Decision to award sole supply for Nicotine Replacement Therapy (NRT)

Medicines

Decision

PHARMAC is pleased to announce the approval of an agreement with GlaxoSmithKline Consumer Healthcare New Zealand Limited (GSK) for the supply of its Habitrol brand of nicotine replacement therapy (NRT) gum, lozenges and patches.

This was the subject of a consultation letter dated 21 July 2017.

Following consultation feedback there were two additions, for clarification, to the way in which the new small pack sizes will be listed in the Pharmaceutical Schedule.  It will be made clear in the Schedule that these pack sizes are funded for distribution by Authorised Providers only. In all other aspects, the proposal was approved as consulted on.

In summary, the effect of the decision is that:

  • There is no change to the funded brand of NRT.
  • From 1 January 2018:
    • The price and subsidy of Habitrol will increase. This will not affect consumers, as the product will continue to be fully funded.
    • New small pack sizes will be listed in Section B of the Pharmaceutical Schedule, available for direct distribution to Authorised Providers only (available for delivery from April 2018 onwards).
  • From 1 April 2018, Sole Supply Status and Hospital Supply Status, with a 1% DV Limit for hospitals, for nicotine gum, lozenges and patches will be applied to GSK’s Habitrol brand until 30 June 2020. PHARMAC has the option of extending the sole supply period for a further two years.
  • Nicotine solution for inhalation 15 mg cartridge and oral spray 1 mg per dose will continue to be listed in Section H of the Pharmaceutical Schedule subject to the current restrictions. These presentations do not form part of this agreement.

PHARMAC has also recently consulted on a separate proposal which, if progressed, would enable patients to receive funded NRT from pharmacies, without a prescription. The outcome of this proposal, when determined, will be notified separately.

Details of the decision

Section B

From 1 January 2018:

  • The price and subsidies for Habitrol (nicotine patch, lozenge and gum) will be increased in Section B of the Pharmaceutical Schedule, as detailed below.
  • New small pack sizes will be listed, restricted for direct distribution only, to be used by Authorised Providers, with the application of the Xpharm rule.

Chemical

Presentation

Brand

Pack size

New price and subsidy

Nicotine

Patch 7 mg

Habitrol

28

$16.00

Nicotine

Patch 7 mg for direct distribution only (Xpharm)

Habitrol

7

$3.94

Nicotine

Patch 14 mg

Habitrol

28

$17.59

Nicotine

Patch 14 mg for direct distribution only (Xpharm)

Habitrol

7

$4.52

Nicotine

Patch 21 mg

Habitrol

28

$20.16

Nicotine

Patch 21 mg for direct distribution only (Xpharm)

Habitrol

7

$5.18

Nicotine

Lozenge 1 mg

Habitrol

216

$16.61

Nicotine

Lozenge 1 mg for direct distribution only (Xpharm)

Habitrol

36

$3.20

Nicotine

Lozenge 2 mg

Habitrol

216

$18.20

Nicotine

Lozenge 2 mg for direct distribution only (Xpharm)

Habitrol

36

$3.24

Nicotine

Gum 2 mg (mint)

Habitrol

384

$33.69

Nicotine

Gum 2 mg (mint) for direct distribution only (Xpharm)

Habitrol

96

$8.64

Nicotine

Gum 2 mg (fruit)

Habitrol

384

$33.69

Nicotine

Gum 2 mg (fruit) for direct distribution only (Xpharm)

Habitrol

96

$8.64

Nicotine

Gum 4 mg (mint)

Habitrol

384

$38.95

Nicotine

Gum 4 mg (mint) for direct distribution only (Xpharm)

Habitrol

96

$10.01

Nicotine

Gum 4 mg (fruit)

Habitrol

384

$38.95

Nicotine

Gum 4 mg (fruit) for direct distribution only (Xpharm)

Habitrol

96

$10.01

(All prices are ex-manufacturer, excluding GST)

From 1 April 2018:

  • Habitrol will be awarded Sole Supply Status for nicotine patch, lozenge and gum forms, until 30 June 2020.

Section H

From 1 January 2018:

  • The prices for Habitrol (nicotine patch, lozenge and gum) will be increased in Part II Section H of the Pharmaceutical Schedule, as follows:

Chemical

Presentation

Brand

Pack size

New price

Nicotine

Patch 7 mg

Habitrol

28

$16.00

Nicotine

Patch 14 mg

Habitrol

28

$17.59

Nicotine

Patch 21 mg

Habitrol

28

$20.16

Nicotine

Lozenge 1 mg

Habitrol

216

$16.61

Nicotine

Lozenge 2 mg

Habitrol

216

$18.20

Nicotine

Gum 2 mg (mint)

Habitrol

384

$33.69

Nicotine

Gum 2 mg (fruit)

Habitrol

384

$33.69

Nicotine

Gum 4 mg (mint)

Habitrol

384

$38.95

Nicotine

Gum 4 mg (fruit)

Habitrol

384

$38.95

(All prices are ex-manufacturer, excluding GST)

From 1 April 2018:

  • Habitrol will be awarded Hospital Supply Status for nicotine patch, lozenge and gum forms, with a 1% DV Limit for hospitals, until 30 June 2020.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 7 August 2017 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, the following issues were raised in relation to specific aspects of the proposal:

Theme Comment

Support

  • Support for continuing to fund Habitrol brand of NRT products, which are considered safe and proven as effective cessation products and for the addition of smaller pack sizes for Authorised Providers.
  • DHBs and other providers do not have to change documentation or retrain staff on new products which will save time and resources.
Noted.

Alternative Forms of NRT

Responses suggested that PHARMAC should fund additional alternative forms of NRT such as the oral spray and/or inhaler which are currently listed with restrictions for use in the hospital setting but not funded in the community.

  • Responders thought it important to be able to offer a variety of cessation products and options to help engage with patients who often have complex health and socioeconomic needs. Not having affordable access to a wider range of products seems inconsistent with the Government’s smoke free 2025 aspirations.
  • Responders identified a few smoking cessation priority subgroups that PHARMAC could consider funding alternative forms of NRT for:
    • pregnant women;
    • mental health patients; and
    • Māori patients.
    Alternatively consider funding a limited supply of the alternative forms of NRT, via Authorised Providers, to research and evaluate their use and guide future decisions.

The 2017 RFP invited proposals for both nicotine solution for inhalation and nicotine oral spray in both the hospital and community settings. The RFP clearly stated that listing would only occur if proposals aligned with the PTAC recommendation from August 2014, that the average daily cost of each treatment was no more expensive than the weighted combined average daily cost of gum, lozenges and patches.

PHARMAC did not proceed with any agreements for these additional forms of NRT as no bids were received which aligned with the PTAC recommendation.

PHARMAC is willing to consider funding applications for specific patient groups. Applications must include evidence in support of inhaler and/or oral spray over the currently funded treatment options in the specific patient group(s).

The oral spray and inhaler remain listed in Section H of the Pharmaceutical Schedule.

Small Pack Size Listing Clarification

One responder requested clarification on how PHARMAC intended to list the new small pack sizes and avoid confusion about who can supply what to whom, given that the new smaller pack sizes would only be available to Authorised Providers.   

The new smaller pack sizes will be listed with the phrase “for direct distribution only” as part of the presentation description.  The “Xpharm” rule will also be applied to the listing, which will mean that community pharmacy will not be able to claim reimbursement for these pack sizes.

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.