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Considerations for Optimal Management of Patients With Pulmonary Arterial Hypertension: A Multi-Stakeholder Roundtable Discussion
Sean M. Studer, MD, MSc; Martha Kingman, FNP-C; DNP; Luis Calo, MD, MMM, FAAFP; H. Eric Cannon, PharmD, FAMCP; Jeffrey D. Dunn, PharmD, MBA; Thomas James III, MD; Sonya J. Lewis, PharmD, MBA; Robert J

Considerations for Optimal Management of Patients With Pulmonary Arterial Hypertension: A Multi-Stakeholder Roundtable Discussion

Sean M. Studer, MD, MSc; Martha Kingman, FNP-C; DNP; Luis Calo, MD, MMM, FAAFP; H. Eric Cannon, PharmD, FAMCP; Jeffrey D. Dunn, PharmD, MBA; Thomas James III, MD; Sonya J. Lewis, PharmD, MBA; Robert J
Stakeholders, including national and regional managed care decision makers and providers, met to discuss the clinical background, health economics, and management strategies for pulmonary arterial hypertension (PAH) at a roundtable meeting on December 10, 2016, in Dallas, Texas.
Dr Kingman agreed on the importance of a right heart catheterization to make the correct diagnosis. “All of us who are specialists in PAH have often had a patient referred who is a group II patient with heart failure, because that’s much more common than PAH. I know the insurance company is acting appropriately when the outside physician has tried to get a PAH drug and the insurance company has denied it because there wasn’t a right heart catheterization,” she said.

Dr Studer advised insurers, “Use the evidence base, make sure you have the right diagnosis upfront, and then make the centers prove that they need additional therapy [for PAH patients]. If [the patients are] on 2 [drugs] and they want to go to the third, you say, ‘Show me the data.’ Show me you went through a methodical process. Prove it to me—evidence, diagnosis, guideline recommendations, and prove to me that you need more.”

PAH Management Strategies

Stakeholders at the roundtable noted how they have seen the profile of PAH change over the years. One remembered that when he first joined his health plan about a decade ago, “There was a lot of discussion around PAH and what are the appropriate criteria for the health plan to have. Every single request for PAH drugs went up to medical directors, some of whom were cardiologists. And then about 5 or 6 years ago we lessened some step criteria and adjusted criteria. We have criteria that you need a right heart catheterization, but the in-depth PA review by a physician is no longer needed with more straightforward PA criteria.”

Looking back 10 years, Dr Dunn remembered PAH as involving high-profile PAs that would be denied and then go through appeals. He has since seen an evolution in awareness and diagnosis: “It seemed to be a lot noisier 8 to 10 years ago,” he said.

Other specialty categories have become far costlier today, said Dr Cannon; PAH is no longer in the forefront. However, he said, it’s important to establish appropriate criteria for PAH treatment: “Let’s collaborate, and let’s make sure that if we get a request, more importantly than approving it or denying it, we’re funneling that person over to care management so that we can make sure that we’ve got enhanced coordination of care [through case managers with the health plan or specialty pharmacy].”

Dr Lewis noted another factor that has changed. “The emphasis on contracting in PAH has decreased with patent expirations and because we have more transparent partnerships with our physicians, ACOs, centers of excellence, and medical homes,” she said. “PAH is not in our top 10 [in amount of expense as a specialty drug spend category]. And I think that’s because we have more outcomes reimbursements with physicians.”

The future of treatment for PAH could become more complicated now that PAH has gone in the direction of multiple combination therapy, similar to cancer in its multiple-drug scenario. “I think we’re going to be in a triple drug regimen,” said Dr Studer, “because what disease do we really know of where there are multiple pathways known? There’s been varying evidence that treating all those pathways helps, and treating it in various circumstances and combination helps, and yet we don’t utilize all 3 pathways. If we had a cancer cocktail and we said, ‘Well, the 4-drug regimen works well, but let’s give you just 1 drug and see if the cancer gets worse,’ everyone would recoil immediately from that.”

Expert Commentary:

Identifying Criteria for a Center of Excellence


Dr Studer described how centers of excellence in PAH are formed. “It’s become an organized process through the Pulmonary Hypertension Association,” he said, which is modeled somewhat on the Cystic Fibrosis Foundation; the 2 associations discussed how the system should work, he said. “There will be a 2-tier system that persists for a while, the comprehensive center—trials, multiple specialists—and then a community-type regional care center that doesn’t necessarily have trials.” The association will make site visits, where, he said, “they look at your records—you can’t be treating in a way that’s totally inconsistent. You need to go through a careful diagnostic process. You have to evidence-base your treatment—there needs to be documentation to your follow-ups.”

“We want to partner with payers to get the center of excellence process to work well,” Dr Studer said. “Even if you’re not using the centers of excellence, you can still use centers of excellence criteria for treatment. If patients aren’t near a geographic center of excellence, there could be a telemedicine consult, and patients need to have a right heart catheterization and then go through the process.”

