Proposal to award sole supply to goserelin (Zoladex) and reference price leuprorelin (Eligard and Lucrin PDS)

Medicines

Consultation Closed

PHARMAC is seeking feedback on a proposal to:

  • reduce the price and subsidy for AstraZeneca’s brand of goserelin (Zoladex) from 1 October 2016.
  • award Sole Supply Status and Hospital Supply Status to AstraZeneca’s brand of goserelin (Zoladex) from 1 December 2016.
    • This means Zoladex would be the only fully funded brand of goserelin in the community and would be the only available brand in DHB hospitals subject to a 1% Discretionary Variance (DV) Limit from 1 December 2016.
  • reduce the subsidy for other listed GnRH analogues listed in Section B of the Pharmaceutical Schedule to the level of subsidy of goserelin (Reference Pricing) as soon as 1 October 2016.
    • If the suppliers of leuprorelin do not reduce the price to the level of subsidy for goserelin, this would result in:
      • A patient part charge applying to leuprorelin medicines; and
      • goserelin being the only fully funded GnRH analogue on the Pharmaceutical Schedule.
  • delist the 4 monthly dose presentation of leuprorelin – leuprorelin Inj 30 mg, prefilled syringe (Eligard) from 1 October 2016.

PHARMAC has previously received advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) and its Cancer Treatments and Endocrinology Subcommittees that it would be clinically reasonable to reference price goserelin to leuprorelin (or vice versa). Further information about this advice can be found in the Background section below.

We are asking for general feedback about this proposal and also specific implementation feedback.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 4:00 pm Monday, 1 August 2016 to:

Chloë Dimock
Procurement Manager
PHARMAC

Email: procurement@pharmac.govt.nz
Fax:     04 460 4995
Post:    PO Box 10 254, Wellington 6143

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.

Details of the proposal

Proposed changes related to goserelin (Zoladex)

  • From 1 October 2016 the price of Zoladex depot implants (goserelin acetate, Implant 3.6 mg and Implant 10.8 mg) listed in Section B and Part II of Section H of the Pharmaceutical Schedule would be reduced as follows (ex-manufacturer and excluding GST):
Chemical Presentation Brand Pack size Current Price Proposed price and subsidy
Goserelin Implant 3.6 mg Zoladex 1 $166.20 $66.48
Goserelin Implant 10.8 mg Zoladex 1 $443.76 $177.50
  • Zoladex (goserelin, Implant 3.6 mg and Implant 10.8 mg) would be awarded Sole Supply Status. This would result in Zoladex remaining the only subsidised brand of goserelin in the Community from 1 December 2016 until 30 June 2019.
  • Zoladex (goserelin, Implant 3.6 mg and Implant 10.8 mg) would be awarded Hospital Supply Status. This would result in Zoladex being 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) from 1 December 2016 until 30 June 2019.

Proposed application of GnRH analogue Reference Pricing

  • From as soon as 1 October 2016, but no later than 1 December 2016, the subsidy for all other presentations of pharmaceuticals listed in the ‘GnRH analogues’ therapeutic subgroup would be reduced in Section B of the Pharmaceutical Schedule 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)
Goserelin 1 monthly Implant 3.6 mg Zoladex 1 $166.20 $66.48
Goserelin 3 monthly Implant 10.8 mg Zoladex 1 $443.76 $177.50
Leuprorelin 1 monthly Inj 7.5 mg syringe Eligard 1 $166.20 $66.48
($166.20)
Leuprorelin 1 monthly Inj 3.75 mg, prefilled syringe Lucrin Depot PDS 1 $221.60* $66.48
($221.60*)
Leuprorelin 3 monthly Inj 22.5 mg syringe Eligard 1 $443.76 $177.50
($443.76)
Leuprorelin 3 monthly Inj 11.25 mg, prefilled syringe Lucrin Depot PDS 1 $591.68* $177.50
($591.68*)
Leuprorelin 4 monthly Inj 30 mg syringe Eligard 1 $591.68 $236.67
($591.68)
Leuprorelin 6 monthly Inj 45 mg syringe Eligard 1 $832.05 $332.82
($832.05)
Leuprorelin 6 monthly Inj 30 mg, prefilled syringe Lucrin Depot PDS 1 $1,109.40* $332.82
($1,109.40*)
* a rebate applies
  • If the suppliers of Eligard and Lucin Depot PDS decide not to reduce the price of their products to match the subsidy, a patient part charge would apply on these medicines. Zoladex may become the only fully subsidised GnRH analogue listed on the Pharmaceutical Schedule. Approximate patient numbers are provided in the background section below
  • Children (defined as 16 years and under) would be eligible for full subsidy by endorsement for non-implant GnRH analogue presentations.

Delisting

  • From 1 December 2016 the 4 monthly dose presentation of leuprorelin – leuprorelin Inj 30 mg, prefilled syringe (Eligard), would be delisted.

