Dear FH Patients!

The following positive information about the domestic support possibility of PCSK9 inhibitors can be shared.

Since the establishment of the FH Group of the SZIVSN Heartily National Patient Association, it has been fighting for domestic support for new cholesterol-lowering medical products (drugs). In recent years, many letters, emails, and even open letter have been sent to policy makers to promote the financing of PCSK9 inhibitors, whereas these new drugs could not be accessed with any form of reimbursement.

We are pleased to report that our request for reconciliation, as described in our latest letter, was responded positively to Prof. Dr. Ildikó Horváth, Secretary of State, and a meeting between SZIVSN Heartily Association and the Secretary of State could take place on 13 August.

The SZIVSN Heartily National Patient Association was represented by President Zsuzsa Bernáth-Lukács and dr. Ákos Gesztes FH group leader. Following the presentation of the Association, reviewing the specific pharmaceutical support situation, we received the following information:

Until PCSK9 inhibitors have been approved for regular reimbursement, the products are already available to patients with the highest risk on an individual named patient basis. Submitted named patient applications can count on a positive assessment if the information described in the application meets the eligibility criteria set by NEAK (National Health Insurance Fund), manufacturing companies, and medical expert panel.

Such criteria are:

• Previous cardiovascular event (eg heart attack, stent implantation, angina)
• Use of already available and reimbursed drugs (statins and ezetimibe) for a sufficient time and at maximum dose, or
• Demonstration of intolerance of the patient to use the available medication (statins, ezetimibe).
• Not reaching the  LDL (bad) cholesterol target (laboratory verified) despite the above medications
• Sufficient patient collaboration for treatment success (eg: switching and taking drugs regularly, quitting smoking)

Individual named patient applications must be submitted to the NEAK and, in justified cases that meet the criteria, the NEAK grant can be obtained.

Almost 20 of our fellow patients have already received a positive evaluation and can receive PCSK9 inhibitors with reimbursement.

Thus, the drug treatment option for PCSK9 inhibitors is already available to patients with high risk who meet the criteria, with only the administrative steps required to submit the individual named patient applications. This requires the involvement of both the patient and the attending physician, bearing in mind that besides the patient’s signed application, a medical application form signed by the physician and a medical history summary must be attached to the NEAK application.

Individual named patient access provides a framework that can treat a few hundred patients. When this number of patients is reached, it is only to be expected that some form of financing with less administrative burden will be introduced.

We hope, based on the above information, that treating physicians will be able to support individual named patient application preparations and submissions and provide more and more needy patients with reimbursement for previously unavailable PCSK9 inhibitor treatment.

Budapest, 28.08.2019
Best regards:

Zsuzsa Bernáth-Lukács, President of SZIVSN Heartily National Patient Association  and

dr. Ákos Gesztes, Head of the group SZIVSN Heartily National Patient Association FH