MOST RECENT
ACNP joins the Immunisation Coalition to Promote the Benefits and importance of Flu Vaccination
"It’s vital that we encourage more conversation about flu, and vaccination. We must not lose interest or momentum after all we have been through with COVID. Flu is not just a cold, it can be devastating, even life threatening, especially for some people, and there is the potential for serious complications. vaccines are recommended for all Australians over the age of 6 months, and they are safe and effective. My profession, Nurse Practitioners, play a big role in immunisation in our community. So speak to your Nurse Practitioner, GP or Pharmacist about having a flu vaccine now, and be ready for this flu season." Leanne Bose ACNP President
Leanne Boase, ACNP President, and Andrea Towny, ACNP Member at Melbourne Town Hall for the Immunisation Coalition 2023 Melbourne Free Flu Vaccination Day, as part of 2023 Immunisation Action Week
Leanne Boase, ACNP President with Elizabeth Miller from the Immunisation Coalition, at Melbourne Town Hall for the Immunisation Coalition 2023 Melbourne Free Flu Vaccination Day, as part of 2023 Immunisation Action Week
The Immunisation Action Week Presented by The Immunisation Coalition
(IAW) is a national awareness program focused on highlighting the importance of vaccination, especially in a pandemic world. All information provided is based on current scientific evidence. The week occurs in April of each year to coincide with World Immunisation Week, with a variety of activities for the general public, as well as healthcare professionals. This annual event reaches a pinnacle with a national, free Influenza Vaccination Day on Friday (28th). Information about planned activities, as well as tools and materials for you to join the awareness campaign, are available below and will be updated regularly. Know the facts #bevaxwise World Immunisation Week 2023 April 24 to 30, 2023 Long Life for All – In pursuit of a long life well lived World Immunisation Week, celebrated in the last week of April, aims to highlight the collective action needed and to promote the use of vaccines to protect people of all ages against disease. For more information see here.
Good morning,
Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st April 2023. Frequently Asked Questions (FAQs) relating to access and use of the Online PBS Authorities system are also attached. This information may be of interest to your members.
This information relates to the administration of these listings by Services Australia. For further information on broader PBS changes, please visit the PBS website. Relevant information and authority application forms have been updated and can be accessed through the Services Australia website.
Chronic rhinosinusitis with nasal polyps
Mepolizumab (Nucala®) (Injection 100 mg in 1 mL single dose pre-filled pen) is now listed on the PBS for the treatment of chronic rhinosinusitis with nasal polyps. Authority applications for initial and grandfather treatment can be made in writing. Authority applications for continuing treatment can be made either in real time using the Online PBS Authorities system or by telephone.
Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
Sapropterin (Kuvan®) (tablet (soluble) containing sapropterin dihydrochloride 100 mg, powder for oral solution 500 mg (as dihydrochloride)) has had an amendment to extend the current listing to allow adults to be eligible for sapropterin responsiveness testing and to also allow access to continuing treatment for those who are sapropterin responsive. Authority applications for initial and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.
Stage II or III oesophageal cancer or gastro-oesophageal junction cancer
Nivolumab (Opdivo®) (Injection concentrate for I.V. infusion 40 mg in 4 mL, injection concentrate for I.V. infusion 100 mg in 10 mL) is now listed on the PBS for the adjuvant treatment of patients with stage II or III oesophageal cancer or gastro-oesophageal junction cancer who have previously received platinum-based chemoradiotherapy and surgery. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.
Human immunodeficiency virus (HIV) infection
Abacavir (Ziagen®) (20 mg/mL oral liquid 240 mL) has been amended to an Authority Required restriction for patients aged less than 13 years of age and for patients that are unable to take tablets. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.
Hypercalcaemia and symptomatic Paget disease of bone
Calcitonin salmon (salcatonin) (Miacalcic 100®) (100 units/mL, 1 mL ampoules) has been amended to an Authority Required restriction for patients who cannot tolerate bisphosphonates due to kidney disease. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.
Hypertension
Methyldopa (Aldomet®) (250 mg, 100 tablets) has been amended to an Authority Required restriction for the treatment of hypertension during pregnancy. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.
