When high out-of-pocket costs spur noncompliance that leads to increased hospitalization, payers take notice. Using therapies for COPD as a case in point, AIS Health, Radar on Drug Benefits interviews Precision for Value Vice President, Access Experience, Charline Shan about the strategies payers may take to lower costs for their beneficiaries—and themselves.

Generic Advair May Help COPD Costs, but Management Is Tough
by Jane Anderson
AIS Health

A new generic alternative for GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) provides payers with the chance to better manage care in chronic obstructive pulmonary disease (COPD), a condition in which high out-of-pocket costs often lead to lower compliance and an increased risk of hospitalization. But payers also are experimenting with innovative care management that they hope will prove to find cost-effective ways to help patients better manage their own conditions.

Advair Diskus, a combination long-acting beta-agonist (LABA) and an inhaled corticosteroid (ICS), has been one of the most common drugs used for COPD, a condition largely dominated by brand products. The generic, marketed by Mylan and approved Jan. 30, joins generics for two additional COPD devices, both also approved in the first quarter of 2019: a generic for Ventolin HFA (albuterol) and one for Proair HFA (albuterol).

All three have the potential to save payers and patients significant money. In the case of Advair Diskus, the generic is retailing for around $135 in the most common dosage, while the brand-name product sells for more than $400.

Charline Shan, R.Ph., vice president, access experience team at payer insights and strategy firm Precision for Value, calls the availability of a generic for Advair a notable advance in COPD management: “The generic of Advair potentially offers payers a way to manage costs and an affordable choice for patients.”

A second notable advance is the availability of triple combination therapy, which combines a LABA, a long-acting muscarinic antagonist (LAMA) and an ICS in one device, Shan tells AIS Health. GlaxoSmithKline’s Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) currently is the only FDA-approved triple combination therapy, although AstraZeneca plans to seek regulatory approval for its own combination therapy, PT010, a combination of budesonide, glycopyrronium and formoterol fumarate.

“Triple combination therapy provides a potential simple option for a patient to manage and prevent exacerbations and improve lung function in one device as well as reduce multiple inhalers a patient has to manage,” Shan says. COPD patients generally juggle two or more inhalers and/or nebulizers, and researchers presenting at the American College of Chest Physicians’ 2018 annual meeting reported that two-thirds of adults with COPD or asthma are making multiple errors in using their metered-dose inhalers.

Other inhaled drugs used to treat COPD include short-acting beta-agonists (SABAs) and short-acting muscarinic antagonists (SAMA), combination SABA with SAMA in one device and combination LABA with LAMA in one device, Shan says. In early April, the FDA approved the LABA/LAMA fixed-dose combination inhaler Duaklir from Circassia Pharmaceuticals. Yupelri (revefenacin), from Mylan and Theravance Biopharma, was approved in November 2018 as the first once-daily nebulized LAMA for COPD patients.

Oral therapy options include AstraZeneca’s Daliresp (roflumilast), a phosphodiesterase-4 inhibitor, and methylxanthines, which include Theo-24 and Uniphyl (theophylline).

Standard pharmacotherapy for COPD is based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, along with the severity of the COPD, Shan says. “All patients are prescribed a rescue short-acting bronchodilator for immediate relief along with their standard therapy,” she says.

Many Generic, Branded Options Exist

With the amount of generic options available, Shan says plans have multiple options for structuring their formularies. Generics are typically included, with brand drugs placed on preferred or nonpreferred tiers based on price, “but not all are required or have to be on the formulary since there are many branded and therapeutic equivalent options,” she says. “If there are only brands available in the class, then the plans evaluate the clinical and economic value of each brand and determine formulary preference of certain brands.”

Most people with COPD are covered by Medicare, and CMS requires that a minimum of two products for each category or class be available on the formulary. However, Medicare Part D plans may also consider additional factors when structuring their formularies for COPD patients, including the total cost of care, and that may lead them to implement more selective branded choices on formularies than commercial plans, Shan says.

Since multiple drug options are available in each therapeutic category for COPD, payers often leverage several strategies of utilization management to manage costs, Shan says. These can include prior authorization, step therapy, quantity limits and formulary exclusions, she says.

“Depending on the tactic, effectiveness varies,” she adds. “The most effective is formulary exclusion, since the patient is not able to obtain the drug under the pharmacy benefit and may choose to pay out-of-pocket for the drug. Prior authorization and step edits ensure the right patient is on the right medication and has tried and failed preferred medications.”

New Products Are in the Pipeline

Shan notes that multiple products are in the pipeline to reduce COPD exacerbations, improve airflow and decrease inflammation, plus novel therapies targeted to treat specific subtypes of COPD. “Given today’s laser focus on price and total cost of care, new treatments will need to demonstrate both clinical differentiation and economic value to positively impact standard of care,” she says. “Payers will continue to manage access to control costs, especially if new treatment options are budget breakers.”

Since hospitalizations and emergency room (ER) visits contribute significantly to the total cost of care for COPD patients, plans also may focus on disease management and care management programs to reduce these costs in high-risk patients. Studies generally show disease management programs can reduce hospitalizations and ER visits in groups of COPD patients, but the savings don’t always offset the cost of the programs.

Given that, PBMs and payers are working to develop more efficient solutions that deliver care management benefits without a prohibitive price tag.

At Express Scripts, high-risk patients with COPD who are prescribed a controller inhaler are offered remote devices to help optimize their medication use. The data from the devices is monitored remotely to look for problematic signs, such as a patient who is overusing a rescue inhaler or is nonadherent with their controller medication, and care managers reach out as needed to offer individualized care and support.

According to Express Scripts, patients with asthma who participated in a pilot program using this remote monitoring showed a 60% to 80% reduction in the use of rescue inhalers, and a nearly 10% improvement in adherence with their asthma controller medication.

Plans Engineer Digital Strategies

Express Scripts and Propeller Health have partnered to provide Propeller’s inhaler sensors and a mobile app to manage asthma or COPD, the companies say. The digital sensors enable remote monitoring for patients enrolled in Express Scripts’ Pulmonary Care Value Program, which combines specialized pulmonary pharmacist clinical support, patient engagement tools and pharmacy networks.

The sensor attaches to a patient’s inhaler and uses Bluetooth to collect data. In addition to being monitored remotely by Express Scripts’ clinicians, the data is tracked in the Propeller mobile app, where patients can track their symptoms and triggers and receive tips for better self-management.

Other payers also are adding the technology. Last August, Anthem Blue Cross and Blue Shield in Ohio said it would roll out a program with Propeller Health to monitor inhaler use for Medicare Advantage members who have COPD and who have had at least one COPD-related hospitalization or emergency room visit.

Contact Shan via spokesperson Tess Rollano at trollano@coynepr.com and Propeller via Rachel Fields at rachel.fields@propellerhealth.com.