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;

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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.