Asthma
Fluticasone propionate (Flixotide Junior®, Axotide Junior®) (50 mcg/actuation, 120 actuations) has been amended to an Authority Required restriction for patients aged less than six years of age with initiation required by a respiratory physician or paediatrician. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.
Moderate to severe chronic graft versus host disease
Ruxolitinib (Jakavi®) (Tablet 5 mg, Tablet 10 mg) is now listed on the PBS for the treatment of moderate to severe chronic graft versus host disease. Authority applications for initial, grandfather and continuing treatments are streamlined.
Grade II to IV acute graft versus host disease
Ruxolitinib (Jakavi®) (Tablet 5 mg, Tablet 10 mg) is now listed on the PBS for the treatment of grade II to IV acute graft versus host disease. Authority applications for initial, grandfather and continuing treatments are streamlined.
SARS-CoV-2 infection
Nirmatrelvir + ritonavir (Paxlovid®) has had an amendment to include patients aged 60-69 years old who are at high risk of requiring hospitalisation for COVID-19 infection. Authority applications are streamlined.
Phenylketonuria
Amino acid formula with vitamins and minerals without phenylalanine (PKU Squeezie®) (Oral gel 85 g, 30) is now listed on the PBS as a restricted benefit.
1 April 2023 delisted PBS listings
Diabetes
Insulin aspart 100 units/mL fast acting injection (Fiasp®, Fiasp FlexTouch®) (10 mL vial and 3 mL pen) has been delisted from the PBS with “Supply Only” arrangements for six months.
Intra-ocular pressure
Apraclonidine (Iopidine 0.5%®) has been delisted from the PBS with no “Supply Only” arrangements.
Severe disabling pain
Hydromorphone (Jurnista®) (4 mg, 8 mg, 16 mg, 32 mg, 64 mg modified release tablets) has been delisted from the PBS with “Supply Only” arrangements for one month.
Multiple sclerosis
Interferon beta-1a (Avonex®) has been delisted from the PBS with no “Supply Only” arrangements.
Androgen deficiency
Testosterone 5 mg/24 hours patch (Androderm®) has been delisted from the PBS with no “Supply Only” arrangements.
Selecting the correct restriction in the Online PBS Authorities system
Balance of Supply (BoS) restrictions are available through the Online PBS Authorities system. Questions and answers (Q&As) have been applied against BoS restrictions for multiple medicines listed on the PBS to ensure prescribers are selecting the correct restriction and treatment phase to determine their patient’s eligibility. These Q&As will also ensure prescribers are using the correct authority submission channel for the required treatment phase to avoid post compliance activities.
Kind regards,
PBS Authorities
Pharmaceutical Benefits Branch
Services Australia
A national strategy for mechanical thrombectomy
A new White Paper on access to mechanical thrombectomy brings together some of Australia’s leading health organisations. They are calling for a national Mechanical Thrombectomy Advisory Committee to improve patient access to this lifesaving treatment.
Full details at: A national strategy for mechanical thrombectomy – Australian Stroke Alliance (austrokealliance.org.au)
The AMH Children's Dosing Companion (CDC) is approaching its 10th birthday. The CDC aims to provide evidence-based, paediatric-specific dosing information for the most commonly used medicines in children for use by health professionals involved in prescribing, dispensing and administering medicines in the community and acute care settings.
In keeping with AMH’s philosophy to produce information resources that offer useful, practical support to health professionals involved in the quality use of medicines, it is important we understand how you use our products.
This survey will help us to understand how nurse practitioners use the CDC so that we can continue to improve this paediatric medicines information resource for you in the future.
The survey should take about 5 to 15 minutes to complete, depending on your contribution; only the questions marked with an asterisk (*) are mandatory. Responses in the survey are anonymous. Any identifying data provided by you in the survey will remain secure and confidential within AMH.
To start the survey, click https://www.surveymonkey.com/r/RYRHZT8
Thank you for your interest and we look forward to your feedback.
Good morning,
Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1 March 2023. Frequently Asked Questions (FAQs) relating to access and use of the Online PBS Authorities system is also attached. This information may be of interest to your members.
