MannKind calls on Asembia to assist in relaunch of Afreeza inhalable insulin

Inhalable insulin therapy has obvious value for patients tired of injecting themselves with needles, but the approach has failed at least twice, notably with Pfizer’s multibillion-dollar Exubera fiasco in the mid-2000s. MannKind, which has a proprietary inhalable drug-delivery platform, tried anew in this decade. But when Sanofi-Aventis, its commercialization partner, dropped the drug earlier this year, MannKind chose to bet the farm on succeeding where those Big Pharma companies failed.

Having won back the rights to Afreeza, its inhalable drug, earlier this year, the company has announced a series of actions, including getting a new NDC drug code for the product (essentially, a restart in the commercial distribution arena). Other actions:

• A new 30-day titration pack combining 90 4-unit cartridges and 90 8-unit cartridges, allowing patients greater flexibility to adjust their dose as they learn how to titrate Afrezza
• MannKind Cares, a patient reimbursement-support program
• A new and enhanced copay-assistance program
• Creation of an opportunity for physician offices to purchase in-office spirometers, allowing them to perform pulmonary function testing during the patient visit
• A speakers bureau to educate healthcare providers about Afrezza.

“Relaunching Afrezza as a MannKind brand is one of the most significant milestones in our company's history," said Matthew Pfeffer, CEO of MannKind. "We are encouraged by the overwhelmingly positive response we have received from patients, physicians and advocates, who have provided us with tremendous feedback on our relaunch of Afrezza, and whose inputs directly influenced some of the programs announced today.”

MannKind Cares and the copay assistance program are aspects of the relaunch common to high-priced specialty drugs as opposed to a mass-market product like diabetes therapy, and that’s where Asembia (formerly Armada Health Solutions) comes in. “We look forward to working with MannKind to support their patients' needs and help them navigate reimbursement challenges and product access for their prescriptions,” said Lawrence Irene, RPh, CEO of Asembia, in a statement.  Irene continued, “As our hub services and technology capabilities at Asembia continue to expand, our organization is well-positioned to support brands which require a high-touch approach to ensure optimized patient care and access.”

Hub providers (a.k.a. third-party patient support vendors) generally are hired by pharma companies to assist with complex prior-authorization and reimbursement issues for specialty products, and to help patients keep on therapy. Asembia, which identifies itself as “the industry's largest specialty pharmacy group contracting and service organization,” provides hub services through its call center, as well as supporting services to specialty pharmacies in its network.

“Utilizing Asembia's comprehensive HUB Services will ensure a white-glove patient experience, and support services that increase patient retention during the first 3 months of treatment and ensure we streamline the prescription process for physicians and patients who are prescribed Afrezza,” added Michael Castagna, chief commercial officer of MannKind.

This program, if successful, not only will be the survival of one-product Mannkink, but also a continuation of a trend that has been developing in the hub services world: adapting its specialty-drug patient support techniques to broader patient populations. Called “hub lite” by some vendors, the approach employs lower-cost interventions (such as telephone support rather than in-home visits by nurse educators) and streamlined distribution (which could involve mail delivery rather than stocking thousands of local pharmacies). The FiercePharma website, in describing Mannkind’s relaunch, called it “a sales-and-marketing strategy on a shoestring budget--at least compared with the typical Big Pharma launch.”

That 30-day titration pack also deserves mention: the package includes a small plastic dispenser, and drug dosages in blister-carded “pods” that are inserted into the inhaler and then consumed—a fairly complex set of resources for diabetes patients to manage. Innovative packaging and assembly was provided by PCI Services, the contract packager.