This paper is a companion piece to a detailed background paper on the use of real-world evidence in coverage decisions developed for the ICER Policy Summit held in December 2017.
This paper presents a new conceptual framework to address three elements largely missing from these earlier efforts focused on defining “best practices” or “standards” for RWE:
- How to understand the role that contextual factors play in determining how high the evidentiary standard, or “bar” will be in each situation;
- How to tailor key process and methodological approaches to the height of that evidentiary bar; and
- How to ensure that broader process principles that support transparency are integrated successfully throughout the course of any RWE initiative.
This guide lists the quality measure areas that can quickly and easily be impacted by mPulse Mobile solutions for each quality measure set and provides an overview of how these programs can be structured.
This paper sets out the potential opportunities and important challenges and limitations that must be addressed in considering options for using RWE to inform insurer coverage decisions.
The primary purpose of developing the paper was to stimulate discussion at the 2017 ICER Policy Summit meeting.
A separate paper is available that summarizes the authors reflections and proposed ways forwards based on the discussions that were had at the meeting.
The first human genome was sequenced in 2001 at a cost of $3 billion. Today, human genome sequencing costs less than $1000, and in a few years the price will drop below $100. Thus, personal genome sequencing will soon be widely adopted as it enables better diagnosis, disease prevention, and personalized therapies.
Furthermore, if genomic data is shared with researchers, the causes of many diseases will be identified and new drugs developed. These opportunities are creating a genomic data market worth billions of dollars.
Nebula Genomics seeks to lead this emerging market by understanding and overcoming key obstacles. We will spur genomic data growth by significantly reducing the costs of personal genome sequencing, enhancing genomic data protection, enabling buyers to efficiently acquire genomic data, and addressing the challenges of genomic big data.
We will accomplish this through decentralization, cryptography, and utilization of the blockchain.
The affordability of healthcare and biopharmaceutical drugs is a top concern for Americans.
It is often asserted that promoting innovation and affordable drugs are conflicting goals. New innovations, however, often provide improved health that was not previously available at any price or obviate the need for more costly care.
They thereby lower the effective price of health down to the price of the patented drugs, and later down to the price of generic drugs. Federal policies that affect drug pricing should satisfy two goals.
First, domestic drug prices paid by Americans should be reduced. Second, the price of better health in the future should also be reduced by spurring medical innovation. This report considers policy options to simultaneously advance these two seemingly conflicting goals.
What’s old is new again, and value-based drug pricing is anticipated to be the cornerstone of a soon-to-be-released U.S. presidential executive order on drug pricing. Building on consultation with industry and government experts, the executive order is the policy follow-up to statements from President Trump’s Jan. 11 press conference promising to “create new bidding procedures for the drug industry because they’re getting away with murder” that will “save billions of dollars over a period of time.” Simply by placing the terms value and pricing in proximity, the initiative generates hope that drugs will become a better value for patients and that recent examples of exploitive pricing (e.g., Daraprim, EpiPen) don’t become a regular occurrence. But is valuebased pricing really a prescription for large-scale savings?
When leading biopharma companies founded SAFE-BioPharma in 2005, it was with a vision of a not too distant future with major changes in the industry: the move to collaboration with many partners, make business processes fully electronic, and to take advantage of all of the benefits of online operations. It’s safe to say that the rate and scale of the digital revolution was even greater than most observers predicted, but this foresight proved correct.
DA has increased scrutiny of the integrity of data generated by biopharmaceutical companies and their suppliers, focusing on analytical laboratory results, batch records, quality procedures, and other documentation related to the development, scale up, analysis, and manufacture of drug products. Threequarters of the warning letters issued by FDA’s Center for Drug Evaluation and Research between January 2015 and May 2016 cited data integrity issues noting problems with how data were recorded and authenticated. In April 2016, the agency issued a draft guidance on data integrity, Data Integrity and Compliance with CGMP, that included a section on electronic signatures for master production and control records.
The U.S. Department of Justice has collected upwards of $17 billion in settlements from the healthcare industry since 2009, including more than $2 billion from a single life sciences company. As part of those settlements, more than half of Fortune 500 pharmaceutical and medical device companies are operating under corporate integrity agreements (CIA) with the U.S. government.
A CIA outlines the ethical obligations a company agrees to in exchange for being allowed to continue participating in federal healthcare programs. CIAs are lengthy contracts—50 to 100 pages—detailing new procedures and protocols that must be meticulously adhered to in order to avoid further penalties. New procedures include the establishment of new regulatory roles and committees, comprehensive quarterly and annual reports, exhaustive record keeping, cumbersome review processes, and seemingly endless approvals.
Your management and IT departments are driving towards tomorrow’s wholly digital world, making critical technology investments in an effort to streamline your business. Unfortunately, they often overlook a critical last step.
A hospital or medical office might be state of the art—until a patient walks in the door and is handed a clipboard full of paper forms to fill out, which then must be manually keyed in, costing precious time, and possibly resulting in serious errors.