This information relates to the administration of these listings by Services Australia. For further information on broader PBS changes, please visit the PBS website. Relevant information and authority application forms have been updated and can be accessed through the Services Australia website.
Severe Crohn’s disease, moderate to severe ulcerative colitis, severe active juvenile idiopathic arthritis, complex refractory fistulising Crohn’s disease, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, moderate to severe hidradenitis suppurativa
Adalimumab (Yuflyma®) (injection 40 mg in 0.4 mL pre-filled pen, injection 40 mg in 0.4 mL pre-filled syringe) has had a new biosimilar listed on the PBS for the treatment of severe Crohn’s disease, moderate to severe ulcerative colitis, severe active juvenile idiopathic arthritis, complex refractory fistulising Crohn’s disease, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, moderate to severe hidradenitis suppurativa. Authority applications for initial and first continuing treatments can be made in writing. Authority applications for subsequent continuing treatment are streamlined.
Paroxysmal nocturnal haemoglobinuria
Ravulizumab (Ultomiris®) (1.1 g in 11 mL injection 11 mL vial, 300 mg in 3 mL injection 3 mL vial) has had an amendment to the existing listing to remove the requirement that the LDH:ULN ratio must be at least 1.5 in the first continuing phase for the treatment of paroxysmal nocturnal haemoglobinuria. Authority applications for first continuing treatment can be made in writing.
Eculizumab (Soliris®) (300 mg in 30 mL injection 30 mL vial) has had an amendment to the existing listing to remove the requirement that the LDH:ULN ratio must be at least 1.5 in the first continuing phase for the treatment of paroxysmal nocturnal haemoglobinuria. Authority applications for first continuing treatment and balance of supply can be made in writing.
Mantle cell lymphoma
Zanubrutinib (Brukinsa®) (capsule 80 mg) has had an amendment to remove the grandfather restriction.
Unresectable stage III or stage IV malignant melanoma
Nivolumab with ipilimumab (Opdivo®, Yervoy®) (nivolumab: Injection concentrate for I.V. infusion 100 mg in 10 mL, Injection concentrate for I.V. infusion 40 mg in 4 mL, ipilimumab: Injection concentrate for I.V. infusion 200 mg in 40 mL, Injection concentrate for I.V. infusion 50 mg in 10 mL) has had an amendment to the listing to allow patients who experience disease recurrence either while receiving or within 6 months of completing adjuvant anti-programmed cell death protein-1 (PD-1 inhibitor) treatment to receive nivolumab combined with ipilimumab for the treatment of unresectable stage III or stage IV malignant melanoma. Authority applications for initial and continuing treatments are streamlined.
Asthma
Salbutamol (Asmol CFC-FREE®) (100 mcg/actuation 200 dose) for the treatment of asthma has had an amendment to delete item codes 8288F and 3495Y due to the new dose counter version available as an unrestricted benefit on the PBS. No Supply Only arrangement.
Antipsychotic
Chlorpromazine (Largactil®) (10 mg 100 tablets) has had an amendment to delete item code 1196Y. Supply Only arrangement for 6 months.
Hypertension
Losartan (Cozavan®) (25 mg, 50 mg, 30 tablets) for the treatment of hypertension has had an amendment to delete item codes 5452Y and 8203R. Supply Only arrangement for 6 months.
Propranolol (Deralin®) (160 mg 50 tablets) has had an amendment to delete item code 2899N. Prescribers can request an authority for the 40 mg tablets if a higher dose is required. Supply Only arrangement for 6 months.
Dry eyes
Polyethylene glycol (Systane®) (28 x 0.8 mL unit doses) for the treatment of dry eyes has had an amendment to delete item codes 5532E and 9170P as the pack of 30 x 0.8 ml is listed on the PBS as a streamlined authority. Supply Only arrangement for 6 months.
Polyvinyl alcohol (Liquifilm Tears®, PVA Tears®) (15 mL bottle) for the treatment of dry eyes has had an amendment to delete item codes 2682E, 5526W and 9220G. Supply Only arrangement for 6 months.
