Proposal to fund candesartan with hydrochlorothiazide tablets for high blood pressures

What we’re proposing

We are seeking feedback on a proposal to fund candesartan with hydrochlorothiazide for people with high blood pressure from 1 July 2023, through a provisional agreement with Arrotex Pharmaceuticals (NZ) Limited.

If this proposal is approved, people using other funded anti-hypertensive medicines would have the option of transitioning to candesartan with hydrochlorothiazide. Candesartan with hydrochlorothiazide would be fully funded without restriction, which means it could be prescribed for any New Zealander who needed it. 

This proposal follows an interruption to supply and the subsequent recall of the Accuretic brand of quinapril with hydrochlorothiazide. 

Candesartan with hydrochlorothiazide is a combination of candesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic. The fixed-dose combination of these two anti-hypertensive medicines provides patients with a convenient medicine form when a single agent is insufficient to achieve the desired reduction in blood pressure. 

Consultation closes at 4 pm on Thursday, 1 June 2023 and feedback can be emailed to consult@pharmac.govt.nz

To provide feedback

Consultation is a very important step in our process. When providing consultation feedback, you might want to think about the following: 

• How we can help prescribers know about the availability of candesartan with hydrochlorothiazide 

Please send us an email: consult@pharmac.govt.nz by 4 pm on Thursday, 1 June 2023. 

What would the effect be?

It is proposed that candesartan with hydrochlorothiazide tablets would be fully funded without restriction. This would mean that candesartan with hydrochlorothiazide could be prescribed for any relevant use. 

The clinical advice we have received indicates that candesartan with hydrochlorothiazide may be a suitable funded alternative to quinapril with hydrochlorothiazide which is no longer available, and as an addition to the available fixed dose combination anti-hypertensive medications which patients could take.

We anticipate that up 45,000 New Zealanders may benefit from this new medicine. 

People prescribed candesartan with hydrochlorothiazide would need to pay a prescription charge (co-payment) as is required for all blood pressure medicines. For most people, this charge is $5.00 for each new prescription item. It is anticipated that this proposal would have minimal impact on Te Whatu Ora in terms of distribution costs as the list price of these products is the same as the quinapril with hydrochlorothiazide (Accuretic) products. 

Who we think will be interested

• People with high blood pressure, heart failure, kidney disease and heart disease and their whānau.
• People currently on other hypertensive medications.
• Healthcare professionals who treat people with high blood pressure, heart failure, kidney disease and heart disease.
• Hospital and community pharmacists, DHBs and wholesalers.
• Suppliers of pharmaceuticals to the New Zealand market. 

About candesartan with hydrochlorothiazide

Candesartan with hydrochlorothiazide is a combination of an angiotensin II receptor antagonist (candesartan) and a diuretic (hydrochlorothiazide). Candesartan and hydrochlorothiazide work together to lower high blood pressure. Candesartan lowers blood pressure by specifically blocking a substance called angiotensin II. Angiotensin II normally tightens your blood vessels. The candesartan ingredient in candesartan with hydrochlorothiazide allows them to relax. Hydrochlorothiazide works by making your kidneys pass more water and salt.  

Candesartan with Hydrochlorothiazide is Medsafe approved for the treatment of hypertension (high blood pressure). We understand it may also be used for the following conditions:

• Left Ventricular Hypertrophy 
• The prevention of cardiovascular events in patients with heart disease 

You can read more about candesartan with hydrochlorothiazide on the Medsafe data sheet(external link). 

Why we’re proposing this

Last year batches of Accuretic, quinapril with hydrochlorothiazide, were found to have small amounts of two impurities, called N-nitroso-quinapril and N-nitroso-hydrochlorothiazide. Medicine safety regulators have determined that exposure to these types of substances over a long time may increase a person’s risk of getting cancer. 

This was a global issue, Pfizer, the supplier of Accuretic, undertook voluntary recalls of the medicine around the world, including in Australia, Europe, the United States of America, and Canada. Pfizer withdrew remaining stock from distribution in New Zealand on 31 October 2022. 

Following advice received from Medsafe patients were encouraged to consult with their medical provider to determine what would be a suitable alternate medicine for them to be prescribed, in many cases this may have been the other funded fixed dose combination anti-hypertensive, losartan with hydrochlorothiazide. 

In order to strengthen the continuity of supply of fixed dose anti-hypertensive medicines in New Zealand following the withdrawal of the Accuretic brand of quinapril with hydrochlorothiazide, we have undertaken to source an alternate therapeutically equivalent product. While attempts were made to source a suitable alternate quinapril with hydrochlorothiazide product, this was not successful due to the requirement to have a product which would be able to achieve Medsafe regulatory approval. 

Candesartan with hydrochlorothiazide was identified as a clinically suitable alternate fixed dose antihypertensive medicine. Funding for this medicine would ensure that there are two fixed dose combination antihypertensives for patients and their prescribers to choose from. 

Details about our proposal

Candesartan with hydrochlorothiazide tab 16 mg with hydrochlorothiazide 12.5 mg and tab 32 mg with hydrochlorothiazide 12.5 mg would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 July 2023 as follows: 

Chemical	Presentation	Brand	Pack size	Price and Subsidy
Candesartan with hydrochlorothiazide	Tab 16 mg with hydrochlorothiazide 12.5 mg	Apo-Candesartan HCTZ	30	$4.10
Candesartan with hydrochlorothiazide	Tab 32 mg with hydrochlorothiazide 12.5 mg	Apo-Candesartan HCTZ	30	$5.25

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. 

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity. 

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.