The age of digital has not only arrived, it is taking over modern society. From ordering rides on Uber, to back to school shopping with a single click, to refilling a prescription via text message, a new world has emerged in which consumers expect digital engagement. Providers are not immune to this trend, which is pushing the industry to reexamine how prescription prior authorization (PA) should work in the digital age.

PAs are here to stay, at least until payers have something better. In any system with significant cost pressures and an industry in which the consumer is 2 steps removed from the direct purchase, a series of controls are needed. PAs provide a necessary management instrument for those paying the bills to maintain insight and some level of control over the process of obtaining a prescription medicine. To be clear, the PA is not the problem, the method in which it is executed, however, can be greatly improved. 

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Manual, paper-driven processes cause unnecessary burdens on time and money while creating an access challenge for those suffering from a debilitating condition. There is a better way. The adoption of digital strategies across the ecosystem is a viable option to improving the PA experience for all stakeholders. Payers maintain an important check in the access to certain medicines; providers enjoy a more streamlined and efficient process; and patients get on treatment faster and have a higher probability of staying on therapy.

Acknowledging Multiple Challenges
Before we discuss digital PAs, let’s review the challenges present in today’s system:
 
    • Challenge 1:  Most complex disease categories and, specifically, genetically-oriented diseases still require PAs year after year. Yet, the clinical relevance of approving a drug for a rare disease no longer applies after the patient has been approved for the first time. They have a life-long disease and furthermore, the approval rates for these medications hover around 98%.
 
    • Challenge 2: The process is largely disconnected and manual as work teams in the provider’s office struggle to complete PAs, conduct subsequent follow up with payers and all the while maintain communication with patients who are waiting for treatment.
 
    • Challenge 3: The governance rules across myriad benefit types are slow to change and for newly launched therapies, typically take over a year to fully be understood.




The Price We Pay
These challenges create cost in the system, offer no clinical relevance, and increase the administrative burden of all participants. The reality is that all of us shoulder this burden. The more intangible side of this is the overall cost to the health care system in the form of increases in expensive hospital visits, lack of adherence to therapy, and increased frustration leading to lack of care for patients. 

As health care succumbs to the digital revolution there is an opportunity to develop more efficient ways to manage PAs while accommodating the wide spectrum of medicines. An ecosystem that removes undue burden, maintains the necessary controls, delivers health care value, and ultimately fosters a more cohesive experience for patients will ultimately result in an environment for better care.

Issues and Approaches
As patient advocates, at CareMetx, we hope to overcome these barriers with multiple strategies that can help providers and patients change the way they interact with our already complicated healthcare system. Ultimately, we believe that the demonstration of clinical value of any product is critical to successful access. The burden of value demonstration falls upon the health care system with a focused role for patient services teams to help manage that effort. 

Strategies that are centered around bringing digital interactions into the mix as well as collaborating with the payer community to re-define the PA process hold significant promise. To that end, we’ve outlined 3 issues and potential approaches below.

Issue 1: The disconnected PA process in the provider’s office.

When executing a PA, 2 main break points can occur in the provider’s office:
 
  1. Patient informed of PA after going to the pharmacy. The provider is unaware of the fact that the payer requires a PA before dispensing.
Impact: Most patients will abandon this prescription and call their provider for an alternate medicine or abandon therapy all-together. Patient care is sacrificed as the patient never goes on therapy.
  1. Provider initiates therapy before the PA is decisioned.
Impact: In some cases, the delay is managed with samples or a bridging of product before the PA is approved; other times the patient falls off therapy altogether.

Approach: Embed the PA process into the natural workflows of the provider’s existing technology system. Make the PA “prospective.” Enable these systems to use digital pharmacy benefit management connectivity for PA decisioning in minutes or a few hours.

For example, a new and more seamless process is the integration of electronic PA (epA) functionality directly in the provider’s practice management system. The ePA allows users to complete the PA and receive an electronic response while the patient is in the office, or in cases for which further review are required, use real-time connectivity to enable the payer to message the practice within the system when the PA is complete. 

For instances in which the payer does not support ePA, innovative “off-ramps” can be useful. At CareMetx, we are collaborating with one of the largest ePA providers with integration into most practice management systems to support instances in which the PA has become distressed and is not progressing. In essence, we electronically intercept failed ePA attempts and generate a guided interview process that contains the questions necessary for the payer to properly decision the PA. For the user, this process is nearly identical to the regular electronic process, so no workflow breakdown occurs.

Issue 2:  Governance of prior authorizations in the practice setting

Practices must contend with many factors when trying to process a PA. The rules, although largely the same for a medication across payers, have complex nuances. The variance in the review process for standard of care for a particular medication can change as new medications are introduced into the market or as payers change formularies. This results in a never-ending PA process as providers must confirm the rules that apply for a particular drug, sometimes for every single PA they submit. 

Approach: Once again, a digital ePA process not only considers the changing rules, but delivers it in the exact same way, every single time. Many patient service organizations can assist in confirming the requirements for a PA, but rarely deliver it electronically.

The goal, in our opinion, is to continue to leverage the ePA functionality and deliver requirements as they develop.  For the most part, an electronic adjudication already provides for this, but for many PAs (approximately one-third), an off-ramp should be utilized when there is no electronic adjudication available. Payer intelligence tools should be embedded into the ePA offering so that practices experience a real-time guided interview process that reflects the health plans protocols. Even the problematic PA for a medical benefit, which is almost completely manual today, can be improved with the integrated off-ramp process. 

Issue 3: The role of PAs in value-based agreements

Approach: Ultimately, our goal should be to go beyond harnessing digital connectivity in the PA process and focus on collaborative efforts with payers to either eliminate or change governance for certain PAs. Indeed, for products that address rare life-long diseases manufacturers are prepared to meet specific efficacy and outcomes benchmarks. These benchmarks serve all stakeholders far more effectively than a general PA process. 

In fact, over the past 24 months, CareMetx has been working on programs that bring a value conversation to the utilization management of a particular product. Our strategy is to craft programs with payers that remove the administrative requirements for PAs and instead focus more on the value of the therapy. To that end, we have developed proprietary processes that not only measure the value of a product, but ultimately allow the manufacturer to issue a guarantee that certain clinical outcomes will be met or the payer will be reimbursed.

The advent of cell and gene therapies (CGTs) is accelerating the adoption of these models. As CGT becomes more prevalent with curative therapies, value-based monitoring will become critical for manufacturers seeking widespread market adoption. Payers are open to eliminating the PA when abundant data demonstrate clinical efficacy in a case-by-case basis and back-end performance guarantees cover outlier patients that don’t respond to therapy. 

Our success with this emerging model comes down to ensuring we are not creating process precedence, but rather embedding our model seamlessly into the payer’s existing strategies for managing high-cost therapies.

In summary, we believe a large portion of PAs will move to a digital model with focus from all stakeholders to remove the unnecessary burden and cost associated with PAs. Ultimately, as value becomes the driver in how health care is evaluated (and paid for) more payers will leverage data to validate whether or not a patient gets access to therapy. The alignment of providers, manufacturers, and payers will result in better care, more adherent patients, and a significant cost reduction within the health care system. That’s welcome news for us all.