Selecting the correct restriction in the Online PBS Authorities system
Balance of Supply (BoS) restrictions are available through the Online PBS Authorities system. New questions and answers (Q&As) have been applied against BoS restrictions for multiple medicines listed on the PBS for multiple Authority Required (Written) programs to ensure prescribers are selecting the correct restriction and treatment phase to determine their patient’s eligibility. These Q&As will also ensure prescribers are using the correct authority submission channel for the required treatment phase to avoid post compliance activities.
Kind regards,
PBS Authorities
Pharmaceutical Benefits Branch
Services Australia
The Guideline provides clear and consistent Recommendations and Practice Points for practitioners who deliver supports to autistic children and their families, to ensure they are doing so in ways that are effective, safe and desirable to children and their families.
The Hon. Justine Elliot MP, Assistant Minister for Social Services, launched the Guideline at Australian Parliament House this morning (Thursday 16 February).
The Guideline is an important national resource for Australia. For the first time, we have clear evidence-based guidelines for good clinical practice.
The National Health and Medical Research Council (NHMRC) has approved all 84 Consensus-Based Recommendations within the Guideline. This indicates that the Guideline has been developed to the highest standard.
The new Guideline focuses on the delivery of non-pharmacological supports in community and clinical settings that aim to support children aged 0-12 years. However, the Guideline has a lifespan perspective, recognising that early supports should lay the foundation for a positive future.
The Guideline will also be a valuable resource for autistic individuals, their families and supporters, organisations providing training to practitioners or students, and government policy-makers, program managers and funding bodies.
Autism CRC funded the development of the Guideline, assisted by the generous bequest of Basil Waugh. We’re proud to have co-produced this guideline with the community, grounded in community need. We thank all who contributed to the development of this important Guideline.
The Guideline is available free of charge, and can be accessed both as a series of interactive webpages and as a downloadable pdf document.
As a registered user of Autism CRC ‘Access resources’, you can login with your email address and then update your preferences and check the Supporting Autistic Children Guideline box to access this new suite of resources. This includes access to the Guideline and all supporting documents, including Recommendations and Good Practice Points.
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If you have any issues logging in to the website, please email hello@autismcrc.com.au for support.
Sustainable Healthcare Module
Members can read th ACNP submission online at Submissions (Members only)
The Commission is seeking your feedback on the Module’s applicability, content and appropriateness to the health sector. Access the draft Module for consultation below and provide feedback by:
- Responding to a short online survey
- Providing a written submission and returning this to NSQHSStandards@safetyandquality.gov.au
Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st February 2023. Frequently Asked Questions (FAQs) relating to access and use of the Online PBS Authorities system is also attached. This information may be of interest to your members.
This information relates to the administration of these listings by Services Australia. For further information on broader PBS changes, please visit pbs.gov.au. Relevant information and authority application forms have been updated and can be accessed through the Services Australia website.
Severe Pain
The Department of Health and Aged Care is making changes to the listing of the below-mentioned products on the PBS to allow pharmacists to dispense volumes smaller than a whole bottle at PBS subsidised prices.
Oxycodone (OxyNorm Liquid®) (Oral liquid 1 mg/mL 250 mL) has had an amendment to the reference units, 1 unit (i.e. 1 bottle) will now appear as 250 mL. Oxycodone is listed on the PBS as a restricted benefit.
Morphine (Ordine®) (Oral liquid 2 mg/mL, 5 mg/mL, 10 mg/mL, 200 mL) has had an amendment to the reference units, 1 unit (i.e. 1 bottle) will now appear as 200 mL. Morphine is listed on the PBS as a restricted benefit.
Morphine (Ordine®) (Oral liquid 5 mg/mL, 10 mg/mL, 200 mL) has had an amendment to the reference units for the palliative care listings, 2 units (i.e. 2 bottles) will now appear as 400 mL. Morphine as a palliative care item is listed on the PBS as Authority Required (STREAMLINED).
Further information regarding these changes can be found at pbs.gov.au/info/news
Attention deficit hyperactivity disorder
Methylphenidate MR (Ritalin® LA, Concerta®) has had an amendment to the administrative advice to clarify that patients may only receive PBS-subsidy with one form of long acting methylphenidate at any one time. Authority applications can be made in real time using the Online PBS Authorities system or by telephone.
