"Good Enough" Is Not Good Enough

The use of a virtual health assistant provides an ongoing measurement of patient outcomes and a precise picture of disease activity, allowing clinicians to better tailor medication therapy to a patient’s needs.

The FDA requires frequent, precise, time-consuming measurement of clinical activity in the process of proving the efficacy of a new drug. But in the case of rheumatoid arthritis (RA), once the drug is approved and prescribed, ongoing measurement of patient outcomes, while encouraged by national guidelines, is seldom performed.

Which raises the question: how do a patient and his physician know if the best drug is being used to provide long-term control of such a crippling systemic disease as RA?

Health plans have put in place processes that demand better measurements to guide changes in therapy, but this raises another question: is the best drug always the one on the health plan formulary, or is there a better one?

The National Association of Specialty Pharmacy (NASP), NextIT, Toshiba, and a large specialty pharmacy company (which has requested to remain unnamed at the current time) have announced a joint pilot initiative to change the way outcomes evidence is gathered for patients with RA (as a prototype for other diseases) by using a virtual health assistant (VHA). If this trial proves effective, a VHA will change how specialty pharmacies define “high touch”!

The goal is to not only provide a more complete picture of the patient, but to improve adherence to the entire treatment plan and change patient behavior, and ultimately to use the VMA and the collected data to improve outcomes. This group is seeking a pharmaceutical company to complete the team.

“We need to empower patients in the management of their own health care and the Virtual Health Assistant is an excellent tool to accomplish this goal. NASP is proud to collaborate on this effort which is in excellent alignment with NASP’s mission to improve patient outcomes,” said Gary M. Cohen, BSPharm, RPh, CSP, founder and chief executive officer of NASP.

Pay for performance, evidence-based guidelines, outcome-driven care, performance measures, the star system, value-based insurance design—it is virtually impossible to read any medical literature without finding evidence of the tectonic shift in medical care from pay for volume to pay for outcome.

With specialty pharmacy drugs, there is good reason for this shift. The yearly cost for these revolutionary therapies is measured in terms of tens of thousands of dollars per year and sometimes even hundreds of thousands of dollars per year.

RA can be considered a representative example of a specialty disease state. RA affects roughly 1% of the population, causing painful inflammation and damage to joints and eventually leading to crippling immobility and loss of function. The treatment of RA was revolutionized with the approval of Enbrel in 1998, which was soon followed by Remicaid and Humira. Prior to that, only relatively ineffective small-molecule drugs were used for the treatment of this disease.

Since 1998, we have seen the approval of numerous other biologic and targeted specialty drugs that focus on core processes in the inflammatory cascade, including the anti-tumor necrosis factor (TNF) pathway, B cells, T cells, Janus kinase pathway, and interleukin pathways, with more in the pipeline.

Anti-TNF agents dominate in sales and overall prescriptions despite the new approaches. There are a variety of reasons for this, including their long history of safety and efficacy. However, the main challenges that physicians face if they want to change a patient’s drug are the rebates and other contracting practices that are entrenched in this category of drugs.

“Good Enough” Versus the Data-Driven Model

This has led to what I term the “good enough” approach to treating RA. Most health plans require a “failure” of the preferred drugs in both the self-administered and infused categories, where the anti-TNF agents have richly contracted with payers to maintain dominance. But failure is not clearly defined in the formularies’ prior-authorization policies—check a few for yourself on their websites! This leads to clinicians accepting a “good enough” standard for treating this devastating disease instead of treating to optimal outcome.

The RA patient’s goal is simple: to obtain total relief of pain, swelling, and other symptoms of their RA and prevent disability. The “2012 Update to the American College of Rheumatology Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agent in the Treatment of Rheumatoid Arthritis” (www.rheumatology.org/Practice/Clinical/Guidelines/Rheumatoid_Arthritis_(Members__Only)/) clearly states as much: “The goal for each RA patient should be low disease activity or remission.” The American College of Rheumatology (ACR) has highlighted 6 tools to systematically measure the disease activity: Disease Activity Score in 28 Joints, Patient Activity Scale, Routine Assessment of Patient Index Data 3 (RAPID3), Clinical Disease Activity Index, Simplified Disease Activity Index, and Health Assessment Questionnaire scales. Many of these tools were designed for and/or primarily used in clinical trials to provide a precise measurement of the patient’s clinical condition, but these assessments can take considerable time to perform in an office, time that few busy rheumatologists can afford to spend.

Thus, few clinicians routinely rely on these measures. The typical clinician does a brief exam and interview and if the patient has improved at all, simply avoids the time-consuming and frustrating attempt to challenge the formulary process and accepts “good enough” as his/her goal of therapy. In fact, in an article by Timothy Glover on the Arthritis Foundation’s website (www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/ongoing-medical-care/measuring-disease-activity-2.php), a rheumatologist who “occasionally uses” one of the recommended measures was quoted as saying, “Some days I’m a DAS [Disease Activity Score 28] user, some days I’m not.” It further quotes him as saying, “I spend more time asking patients, ‘How are you doing?’”

