Innovative drug delivery methods should demonstrate value

NEW DRUG DELIVERY methods have potential to improve compliance through ease of use, but have brought up some new questions. Is reconfiguring an injected insulin into an inhaled version, for example, just a way to relaunch a product, or does the invention provide more than a "me-too" product?

"There is an emphasis on lifestyle management, on making drugs easier to take, such as a new inhaled insulin for those who are needle-phobic," he says.

Radius's director of quality, John Sullivan, adds that improving user interaction with a device will increase compliance. He sees a trend from drug delivery at point of care to the home setting, such as testing for HIV, strep and pregnancy using blood, saliva and urine.

"It's common to see small changes in existing medications, from caplets to tablets or vice versa, liquids to replace pills-especially for children and older adults who can't swallow pills-or skin creams transformed into ointments, foams and gels," says Edmund J. Pezalla, MD, vice president and medical director for Prescription Solutions, a pharmacy benefits manager (PBM) in Irvine, Calif.

Consider the new insulin inhalation powder for type 1 diabetes, in conjunction with long-acting injected insulin, and for type 2 diabetes, the latter of which Dr. Pezalla believes will fill a niche for patients with diabetes who are afraid of needles.

He says it is no more effective than injectable insulin but is more expensive-an issue for both insurers and patients-and is only short-acting.

IS DIFFERENT BETTER?

Helen Sherman, chief pharmacy officer for RegenceRx, a PBM in Portland, Ore., also questions the value of some of the new delivery systems and whether they show enhancements over existing ones.

"There is no compelling evidence. Sometimes we see that after a length of time on the market, the old products prove to be better. We need to help shape the market so that new products really demonstrate a medical advancement," she says.

Anthony Staresinic, clinical coordinator for Navitus Health Solutions, a PBM based in Madison, Wis., says that drug delivery should be based on compliance, competence and contrivance. He illustrates his point by referring to newer oral anti-cancer drugs used instead of an IV delivery. "These oral drugs are more convenient, easier to use and lead to more compliance," he says.

Although Staresinic says the healthcare industry can look forward to such innovative delivery systems, such as transdermal patches to replace IV drugs, less-invasive techniques for injecting drugs and slow-release injections, he is concerned whether these new systems will be readily accepted by patients who may be confused by the new methods.

In addition, he notes that changes in delivery also can have an effect on formulary costs and coverage issues-for example, the move from IV-delivered immune globulin for immune deficiency, which falls under the medical benefit, to subcutaneous delivery which is covered under pharmacy.