Methylphenidate IR (Ritalin® 10, Artige®) has had an amendment to the administrative advice to clarify that requests for increased quantities greater than 2 times the listed quantity will not be approved and increases to the listed maximum number of repeats will not be authorised. Authority applications can be made in real time using the Online PBS Authorities system or by telephone.
Osteoporosis
Romosozumab (Evenity®) (Injection 105 mg in 1.17 mL single use pre-filled syringe) has had an amendment to the continuing treatment criteria to allow general practitioners to prescribe continuing treatment. Authority applications for initial and continuing treatments can be made in real time using the Online PBS Authorities system or by telephone.
Asthma
Beclometasone with formoterol (Fostair®) (Pressurised inhalation containing beclometasone dipropionate 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses) is now listed on the PBS for the treatment of asthma. Authority applications are streamlined.
Parkinson’s disease
Opicapone (Ongentys®) (Capsule 50 mg) is now listed on the PBS for the treatment of Parkinson’s disease as a restricted benefit.
Severe dry eye syndrome, including Sjogren’s syndrome
Polyethylene glycol 400 with propylene glycol (Optix®) (Eye drops 4 mg-3 mg per mL, 15 mL) is now listed on the PBS for the treatment of severe dry eye syndrome, including Sjogren’s syndrome, as a restricted benefit.
SARS-CoV-2 infection
Molnupiravir (Lagevrio®), nirmatrelvir + ritonavir (Paxlovid®) has had an amendment to the restriction for patients who are moderately to severely immunocompromised to include patients who have previously been hospitalised due to COVID-19 infection. Authority applications are streamlined.
Multiple myeloma and myelodysplastic syndrome
Lenalidomide (Revlimid®, Lenalide®, Lenalidomide Sandoz®, Lenalidomide Dr Reddy’s® and Cipla Lenalidomide®) (25 mg, 15 mg, 10 mg, 5 mg, 14 and 21 capsules) has had an amendment to the administrative advice for the treatment of multiple myeloma and myelodysplastic syndrome. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or in writing. Continuing treatment applications can be made either in real time using the Online PBS Authorities system or by telephone.
Chronic severe atopic dermatitis
Upadacitinib (Rinvoq®) (15 mg modified release tablet, 30 mg modified release tablet) has had an amendment to remove the grandfather restriction for the treatment of chronic severe atopic dermatitis.
Mantle cell lymphoma
Acalabrutinib (Calquence®) (100 mg capsule 56) has had an amendment to remove the grandfather restriction for the treatment of mantle cell lymphoma.
1 February 2023 delisted PBS listings
Diabetes mellitus type 2
Exenatide (Byetta® 10 microgram, Byetta® 5 microgram) has been delisted from the PBS with no “Supply Only” arrangement.
Selecting the correct restriction in the Online PBS Authorities system
Balance of Supply (BoS) restrictions are available through the Online PBS Authorities system. New questions and answers (Q&As) have been applied against BoS restrictions for multiple medicines listed on the PBS for multiple Authority Required (Written) programs to ensure prescribers are selecting the correct restriction and treatment phase to determine their patient’s eligibility. These Q&As will also ensure prescribers are using the correct authority submission channel for the required treatment phase to avoid post compliance activities.
Kind regards,
PBS Authorities
Pharmaceutical Benefits Branch Services Australia
PAST UPDATES
From: Australian Commission on Safety and Quality in Health Care
Sent: Thursday, 19 January 2023 8:30 AM
To: ACNP Membership <membership@acnp.org.au>
Subject: National Clinical Trials Governance Framework implementation begins
From March 2023, all heath service organisations conducting clinical trials will need to implement the National Clinical Trials Governance Framework in alignment with assessment to the National Safety and Quality Health Service Standards.
Accreditation timeframe
To give health service organisations time to implement the Framework, for the first three years, or one accreditation cycle, health services will be assessed against a maturity scale.
Health service organisations will be assessed as either having Established systems, Growing systems, or Initial systems in place to meet the NSQHS Standards for clinical trial service provision.
