Thought Leadership
Reimbursement for Digital Health Products: What can we learn from the Diagnostics Industry?
Previous coverage and reimbursement processes for diagnostic testing can provide valuable insights and the start of a blueprint for digital health products. On Monday, March 11, 2019, Mark Girardi, Vice President will review several key considerations and recommendations for coverage and reimbursement of innovative digital health products at the 26th International Molecular Medicine TriConference.
Global Commercial & Partnership Considerations for Companion Diagnostics
On Monday 11 March 2019 at the 26th International Molecular Medicine TriConference, Joseph Ferrara, CEO and President will highlight key commercialization considerations for drug and test innovators, including balancing test access and quality and embedding CDx global commercial considerations in pharma and diagnostic company partnerships.
Practical Considerations to Evidence Planning & Implementation
In a challenging reimbursement environment for advanced diagnostics, innovators are confronted with the need to develop adequate clinical evidence supporting the value proposition of their assays. Shivang Doshi, Director will discuss practical considerations around evidence planning and implementation, including relevant case studies at the 26th International Molecular Medicine Triconference on Thursday, 14 March 2019.
First Meeting of the Italian Regional Purchasing Centers
Quality is not anymore limited to the functional and esthetic products features and its handling use. The attention is now focused on the commercialization phase, innovative and efficacy features, profitability and usability of instruction for final users, as well as Eco-friendly features...
New Independent Medical Review Board for Germany
For medical device and diagnostic innovators, a planned organizational change in review boards for Germany’s Statutory Health Insurance (SHI) could lead to new opportunities for market access of their products.
Winter Has Come – Aggressive National Programs To Drive Down Drug Costs
China: 2018 was another eventful year for the pharmaceutical industry, highlighted by the Chinese government’s radical attempts to slash drug prices by the annual national drug price negotiation and along with the introduction of a national procurement program.
The Evolution of Medical Device Procurement in Italy
Assobiomedica, the body representing the medical device sector in Italy, published an update to the report ‘Public Policies for the Purchase of Medical Devices’ in October 2018. Boston healthcare outline procurement trend in the Italian reimbursement environment.
Defining the value of innovative treatment methods in Germany
A recent proposal by Jens Spahn, Federal Minister for Health in Germany, would limit the decision-making power of the Joint Federal Committee (G-BA) and lead to new evidence approaches for healthcare decision making.
FDA Issues New Draft Guidance on Class Labeling of Companion Diagnostics
Earlier this month, the Food and Drug Administration announced a new draft guidance for companion diagnostics. The guidance describes considerations for the development and labeling of companion diagnostics to support the indicated uses of multiple therapeutic oncology products.
Access our presentations: MedTech Access Leaders Forum, EU
Boston Healthcare spoke at the MedTech Access Leaders Forum in Berlin, Germany on 3-5 December 2018. Vice President, Rob Wenthold spoke on maximizing the organizational impact of the market access function, and CEO, Joe Ferrara spoke on global considerations for companion diagnostics. Register your details to receive your copy!
Top Chinese Think Tank Visits Boston for Study on Health Information Technology
Earlier this month we hosted a forum on Health Information Technology with a Delegation from the China Development Research Foundation (CDRF)
Germany’s Approach to Biosimilars
Germany’s Health Minister, Jens Spahn has called for the faster adoption of cheaper copies of biotech drugs to cut the cost of healthcare in Germany.
China set to relax regulations for medical device and IVD products
BHA_China Medical Device_IVD Policy Update - Proposed [...]
The growing role of Artificial Intelligence in Healthcare
In October, Boston Healthcare connected with the innovators of AI-enabled companies at the AI in Healthcare Conference. Use cases for AI in healthcare were presented, along with some of the barriers to adoption that still exist.
CMS Proposes International Pricing Index for Medicare Part B Drug Spending
In a proposed rule issued last week, the Centers for Medicare & Medicaid Services (CMS) took action to build upon the Administration’s efforts to lower drug costs and reduce out-of-pocket costs for patients.
News
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. Download a PDF 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. Read the press release here.
PRESS RELEASE
FOR IMMEDIATE RELEASE
CONTACT: Kylie Ullmann
(617) 912-5131
kullmann@bostonhealthcare.com
Boston Healthcare Senior Vice President speaking at the World Orphan Drug Congress
Attendees will gain insight into the unique environment for commercialization of therapies for orphan diseases
BOSTON, 26 April 2018 – Boston Healthcare Associates, Inc. (Boston Healthcare), a global life sciences consulting firm today announced that Thomas F. Goss Pharm.D., Senior Vice President of Boston Healthcare, is presenting at the 8th Annual World Orphan Drug Congress.
The Congress is taking place at the Gaylord National Harbor Hotel, Oxon Hill, MD, with Dr. Goss presenting on Thursday, April 26 at 12.40 p.m. in the Global Market Access track.
Informed by clinical and economic evidence, Goss’ presentation on Market Access Challenges and Opportunities for Orphan and Ultra-Orphan Disease Therapies will provide insight into the:
- global demand for an evidence-based approach toward market access for orphan disease therapies,
- current landscape on development practices,
- tools to overcome gaps in data to document the cost and burden of orphan diseases, and
- strengths and limitations of available methods of data capture.
“Our attendance and sponsorship of the World Orphan Drug Congress underscores our commitment to solving key challenges associated with supporting patient access to important orphan disease therapies where significant unmet medical need remains,” said Goss. “To achieve success, it is critical that innovators address evidence requirements to document clinical and economic value and improve patient outcomes.”
With more than 20 years of experience examining regulations and the impact of public and private Payor policy on patient access, Goss has equipped both emerging and established pharmaceutical and medical device companies with the strategic and tactical guidance needed to solve complex problems and implement successful commercialization strategies across their product portfolios.
Goss also has more than 50 peer-reviewed publications in the areas of health economic evaluations (cost-effectiveness and budget impact analysis) for multiple markets including the U.S., EU-5, and Japan, and disease management and patient outcomes data.
Boston Healthcare representatives will be available at booth 405 for inquiries on our global capabilities.
Please contact Kylie Ullmann to schedule a meeting or interview with Dr. Goss.
About The World Orphan Drug Congress
World Orphan Drug Congress USA focusses on the most pressing challenges and opportunities to bring rare disease therapies to patients faster. World Orphan Drug Congress USA has evolved from a one- track conference focused on regulatory pathways, policy and incentives, to a global gathering of 1,000 leaders in orphan drugs from 38 countries, and over 135 presentations covering all aspects of orphan drug development and rare disease research.
About Boston Healthcare
Boston Healthcare is a global consulting firm that develops successful market access and value optimization strategies for emerging and established medical device, diagnostics and pharmaceutical companies seeking to commercialize specialized products and services that have the potential to transform standards of care and significantly improve health outcomes. We combine our multi-disciplinary consulting expertise and analytic rigor, with a deep and current understanding of evolving market and sector dynamics and trends, enabling our global clients to implement value and access strategies across their product portfolio successfully.
Our offices in Berlin, Shanghai, and Hong Kong, give us significant experience and in-market expertise with emerging and established medical device, diagnostics and pharmaceutical innovators worldwide.
For more information, please visit www.bostonhealthcare.com. PDF of this press release available here.
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. Read 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.