Marc Oâ€™Connor

With more than 5000 attendees, 100 seminars, and 900 companies befitting a $150 billion industry, the annual Asembia Specialty Pharmacy Summit maintains its place as the industry’s leading event. While its growth continues to make the valuable new connections difficult amid the hubbub and crowds, Asembia 2017 delivered high-value insights about 2 of specialty’s hottest topics: value-based contracts and the race for health systems to enter the specialty pharmacy space.

Here are our top takeaways from Asembia 2017.

Integrated Health Systems and Specialty Pharmacy Integration: Proceed With Extreme Caution

Integrated health systems and large hospitals are racing to enter the specialty pharmacy space, which they perceive to be a highly lucrative proposition. The top question that they must address is how: build or partner? This explains, in part, why we saw far more health systems represented at Asembia 2017 than in any other year in memory.

Asembia is an outstanding event, during which those entities can get educated about the intricacies, nuances, and risks associated with specialty pharmacy as a business that is incredibly complex and often crosses the border into convoluted territory. Driven by an interest in moving towards a health maintenance organization (Kaiser) model and perceived profit generator, we, and industry colleagues like Apogenix, urge health systems to use extreme caution when considering their next steps in specialty pharmacy.

The resources required and mandatory risks to assume should be impossible-to-miss red flags that prudent health systems acknowledge and assess before advancing a build strategy. As Adam Fein, PhD, president of Pembroke Consulting, detailed during Asembia, the battle being waged over the patient journey, especially relating to data access, may be driving systems to enter the specialty pharmacy space as well.

That said, distribution network issues, direct and indirect remuneration fees, and loss of focus from the core business for a poorly compensated piece of the puzzle are the top reasons health systems should proceed in their specialty pharmacy integration plans with extreme caution. The most prudent path forward appears to be partnering with a stable specialty pharmacy committed to improving patient outcomes through programs proven to improve adherence and reduce the overall health care spend.

To Maximize the Potential of Value-Based Contracting: Keep it Simple for Now 

Few, if any, first generation value-based contracts among pharmaceutical manufacturers and payers have achieved success levels necessary to drive systemic change. This is largely because many of these agreements cover only 1 drug, and/or rely on volumetric math as the arbiter of contractual conditions and payment. That appears to be changing.

Contracts that base reimbursement on the value-based notion of improved patient outcomes, in addition to drug efficacy, are compelling and gaining traction. Manufacturers can benefit from pharmacy and medication therapy management partners with proven capabilities in improving adherence and patient engagement. This frequently results in positive health outcomes, such as sustained virologic response, thereby realizing greater therapeutic and financial potential of their specialty therapies.

, Novartis CEO Joseph Jimenez wrote, “We believe in the efficacy of our products, and by collaborating with payers on solutions for reimbursement, we hope to help start a shift toward value pricing in the health care system.”

According to a Deloitte presentation at Asembia 2017, pressures driving the shift from volume to value include reimbursement shifting to outcomes, consolidation of buyers, increased competition thanks in part to generics and biosimilars, and more highly engaged patients sensitive to increasing out-of-pocket costs and gaining increased access to information. What we found particularly curious was the assignment of patient adherence to therapy as an uncontrollable factor among the challenges in executing new value-based agreements.

At Curant Health, our medication management programs are proven to improve adherence among chronically ill patients. It is difficult work, but we would disagree with the assertion that patient adherence is uncontrollable. It is absolutely true: value-based contracts are relatively young tools and will undergo continuous change for the foreseeable future. Our best advice is to start simple and select your outcomes measurement data carefully.

For example, A1c count may only be measured in 30% of the diabetic population. The value-based contract gold standard will likely be significantly different from the clinical gold standard due to data limitations. In the end, value-based contracting is about data, its quality, and using it to generate better clinical outcomes. Organizations that effectively ameliorate the shared pain points between manufacturers and payers will be winners.&ensp;

Articles

The summit provides a place for specialty pharmacy stakeholders to discuss the industry.

Value-Based Contracts and Health Systems Specialty Pharmacy Integration: 2 Key Insights From Asembia 2017

Each year, spring heralds the arrival of the annual Asembia (formerly Armada) Specialty Pharmacy Summit. The significant increase in attendance the event has demonstrated year after year is a testament to the growth of the industry, and the quality content served up at the conference.

