Still running your MNP on paper?📝 Discover e-MNP's from Novellas Healthcare

Be efficient

You’re currently running a Medical Need Program (MNP) or Compassionate Use Program (CUP), and you are struggling with the logistic part and the administration. Even the implication of multiple stakholders can look complex.
We feel you!

We got you covered! With the E-MNP portal from Novellas Healthcare.

Make your Medical Need Program:

  • Easy to access
  • Structured
  • Dynamic

How do we make your Medical Need Program better?

  • Medical Officer access
  • Online patient registrations
  • Live supply overview per patients
  • View of upcoming supply requests
  • Online access to patient’s letter of agreements
  • View of upcoming /expired supply requests
  • Online statistics

Benefits of our E-Medical Need Program tool

Easy Tracking & Monitoring

Logistical monitoring, tracking, and follow-up processes are seamless now more than ever with Novellas Healthcare’s e-MNP tool. Get a clear overview of current activities and upcoming steps, and thus ensure a smooth workflow.

Easy Market Introduction

Introducing life-changing treatments at an earlier stage not only enables healthcare professionals to gain experience sooner, but also allows patients to experience the benefits sooner. This sums up the essence of healthcare: improving patient’s quality of life.

Online Patient Approval Process

The e-MNP tool facilitates the enrolment, eligibility evaluation, and approval of patients, all within a single platform. It serves as a key illustration of efficient collaboration between healthcare professionals and the life sciences industry.

Frequently Asked Questions

What is a Medical Need Program (MNP)?

An unmet medical need is present when the Medical Need Program (MNP) or Compassionate Use Program (CUP) patient population has a life threatening disease, a chronic disease or a seriously debilitating disease which cannot be treated satisfactorily with a product that is licensed AND reimbursed for this indication and commercially available in Belgium.

Can you collect data in an Medical Need Program (MNP)?

Patients should always be considered for inclusion in clinical trials before being offered inclusion into a CUP or MNP. Clinical data collection in MNP/CUP is NOT POSSIBLE. MNP/CUP cannot replace clinical trials for investigational purposes. However, data collected during a CUP or MNP that are necessary to conduct the program (e.g. to check inclusion / exclusion criteria, to follow-up the benefit / risk of a patient, pharmacovigilance data) could be used to increase the understanding of the treatment. Processing of data collected (e.g. AE information) can only happen to evaluate the dossier with focus on quality and cost of the medicine. It is not possible to collect more data than strictly needed for the conduct and evaluation of the program.

What are the components of a Medical Need Program (MNP)?

There are 4 main components in a Medical Need Program: - Patient Eligibility Assessment - Consent & Letter of Agreement - Medication Provision - Monitoring Supplies

What medicines can patients receive in an Medical Need Program (MNP)?

The law from 1964, March 25, outlines conditions for providing unapproved medicinal products in Belgium, either for compassionate use or medical need programs. Compassionate use is allowed for non-authorized products undergoing clinical trials or seeking marketing authorization. Medical need programs apply to authorized products when other treatments are inadequate. Additional conditions include ongoing authorization processes, unavailability in the market, ongoing trials, or demonstrated relevance in the intended use. As long as eligibility criteria are met, the same company can submit a marketing notification for one indication while reimbursement procedures for another indication are underway for the same medicine.

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