As information changes about COVID-19, the Pulmonary Hypertension Association (PHA) continues to address concerns from the pulmonary hypertension (PH) community. While there are many unknowns in this changing environment, here is what PHA has learned this week about treatment availability, supplies, oxygen delivery and lab tests.
PH-Specific Therapy Manufacture and Delivery
Members of PHA’s Corporate Committee — including Actelion, Bayer, Gilead and United Therapeutics — say they don’t anticipate pharmaceutical supply disruptions. Specialty pharmacy members also say they don’t expect access to generic therapy to be disrupted. They say they have strategies to provide a seamless patient experience if a generic manufacturer experiences a disruption.
Some PH community members are concerned about developing COVID-19 from contaminated mail or packages. The Centers for Disease Control and Prevention (CDC) reports no evidence of the virus transmitted by mail in its COVID-19 FAQ. However, CDC recommends common safety precautions such as frequent hand washing to reduce infection risk.
Lab Test Requirements for REMS Products
The Food and Drug Administration (FDA) has advised health care providers to use their best medical judgment for people who need Risk Evaluation and Mitigation Strategy (REMS) testing, such as pregnancy and liver function tests. That means weighing the risks of completing tests against the risks of continuing treatment without those tests.
If women enrolled in the Ambrisentan REMS Consortium can’t undergo monthly pregnancy tests because of COVID-19, their prescribing physicians can authorize their pharmacies to ship the drug without a pregnancy test, according to Ambrisentan REMS Consortium guidance for physicians and pharmacists. The Ambrisentan REMS Consortium includes brand Letairis and generic ambrisentan manufacturers.
Bayer, which manufactures Adempas (riociguat), has advised specialty pharmacies to reach out prescribing physicians for an override if a patient has difficulty completing a pregnancy test.
Patients subject to other REMS requirements should speak with their PH medical teams about the best way to maintain uninterrupted access to their REMS therapy while limiting their risk exposure.
PHA urges people with PH, health care providers and oxygen suppliers to use new Centers for Medicare and Medicaid Services (CMS) guidelines during the COVID-19 pandemic. The latest rules, issued March 30, waive in-person testing and signature requirements for supplemental oxygen deliveries. According to CMS, the in-person testing and signature requirement waivers will remain effective throughout the COVID-19 public health emergency.
Questions? Contact PHA’s Treatment Access Program or call 301-565-3004 x749.