Payer coverage of FDA-approved drugs

Many people think that once a treatment is approved, your insurance automatically covers the treatment.  However, that is no longer the case.  Some health plans may keep certain drugs off of formularies.  Others health plans have drugs on formulary but may require step edits (failing another drug first before moving to the novel treatment) and…

Off-label prescribing

How frequently are pharmaceuticals used off label?  Perhaps more than you think.  Although these figures are a bit dated, Tabarrok (2000) details the extent of off-label prescribing in the U.S. as follows: According to a study by the U.S. General Accounting Office, 56 percent of cancer patients have been given non-FDA-approved prescriptions, and 33 percent…

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…

The Voice of the Patient

Did you ever wonder what is is like having lung cancer?  Or narcolepsy?    What factors are most important to patients when receiving treatment for these diseases? The FDA is working to collect these answers to help guide their drug approval process.  The FDA’s “Voice of the Patient” aims to “…more systematically gather patients’ perspectives…

Off label prescribing: Q&A

The Duke-Margolis Center for Health Policy has a great overview of some of the issues related to off-label prescribing.  Below is a summary of some key points from this article. What is off-label prescribing? Off-label prescribing and use can take many forms, such as use of an approved drug for an unapproved clinical indication, use at…