Exubera Exuberance

The first inhaled insulin will be expensive. The manufacturers are exuberant because they stand to make billions from its sales. But it might be too expensive for some people with diabetes who want to use it.

Will your health insurance company reimburse you for inhaled insulin? If they will, you might be exuberant too. But right now that’s the big unanswered question.

On January 27 the Food and Drug Administration approved the first inhaled insulin. By coincidence the European Commission approved it for use in Europe just the day before.

The manufacuters Pfizer, and Nektar Therapeutics, call the inhaled insulin Exubera (eg-ZU-ber-uh). At least within those companies they are probably dancing in the boardrooms in exuberant joy.

Its approval is such big news that The New York Times on January 28 featured it on its front page. Not since the early 1920s, when insulin injections became possible, has there been such a significant advance in medicine for people with diabetes. Not even the approval of the first diabetes pills, the sulfonylureas in 1955, was as significant.

In part that’s because the pills are only for type 2s. Insulin, and specifically Exubera, are for both type 1s and types 2s.

But not for all people with diabetes. The manufacturers haven’t even tested it in children yet.

I, for one, won’t be able to use it because of my asthma. The FDA still has some concern about how inhaled insulin affects the lungs. So it doesn’t recommend it for people who have chronic lung disease – like asthma or chronic obstructive pulmonary disease or emphysema. Anyone who smokes – or has smoked in the last six months – can’t get it. Even those who can use it will have to get lung tests before and after starting Exubera.

Exubera is a powdered form of insulin inhaled into the lungs using a specially designed inhaler. While this inhaler just about the size of an eyeglass case when not in use, when you use it, the inhaler is about a foot long.

Would you use something that big in public? That’s one of the questions you need to answer if you are thinking of going on Exubera and you eat out often.

Unfortunately, many people will have to continue to take insulin injections even when using Exubera. That’s because inhaled insulin only addresses the bolus insulin — the extra amount of insulin to cover an expected rise in blood glucose after eating — not the basal insulin — the steady trickle of longer-acting insulin.

Exubera is a fast-acting insulin with a peak about 30 to 90 minutes after dosing. That’s the same as Humalog (lispro) and more rapid than regular insulin.

Adult type 2s will be able to use Exubera by itself, or with diabetes pills, or with a basal insulin. But adults with type 1 will have to use it with a basal insulin.

We don’t have any non-invasive blood glucose meters yet. Until they finally arrive, all of us will have to prick our fingers or some alternative sites all the time.

Pfizer and Nektar are aiming Exubera mostly at type 2s. It’s those type 2s who don’t have good blood glucose control – an A1C above 7 – who are the key target. Many of these people with diabetes have some fear of needles, and Exubera can be a godsend for them.

Exubera won the race for approval of inhaled insulin. But three other inhaled insulins are in clinical trials.

Of these competitors the closest to market is probably an insulin and aerosol inhaler developed by Alkermes with Lilly. Their inhaler is reportedly smaller and easier to operate than the Exubera inhaler.

Novo Nordisk, along with Lilly, the other insulin giant, is in the race too. MannKind is also in Phase 3 clinical trials of its inhaled insulin, which is very fast acting and has higher bioavailability. Full disclosure: I own stock in MannKind.

The question of bioavailability might be a major one when it comes to cost and insurance reimbursement. Bioavailability means how much of the dose gets into circulation.

The bioavailability of Exubera is about 10 percent compared to regular insulin injections, Anne Cropp told the FDA’s advisory committee in its September 8 meeting. She is Pfizer’s global clinical leader for inhaled insulin.

This sounds to me like Exubera requires ten times as much insulin for the same effect. That’s not clear, because one analyst told The New York Times that when Exubera goes on sale, it will cost three times as much as regular insulin. That probably won’t be until this summer.

What does this mean for insurance reimbursement? I think that’s one of the biggest questions. It’s also one that we are not likely to find the answer to until we try to buy Exubera.

This article is based on an earlier version of my article published by HealthCentral.