A review of market access for treatments of adults with chronic obstructive pulmonary disease (COPD) shows that under the pharmacy benefit, about 13% of the lives under commercial formularies are covered with utilization management restrictions. Around 26% of the lives under Medicare formularies are not covered for at least one of the drugs.
Under the medical benefit, about 6% of the lives under commercial policies are covered with utilization management restrictions. About 91% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.
For about 91% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 39% require multiple steps. Around 14% of payer-controlled pharmacy benefit covered lives require prior authorization, with 55% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
Most older adults in the U.S. have been diagnosed with one or more chronic illnesses, and managing these conditions presents a significant cost burden, according to a January 2022 study in JAMA Internal Medicine. The authors studied eight of the most common chronic conditions, both as single disease states and in clusters, and determined hypothetical annual out-of-pocket (OOP) costs for individual seniors enrolled in Medicare Advantage-Prescription Drug plans and Standalone Part D plans in 2009 and 2019. While annual costs for many of the conditions dropped, likely due to the availability of new generic drugs, OOP costs for atrial fibrillation, type 2 diabetes and heart failure skyrocketed.
Of the 62 inhalers approved for asthma and chronic obstructive pulmonary disease (COPD) between 1986 and 2020, only one product had a new mechanism of action, according to new research published in the journal Health Affairs. However, the researchers found that 53 of the approved inhalers were brand-name products with a median of 16 years of patent exclusivity. The authors add that “manufacturers augmented periods of brand-name market exclusivity by moving active ingredients from one inhaler device into another (‘device hops’). The median time from approval of an originator product to the last-to-expire patent or regulatory exclusivity of branded follow-ons was twenty-eight years.”
In January 2021, the FDA approved the Investigational New Drug (IND) application for Organicell Regenerative Medicine, Inc.’s Zofin (Organicell Flow) for the treatment of patients diagnosed with chronic obstructive pulmonary disease. The company said that the trial design would be a double-blinded, placebo-controlled Phase I/II trial investigating the safety and potential efficacy of an intravenous infusion of Zofin.
Market Events Drive Changes
In July 2020, the FDA approved AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). In January 2019, the FDA approved the first generic of GlaxoSmithKline plc’s Advair Diskus (fluticasone propionate/salmeterol), Wixela Inhub, which is manufactured by Mylan N.V., a company that is now part of Viatris Inc. The nebulized long-acting muscarinic antagonists (LAMAs) Yupelri (revefenacin), from Theravance Biopharma Inc. and Viatris, gained approval in November 2018 and Sunovion Pharmaceuticals, Inc.’s Lonhala Magnair (glycopyrrolate) in December 2017.
Competitive Market Landscape
Once-a-day combination products and monoclonal antibodies have created new opportunities for COPD market growth. The class continues to grow with an influx of pipeline products. Breztri Aerosphere continues to compete with GlaxoSmithKline’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) as the only triple combination inhalers for COPD on the market. Product placement will be crucial as manufacturers will want to maintain favorable statuses for their products.
Pharmacy, Medical Benefit Implications
Coverage is apparent for most COPD products. When prior authorization is defined, a diagnosis will be required. Step restriction through a short-acting beta agonist (SABA), long-acting beta agonist (LABA), short-acting muscarinic antagonist (SAMA), LAMA or inhaled corticosteroid (ICS) is commonly seen in policies. Coverage is primarily under the pharmacy benefit, except for Yupelri, Sunovion’s Brovana (arformoterol tartrate) and Viatris’ Perforomist (formoterol fumarate), which can be covered under both the pharmacy and medical benefits.