Dr Kingman noted that the Pulmonary Hypertension Association, just in the last few years, has created the centers of excellence at 2 levels. The PAH center in which she practices is characterized as a comprehensive care center, where—as opposed to the regional care centers—patients are on all therapies and research is done. “We, as the comprehensive care center, are working with the regional center to partner with them and assist them in appropriately treating these patients,” she said. “It’s not telemedicine, but I like that idea” for patients with travel constraints.

 


Right Patient, Right Drug, Right Time

“One of the views of the ‘wrong treatment’ right now is not treating early: Doing nothing does have a cost upfront,” said Dr Studer. Going back to the meta-analysis, he said, “In trials where you had treatment versus no treatment, there was separation in function.” When the untreated group was started on therapy, they might improve somewhat, “but they never made it to the functioning of the people who had even a 12- to 16-week lead time.”26

Misdiagnosis is another problem. Dr Kingman explained, “Patients may come to us on a drug or 2 drugs, but they haven’t had a right heart catheterization. So we stop their drugs and do the catheterization, and we may find that they never had PAH in the first place.” “Wrong therapy is wrong diagnosis,” agreed Dr Studer. “We don’t want people who don’t have this disease to be treated with expensive drugs. It’s wrong economically, and it’s very wrong, obviously, for the patients.”

Dr Kingman said, “I would question why patients are on PAH drugs if they haven’t had a right heart catheterization, because a lot of them are going to end up not having PAH.” Added Dr Studer, “I would be very worried about a patient who went on a PAH drug for a short period—2 or 3 months as a ‘therapeutic trial’; that’s not always long enough to realize you’re doing worse on it.”

“That’s where the expenses start mounting up,” said Dr James. “If we only look at the drug costs for a true diagnosis, that’s one thing. But mislabeling, mistreating: We have to get that out of medicine.”

Roundtable Commentary:

Coordination of Care Management


Dr Dunn suggested looking further into coordination of care management: “How the payers work with the provider to care-manage the patient, because there is so much hospitalization [of patients with PAH], transitions of care, and rehospitalization.”

Dr James said, “What I learned with hepatitis C was that it’s a big drug cost, but you’ve got to make sure the person takes it; otherwise they may have relapses. I have to make sure that when a patient is on an expensive drug, we have someone following along and making sure there’s compliance.”

But Dr Kingman and Dr Studer both said they don’t have much contact with case managers. Said Dr Kingman, “Case managers are not interacting with us, but who we do interact with on a regular, daily basis are the specialty pharmacy nurses.”

Dr Lewis added, “Because we own our specialty pharmacy, it’s internal to us, so if you are interacting with a specialty pharmacy, that information is getting to our case managers.”

“That’s the issue,” said Dr Dunn. “Is there appropriate care management, and who is doing it?” You don’t want to have everyone talking to the patient but not in coordination, because “that’s probably compromising the quality of care, and probably irritating the patient.” He said his company has robust clinical programs consisting of lab data, hospitalization data, and pharmacy data, so they know what patients are doing: “We know if they’re refilling their meds, we know what other conditions they have, we know when they’re in the hospital.” Coordinating this type of information through a case manager could be helpful to the patient.


How Can Management of PAH Be Improved?

Dr Lewis asked, “How do we look for PAH in a way that makes sense, how can we address it in a more effective way, and how can we look for patients who could be more at risk so that we could possibly treat them earlier? If you believe the premise of treating them earlier, I still would feel that, from a management perspective, we might need more data about what’s going to save us money long-term. Keeping patients from transitioning from an FC III to a IV would be very vital to a health plan, but do we put our resources into trying to catch it earlier and trying to find those PAH patients earlier?”

 “There are screening guidelines for patients in high-risk groups,” said Dr Kingman. If PAH patients “were diagnosed sooner, theoretically they would do better and be stable for much longer, out of the hospital, and saving money.”

“We are in the business of looking for methods and ways to risk stratify in certain disease states,” Dr Lewis said. “We will send someone out to a patient’s home to get a lab value, and we will send nurses out to see what’s going on at the home so that we can keep the readmission rates lower in certain disease categories.” Dr Kingman said, “If the insurance industry can direct patients to the comprehensive care centers, or at least to a regional care center, then you’ll have a really high likelihood that you’ve got the right diagnosis. More and more centers are being accredited. Sometimes the center just does the workup and the evaluation, gets the diagnosis, and then coordinates with the local doctor so care can stay managed largely on the local level.”

Dr Studer agreed on the importance of collaboration with a center, “not completely divorcing from your local care community; that [lack of collaboration] doesn’t work. But there’s got to be the collaboration, which could be a diagnosis, or it could be at other varying points when things get more complicated.”

“We know that these drugs are all really expensive, and when you start adding 1, 2, and 3, it gets very expensive,” said Dr Kingman. “As another example, there’s a prostacyclin (treprostinil), now in oral formulation, that some centers use. we  have chosen not to use oral treprostinil as we feel the clinical trial data does not support the cost of the medication.”

Takeaway Comments

 
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