Marc Oâ€™Connor, COO, Curant Health

 prescription drugs dropped in 2016 as intense competition among manufacturers and payers ramped up efforts to limit price increases, according to the report “Medicines Use and Spending in the US,” released earlier this year by the QuintilesIMS Institute.

New drugs launched over the past 2 years have driven at least half of the total spending, with innovative treatments for cancer, autoimmune diseases, HIV, multiple sclerosis, and diabetes becoming accessible to patients. The potential for innovative new treatments over the next 5 years is even more promising, fueled by a robust late-phase pipeline of over 2300 novel products, which include more than 600 cancer treatments. According to the QuintilesIMS report, US net total spending is expected to increase an average 2% to 5% through 2021, reaching $375 billion to $405 billion.

Downward pressure on drug pricing can only go so far before manufacturers abandon the development of new therapies due to their inability to recover research and development costs and a reasonable return on investment. The effects on accessibility to patients will likely be short term, as well. What does the future of access to specialty therapies look like and how are we going to pay for all of this?

Following the uproar over the cost of the new wave of hepatitis C antiviral drugs, the arrival of PCSK9 inhibitors in 2016—and their $1000 per month for life price tags&mdash;triggered swift, stringent prior authorizations (PAs). This was an attempt to ensure that less costly, yet indicated, medications were first shown to be ineffective, a practice commonly referred to as step therapy, before the more expensive medications were prescribed.

As specialty drugs proliferate, there comes a commensurate increase in PAs. Unfortunately, these fall immediately at the feet of prescribers and clinicians. It is possible that PAs can stifle medication adherence and increase the likelihood of patient resistance to medication therapy.

There can be as few as 3 or 4 line items among the pages of a single PA form that are critical to fair evaluation and patient access. Yet we have seen some patients have their prescriptions authorized and filled, only to learn that the refills of therapies, such as Harvoni, require monthly PA approval. This process puts the patient at risk of resistance to therapy and the payer at risk of massive amounts of wasted spending on prescription drugs.

The more PA forms with which specialty pharmacists can become intimately familiar, especially for high-cost medications for chronically ill patients, the more attractive pharmacists will be to the time-constrained clinicians and the patients who rely on them for care.

Value-Based Contracts: Who’s in for the Leading Role? 

To date, value-based contracts among pharmaceutical manufacturers and payers have not achieved the adoption and success levels necessary to drive significant systemic change. This is because many of these agreements cover only 1 drug and/or rely on simple volumetric math as the arbiter of contractual conditions and payment.

Contracts that base reimbursement on improved patient outcomes are gaining traction. Manufacturers stand to benefit from pharmacy and medication therapy management (MTM) partners with proven capabilities to improve adherence and patient engagement that results in positive health outcomes, such as sustained virologic response. A strong case can be made that clinical pharmacists are the most appropriate, near-neutral arbitrators of value-based contracts given the following qualifications: 

 - Clinical pharmacists possess the pharmacologic knowledge critical to side effect mitigation (a contributor to adherence and outcomes) and for conducting appropriate medication reconciliation for polychronic, polypharmacy patients. These individuals account for roughly 20% of the population that is responsible for 80% of health care spending.

 - Specialty pharmacists interact with all parties concerned: patients, prescribers, manufacturers, and payers. They have a clear line of sight into the patients’ living rooms, kitchens, and medicine cabinets that the other stakeholders do not have. This enables them to understand the whys of medication nonadherence and gives them the ability to alter what is needed in order to effect and support individualized changes that improve adherence, outcomes, and value derivation for all parties. 

- Improving adherence requires a trusting relationship with the patient. We have discovered through more than 16 years of patient service that patients tell us things they have not even told their prescribers. Building trusting patient relationships takes time and dedicated, patient-focused teams. 

 - Although electronic health record systems have a long way to go to reach needed levels of efficiency and interoperability, specialty pharmacies and medication management providers are uniquely positioned to collect the minimum levels of data needed to fairly adjudicate value-based contracts. These systems should enable ease of access to data sources from multiple stakeholders and to analysis that all parties can understand. 

 - Placing the highest priority on patient outcomes is a good first step in building a dialogue everyone can embrace and understand. Specialty pharmacies can play a leading role in value-based contracts because they are well versed in each party’s language and top interests. 