However, our industry faces significant challenges in pricing pressures on manufacturers, highly uncertain national insurance policy shifts, and high levels of concern over direct and indirect remuneration (DIR) fees being imposed on specialty pharmacies by Medicare Part D sponsors and pharmacy benefit managers (PBMs). Through this lens, how can Asembia 2017 attendees derive the most value from the event?

Here are a few tips for specialty pharmacy and manufacturer representatives on effectively leveraging your investment in time, and benefit from the networking and educational opportunities.

For specialty pharmacy representatives, large and small: 

1. Go with an alignment mind-set focused on care

We maintain that specialty pharmacists have the greatest opportunity to improve outcomes for patients with chronic conditions due to the frequency of direct patient engagement opportunities that support providers who simply do not have the time, and payers who need to derive the highest value from the cost of specialty therapies from improvements in adherence. How do you align often divergent interests?

2. Manage your calendar by starting with the after hour, highest priority meetings

It should come as no surprise, but it bears repeating. Business deals typically do not get done during the day at the Asembia conference. The introductions may happen at that time, but the real advancement or consummation of deals at Asembia gets done after hours. Reach out to your colleagues with whom you have value-based opportunities to schedule coffee, drinks, dinner, or a nightcap. Get them on your calendar as soon as possible.

3. Don’t anticipate meeting with many PBM representatives

Last year’s Asembia event saw the fewest number of PBM representatives attending in recent memory. This is unfortunate, because the gap between specialty pharmacists, PBMs, payers, and manufacturers appears to be widening when the entire care community needs to be coming together. DIR fees will be a hot topic in the background of the event. Identifying solutions for improving outcomes, while keeping specialty pharmacies in business, is going to require an aligned ecosystem-wide effort.

How and what do you offer the community that advances specialty pharmacy in ways no one else does? Be it a widget, process, or system, breaking through the status quo and making a measurable contribution to true patient centricity and outcomes improvement can be the difference between a thriving specialty pharmacy and one that may quickly face its demise in today’s volatile landscape.

1. What are your limited distribution partners up to?

How are your limited distribution partners performing? How are they contributing value across the board? What levels of adherence are they seeing in patients on specialty medications? Are they exploring relationships, or otherwise engaging, with health systems to examine adherence and efficacy in real-world conditions? Are they exploring or implementing innovative, patient-supporting processes or technologies that are intended or, better yet, proven to improve outcomes? If I were a manufacturer representative, these are the questions I would be asking my limited distribution partners, existing and prospective, at Asembia 2017.

The first wave of “value-based” contracts between pharmaceutical manufacturers were purported to be driven by patient outcomes, when in reality many of these agreements cover only 1 drug and/or rely on simple volumetric math as the arbiter of the contract conditions and payment. What should the next iteration of value-based contracts include, and how does a specialty pharmacy advance them to the benefit of all concerned?

What role can, will, or should, specialty pharmacies play in value-based contracts? Again, if I were a manufacturer representative, this is what I would want to know most from specialty pharmacies and service providers seeking access to my therapy in any distribution arrangement, value-based, limited, or open. Based on my role with Curant Health, I will be keeping my ears open for anything I can learn about the state of value-based contracts between manufacturers and PBMs.

Based on the drug and disease state, bring your top challenges and be prepared to articulate your goals as succinctly as possible. Which drugs are you willing to take a risk on? At Asembia 2017, seek and find partners in the specialty community capable of mitigating risk and ensuring the efficacy of those drugs. Keep your ears open for new ways to augment patient management, access and support.

When you hear it, insist on validated, metric-driven supporting evidence. How do your prospective partners and industry colleagues work to gauge the patient voice? Does it align with your view of patient centricity, your needs and goals? That’s something I will be keenly interested in hearing from the Asembia 2017 community.

4. Making the most of educational opportunities and the program 

With your value proposition honed, your needs and goals clearly defined, and your top-level meetings scheduled after hours, you will be set to cherry-pick from the multitude of sessions on the program. Pay close attention to the first sessions of the mornings.

While many are slow to rise at Asembia, the early sessions suffer from less of an attendance crush, and provide those who do attend an outstanding opportunity to engage in a direct, meaningful way with the speakers and panelists that the most heavily attended, prime-time sessions simply cannot. For any interested in improving the intergration of health care systems and accountable care organizations, I will be leading a discussion on this topic on May 3 at the Asembia Specialty Pharmacy Summit 2017.&ensp;â—†

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 health care professionals provide individualized care proven to improve the lives and reduce the overall healthcare costs of chronically ill patients.

