Decision to award sole supply of venlafaxine
PHARMAC is pleased to announce a decision to award a sole supply arrangement for venlafaxine to Mylan New Zealand Limited (Mylan) for its Enlafax XR brand from 1 June 2017 in DHB hospitals and from 1 September 2017 in the community.
Venlafaxine is an antidepressant. It is indicated for the treatment of major depression, generalised anxiety disorder; social anxiety disorder and panic disorder.
This decision was made following a Request for Tender (RFT) for the supply of venlafaxine issued on 15 June 2016 and a consultation letter dated 10 August 2016, amended 18 August 2016.
The decision is as consulted on, except that a Brand Switch Fee will be available to pharmacies, the implementation of the stat dispensing rule will be delayed until 1 December 2017 and the reference price subsidy of the incumbent 37.5 mg strengths will be $2.13 per pack of 28 not $2.12.
This decision is expected to provide savings of up to $5.4 million per year that can be used to fund other pharmaceuticals.
In summary:
- Mylan’s Enlafax XR brand of venlafaxine will be listed on the Pharmaceutical Schedule from 1 April 2017 without the requirement for Special Authority
- The subsidies for Efexor-XR and Arrow-Venlafaxine XR in the community will be reduced to the level of the subsidies for Enlafax XR from 1 June 2017 via the application of reference pricing
- The Efexor-XR and Arrow-Venlafaxine XR brands of venlafaxine will be delisted from the hospital and community sections of the Pharmaceutical Schedule from 1 June 2017 (hospital) and 1 September 2017 (community), respectively
- Following delisting of the other brands, Enlafax XR will be the only subsidised brand of venlafaxine until 30 June 2020
- A Brand Switch Fee will apply to dispensings of venlafaxine from 1 September 2017 to 30 November 2017
- The stat dispensing (three months dispensed all-at-once) rule will be added to venlafaxine from 1 December 2017.
Details of the decision
- Enlafax XR (venlafaxine) modified release capsules will 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:
Chemical |
Presentation |
Brand |
Pack size |
Price and subsidy |
---|---|---|---|---|
Venlafaxine |
Cap 37.5 mg |
Enlafax XR |
84 |
$ 6.38 |
Venlafaxine |
Cap 75 mg |
Enlafax XR |
84 |
$ 8.11 |
Venlafaxine |
Cap 150 mg |
Enlafax XR |
84 |
$11.16 |
- Enlafax XR will have 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) will be added to venlafaxine in Section B of the Pharmaceutical Schedule from 1 December 2017.
- The subsidies for the currently listed brands of venlafaxine (Arrow-Venlafaxine XR tablets and Efexor XR capsules) will be reduced from 1 June 2017 to the level of the subsidies for Enlafax XR via the application of reference pricing as follows:
Chemical and presentation |
Brand |
Pack size |
Current subsidy and price |
New subsidy |
---|---|---|---|---|
Venlafaxine Tab 37.5 mg |
Arrow-Venlafaxine XR |
28 |
$5.06 |
$2.13 |
Venlafaxine Tab 75 mg |
Arrow-Venlafaxine XR |
28 |
$6.44 |
$2.70 |
Venlafaxine Tab 150 mg |
Arrow-Venlafaxine XR |
28 |
$8.86 |
$3.72 |
Venlafaxine Tab 225 mg |
Arrow-Venlafaxine XR |
28 |
$14.34 |
$8.10 |
Venlafaxine Cap 37.5 mg |
Efexor XR |
28 |
$5.69 |
$2.13 |
Venlafaxine Cap 75 mg |
Efexor XR |
28 |
$11.40 |
$2.70 |
Venlafaxine Cap 150 mg |
Efexor XR |
28 |
$13.98 |
$3.72 |
- If the suppliers of Efexor-XR and Arrow-Venlafaxine XR do not reduce the price of their brands to match the new subsidy, a manufacturer’s surcharge will apply to Efexor-XR and Arrow-Venlafaxine XR from 1 June 2017 and patients will need to change to the Enlafax XR brand in order to remain on a fully funded product.
