Jadelle (levonorgestrel 2 x 75 mg rods) funding proposal approved

Medicines

Decision

PHARMAC is pleased to announce the approval of an agreement with Bayer New Zealand Limited for the listing and supply of levonorgestrel 2 x 75 mg rods (Jadelle). This was the subject of a consultation letter dated 29 August 2014

Details of the proposal

Jadelle will continue to be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical Presentation Brand Pack size Price and Subsidy
Levonorgestrel Subdermal implant (2 x 75 mg rods) Jadelle 1 $133.65
  • Jadelle will be the sole subsidised Hormonal Long Acting Reversible Contraceptive in the Progesterone-only Contraceptives, Contraceptives – Hormonal sub-group on the Genito-Urinary System of Section B and Part II of Section H of the Pharmaceutical schedule From 1 October 2014 until 31 December 2017.
  • This proposal maintains the incumbent supplier of implants to the market, and Bayer New Zealand Limited will continue to provide insertion and removal training of Jadelle for clinicians (please contact Bayer for details).

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 12 September 2014 were considered in their entirety in making a decision on the proposed changes. The table below summarises the issues that were raised during the consultation period in relation to specific aspects of the proposal:

Theme Comment

Pleased with the high uptake of the Jadelle contraceptive, noting there is no significant difference in the international literature between the efficacy or side effect profile of Jadelle and Implanon

PHARMAC agrees that there has been good uptake of the funded implant with on average over 12,000 units being subsidised each year for patients requiring long term contraception.

There is a higher likelihood that a rod may be placed deeper with a two rod system, therefore requiring interventional removal.

Implanon NXT is easier to grasp during removal than the more slippery Jadelle rods.

PHARMAC will provide this feedback to the supplier so that they can provide extra support to clinicians particularly for insertion.

Less than 0.067% of implants are difficult to remove. This, on balance, was not considered to outweigh the advantages of Jadelle.

To date there are no published direct comparator studies between Jadelle and Implanon to support this statement regarding removal of the rods.

PHARMAC considers the costs to the health sector, including the cost of insertion and removal of implants, as part of this decision.

Sole subsidised supply would reduce access to the preferred implant and thus limit clinician’s choice.

The high uptake of the Jadelle implant (over 1000 women per month) indicates that despite information about the ease of removal of a one versus a two rod implant, Jadelle is still a popular funded contraceptive choice.

PHARMAC is mandated to maintain a fixed budget in terms of pharmaceutical expenditure and to get the ‘best health outcomes’ from its funding decisions. These decisions may not always align with an individual clinician’s choice of treatment.

The time delay was highlighted from end of previous sole supply period (December 2013) to current issue of Request for Proposals (RFP) on 17 March 2014.

While the sole supply contract for Jadelle ended in December 2013, Jadelle has remained fully funded and available for patients since this time.

PHARMAC is purely motivated by cost in its decision making.

As PHARMAC operates within a fixed budget, we must take cost into consideration. However, cost is only one of a number of factors that PHARMAC considers to ensure that the funded pharmaceutical would provide the best health outcome for New Zealanders.  Other factors include evidence-based efficacy of a product, cost to the health sector, availability of product supply and clinical support.

Assume that as part of the selection process end-user engagement would have occurred, indicating the level of dissatisfaction with Jadelle amongst general practitioners

During the evaluation process PHARMAC received clinical submissions regarding the products.  These were considered in full alongside all other factors. PHARMAC chose Jadelle because it provides the best combination of efficacy and cost. Additionally, compared with another implant, its therapeutic effect is five years.

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.