Tips for specialty pharmacy and manufacturer representatives on effectively leveraging your time at the annual Asembia Specialty Pharmacy Summit.

How To Make the Most Out of Asembia 2017 

In December 2016, QuintilesIMS reported that US spending on prescription medications will reach upwards of $675 billion by 2021.

The pricing pressure on manufacturers is expected to grow along with the demand that specialty therapies, in particular, demonstrate positive outcomes in real-world conditions, as the shift from fee-for-service to value-based care accelerates, regardless of future shifts in health care policy.

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

The concept of contracts that base reimbursement on the broader notion of improved patient outcomes, in addition to drug efficacy, is compelling and could quickly gain traction. Manufacturers stand to benefit from pharmacy and medication therapy management partners with proven capabilities in improving adherence and patient engagement that result in positive health outcomes, such as sustained virologic response, thereby realizing the full financial potential of their specialty therapies.

Manufacturers appear open to advancing and improving value-based contracts. In a November 2016 column for 

, Novartis CEO Joseph Jimenez wrote, “We believe in the efficacy of our products, and by collaborating with payers on solutions for reimbursement, we hope to help start a shift toward value pricing in the health care system.

We want to be rewarded for the tangible outcomes our products provide patients, not for simply selling pills.” Specialty pharmacies and medication management providers that offer effective medication therapy management, along with support teams that deliver valuable patient care and report real-world outcomes, are best suited to serve as arbiters of the next generation of value-based contracts.

The ideal stakeholders to arbitrate value-based contracts 

First and foremost, the specialty pharmacy or medication management provider is patient-focused, and is the nearest neutral party to a value-based contract (assuming the absence of a limited distribution relationship).

The most robust and competent of these organizations improve both variables in the value equation—outcomes and costs–for every member of the continuum: patients, prescribers, manufacturers, and payers.

Of equal importance are the clinical pharmacists capable of acquiring, generating, and analyzing outcomes data critical to the adjudication of true value-based contracts. They also 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 comprise roughly 20% of the population responsible for 80% of health care spending.

Third, specialty pharmacists interact with all parties concerned: patients, prescribers, manufacturers, and payers. Most importantly, they have a clear line of sight into the patients’ living rooms, kitchens, and medicine cabinets that the manufacturers, prescribers, and payers do not. This enables us to understand the whys of medication non-adherence, and gives us the ability to change what is needed in order to affect 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 15 years of patient service that these patients tell us things they have not even told their prescribers. Building trusting patient relationships takes time and dedicated, patient-focused teams.

While electronic medical record systems have a long way to go to reach needed levels of efficiency and interoperability (especially from the provider’s perspective), specialty pharmacies and medication management providers are uniquely positioned to collect minimum levels of data needed to fairly adjudicate value-based contracts.

These data include, but are not limited to, challenges in obtaining access to medications and speed-to-therapy, adherence assessment, costs, and efficacy of therapy. These systems should enable ease of access to data sources from multiple stakeholders, and to analysis that all parties can understand.

At times, it seems payers, manufacturers, prescribers, and patients speak different languages. Placing the highest priority on patient outcomes is a good first step in building a dialogue everyone can embrace and understand. Patients are not concerned with a drug’s market share. Similarly, providers have neither the time or resources to identify payers’ prior authorization criteria and complete complex, sometimes lengthy forms.

Manufacturers assume costs in research and development that are not always fully known to other stakeholders. If a specialty pharmacy or medication management provider is going to play a leading role in value-based contracts, the responsible specialty pharmacy team members and leadership are going to need to be well versed in each party’s language and top interests, and to demonstrate significant experience with productive interactions with each stakeholder.

There will be many patient lives and millions of dollars at stake in the next generation of value-based contracts. At the end of the day, you can rest assured that the C-suite level will be sitting at the table with top executives from both payers and manufacturers during the design, negotiation, implementation, and adjudication of value-based contracts should a specialty pharmacy or medication management provider choose to accept the challenge of playing a leading role.

While improving medication adherence is health care’s greatest divide and greatest opportunity, 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. This will allow them to demonstrate real leadership in the value-based health care spotlight to the benefit of all concerned parties.&ensp;

Specialty pharmacies that offer effective medication therapy management and support are best suited to serve as arbiters of the next generation of value-based contracts.

Value-based Contracting 2.0: Is Specialty Pharmacy Ready for its Shot at the Spotlight?

 proffered the topic of cost versus cure, and the responsibility of the payer (including the employer and patient), prescriber, patient or pharmacy, I hesitated.

Answering the question by making one party more responsible than another reinforces the legacy silos that must be razed if we wish to transform health care into a value-based system. Arriving at one responsible party would necessitate a single-payer system, which is far from likely in the United States.

Since that is the case, every party shares an equal burden of responsibility on decision points relating to cost versus cure. Cure is the key word. We have cured hepatitis C. But we have yet to cure cancer. In fact, cancer is going to trend toward being a hugely expensive chronic condition in the near future.

According to an article by Alice Park in the April 4, 2016 edition of 

, there are currently 3400 immunotherapy trials ongoing in the United States. The better questions for the editorial team to ask are how long is it going to take the needed parties to engage in non-threatening, meaningful dialogue to create solutions, and who leads that conversation?

The short answer to the second question is all of the above and more. Real alignment among all stakeholders, inclusive of the aforementioned, is arguably the most urgently needed new practice in health care. There must be immediate meaningful discussions about the value of care (including pharmaceutical therapies) and the value of life, led by plan sponsors, commercial and government payers, manufacturers, pharmacy benefit managers, policy makers, patients, and patient advocates.

As with any industry, health care decisions are all about the allocation of scarce resources. 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. In 2014, the independent Institute for Clinical and Economic Review set the value of each quality adjusted life year (QALY) at $100,000 to $150,000.

This range includes, among other elements, the incremental costs associated with drugs, medical devices, and procedures. It should be noted that the question of how to define health care value extends well beyond the United States. The approach to quantifying the value of new pharmacological therapies in the UK, for example, is supported by the National Institute for Health and Care Excellence (NICE).

This organization is tasked with providing evidence-based guidance about the cost-efficacy of new treatments, among other responsibilities, and national law requires that therapies approved by NICE be included in the National Health Service. In general, NICE refuses to recommend medications that cost more than £20,000 to £30,000 per QALY. Historically, these non-recommended therapies have not been covered under the UK single-payer system.

Back home, it appears that until US health care policy makers assign a similar QALY 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. In the foreseeable future, here is what payers, manufacturers, prescribers, patients, and specialty pharmacists should expect and do in order to navigate the shift to value-based health care.

Expect to prove you are taking steps to prevent events detrimental to your well-being or events that frequently lead to acute care requirements. Acquire your electronic health record and be prepared to provide increasing access to your health history as a coming “price of admission.” When it comes to pharmaceuticals specifically, be 100% adherent to your medication regimens and be prepared to prove that you are.

Be prepared to educate your patients on step therapy and the importance of adherence. Be further prepared to provide outcomes data, including lab data, to your pharmacist partners and payers in order for your patients to gain access to the most appropriate and effective medication therapy available. Refer your patients who require specialty drugs to companies that can help them navigate the prior authorization process so you and your staff can focus on provision of care.

Expect the drumbeat of those railing against ever-increasing drug costs to continue to rise. Be prepared to accept a shift in thinking about the amount of time required to recoup research and development expenditures for new therapies. It will almost certainly be a longer cycle than the one you currently drive toward. An industry expert recently posited the idea of payment, based only on manufacturing costs for breakthrough therapies, until a sufficient amount of real-world data is collected on efficacy to determine value-based pricing and reimbursement.

You can also expect serious downward pressure on patent length. Demonstration of the therapies’ efficacy and value in real-world conditions will be among the top ways to show value to satisfy your shareholder, payer, patient and policy maker constituents. Engage patient support services companies and pharmacy fulfillment providers proven to improve adherence and outcomes, especially within your limited distribution networks.

Expect your spending on prescription medications, especially specialty pharmaceuticals, to rise unless you are prepared to limit access and increase patient out-of-pocket costs and copays considerably. Expect uncertainty in the amount of time your customers, including patients, will need to spend on new prescription therapies, especially immunotherapeutics and immuno-oncolytics. Insist on robust clinical trials, or better, real-world results for value derivation and pricing for specialty drugs. Install electronic health records systems that enable physicians and pharmacists to deliver and access outcomes data critical to value-based care and analysis.

