The responsibility for improving and maximizing patient compliance, adherence and persistence lies not only with patients but also with pharma marketers, providers, insurance companies, pharmacies and the government. Here’s a prescription for success.

For years, pharma has been fixated on new prescriptions as the single biggest determinant of success. The industry, however, has begun to understand that its focus must be on shifting from just gaining compliance to patient adherence and persistence if health outcomes are to dramatically improve. Clearly it’s not too difficult to figure out the impact of lost revenue to pharma on sub-optimal CAP, let alone the long-term cost and impact on society. In fact, the World Health Organization (WHO) stated that the effectiveness of CAP interventions “. . .may have a far greater impact on the health of the population than any improvement in specific medical treatments.”

Traditionally, stakeholders within the healthcare system, including
pharmaceutical marketers, healthcare providers, insurance companies,
pharmacies and the government, have typically focused on the patient’s
responsibility for the CAP problem. And patients have been at the forefront
of over 25,000 peer-reviewed CAP journal articles that have been written
since 1995, as well as the flood of trade articles on various CAP “fixes” (e.g.,
SMS texts, co-pay cards/vouchers/rebates, starter samples, pharmacy
calls, CRM programs, etc.).

More recently there has been an increased assumption of responsibility for optimal patient CAP by all stakeholders within the healthcare value chain. However, there is still a significant under-appreciation for the broad range of patient CAP drivers, and a one-size-fits-all mentality still permeates the system. Unfortunately (and often erroneously), the focus is usually on financial considerations, without much thinking relative to the critical behavioral psychology and underlying patient attitudes/beliefs impacting patients. The bottom line is that much more than cost impacts a patient’s journey.

So why do patients shoulder most of the responsibility? It’s easier to blame patients and hold onto the simplistic view that cost is the key driver, rather than to understand the underlying symptoms that can lead to the right interventions at the right time to increase CAP. Accountability and responsibility should not rest solely on the patient’s shoulders. This is not a new problem: As Hippocrates in approximately 300 B.C. stated, “Keep watch also on faults of the patients which often make them lie about the taking of things prescribed.” More than 2,000 years later this extraordinarily serious issue dramatically impacts health outcomes and remains unresolved.

The pharma industry must re-orient itself to understand and develop a much broader appreciation for CAP barriers. Issues and opportunities related to optimizing CAP vary substantially by disease area, therapeutic category and brand. As such, the industry’s attempt to find that “one-size-fits-all approach” is not only inadequate, but it’s also severely misguided. Here’s a look into two areas where we can better understand the dynamics at play.

Specialty Pharmaceuticals Considerations

According to the 2011 Express Scripts Specialty Drug Trend Report, specialty therapies (on the rise as primary therapeutics) can be commonly classified as: being utilized in complex conditions requiring extensive patient monitoring; costly treatment for conditions with gaps in care common; often part of a medication regimen with several products with different modes of administration; affected by non-adherence that can lead to significant adverse events, including death; and adherence levels necessary for adequate clinical control that need to exceed 80% rate.

It’s easy to see why specialty therapies possess unique properties that completely revolutionize the CAP value proposition relative to traditional pharmaceuticals. As a result, patients often require high-touch care and frequent contact with nurses and pharmacists to maintain adherence and persistence. In addition, these specialty therapeutics (i.e., those treating cancer, MS, HIV, and RA, etc.) often require distribution and related support services through a Specialty Pharmacy Provider (SPP). SPPs often provide a comprehensive suite of end-to-end, high-touch solutions that often result in increased adherence rates relative to the traditional retail pharmacy channel. To affect change, HCPs and SPPs need to work closely with each other and pharma to develop needed and well coordinated, high-touch programs.

An example of where CAP tools are of high value is in the treatment of Hepatitis C (HCV), the leading cause of liver transplant which may result in costs that exceed $300,000 for the transplant and annual costs that exceed $20,000. While evolving, the current standard of care (SOC) consists of a regimen that includes pegylated interferon, ribavirin and a new class of protease inhibitors (i.e., boceprevir, telaprevir). With adherence to therapy often quite difficult given the side effects of pegylated interferon, the consequences of non-adherence are substantial. However, HCV patients can be cured if they’re adherent to the prescribed regimen. Therefore, multiple healthcare stakeholders need to collaborate to coordinate optimal CAP given the wide range of barriers to achieve success.

