In order to be eligible for enrolment in the VYNDAMAX Patient Assistance Program, the following must apply:
- 18 years of age or older
- Wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM)
- Evidence of cardiac involvement on echocardiography with an end-diastolic interventricular septal wall thickness ≥ 12 mm
- Documentation that AL amyloidosis has been excluded
- New York Heart Association (NYHA) Heart Failure Functional Classification III. Please note: patients who are newly diagnosed as NYHA Classification III or who have progressed to a permanent NYHA Classification III, and may have received treatment via Pharmaceutical Benefits Scheme (PBS) supply, are eligible
The full name of the specialist medical practitioner consulted and the date of consultation must be recorded in the patient’s notes and is required for enrolment in the VYNDAMAX Patient Assistance Program. Please note: treatment with VYNDAMAX via this program may only occur under the supervision of a medical practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders.
The results of the following tests† must be recorded in the patient's notes at the time of enrolment and during all follow up as per standard of care for the duration the patient remains in this Program. Prescribers must confirm all tests† have been conducted as follows:
- Renal function (initiation, month 1 and then every 6 months thereafter)
- Liver function (initiation, month 1 and then every 6 months thereafter)
- Cardiac markers: Troponin (initiation, 6 monthly), NT-pro BNP level (initiation, 12 monthly)
- Echo (initiation, 12 monthly)
† Please note: any costs associated with the above tests will not be reimbursed under the Program. For all patients transitioning from PBS supply to this Program, tests must have been conducted and recorded in the patient's notes as per the schedule above at initiation, month 1 and then every 6-12 months as applicable)
VYNDAMAX Patient Assistance Program patient exclusion criteria
Patients with the following conditions will not be eligible for the VYNDAMAX Patient Assistance Program:
- Transthyretin amyloid of a predominantly polyneuropathy phenotype
- Hypersensitivity to tafamidis or to any of the excipients in the capsules
- Organ transplant recipient
- Severe renal impairment (creatinine clearance ≤30 mL/min)
- Severe liver impairment (transaminase levels >2.0 x ULN)
- Pregnancy
- Women of childbearing potential not using contraception
- Women who are breastfeeding
- Paediatric patients (aged <18 years)
- Implanted cardiac ventricular assist device (not including pacemakers or implantable cardioverter-defibrillators)
- New York Heart Association (NYHA) Heart Failure Functional Classification I, II or IV
- Is eligible for tafamidis via the Pharmaceutical Benefits Scheme (PBS)