Unbiased Analysis of Today's Healthcare Issues
Making a generic version of a single molecule drug is fairly straightforward. Making a replica of a biologic treatment, however, is not. Nevertheless, Congress signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) to create a fast-track approval process for biological products that are demonstrated to be highly similar an FDA-approved biological product. These products…
The Food and Drug Administration (FDA) reviews and approves all drugs. But what criteria does the FDA use to evaluate new drugs? Namely that they are effective (i.e., improve health outcomes) and safe (i.e., have limited adverse health events). In a 2007 guidance document from the FDA’s Center for Drug Evaluation and Research (CDER) and…
Which treatments are better than others? Ideally, medicines that provide large health benefits and cost little will be preferred to those that offer little health benefits and/or cost a lot. In health economics, one way to systematically evaluate different treatments is the efficiency frontier. The efficiency frontier methodology is an extension of the standard approach…
Rarely due consumers think that too much competition is a problem. According to the Centers for Medicare and Medicaid Services (CMS), however, this is a major issue for consumers when they choose Part D prescription drug health plans. Avalere reports that: Proposed revisions to the meaningful differences policy will restrict the market’s top sponsors from…
Bilsimilars are biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods. Biologic drugs can be patented, but once the patents expire, biosimilars can enter the market. Are biosimilars> priced similarly to generics? According to Ana…
Is your randomized controlled trial (RCT) generalizable to the general population? This question is known as external validity and is a major issue for a number of treatments. Sometimes, a treatment is very effective in an RCT, but less so in the real world. One reason why this may be the case is that the…
The pharma industry’s reputation is getting worse. Pharmafile reports that “35.4% said that multinational pharma companies had either an ‘excellent’ or ‘good’ reputation in 2013. While this is about the same result as in 2012, it is well below 2011 when 41% of respondents gave that answer.” Below are the 2013 reputation rankings for different…
In a previous post in 2006, I wrote that the cost to bring a drug to market is $802 million. Although that is a huge number, it may be an underestimate. Pharmafile reports that the cost to bring a brand drug to market is now over $1 billion. the cost of bringing a brand from…
Where has public policy gone in the last few years? Popular policies include move towards more bundled payments, the creation of accountable care organizations, additional funding for comparative effectiveness research (CER), evidence-based medicine (EBM) and value-based purchasing programs that link payments to various quality metrics. With health care costs rising, payers are looking to decrease…
Looks likes cuts to UK reimbursement rates for Pharma are on the way: People involved in the PPRS drug pricing talks have told the Financial Times on Tuesday, that drug companies operating in the UK have agreed the drugs bill to the NHS for their patented (but not generic drugs or vaccines) products will fall…