Support
To assist implementation, the Commission has developed new resources, including a tool to conduct a self-assessment, manage examples of evidence and report on trial operations.
Organisations can also access direct support through the Safety and Quality Advice Centre, and join preparatory information sessions to learn more. If you'd like to join a session please email the clinical trials team at HMR@saftyandquality.gov.au.
Background
The Framework is recognised as a significant reform for the clinical trials sector. It embeds clinical trials into routine health service provision under the NSQHS Standards. Importantly, it will do so in a way that will reduce duplication and increase efficiency, cohesion and productivity across the clinical trials sector.
Stay updated
To stay updated on the progress of the National Clinical Trials Governance Framework, visit safetyandquality.gov.au/ctgf and join the NCTGF mailing list by emailing your contact details to HMR@saftyandquality.gov.au.
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UPDATE: Short Notice Accreditation Assessment |
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16 January 2023 Short Notice Accreditation Assessment to the National Safety and Quality Health Service Standards Short notice assessments will replace existing announced assessments from July 2023. This change applies to all health service organisations where licencing require accreditation to the NSQHS Standards. For more information and a dedicated FAQ sheet on the introduction of Short Notice Assessment across the acute care sector, visit our website. Providing greater support Short notice assessments will support the continuous implementation of the NSQHS Standards and reduce the administrative burden of preparing for accreditation assessment. The transition The Commission will work with regulators, accrediting agencies, and health service organisations to prepare for the transition to short notice assessments. This change is one of the six strategies identified to improve the reliability of accreditation processes. To get the latest updates follow us on LinkedIn and Twitter. |
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From: On Behalf Of AUTHORITIES.COMMS.CHANGE
Sent: Tuesday, 3 January 2023 7:46 AM
Subject: PBS Changes from 1 January 2023 [SEC=OFFICIAL]
Good morning,
Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st January 2023. Frequently Asked Questions (FAQs) relating to access and use of the Online PBS Authorities system is also attached. This information may be of interest to your members.
This information relates to the administration of these listings by Services Australia. For further information on broader PBS changes, please visit the PBS website. Relevant information and authority application forms have been updated and can be accessed through the Services Australia website.
Thrombopoietin-receptor agonists (TPO-RA’s for severe thrombocytopenia)
Romiplostim (Nplate®) (powder for injection 375 micrograms and powder for injection 625 micrograms) has had an amendment to the restrictions and authority required procedures for the treatment of immune-related (idiopathic) thrombocytopenia purpura. Authority applications for initial treatment can be made in writing. First continuing, subsequent continuing and change of treatment applications can be made either in real time using the Online PBS Authorities system or by telephone.
Eltrombopag (Revolade®) (tablet 25mg and tablet 50mg ) has had an amendment to the restrictions and authority required procedures for the treatment of immune-related (idiopathic) thrombocytopenia purpura. Authority applications for initial treatment can be made in writing. First continuing, subsequent continuing and change of treatment applications can be made either in real time using the Online PBS Authorities system or by telephone.
Diabetic macular oedema
Faricimab (Vabysmo®) (solution for intravitreal injection 28.8 mg in 0.24 mL vial) is now listed on the PBS for the treatment of diabetic macular oedema. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or in writing. Continuing treatment is streamlined.
Neovascular (wet) age-related macular degeneration
Faricimab (Vabysmo®) (solution for intravitreal injection 28.8 mg in 0.24 mL vial) is now listed on the PBS for the treatment of neovascular (wet) age-related macular degeneration. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or in writing. Continuing treatment is streamlined.
Systemic light-chain (AL) amyloidosis
Daratumumab (Darzalex SC®) (solution for subcutaneous injection 1,800 mg in 15 mL vial) is now listed on the PBS for the treatment of systemic light-chain (AL) amyloidosis. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or in writing. For continuing, change or recommencement treatment, applications can be made either in real time using the Online PBS Authorities system or by telephone.
Multiple myeloma
Pomalidomide (Pomalyst®, Pomolide®, Sandoz®) (3mg, 4mg, 14 tab, 21 tab) has had an amendment to the administrative advice for the treatment of multiple myeloma. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or in writing. Continuing treatment applications can be made either in real time using the Online PBS Authorities system or by telephone.
