Decision to fund rosuvastatin for people with high cholesterol

17 August 2021

We have made the decision to fund rosuvastatin for New Zealanders at increased risk of cardiovascular complications due to high cholesterol.

Clinician guidance

He Ako Hiringa have produced an article to support clinicians when considering prescribing rosuvastatin.

Read the article(external link)

This medicine will be available, fully funded from 1 December 2021. We would like to thank everyone who has helped contribute to this decision.

What we’re doing

We're pleased to announce a decision to fund rosuvastatin for people with high cholesterol through an agreement with Viatris Ltd (previously Mylan New Zealand Ltd), from 1 December 2021.

The medicine will be funded subject to patients meeting certain eligibility criteria.

What does this mean for people?

This decision means that people at high risk of cardiovascular disease who have high cholesterol despite treatment with other funded medicines will have access to funded rosuvastatin, subject to certain eligibility criteria.

We have also included a pro-equity component in the criteria whereby Māori and Pacific peoples who have a higher risk of cardiovascular disease can access rosuvastatin as a first line treatment option.

We expect approximately 75,000 people will benefit from the funding of rosuvastatin.

Any relevant practitioner, including Nurse Practitioners and Pharmacist Prescribers, will be able to apply for a Special Authority.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 5 February 2021. We received substantive feedback from consumers, clinicians, professional societies, and advocacy groups.

We want to thank everyone who took the time to provide us with their feedback.

We took additional time to consider the matters raised during consultation before making a decision. As a result, this medicine will be funded from 1 December 2021 for a wider group of patients than had originally been envisaged.

After carefully considering the consultation feedback we made some changes to the Special Authority criteria to clarify the intent to target the treatment to people who would be expected to benefit the most.

The original proposed criteria were outlined in the consultation letter.

Changes were made to clearly identify the specific patient groups at high risk of cardiovascular disease due to high or abnormal cholesterol and other risk factors. In addition, we have amended the criteria to improve access for Māori and Pacific peoples in recognition of the higher rate of cardiovascular disease in these populations.

Who we think will be most interested

People with high cardiovascular risk due to abnormal cholesterol and their whānau.
People, including healthcare professionals, involved in supporting people with high cardiovascular risk and disease.
Pharmaceutical suppliers.
Community pharmacies.

Detail about this decision

Rosuvastatin

Rosuvastatin (Viatris) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 December 2021 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Price and subsidy
Rosuvastatin	Tab 5 mg	Rosuvastatin Viatris	30	$1.70
Rosuvastatin	Tab 10 mg	Rosuvastatin Viatris	30	$2.42
Rosuvastatin	Tab 20 mg	Rosuvastatin Viatris	30	$3.92
Rosuvastatin	Tab 40 mg	Rosuvastatin Viatris	30	$5.28

Viatris rosuvastatin will have sole subsidised supply status and hospital supply status. A discretionary variance (DV) limit of 1% will apply to this medicine in DHB hospitals. This means 99% of the total volume purchases of 5mg, 10mg, 15mg and 20mg rosuvastatin tablets are required to be the Viatris brand, this applies until 30 June 2023.

Rosuvastatin will be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

Rosuvastatin

Special Authority for Subsidy - from any relevant practitioner. Approvals are valid without further renewal unless notified for applications meeting the following criteria:

Cardiovascular disease risk

Either:

Both:
1. Patient is considered to be at risk of cardiovascular disease; and
2. Patient is Māori or any Pacific ethnicity; or
Both:
1. Patient has a calculated risk of cardiovascular disease of at least 15% over 5 years; and
2. LDL cholesterol has not reduced to less than 1.8 mmol/litre with treatment with the maximum tolerated dose of atorvastatin and/or simvastatin.

Familial hypercholesterolemia

Both:

Patient has familial hypercholesterolemia (defined as a Dutch Lipid Clinic Network score greater than or equal to 6); and
LDL cholesterol has not reduced to less than 1.8 mmol/litre with treatment with the maximum tolerated dose of atorvastatin and/or simvastatin.

Established cardiovascular disease

Both:

Any of the following:
1. Patient has proven coronary artery disease (CAD); or
2. Patient has proven peripheral artery disease (PAD); or
3. Patient has experienced an ischaemic stroke; and
LDL cholesterol has not reduced to less than 1.4 mmol/litre with treatment with the maximum tolerated dose of atorvastatin and/or simvastatin.

