Where have we been and where are we now?
We have long maintained that medication adherence is the longest lever available to reduce $105 billion to $300 billion in wasted health care spending every year, according to the Institute for Healthcare Informatics. According to a study published in the Journal of General Internal Medicine, between 28% and 31% of new prescriptions for chronic conditions, such as diabetes, high blood pressure, and high cholesterol, never get filled.

A study by the Mayo Clinic suggests that up to 50% of patients are, or will be, nonadherent to their medication. This waste is the result of multiple factors, including soaring prescription drug costs; barriers to access, including prior authorizations, polypharmacy; absence of patient education; and a huge gap in the care continuum between the time a patient leaves their clinician’s office and the time they return for their next visit.

Let’s use HIV as an example.

According to Kenneth L. Schaecher, MD, FACP, CPC, as published in the American Journal of Managed Care, “In the United States, the rate of adherence to HIV therapy is generally low. A meta-analysis of adherence studies—the durations of which ranged from a few days to 1 year—observed a rate of 55% who ‘achieved adherence’ among a pooled group of 17,573 patients. The definition of ‘achieving adherence’ in the studies ranged from above 80% adherence to 100% adherence. By comparison, in sub-Saharan Africa, the pooled adherence rate in studies comprising 12,116 patients was 77%.”

What have we learned?
We have learned that achieving meaningful alignment among manufacturers, patients, payers, and clinicians appears to be more difficult than summiting Mount Everest. The shift to value-based care has the potential to be an alignment and adherence improvement catalyst.

However, the existing gap between patients and their prescribers is the bridge that needs the most repair, if not rebuilding. In far too many cases, providers send patients out the door with a prescription for which there is little assignment of responsibility for the critical support needed to ensure access, let alone excellent adherence. Common results of this gap between patients and their care teams, including providers, include high abandonment of therapies, significant decreases in adherence, higher cost of care, and poor patient outcomes.

In a glaring example of how badly this gap needs bridging, we were recently told the story of a Texas patient referred to an out-of-state clinic. The patient was issued a prescription, sent home, and told to return in 3 months. At the assigned time, the compliant patient flew back to the clinic as directed.

When the physician asked how the new medication was working, the patient replied, “I haven’t even received it yet. The insurance payment has not been approved and I can’t afford the drug without it.”

While the industry appears to have survived the arrival of $1000-per-pill cures for hepatitis C, what will happen as immunotherapeutics proliferate? According to Alice Park, as published in the April 4, 2016 issue of Time, there are 3400 immunotherapy trials ongoing in the United States.

One such trial cited by Leonard Salts, MD, from Memorial Sloan Kettering Cancer Center in New York City, would result in a cost of more than $1 million per melanoma patient per year. Calling this type of advancement untenable would be putting it mildly. As I wrote in the July/August edition of Specialty Pharmacy Times, “Ultimately, value-based care will require a value algorithm, perhaps customized by disease state. The development of that algorithm will require difficult conversations among multiple parties not accustomed to collaboration,” particularly as diseases such as cancer continue to trend towards a chronic condition, rather than a death sentence.

Until that algorithm comes to light and practice, we must continue to do whatever is needed to ensure outstanding medication adherence, especially to high-cost specialty medications for chronically ill patients.

Recent program results
Effective medication management programs that provide statistically significant improvements in patient adherence and clinical outcomes are complex and labor-intensive. There is a level of continuous patient engagement required. This is a top reason improvements are slow to come about, yet there remains reason to be optimistic that hard work pays off.

In May, Curant Health reported 90% real world cure rates for patients coinfected with hepatitis C and HIV.

“It’s one thing to achieve high cure rates in tightly controlled clinical trials, but achieving high cure rates in real world conditions for coinfected patients who have difficulty accessing therapies is something else entirely,” said Vickie Andros, PharmD, director of clinical services for Curant Health. “The ability to overcome challenges related to access and helping our patients maintain outstanding adherence to their medication regimens allow us to achieve positive outcomes like these.”

In a study presented during the 10th International Conference on HIV Treatment and Prevention Adherence by our colleagues at UAB’s 1917 Clinic, out of 157 HIV patients whose viral loads were not suppressed prior to enrollment in Curant’s medication management protocols, 103 have since achieved viral suppression. In a study of 130 patients with our partner, Virginia Commonwealth University, 87% of our shared patients were determined to be adherent to antiretroviral therapy.

We are eagerly anticipating the poster presentation by the aforementioned Vickie Andros with Sharon Dudley-Brown of Johns Hopkins at ACG 2016. Vickie and Sharon will deliver preliminary results of their analysis of an ongoing study dubbed Project A.L.I.V.E. The project seeks “to implement and evaluate the effectiveness of an Inflammatory Bowel Disease Medication Therapy Management patient fulfillment model compared to standard care in a large university hospital setting.”

What is most needed now?
Improving overall adherence is going to require improved access to therapies; significant improvements in technology, including electronic health records; and, for the foreseeable future, patient support services rooted in trusting relationships between pharmacists, patient care coordinators, and patients.

Access
Given the immense increases in the cost of specialty drugs, prior authorization forms have become increasingly complex and time consuming to complete successfully. According to a recent report from The Pew Charitable Trusts, less than 1% of all prescriptions were written for specialty drugs in 2014, yet they accounted for approximately 32% of total drug expenditures. The Pew report further states, “Utilization rose by 5.8% in 2014 because of increased use of existing drugs and the introduction of new pharmaceuticals. In 1990, only 10 specialty drugs were on the market. Currently, approximately 300 such drugs are on the market, 19 of which became available in 2014 alone. And nearly 700 specialty drugs are under development.”

Some prior authorization forms have reached 10 pages or more in length. Clinicians are now forced to choose between another administrative task or serving more patients. It’s a lose-lose proposition for clinicians and patients. Simplification of specialty medication authorization requirements for patient populations with high-volume impact, such as hepatitis C, should be a top priority for manufacturers, payers, and clinical pharmacists in order to improve the value derived from specialty drugs. Collectively generated improvements on this task should improve outcomes and reduce costs for all concerned.

Technology
Health care technology, especially information technology, has yet to find its stride in adherence improvements. Tools such as smart pill packets and bottles, apps (we are fans of OneCare), and even IBM’s Watson and the IoT (Internet of Things) are becoming available with the potential for profound impact. User-friendly EMR interoperability appears to be improving, but integration and alignment across the multiple parties that need improved access and utility is still a long way off.

The human hand
The results of effective medication management and patient support services listed above represent the best of our knowledge on what is required to improve adherence and outcomes for chronically ill patients. Access solutions and ongoing patient support are labor intensive enterprises, and will continue to be so. However, trusting relationships generated between members of the pharmacy team provide patient lifestyle insights, and identify barriers to adherence without which medication adherence will always suffer. 



About the Author
Marc O’Connor is Chief Operating Officer for Curant Health. Curant Health treats patients nationwide through its medication management protocols, including medication reconciliation and establishment of personalized medication regimens, and supports its provider partners and care coordination with its award-winning EHR, MedPlan™. Curant’s healthcare professionals provide individualized care proven to improve the lives and reduce the overall healthcare costs of chronically ill patients.