Proposal to fund pregabalin, and change the funded brand of gabapentin and listing restrictions
We propose the following three key changes to the funding of oral gabapentinoids (pregabalin and gabapentin) used in the treatment of seizure control and neuropathic pain:
- to fund Pfizer New Zealand Ltd’s brand of pregabalin (Pregabalin Pfizer) via a sole supply arrangement in both the community and hospital settings.
- to fund gabapentin, Apo-Gabapentin (supplied by Apotex New Zealand Ltd), via a sole supply arrangement in both the community and hospital settings.
- to remove current funding restrictions for gabapentin, and apply a funding condition to each of gabapentin and pregabalin which would prevent funded concurrent use of those products.
Consultation closes at 4 pm on 10 November 2017 and feedback can be emailed to procurement@pharmac.govt.nz
What would the effect be?
For patients
- From 1 May 2018, people would have funded access to a newly funded treatment for neuropathic pain, pregabalin;
- From 1 June 2018, people would have funded access to a new brand of gabapentin (Apo-Gabapentin);
- During a transition period, from 1 August 2018 to 31 October 2018, the subsidy for currently funded brands of gabapentin (Arrow-Gabapentin, Neurontin, and Nupentin) would be reduced so, if the suppliers of those brands did not reduce their price, people currently using funded gabapentin would need to pay a part charge or change to the fully funded brand (Apo-Gabapentin).
- From 1 November 2018, all currently funded brands of gabapentin (Arrow-Gabapentin, Neurontin, and Nupentin) would be delisted, so people using these brands of gabapentin would need to change to Apo-Gabapentin to keep accessing a funded treatment.
- Gabapentin and pregabalin would not be funded for concurrent use.
More information would be available during the transition period from pharmacists, prescribers and PHARMAC’s website.
For community pharmacies
Pharmacies could continue to dispense and claim for any listed brand of gabapentin capsules until 31 October 2018 (although noting that some brands of gabapentin may not be fully funded between 1 August 2018 – 31 October, depending on the supplier’s pricing). From 1 November 2018, Apo-Gabapentin would be the only funded brand of that strength of gabapentin capsules.
A Brand Switch Fee would apply to dispensings of Apo-Gabapentin from 1 November 2018 to 31 January 2019 (the three months following the commencement of sole supply).
Gabapentin and pregabalin would not be funded for concurrent use.
For hospital pharmacies
Pharmacies could continue to purchase any brand of gabapentin capsules until 31 July 2018. After that only 1% of total purchases of gabapentin capsules could be a brand other than Apo-Gabapentin.
For prescribers
Prescribers would be able to prescribe funded pregabalin or gabapentin, for any indication, without the need to complete Special Authority applications.
Gabapentin and pregabalin would not be funded for concurrent use.
For DHBs
Significant savings would be achieved through this proposal and more people would have access to funded pregabalin and gabapentin.
Who we think will be 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.
About pregabalin and gabapentin
Gabapentin and pregabalin are anticonvulsant agents that have a structural resemblance to gamma-aminobutyric acid (GABA), an amino acid which acts to inhibit the transmission of nerve impulses in the central nervous system. Both are indicated for the same or similar therapeutic uses, such as the treatment of neuropathic pain and seizure control in some forms of epilepsy.
Pregabalin is not currently funded.
Gabapentin is currently funded subject to Special Authority and hospital restrictions as a treatment for epilepsy, neuropathic pain and chronic kidney disease associated pruritus.
We note that we received expert clinical advice from the Neurological Subcommittee in November 2015 that switching-brands of gabapentin was unlikely to be clinically problematic for people living with epilepsy who are using gabapentin as a treatment for seizure control. [PDF, 51 KB] The Neurological Subcommittee also considered New Zealand Transport Association guidance, which requires monitoring of a new treatment for epilepsy to assess its impact, and considered that a brand-change would not constitute a change in treatment. If you have concerns please ask your health care professional.
Approximately 46,000 people use gabapentin annually, with 23,000 using it on a regular basis. There are approximately 100 people aged 0-9 years, 712 aged 10-19, 31,000 aged 20-60, and 14,000 aged 60+ using gabapentin. Approximately 1,300 people living with epilepsy use gabapentin for seizure control There are approximately 4,500 Māori and 1,200 Pacific people using gabapentin.
Why we’re proposing this
As a result of the RFP, PHARMAC has entered into provisional agreements with Apotex New Zealand Limited for the supply of gabapentin and Pfizer New Zealand Limited for supply of pregabalin and feedback to this consultation will help us to decide if these agreements should be confirmed.
Details about our proposal
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) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:
|
Chemical |
Presentation |
Brand* |
Pack size |
|---|---|---|---|
|
Pregabalin |
Cap 25 mg |
Pregabalin Pfizer |
56 |
|
Pregabalin |
Cap 75 mg |
Pregabalin Pfizer |
56 |
|
Pregabalin |
Cap 150 mg |
Pregabalin Pfizer |
56 |
|
Pregabalin |
Cap 300 mg |
Pregabalin Pfizer |
56 |
- The price and subsidy would be notified should PHARMAC decide to progress the proposal following consideration of consultation feedback.
- There would be a funding restriction preventing concurrent funded use of gabapentin and pregabalin.
* Note: Pfizer has Medsafe approval for pregabalin 25 mg, 75 mg, 150 mg and 300 mg capsules under the brand name Lyrica since 24 November 2005. A Change Medicine Notification (CMN) would be lodged with Medsafe to change the brand name to Pregabalin Pfizer.
Listing of Apo-Gabapentin
- From 1 June 2018 Apotex’s brand of gabapentin 100mg, 200 mg and 300 mg capsules (Apo-Gabapentin) would 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 |
|---|---|---|---|
|
Gabapentin |
Cap 100 mg |
Apo-Gabapentin |
100 |
|
Gabapentin |
Cap 300 mg |
Apo-Gabapentin |
100 |
|
Gabapentin |
Cap 400 mg |
Apo-Gabapentin |
100 |
- There would be no Special Authority restrictions applying to Apo-Gabapentin.
- There would be a funding restriction preventing concurrent funded use of gabapentin and pregabalin.
- The price and subsidy would be notified should PHARMAC decide to progress the proposal following consideration of consultation feedback.
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) would 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 Arrow-Gabapentin, Neurontin, and Nupentin in Section B would be removed 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) would be awarded Hospital Supply Status (HSS) for pregabalin capsules in DHB hospitals. This would 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 would be required to be Pregabalin Pfizer).
Gabapentin
- From 1 August 2018 until 30 June 2021, Apo-Gabapentin (cap 100mg, 200 mg and 300 mg) would be awarded HSS for gabapentin capsules in DHB hospitals. This would 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 would be required to be Apo-Gabapentin).
- From 1 August 2018, all other brands of gabapentin would 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) would be awarded Sole Supply Status for pregabalin capsules in the community. This would 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 100mg, 200 mg and 300 mg) would be awarded Sole Supply Status for gabapentin capsules in the community.
- From 1 November 2018, all other brands of gabapentin would be delisted from Section B of the Pharmaceutical Schedule.
- A Brand Switch Fee would be able to be claimed on the first gabapentin dispensing by community pharmacies, 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).
To provide feedback
Send us an email: procurement@pharmac.govt.nz, by 4pm on 10 November 2017.
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.