Asthma drug pipeline: Prevalence, costs to increase

In the United States, more than 24 million people have asthma, and the cost of the disease is approximately $56 billion annually, according to the CDC. Direct costs, including hospital stays, account for nearly $50.1 billion of the healthcare burden, with indirect costs, such as lost pay from illness or death, comprising the other $5.9 billion.

Spending on asthma medications in 2015 decreased 1.6% from 2014, moving asthma down to the eighth most-expensive traditional therapy drug class, according to Express Scripts’ 2015 Drug Trend Report.

Despite having multiple treatment options available, approximately 10% to 20% of asthmatics are poorly controlled, studies say. Uncontrolled asthma inevitably leads to exacerbations of symptoms, or “asthma attacks.” These asthma exacerbations result in about 1.8 million emergency department visits and 3,400 deaths in the United States each year, according to the CDC.

Ambres“Medication adherence for maintenance medications is a big problem for patients, which can lead to the use of emergency inhalers and avoidable emergency department visits,” says Cynthia Ambres, a principal at KPMG Strategy and a member of the firm’s Global Healthcare Center of Excellence.

Patients most affected

Although adults comprise the majority of patients diagnosed with asthma, the pediatric population also is affected. Asthma is the leading chronic disease diagnosed in children and is the top reason for missed school days, according to Farrah Wong, PharmD, director of pipeline and drug surveillance at OptumRx.

Due to the high prevalence of Medicaid enrollees with asthma, Medicaid is the largest payer for asthma-related hospitalizations among children and adults, according to the Agency for Healthcare Research and Quality.

WardAccording to the Express Scripts Drug Trend report, asthma drugs were among the top three costliest traditional therapy classes for the Medicaid population in 2015. Medicaid plans spent $62.73 per member per year in 2015, an increase of 2.6% from 2014. The increase in spending was due to increases in drug costs; utilization actually declined slightly between 2014 and 2015. While AstraZeneca’s Symbicort (budesonide/formoterol) had the highest per member per year drug spend in Medicaid at $10.74, GlaxoSmithKline’s Ventolin HFA (albuterol sulfate) had the highest asthma market share in Medicaid.

“Patient education on the proper use of asthma therapies is key to keeping patients with asthma, particularly Medicaid enrollees, out of the hospital,” says Krista Ward, senior director of Medicaid programs at Express Scripts. “Our pulmonary specialist pharmacists encounter many patients who stop taking their medication when their symptoms abate, or rely too heavily on their rescue inhaler, and thus have poorly controlled asthma and are on the verge of a hospitalization. We’ve found that our pharmacist interventions help get them back on track and keep them out of the hospital.”

Next: Current treatments

Current treatments

Although non-pharmacologic therapies can help with asthma management, drug therapy is the mainstay of treatment and is categorized into two main groups: long-term control medications and quick-relief medications.

Long-term control medications are used as maintenance therapy to help reduce airway inflammation and prevent asthma symptoms and exacerbations. Some of the traditional long-term control medications used in asthma include inhaled corticosteroids (ICS), long-acting beta-agonists (LABAs), leukotriene modifiers, theophylline, and combination ICS/LABA products.

According to the Express Scripts Drug Trend Report, the leukotriene receptor antagonist, montelukast (Singulair, Merck) is the most commonly prescribed asthma therapy. The unit cost of montelukast decreased in spend by 37.4% from 2014 to 2015, despite an 8% increase in utilization.

The second group of drugs used in asthma are the quick-relief medications used as “rescue” therapy in asthma exacerbations. These include short-acting beta agonists, such as albuterol, and anticholinergics.

According to Wong, the average cost of traditional long-term control medications, such as fluticasone propionate and salmeterol inhalation powder (Advair Diskus, GlaxoSmithKline) and budesonide and formoterol (Symbicort, AstraZeneca) is approximately $200 to $300 per month, while the newer immunologic products, such as omalizumab (Xolair, Genentech and Novartis), mepolizumab (Nucala, GlaxoSmithKline) and reslizumab (Cinqair, Teva Pharmaceuticals) cost approximately $1,000 to $3,000 per month.

Because of FDA’s reformulation requirements in 2008 from CFC-containing devices to HFA or other devices, there are few generic inhalers available, according to April Kunze, director of formulary development and pipeline at Prime Therapeutics. Asthma and COPD drugs comprise about 4% of Prime’s total drug spend. However, there are now Abbreviated New Drug Applications submitted for some highly utilized products, such as Advair, that may help contain costs. 

Nucala and Cinqair, both anti-interleukin-5 monoclonal antibodies, were recently approved as adjunctive therapies for the treatment of severe eosinophilic asthma. Nucala is administered subcutaneously by a healthcare professional once every four weeks. Cinqair is administered by intravenous infusion once every four weeks.

LyleAccording to Kunze, these new therapies will compete most closely with Xolair, a humanized monoclonal antibody used in moderate to severe persistent asthma. Nucala and Cinqair are only to be used in patients whose asthma has failed first-line therapies, such as ICS and combination products.

“With more complexity, efficacy and personalization comes a high price tag,” says Andrew Lyle, director of business development at Curexa Pharmacy. “For example, Nucala is priced at $36,000 annually which has had payers extremely concerned. Payers have put strict regulations on this product such as requiring prior authorization and putting the product through a step therapy, meaning to try alternative products first. While extremely efficacious, patient access will be delayed due to these tight restrictions. As a provider, providing the best therapy to improve patient health is always our number one priority.”

Next: In development

In development

A new trend in the development of asthmatic therapy is monoclonal antibodies that target specific interleukins in the inflammatory pathways, says Wong.

These monoclonal antibodies, benralizumab (AstraZeneca), dupilumab (Regeneron and Sanofi), lebrikizumab (Roche) and tralokinumab (AstraZeneca), are currently in phase 3 trials for uncontrolled and/or severe asthma and will likely be considered specialty medications. As such, their costs will likely be substantially higher than traditional inhaled asthma therapies.

“Unlike traditional inhaled asthma medications, these monoclonal antibodies are administered as either subcutaneous or intravenous injections,” Wong says.

Most of the new developments for asthma treatments are aimed at developing new delivery mechanisms for existing treatments or developing biologics that take a targeted approach at controlling asthma.

“Prior authorization and step-therapy programs will most likely be required for coverage of these medications,” says Ambres. “Drugmakers looking to create a new delivery platform for existing treatment will have a more difficult task in proving their worth to payers unless they can show improvements in medication adherence or outcomes.”

The future

The Express Scripts Drug Trend Report predicts that spending on asthma medication will increase slightly in 2016 and 2017 from anticipated brand inflation. For 2018, however, Express Scripts expects trend will be flat after the first generic for Advair Diskus is approved by FDA, which is expected in late 2017. Proair HFA (albuterol inhaler) is also expected to face generic competition in December 2016, although a settlement agreement will only allow limited supplies of the generic to become available, resulting in reduced cost savings.

Pending clinical trial results, the new biologic drugs have the potential to provide promising benefits in reducing asthma exacerbations for patients with uncontrolled and/or severe asthma. As the novel development of these medications targeting various inflammatory pathways improves, more therapeutic options will be available.

Erin Bastick, PharmD, is a University Hospitals, Cleveland, inpatient graduate intern.