Affordable relief

Hardik Chaudhari a Pharmacy Technician at Lake Sumter Landing Pharmacy in The Villages fill a prescription Thursday, September 6th, 2018 with a generic drug. An increase in generic drug approval by the FDA is part of a push by the Trump administration to lower prices for patients.

Working as a pharmacist, Gail Orr saw the burden high prescription drug prices places on patients.

“I had people come in and say they were making decisions whether to buy a loaf of bread or pay the co-pay on the prescription because they didn’t have the money for both,” recalled Orr, president of the Pharmaceutical Club.

Prices remain high today, but lower-cost generics are becoming more available.

A recent influx of generic drug approvals is part of a push to reduce patient costs. Generics typically cost 80 to 85 percent less than name-brand drugs, according to the Food and Drug Administration.

In July, the FDA approved more generic drugs than in any month in its history.

Accelerating approval of generics is part of a blueprint to lower drug prices released by the Trump administration in May.

“The extensive number of proposals in the blueprint reflects the scale of the task: restructuring and reforming a fundamentally flawed drug-pricing system that governs a more than $400 billion sector of our economy,” said Dan Best, senior adviser to the secretary for drug pricing reform, in a recent report.

The administration’s effort is encouraging, said Rachel Schwartz, director of communications for the Association for Accessible Medicines, a trade association.

In 2017, generics generated $265 billion in savings, including $16.2 billion in Florida, according to AAM’s 2018 Generic Drug Access & Savings Report.

Brand-name drugs represented 10 percent of prescriptions but 77 percent of spending, the report states.

Generics can be especially beneficial for seniors who are looking to save. Each year, Medicare patients risk falling into a doughnut hole, meaning they have exhausted the money insurance will pay for prescriptions and must pay for additional drugs out of pocket.

“At this time of the year, about 60 to 65 percent of the population is in the doughnut hole,” said Vatsal Patel, owner of Lake Sumter Landing Pharmacy.

The lower cost of generics helps keep patients from using up their Medicare funds.

For example, Synthroid, a name-brand drug for hyperthyroidism, costs about $200 to $250 for a three-month supply. A generic is available for $10, Patel said.

Generics account for at least 80 percent of prescriptions filled by the pharmacy, he said.

Generics must have the same dosage, safety, effectiveness, strength, stability and quality as name-brand drugs to gain FDA approval.

Getting a generic approved can be difficult, said Patrick Bridgeman, clinical assistant professor of the Ernest Mario School of Pharmacy at Rutgers University.

“There’s a significant amount of research that goes into developing the novel treatments that are available,” he said.

To recoup those costs, companies patent products, preventing other companies from producing a copy for years.

Because so much money is at stake, some companies try to extend this period through legal maneuvering. “They’re throwing patents on the wall and seeing what sticks,” she said.

It’s frustrating when consumers are waiting for those lawsuits to settle so they can access more affordable options, said Ray Bailey, pharmacy director for Rx to Go, Florida Cancer Specialists’ in-house pharmacy.

Branded oral cancer medications typically cost $10,000 a month. Few generics have been approved, but some that have are 80 percent cheaper, he said.

“We struggle with that,” Bailey said. “We think we’re going to get a drug, and it takes two more years to get to us.”

Once generics are approved and make it to market, it can take time for consumers to see significant price drops, he said.

Generic oral cancer drugs have typically been 10 to 20 percent cheaper when they first go on sale, Bailey said.

Bigger reductions occur when multiple companies start marketing a generic.

“Anytime we have more competition for medications essential for people’s health it hopefully, in time, drives prices down and makes it more accessible,” said Dr. Richard Lockey, director in the division of allergy and immunology and professor of medicine at the University of South Florida.

Patients with life-threatening allergies hope to see this translate to the FDA’s approval of a first generic for the EpiPen and EpiPen Jr.

EpiPen’s manufacturer, Mylan, has drawn criticism for soaring prices. A two-pack of the epinephrine injection sold for about $100 in 2009. The same pack now costs $600.

Other firms are marketing cheaper epinephrine injections, but the new drug produced by Teva Pharmaceuticals is the first that can be automatically substituted by a pharmacist.

It’s especially important, Bridgeman said, because for many, EpiPens mean life or death. So most users have multiple injectors.

“It’s a big deal for them,” he said.

Schwartz hopes for a continued push for more generic approvals.

“Any time a generic is approved is a win for consumers,” she said. “It’s an important piece of the puzzle for health care savings.”