Tuesday, May 27, 2014

Dalbavancin: about to be launched

A Dalvance drug rep will be bringing lunch to a hospital near you, and soon. So you might as well learn a little about it now. Here's a summary at Academic Life in Emergency Medicine. Here's more from Medscape ID.

You can think of dalbavancin as a second generation vanco but there are some unique properties, particularly its pharmacokinetics which enable once weekly dosing.

Dalvance is the first drug to benefit from the FDA's new fast track process for antibiotics. From the FDA bulletin:

Dalvance is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Dalvance was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections.
“Today’s approval demonstrates the FDA’s commitment to encouraging increased development and approval of new antibacterial drugs, providing physicians and patients with important new treatment options,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
As part of its QIDP designation, Dalvance was given priority review, which provides an expedited review of the drug’s application. Dalvance’s QIDP designation also qualifies it for an additional five years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug and Cosmetic Act.

Here are a few of my questions and concerns:

There was a mild signal of liver toxicity in clinical trials.

It will probably be very expensive.

Given the many options for gram positive infections that we already have exactly where will this drug fit in?

The drug's approval is narrow in scope. What off label uses might be appropriate as we gain more experience?

Many patients with skin infections do not need MRSA coverage at all. That's a matter for clinical judgment.

I don't anticipate heavy usage of this drug. It's one more option, which is great.

The concluding comments of the Academic Life in Emergency Medicine post came across to me as a little hard line:

Even if the company adjusts the price to less than $100 per dose, hospital antimicrobial stewardship programs need to rationalize and limit the use of this new antibiotic for cases when cheaper non-inferior treatments have failed.

Rationalize? How rational is it to wait for treatment failure before considering another option that might be better for the patient? He goes on:

Advertisers’ persuasion of better compliance for “high-risk patients,” convenience, and non-inferiority, are not enough to challenge the standard care of SSTIs in the ED.

Not enough to even challenge standard care? It seems to me that the convenience advantage is pretty substantial. This is an illustration of the difference between two approaches to medicine: medicine by committee and evidence based medicine (EBM). The author of the post is advocating medicine by committee. It's incompatible with EBM because it proscribes two of EBM's essential components in decision making about whether to use dalbavancin: the individual patient's unique attributes, preferences and values and the judgment and expertise of the treating clinician.


james gaulte said...

Rationalize is a interesting word with more than one meaning.It can be used to describe the situation in which someone suggests a rational reason for an actin even if that is not the real reason for that action. It is also used to mean make more efficient as in rationalize production in a factory or as Drs. Berwick and Brennan said in their book, The New Rules. "Health care is being rationalized through critical pathways and guidelines. The primary function of regulation in health care, especially as it affects the quality of medical care, is to constrain decentralized individualized decision making." That pesky individualized decision making just gets in the way.

R. W. Donnell said...

Patient centered and clinician centered individualized decision making are two of the key components of EBM by its very definition. Those who advocate decisions by committee or any form of central control are opposing EBM. They may not own that fact, which means they're being disingenuous or don't understand EBM.