Featured Health Business Daily Story, July 18, 2013

Last Inhalers Containing CFCs Will Exit U.S. Market by End of This Month and Year

Reprinted from DRUG BENEFIT NEWS, biweekly news, proven cost management strategies and unique data for health plans, PBMs, pharma companies and employers.

By Angela Maas, Managing Editor
July 12, 2013Volume 14Issue 13

2013 will be the final year that the two remaining inhalers containing chloroflurocarbons (CFCs) will be available on the U.S. market. And with one of these products facing a July phaseout, payers should make sure sooner rather than later that any patients they have on these products are properly transitioned to other inhalers.

By the end of this month, Boehringer Ingelheim Pharmaceuticals, Inc.’s Combivent (ipratropium bromide and albuterol sulfate) inhalation aerosol will no longer be available. And after Dec. 31, Medicis Pharmaceutical Corp.’s Maxair Autohaler (pirbuterol acetate) will exit the market. The drugs help treat bronchospasms, or airway narrowing, in people with conditions such as asthma and chronic obstructive pulmonary disease (COPD).

The FDA made the decision to phase out the inhalers in April 2010. At that point, there were seven inhalers that required a prescription available, but only three — the Combivent and Maxair products as well as Forest Laboratories, Inc.’s Aerobid Inhaler System — were still being manufactured. The phaseout also applied to the over-the-counter inhaler medication Primatene Mist (epinephrine).

The move was the result of the Montreal Protocol on Substances that Deplete the Ozone Layer, a treaty initially ratified in 1987 by all U.N.-recognized countries. These nations pledged to phase out the production of chemicals that deplete the ozone layer while trying to find safer alternative products.

Boehringer Ingelheim’s Combivent Respimat inhalation spray is the same product as the aerosol but without the CFCs. On the Combivent website, the company notes that the aerosol will be discontinued this month and will be replaced with the spray.

Medicis purchased the Maxair Autohaler from Graceway Pharmaceuticals, LLC in late 2011 through a bankruptcy auction after Graceway filed for Chapter 11 bankruptcy protection. Then about one year later, Valeant Pharmaceuticals International, Inc. purchased Medicis, which now operates as a division of Valeant. A spokesperson for Valeant tells DBN that “We have not disclosed anything as yet and will send out appropriate communications in the coming months.”

10,000 Prime Members Use Inhalers

David Lassen, chief clinical officer at Prime Therapeutics LLC, tells DBN that during the first quarter of 2013, his company had 9,065 patients on the Combivent inhaler and 1,291 on the Maxair product. Jeff White, director of pharmacy clinical analytics strategies at WellPoint, says that the insurer does not “generally provide this information.”

In order to help its members who need to transition off these products, Prime has “added the new Combivent Respimat to formulary as an option for patients.…We would assume most patients will transition over” to it from the aerosol.

He explains that the Combivent aerosol is on Prime’s formulary, but Maxair is not.

According to White, “We do not plan to communicate to providers on Combivent, as there is an equivalent product available and…[we] anticipate the member’s pharmacist will assist with this switch. For Maxair we are still evaluating whether WellPoint will communicate.”

Lassen says there is “minimal use” of Maxair; “the bulk of the use in this category is in ProAir and Ventolin.” He says there are “other long-acting and short-acting beta-agonists” available, and physicians “will need to determine the best alternative for their patients.”

Many CFC-Free Inhalers Are Available

In the overall inhaler category, patients will have a large number of options from which to choose. Overall there are more than 25 CFC-free inhalers for people with asthma and COPD, according to the FDA.

When viewed within the scope of the overall class of medications, the Combivent aerosol and Maxair Autohaler “are not heavily used in the asthma/COPD space compared to other available products,” says Lassen.

“This drug class represents about 3% of total drug spend; the number of prescriptions used each month appears to be relatively flat in this category,” White tells DBN.

The soon-to-be-phased-out products compare with their competitors in the following ways:

  • Cost: “Maxair is more expensive than ProAir and Ventolin,” Lassen says, with a prescription for Maxair priced at about $185 compared with about $50 for albuterol products Pro Air and Ventolin. Combivent “is comparable in price to other combination products.”

  • Effectiveness: The albuterol products are “the standards of care.” However, he says, “There is concern that patients may not be able to actuate the Maxair Autohaler, particularly those experiencing an exacerbation.” In addition, with albuterol combination products such as Combivent, “The FDA does not recommend the use of these combination products over the singular-entity products as they do for the ICS/LABA [i.e., inhaled corticosteroid/long-acting beta agonist] combination therapies,” he explains.

  • Patient Adherence: According to Lassen, Maxair and the Combivent aerosol “don’t have any data to support they improve adherence over other products.”

View the FDA list of CFC-free inhalers at http://tinyurl.com/26ah3to.

© 2013 by Atlantic Information Services, Inc. All Rights Reserved.

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