Unbiased Analysis of Today's Healthcare Issues

Too much competition?

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 […]

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Quotation of the Day: Pricing of Biosimilars

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 […]

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Increasing Generalizability of RCTs

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 […]

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2013 Cost to bring drug to market: $1.3 billion

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 […]

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What is value-based pricing?

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 […]

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UK to Pharma: Cut spending by 4%

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 […]

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Getting approval for regulators and payers

Once a pharmaceutical is approved by country regulators, how does one justify to payers that the product is worth the price.  An article at Real End Points identifies a number of key trial design aspects that are vital to proving to payers that the product is cost effective. First, having having a “meaningful comparator is […]

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Pharmaceuticals in Italy

Thomas Schael, ex-commissioner at the Public Health Authority of Naples, led the implementation of a system that produced annual drug expenditure savings of €20m.  How did he do it?  Eye for Pharma has a revealing two-part interview. The first thing Schael did to reduce the cost of pharmaceuticals in Italy was to improve the efficiency […]

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Drug development is a very long process

Any new drug that you see released to the market probably started in a lab some 8 – 15 years ago….For every FDA-approved drug that makes it to market, 5000 to 10000 compounds were explored during the drug discovery phase. This is expected, what most companies optimize for is to have the failure occur as […]

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Use Of Comparative Effectiveness Research By Four European Health Authorities

How do different European health authorities use comparative effectiveness research (CER) to determine drug coverage and pricing?  A recent Health Affairs article by Cohen, Malins and Shahpurwala answer just this question.  Here is a table summarizing the mission and priorities of health authorities in England, France, Germany and the Netherlands.   Source: Joshua Cohen, Ashley […]

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