Decision to award sole supply to Zoladex and reference price Eligard and Lucrin

Medicines

Decision

PHARMAC has made decisions to award the Zoladex brand of goserelin Sole Subsidised Supply in the community and Hospital Supply Status in DHB hospitals and to apply reference pricing to leuprorelin (Eligard and Lucrin) in the community. This was the subject of a consultation letter dated 7 July 2016. The consultation letter is available online.

In summary, the effect of the decisions is that:

  • the price and subsidy for the Zoladex brand of goserelin (supplied by AstraZeneca) will be reduced from 1 October 2016.
  • the Zoladex brand of goserelin will be the community Sole Subsidised Supply brand and have Hospital Supply Status from 1 December 2016 until 30 June 2019. This means that Zoladex will be the only fully funded brand of goserelin in the community and will be the only available brand in DHB hospitals subject to a 1% Discretionary Variance (DV) Limit from 1 December 2016 until 30 June 2019.
  • the subsidy for leuprorelin (Eligard, Lucrin) listed in Section B of the Pharmaceutical Schedule will be reduced to the level of subsidy of goserelin via the application of reference pricing from 1 December 2016.  If the suppliers of leuprorelin do not reduce their prices to match the level of subsidy for goserelin, this would result in:
    • a manufacturer’s surcharge applying to leuprorelin medicines; and
    • goserelin being the only fully funded GnRH analogue.
  • a Higher Subsidy by Endorsement for leuprorelin will be available for children or adolescents who are unable to tolerate administration of goserelin.
  • a Higher Subsidy by Endorsement for leuprorelin will also be available from 1 December 2016 until 28 February 2017 for patients who have outstanding repeat dispensings of leuprorelin.
  • the 4 monthly dose presentation of leuprorelin inj 30 mg, prefilled syringe (Eligard) will be delisted on 1 October 2016.

Several changes were made following consideration of consultation feedback received, including:

  • the date for applying reference pricing to leuprorelin (a range for commencement was proposed during consultation).
  • the criteria for Higher Subsidy by Endorsement for leuprorelin (the proposal consulted on was that this would be restricted to those aged 16 years and under and did not propose a criteria to address patients with outstanding prescriptions).

It is estimated that this decision will result in significant savings to the Combined Pharmaceutical Budget, with discounted savings of approximately $16.4 million anticipated over the period ending 30 June 2019. This means that more money will be available to fund other medicines to treat other people in our communities.

Details of the decision

Changes related to goserelin (Zoladex)

  • From 1 October 2016 the price and subsidy of goserelin (Zoladex) listed in Section B and Part II of Section H of the Pharmaceutical Schedule will be reduced as follows (ex-manufacturer and excluding GST):
    Chemical Presentation Brand Pack size Current price and subsidy New price and subsidy
    Goserelin Implant 3.6 mg, syringe Zoladex 1 $166.20 $66.48
    Goserelin Implant 10.8 mg, syringe Zoladex 1 $443.76 $177.50
  • Zoladex will be awarded Sole Subsidised Supply for goserelin from 1 December 2016 to 30 June 2019, meaning that Zoladex will be the only subsidised brand of goserelin during this time.
  • Zoladex will be awarded Hospital Supply Status for goserelin from 1 December 2016 to 30 June 2019, meaning that Zoladex will be the only available brand of goserelin in DHB hospitals, subject to a 1% DV Limit (99% of total volume of goserelin purchased by DHB hospitals must be Zoladex) during this time.

Application of GnRH analogue Reference Pricing

  • From 1 December 2016, the subsidy for all presentations of leuprorelin will be reduced in Section B of the Pharmaceutical Schedule to the level of the subsidy for goserelin via the application of reference pricing as follows (ex-manufacturer, excluding GST):
    Pharmaceutical Dose Formulation Presentation Brand Pack size Current subsidy and price Proposed subsidy (Manufacturer’s Price)
    Leuprorelin 1 monthly Inj 7.5 mg syringe with diluent Eligard 1 Month 1 $166.20 $66.48
    ($166.20)
    Leuprorelin 1 monthly Inj 3.75 mg, prefilled dual chamber syringe Lucrin Depot
    1-Month
    1 $221.60* $66.48
    ($221.60)
    Leuprorelin 3 monthly Inj 22.5 mg syringe with diluent Eligard 3 Month 1 $443.76 $177.50
    ($443.76)
    Leuprorelin 3 monthly Inj 11.25 mg, prefilled dual chamber syringe Lucrin Depot
    3-Month
    1 $591.68* $177.50
    ($591.68)
    Leuprorelin 6 monthly Inj 45 mg syringe with diluent Eligard 6 Month 1 $832.05 $332.82
    ($832.05)
    Leuprorelin 6 monthly Inj 30 mg, prefilled dual chamber syringe Lucrin Depot
    6-Month
    1 $1,109.40* $332.82
    ($1,109.40)

