Sanofi Addresses Need for Spirometry Before Physicians Can Prescribe Afrezza

Evidence-Based Diabetes Management, July 2015, Volume 21, Issue SP11

The need for spirometry before physicians can write an Afrezza prescription has been cited by analysts as an impediment to broader use of the inhaled insulin.

Rarely does a new therapy generate as much divided opinion and passion as Afrezza, the inhaled insulin developed by MannKind Corporation and now marketed by Sanofi.

The fast-acting human insulin, administered through an inhaler that fits in a palm, has won loyal fans among users with type 1 diabetes mellitus (T1DM). Those who praise the product cite its ability to provide better glycemic control as well as a winning design, which offers convenience that those with T1DM have long sought.

Social media plays an important role in the T1DM community, and Afrezza has been a hot topic on Twitter since its launch. It’s common to see an Afrezza user post “Best A1C results ever”; some users have even uploaded copies of test results to show the drug’s effectiveness. Others share tales of taking insulin in public places or aboard planes without being noticed. Although Afrezza complements, but does not replace, long-acting insulin, users describe the product in life-changing terms:

“I can finally eat and enjoy family gatherings, barbecues, and holidays without worrying if my (blood sugar) will spike into the 200s for hours,” one wrote.

And then, there are the skeptics: throughout the spring, analysts who follow MannKind reported slower than expected sales and reluctance from some physicians to prescribe the product, often because of a requirement imposed by the FDA at approval:1 Because the insulin powder is inhaled, underlying lung problems must be ruled out before a patient can gain access to the therapy. (Afrezza is not indicated for patients with chronic obstructive pulmonary disorder or other chronic lung diseases, such as asthma. Safety and efficacy in patients who smoke have not been established.2)

Ruling out lung problems requires spirometry, a test that until now may have been uncommon among endocrinologists, although it better known among primary care physicians.

FIGURE 1

The test involves the use of specialized medical equipment called a spirometer (). According to educational information from Sanofi, a clip is placed over the nose, which forces the patient to breath by mouth through an attached tube. The patient is asked to breathe at different rates to measure lung capacity and volume. Results are expressed as a percentage, which is a measure of the patient’s actual performance compared with anticipated results based on age, height, gender, and ethnicity. A result is considered abnormal if it is less than 80% of what is predicted.

Besides testing before the first use of Afrezza, spirometry must be repeated after 6 months of therapy and then annually, even if the patient shows no sign of pulmonary symptoms.2

Analysts watching early drug sales saw these requirements as a barrier. This May 11, 2015, quote from Seeking Alpha is typical: “JP Morgan’s Cory Kasimov downgrades MannKind…due to lower-than-expected prospects for Afrezza. He attributes the inhalable insulin’s slow ramp to significant impediments to adoption that may be difficult to overcome.” The first “impediment” mentioned is the need for spiromentry.3

Sanofi is taking steps to turn the tide. At the annual Scientific Sessions of the American Diabetes Association (ADA) held June 5-9, 2015, in Boston, the education session on Afrezza was packed with physicians seeking information. The Afrezza floor display included efforts to deal with the spirometry issue head on, such as a document, “Guide to spirometry,” which described who can give the test and how, what the parameters mean, and—most important of all—which codes to use for reimbursement, both current procedural terminology and ICD-9 diagnosis codes.3

Officially, Sanofi does not see spirometry as a challenge to broader use of the drug. “While spirometry testing is required in order for a patient to be prescribed Afrezza, we do not see this as a barrier since many healthcare professionals are familiar with and have spirometry equipment in their offices,” said Susan Brooks, spokeswoman for Sanofi Diabetes, in an email to Evidence-Based Diabetes Management. “We have and will continue to make sure to get feedback and input from healthcare professionals and patients to help make Afrezza available to appropriate patients.”

Wall Street reports following the ADA meeting have been mixed. Adam Feuerstein of TheStreet.com, a consistent skeptic of Afrezza, reported on June 30, 2015, that sales thus far did not match those of Exubera,4 an earlier generation of inhaled insulin made by Pfizer. Exubera’s failure was widely attributed to its oversized inhaler, which patients said looked like a “bong” and required cleaning. The small Afrezza inhaler (FIGURE 2) has been praised by users as a dramatic improvement.5

An analyst whose firm attended ADA reported positive feedback. “At the ADA meeting we spoke to 20 US physicians who were familiar with Afrezza and found that while only 6 had prescribed the drug to date, only 1 physician was fundamentally concerned about prescribing it. The 1 physician who ex-pressed caution about prescribing Afrezza said that he remained worried about delivery of insulin, a hormone, into the lung,” said Shaunak Deepak of Jeffries.6

Physicians and insurers may start getting more requests for Afrezza soon. Sanofi is expected to launch a direct-to-consumer marketing campaign in the third quarter of 2015, focused on publications that reach patients with T1DM. References

1. MannKind Corporation announces FDA approval of Afrezza; a novel, rapid-acting inhaled insulin for treatment of diabetes [press release]. http://www.news.mannkindcorp. com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1943390. Valencia, CA: Globe Newswire; July 24, 2014.

2. Guide to spirometry: testing and coding for patients initiating or using Afrezza. Bridgewater, NJ: Sanofi-Adventis US; 2015. Distributed at the 2015 Scientific Sessions of the American Diabe-tes Association, June 5-9, 2015.

3. House DW. Analyst downgrades MannKind on lackluster prospects for Afrezza. Seeking Alpha website. http://seekingalpha.com/ news/2511656-analyst-downgrades-mannkind-on-lackluster-prospects-for-afrezza. Published May 11, 2015. Accessed June 22, 2015.

4. Feuerstein A. MannKind’s Afrezza lags behind biggest failure in inhaled insulin. The Street website. http://www.thestreet.com/sto-ry/13203821/1/mannkinds-afrezza-lags-behind-biggest-failure-in-inhaled-insulin.html. Published June 30, 2015. Accessed July 6, 2015.

5. Smith A. Toujeo and Afrezza: new and im-proved insulins, limited by FDA labeling con-straints. Am J Manag Care. 2015;21(SP7):SP226-SP227.

6. Gerson M. Afrezza feedback ‘largely positive’ for MannKind, Jeffries says. Benzinga website. http://www.benzinga.com/analyst-ratings/an-alyst-color/15/06/5579869/afrezza-feedback-largely-positive-for-mannkind-jefferies. Published June 9, 2015. Accessed July 6, 2015.