Recurrent major cardiovascular events

Both:

Patient has experienced a recurrent major cardiovascular event (defined as myocardial infarction, ischaemic stroke, coronary revascularisation, hospitalisation for unstable angina) in the last 2 years; and
LDL cholesterol has not reduced to less than 1.0 mmol/litre with treatment with the maximum tolerated dose of atorvastatin and/or simvastatin.

Similar restrictions will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List).

Our response to what you told us

The feedback we received was extensive, thoughtful and invaluable in informing our decision-making process.

A summary of the main themes raised in feedback, and our responses, are set out in the table below.

After carefully considering the consultation feedback, we made the decision to specifically name Māori and Pacific ethnicities within the funding criteria. We consider this to be an intentional, proactive move to address medicines access equity for these population groups who are at high risk of complications of high cholesterol and for whom there is evidence of inequities in access to already funded medicines for high cholesterol.

We know that the causes of health inequities are complex, and solutions do not lie solely with the funding of medicines, or within the health system, but we also know that Pharmac has a role to play.

We have a broader programme of policy work considering how we can directly influence medicines access equity. You can read more about our medicines access equity work here.

We will support the implementation and monitor the uptake of this medicine to see whether it is being accessed by those people with highest need. We will also work with external experts to evaluate uptake and assess whether any further changes are needed to support the appropriate use of this medicine.

Theme	Pharmac Comment
General support for the funding of rosuvastatin with the proposed access criteria, felt that the proposed listing would benefit Māori and Pacific people who had a high risk of cardiovascular disease	Pharmac considers that many Māori and Pacific people would benefit through greater access to statin therapy, which is why we have consciously included a pro-equity aspect to the final special authority criteria.
General support for the funding of rosuvastatin due to its international availability and welcoming the ability for selected patients to access a more powerful statin therapy.	We acknowledge the support received for the funding of rosuvastatin. This aligns with the clinical advice received.
Many respondents commented that the Cholesterol (LDL) target levels should be aligned with the US and European guidelines.	In light of the feedback received, we have more clearly targeted funding to those patient groups most likely to benefit from rosuvastatin and adjusted the LDL targets in line with the latest international guidelines.
Several respondents commented that initial approvals should be for an indefinite period rather than requiring renewal criteria.	We amended the proposal in light of this feedback. Special Authorities will be approved without the need for renewal applications.
Suggestion that patients who have been diagnosed with coronary artery disease (CAD)/peripheral artery disease (PAD) without meeting the CV risk level requirement should be included as the proposed criteria did not cover these patients explicitly and they may not fall with the proposed Special Authority criteria	We have included an additional category within the Special Authority criteria for people with CAD/PAD.
Several respondents asked whether people currently self-funding would be able to access funded rosuvastatin publicly. It was noted this could be a large patient population	If it can be shown, at the time of commencing privately funded rosuvastatin, that the person would have met the proposed Special Authority criteria, then they may be eligible to receive funded rosuvastatin, via a waiver process.
Suggestion that the Special Authority should be only for those patients who have intolerance to other statins, regardless of failure to meet target LDL levels.	We consider that it is difficult to accurately define statin “intolerance” and therefore estimate what the potential patient population size would be. It remains an option to widen access in the future.
Suggestion that the setting of target LDL levels in the Special Authority criteria would make it difficult for Māori patients to access rosuvastatin as there are equity issues with achieving effective titration of statin dose.	The funding criteria have been altered meaning Māori and Pacific peoples do not need to meet the LDL target level criteria. Access to rosuvastatin will be a first line statin option for Māori and Pacific peoples.
Questions regarding whether rosuvastatin would be available for patients who are on a microbial regime using drugs which inhibit the CYP3A4 enzymes (contradicted due to increased risk of rhabdomyolysis).	Concurrent use of antifungal agents and the interaction with CYP3A4 enzyme pathway-based statins (simvastatin / atorvastatin) is a recognised issue. Due to the relatively short treatment period of antifungal agents, our understanding is that the recommended course of action is to temporarily stop statin treatment rather than to switch statin type. Another funded alternative is the use of pravastatin which works on the same pathway as rosuvastatin.

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 660 050.