Proposal to award sole supply of venlafaxine - Extension to deadline

Please note – The web version of the consultation document dated 10 August 2016 has been amended on 18 August 2016 to make it consistent with the consultation document pdf that was emailed to interested parties on 10 August 2016. This revised web version of the consultation document amends the pack size from a 90 pack to a 84 pack. In consideration of this amendment, PHARMAC extends the period to submit feedback on this proposal until Thursday 01 September 2016.

Following a Request for Tender (RFT) for the supply of venlafaxine issued on 15 June 2016, PHARMAC is seeking feedback on a proposal to:

• award Sole Supply Status in the community for venlafaxine to Mylan New Zealand Limited (Mylan) for its Enlafax XR brand of modified-release capsules: 37.5 mg, 75 mg and 150 mg from 1 September 2017 until 30 June 2020.
• award Hospital Supply Status for venlafaxine to Mylan for its Enlafax XR brand of modified release capsules: 37.5 mg, 75 mg and 150 mg from 1 June 2017 until 30 June 2020, with a 1% DV limit.

In summary, this proposal would result in:

• the 37.5 mg, 75 mg, and 150 mg presentations of Mylan’s Enlafax XR brand being listed on the Pharmaceutical Schedule from 1 April 2017 without any restrictions.
• a reduction in subsidy and price across all strengths of venlafaxine.
• a reduction in subsidy for the currently listed venlafaxine brands (Efexor XR capsules and Arrow-Venlafaxine XR tablets) from 1 June 2017.
• Efexor XR capsules and Arrow-Venlafaxine XR tablets being delisted from 1 September 2017.
• no 225 mg presentation being listed from 1 September 2017.
• a change in all pack sizes from 28 to 84 (6 strips of 14 capsules) with the days of the week on the foil backing.
• stat dispensing (three months dispensed all-at-once) of venlafaxine from 1 September 2017.

It is estimated that this proposal would provide discounted savings of approximately $19 million over the next five years ($14.8 million of savings over the sole supply period). These savings would then be available to invest in other pharmaceuticals.

We are asking for general feedback about this proposal and also specific implementation feedback.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Thursday 1 September to:

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.

Details of the proposal

• Enlafax XR (venlafaxine) modified release capsules would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following prices and subsidies (ex manufacturer, excluding GST) from 1 April 2017:

• Enlafax XR would be awarded Sole Supply Status for venlafaxine from 1 September 2017 until 30 June 2020 and Hospital Supply Status for venlafaxine from 1 June 2017 until 30 June 2020, with a 1% DV limit.

• The stat dispensing rule (three months dispensed all-at-once) would be applied to all three strengths of venlafaxine (Enlafax XR) in Section B of the Pharmaceutical Schedule from 1 September 2017.

• The subsidies for the currently listed brands of venlafaxine (Arrow-Venlafaxine XR tablets and Efexor XR capsules) would be reduced from 1 June 2017 via the application of reference pricing to Enlafax XR as follows:

• If the suppliers of Efexor XR capsules and Arrow-Venlafaxine XR tablets decide not to reduce the price of their products to match the subsidy, a patient part charge would apply on these medicines.
• All strengths of Efexor XR capsules and Arrow-Venlafaxine XR tablets would be delisted from Section B of the Pharmaceutical Schedule from 1 September 2017 and would be delisted from Part II of Section H of the Pharmaceutical Schedule from 1 June 2017.
• Should the proposal be approved this would result in the removal of the 225 mg tablet presentation, which is currently received by approximately 1,500 patients. These patients would need to change to a dose of 2 or more Enlafax XR capsules (3 x 75mg or 1 x 150mg + 1 x 75mg) in order to remain on funded venlafaxine treatment.
• The Special Authority for Efexor XR would be removed from the date of reference pricing, 1 June 2017.

Specific feedback sought

In addition to general feedback that will help inform changes that might be required to the proposal, we would like your specific feedback to help us develop any implementation support that may be required.

1. Health professionals play an important role in reassuring patients when there are changes to brands of medicines. What would help health professionals support patients with a change in brand of medicine? For example:
   1. Information for health professionals on how to support patients through a change of brand;
   2. Information for patients about the change of brand.
2. Are there any other types of implementation support that would be useful for patients or health professionals?

Background

Venlafaxine is indicated for the treatment of major depression, generalised anxiety disorder; social anxiety disorder and panic disorder. Venlafaxine is also indicated for the prevention of relapse and recurrence of major depression where appropriate.

Current annual expenditure on venlafaxine is $7.25 million in the community (financial year ending 30 June 2016). There are approximately 45,000 people in New Zealand receiving venlafaxine, and 73% are dispensed venlafaxine over a period greater than four months.

In June 2016, PHARMAC invited tenders for the sole supply of venlafaxine to DHB hospitals and/or community pharmacies. This proposal to award tenders for Sole Supply Status and Hospital Supply Status for venlafaxine is the result of this process.

PHARMAC currently lists and fully subsidises the following presentations of venlafaxine extended-release in Section B and Part II of Section H of the Pharmaceutical Schedule. All presentations have subsidy and delisting protection until 31 March 2017.

Arrow-Venlafaxine XR tablets are listed without any restriction, whereas Efexor XR capsules are only funded for patients with treatment-resistant depression via Special Authority as follows:

Should the proposal be approved this would result in an open listing of venlafaxine for the Enlafax XR brand with no restrictions/Special Authority.

Enlafax XR has met Medsafe’s standards for registration in New Zealand, including a requirement that Enlafax XR demonstrates bioequivalence to Efexor XR, meaning that patients could expect to get the same clinical benefit from Enlafax XR as from their current brand.

The Enlafax XR 84 capsule pack with days of the week printed on the foil packaging would be consistent with the existing Efexor XR 28 capsule packaging, which is the brand that most people are currently dispensed.

PHARMAC staff note that the 84 blister pack of Enlafax XR is not currently registered with Medsafe. Should the proposal be approved then Mylan would register the additional pack size with Medsafe. It is not expected that this would impact on the proposed timelines.

It is estimated that this proposal would provide discounted savings of approximately $19 million over the next five years ($14.8 million of savings over the Sole Supply period). These savings would be available to invest in other pharmaceuticals.