Manufacturers can now have more certainty about the process of inclusion of a new laboratory, new human-genetic, or new tumor-genetic diagnostics in the SHI reimbursement fee scale EBM. In the past, the inclusion of new diagnostic tests in the EBM was not transparent,...
Germany Paves the Way for Reimbursement of Digital Health Care Apps
In Germany, doctors could potentially be prescribing health apps as medicines as early as 2020. This is one of the main objectives of the draft bill on the “Law for better provision through digitalization and innovation” (Digitale Versorgung Gesetz – DVG), which is...
ICER Set to Evaluate Non-Drug Products in 2020
The Boston-based Institute for Clinical and Economic Review (ICER), an independent research organization that conducts health technology assessments to examine the clinical and economic value of prescription drugs, medical tests, and other health care and health care...
Navigating the Italian HTA Process: Essentials to a Favorable Review
From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA (Agenzia Italiana del Farmaco) evaluated a total of 166 Dossiers – 28 were related to orphan drugs, 56 to new active substances, 57 to extensions of indications for drugs already...
German Draft Executive Order Provides Clarity for Reimbursement of Health Apps
Towards the end of 2019, the German Federal Parliament introduced a simplified process for approval and reimbursement of digital health apps prescribed to patients covered under the statutory health insurance (SHI). This brings opportunities for both developers of...
The VALID and VITAL Acts: What Do They Mean for Diagnostic Innovators?
In early March, lawmakers in the U.S. House of Representative and U.S. Senate introduced the Verifying Accurate, Leading-edge IVCT Development ACT, or VALID Act. This legislation would alter the current regulatory landscape for many types of diagnostic tests,...
FDA Releases Final Guidance on Oncology Therapeutic Class Labeling of Companion Diagnostics
April 2020 On April 13th, 2020, The Food and Drug Administration (FDA) published a final guidance entitled “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products,” in which the FDA lists several key...
DTx Part II: Building Evidence-Based Value Propositions for Digital Therapeutics
In DTx Part I: Identifying Optimal Payment Models for Digital Therapeutics we identified several potential payment models for monetizing the value of DTx. While establishing payment mechanisms is essential for capturing the value of DTx products, value assessment...
DTx Part I: Identifying Optimal Payment Models for Digital Therapeutics
According to the Digital Therapeutics Alliance (DTA), digital therapeutics (DTx) are products that deliver “software-generated therapeutic interventions directly to patients to prevent, manage, or treat a medical disorder or disease.”1 DTx products have the potential...
An Overview of Digital Health in China
We recently discussed the challenges and opportunities for diagnostic players amidst and post- the COVID-19 chaos in the context of China’s health care system. In this issue, we will discuss another industry sector that may benefit from this global pandemic, digital...