Medical Marketing and Media (MM&M) has an interesting article regarding MannKind Corp’s Afrezza inhaled insulinmedical devices must prove value. Initial roll-out of the therapy has been below expectations. One of the reasons for that, the article contends, is that the Afrezza therapy has not yet proven that it will provide increased value over other current therapies, pen injectors, for example. From the article:

“It’s more difficult for companies in general to make a significant impact in the marketplace without going forward to physicians and insurers with some sort of clear efficacy improvement and/or really substantial safety improvement,” said Nathan Dowden, managing director of life sciences at Huron Consulting Group.

Whether drugmakers can demonstrate the value of new products is now a primary factor for adoption and coverage of new medical products, both in the insulin market as well as with most new drugs and devices. Payers and healthcare providers want to know if a product can reduce trips to the hospital or lower overall medical costs. For example, if Afrezza’s delivery mechanism—a patient inhales the drug instead of having to prick his or her finger—can boost adherence and deter visits to the emergency room, insurers and PBMs may be willing to give the therapy preferred formulary status. But without that kind of data, adoption may remain limited to certain patients.

“Payers and healthcare providers want to know if a product can reduce trips to the hospital or lower overall medical costs.” This is going to be a critical factor for medical device design going forward. Of course, most companies are confident that the product they are developing will be better than anything currently on the market. Increasingly, customers are going to want proof with hard data, not claims.

Having been involved with the Afrezza project early on, we at Forma believe the therapy will in fact prove its value – mostly through substantial improvement in compliance. The early research we conducted showed patients greatly preferred the Afrezza therapy over standard insulin injection, even with a pen device. Not only could they avoid the pain of needle stick, but they considered the device itself would allow them to be much more discreet in adhering to their treatment protocol when in public – in a restaurant, for instance.

It will take time before the data can be compiled that will show Afrezza’s effect on patient compliance. It would be a shame if this technology is allowed to wither due to the lack of provable value before it’s been given a chance.