Prior Authorization Programs for Specialty Drugs

Prior authorization (PA) programs are an integral part of managed care, and arguably even more crucial when specialty drugs are involved, given their high cost and potential for serious adverse events. While there are similarities between all PA programs, many experts believe that the stakes are potentially higher in the specialty arena. 

Arthur F. Shinn, PharmD, president of Managed Pharmacy Consultants, LLC, and a member of the First Report Managed Care (FRMC) editorial advisory board (EAB), says it pays to distinguish between true PA programs, and those that merely ensure that one drug is used before another is tried. “We try to use PAs for the purpose for which they were originally intended. That is, we do not use them primarily as a cost-savings mechanism, but as a way to know that we have the correct diagnosis, appropriate treatment approach, correct drug and dose, etc.”

A 360-degree approach such as this, he says, is crucial when dealing with conditions such as hepatitis C, cancer, and other illnesses that rely on specialty drugs. Others concur, noting that issues, such as safety, are amplified much more than with traditional drugs. 

“For medications that have a narrow niche of appropriate indications, safety is always top of mind,” notes Winston Wong, PharmD, president of W-Squared Group, and formerly associate vice president of pharmacy management with CareFirst BlueCross BlueShield. “You are dealing with drugs that can have serious adverse events, so it makes sense to put them under a PA that places the patients into a distribution channel—a specialty pharmacy—that has higher monitoring capability,” he says. Cost is one consideration, but another reason for monitoring is the risk of serious side effects. 

Michael White, PharmD, director, clinical pharmacy at BlueCross BlueShield of Tennessee, agrees. “Certainly the cost impact is considered with specialty drugs, but safety and efficacy are our first concerns for formulary inclusion, placement, and utilization management.” He adds that at his organization there is a choice of adopting the standard criteria from its PBM or using customized criteria. 

“We use the FDA label, nationally recognized compendia, peer-reviewed published literature, and input from key opinion leaders when we develop custom criteria,” said Dr White. “It would be rare for us to extend the same level of effort into a medication that was not considered to be a specialty medication.” 

More Time to Focus

John Watkins, PharmD, MPH, BCPS, formulary manager, Premera Blue Cross, says the PA process is the same for both specialty and traditional drugs at his organization. “In the last 5 years, most traditional drug classes have become commodities due to patent expiration of the leading drugs in each class. Fortunately, this gives us more time to focus on the new biologics and small molecule targeted therapies. With a novel pharmacologic agent, there is always concern that unexpected rare but serious adverse events will pop up after the product is launched.” 

Of course cost is always an important factor, and a big reason for the PA process. It occasionally leaves some questioning if sometimes the process is in place just for cost reasons. “With some biologics, you have PAs in place because of the drugs’ costs—there is little utility in the PA itself,” says Norm Smith, president of Viewpoint Consulting, Inc, and also a member of the FRMC EAB. For example, “Why does a neurologist need a PA for an MS drug? How would they use it inappropriately?”

“I believe that there are times when plans put PA processes in place to make the hassle-factor high enough for more expensive drugs, such that they serve as a barrier to use,” adds Smith. “Also, sometimes with branded drugs, a PA might be used to steer toward use of generics. It’s all part of contract negotiations.” 

Minimizing Delays

Regardless of the reasons, PAs are here to stay, and will likely remain particularly onerous in the specialty drug area. 

Dr Wong, who serves as Editor-in-Chief of Journal
of Clinical Pathways, a peer-reviewed journal featuring original research, insights, and perspectives on clinical pathways and other value-based approaches in health care, points out the potential for delays. With traditional drugs and common chronic conditions such delays can be aggravating. But the problems are bigger in the specialty drug arena, for instance, in oncology. “All too often—even in situations where there is a defined time period in which cases must be reviewed and a determination rendered—the timeframe for oncology reviews take much longer,” he says.  

Some of this is due to the nature of the process, but often delays can be minimized. “You don’t always have the expertise on the other side of the phone evaluating the patient’s clinical situation. They are merely looking at a checklist or a criteria set that has been developed. When you see this, it usually means the [PA] program has not been developed with collaboration from oncologists. It’s a real problem in oncology because if the patient has an aggressive cancer, he or she needs to be treated quickly,” Dr Wong says. 

A Double-Edged Sword

Over time, technology is playing an increasing role in the PA process. Whether that role is good or bad depends on perspective. 

“In truth, neither manual nor electronic processes are truly ideal,” says Dr Wong. While some think that an electronic, web-based PA is less burdensome, he does not see it that way. “As a provider, no matter what method you use to get at the information, the office still has to pull the chart, gather the information, and enter it somewhere. In many ways it’s the same as with a manual process.” 

Plus, a practice that works with multiple payers has to work in numerous portals, which Dr Wong notes is another potential nuisance. 

Dr Shinn has his own love-hate relationship with technology’s impact on PAs. “It’s great that it speeds things up, but to me the technology has taken away the personal touch points that I prefer to have in a PA program. I’m not 100% sold that the tradeoff is worth it.” 

For this reason, Dr Shinn advises the groups he work with to make a phone hotline available. “We have a specific timeline for turnaround. If a request is denied, we get right back to the provider and discuss the reasons. We always try to communicate that verbally.