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Pulmonary arterial hypertension (PAH) Clinical criteria: Treatment Phase: Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent, AND Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH, AND The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH. Treatment criteria: Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). (1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition: (a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or (b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function. (2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted: - RHC composite assessment; and - ECHO composite assessment; and - 6 Minute Walk Test (6MWT) Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is: - RHC plus ECHO composite assessments; - RHC composite assessment plus 6MWT; - RHC composite assessment only. In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is: - ECHO composite assessment plus 6MWT; - ECHO composite assessment only. (3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s: (i) for why fewer than 3 tests are able to be performed on clinical grounds; (ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records. (4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
“Tadalafil is a reversible inhibitor of cyclic guanosine monophosphate (cGMP) – specific phosphodiesterase type 5 (PDE5) in the smooth muscle of the corpus cavernosum, the prostate, the bladder and their vascular supply.”
“The mean oral clearance for tadalafil is 2.5 L/hr and the mean half-life is 17.5 hours in healthy subjects.”
Working under the parallel aged-care framework? Aged-care equivalent →
Erectile dysfunction Clinical criteria: The condition must be vasculogenic; OR The condition must be psychogenic; OR The condition must be neurogenic, AND Patient must have a specific accepted war-caused or service-related disability. Population criteria: Patient must be male. Authorisation will not be given for any additional prescriptions within 6 months or for any increased quantities or repeats.
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolised by CYP450 isoforms. Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6 and CYP2E1.”