- Patients currently receiving the 225 mg tablet will need to change to a dose of 2 or more Enlafax XR capsules (3 x 75mg, or 1 x 150mg + 1 x 75mg). Note that if the latter option is selected by prescribers, an additional co-payment would be payable by the patient as there is one co-payment per strength.
- The Special Authority and hospital restrictions for Efexor XR will be removed from 1 June 2017.
- Efexor XR capsules and Arrow-Venlafaxine XR tablets will be delisted from Section B of the Pharmaceutical Schedule from 1 September 2017 and will be delisted from Part II of Section H of the Pharmaceutical Schedule from 1 June 2017.
- A Brand Switch Fee will be available to be claimed on dispensing by pharmacies, once per patient, between 1 September 2017 and 30 November 2017, of Enlafax XR.
Feedback received
We appreciate all of the feedback that we received, and acknowledge the time people took to respond. All consultation responses received by 1 September 2016 were considered in their entirety in making a decision on the proposed changes. There were some responses related to the RFP process itself which we are responding to separately. The following issues were raised in relation to specific aspects of the proposal:
Theme |
Comment |
---|---|
Removal of the 225 mg strength |
We acknowledge there will be an inconvenience to the very small group of patients (~1,500 out of a total 45,000 patients receiving funded venlafaxine treatment) taking the 225 mg tablets.To remain on funded treatment patients could take:
People will be able to choose which option works best for them. It is correct that if they choose to take one 150 mg capsule and one 75 mg capsule they would likely have to pay a co-payment for each strength (i.e. 2 x $5), while those who choose to take three 75 mg capsules would pay one co-payment ($5). Co-payments are determined and administered by the Ministry of Health – see here(external link) for more information. |
Appearance/Dosage/Titration
|
|
Table 1
Strength |
Variations |
Arrow-Venlafaxine XR |
Efexor XR |
Enlafax XR |
---|---|---|---|---|
37.5 mg |
Size |
Round tablet Φ 7 mm |
Capsule 6mm x 16mm |
Capsule 8mm x 22mm |
75 mg |
Size |
Round tablet Φ 8 mm |
Capsule 7mm x 19mm |
Capsule 8mm x 22mm |
150 mg |
Size |
Round tablet Φ 10 mm |
Capsule 9mm x 23mm |
Capsule 9mm x 23mm |
Theme |
Comment |
---|---|
Stat Dispensing
|
|
Patient Group Concerns and bioequivalence Four responders raised safety concerns for what they perceived as a vulnerable patient group, who find changing to generics very difficult. Noting negative experiences, adverse reactions, potential for increased hospitalisations and one specific patient experience of a similar previous brand switch (fluoxetine). One respondent noted that they were unaware of any data on comparative bioequivalence between Enlafax XR and Arrow-Venlafaxine XR. |
Enlafax XR has met Medsafe’s standards for registration for use in New Zealand, including demonstration of bioequivalence to Efexor XR. This means that patients can expect to get the same clinical benefit from Enlafax XR as from their current brand. We understand that changing brands can be challenging for some patients, and PHARMAC will develop a range of resources to support health professionals and patients during the brand change. As with any generic to generic switch, our view is that if both generics have demonstrated bioequivalence against the innovator brand, then patients could expect to get the same clinical benefit from either generic brand. |
Implementation & Brand Switch Fee One respondent considered that:
|
|
Sole Supply One respondent did not think a sole supply agreement for venlafaxine was appropriate, noting several issues common to abrupt supply disruptions with any sole supply agreement. |
PHARMAC notes that having multiple brands of a product in a market does not necessarily improve security of supply. When there is one supplier, our experience is that supplier forecasting is typically more accurate, which helps reduce the risk of out-of-stock situations. Further, in exchange for market exclusivity, the supply contracts we have in place require suppliers to agree to rigorous conditions to prevent and manage potential out-of-stocks. We note that prior to the listing of Arrow-Venlafaxine XR in 2011 there was only one supplier/one brand in the market for at least six years. |
Registration Status One respondent raised a concern regarding the registration status of Enlafax XR with Medsafe. |
Enlafax XR was registered by Medsafe on 12 March 2009. |
More information
If you have any questions about this decision, 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.