I liken this to feeling a pulse to estimate a patient’s blood pressure because taking the blood pressure takes too much time! No one would accept this kind of shortcut in the diagnosis and treatment of cardiovascular disease, so why are we accepting it for RA? Now to be fair, this is not the way physicians would like to practice, but they do not have the luxury of time precisely measure disease activity, and the reimbursement just isn’t there to justify the time it would take to perform these measurements in a careful manner.

Health Plan Processes Support “Good Enough”

If a patient states he has improved even moderately, the clinician cannot define the patient as a failure, and without precise, comprehensive, detailed, trended outcome measures, he or she risks being denied the ability to prescribe another agent. Even the process of satisfying a prior authorization requirement takes considerable time and effort, adding a barrier to any attempt to switch a patient to a potentially better drug. Patients tacitly, sometimes knowingly, accept this approach since they know little about the other approved drugs and also may fear that using non-formulary drugs will result in a much higher out-of-pocket expense.

The VHA in development uses Next IT’s Alme platform and aims to implement a more complete, reproducible, simple, and accurate assessment of the patient’s adherence, response, and overall RA disease activity. The VHA will create a computer-to-human, behavior-modifying relationship with patients. Hollywood has provided models for this technology in the movie Her and through J.A.R.V.I.S. of the Iron Man series, and of course, iPhone users are accustomed to Siri.

Alme uses advanced natural language recognition and smart device technology to create a platform for the VHA which will measure, trend, and compare self-reported patient data in a variety of domains. Several of the ACR-recommended measures are currently self-reported and some that are not could easily be converted. Does it take a physician to tell a patient that his/her joint is tender or swollen?

The foundation of this program will be a “smart tablet” which will interact with the patient in a truly conversational manner. The VHA will be programmed to engage the patient on a daily basis in short interactions (1 to 2 minutes each day) where the VHA can actually talk to the patient. The VHA will “ask” the patient if his medication was taken as directed (weekly, daily, etc). Using anatomical diagrams, the VHA will also periodically ask the patient to indicate each painful and swollen joint by touching the diagram.

The VHA can ask patients if they are limited in performing specific daily activities or having emotional or sleep difficulties and to rate their pain and overall health on a scale of 1 to 10, all part of the RAPID3 scale recommended by the ACR guidelines. The VHA will also remind patients of their next dose of medication, record the administration of the medication, inquire about barriers to adherence (such as adverse events, financial issues, unfulfilled expectations, prior authorization delays, communication issues), contact the specialty pharmacy for a refill, remind the patient of an upcoming appointment—the list goes on and on.

The device will also be programmed to answer hundreds of questions about RA that the user can ask in his or her own way. The system can eventually also be programmed to converse at various grade levels and even different languages to ensure that a broad segment of the US population can benefit from this unique tool.

Using motivational interviewing techniques and proven behavioral psychological techniques, the purpose of the VHA is to help patients maintain high levels of adherence to the physician-ordered protocol and report lack of adherence back to the patient’s physician for resolution.

The VHA will also be programmed to encourage healthy lifestyle activities such as smoking cessation, weight and diet control, prescribed exercise, and aerobic and strengthening activities and stretching to maintain joint flexibility and muscle fitness, as well as to encourage non-drug modalities such as application of heat and cold. If desired, the VHA could also serve as a reminder for other physician-ordered activities and drugs. Patients can also be reminded of other recommended periodic health care needs such as immunizations, per the guidelines of the ACR and the US Preventive Services Task Force (www.uspreventiveservicestaskforce.org/recommendations.htm). All of these functions will be compliant with the Health Insurance Portability and Accountability Act as well as user defined and approved.

The goal is to produce a personalized experience that will create the optimal outcome for each patient. The tablet can be designed to be “self-contained” or to communicate via Wi-Fi with outside servers to record and transmit data. It can also allow video chat communication if desired by the health care provider and patient.

Outcome measures would include (among others):

• Adherence measures
• Adverse events measures
• ACR-recommended tools to monitor disease activity
• Activities of daily living scale results
• Adherence to exercise prescription data
• Patient satisfaction measures

The RA Study will build up the foundation for this technology to be developed for patients with multiple sclerosis, hemophilia, cancer, and others. SPT

Additional Reading

Morrow T. An Introduction to Virtual Health Assistants. Spokane, WA: Next IT; 2013.

About the Author

Author of “Tomorrow’s Medicine,” the longest running health care technology column in the United States, Thomas Morrow, MD, has been the founding medical director for 5 health maintenance organizations, a clinical lead for a national disease management company, and a National Committee for Quality Assurance surveyor. He is chief medical officer at NextIT and medical director at Genentech. Dr. Morrow can be reached at TMorrow@NextIT .com. The opinions expressed in this article are his alone and do not reflect the opinions of his employer.