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Riociguat, sold under the brand name Adempas, is a medication by Bayer that is a stimulator of soluble guanylyl cyclase (sGC). It is used to treat two forms of pulmonary hypertension (PH): chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH). Riociguat constitutes the first drug of the class of sGC stimulators. The drug has a half-life of 12 hours and will decrease dyspnea associated with pulmonary arterial hypertension.
Read the full article on WikipediaChronic thromboembolic pulmonary hypertension (CTEPH) Clinical criteria: Treatment Phase: Initial treatment Patient must have WHO Functional Class II, III or IV CTEPH, AND The condition must be inoperable by pulmonary endarterectomy; OR The condition must be recurrent or persistent following pulmonary endarterectomy, AND The treatment must be the sole PBS-subsidised therapy for this condition. Treatment criteria: Must be treated in a centre with expertise in the management of CTEPH. Population criteria: Patient must be at least 18 years of age. CTEPH that is inoperable by pulmonary endarterectomy is defined as follows: (a) Right heart catheterisation (RHC) demonstrating pulmonary vascular resistance (PVR) of greater than 300 dyn*sec*cm-5 measured at least 90 days after start of full anticoagulation; and (b) A mean pulmonary artery pressure (PAPmean) of greater than 25 mmHg at least 90 days after start of full anticoagulation. CTEPH that is recurrent or persistent subsequent to pulmonary endarterectomy is defined as follows: RHC demonstrating a PVR of greater than 300 dyn*sec*cm-5 measured at least 180 days following pulmonary endarterectomy. Where a RHC cannot be performed due to right ventricular dysfunction, an echocardiogram demonstrating the dysfunction must be documented in the patient's medical records. 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). The following must be provided at the time of application and documented in the patient's medical records: (a) the results from the 3 tests below, to establish baseline measurements, where available: (i) RHC composite assessment, and (ii) ECHO composite assessment, and (iii) 6 Minute Walk Test (6MWT); and (b) confirmation of evidence of inoperable CTEPH including the pulmonary vascular resistance (PVR) value, a mean pulmonary artery pressure (PAPmean) and the starting date of full anticoagulation; or (c) confirmation of evidence of recurrent or persistent CTEPH including the PVR value and the date that pulmonary endarterectomy was performed; or (d) confirmation of an echocardiogram demonstrating right ventricular dysfunction. Where it is not possible to perform all 3 tests above on clinical grounds, the expected test combination, in descending order of preference is: (1) RHC plus ECHO composite assessments; (2) RHC composite assessment plus 6MWT; (3) RHC composite assessment only. In circumstance where a RHC cannot be performed on clinical grounds, the expected test combinations, in descending order of preference is: (1) ECHO composite assessment plus 6MWT; (2) ECHO composite assessment only. Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be documented in the patient's medical records. The test results provided must not be more than 2 months old at the time of application. Prescriptions for dose titration must provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions. Approvals for subsequent authority prescription will be limited to 1 month of treatment, The quantity approved must be based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 3 repeats. The assessment of the patient's response to the initial 20-week course of treatment should be made following the preceding 16 weeks of treatment, in order to allow sufficient time for a response to be demonstrated. Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
Pulmonary arterial hypertension (PAH) Clinical criteria: Treatment Phase: Initial 1 (new patients) Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent, AND Patient must have been assessed by a physician with expertise in the management of PAH, AND Patient must have WHO Functional Class III PAH or WHO Functional Class IV PAH, AND The treatment must be the sole PBS-subsidised PAH agent for this condition. A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat. 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 the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current. (5) 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. The test results must not be more than 6 months old at the time of application. Approvals for prescriptions for dose titration will provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions. Approvals for subsequent authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.
“12 h (patients); 7 h (healthy people)”
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