Marc O'Connor

Done well, pharmacist-led care management programs attack multiple underlying causes that commonly hinder treatment and nonadherence among patients with HIV and other chronic conditions. Patients often suffer from depression, denial about their condition, and embarrassment and face logistical challenges that prevent them from accessing care, including critical, regular lab work.

Our colleagues at Chattanooga CARES are taking a hands-on, personalized approach to the way their pharmacy and partners use care management to improve access to care, medication adherence, and outcomes for patients with HIV. Below are the challenges the program addresses and the solutions implemented to date that have resulted in adherence levels of greater than 90% across the target program population, as measured by viral load in the early stages of the care management program.

Charlie was referred to Chattanooga CARES’ care management program in July 2017. He was an ideal fit for the program: He hadn’t been to the clinic or on HIV medication since November 2016. Despite repeated phone calls to the patient to come in for a checkup and to pick up his medication refill, the staff could not reach him and were unable to schedule an appointment.

When the care management program staff finally reached him, Charlie admitted he was struggling with his HIV diagnosis and did not like taking his medication because it reminded him of the disease. That aside, he couldn’t even get a prescription for his medication without going to the clinic for a scheduled office visit.

The care management team was able to persuade Charlie to come in for a visit, his first in 6 months. The team enrolled him in the care management program (we’ll elaborate on its key elements and fixes below), and all was progressing nicely until the clinical pharmacist discovered Charlie had missed a week of medication therapy and needed a refill.

The same pharmacist discovered that Charlie had just started a new, third shift job. Scheduling appointments around 8 hours or more on the third shift became another barrier the team had to overcome.

Care managers cannot diagnose depression, but Charlie’s care manager suspected he was suffering from it. Antidepressants aren’t particularly expensive, but if patients aren’t adherent to those, they’re not likely to be adherent to other medications. Effectively addressing depression is often a required step toward successful management of patients’ other, more complicated chronic conditions, such as HIV. Charlie’s care manager notified the provider of the suspected depression, and the provider followed up with Charlie on his next visit to the clinic.

Results from multiple studies indicate that doctors have time only to diagnose. Frequently, they don’t have time to provide the information on the importance of medication regimens, adverse effects (AEs), and AE mitigation.

Care management teams do have time for this. It starts with building a trusting relationship with patients such as Charlie, listening to and understanding their concerns, and convincing them that they have the power to take control of their treatment and improve the quality of their lives. Clinical pharmacists also have significantly more pharmacological expertise to draw on in communicating the importance of medication adherence and adverse effect mitigation with patients.

IMPROVE COORDINATION BETWEEN PROVIDER AND PHARMACY. 

The stronger the communication between providers and pharmacy teams, the greater the probability that obstacles to treatment and adherence will be identified and positively addressed. Without consistent, strong communication between the care manager and the provider, the larger team would not have identified Charlie’s new work responsibilities, his need for a new clinic visit schedule, and the teamwork needed to effect critical change and the resultant positive outcomes.

TAKE A CLOSER LOOK AT THE PATIENT POPULATION. 

How many patients with HIV suffer from denial, embarrassment, depression, and other comorbidities that obstruct effective treatment of their disease? Patients with HIV not retained in care commonly report expensive and unreliable transportation and the stigma of having the disease as barriers. Failure to address social and structural issues will almost always result in failure to achieve desired outcomes, such as adherence measures and viral suppression.

Taking a close look at an individual patient’s experi- ence with HIV and his treatment challenges provides insight into actions likely applicable across a much larger patient population. In Charlie’s case, his viral load went from 35,000 in October 2017 to 255 in November 2017. His Bactrim prescription was discontinued in December because his CD4 count had risen from 149 in October to 419 in November. And of equal, if not greater, importance, Charlie recently told his doctor he is now positive about his future and living with HIV. This is what care management and committed providers plus specialty pharmacy and specialty therapies should aspire to every single day.

Articles

A real-life look at pharmacist-led care management's ability to overcome barriers to care and adherence in HIV treatment. 

The Missing Link: Care Managementâ€™s Ability to Improve Specialty Pharmacyâ€™s Value Proposition

The Status of HIV Medication Adherence and Viral Load Suppression 

At the end of 2010, the American South accounted for 45% of the estimated 33,015 new AIDS diagnoses in the 50 states and the District of Columbia, followed by the Northeast (24%), the West (19%), and the Midwest (13%).

Several studies have demonstrated that medication adherence is second only to CD4 count in accurately predicting progression to AIDS and death. For example, in a study of 76 HIV-positive patients that measured adherence by unannounced pill count every 3 to 6 weeks, no patient with >90% adherence progressed to AIDS over the 13-month follow-up period compared with 8% of those with adherence between 51% and 90%, as well as 41% with ≤50% adherence.

In bivariate analysis, each 10% difference in mean adherence was associated with a 28% reduction in the risk of progression to AIDS. Although medication adherence among chronically ill patients, including those with HIV, remains an ongoing issue, we seek to improve every single day in our efforts to improve patient care. Data from the Medical Monitoring Project, presented at the 2016 Conference on Retroviruses and Opportunistic Infections, indicate that the proportion of HIV-positive individuals “in care” with fully suppressed viral loads at their most recent test increased from 72% to 80% between 2009 and 2013.

It is certain that much work remains to be done to combat HIV and the tens of thousands of new diagnoses every year. Nevertheless, there is reason for optimism through continuing improvements in the “medicine of infectious disease care,” inclusive of remarkable new pharmaceutical therapies, collaborative care, outstanding patient support, and medication management.

