In a 2-part Q&A with Specialty Pharmacy Times, NASP President Rebecca Shanahan discussed how direct and indirect remuneration (DIR) fees affect specialty pharmacy, how to improve patient outcomes, the impact of Any Willing Provider legislation on payer access and patient services, and many other hot topics in the specialty landscape.
 
Click here to read part 1 of the interview. 

SPT: What is the role of ACOs, GPOs, or individual institutions in specialty pharmacy?

Shanahan: We think ACOs are an interesting concept. We believe that specialty pharmacy is a uniquely positioned service model to be successful with an ACO because specialty pharmacy really is a connector amongst health care providers for specific disease states, and so we think that we become knowledgeable partners. Today, we are highly integrated with both hospitals and doctors, both doctors who are affiliated with hospitals by virtue of an employment agreement or who are affiliated by virtue of their participation on the hospital’s medical staff. We really fit hand and glove with doctors and doctor’s offices, regardless of their affiliation, if they’re in a hospital affiliated clinic or if they’re in an independent clinic, we fit hand in glove with them relative to keeping that patient on therapy and keeping track of that patient. We also coordinate not only the clinical coordination and the pharmacy coordination, but also all of the paperwork that needs to happen.

We know that we provide value, so when a patient transitions either out of the hospital into their home, or transition out of an inpatient setting into a home setting, then we know that we are the folks that provide the support as the patient goes into their home. We also know that readmissions for conditions that are treated by specialty pharmacies can be high, and that by virtue of how specialty pharmacies manage these complex and chronic conditions, including our ongoing communication with the patient care team in the hospital and in the doctor’s office, that we are in fact assuring clinical outcomes in a way that that’s very holistic for the patient, and I think that’s what a ACO model is intended to do. In addition, there are currently doctors and hospitals that require either compounded medications and/or services with respect to specialty pharmaceuticals as a part of their care model. We are tightly integrated with these hospitals, outpatient centers, and doctors to ensure that all of the pharmaceutical products these folks require for their patients are provided in the highest quality, lowest cost, most appropriate setting. So, 47% of total specialty medical costs are provided in an outpatient setting, another 40% in a physician’s office, and 9% at the patient’s home, and we have a reach and a partnership into all those platforms for purposes of managing outcomes.

SPT: How providing specialty pharmacy services smooths the transition from inpatient hospital pharmacy to outpatient specialty pharmacy?

Shanahan: For many pharmacies who have relationships with hospitals, there is a coordination of the meds that are going to be provided at the discharge of a patient. They’re going to transition from that brick and mortar care that’s very immediate, into a situation where there’s not a lot of immediacy if they don’t have a coordinator of care. We would generally identify medications that are specialty drugs that are going to need to be provided to that patient in their home. We would either go to the hospital or we would arrange for the hospital to have the package of medication for the patient when they get discharged from the hospital. We then counsel the patient with respect to those medications, ensure that they have the medications when they arrive at their home, initiate a conversation with those patients and their families as they arrive home, and call the patient back after they receive their medication to be sure they’ve gotten it, that they understand the intervals during which they’re supposed to take it, where they need to store it––in the refrigerator if it’s refrigerated medication— how they need to take it in terms of times of the day––with water without water, with other food without other food––and we follow up based on how we assess the patients’ capability of managing themselves at regular intervals to check to see have they been taking their pills, and if they have taken the right dose at the right time. Interestingly enough, even if they’re taking a dose every day, if they’re taking 1 dose at 8 o’clock in the morning, and the next day taking the same medication at 4 o’clock in the afternoon, they’re likely to get less optimal results out of those therapies. So we’re constantly intervening with them to be sure that they are adhering to their therapy, adhering to it at the right dose and the right time, and with the right results.

SPT: Compare the services of physician clinics and in-house specialty pharmacies, such as in oncology?

Shanahan: If you’ve seen 1 doctor’s office that’s dispensing medication, you’ve seen 1 doctor’s office that’s dispensing medication. For some doctor’s, they have pharmacists on site and on staff, and they have a pharmacist who is experienced, not only with giving the patient information at the time the patient receives their prescription, but at follow-up when the patient leaves the office. Other doctors and pharmacists are really good with in-office visits and engaging with the patient there, but may or may not have the staffing components necessary to make the kind of outbound calls and follow-up on a regular basis that are needed––and that’s really just a function of staffing of that particular office’s support for patients. You will hear the doctors’ offices say that they provide much better service because they are intimately involved with the patient, whereas, in some cases specialty pharmacies are all telephonic, or are telephonic and mobile app or telephonic and technology app. Avella has mobile apps for disease categories where patients can register online and then engage in self-reporting around what’s happening with their medication. We are able to demonstrate that patients who are engaging with us and using a mobile app have better outcomes than patients who are just engaging with us telephonically. We also have pilot programs that have demonstrated outcomes with respect to technology-capped bottles that will report when the patient is taking their medication and how that patient is adhering to their medication schedule. Our engagements of pilot programs was a cool product that is the size of a grain of sand. It’s a technology tool that gets ingested––its compounded with the drug in a capsule––and then measures how the drug is being absorbed in the body, and with a patch that’s placed on the patient’s arm transmitting that data so you can actually tell hour-by-hour what’s happening with that patient.

