Decision to fully fund oestradiol transdermal patches without restriction

10 June 2016

Medicines Decision

PHARMAC is pleased to announce the widening of access to fully-funded oestradiol transdermal patches in conjunction with the awarding of oestradiol tender bids as part of PHARMAC’s 2015/16 annual Invitation to Tender.

This was the subject of a consultation letter dated 4 May 2016.

In summary, the effect of the decision is that:

The price and subsidy of Novartis New Zealand Limited’s brand (Estradot) of oestradiol patch 25 mcg, 50 mcg and 100 mcg per day in Section B of the Pharmaceutical Schedule will be amended to fully fund these products without restriction from 1 August 2016;
A new strength of Estradot (patch 75 mcg per day) will be listed fully funded in Section B of the Pharmaceutical Schedule from 1 January 2017;
Sole Supply Status has been awarded to Novartis New Zealand Limited for its Estradot brands to be the sole subsidised brand of oestradiol patches until 30 June 2019;
The Special Authority criteria currently applying to the Climara 50 and Climara 100 brands of oestradiol patches to enable access to a higher subsidy will be removed from 1 October 2016, meaning that all patients currently receiving full funding for these brands will need to change to Estradot to continue to receive a fully-funded oestradiol patch.
Climara 50 and Climara 100 will be delisted from 1 January 2017.

Details of the decision

The price and subsidy of Novartis New Zealand Limited’s brand of oestradiol patch 25 mcg, 50 mcg and 100 mcg per day will be amended in Section B, and will be listed in Part II of Section H, of the Pharmaceutical Schedule from 1 August 2016 as follows (ex manufacturer, excluding GST):

Chemical and presentation	Brand	Pack Size	Current subsidy (and price)	New subsidy and price
Oestradiol patch 25 mcg per day	Estradot	8	$3.01($10.86)	$6.12
Oestradiol patch 50 mcg per day	Estradot 50 mcg	8	$4.12($13.18)	$7.04
Oestradiol patch 100 mcg per day	Estradot	8	$7.05($16.14)	$7.91

Novartis New Zealand Limited’s brand of oestradiol patch 75 mcg per day will be listed in in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 January 2017 as follows (ex manufacturer, excluding GST):

Chemical and presentation	Brand	Pack Size	Subsidy and price
Oestradiol patch 75 mcg per day	Estradot	8	$7.91

The Special Authority criteria currently applying to the Estradot brands of oestradiol patches to access a higher subsidy will be removed from 1 August 2016; meaning that all patients prescribed Estradot from this date will receive a full-subsidy without needing a valid Special Authority approval.
Novartis New Zealand Limited’s Estradot patch 25 mcg per day will be the sole subsidised brand of 25 mcg per day oestradiol patches in Section B the Pharmaceutical Schedule from 1 November 2016 until 30 June 2019, and be the Hospital Supply Status brand of the Hospital Pharmaceutical oestradiol patch 25 mcg per day, with a DV Limit of 1%, from 1 October 2016 until 30 June 2019.
Novartis New Zealand Limited’s Estradot patch 50 mcg and 100 mcg per day will be the sole subsidised brand of patch 50 mcg and 100 mcg per day oestradiol patches in Section B the Pharmaceutical Schedule from 1 January 2017 until 30 June 2019, and be the Hospital Supply Status brand of the Hospital Pharmaceutical oestradiol patch 50 mcg and 100 mcg per day, with a DV Limit of 1%, from 1 October 2016 until 30 June 2019.
Novartis New Zealand Limited’s Estradot patch 75 mcg per day will be the sole subsidised brand of 75 mcg per day oestradiol patches in Section B the Pharmaceutical Schedule from 1 April 2017 until 30 June 2019, and be the Hospital Supply Status brand of the Hospital Pharmaceutical oestradiol patch 75 mcg per day, with a DV Limit of 1%, from 1 March 2017 until 30 June 2019.
The Special Authority criteria currently applying to the Climara 50 and Climara 100 brands of oestradiol patches to enable access to a higher subsidy will be removed from 1 October 2016.
From 1 January 2017 Climara 50 and Climara 100 patches, as follows, will be delisted from Section B of the Pharmaceutical Schedule:

Chemical and presentation	Supplier	Brand
Oestradiol TDDS 3.9 mg (releases 50 mcg of oestradiol per day)	Bayer	Climara 50
Oestradiol TDDS 7.8 mg (releases 100 mcg of oestradiol per day)	Bayer	Climara 100

The partial subsidy that currently applies to Climara 50 and Climara 100 patches will not be increased during the transition period (from 1 October 2016 to 31 December 2016), so manufacturer’s surcharge will apply to all dispensings of Climara 50 and Climara 100 during that time.

Feedback received

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

Theme	Comment
Respondents supported the proposal to fully subsidise oestradiol transdermal patches without restriction, as this will reduce barriers for many New Zealand women needing HRT.	Noted.
The proposal will provide the most benefit to younger women who have had a womb and ovaries removed and are prematurely in surgical menopause. They have a much higher risk for osteoporosis and require longer duration of treatment, so are likely to benefit most from the lower thrombotic risk and reduced patient costs.	Noted.
Respondents would like to see this proposal widened to include further subsides on other forms of HRT, such as progestogen and oestrogen combination products.	This proposal doesn’t prevent us from considering subsidy increases on other on other forms of HRT. We have obtained clinical advice that for transdermal delivery of oestrogens is preferable to oral delivery.
Transdermal oestrogen avoids the first-pass metabolism occurring following oral administration. There is evidence that transdermal oestrogen patches are associated with lower risks of venous thromboembolism and stroke and a reduced risk of breast cancer. The lower doses also mean that transdermal oestrogen patches are well tolerated with few side effects that necessitate stopping treatment.	Noted.
Respondents expressed a desire to see a range of patch strengths funded or patches that are able to be cut in order to provide lower doses if required.	Under this proposal a range of strengths from 25 mcg to 100 mcg per day would be fully funded, allowing commencement of treatment at a low dose and depending on the clinical response adjusted to the woman’s individual needs.
A potential concern was raised around a possible increase in the prescription of unopposed oestrogen.	Noted. We intend to seek additional clinical advice from the Endocrinology Subcommittee on this matter.
A number of respondents felt that funding a levonorgestrel IUD for contraception was clinically more important than funding transdermal HRT.	Noted. We note that a request for proposals for widening funded access to progestogen-only long-acting intrauterine was issued 11 September 2015 which remains unresolved. A funding decision on the progestogen-only long-acting intrauterine systems RFP will be considered separately and is not related to this decision. Various pharmaceuticals are funded for contraception including a Long Acting Reversible Contraceptive (LARC), being the levonorgestrel subdermal implant.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz.