Q&A: Gaps in adoption remain 1 year after new pulmonary hypertension guidelines
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Key takeaways:
- There is generally high awareness surrounding the 2022 guidelines for pulmonary hypertension, although some gaps remain in adoption.
- The concept of when patients are “treated” has evolved with this guideline.
Guidelines on diagnosing and treating pulmonary hypertension from the European Society of Cardiology and the European Respiratory Society, released 1 year ago, dictated changes in how clinicians care for these patients.
These changes included an updated definition of pulmonary hypertension (PH) and two major changes to the pulmonary arterial hypertension treatment algorithm.
To learn more about the changes made in the 2022 guidelines, clinician uptake 1 year after the release in the U.S. and considerations for a future guideline, Healio spoke with Sean Studer, MD, MSc, vice president of medical affairs at The Janssen Pharmaceutical Companies of Johnson & Johnson.
Healio: What were the most significant changes made in the 2022 European Society of Cardiology/European Respiratory Society Guideline for diagnosing and treating PH?
Studer: Regarding the diagnosis, the updated cutoff value for the mean pulmonary artery pressure (mPAP) that defines PH has been reduced to greater than 20 mm Hg. This change was based on studies that confirmed a prognostic association with an mPAP greater than 20 mm Hg; however, the implications of this new definition for prescribing therapy for those with mPAP greater than 20 mm Hg, but below the historical defining mPAP cutoff of 25 mm Hg or more, requires further evaluation.
On the treatment side, there is still some coalescence occurring around the way cardiopulmonary comorbidities factored into the guidelines. Many patients do not have “clean” PAH, per se — they may have other health conditions which affect which WHO group they fall into. When the updated algorithm was laid out, it specified that the foundational treatment was dual combination therapy for patients who have PAH unless they have significant cardiopulmonary comorbidities, in which case clinicians should start with monotherapy and reassess patients regularly to potentially escalate to combination therapy. This is controversial because escalating patients to combination therapy in a timely fashion is still challenging. When it is suggested that there is an appropriate group to receive monotherapy — if those patients aren’t reassessed regularly or in a timely fashion — they may remain on monotherapy for longer periods of time, and their prescribers may feel justified in keeping these patients on monotherapy. It’s important that we continue to consider what we think is the right approach for patients with cardiopulmonary comorbidities and whether a general directive of monotherapy is the right first step or whether they should be treated more in line with patients who do not have these comorbidities.
Healio: Could you explain the changes made to the PAH treatment algorithm in the guideline?
Studer: There are two major changes. The first is the way patients with cardiopulmonary comorbidities are treated. It is recommended that these patients are initiated on monotherapy, eventually progressing to combination therapy with frequent follow-ups and reevaluations by their clinicians.
Second, the guidelines now lay out four categories of risk for patients assessed at follow-up — low, low-intermediate, intermediate-high and high — as opposed to the three categories prior to the updates.
Previously, most patients fell into the “intermediate” category, which made it challenging for clinicians to clearly understand how to proceed with treatment. Now, with four categories, there is a greater ability to distinguish exactly where the patient falls, and subsequently determine a treatment plan. In addition, a numeric system was developed to help determine which category patients fall into. With this numeric system, patients are assigned a score for each data point, and based on their total score clinicians can appropriately and confidently categorize them. The goal remains to get patients to the lowest-risk status that is achievable or is reasonable according to the patient goals. There is acknowledgement now that not every patient will be low risk but may still experience improved function — and that is considered success.
Healio: How has rollout and clinician uptake been for these updated guidelines?
Studer: In my experience, rollout has occurred through the usual mechanisms — at academic conferences, in educational sessions and by thought leaders in their institutions. Although clinicians are impressed with the depth, thoroughness and comprehensiveness of the updated guidelines, they may take their own approach to treatment vs. what’s now recommended. The level of awareness is high, but there are gaps in adoption.
Healio: Have there been any observed positive effects of the changes 1 year after the release of this guideline?
Studer: One of the positive effects of these updates is that when new guidance is released, it creates a lot of excitement and discussion around whether we, as a community, are doing everything we can to help patients. Many years ago, this was considered a disease that simply needed to be treated. Clinicians often had an approach that once a patient was prescribed treatment, they were “treated.” Over time, and with these new guidelines, the community has evolved to believe that “treated” really means moving patients into lower-risk categories and considering combination therapy as a means to get them there.
Healio: What are some difficulties/obstacles clinicians face when implementing changes made in the 2022 guideline?
Studer: One obstacle clinicians may face is that they may want to do certain things consistent with the guidelines that payers or insurance companies may not see as imperative based on the guideline data. These are European guidelines used for U.S. implementation, and these two payer markets are very different. Payers tend not to look to ex-U.S. guidelines to make determinations around coverage.
Another challenge is the speed of uptake in general. It can take time for people to internalize and absorb the new guidelines, but even longer for day-to-day patient care systems such as electronic health records to catch up.
Healio: What should be considered in a future guideline?
Studer: The type of practice that an individual expert clinician is in would be an interesting consideration in future guidelines. If a provider is in a small practice, he or she may be able to diagnose and initiate treatment for a patient in a timely manner, which is extremely valuable, but may lack resources or expertise to appropriately escalate patients’ treatment as needed. I think it could be highlighted that the treatment paradigm may need to consider the level of complexity that the practice can manage. Patients might begin treatment at a smaller practice, then move to a more comprehensive care center that has the resources and expertise to operationalize the guidelines.
It would be helpful if specialty societies would take on the challenge of putting together a U.S. interpretation of how the guidelines can best be implemented, because the European payer market is so different that several things that were established in the guidelines don’t necessarily translate well to the U.S. market. We really hope there is a willingness and acceptance not to rebut, refute or recreate the guidelines, but to try to translate it into a way clinicians could best integrate such significant, valuable guidelines into a U.S. patient and payer health system.