U.S. Department of Veterans Affairs (’V.A.’) has some fascinating conditions associated with the agency’s formulary list for approving health plan members’ use of Pfizer’s Exubera inhaled insulin.

Both of these conditions must be met:

• Doctor’s must have experience in managing diabetic patients on insulin
• Patient must have baseline spirometry and diffusing capacity for carbon monoxide (DLCO)

Also, the insured diabetic patient must either:

• Have severe persistent injection site problems such as lipohypertrophy, or
• Work in an environment that does not allow needles (e.g. prison guard)

In effect, it appears that the V.A.’s forumulary committee concluded that Exubera is generally not more effective than subcutaneous injectable insulin for either Type 1 or Type diabetics, and that working in a place where needles aren’t allowed would limit coverage of the diabetes drug to a relatively small class of insured patients.

You can read the V.A.’s full explanation of conditions associated with Exubera forumulary coverage by clicking here.

Spain’s National Health System decided to fund the cost of Exubera insulin inhalers for diabetics.

Patients will pay no more than 3€ for the Pfizer inhaled insulin, and a new report says that pharmacies in Spain now have the drug in stock.

It looks like Pfizer may have spent some big bucks on a ’survey,’ that — surprise, surprise — appears to have achieved results designed to get more doctors to write prescriptions for the drugmaker’s Exubera inhaled insulin.

The new survey titled “Reimbursement of Inhaled Insulins: Safety and Efficacy Concerns vs. Improved Patient Compliance,” was done by Physician & Payer Forum, a primary research service of Decision Resources, a pharmaceutical consultant and advisory company.

Guess who the company’s clients are? Drug companies like Pfizer!

Decision Resources boasts that its:

“client base is diverse - including large pharmaceutical companies, emerging biotechnology concerns, financial services, managed care organizations, and medical device manufacturers who turn to Decision Resources to help shape their strategy and master their chosen markets.” (emphasis added)

That means the company’s recent press release extolling praise for its new statistical look at Exubera inhaled insulin prescriptions could be viewed by some cynics as essentially an advertorial.

It paints a rosy sales outlook for Exubera, something that Pfizer certainly hasn’t felt since it bought exclusive worldwide rights from sanofi-aventis for $1.3 billion in 2006 to launch the drug. Critics have called the company’s acquisition of these rights little more than the purchase of a ‘billion-dollar bong.’

Saying that their survey shows “54 percent of primary care physicians and 41 percent of endocrinologist say they will increase the number of prescriptions they write for insulin generally,” they also allege that half of the seventeen (17) managed care pharmacy directors that they surveyed think that Exubera will help diabetic patients start using insulin earlier than they othewise might using injectable insulin.

How is asking just 17 managed care pharamcy directors about Exubera noteworthy? On the contrary, it’s such a miniscule number that it appears statistically insignificant.
Why is that significant? Because there have been widespread reports that physicians remain reluctant to presecribe Exubera for their newly diagnosed and existing diabetic patients.

For roughly a year, Pfizer’s Exubera sales were so poor that it wasn’t even reporting them to shareholders in its SEC filings. In February it was revealed that Exubera sales were $110M for 2006, the first year that the drug received FDA approval.

that offers access to high volume-prescribing physicians, specialists, and managed care organization representatives in the United States; analysis of events and survey participants’ responses to them; insight into prescribing patterns; and an examination of the implications of events and issues for the pharmaceutical market.

A second Gulf country just approved the sale of Pfizer, Inc.’s (NYSE:PFE) inhaled insulin. Dubai’s Dept. of Health and Medical Services added the Pfizer diabetes drug to the country’s drug formulary list.

In January, the United Arab Emirates’ Ministry of Health gave Pfizer conditional approval to make Exubera available to diabetics in the Gulf state.

Pfizer, Inc. (NYSE:PFE) will report First Quarter earnings for 2007 to investors tomorrow. Lackluster Exubera sales of the drugmaker’s inhaled insulin are likely to be mentioned.
One report summarized the problems this blog continues to report on since the diabetes drug received FDA approval last year:

Acceptance of the company’s inhaled insulin Exubera was not promising despite hype on the product as some doctors still worried about long-term lung safety and lacked reimbursement as insurers considered the drug a convenience.

Deutsche Bank analyst Barbara Ryan rates Pfizer stock as a “Buy,” while Prudential Equity analyst Tim Anderson called it a “Neutral” securities purchase.
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