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Shire alleges Allergan blocked Xiidra from Medicare contracts
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Shire is alleging that Allergan has blocked Medicare Part D access to Xiidra in order to allow Restasis to keep a monopoly on dry eye treatments offered through Part D plans, according to a lawsuit filed in U.S. District Court, District of New Jersey.
The suit claims Allergan has maintained a high market share by “employing egregiously anticompetitive and unlawful tactics.”
“Allergan has and will continue to use bundled discounts, exclusive dealing, coercion and interference to unlawfully ‘block’ Shire from competing with it, and to maintain its monopoly in the Part D market at all costs and at the expense of Part D beneficiaries until Xiidra is effectively eliminated as a competing product in the Part D market,” Shire alleges in the lawsuit.
Xiidra (lifitegrast ophthalmic solution 5%) and Restasis (cyclosporine ophthalmic emulsion 0.05%) are both indicated for the treatment of dry eye disease; however, Xiidra is approved for both the signs and symptoms of dry eye disease, including inflammation, applying to all dry eye patients, while Restasis is approved for only patients with the specific sign of reduced tear fluid volume, which represents about 10% of dry eye patients, according to Shire’s lawsuit.
Shire maintains that Allergan has used “anticompetitive” and “coercive” tactics to keep an annual nearly $1.5 billion monopoly on the Medicare Part D market, while restricting Xiidra to just 10% of the dry eye drugs dispensed to Part D patients. These tactics include rebate bundles across several Allergan products and anticompetitive discounts.
Allergan claims the suit "has no merit" and that the company has operated within all CMS Medicare Part D policies and regulations.
"In our negotiations with Medicare Part D sponsors, we are competing on value and price, and competition in the chronic dry eye therapeutic market has driven down pricing for patients and payers in Medicare Part D and commercial plans. Restasis continues to provide significant value to Medicare beneficiaries, providers and the Part D program for the treatment of dry eye disease," a statement from Allergan Director of Corporate Affairs Mark Marmur said.
Editor's note: This article has been updated to include a response from Allergan.