Decision to fund pregabalin, and change the funded brand of gabapentin and listing restrictions

7 December 2017

Medicines Decision

We’re pleased to announce the approval of two agreements, one with Apotex New Zealand Ltd for supply of gabapentin and the other with Pfizer New Zealand Ltd for supply of pregabalin.

These agreements were the subject of a consultation letter dated 20 October 2017.

In summary, the effect of the decision is that:

From 1 May 2018 Pfizer New Zealand Ltd’s brand of pregabalin (Pregabalin Pfizer) will be funded, via a sole supply arrangement in both the community and hospital settings, without a Special Authority restriction applying.
From 1 June 2018 Apo-Gabapentin (supplied by Apotex New Zealand Ltd) will be funded, via a sole supply arrangement in both the community and hospital settings, without a Special Authority restriction.
From 1 August 2018 Arrow-Gabapentin, Neurontin, and Nupentin will be referenced priced to the cost of Apo-Gabapentin and from 1 November 2018 Arrow-Gabapentin, Neurontin, and Nupentin will be delisted. People using Arrow-Gabapentin, Neurontin, and Nupentin brands of gabapentin will need to switch brands to Apo-Gabapentin to remain on a fully funded product.
A funding condition will be applied to both gabapentin and pregabalin which will prevent funded concurrent use of those products.

Any changes to the original proposal?

One change has been made to the proposal consulted on (see link above), namely that funded prescriptions of each of pregabalin and gabapentin will be able to be dispensed all-at once (STAT). Pricing/subsidy information is disclosed in this notification.

Who we think will be most interested

People currently using gabapentin capsules or pregabalin capsules, epilepsy-related consumer support organisations, pharmacists, clinicians involved in the management of neuropathic pain and/or seizure disorders, DHBs, and suppliers of gabapentin and pregabalin capsules.

Detail of our decision

New listing - Pregabalin Pfizer

From 1 May 2018 Pfizer’s brand of pregabalin 25 mg, 75 mg, 150 mg and 300 mg capsules (Pregabalin Pfizer) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

Chemical	Presentation	Brand	Pack size	Price and subsidy
Pregabalin	Cap 25 mg	Pregabalin Pfizer	56	$2.25
Pregabalin	Cap 75 mg	Pregabalin Pfizer	56	$2.65
Pregabalin	Cap 150 mg	Pregabalin Pfizer	56	$4.01
Pregabalin	Cap 300 mg	Pregabalin Pfizer	56	$7.38

Pregabalin capsules will be listed with all-at-once (STAT) dispensing.
There will be a funding restriction preventing concurrent funded dispensing of gabapentin and pregabalin.

Listing of Apo-Gabapentin

From 1 June 2018 Apotex’s brand of gabapentin 100 mg, 300 mg and 400 mg capsules (Apo-Gabapentin) will be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

Chemical	Presentation	Brand	Pack size	Price and subsidy
Gabapentin	Cap 100 mg	Apo-Gabapentin	100	$2.65
Gabapentin	Cap 300 mg	Apo-Gabapentin	100	$4.07
Gabapentin	Cap 400 mg	Apo-Gabapentin	100	$5.64

Apo-Gabapentin will be listed without a Special Authority restriction.
There will be a funding restriction preventing concurrent funded use of gabapentin and pregabalin.

Reference pricing other listed brands of gabapentin in the community

From 1 August 2018, the subsidies for the currently listed gabapentin brands (Arrow-Gabapentin, Neurontin and Nupentin) will be reduced, via the application of reference pricing, to the subsidy for Apo-Gabapentin.
If the suppliers of Arrow-Gabapentin, Neurontin, and Nupentin decide not to reduce the price of Arrow-Gabapentin, Neurontin, and/or Nupentin to match the new proposed subsidy, a manufacturer’s surcharge would apply when these brands are dispensed.
The Special Authority restrictions applying to gabapentin (all brands) brands in Section B will be removed from 1 August 2018.
All-at-once (STAT) dispensing will be applied to all listed brands of gabapentin from 1 August 2018.

Pregabalin and gabapentin sole supply

In DHB hospitals

Pregabalin

From 1 July 2018 until 30 June 2021, Pregabalin Pfizer (cap 25 mg, 75 mg, 150 mg and 300 mg) will be awarded Hospital Supply Status (HSS) for pregabalin capsules in DHB hospitals. This will result in Pregabalin Pfizer being the only available brand of pregabalin in DHB hospitals, subject to a 1% Discretionary Variance (DV) Limit (i.e. 99% of total volume of pregabalin purchased by DHB hospitals will be required to be Pregabalin Pfizer).