 - There will be many patient lives and millions of dollars at stake in the next generation of value-based contracts. C-suite from payers and manufacturers will be sitting at the table during the design, implementation, and adjudication of value-based contracts if a specialty pharmacy or medication management provider chooses to accept the challenge of playing a leading role. The opportunity to help develop and implement the next generation of patient-centric, value-based contracts is one that could move the right specialty pharmacies and medication management providers out of the shadows of care.

Can Amazon’s Interest in Pharmacy Raise the Level of Industry Transparency? 

As has been widely reported, online retail giant Amazon may be getting serious about entering the pharmacy business. With consumers’ self-education about their health care on the rise due to the proliferation of high-deductible plans and the associated out-of-pocket costs, it makes sense that pharmacy needs to adapt consumers’ associated shifts in buying habits into the online space.

Max Nisen recently wrote on Bloomberg.com, “Amazon has many advantages when it comes to selling just about anything. Hundreds of millions of people buy something from Amazon every year; something no other company, let alone another pharmacy, can really match. It’s arguably better at managing speedy delivery and consumer experience than its potential competitors. That gives it a real chance to increase the market penetration of online and mail order drug options.”

A valuable pathway to reducing overall health care costs—including specialty medications&mdash;that has not been given sufficient focus is wellness programs, including those focused on reducing obesity. 

 study published in June that more than 10% of the world’s population is obese. The study authors found that excess weight was a factor in 4 million deaths in 2015 from such conditions as heart disease, diabetes, and kidney disease.

 Jayne O’Donnell, Erin Barry, and Kate Covington wrote that, “obesity, inactivity could outpace smoking in cancer death risk.” The American Cancer Society’s Rebecca Siegel told the authors, “Twenty percent of cancers are caused by poor diet, alcohol consumption, a lack of physical activity, and/or excess weight that can’t be combined with the 30% of cancer deaths caused by cigarette smoking.”

So How Are We Going to Pay for All of This? 

In 2 words, we’re not. The economic machine that drives the provision of US health care, including pharmaceutical innovation and patient access to therapies, runs on the allocation of scarce resources. As I wrote in an earlier piece for 

®, “Those allocations are based on the value placed on every element that serves or receives service from the industrial players. Perhaps the most difficult assignment of value involves that of the extension of life, a figure that US health care policy makers have yet to quantify.”

Until US health care policy makers assign a quality-adjusted life-year value determination nationwide, we will continue to wade through a disjointed process by which access to, and prices for, specialty medications, including nascent immunotherapeutics, are determined.

Moving the Longest Lever in Addressable Wasted Health Care Spending: Adherence 

According to QuintilesIMS, medication nonadherence remains the longest lever available to affect more than $200 billion in wasted health care spending. We know that improvements in adherence also improve outcomes for chronically ill patients, particularly those with inflammatory bowel disease (IBD), hepatitis C, and HIV, through our clinical study work with Johns Hopkins, Northwestern University, and the University of Alabama-Birmingham, among others.

Results from a study delivered during the 10th International Conference on HIV Treatment and Prevention 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. And in October 2016, Curant Health and Johns Hopkins Medicine’s Meyerhoff Inflammatory Bowel Disease Center found that MTM improves adherence more than 30% compared with the standard of care for patients with IBD.

The business of improving outcomes while reducing costs is arduous work. Specialty pharmacy has an opportunity to deliver value by investing in patient support services that improve medication access and adherence, while simultaneously providing the alignment and support that the balance of the care continuum needs to ensure available resources are used most effectively.&ensp;

Articles

Value-based contracts among pharmaceutical manufacturers and payers have not achieved the success levels necessary to drive significant systemic change.

Indispensable: Opportunities for Specialty Pharmacy to Deliver Value and Access

WHEN WE LAUNCHED CURANT HEALTH in 2000, we knew there would be a few bumps and bruises along the way. We also knew how much individualized attention patients needed in order to adhere to their specialty medication regimens, particularly those with multiple chronic conditions.

What we did not know was the magnitude of how important patient support services and patient centricity would be to the business. More than a decade later, we have learned that building a specialty pharmacy organization to last requires more than URAC accreditation and pharmacists.

It requires an organizational philosophy built around patient care, which just happens to be supported by fulfillment of specialty prescriptions. Patient centricity, clinical expertise, commitment to acquiring outcomes data to prove value, and the ability to integrate into larger organizations within the continuum are 4 requirements specialty pharmacy organizations need to demonstrate to remain viable and competitive at a minimum, let alone thrive in the shift from fee-for-service to value-based care.