Recent Success Stories Offer Reasons for Optimism and Action 

Presenting with a CD4 count of only 21, doctors gave Robert W. mere months to live. Weighing only 98 pounds, his HIV had progressed to stage 3 AIDS, and he was on his deathbed. Robert had been prescribed 7 different HIV medications and had a long history of struggling with compliance due to the complexity of his therapy coupled with the financial burdens of high co-pays.

Although he wanted to get better, he had to make decisions on which medications to buy based on what he could afford. Years of treating his condition with this hodgepodge approach left him resistant to many of the medications that could effectively treat his HIV. His roadblocks to adherence reached a crescendo when the loss of a brother he was close to left him hopeless and his inner fortitude to fight began to fade.

Complicating Robert’s case was the development of coronary artery disease that required a bypass. Surgeons could not consider him a candidate for the procedure until his HIV viral load became undetectable. Knowing that heart disease was what claimed his brother’s life at the age of 50, Robert gave up hope and lost his will to live. He was on the sidelines of a tragic race that would determine which condition would claim his life first: AIDS or heart disease.

This was Robert’s condition when he enrolled with Curant Health. The Curant Health team partnered with Robert’s clinical team at Virginia Commonwealth University to eliminate the roadblocks to compliance that were having the greatest impact on him. His medications were aggregated and sent in bubble packs to simplify the dosing schedule, making it much easier for him to adhere to his prescribed therapy.

As part of Robert’s outreach team program, an assigned patient care coordinator spoke with him every month to ensure he had no problems and was remaining compliant. She was his friendly reminder, a voice of compassion and knowledge that served equal parts encouragement and information source. But the most important roadblock Robert needed to have removed was financial. Even though he was covered by insurance, Robert faced medication co-pays totaling $700 per month. Since he received treatment at a 340B-covered clinic, however, the covered entity’s 340B funds could be used to cover those co-pays.

Thanks to an attentive team, the 340B program, and the manufacturers who support it, Robert no longer had to worry about affording the medications that would save his life. For the first time, he had full access to all of the treatments he needed at the same time. With fully covered medication, easy to administer bubble packs, and monthly check-ins, Robert began a remarkable recovery that surprised and delighted his health care team.

By July, his CD4 count rose to 96. More importantly, his viral load became undetectable, making him a candidate for the bypass surgery he needs to treat his heart disease. Assuming his bypass surgery is successful, Robert is likely to enjoy a normal lifespan.

In a broader example of success in larger populations of patients with HIV, the University of Alabama’s 1917 Clinic, a Ryan White grantee, presented a study during the 10th International Conference on HIV Treatment and Prevention Adherence. The results showed that out of 157 patients with HIV whose viral loads were not suppressed prior to enrollment in enhanced medication management protocols, 103 have now achieved viral suppression.

The Top Remaining Hurdles in HIV Care for Specialty Pharmacy 

Health systems manager Amber Adams Keith works on the front lines of patient support, provider support and medication management for patients with HIV served by Curant Health.

She shares the following top hurdles these patients face in achieving suppressed viral loads and how to overcome them:

1) Access to medication (including insurance plans, co-pay cards and cost) 

A high percentage of the HIV population lives within 150% of the federal poverty level. Medication for the treatment and prevention of HIV is very expensive. As such, patients are dependent on their health care team to help them gain access to their medications. Dedicated patient care coordinators are needed to identify and acquire co-pay cards that the patients might not be aware of.

Bridging the gap between the providers and the pharmacy, especially with respect to prior authorization burdens, is a high priority for our team. We facilitate prior authorization processes when needed, and we help health care facilities leverage programs, including 340B, to help the most vulnerable patients afford their medications.

Unfortunately, patients with HIV still live with the stress of stigma, which, when combined with managing the disease itself, can be overwhelming for patients. Discretion among the care teams of patients with HIV is critical to value-based therapy success. Patients need regular, consistent contact, ideally from a trusted patient care coordinator trained on how to appropriately manage the patient and how to discuss medication needs.

The most appropriate, efficient, discrete methods and locations of delivery should be utilized, including boxes with no signs of pharmacy on the package. This approach is much less stressful than requiring patients to pick up medications from a local pharmacy, where they might run into someone they know or know the pharmacist filling the prescriptions.

An HIV diagnosis can be very overwhelming for patients, and it is not uncommon for patients to ignore the diagnosis. A surprising number of patients often seek excuses not to get their medications filled. With regular outreach, contact, and education resource availability, patients often feel more comfortable with their therapy knowing they have a direct phone number and can e-mail their care coordinator should they have questions about their medication.

Inclusion of available educational materials in patients’ medication shipments should be standard practice. Examples include guide books with descriptions of the medications that identify them by shape, size, and color. We have learned that customized adherence packaging that sorts medication into pill packs by date and time increases medication adherence for many patients.

Improving outcomes and reducing viral loads for patients with HIV is going to require improvements in adherence on a national level; improvements in access to therapies, including simplification of prior authorization forms and processes; continuing support of the federal 340B program; and, perhaps most importantly, patient support services rooted in trusting relationships between pharmacists, patient care coordinators, and patients.&emsp;

 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. 

Advances in the support of patients with HIV include remarkable new pharmaceutical therapies, collaborative care, outstanding patient support, and medication management.

Active Patient Support and Personalization Key to Improving Adherence Rates and Reducing Viral Loads

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 

, 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.

According to Kenneth L. Schaecher, MD, FACP, CPC, as published in the 

, “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&mdash;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%.”

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 

, 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 

, “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.

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.”

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.

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.

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 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. 

 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.

How well are we using the longest lever available to affect hundreds of billions of dollars in wasted health care spending?