MMIT Reality Check on Chronic Obstructive Pulmonary Disease

Payer Coverage:

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 29% 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 92% 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 52% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

Infographic: Out-of-Pocket Prescription Drug Costs Remain a Burden for Medicare Beneficiaries

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.

FDA Approves IND Application for Zofin

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.

FDA Approves Breztri Aerosphere

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. The medication is a single-inhaler, fixed-dose, triple-combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, a long-acting muscarinic antagonist (LAMA); and formoterol fumarate, a long-acting beta2-agonist (LABA), delivered in a pressurized metered-dose inhaler.

Key Findings:

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 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), LABA, short-acting muscarinic antagonist (SAMA), LAMA or 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.

Key Players in Market:

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