In the short to midterm, expect to assign additional resources to the prior authorization process if you are concerned about patient access to therapies and improving health outcomes. Be prepared for challenges in acquiring lab data needed to demonstrate that your medication management protocols bring real-world outcomes to validate the prices of the drugs you are dispensing from your patients’ prescribers due to ongoing resource constraints.

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. But, the time is coming soon that we will have to rip off the band aid and tackle these decidedly difficult questions, together, in order to affect meaningful change. Otherwise, we are much more likely to suffocate in our individual silos.

 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 health care professionals provide individualized care proven to improve the lives and reduce the overall health care costs of chronically ill patients.

Payers, providers, manufacturers, and patients will need to navigate a complicated landscape in the shift to value-based health care.

Cost versus Cure: Achieving a Value-Based Care Algorithm We Can Live With

 becoming a chronic condition in the near future.

According to a study by Wei Zheng, MD, PhD, and others, published in the 

Journal of the American Medical Association

 as reported by Reuters in 2015, “For men and women ages 50 to 64, who were diagnosed in 2005 to 2009 with a variety of cancer types, the risk of dying from those cancers within five years of diagnosis was 39 to 68 percent lower than it was for people of the same age diagnosed in 1990 to 1994, researchers found.”

Increasing survival rates are a leading indication that the future of cancer treatment may start to mirror the treatment of chronic conditions. Such a shift will have massive effects on payers, and will accelerate incredibly difficult conversations and decisions about the value of extending life. Oncology patients on new immunotherapies are demonstrating 3- to 5-year survival rates and 30% remissions.

However, not nearly enough is known about when it is safe for many patients to stop treatment. There exists a massive difference for the continuum between paying $120,000 or more for 1 year of therapy with 6- to 12-month survival rates for cancer patients compared with the same $120,000 per year for an indefinite number of years as treatment efficacy grows.

, there are currently 3400 ongoing immunotherapy trials in the United States. As reported in late March by the 

, Michael Bloomberg and others recently gave $125 million to Johns Hopkins University for a new institute focused solely on immunotherapy research seeking a cure for cancer.

Concurrent to the growth of immunotherapies for oncology patients, oral oncolytics are also on the rise. But, like a large number of specialty medication therapies, adherence rates are frustratingly low. While many industry experts believe the future of oncology drugs are infused immunotherapeutics, oral oncolytics represent about 50% of oncology drugs currently in use and about 25% of drugs in the pipeline.

Oral oncolytics are convenient for patients who do not have to travel to their oncologist for a session in the infusion chair, and they can be a psychological boost due to the commonality of oral medications. However, that convenience ends with the patient. The physicians no longer have eyes on the patient to assess their condition, and they do not know about true levels of compliance to therapies that can have toxic, swift side effects.

Patient care is further impacted by the financial offset that is absent when physicians cannot bill for infusion time to support the funding of critically needed staff to ensure adherence. Overall adherence to oral oncolytics is in the neighborhood of 50%. There is evidence that suggests for some groups, adherence rates are much, much lower.

As long as immunotherapy requires infusion, the payment responsibility remains, for the moment, on the medical side. This provides the opportunity for oncologists to have close eyes on patients. But oral immunotherapeutics will eventually enter the market; what then?

Payers and pharmacy benefit managers run the greatest risk of bearing the brunt of the financial burden, as cancer shifts toward a chronic condition treated increasingly by oral oncolytics, and eventually, oral immunotherapies. The consequences for payers could be enormous.

If cancer treatment trends toward HIV or hepatitis C, we will see a slew of combination therapies while the industry works steadily towards a 1-pill, once-a-day treatment. If adherence were to remain in the 20% to 50% realm, it would be disastrous for all concerned, and lead to significant increases in the existing $100 billion to $300 billion in wasted health care spending due to medication nonadherence.

What’s Needed to Prepare: A Hard Look at the Chronic Care Management Team 

As with any chronic condition, the goals for advanced oncology therapies should be improving outcomes while containing costs, reducing drug waste, and increasing adherence rates. What will be needed is a holistic approach to chronic care management with clinical pharmacists playing a larger role within the entire team.

As we have seen in multiple studies for patients with difficult-to-treat chronic conditions, such as HIV and hepatitis C, enhanced medication therapy management protocols, led by clinical pharmacists and robust patient support services, accomplish these goals.

