Updates on Opsumit and Adempas; New Treatments for PAH

Update on PAH TreatmentsIn October 2013 the FDA approved Opsumit (Macitnentan) and Adempas (Riociguat) to treat pulmonary arterial hypertension.  Adempas was the first medication approved to treat two kinds of pulmonary hypertension.  It can be used to treat pulmonary arterial hypertension as well as chronic thromboembolic pulmonary hypertension.

Updates on Adempas used to treat PAH and CTEPH

Adempas is now available commercially.  It comes in 0.5mg, 1mg, 1.5mg, and 2.5 mg tablets and is only available through a small group of specialty pharmacies at this time.  Because Adempas has a risk of teratogenicity it is only available through the Adempas REMS (risk evaluation and mitigation strategy) program.  Prescribers must be enrolled in the program and female patients have requirements they must meet prior to receiving the therapy.  All patients will be required to review and sign the Adempas enrollment form.  The form outlines which females are considered to be of child bearing potential and which females are not considered of child bearing potential.  It also describes the requirement for female patients of child bearing potential to be on two reliable forms of birth control.  Female patients of child bearing potential are also required to have a negative pregnancy test prior to starting therapy and monthly while on therapy.

Adempas is started at a small dose and gradually titrated up.  This medication requires nurses from the specialty pharmacy providing the medication have multiple visits.  The first shipment of the medication may come before you have set up a nursing visit.  DO NOT START THE MEDICATION UNTIL A NURSE FROM YOUR SPECIALTY PHARMACY HAS INSTRUCTED YOU TO DO SO.

Adempas Assistance Programs

The AIM Patient Support Program is the manufacturers assistance program for Adempas.  This program provides copay assistance for patients with commercial and private insurance.  The TPAP (temporary patient assistance program) is available for patients with a gap in insurance or for patients who may be waiting for their insurance policy to kick in.  The PAP (patient assistance program) is available for uninsured or underinsured patients.  Unfortunately these assistance programs are not available for medicare patients.   The program also provides lab coordination services to help female patients of child bearing potential meet their monthly pregnancy test requirements.  For more information or to enroll in an assistance program patients may call 1-855-4ADEMPAS (1-855-423-3672).

If the AIM program cannot provide the assistance a patient needs Caring Voice Coalition may be able to help.

Updates on Opsumit used to treat PAH

Opsumit is also available commercially.  It comes in a 10mg tablet and is available through a select group of specialty pharmacies.  Because Opsumit has a risk of teratogenicity it is only available through the Opsumit REMS (risk evaluation and mitigation strategy) program.  Prescribers will have to be enrolled in the program and female patients will have a few extra steps they must take prior to receiving the therapy.  All patients will be required to review and sign the Opsumit enrollment form.  The form outlines which females are considered to be of child bearing potential and which females are not considered of child bearing potential.  It also describes the requirement for female patients of child bearing potential to be on two reliable forms of birth control.  Female patients of child bearing potential are also required to have a negative pregnancy test prior to starting therapy and monthly while on therapy.

Opsumit Assistance Program

Actelion manufactures Opsumit and offers assistance through their Actelion Pathways program.  Patients may contact Actelion at 1-866-228-3546 to find out if they qualify for assistance.  If a patient does not qualify for assistance through Actelion Pathways the Caring Voice Coalition may be able to help.

You can read more about Adempas and Opsumit under our therapies section and also in our October 2013 blog about their approval.

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