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"prescribing_txt_id": 8211, "prescribing_txt": { "prescribing_type": "CAUTION", "prescribing_txt": "The risk of drug dependence is high.", "complex_authority_rqrd_ind": "N", "assessment_type_code": null, "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_txt_id": 25574, "prescribing_txt": { "prescribing_type": "ADMINISTRATIVE_ADVICE", "prescribing_txt": "Real time online applications for increased maximum quantities/repeats may be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/organisations/health-professionals/services/medicare/hpos/services/request-authority-using-online-pbs-authorities-hpos). Phone applications for increased maximum quantities/repeats may be made by calling 1800 888 333. Written authority applications for increased maximum quantities/repeats can be uploaded online through HPOS form upload or mailed to: Pharmaceutical Benefits Scheme Reply Paid 9857 [Your capital city]", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ], "item_restrictions": [ { "res_code": "10764_10764_R", "restriction_indicator": "Y", "restriction_text": { "res_code": "10764_10764_R", "treatment_phase": "Continuing PBS treatment after 1 June 2020", "authority_method": "RESTRICTED", "treatment_of_code": 10764, "restriction_number": 10764, "note_indicator": "N", "caution_indicator": "N", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "criteria_relationship": "ALL", "variation_rule_applied": "Y", "first_listing_date": "2020-10-01" }, "restriction_prescribing_texts": [ { "prescribing_text_id": 7861, "pt_position": 1, "prescribing_text": { "prescribing_type": "INDICATION", "prescribing_txt": "Severe pain", "complex_authority_rqrd_ind": "N", "assessment_type_code": null, "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": { "condition": "pain", "episodicity": null, "severity": "Severe" } } }, { "prescribing_text_id": 26382, "pt_position": 2, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Clinical criteria: Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "CLINICAL", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 26381, "pt_position": 1, "parameter": { "parameter_type": "CLINICAL_PATIENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 26401, "pt_position": 3, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "Authorities for increased maximum quantities and/or repeats must only be considered where the patient has received initial authority approval for: (i) severe disabling pain associated with malignant neoplasia; or (ii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months; or (iii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or (iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or (v) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "Y", "apply_to_increase_nr_flag": "Y", "criteria": null, "indication": null } }, { "prescribing_text_id": 26384, "pt_position": 4, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 26378, "pt_position": 5, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia. Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "Y", "apply_to_increase_nr_flag": "Y", "criteria": null, "indication": null } } ] }, { "res_code": "10769_10765_R", "restriction_indicator": "Y", "restriction_text": { "res_code": "10769_10765_R", "treatment_phase": "Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months", "authority_method": "RESTRICTED", "treatment_of_code": 10765, "restriction_number": 10769, "note_indicator": "N", "caution_indicator": "N", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "criteria_relationship": "ALL", "variation_rule_applied": "Y", "first_listing_date": "2020-10-01" }, "restriction_prescribing_texts": [ { "prescribing_text_id": 7861, "pt_position": 1, "prescribing_text": { "prescribing_type": "INDICATION", "prescribing_txt": "Severe pain", "complex_authority_rqrd_ind": "N", "assessment_type_code": null, "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": { "condition": "pain", "episodicity": null, "severity": "Severe" } } }, { "prescribing_text_id": 26414, "pt_position": 2, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Clinical criteria: Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; OR Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; OR The treatment must be part of pre-operative care; OR The treatment must be used as an analgesic adjunct in general anaesthesia", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "CLINICAL", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 26391, "pt_position": 1, "parameter": { "parameter_type": "CLINICAL_PATIENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "parameter_prescribing_txt_id": 26392, "pt_position": 2, "parameter": { "parameter_type": "CLINICAL_PATIENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "parameter_prescribing_txt_id": 25632, "pt_position": 3, "parameter": { "parameter_type": "CLINICAL_TREATMENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "The treatment must be part of pre-operative care", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "parameter_prescribing_txt_id": 25633, "pt_position": 4, "parameter": { "parameter_type": "CLINICAL_TREATMENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "The treatment must be used as an analgesic adjunct in general anaesthesia", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 26399, "pt_position": 3, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "Y", "apply_to_increase_nr_flag": "Y", "criteria": null, "indication": null } }, { "prescribing_text_id": 26378, "pt_position": 4, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia. Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "Y", "apply_to_increase_nr_flag": "Y", "criteria": null, "indication": null } } ] }, { "res_code": "10816_10762_R", "restriction_indicator": "Y", "restriction_text": { "res_code": "10816_10762_R", "treatment_phase": "Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months", "authority_method": "RESTRICTED", "treatment_of_code": 10762, "restriction_number": 10816, "note_indicator": "N", "caution_indicator": "N", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "criteria_relationship": "ALL", "variation_rule_applied": "Y", "first_listing_date": "2020-10-01" }, "restriction_prescribing_texts": [ { "prescribing_text_id": 7861, "pt_position": 1, "prescribing_text": { "prescribing_type": "INDICATION", "prescribing_txt": "Severe pain", "complex_authority_rqrd_ind": "N", "assessment_type_code": null, "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": { "condition": "pain", "episodicity": null, "severity": "Severe" } } }, { "prescribing_text_id": 26414, "pt_position": 2, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Clinical criteria: Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; OR Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; OR The treatment must be part of pre-operative care; OR The treatment must be used as an analgesic adjunct in general anaesthesia", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "CLINICAL", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 26391, "pt_position": 1, "parameter": { "parameter_type": "CLINICAL_PATIENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "parameter_prescribing_txt_id": 26392, "pt_position": 2, "parameter": { "parameter_type": "CLINICAL_PATIENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "parameter_prescribing_txt_id": 25632, "pt_position": 3, "parameter": { "parameter_type": "CLINICAL_TREATMENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "The treatment must be part of pre-operative care", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "parameter_prescribing_txt_id": 25633, "pt_position": 4, "parameter": { "parameter_type": "CLINICAL_TREATMENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "The treatment must be used as an analgesic adjunct in general anaesthesia", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 26400, "pt_position": 3, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "Authorities for increased maximum quantities and/or repeats must only be considered for: (i) severe disabling pain associated with proven malignant neoplasia; or (ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or (iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or (iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "Y", "apply_to_increase_nr_flag": "Y", "criteria": null, "indication": null } }, { "prescribing_text_id": 26384, "pt_position": 4, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 26378, "pt_position": 5, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia. Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "Y", "apply_to_increase_nr_flag": "Y", "criteria": null, "indication": null } } ] }, { "res_code": "8211_C", "restriction_indicator": "N", "restriction_text": { "res_code": "8211_C", "treatment_phase": null, "authority_method": null, "treatment_of_code": null, "restriction_number": null, "note_indicator": "N", "caution_indicator": "Y", "complex_authority_rqrd_ind": "N", "assessment_type_code": null, "criteria_relationship": null, "variation_rule_applied": "N", "first_listing_date": "2013-02-03" }, "restriction_prescribing_texts": null }, { "res_code": "25598_N", "restriction_indicator": "N", "restriction_text": { "res_code": "25598_N", "treatment_phase": null, "authority_method": null, "treatment_of_code": null, "restriction_number": null, "note_indicator": "Y", "caution_indicator": "N", "complex_authority_rqrd_ind": "N", "assessment_type_code": null, "criteria_relationship": null, "variation_rule_applied": "N", "first_listing_date": "2020-06-01" }, "restriction_prescribing_texts": null }, { "res_code": "25574_N", "restriction_indicator": "N", "restriction_text": { "res_code": "25574_N", "treatment_phase": null, "authority_method": null, "treatment_of_code": null, "restriction_number": null, "note_indicator": "Y", "caution_indicator": "N", "complex_authority_rqrd_ind": "N", "assessment_type_code": null, "criteria_relationship": null, "variation_rule_applied": "N", "first_listing_date": "2020-06-01" }, "restriction_prescribing_texts": null } ], "item_atcs": [ { "atc_priority_pct": 100, "atc": { "atc_code": "N02AA01", "atc_description": "morphine", "atc_level": 5, "atc_parent": { "atc_code": 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null, "prescribers": [ { "prescriber_code": "N", "prescriber_type": "Nurse Practitioners" }, { "prescriber_code": "M", "prescriber_type": "Medical Practitioners" } ], "organisation": { "name": "Medsurge Healthcare Pty Ltd", "abn": "92 124 728 892", "street_address": "Unit 2, 6-7 Gilda Court", "city": "Mulgrave", "state": "VIC", "postcode": "3170", "telephone_number": "+1 (300)788 261", "facsimile_number": null }, "item_organisations": null }, { "li_item_id": "10976Q_14274_31882_31905_31909", "drug_name": "riociguat", "li_drug_name": "Riociguat", "li_form": "Tablet 1 mg", "schedule_form": "riociguat 1 mg tablet, 42", "brand_name": "Adempas", "program_code": "HB", "pbs_code": "10976Q", "benefit_type_code": "A", "caution_indicator": "Y", "note_indicator": "Y", "manner_of_administration": "ORAL", "maximum_prescribable_pack": 1, "maximum_quantity_units": 42, "number_of_repeats": 0, "organisation_id": 30, "manufacturer_code": "BN", "pack_size": 42, "pricing_quantity": 42, 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"assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 7890, "pt_position": 4, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Clinical criteria: The treatment must be the sole PBS-subsidised therapy for this condition", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "CLINICAL", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 7889, "pt_position": 1, "parameter": { "parameter_type": "CLINICAL_TREATMENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "The treatment must be the sole PBS-subsidised therapy for this condition", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 19913, "pt_position": 5, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Treatment criteria: Must be treated in a centre with expertise in the management of CTEPH", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "TREATMENT", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 19912, "pt_position": 1, "parameter": { "parameter_type": "TREATMENT_LOCATION" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Must be treated in a centre with expertise in the management of CTEPH", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 27771, "pt_position": 6, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Population criteria: Patient must be at least 18 years of age", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "POPULATION", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 27770, "pt_position": 1, "parameter": { "parameter_type": "POPULATION_AGE" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Patient must be at least 18 years of age", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 28500, "pt_position": 