What Does Patient Centricity Really Mean to You? 

At Curant Health, patient centricity means placing the patient at the center of every conversation, be it a business conversation, an individualized care conversation, or a population health conversation. We define value as improving outcomes while reducing costs. Placing outcomes first in this equation does more than make for a convenient numerator. It demands focus on the patient.

I would encourage those within existing specialty pharmacy organizations or those attempting to build new ones to create a laser-focused definition of patient centricity. What exactly does it mean to you? Write it down, share it with your team, build consensus, and commit to it. You will discover it means different things to different elements and individuals within your organization. Moreover, you will discover that every part of your organization—from the C-suite to administration to the clinical team to patient support staff and, especially, finance&mdash;affects it.

Clinical Expertise and Commitment to Outcomes Data 

Highly qualified clinical pharmacists not only have the ability to communicate in the same language as traditionally defined health care providers, they also exhibit a thirst for new knowledge. New knowledge not only advances our science, it has the ability to improve the standard of care.

Specialty pharmacy organizations must prove their worth through data that must be acquired from payers, providers, and patients. This will be quite the challenge. Securing partners with an interest in obtaining outcomes data must be a shared goal. Otherwise, this will be a massive challenge. You can’t do this by yourself. It must be a strategic decision to which you commit on the front end, early on in partner discussions of any kind: payer, pharmacy benefit manager, provider, or manufacturer.

Studies involving large university hospitals, particularly those that require internal review board approval, are not for the faint of heart, but they have tremendous value. A shared commitment to improving the standard of care for patients with inflammatory bowel disease (IBD) motivated our team, along with Johns Hopkins Medicine, to embark on Project ALIVE (Adherence and Long-term IBD Value-added Effectiveness).

According to Sharon Dudley-Brown, PhD, the project’s principal investigator and assistant professor of medicine at Johns Hopkins, Crohn’s disease and ulcerative colitis are chronic, debilitating conditions that can have significant economic and clinical implications.

In 2004, the annual cost of IBD in the United States was estimated at $1.84 billion. IBD also is associated with high morbidity, loss of work productivity, and impaired quality of life. While there was much heavy lifting by clinical members of both teams, we have generated data that indicates medication therapy management improves adherence by 30% over the standard of care in a large hospital setting.

“Project ALIVE is well on its way to measuring program value for patients with IBD and their caregivers with preliminary results showing improved adherence in the treatment arm,” said Vickie Andros, PharmD, director of clinical services for Curant Health. “We anticipate that our enhanced medication therapy management and patient support services will continue to demonstrate project value through outcomes improvement and impact on cost through a reduction in hospitalizations and emergency department visits for this patient population. Continuing to validate our work alongside Dr. Dudley-Brown, her colleagues, and, most importantly, improving the lives of people suffering from IBD, is central to our mission.”

These types of programs and data not only accomplish our primary goal of improving outcomes while reducing costs, they provide us with the fuel we need to accelerate growth and improve the lives of more chronically ill patients than ever before.

Specialty Integration: It’s Coming Sooner Than You Think 

The exploding costs of specialty pharmaceuticals, slated to be more than $550 billion by 2020, continued to exert pressure on specialty pharmacies through reimbursement policies and network designs. The maturity of pharmacy systems are driving specialty pharmacies to link with integrated delivery networks (IDNs) and accountable care organizations (ACOs). Several retail pharmacies are already moving ahead with these types of integrations.

As the shift to value-based care accelerates, IDNs and ACOs need to mitigate risk by improving adherence to, and thus value derivation from, specialty therapies. Specifically, IDNs must look for mechanisms to better control the payer component and in-home support of their most costly patients.

Ongoing, consistent medication management for chronically ill patients in the home will be critical to the success of any IDN or ACO specialty pharmacy integration, whether it’s a buy or partner scenario. The focus of stakeholders is now on improving the patient journey, not the prescription journey. What is clear is that this full-scale integration is coming sooner than you probably think.

We have long spoken about the value in placing a clinical pharmacist at the center of a patient’s in-home care team. It appears specialty pharmacy organizations—with a well-defined, well-understood approach to patient centricity, robust patient support services, a commitment to developing rock solid outcomes evidence, and an ability to integrate into larger organizations within the care continuum&mdash;are poised to both survive and thrive within the grinding shift to value-based care. 

Building a durable specialty pharmacy organization requires more than URAC accreditation and pharmacists.