To the extent that we are employing technology in a way that’s more fast-forward than perhaps the traditional doctor’s office, we think we’re able to build upon what the doctor does and continue to be highly integrated with the outcomes for that patient. I think it’s really variable what the doctor’s office can do, and we have relationships with doctors where they dispense the drugs that they can dispense and manage the patient, but where they want to refer limited distribution drugs to us, for us to dispense them. We also have relationships with doctors where they want to dispense the drug, but they want to have a consistent approach in terms of how we engage with the patient. But we will do the patient engagement and we will coordinate that. There are a lot of different models right now, and I don’t know that they’re all good or they’re all bad. I think it’s really dependent upon the individual practice, the individual pharmacy, what drugs they have access to in the distribution channel, how much active engagement they have with the patient that is not patient-driven, but is service-driven by the provider of the service.

SPT: How do accredited specialty pharmacy services differentiate themselves beyond the “specialized” services of the Valeant/Philador model?

Shanahan: The Valeant/Philador model really wasn’t a specialty pharmacy model. The Valeant/Philador model was a customized dispensing of a drug to a set of manufacturer requirements. Specialty pharmacy, both in terms of accreditation and in terms of what we would consider to be, these are the things you have to do in order to be a significant player in specialty pharmacy, include coordination of benefits, identification of patient assistant programs––whether it be in a foundation or a manufacturer program, managing the reimbursement for that patient to qualify for the post appropriate reimbursement under their health benefits, and clinical case management of the patients––these are things that specialty pharmacies do that really weren’t done by Philador at all. Philador got a specific drug, not a broad range of drugs, and managed the dispensing of that drug to a set of programs that were manufacturer sponsored, but did not include clinical management of the patient, reporting an analytics of a patient, or any of the benefits coordination or patient care management services that are required by independent regulatory bodies, such as URAC or ACHC. Also, that sort of results in you getting limited distribution products for orphan patient populations, or for populations of patients that have real complexity around persistence and compliance.

SPT: Why do limited distribution products exist?

Shanahan: Usually a limited distribution product exists because the drug has unique properties or unique requirements around patient support that need to be customized, and so you want a set of providers that have already demonstrated that they have expertise in the disease category, that they have a strong set of relationships with health plans from a coverage perspective, and that they have a strong set of relationships with the providers that are in that disease category. Doctors’ offices have a very high functioning, but very small group of people that are working together as a team to manage the patients that they have coming through the doctor’s office. So it’s not like they have a whole lot of focus sitting around trying to fill in the gaps that develop when a patient either has a complexity around their benefit design or has an economic difficulty in affording the co-payment. This becomes particularly important as we’ve gotten into Obamacare because of an effort on the part of PBMs and health plans to reduce the overall premium costs; a lot more of the co-payment responsibility has been pushed to the patient. Particularly specialty pharmaceuticals, if a patient has a $4000 to $5000 co-payment out of pocket before the insurance kicks in, they’re probably going to be in that situation pretty rapidly. Our ability to understand how to get the patient on therapy; coordinate the patient getting on therapy in a timely manner, with the unique requirements of that patient both clinically and economically; and then being able to turn around and report a set of complex outcomes so that the manufacturer can demonstrate the document for purposes of formulary requirements from the health plans, how the real world experience on this drug is, as compared to the clinical trial world for this drug, are all things that a specialty pharmacy are adept at doing, has the systems and the infrastructure set-up to do, and reliably reproduces the kinds of outcomes from persistency and compliance that both drug manufacturers and health plans want. That is why there are limited distribution drugs, because there are a lot of complexities in the distribution channels for specialty pharmacy, and having accredited specialty pharmacies that are deep into disease categories, understand the patient population, understand the prescribing and treating providers of that patient population, and how that group interacts with health plans, is critically important to therapy success and to reporting outcomes.

In addition, new drugs for complex or chronic diseases approved by the FDA with a risk evaluation and mitigation strategy require a lot of additional reporting that can only be done really by a limited number of people in order for it to be accurate, timely, and effective. Twenty-two novel drugs were FDA-approved in 2016, and about half of those novel drugs were considered specialty drugs, and 82% of that group required a special FDA designation, such as a breakthrough or orphan drug as the approval process. So managing those drugs appropriately and reporting back outcomes data is the most important thing that we can do.

SPT: What is the impact of polypharmacy, especially among the elderly population?

