For decades, the stated purpose of prior authorization (PA) for managed health care plans has been as follows: to ensure the appropriateness of a specific drug for any specific patient. The Academy of Managed Care Pharmacy states, “[PA] is an essential tool that is used to ensure that drug benefits are administered as designed and that plan members receive the medication therapy that is safe, effective for their condition, and provides the greatest value.” Or to put it yet another way, getting the right drug to the right patient at the right time.
The announcement in late June that major health plans and insurers are pledging to “smooth out the PA process” is just another in a long line of pronouncements along a similar theme. Prior authorization has been a basic component of pharmacy benefit management for almost 40 years, and a bane of providers and patients since its introduction. Back in the early 2000s, a slew of complaints prompted United Healthcare to announce that it was removing PA criteria for many therapies after analyzing data demonstrated that more than 95% of these PA requests were approved. In another move, it created a new network level of providers for whom PA burdens were reduced for physicians with cost-effective practices. Yet, PA is still in every managed care plan’s toolbox. More than 10 years ago, the introduction of electronic PA (ePA) promised to speed approvals, perhaps even yielding real-time decisions, but implementation has been inconsistent and relatively slow.
As part of my work with payers, I am sometimes asked to help analyze coverage policies and how coverage policies might be created for new pharmaceutical products or medical procedures. I can say without qualification that PA practices are as strong as ever. In fact, I can see benefit for payers for reducing their use of PA criteria in these particular areas. It may be that innovations in medical practice and pharmaceutical care will always require more intense scrutiny than the use of older treatments.
Biosimilars and PA Practices
As once innovative therapies are newly promoted to first-line treatments, it is logical to assume that PA criteria would be reduced or removed entirely. In the past, we had seen that latitude be given to oncology treatments, but this was largely a concession to the reality of the variety of chemotherapies being used to treat individual patients with cancer and the fact that cost control was not practical on a public relations basis as well as on a patient care basis.
Now consider biosimilar use for autoimmune disease. Biosimilar competition has allowed the conversation around drugs like adalimumab and infliximab to be reconsidered in terms of their place in therapy and the need for PA. The cost reductions resulting from biosimilar competition have nearly taken a discussion of drug cost off the table, removing at least one rationale for the application of strict PA criteria. Of course, they will never cost as little as corticosteroid therapy, but they are entering the range of generic immunomodulator therapy (partly because of price increases seen in the generic marketplace). These biologics still have potentially serious side effects and risk, so PA criteria still need to be applied. Yet, one of the potential incentives for physicians prescribing biosimilars was a reduction in their PA burden. Like the implementation of a biosimilar tier, we have not observed this in real life..
It makes perfect sense that with the extremely high cost of medical innovation and new treatments, payers will continue to emphasize prior authorization which includes step therapy, confirmation of diagnosis, confirmation of severity of the condition, and other valid criteria for patient eligibility. This is to ensure the appropriateness and cost effectiveness of therapy—the very essence of what prior authorization was supposed to accomplish over 3 decades ago.
I would be surprised if the current push to improve PA processes results in significant patient-facing or provider-facing changes. The call for greater use of ePA is important and valid, and it should have been implemented years ago. This is the one element that likely will have the greatest benefit.
I remain skeptical of any pledge to curtail PA processes in general by payers, as I believe it is still an essential component of managed care, and it is needed even today to ensure high-cost therapies are being accessed and utilized appropriately. Until these high-cost therapies are not high cost (through generic or biosimilar competition) or that the risks of these therapies were found to be insignificant, the need for PA will remain.