For those payers and manufacturers seeking the greatest value for ALL stakeholders, their plan sponsors, shareholders and the patients, there are 3 key tools that must be part of the toolbox.

Within the pharmaceutical realm, patient support or patient assistance is traditionally defined as financial or copay assistance. Due to the shift in burden away from the medical coverage afforded to oncology drugs administered within the providers’ facilities, manufacturers are going to have to provide traditional financial assistance for oral oncolytics in order for patients to gain access.

Similar to myriad treatments for chronic conditions such as HIV and hepatitis C, this will remain a necessary provision from manufacturers, as cancer becomes a chronic condition.

These 4 commonly used words in the pharmaceutical realm describe adherence support, as our team knows it. Continuity of the person providing support is key here.

Far from a call center experience, dedicated patient care coordinators who speak with the same patient on a frequent basis, generate trusting relationships during the time a patient is not in their physician’s or oncologist’s office.

Gathering and archiving data, especially as it relates to lifestyle and barriers to adherence, provides a level of understanding and the ability to influence adherence and outcomes for chronically ill patients that lie with no other member of the patient services or care management team.

Providers tell us that patients frequently start therapies when they want and stop when they want. This does not work for any health care stakeholder.

Adherence to medication protocols is paramount to their efficacy. Physicians should be alerted when refills are requested and shipped.

As value-based contracts for high-cost therapies between payers and manufacturers proliferate, not only does agreement upon outcome metrics become critical, the acquisition of data points and sharing of information among chronic care team members becomes critical. Every member of a cancer patient’s care team should have visibility into the factors that influence access, adherence, and outcomes. 

 is chief operating office for Curant Health, a provider of enhanced medication therapy management and specialty pharmacy services proven to improve patient outcomes and reduce total health care spending. Marc is also a board member of the Team Type 1 Foundation, an organization whose mission is to “instill hope and inspiration for people around the world affected by diabetes.”

As with care for any chronic condition, the goals for advanced oncology therapies should be improving outcomes, containing costs, and increasing medication adherence.

Cancer: The Next Frontier in Chronic Care Management

 succeeded in increasing the number of insured Americans.

According to the National Center for Health Statistics, there were 16 million fewer uninsured Americans as of September 2015, than in 2013. More specifically, the percentage of uninsured adults aged 18-64 decreased from 22% in 2010 to 13% in the first 9 months of 2015.

One unintended consequence of the ACA, however, is the creation of a glut of patients awaiting authorization for the exact therapies, or actual cures, for which payers have long clamored.

What is even worse, some patients who stand to benefit most from specialty medications have their prescriptions authorized and filled, only to learn that refills of Harvoni, for example, run into a monthly prior authorization barrier from their pharmacy benefit manager or payer.

At risk of failing to adhere to the costly but valuable regimen due to this barrier, the patient, their payer, and their physician increase the collective risk of resistance to the therapy. We are learning that new curative therapies cannot be treated the same way as legacy and low-cost medication therapies.

Rising Number of Insured + Rising Numbers of Specialty Drugs and Prices = Roadblocks to Value 

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.

“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,” the authors wrote. “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.”

The meteoric increase in the number and cost of specialty medications, added to the growing population of insured Americans, has created a one-two punch in the guts for patients and providers. While the average time per patient interaction for clinicians continues to shrink, providers are now mired in a worsening administrative bog of prior authorization forms.

At the same time, patients often forego therapy—putting them at greater risk of becoming acute or requiring other, more costly care–due to slow prior authorization processes or out-of-pocket costs, including medication co-payments, they simply cannot afford. It’s a situation akin to classic traffic congestion.

Increasing the volume of vehicles to a constant volume of highway capacity breeds gridlock. Adding new lanes, an immensely expensive proposition, is only a short-term solution. What is needed is taking vehicles off of the roads by giving users effective alternatives.

In the same way bike paths and mass transportation options move people efficiently through a city, pharmaceutical industry alignment should improve access, adherence, and outcomes for all concerned.

Where There is Hope and a Productive Path Forward 

In November 2015, pharma’s at-risk day in the United States arrived with the announcement of the Harvard Pilgrim deal with Amgen for the PCSK9 inhibitor Repatha. Others have since followed, including Aetna and Cigna’s agreement with Novartis for its heart failure drug Entresto.

