Brand Name Vs Generic Drugs: The Fight Continues

Many patients and practitioners are looking to generics to ease the pressure of skyrocketing antiretroviral (ART) drug prices, but according to Rochelle P Walensky, MD, Professor of Medicine at Harvard Medical School, they shouldn’t hold their breath.

There's a longstanding misconception that drugs become cheaper as soon as they come off patent, Walensky said during a presentation at IDWeek in San Diego, CA. But that simply isn’t the case.

“It generally takes 2 to 5 years for generic drug competitors to make enough of a drug to actually reduce its price. When that happens, the drug prices are usually reduced to about 75% of the cost of the branded drug,” Walensky said.

In 2016, the average wholesale price of recommended first-line ART regimens was more than $40,000 annually per patient, so even a 25% discount would leave patients with a heavy price burden. Still, generic substitution could result in up to $6 billion in overall cost savings, Walensky said, and not just for patients.

“Branded prescriptions are more than twofold likely to be abandoned at the pharmacy for lack of being able to afford them, and adherence is increased by between 5% to 7% with generics as compared to branded drugs, because people are actually picking them up,” she said.

Walensky cited a meta-analysis of 47 studies across 9 drug classes that found no evidence of branded drugs’ superiority over generics. Of course, that doesn’t imply that generics are better than branded drugs, either — the pros and cons of generics are essentially equal, she said.

Pros of generic drugs:

• They’re required by the FDA to meet bioequivalence and manufacturing standards
• They lower drug costs
• Potential for lower co pays may improve treatment adherence
• They are less likely to require prior authorization, and are easily accessible
• Their longer history implies more data on drug safety and efficacy

Cons of generic drugs:

• Patients perceive them as inferior to branded drugs
• If they’re not co-formulated, higher pill burdens may deter adherence
• Overall co-payments for a regimen could result in higher costs to patients
• They may have a different pill size/color when generic suppliers change
• By the time of patent expiration, newer drugs may have improved tolerability or clinical outcomes

HIV providers are interested in lowering the cost of drugs so their patients can improve adherence and experience better quality of life, but the road to affordable ART is complicated, and dependent on factors like the 340B Drug Discount Program — a US federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations at significantly reduced prices.

340B targets HIV infected patients specifically, Walensky said. The 13 most commonly dispensed drugs under the program are ART, and of the 500 million prescriptions dispensed by walgreens in 2012, almost 80% were ART, and most of those were branded.

“Here’s how it works: our clinics and our hospitals buy these drugs at a deep discount and we get reimbursed at insurance reimbursement rates. That price gap produces revenue. We fund our clinics with that,” Walensky said. “If 340B goes away, that margin goes down and we lose money that we often feed back to our patients in the flavor of social workers, case managers and dental care.”

It all leads to a conundrum that makes it difficult to choose a side between branded or generic drugs.

“If you spend any time at a meeting in Washington talking about generics, it’s incredibly humbling,” Walensky said. “You start to realize that there is a whole world of drug pricing that is very opaque.”

A few things are clear, though, she added: we are on an unsustainable path of rising drug costs, and the treatment guidelines that inform clinical practice are more likely to move because of trial performance than cost considerations.

Whether generic drugs are the answer our collective cost woes depends on 3 big questions:

• Will generic manufacturers be able to undercut the deep discounts provided by brand-name ART manufacturers?
• Are we, as a society, ready to forgo small individual survival benefits for large national savings?
• Can we ensure that cost savings from generics are reinvested in systems and programs to meet HIV treatment and prevention targets?

For Walensky, it boils down to a simpler question, but one that still has a complicated answer.

“What would you want your mother to have? I want her to have the sky, wind and stars, and we want that for all of our patients, too,” she said. “But when we’re thinking about guidelines, we have a responsibility to not just think about those patients in front of us, but those who never got to us and never got their prescriptions because of lack of access.”