The primary barriers that HCV patients receiving the new, evolving SOC face include product administration, financial challenges, and the need for increased social support. As a result, the manufactures have developed comprehensive patient support programs to address these multiple barriers. For example, through Vertex’s Guidance and Patient Support (GPS) program and Merck’s Care program, patients receiving protease inhibitor therapy have access to a suite of programs designed to optimize CAP. These include access to a 24/7 nurse support line for patient education and social support, patient starter kits to optimize treatment initiation and various financial support and reimbursement support programs to optimize the prior authorization process. These programs are not necessarily unique to HCV; rather, they are a foundational part of the commercialization strategy for virtually all new specialty pharmaceuticals.

Chronic Disease Considerations

Chronic diseases, such as diabetes, hypertension, dyslipidemia, asthma and osteoporosis, impact millions of patients, as well as represent a substantial societal health burden. These conditions require chronic drug management over long periods of time in order to mitigate downstream medical events and related costs. Given the population size and lower threshold for adherence, CAP programs in small molecule, chronic diseases often take a different form than specialty pharmaceuticals.

In the past, pharma has worked with MCOs and employers to develop value-based benefit design strategies that alleviate co-pay as a barrier to optimal drug therapy in many of these areas. In addition, and with so much at stake, pharma has developed CAP-related programs to support branded medications in these types of diseases. For example, virtually all of the leading branded products for the treatment of cardio-metabolic conditions, such as type 2 diabetes, hypertension and lipid disorders, offer programs designed to optimize patient CAP. Typically, the focus is on deploying reminder systems to get patients to refill their prescriptions, and financial assistance programs such as co-pay cards/coupons, samples/vouchers, insurance support programs, patient education and peer-to-peer engagement.

While uptake of these programs have waxed and waned over the years, there has been some short-term success. But why haven’t results been achieved over the long term? In large part, this gets to the heart of the CAP problem and why responsibility can’t rest solely on the patient. There is a significant disconnect between the reasons for non-adherence and the programs designed to thwart it. In these circumstances, CAP issues are not necessarily cost related. The missing link is the patient’s psycho/ social factors such as disdain or concern over taking medication, or their disease denial as they often feel/look well despite what their diagnostics say (e.g., blood work, blood pressure or glucometer readings, etc.). Research utilizing MARS (Medication Adherence Rating Scale) can provide HCPs with insight into a patient’s views on taking medication. Still, other patients are given a therapy that produces side effects which alters their willingness to take medication, particularly when there is no seemingly outward impact from the condition. So what or who is needed to affect change in these circumstances?

The physician or other prescribing healthcare professional can have an enormous impact. But while costs may not influence patients in these situations, it does influence HCPs. How much time does the average patient spend with their physician during a visit? If a patient is given a new prescription, is there discussion about its importance in treating their condition. How will the new therapy change the course of his/her disease and what is the best way to manage potential side effects? Given the crush of patients on their daily schedule, HCPs don’t spend much time worrying about CAP (they also see it as the patient’s role), and don’t accept the necessary level of accountability and responsibility required to make an impact. Their hope is that insurance and pharma companies, both of whom have significant value at stake, can make an impact. These days, discussing a patient’s feelings or personalizing a discussion of why he/she prescribed a particular drug, is simply part of the lost art of medicine.

Opportunity Moving Forward

It’s not only important to appreciate that accountability and responsibility for CAP doesn’t solely reside with the patient, but also that it’s in the best interests of all healthcare stakeholders. By ensuring that the developing healthcare system rewards and incentivizes—and punishes, if necessary—all healthcare value chain stakeholders (including patients), a “skin in the game” approach will ensure increased focus on the goal.

The good news is that patient CAP is one of the unique areas where the incentives among all stakeholders within the healthcare value chain are being increasingly aligned. The benefits of optimizing patient CAP are most evident to both pharmaceutical manufacturers and pharmacy intermediaries as this often results in more product volume, and hence revenue, particularly in specialty pharma. Shifts in physician payment mechanisms from a traditionally fee-for-service reimbursement methodology to increasingly outcomes-based measures will only increase HCP focus on their patients, thus ensuring CAP to optimize patient outcomes. Furthermore, end payers, such as CMS and employers, need to continue working with Managed Care Organizations and Pharmacy Benefit Managers to increasingly track, measure and reward optimal CAP such as the introduction of the Medicare STARs program, which aligns payment incentives to adherence in core chronic disease categories for Medicare Part D carriers. Finally, all stakeholders must recognize CAP is part of a patient’s emotional disease journey and is therefore subject to changes over time.

  • Richard Minoff

    Richard T. Minoff is Associate Professor of Pharmaceutical and Healthcare Business, and Director, Undergraduate Program at the Mayes College of Healthcare Business and Policy at the University of the Sciences.

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