Navigating the Italian HTA Process: Essentials to a Favorable Review
From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA 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 reimbursed, and 25 to other types of negotiations.
DTx Part I: Identifying Optimal Payment Models for Digital Therapeutics
The field of DTx has gained traction over the last couple of years, with FDA approvals/clearances, the founding of a DTx specialty society, large-scale acquisitions of DTx firms, pharma investments in DTx, and pharma co-development deals, amongst other key developments.
ICER Set to Evaluate Non-Drug Products in 2020
The Boston-based Institute for Clinical and Economic Review (ICER) recently announced that in 2020, they are considering selecting two or more non-drug topics for assessment.
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”, which is expected to be approved by the parliament early November.
Medical Disposables & Consumables Players Face Challenge of Government-Initiated Price Cuts in China
When the Chinese government started to slash the drug prices in 2018, we knew that it was only a matter of time before medical consumables would be affected.
Possibility for Examination to be Included in the SHI Fee Scale Brings More Certainty for Reimbursement for New Diagnostics in Germany
In the past, the inclusion of new diagnostic tests in the EBM was not transparent, with unclear timelines and requirements and manufacturers were unable to...
Events
Press Releases and Publications
Diagnostics Developers Rapidly Utilizing New Payment Codes Established by PAMA
7 November 2018
Access the article from 360Dx here.
Clinical Omics
Compliance Conundrum: Genomic Health Faces DoJ Investigation after CMS Changes Date of Service Regs
Genomic Health has disclosed that it is the subject of a U.S. Department of Justice investigation into its compliance with changes that took effect in January to Medicare’s Date of Service billing regulation. Adam Crowther, Manager, spoke with Clinical Omics about the impact on diagnostics companies. Access the Article Here.
Medical Device & Diagnostics Industry
Considering Market Access Risk as Part of Today’s M&A Process
In an exclusive published today in Medical Device and Diagnostics Industry, Vice President, Rob Wenthold discusses the key market access issues examined during the M&A process and demonstrates the importance of market access to inform M&A through case studies and business decision-making in general. Read the article here.
Boston Healthcare Adds Seasoned Market Access Leader to Global Life Science Consulting Team.
Clinical Omics
Cost-Conscious MedSeq Project Provides Snapshot to Suggest Genomic Sequencing does not Increase Downstream Healthcare Costs
CEO, Joseph V. Ferrara commented on the value sequencing might bring to the clinical setting in the May-June 2018 Issue of Clinical Omics. Access the article here.
Global Business Reports
United States Biopharmaceuticals 2018
Thomas F. Goss spoke to Global Business Reports on the US Biopharmaceutical Industry. Read the report here.
Clinical Omics
Real-World Evidence in the Era of Advanced Diagnostics
Shivang Doshi, Director at Boston Healthcare wrote an op-ed for the March-April edition of Clinical Omics on real-world evidence for advanced diagnostics. Access the article here.
360Dx News
International Regulatory Group Proposes Principles for Evaluating Safety, Performance of Diagnostics
Joseph V. Ferrara, CEO of Boston Healthcare spoke with 360Dx News about the proposed Principles for safety and performance of medical devices, including IVD medical devices, put forward by the International Medical Device Regulators Forum (IMDRF). Read the article here.
C&EN
Year in Pharma
Senior Vice President, Thomas F. Goss speaks with Lisa Jarvis from C&EN about drug prices in 2017.