Specific feedback sought

In addition to general feedback on the proposal, we would like your specific feedback about the questions below to help us understand how the proposed change may impact healthcare professionals and patients.

Feedback will help inform changes that might be required to the proposal as a result of this consultation. It will also help us develop any implementation support that may be required.

Background

Current Funding

  • GnRH analogue treatment indications include prostate cancer, breast cancer, endometriosis, uterine fibroids, central precocious puberty, and assisted reproduction.
  • Two GnRH analogues (goserelin and leuprorelin) are currently listed and fully subsidised by PHARMAC without any restrictions.
  • There are two presentations of goserelin and seven presentations of leuprorelin currently listed in Section B and Part II of Section H of the Pharmaceutical Schedule, as follows:
    Subsidy/Price$ Per Fully Subsidised Brand or Generic Manufacturer
 GOSERELIN            
Inj 3.6 mg, depot implant ……………… 166.20 1 Yes Zoladex
Inj 10.8 mg, depot implant ……………… 443.76 1 Yes Zoladex
 LEUPRORELIN           
Inj 3.75 mg prefilled syringe ……………… 221.60* 1 Yes Lucrin Depot PDS
Inj 7.5 mg ……………… 166.20 1 Yes Eligard
Inj 11.25 mg prefilled syringe ……………… 591.68* 1 Yes Lucrin Depot PDS
Inj 22.5 mg ……………… 443.76 1 Yes Eligard
Inj 30 mg ……………… 591.68 1 Yes Eligard
Inj 30 mg prefilled syringe ……………… 1,109.40* 1 Yes Lucrin Depot PDS
Inj 45 mg ……………… 832.05 1 Yes Eligard
* A rebate exists
  • The currently funded GnRH analogues represent significant expenditure to the Combined Pharmaceutical Budget (CPB). For the 2015 calendar year, the approximate expenditure on leuprorelin and goserelin was as follows:
Chemical Approximate net expenditure for community market Approximate net expenditure for DHB hospital market*
Leuprorelin $5.3 million* $90,000*
Goserelin $4.2 million $150,000
Total $9.5 million* $230,000*
 *a rebate exists [PDF, 66 KB] for three presentations of leuprorelin

Clinical Advice

PHARMAC previously received advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) that goserelin and leuprorelin were in the same therapeutic sub-group, and had the same or similar therapeutic effect. As such reference pricing has been applied to this subgroup in the past. The currently listed GnRH analogue presentations have the same net price for all listed brands with the same dose formulations, i.e. monthly, 3 monthly and 6 monthly (links to previous notifications relating to goserelin [PDF, 130 KB] and leuprorelin [PDF, 66 KB]).

In September 2015, PHARMAC received advice from the Cancer Treatments Subcommittee (CaTSoP) of PTAC. The Subcommittee considered that it would be clinically reasonable to reference price goserelin to leuprorelin (or vice versa), or to run a competitive process that would result in only one of goserelin or leuprorelin being subsidised. The relevant minutes can be found on the PHARMAC website [PDF, 83 KB].

PHARMAC recently received advice from the Endocrinology Subcommittee of PTAC that, on the basis that leuprorelin and goserelin can be expected to provide the same or similar therapeutic effect in the endocrinology indications, it would be clinically reasonable to apply reference pricing of leuprorelin to goserelin (or vice versa), or to run a competitive process that would result in only one of leuprorelin or goserelin being subsidised. The relevant minutes can be found on the PHARMAC website [PDF, 1.2 MB].

PHARMAC has been advised that implant presentations such as Zoladex are not as acceptable to paediatric patients. Therefore it is proposed that children (defined as 16 years and under) would be able to seek full subsidy by endorsement for non-implant GnRH analogue presentation.

Patient demographic

The below table summarises approximate patient numbers split by age and sex.

GnRH analogue patient age and sex
Duration of Chemical Action Brand Chemical and Presentation Patient Market Data (2015 FYR)
Patients 16 years and younger Patients 17 years and older
Male Female Male Female
1 month Zoladex Goserelin Implant 3.6 mg 0 <5 190 690
Eligard Leuprorelin
Inj 7.5 mg, syringe
<5 <5 20 <5
Lucrin Depot 1- Month Injection Leuprorelin
Inj 3.75 mg prefilled syringe
10 40 100 220
3 month Zoladex Goserelin Implant 10.8 mg <5 5 2,420 320
Eligard Leuprorelin
Inj 22.5 mg syringe
<5 <5 150 <5
Lucrin Depot 3- Month Injection Leuprorelin
Inj 11.25 mg prefilled syringe
30 110 1,510 180
4 month Eligard Leuprorelin
Inj 30 mg syringe
0 0 0 0
6 month Eligard Leuprorelin
Inj 45 mg syringe
0 0 670 <5
Lucrin Depot 6- Month Injection Leuprorelin
Inj 30 mg prefilled syringe
<5 0 920 10