Pulmonary arterial hypertension (PAH) Program in Pharmaceutical Benefits Schedule (PBS) 012-18051131

PAH restriction and item codes

Do not share this attachment externally. See Freedom of Information - Information Publication Scheme.

$\\INTERNAL.DEPT.LOCAL\Shared\NAT\SERDELEXCEL\WORKPRODIMP\Operation Blueprint Migration\RDT Release Icons\32w\icon-hidden-attachment.png$ PBS PAH restriction and item codes

Contact details

PBS Complex Drugs Programs

Forms

Pulmonary arterial hypertension - initial monotherapy authority application (PB070)

Pulmonary arterial hypertension - initial dual or triple therapy authority application (PB303)

Services Australia website

Pulmonary hypertension - arterial

External website

PBS schedule for pulmonary arterial hypertension

FAQs from Service Officers

Table 1: see Table 2 in Processing Complex Authority Required Listings for FAQs about all Complex programs.

Item	Description
1	Does a PBS application form have to be completed for initial PBS treatment? No, a PBS application form is not required if prescribers obtain the initial approval using the online PBS authority system. Alternatively, prescribers can complete the PBS application form and submit it via mail or HPOS.
2	Is a PBS application form required to switch from PBS monotherapy to dual therapy? No, once a patient has been approved for PBS monotherapy, a change to dual therapy can be requested over telephone or by prescribers using the online PBS authority system under the initial 2 restriction code for both agents.
3	Is a PBS application form required to switch from PBS dual therapy to triple therapy (without selexipag)? No, once a patient has been approved for PBS monotherapy, a change to dual therapy can be requested over telephone or by prescribers using the online PBS authority system under the initial 2 restriction code for both agents.
4	Is a PBS application form required to switch from PBS dual/triple therapy to triple therapy (with selexipag)? No, once a patient has been approved for PBS dual or triple therapy (without selexipag), a change to triple therapy (with selexipag) can be requested over telephone or by prescribers using the online PBS authority system.
5	Can triple therapy with selexipag be the patient’s first PBS approval? No, patients must have failed dual therapy to meet the PBS restriction requirements for selexipag.
6	What does WHO stand for? WHO is the World Health Organisation - a specialised agency of the United Nations responsible for global public health.
7	Can selexipag be approved as dual therapy? If patients are unable to tolerate either the ERA or PDE-5i, selexipag can be approved as dual therapy. However, its triple therapy item and restriction codes must still be used.
8	Can a patient have multiple selexipag initial (titration) approvals? Yes, the intention is that titration is completed within 12 weeks. However, depending on the patient’s dose, multiple titration prescriptions can be requested but only for the 200mcg (140 pack) and the 800mcg strengths.
9	Once a patient has completed titration with selexipag, is the next approval continuing treatment? No, once a titration is completed the first PBS approval must be under ‘initial - following dose titration’. The next PBS approval after this will be continuing.
10	Is the listing of macitentan 10mg + tadalafil 40mg (hereafter referred to as MAC+TAD) fixed dose combination (FDC) PBS-subsidised for the initial treatment of PAH? No, this is not listed for the use as initial therapy. This FDC is for the continuing treatment of PAH in patients stable on separate doses of macitentan 10mg and tadalafil 40mg (2 x 20mg) as dual therapy or part of the triple therapy.
11	Is MAC+TAD FDC bioequivalent to treatment with the individual medicines (one macitentan 10mg and two 20mg tadalafil)? Yes, one tablet of MAC+TAD FDC 10mg/40 mg daily will be equivalent to one macitentan 10mg tablet with two 20mg (40 mg) tadalafil tablets daily.