need to collect it from the pharmacy prior to the administration date and take it with you to your appointment, in others the health service would arrange this. 

If the medicine is dispensed 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) would apply.

For Community and Hospital Pharmacies

The proposal is to list dexamethasone implants in both Section B and Part II of Section H of the Pharmaceutical Schedule from 1 November 2017. This means that patients could bring a prescription from their ophthalmologist to a community pharmacy to access funded dexamethasone implants or that 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 safety stored at room temperature.

For Ophthalmologists

This proposal would mean that, from 1 November 2017, fully funded dexamethasone implants would be available for eligible patients for the treatment of diabetic macular oedema.

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

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

For DHB Hospitals

The proposal would enable dexamethasone implants to be funded, from 1 November 2017, for use in both in the hospital and community settings.

It is anticipated that this proposal may reduce demand on DHB ophthalmology services. This is because dexamethasone implants should deliver a longer therapeutic effect compared to intravitreal bevacizumab and because patients who are being treated by private ophthalmologists will be able to access this funded medicine in the community.

Who we think will be interested

This decision will be of interest to:

  • Patients with diabetic macular oedema 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

About dexamethasone ocular implants

Each implant contains 700 mcg of dexamethasone, a potent steroid, in a polymer drug delivery system which is administered as an intravitreal injection.

Once implanted, the polymer drug delivery system degrades and dexamethasone is released slowly into the eye by gradually dissolving. Each dexamethasone implant is expected to have therapeutic effects lasting 3 to 6 months.

Administration of dexamethasone ocular implants should be conducted by ophthalmologists experienced in intravitreal injections.

Why we’re proposing this

Diabetic Macular Oedema (DMO)

Diabetic Macular Oedema (DMO) is a serious complication of type 1 and 2 diabetes. It is associated with poor diabetic control and is the leading cause of blindness in people with diabetes.

DMO disproportionately affects Maori and Pacific populations as the rates for diabetes are two to three times higher in these populations compared with Europeans, as are the rates of uncontrolled diabetes.

Currently, the only funded pharmaceutical treatment for DMO is intravitreal bevacizumab injection, which is available in DHB hospitals (listed in Section H of the Pharmaceutical Schedule) subject to restrictions. Bevacizumab is an anti-vascular endothelial growth factor (anti-VEGF) agent and its use for treatment of DMO is ‘off label’ (meaning Medsafe has not approved its use in this indication). Bevacizumab is administered as an injection into the eyes generally on a monthly to two-monthly basis, however in some patients after cataract surgery it may need to be administered more frequently.

Dexamethasone implants contain a potent steroid, and are formulated using a slow release profile allowing for a sustained period of activity for up to 6 months after administration. It has a different mechanism of action to bevacizumab, and may be another treatment option for patients with DMO and be particularly suitable for patients who have had cataract surgery.

Clinical advice

A supplier application for the listing of dexamethasone 700 mcg implants for the treatment of DMO was reviewed by the Ophthalmology Subcommittee in February 2016 was recommended for funding as a second-line treatment for DMO with medium priority (and high priority for pregnant women with DMO).  The Pharmacology and Therapeutics Advisory Committee (PTAC) endorsed the Subcommittee’s recommendations in May.

The Subcommittee considered that bevacizumab (an anti-VEGF agent) would still be the treatment of choice for DMO, however in patients with pseudophakic lens post cataract surgery whose disease progresses or in those patients who cannot tolerate bevacizumab, dexamethasone implants may be another appropriate treatment option. The recommendation to restrict funding to patients with a pseudophakic lens was made following consideration of both safety and efficacy. It was noted that long term use of corticosteroids in the eyes increase the risk of cataract development, a risk that is which is nullified in patients already with pseudophakic lens.

In summary, the Subcommittee recommended that dexamethasone implants be funded as a second-line treatment for DMO with a strict entry criteria with a medium priority, and that dexamethasone implants be funded as a second line treatment for DMO for pregnant women with a high priority due to the unmet health need of this group.

The minutes of the Ophthalmology Subcommittee related to this proposal can be found on PHARMAC’s website at:

https://www.pharmac.govt.nz/patients/ApplicationTracker?ProposalId=1439 [link no longer available]

https://www.pharmac.govt.nz/patients/ApplicationTracker?ProposalId=1440 [link no longer available]

Details about our proposal

PHARMAC is seeking feedback on a proposal to list dexamethasone 700 mcg ocular implants from 1 November 2017, subject to restrictions, in Section B and Part II of Section H of the Pharmaceutical Schedule, at the following price and subsidy (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 dexamethasone 700 mcg ocular implants which would reduce the net price to the Funder.

It is proposed that dexamethasone ocular implants be listed in Section B 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:

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.

It is proposed that dexamethasone ocular implants be listed in Part II of Section H subject to the following restrictions:

Restricted

Initiation – Diabetic macular oedema

Ophthalmologist

Limited to 12 months treatment

All of the following:

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.

The proposed criteria are in line with the clinical advice received.

We estimate that this proposal would benefit approximately 200 patients in the first year.

To provide feedback

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Tuesday, 3 October 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.