Managed Access Programme
GENERAL OVERVIEW OF MANAGED ACCESS PROGRAM
EUSA Pharma is committed to developing innovative therapies for patients with Neuroblastoma. We take our responsibility to act as a true partner with patient communities seriously, and we are committed to working with physicians who have determined that their patient has an unmet medical need.
We understand that patients and families may be interested in accessing our therapies prior to regulatory approval, and outside of the clinical trial setting, through a managed access programs (also known as an early / expanded access, or named patient program).
A managed access program (MAP) is a mechanism through which physicians can prescribe, within their professional responsibility, a yet unapproved treatment for patients. Use of an unapproved treatment is based on physicians’ informed assessment of the patients under their care to determine whether there is a special need for the unapproved treatment because (a) there is no approved treatment available or (b) available treatments are not suitable for that patient. For this MAP, physicians will need to assess patient eligibility by determining whether the patient meets pre-specified medical and other criteria and also confirming funding can be secured.
MANAGED ACCESS PROGRAM ELIGIBILITY FOR QARZIBA® (Dinutuximab Beta)
For certain patients in certain jurisdictions, as part of our commitment to facilitating patient access, we support a managed access program in selected geographies where Dinutuximab Beta is not currently approved.
COUNTRIES WHERE THE PROGRAM IS OFFERED
Russian Federation, Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Uzbekistan, Ukraine, Japan, Argentina, Brazil, Mexico, Peru, Colombia, Chile, Uruguay, Indonesia, Vietnam, Thailand, New Zealand, Singapore, Philippines, Malaysia, Hong Kong, Pakistan, Afghanistan, Taiwan, Sri Lanka, Mongolia, Bangladesh, Bhutan, Laos, Republic of Korea, Nepal.
All requests must be submitted by the treating physician on behalf of the patient and must be unsolicited.
HOW DO I SUBMIT A REQUEST FOR MANAGED ACCESS?
Healthcare providers can obtain details about submitting requests by calling a FarmaMondo representative at +41 91 697 6370, or emailing email@example.com.
HOW DO I SUBMIT A MEDICAL INFORMATION REQUEST FOR THE MANAGED ACCESS PROGRAM?
If you need additional medical information in connection with a request for medication through this program, Healthcare Providers and Health Authorities can submit requests to Medicalinformationfirstname.lastname@example.org.