Gabapentin

From 1 August 2018 until 30 June 2021, Apo-Gabapentin (cap 100 mg, 300 mg and 400 mg) will be awarded HSS for gabapentin capsules in DHB hospitals. This will result in Apo-Gabapentin being the only available brand of gabapentin in DHB hospitals, subject to a 1% DV limit (i.e. 99% of total volume of gabapentin purchased by DHB hospitals will be required to be Apo-Gabapentin).
From 1 August 2018, all other brands of gabapentin will be delisted from Part II of Section H of the Pharmaceutical Schedule.

In the community

Pregabalin

From 1 July 2018 until 30 June 2021, Pregabalin Pfizer (cap 25 mg, 75 mg, 150 mg and 300 mg) will be awarded Sole Supply Status for pregabalin capsules in the community. This will result in Pregabalin Pfizer being the only funded pregabalin capsules in the community during this time period.

Gabapentin

From 1 November 2018 until 30 June 2021, Apo-Gabapentin (cap 100 mg, 300 mg and 400 mg) will be awarded Sole Supply Status for gabapentin capsules in the community.
From 1 November 2018, all other brands of gabapentin will be delisted from Section B of the Pharmaceutical Schedule.
A Brand Switch Fee will be able to be claimed on the first funded Apo-Gabapentin dispensing by community pharmacies, once per patient, during the three-month period from 1 November 2018 to 31 January 2019 (i.e. after the delisting of the other gabapentin brands).

Our response to what you told us

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 10 November 2017 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme	Comment
Support for the proposal
The vast majority of responses received through consultation were supportive. Responders noted: The removal of Special Authority restrictions would be better for prescribers, pharmacists and patients. Benefits to patients by having pregabalin as an alternative funded treatment option, particularly patients who have been unable to tolerate gabapentin or tricyclic antidepressants. Pregabalin is also viewed by some clinicians as easier to start patients on with fewer adverse effects as dose is escalated. Availability of an alternative non-opioid treatment option for pain would be beneficial in reducing the number of patients on long term opioids for non-palliative pain. Both medicines are both strongly recommended for use as a first-line treatment for neuropathic pain, by the International Association for the Study of Pain. It would increase in funded access to these medicines for people with epilepsy or neuropathic pain. It would ensure timely access as well as reducing administrative burden.	Noted.
Concerns raised
Gabapentinoids have the potential for abuse, so prescribers will need to carefully evaluate patients in terms of history of drug abuse, or signs of possible gabapentin abuse, and prescribing rates should be monitored.	Clinicians are expected to prescribe within their registered scopes of practice, appropriately and safely. This includes consideration of abuse potential for an individual patient.
Ensuring there is an understanding of appropriate use and initiation on to these pharmaceuticals for all prescribers.	PHARMAC intends to support healthcare professionals by facilitating the availability of information on appropriate use of gabapentinoids.
Quality of PHARMAC’s consultation document omits necessary information, in particular pricing, in order for interested parties to provide informed feedback on the proposal and the proposal should be re-issued with proposed pricing.	PHARMAC considers that all necessary aspects of the proposal were included in the consultation to allow for informed feedback e.g. proposed Pharmaceutical Schedule changes such as listing of a new treatment, removal of Special Authority, a proposed brand switch and all proposed timeframes for Schedule changes. Pricing detail was not included to avoid the disclosure of commercially sensitive information, thereby leaving alternative bidder options open in the event that PHARMAC decided not to progress the proposal. Pricing is disclosed in this notification, which gives the suppliers of Arrow-Gabapentin, Neurontin, and Nupentin just over 7 months’ notice to make decisions about the pricing of their products from 1 August 2018 and others involved in the supplier chain (distributors/wholesalers and pharmacists) time to make considered decisions about stock management.
Other
How is the prevention of concurrent funded dispensing of gabapentin and pregabalin going to be administered and monitored?	A rule will be included in the Pharmaceutical Schedule which will ban the concurrent reimbursement of both pregabalin and gabapentin. Reimbursement claims for both gabapentinoids is auditable and non-compliance, if it occurred, is able to be addressed with relevant prescribers and pharmacy. PHARMAC would monitor use and assist the Ministry of Health and DHBs with compliance activities. We intend to support prescribers by facilitating provision of information on appropriate use of gabapentinoids and relevant funding restrictions.
New Zealand Transport Agency (NZTA) noted a brand change does not constitute a treatment change for purposes of driving, and considered any risks from changing would be low.	Noted

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.