Through these value-based agreements, payers recoup additional rebates from manufacturers if patients do not achieve specific outcomes targets. Given the need for improved alignment within the entire industry (manufacturers, payers, providers and patients), at-risk or value-based contracts are a solid advancement in value-based care.

What is needed next is agreement on outcomes metrics and a near-neutral arbiter of those outcomes. According to a Kaiser Family Foundation “Health Tracking Poll” from February 2016, 36% of Americans say policymakers should build on the ACT to improve affordability and access to care.

Sixteen percent said they would like to see the health care law repealed and not replaced, 13% said it should be repealed and replaced with a Republican-sponsored alternative, and 24% said the United States should establish guaranteed universal coverage through a single government plan.

To our respective parties’ candidates in the race to be the 45th President of the United States, I say: no matter which approach you take to national health care, the longest lever available to increasing value by improving outcomes and reducing overall costs is medication adherence.

According to a report from the US Centers for Disease Control and Prevention, medication nonadherence accounts for $100 billion to $289 billion in wasted health care spending every year.

AbbVie sponsored a study in April 2015, where the sample included patients aged 18 years or older with a diagnosis of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis.

Journal of Managed Care and Specialty Pharmacy

, found that AbbVie’s Humira Ambassadors patient assistance and education program:

		Lowered 12-month medical cost by 23% associated with patients using patient support program (PSP)

		Lowered disease-related medical cost for PSP patients by 22%

		Lowered total costs for patients enrolled in the PSP program by 10%

A study published, in 2012, by Curant Health CEO, Patrick Dunham, and Jeffrey Karkula, RPh, BSPharm, demonstrated the impact of medication therapy management on a population of HIV patients taking Highly Active Antiretroviral Therapy (HAART):

		Medication adherence was increased by 28% over baseline through enhanced medication therapy management.

		There was a 69% increase in patients who were at least 95% adherent to all medications; 95% represents the commonly applied definition of an acceptable level of adherence to HAART.

		The percentage of patients whose viral loads were considered undetectable increased from 28% to 66% with medication therapy management.

		The same patients’ overall health care costs decreased $3,000 per patient per year.

Directing CMS to expand upon its definition of medication therapy management and adding it to the Chronic Care Management program is one way the next president can lead the nation to better health, the moment he or she takes office.

CMS also has the capability to effectively accelerate the shift to value-based care by more clearly defining value as outcomes divided by costs, committing to reliable outcomes measurement, and improving adherence rates through effective medication management among the nation’s chronically ill patients.

As the nation’s largest payer and arguably the nation’s largest driver of health care innovation, CMS should lead the charge and our next president should ensure they do so. 

1. National Center for Health Statistics. Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, January—September 2015. http://www.cdc.gov/nchs/data/nhis/earlyrelease/insur201602.pdf. Published February 2016. Accessed February 2016.

2. The Pew Charitable Trusts. Specialty Drugs and Health Care Costs. http://www.pewtrusts.org/~/media/assets/2015/11/specialty-drugs-and-health-care-costs_artfinal.pdf. Published November 2015. Accessed February 2016.

3. The Henry J. Kaiser Family Foundation. Kaiser Health Tracking Poll: February 2016. http://kff.org/health-reform/poll-finding/kaiser-health-tracking-poll-february-2016. Published February 2016. Accessed February 2016.

4. US Centers for Disease Control and Prevention. Medication Adherence. http://www.cdc.gov/primarycare/materials/medication/docs/medication-adherence-01ccd.pdf. Published March 2013. Accessed February 2016.

5. Rubin D, Skup M, Davis M, Johnson S, Chao J. University of Chicago Medicine; AbbVie; Medicus Economics. Impact of AbbVie’s Patient Support Program on Resource Costs in Crohn’s Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriasis, Psoriatic Arthritis, and Ankylosing Spondylitis. (See U7, page S74) Meeting Abstracts Academy of Managed Care Pharmacy 2015 Annual Meeting& Expo. Published April 2015. Accessed February 2016.

6. Dunham, P and Karkula, J. “Effects of a Pharmacy-Care Program on Adherence and Outcomes.” Am J Pharm Benefits. 2012;4(1):e8-e14. January/February 2012. http://www.ajmc.com/journals/issue/2012/ajpb_janfeb2012/effects-of-a-pharmacy-care-program-on-adherence-and-outcomes. Accessed February 2016.

The Affordable Care Act has created a glut of patients awaiting authorization for the therapies payers have longed for. 