The Pulmonary Hypertension Association recently asked the Institute for Clinical and Economic Review (ICER) to modify its draft document about sotatercept for pulmonary arterial hypertension (PAH). PHA seeks changes to language about the diagnosis process, medication side effects and the importance of supplemental oxygen access.

ICER is a private, non-governmental organization that publishes cost-analysis reports on emerging “health technologies.” Each year, ICER reviews select new therapies, such as prescription drugs, and issues recommendations about their value compared to existing treatments and how they should be priced.

Prescription drug manufacturers can use ICER’s recommendations to guide pricing. Health insurance companies can use the recommendations to determine how much to reimburse patients for treatments and how they distribute costs between the company and the patient.

This year, ICER is reviewing sotatercept, a potential new therapy for PAH pending Food and Drug Administration approval.

The ICER review process includes multiple steps and will continue through December. In the first step, ICER spoke with PHA, including patients and health care professionals, to learn about the challenges of living with PAH and pros and cons of available treatments.

Based on those conversations, ICER released “Sotatercept for Pulmonary Arterial Hypertension: Draft Background and Scope,” then PHA commented on the draft. Over the next few months, ICER will finalize its proposal, conduct focus groups with PAH patients and PH experts recommended by PHA. In September, ICER will release a draft report and accept public comments through Oct. 23.

PHA plans to review and comment again at that time. PHA is engaging with ICER to improve its reviewers’ understanding of the experiences of people with PAH and the value of expert medical care. Our engagement doesn’t endorse results of their study.

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