Proposal related to 2nd & 3rd line anti-VEGF treatments for ophthalmic use

Medicines

Consultation Closed

Following a Request for Proposals (RFP) for the supply of anti-endothelial growth factor (anti-VEGF) agents for ophthalmic use (primarily wet aged macular degeneration (wAMD)) issued on 5 May 2016, PHARMAC has entered into provisional agreements with Novartis New Zealand Limited and Bayer New Zealand Ltd and is seeking feedback on a proposal to award Hospital Supply Status from 1 November 2016 until 31 October 2019 to:

  • Novartis’s ranibizumab (Lucentis) to be the 2nd line anti-VEGF treatment for ophthalmic use in DHB hospitals;
  • Bayer’s aflibercept (Eylea) to be the 3rd line anti-VEGF treatment for ophthalmic use in DHB hospitals.

In summary, this proposal would result in:

  • bevacizumab remaining as the 1st line treatment for ophthalmic use in DHB hospitals as per the current Hospital Medicines List (HML) restriction;
  • ranibizumab (Lucentis) remaining as the 2nd line treatment for ophthalmic use in DHB hospitals, subject to amended HML restrictions;
  • a reduction in the price of ranibizumab to DHB hospitals;
  • delisting of the 10 mg per ml, 0.3 ml vial presentation of ranibizumab from the HML.
  • the listing of aflibercept (Eylea) for 3rd line treatment for ophthalmic use in DHB hospitals subject to HML restrictions.

Feedback sought

PHARMAC welcomes feedback on these proposals. To provide feedback, please submit it in writing by 5pm on Monday 19 September 2016 to:

An-Ruo Bian
Therapeutic Group Manager
PHARMAC
PO Box 10 254
Wellington 6143

Email: an-ruo.bian@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 withheld.  PHARMAC will give due consideration to any such request. 

Details of the proposals

First line anti-VEGF treatment

Bevacizumab inj 25 mg per ml in a 4 ml or 16 ml vial for ophthalmic use would remain listed in the HML with no changes to the current HML restriction, which is:

Either:

  1. Ocular neovascularisation; or
  2. Exudative ocular angiopathy.

Second line anti-VEGF treatment

  • From 1 November 2016 ranibizumab (Lucentis) would be listed in Part II of Section H of the Pharmaceutical Schedule at the following price (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Price

Ranibizumab

Inj 10 mg per ml, 0.23 ml vial

Lucentis

1

$1,250.00

  • A confidential rebate would apply to Lucentis, which would reduce the net price to DHB Hospitals.
  • The inj 10 mg per ml, 0.3 ml vial presentation of ranibizumab would be delisted from Part II of Section H of the Pharmaceutical Schedule from 1 February 2017.
  • Lucentis would be subject to the following HML restriction (note this differs to the current restriction – additions in shown in bold and deletions in strikethrough):

Restricted

Initiation

Re-assessment required after 3 months doses

Both

Continuation

Reassessment required at 6 months

Both:

  1. Documented benefit after three doses must be demonstrated to continue; and
  2. In the case of but previous non-response to bevacizumab, a retrial of at least one dose of bevacizumab is required at 6 months, 12 months and 24 months to confirm non response before continuing with ranibizumab.
  • Lucentis would be awarded Hospital Supply Status for the indication of 2nd line anti-VEGF treatment of wAMD in DHB hospitals, with a 0% discretionary variance limit, from 1 November 2016 to 31 October 2019.  This would result in Lucentis being the only of anti-VEGF agent that could be used for 2nd line treatment of wAMD in DHB Hospitals.

Third line anti-VEGF treatment

  • From 1 November 2016 aflibercept (Eylea) would be listed in Part II of Section H of the Pharmaceutical Schedule at the following price (ex-manufacturer, excluding GST):
Chemical Formulation Brand Pack size Price
Aflibercept Inj 40 mg per ml, 0.1 ml vial Eylea 1 $1,650.00
  • A confidential rebate would apply to Eylea, reducing the net price to DHB Hospitals.
  • Eylea would be listed subject to the following HML restriction:

Restricted

Initiation:

Reassessment required after 3 months

Both:

Continuation

Reassessment required at 6 month

Both:

  1. Documented benefit from treatment must be demonstrated to continue; and
  2. A retrial of bevacizumab is required after 6 months, 12 months and then 24 months to confirm non response before continuing with aflibercept.
  • Eylea would be awarded Hospital Supply Status for the indication of 3rd line anti-VEGF treatment of wAMD in DHB hospitals, with a 0% discretionary variance limit, from 1 November 2016 to 31 October 2019. This would result in Eylea being the only anti-VEGF agent that could be used for 3rd line treatment of wAMD in DHB Hospitals.

Background

Age-related Macular Degeneration (AMD) is the most common cause of blindness and it affects 1 in 7 people over the age of 50. The incidence of AMD increases with age; it is estimated by the age of 80, one in four New Zealanders have vision loss from AMD.  There are two forms of AMD, wet and dry. Wet (neovascular) AMD affects 85-90% of patients with AMD and is a degenerative disease of the central portion of the retina (the macula) that results primarily in loss of central vision.  

Treatments

Anti-VEGF agents are considered to be the standard treatment for wet AMD.  They are intravitreal injections which are administered into the eye by an ophthalmologist.

Bevacizumab is the first-line anti-VEGF agent listed on the HML and there would be no change to its listing as a result of this proposal.

Ranibizumab is currently listed on the HML with restrictions. It is a recombinant humanised monoclonal antibody with specificity for VEGF and is administered by intra-vitreal injection. The Lucentis brand of ranibizumab (supplied by Novartis Limited New Zealand) is currently the only brand of ranibizumab available and funded in New Zealand.

Aflibercept (brand name Eylea) is a recombinant fusion protein that competes for binding of VEGF and is a newer generation anti-VEGF treatment.

Both Lucentis and Eylea are Medsafe registered for the treatment of wAMD.

Clinical advice

PHARMAC received clinical advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) that there was no clinical reason not to run a competitive process for anti-VEGF agents for the treatment of wAMD. We note that the intravitreal use of bevacizumab is not a Medsafe approved indication, however PTAC considered that it was appropriate for bevacizumab to remain the first-line treatment option given its good cost-effectiveness relative to aflibercept and ranibizumab.

The proposed HML restriction criteria were formed with the advice provided by the Ophthalmology Subcommittee and PTAC. More information, including minutes from PTAC and the Ophthalmology Subcommittee, can be found on the PHARMAC website.

This proposal, if approved, would result in significant savings to DHB Hospitals and would introduce an additional line of therapy for patients where bevacizumab and ranibizumab are ineffective or intolerable due to side-effects.

Other indications

For the avoidance of doubt, the proposed restrictions for second and third line anti-VEGF treatment do not include other indications such as diabetic macular oedema (DMO).

PHARMAC has received a funding application for aflibercept for the treatment of DMO, and it is currently still under assessment. More information regarding that application can be found on the PHARMAC website.