7, "prescribing_text": { "prescribing_type": "ADMINISTRATIVE_ADVICE", "prescribing_txt": "Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).", "complex_authority_rqrd_ind": "Y", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, { "res_code": "15275_15274_R", "restriction_indicator": "Y", "restriction_text": { "res_code": "15275_15274_R", "treatment_phase": "Initial treatment", "authority_method": "AUTHORITY_REQUIRED", "treatment_of_code": 15274, "restriction_number": 15275, "note_indicator": "N", "caution_indicator": "N", "complex_authority_rqrd_ind": "Y", "assessment_type_code": "FULL", "criteria_relationship": "ALL", "variation_rule_applied": "N", "first_listing_date": "2024-06-01" }, "restriction_prescribing_texts": [ { "prescribing_text_id": 18191, "pt_position": 1, "prescribing_text": { "prescribing_type": "INDICATION", "prescribing_txt": "Chronic thromboembolic pulmonary hypertension (CTEPH)", "complex_authority_rqrd_ind": "N", "assessment_type_code": null, "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": { "condition": "thromboembolic pulmonary hypertension (CTEPH)", "episodicity": "Chronic", "severity": null } } }, { "prescribing_text_id": 19911, "pt_position": 2, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Clinical criteria: Patient must have WHO Functional Class II, III or IV CTEPH", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "CLINICAL", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 19910, "pt_position": 1, "parameter": { "parameter_type": "CLINICAL_PATIENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Patient must have WHO Functional Class II, III or IV CTEPH", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 19699, "pt_position": 3, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Clinical criteria: The condition must be inoperable by pulmonary endarterectomy; OR The condition must be recurrent or persistent following pulmonary endarterectomy", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "CLINICAL", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 19697, "pt_position": 1, "parameter": { "parameter_type": "CLINICAL_CONDITION" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "The condition must be inoperable by pulmonary endarterectomy", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "parameter_prescribing_txt_id": 19698, "pt_position": 2, "parameter": { "parameter_type": "CLINICAL_CONDITION" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "The condition must be recurrent or persistent following pulmonary endarterectomy", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 7890, "pt_position": 4, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Clinical criteria: The treatment must be the sole PBS-subsidised therapy for this condition", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "CLINICAL", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 7889, "pt_position": 1, "parameter": { "parameter_type": "CLINICAL_TREATMENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "The treatment must be the sole PBS-subsidised therapy for this condition", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 19913, "pt_position": 5, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Treatment criteria: Must be treated in a centre with expertise in the management of CTEPH", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "TREATMENT", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 19912, "pt_position": 1, "parameter": { "parameter_type": "TREATMENT_LOCATION" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Must be treated in a centre with expertise in the management of CTEPH", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 27771, "pt_position": 6, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Population criteria: Patient must be at least 18 years of age", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "POPULATION", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 27770, "pt_position": 1, "parameter": { "parameter_type": "POPULATION_AGE" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Patient must be at least 18 years of age", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 32048, "pt_position": 7, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "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.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 32049, "pt_position": 8, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "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.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 32043, "pt_position": 9, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "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.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 29184, "pt_position": 10, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "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) a completed authority prescription form; 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).", "complex_authority_rqrd_ind": "N", "assessment_type_code": "FULL", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 32042, "pt_position": 11, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "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.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "FULL", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 19917, "pt_position": 12, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "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.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 19918, "pt_position": 13, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "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.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 19919, "pt_position": 14, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "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.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 11007, "pt_position": 15, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "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.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 28755, "pt_position": 16, "prescribing_text": { "prescribing_type": "ADMINISTRATIVE_ADVICE", "prescribing_txt": "Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday). Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos) Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos Or mailed to: Services Australia Complex Drugs Reply Paid 9826 HOBART TAS 7001", "complex_authority_rqrd_ind": "Y", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, { "res_code": "15273_15271_R", "restriction_indicator": "Y", "restriction_text": { "res_code": "15273_15271_R", "treatment_phase": "Continuing treatment", "authority_method": "AUTHORITY_REQUIRED", "treatment_of_code": 15271, "restriction_number": 15273, "note_indicator": "N", "caution_indicator": "N", "complex_authority_rqrd_ind": "Y", "assessment_type_code": "IMMEDIATE", "criteria_relationship": "ALL", "variation_rule_applied": "N", "first_listing_date": "2024-06-01" }, "restriction_prescribing_texts": [ { "prescribing_text_id": 18191, "pt_position": 1, "prescribing_text": { "prescribing_type": "INDICATION", "prescribing_txt": "Chronic thromboembolic pulmonary hypertension (CTEPH)", "complex_authority_rqrd_ind": "N", "assessment_type_code": null, "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": { "condition": "thromboembolic pulmonary hypertension (CTEPH)", "episodicity": "Chronic", "severity": null } } }, { "prescribing_text_id": 11365, "pt_position": 2, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Clinical criteria: Patient must have previously received PBS-subsidised treatment with this drug for this condition", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "CLINICAL", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 11364, "pt_position": 1, "parameter": { "parameter_type": "CLINICAL_PATIENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Patient must have previously received PBS-subsidised treatment with this drug for this condition", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 19923, "pt_position": 3, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Clinical criteria: Patient must demonstrate stable or responding disease", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "CLINICAL", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 19922, "pt_position": 1, "parameter": { "parameter_type": "CLINICAL_PATIENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Patient must demonstrate stable or responding disease", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 7890, "pt_position": 4, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Clinical criteria: The treatment must be the sole PBS-subsidised therapy for this condition", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "CLINICAL", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 7889, "pt_position": 1, "parameter": { "parameter_type": "CLINICAL_TREATMENT" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "The treatment must be the sole PBS-subsidised therapy for this condition", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 19913, "pt_position": 5, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Treatment criteria: Must be treated in a centre with expertise in the management of CTEPH", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "TREATMENT", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 19912, "pt_position": 1, "parameter": { "parameter_type": "TREATMENT_LOCATION" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Must be treated in a centre with expertise in the management of CTEPH", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 27771, "pt_position": 6, "prescribing_text": { "prescribing_type": "CRITERIA", "prescribing_txt": "Population criteria: Patient must be at least 18 years of age", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": { "criteria_type": "POPULATION", "parameter_relationship": "ANY", "criteria_parameters": [ { "parameter_prescribing_txt_id": 27770, "pt_position": 1, "parameter": { "parameter_type": "POPULATION_AGE" }, "prescribing_text": { "prescribing_type": "PARAMETER", "prescribing_txt": "Patient must be at least 18 years of age", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, "indication": null } }, { "prescribing_text_id": 32044, "pt_position": 7, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "Response to this drug is defined as follows: For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease. For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease. For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease. Test requirements to establish response to treatment for continuation of treatment are as follows: The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment: (1) RHC plus ECHO composite assessments plus 6MWT; (2) RHC plus ECHO composite assessments; (3) RHC composite assessment plus 6MWT; (4) ECHO composite assessment plus 6MWT; (5) RHC composite assessment only; (6) ECHO composite assessment only. The results of the same tests as conducted at baseline should be documented in the patient's medical record with each continuing treatment application (i.e., every 6 months), except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be documented in the patient's medical records. The test results conducted for continuing treatment must be no more than 2 months old at the time of application.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 19925, "pt_position": 8, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "The assessment of the patient's response to the continuing 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 19926, "pt_position": 9, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "The maximum quantity per prescription must be based on the dosage recommendations in the TGA-approved Product Information and be limited to provide sufficient supply for 1 month of treatment.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 18574, "pt_position": 10, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "A maximum of 5 repeats will be authorised.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 19928, "pt_position": 11, "prescribing_text": { "prescribing_type": "PRESCRIBING_INSTRUCTIONS", "prescribing_txt": "Patients who fail to demonstrate disease stability or improvement to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.", "complex_authority_rqrd_ind": "N", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } }, { "prescribing_text_id": 28500, "pt_position": 12, "prescribing_text": { "prescribing_type": "ADMINISTRATIVE_ADVICE", "prescribing_txt": "Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).", "complex_authority_rqrd_ind": "Y", "assessment_type_code": "IMMEDIATE", "apply_to_increase_mq_flag": "N", "apply_to_increase_nr_flag": "N", "criteria": null, "indication": null } } ] }, { "res_code": "19700_C", "restriction_indicator": "N", "restriction_text": { "res_code": "19700_C", "treatment_phase": null, 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