PH and PAH: Defining Barriers and Gaps in Care

Key opinion leaders consider what the greatest barriers to and gaps in care are for patients with PH or PAH.

Transcript

Derek van Amerongen, MD, MS, FACOG: In terms of authorization of drugs, there’s no difference in terms of the prior-authorization process regarding route of administration or frequency of administration. We realize that as treatment paradigms have evolved over the last few years, they’ve become very complex. You’ll see patients start on an oral therapy, move to an IV [intravenous] therapy, and then use a subQ [subcutaneous] therapy and an oral therapy. We have to be prepared to view the holistic treatment approach to the patient and not get bogged down in, “This is a medical benefit, this is a pharmacy benefit, this is IV, this is self-administered.” One of the advantages we have at Humana is that we’ve always owned our own PBM [pharmacy benefits manager], so we’ve had the ability to have that visibility over both medical and pharmacy benefits.

Ultimately, we also need to put ourselves in the shoes of the clinician. Physicians typically say a drug is a drug and some are IV, some are subQ, and some are PO [oral administration]. Some of the artificial differentiation you see in terms of medical and pharmacy benefit is not going to be helpful to the clinician in terms of making his or her decision. At Humana Inc, our medical policies obviously reflect whether a drug is self-administered or administered by a health care professional. But the process of developing that prior authorization based on the evidence-based literature, the FDA label, and the current standard of care is going to be the same regardless of the mode of administration, the route, the dosing, or any of those secondary elements.

Charles D. Burger, MD: Patients with pulmonary hypertension [PH] are often challenged on multiple fronts. First, they’re receiving a diagnosis that can be life-threatening. The psychological impact of that is quite significant to them and their loved ones. If you evaluate that objectively, it’s quite prevalent. Patients in pulmonary hypertension struggle on that front. Secondly, if they’re on medication for the pulmonary hypertension, all these medications have something in the way of adverse effects. These can be very mild in certain circumstances or easily controlled with certain strategies, but they can be quite significant and affect quality of life in and of themselves, regarding the burden of therapy with adverse effects.

The second category of burden of therapy is expense. Health care is expensive, and at a high level; the United States approaches $4 trillion annually in health care costs. Prescription medications are in the $400 billion range. Specialty medications such as those for cancer or pulmonary hypertension are an ever-increasing percentage of that prescription medication. Pulmonary hypertension medications are often expensive. Almost all of them require a prior authorization through their insurance companies. There are even issues with approval through the insurance company. The co-pays may be significant.

We’ve done some recent survey data with our patients and at the Pulmonary Hypertension Association International Conference and Scientific Sessions, showing that the reality of the burden of getting these medications paid for and strategies that patients might employ to try to mitigate that expense are significant burdens in and of themselves. They may ask for assistance programs from the pharmaceutical companies, which might be available. They may apply for assistance programs through the Pulmonary Hypertension Association, which might be available. Some patients have skipped doses of medications to try to make them last longer, which of course is far from ideal when you’re treating a life-threatening illness. This can be quite challenging to the patient.

The last thing I would say is that we know patients with pulmonary hypertension are often deconditioned. They’ve had shortness of breath and limitation of their activity. It’s easy for them to lose muscle tone, to lose conditioning. Formal exercise programs—for example, pulmonary rehabilitation—can help the patient gain some functional status, some conditioning. They’re able to do more. It doesn’t change the pulmonary hypertension per se, but it allows them to acclimate to, accommodate, and compensate for the limitation they have with the pulmonary hypertension through improved conditioning with these formal exercise or reconditioning or rehabilitation programs. Pulmonary hypertension is not 1 of the classic indications for this intervention. Usually, that’s been utilized after major heart or lung surgery or if you have congestive heart failure or COPD [chronic obstructive pulmonary disease]. Access to care can be a challenge for what we know is an effective therapy for these patients. That’s often a back and forth.

Hilary M. DuBrock, MD: There are several important gaps in care for patients with PH and PAH. First, we need to focus more on improving a patient’s overall quality of life and how they feel related to their pulmonary hypertension, as opposed to specific end points like hemodynamics. Additionally, as we’re getting into this era of a more-is-better approach to treating pulmonary hypertension, we need to focus on how we can improve a patient’s burden of taking multiple medications and dealing with multiple adverse effects as we treat the person as a whole rather than just the pulmonary hypertension itself.

A more personalized approach to treating pulmonary arterial hypertension [PAH] starts with a better understanding of how different subtypes respond to different treatments and different treatment approaches, with medications such as immunomodulators and different classes of PAH therapies. Lastly, a significant gap in care for patients with pulmonary arterial hypertension remains the cost and access to medical therapy. If a medication is effective, but a patient cannot afford it because of the out-of-pocket cost, then it will not work for that individual patient.