Unbiased Analysis of Today's Healthcare Issues

Archive for the 'Pharmaceuticals' Category

Off-label use of cancer drugs

When each drug is approved by the FDA, the drug is not approved to treat all patients.  Each drug receives an “indication” which basically represents the types of patients the drug can treat.  Giving the treatment to patients with said indication is known as “on label” prescribing. Drugs developed to treat one disease may sometimes […]

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Too many trials, not enough patients

As research in new cancer treatments has grown, scientists may have run into a serious roadblock: there many not be enough patients to fill the needed clinical trials.  As the New York Times reports: There are too many experimental cancer drugs in too many clinical trials, and not enough patients to test them on. The logjam […]

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Does value vary by stakeholder perspective?

According to Innovation and Value Initiative Executive Director Darius Lakdawalla, the answer is yes.  Here is his interview response on AJMCtv.

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Innovation in small markets

The introduction of new treatment technologies typically occurs where there is a large market.  A lot of innovations are developed to treat disease that affect a large number of people in the developed world because the financial returns are large.  It is less likely to observe innovation in the treatment of rare diseases or diseases […]

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Prior authorization and opioid abuse

An interesting article by Cochran et al. (2017) examines whether health plan prior authorization rules can help prevent opioid abuse.  The authors use Pennsylvania Medicaid data from 2010 to 2012.  The data included both fee-for-service and managed care enrollees. The authors measured opioid abuse based on diagnosis codes for opioid use disorder (304.0, 304.00, 304.01, […]

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Predicting Real-World Effectiveness of Cancer Therapies Using OS and PFS Clinical Trials Endpoints

Clinical trials for cancer treatments aim to demonstrate whether one treatment is better than another. What is of most interest to patients, providers and payers, however, is which treatment works best in the real-world, not in a randomized controlled trial. Further, clinical trials often use progression free survival to measure treatment outcomes rather than overall […]

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Highlights from the 2017 ISPOR Conference

Over the past few days, I have been attending the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2017 Annual Conference in Boston. The session had a number of interesting presentations. While I was not able to catch them all, below are links to a few highlights. Darius Lakdawalla, Defining and Measuring Value in Healthcare […]

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Will the UK become a “desert for healthcare innovation”?

That is the claim made by the Association of the British Pharmaceutical Industry (ABPI).  Lisa Anson, who took over as ABPI president last week, told The Times that the financial squeeze on the NHS threatened the whole of Britain’s £30 billion life sciences sector as firms would reconsider working in the UK.  ABPI asked for the […]

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FDA Hedges

Pharmaceutical companies face major risk.  There is risk that the drugs they are researching don’t work (e.g., lack of efficacy) or are not safe.  There is risk that health insurers or government payers will not cover their treatment.  And there is risk that the FDA will not approve a drug after a Phase III clinical trial. […]

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Applying Cost Effectiveness Analysis to all Health Care Interventions

That is the topic of a Health Affairs blog post published today by James Baumgarder and Peter Neumann.  An excerpt is below. Cost-effectiveness analysis (CEA) is an important tool for assessing and pointing the way toward better health care efficiency. The number of published CEAs on health care interventions has blossomed, averaging 34 per year […]

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