Shanahan: The use of multiple medications is an increasingly serious problem. Inappropriate use of multiple medications rapidly increases morbidity and mortality and CMS estimates that accounts for about $50 billion in costs annually. The prevalence of patients with polypharmacy issues has grown stronger. I think that our clinical pharmacist-driven engagements with patients helps us identify and manage side effects and drug-drug interactions before they escalate. We have a countless number of stories where we are on the phones with patients to find out how they’re doing on their therapy, what their side effects are that they are experiencing, and in some cases, the side effects are depression and suicidal tendencies. So identifying that and getting that information to a physician that’s treating that patient, and getting that patient access to immediate services is really important. Those are the kinds of things that specialty pharmacy does every day anyway, and we find ourselves to be really highly valued by both manufacturers and health plans when it comes to identifying patients who have problems with polypharmacy or at risk for health care deficiencies or addiction, or other issues.

SPT: What is the role of specialty pharmacy in 340B and will they expand or diminish?

Shanahan: A 340B program provides disproportionate share hospitals with access to discount on medications that are used in the outpatient facility environment. The purpose of the program was to help find additional revenues by, a sort of, this imposition of a better price or cost of goods from pharma, so that disproportionate share hospitals would have funding to support their services in their community. That has generated about $7 billion in 2013, and they’re estimated to grow to about $16 billion in 2019 to support disproportionate share hospital services with doctors’ offices and community health centers that are in the disproportionate share catchment area to serve patients who are not necessarily being served inside the hospital’s brick and mortar. Specialty pharmacy is about $5.5 billion of that $16 billion, and we know that as integrated delivery systems are developing, and as hospitals are continuing to grow the number of doctors that are employed by affiliated provider networks, that these physicians are integrating how and where they prescribe their medications with what the formulary requirements are for an integrated delivery system, what the health care programs are for an affordable or accountable care organizations, and that all gets coordinated. It’s important that specialty drugs that come under that rubric are managed by specialty pharmacies that have experience. We have a significant number of specialty pharmacy contracts at Avella and I know other specialty pharmacies do, as well. What that does is provide a coordinated approach to patients being seen outside the hospital setting but with affiliated physicians. We can provide the same kinds of clinical services and cost savings benefits around therapy management as we do for our commercial patients.

I don’t think it’s going away, because it’s not like there are a whole lot of other ways for disproportionate share hospitals to gain revenue to be able to support patients outside of the hospital system, and we know that more and more patients are being treated for clinical diseases with pharmacy as opposed to procedural activities. As the treatment model goes into the community and out of the bricks and mortar, and as patients and more diseases are treated by drugs than are treated by procedures, we know that it’s going to grow.

The number of disproportionate share hospitals is growing because patients are increasingly finding it challenging to manage the out of pocket costs associated with even affordable care, because affordable care under the rubric of a low premium envisions certain cost management parameters, which include higher out of pocket costs to patients. Many patients in disproportionate share catchment areas don’t have the out of pocket funds that are required for these plans, so we know that it’s going to continue to grow. Will it be tweaked to require more reporting and more auditing to be sure that the appropriate drugs are being claimed for these discounts, and that the disproportionate share health care systems are delivering care in the communities? Probably, but I don’t think the 340B program will go away.

SPT: How can NASP create best practices for specialty data elements and formats?

Shanahan: We were really founded on the basis of enhancing best practices. We have a very robust continuing education program designed to certify and expand the number of people who understand specialty pharmacy and who have skills to implement with their patients.

Additionally, this year NASP has developed a specialty pharmacy assessment of patient satisfaction that’s being operated by an independent party, SullivanLuallin Group, and will address unique patient drivers of patient engagement and satisfaction, that will then be able to compare all this against a national standard, and then provide that data to pharma manufacturers and payers. That’s pretty exciting, and we think that we will continue to find additional ways to identify performance metrics so that we can be in a continuous improvement cycle as an industry of specialty pharmacy providers.

SPT: Is it time to create standards under NCPDP?

Shanahan: I am really not adequately familiar with the NCPDP’s proposal of standards of how those apply to specialty, but we do know that NCPDP provides some standardized actions for electronic prior authorization to provide more complete information and cleaner scripts, and we would be all for that kind of a thing. We think that the more transparent the information is, and the more complete the information is between the prescriber and a patient, the more likely it is that we can get that patient on therapy, eliminating unnecessary costs in the health care channel. We want to spend money in health care on delivering patient outcomes, so to the extent that we can streamline processes and eliminate manual or mismatch of automated processes, we are really supportive of that.

SPT: What are your thoughts on the impact of the Trump administration on specialty pharmacy?

Shanahan: I think it’s just way too early to have any assessment of what’s going to happen in the coming 12 months. We at NASP are taking a wait and see attitude. We think that there’s a lot of good things happening with respect to the focus on health care and what is the best way to provide optimal health care for Americans. We’re anxiously awaiting insights that will let us have any opinion at all about that.