    * a rebate applies

  • if the suppliers of Eligard and Lucin Depot decide not to reduce the price of their products to match the new subsidies, a manufacturer’s surcharge will apply to these medicines, meaning that patients would need to pay a part charge if they wished to continue using leuprorelin.  If they wanted to use a fully funded GnRH analogue, they would need to switch to goserelin (Zoladex).
  • A Higher subsidy with Endorsement would apply to all listed presentations of leuprorelin from 1 December 2016 as follows:

Higher subsidy with Endorsement

Additional subsidy by endorsement where:

1. the patient is a child or adolescent and is unable to tolerate administration of goserelin and the prescription is endorsed accordingly;

For the period 1 December 2016 until 28 February 2017 patients who have an outstanding repeat dispensing on their leuprorelin prescription at 1 December 2016 will also be eligible for a Higher Subsidy by Endorsement as follows:

2. the patient has outstanding repeat dispensings at 1 December 2016 and the prescription is endorsed accordingly. From 1 December 2016 until 28 February 2017 pharmacists may annotate a prescription as endorsed where the patient has outstanding repeat dispensings at 1 December 2016.

Delisting

  • From 1 October 2016 the 4 monthly dose presentation of leuprorelin inj 30 mg, prefilled syringe (Eligard), will be delisted, as this presentation is no longer supplied.

Healthcare professional support

Further information is available on the PHARMAC website to support healthcare professionals who need to change patients from leuprorelin to goserelin in order for them to remain on a fully funded GnRH analogue when reference pricing commences on 1 December 2016.

Feedback received

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

Theme Comment
Some responders raised concern about the proposed wording of the full subsidy for leuprorelin by Endorsement for patients aged 16 years and under, noting that this may not sufficiently cover the intended patient groups. PHARMAC has changed the wording to allow full subsidy by Endorsement for children and adolescents who are unable to tolerate administration of goserelin, rather than specifying an age limit.
Responders identified other patient groups/situations where Zoladex could be considered unsuitable, including patients taking anticoagulants, patients with a low BMI and patients who are needle phobic. The Medsafe datasheet for Zoladex notes that extra care must be taken when administering Zoladex to patients with a low BMI or on anticoagulant medication but its use in these patients is not contraindicated. We note that subsidy data show that, of patients taking anticoagulants and a GnRH analogue, more than half of the monthly and 3 monthly GnRH analogue use is for Zoladex. We note that all currently subsidised GnRH analogues are injectable formulations, and consider that it is likely patients with needle phobias would experience some anxiety with treatment regardless of needle size.
Some responders raised concerns about the therapeutic equivalence and side effect profiles of goserelin versus leuprorelin. PHARMAC received advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) and the Endocrinology and Cancer Treatments Subcommittees of PTAC that goserelin and leuprorelin can be expected to provide the same or similar therapeutic effect and that it would be reasonable to apply reference pricing to the GnRH analogues therapeutic sub-group. The side effect profiles of goserelin and leuprorelin are also similar.
Some responses noted potential difficulties with Zoladex administration, in particular because of the larger needle size/pain on injection and that Zoladex cannot be self-administered. We have been advised that pain on injection is largely dependent on administration technique. PHARMAC and AstraZeneca will ensure that healthcare professionals have access to resources regarding administration techniques.We note that the Medsafe datasheets for all currently available GnRH analogues advise that these treatments should be administered by or in the presence of a health care professional
Some responses expressed concern with the potential loss of access to a 6-monthly GnRH analogue formulation and the impact this could have on the patients and the health care system. We acknowledge that the removal of a fully funded 6-monthly presentation of a GnRH analogue may have financial and resource impacts on patients and health care providers (e.g. extra injections, costs of travel). We note that subsidy data shows most patients (95%) who are currently treated with 6-monthly leuprorelin have other long-term conditions that require 3-monthly prescriptions and are therefore already likely to be attending regular appointments with their General Practice.
Some responders raised concern with having only one supplier of GnRH analogues. AstraZeneca is currently the only supplier of goserelin and this decision would maintain this situation until at least until 30 June 2019. Leuprorelin will remain listed (at a reduced subsidy) and the decision will not prevent the listing of additional leuprorelin brands.
Responders raised concerns that there could be anxiety among patients who have received benefit from one GnRH analogue and need to switch to an alternative GnRH analogue to remain on a fully funded product. Health care professional support for these patients may be required. We acknowledge that patients may be concerned. We consider that healthcare professionals are best placed to inform patients of the proposed change to a different GnRH analogue, and resources will be provided to support health care professionals in their discussions with patients.
Some responders raised concerns around transition timeframes. Having considered this feedback, PHARMAC has decided to commence reference pricing from 1 December 2016. Patients on leuprorelin who have outstanding repeats at 1 December 2016 will be able to get their repeats subsidised via a Higher Subsidy by Endorsement until 28 February 2017 to help manage this transition.

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.