Rehydration in intestinal failure
Sodium chloride + Potassium Chloride + Glucose Monohydrate + citric acid (O.R.S sachets) is now listed on the PBS for the treatment of rehydration in intestinal failure. Authority applications for treatment can be made either in real time using the Online PBS Authorities system or by telephone.
Treatment of SARS-CoV-2 infection
Molnupiravir (Lagevrio®), nirmatrelvir + ritonavir (Paxlovid®) has had an amendment to the existing listing. Authority applications for the treatment of SARS-CoV-2 infection is streamlined.
Stage IV non-small cell lung cancer
Cemiplimab (Libtayo®) has had an amendment to the existing listing. Authority applications for the treatment of Stage IV non-small cell lung cancer is streamlined.
Asthma
Beclometasone with formoterol and glycopyrronium (Trimbow®) (pressurised inhalation containing beclometasone dipropionate 100 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses, pressurised inhalation containing beclometasone dipropionate 200 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses) is now listed on the PBS for the treatment of asthma. Authority applications for the treatment of asthma is streamlined.
Elevated intra-ocular pressure
Dorzolamide with timolol (Vlzo-PF Dorzolatim®) (eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL) is now listed on the PBS for the treatment of elevated intra-ocular pressure as a restricted benefit.
Severe active psoriatic arthritis
Leflunomide (tablet 10 mg, tablet 20 mg) has had an amendment to the existing listing for the treatment of severe active psoriatic arthritis as a restricted benefit.
Unrestricted benefit
Doxorubicin (as pegylated liposomal) (Caelyx®) (suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL, suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL) is now listed on the PBS under the Section 100 Efficient Funding of Chemotherapy legislative instrument as an unrestricted benefit.
1 January 2023 delisted PBS listings
Type 2 Diabetes
Ertugliflozin with metformin (Segluromet 2.5/1000, Segluromet 2.5/500, Segluromet 7.5/1000, Segluromet 2.5/500) has been delisted from the PBS with “Supply Only” arrangement until 1 June 2023.
Selecting the correct restriction in the Online PBS Authorities system
Balance of Supply (BoS) restrictions are available through the Online PBS Authorities system. New questions and answers (Q&As) have been applied against BoS restrictions for multiple medicines listed on the PBS for multiple Authority Required (Written) programs to ensure prescribers are selecting the correct restriction and treatment phase to determine their patient’s eligibility. These Q&As will also ensure prescribers are using the correct authority submission channel for the required treatment phase to avoid post compliance activities.
Kind regards,
PBS Authorities
Pharmaceutical Benefits Branch
Services Australia
Email: Authorities.comms.change@servicesaustralia.gov.au
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New TGA email subscription service Dear subscriber We wrote to you in September to let you know that we were working on an improved email subscription service. We are excited to let you know that the new look email newsletters and notifications will be launched in January. Our notification services remain largely unchanged. We’ll still provide a range of updates and alerts direct to your inbox, shortly after they are published on the TGA website. If you were previously subscribed to our notifications, you will keep receiving the notifications you were subscribed to. The biggest changes are to the TGA update email newsletter. To give you more relevant content to your needs, we’re splitting our updates into segments. There will now be three email newsletters:
As a current subscriber, we have added you to our new Australian hosted platform, Telstra Whispir. For now, your subscription has been migrated to match what you were receiving. In the new year you will be able to log in to manage your email preferences, including which other updates and notifications you want to receive. Until then, if you have any questions about your subscriptions, please email us attga.education@tga.gov.au. We are committed to upholding the privacy of our subscribers and we will only collect and store data that is required to deliver updates to you. Further information about privacy is available at the link below. Regards TGA Communication Team.
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From: On Behalf Of AUTHORITIES.COMMS.CHANGE
Sent: Thursday, 15 December 2022 4:05 PM
Subject: PBS Authorities – written authority application forms [SEC=OFFICIAL]
Good afternoon
Please see the below important information about PBS Authorities for written authority application forms. Appreciate if you could please share this with your members.
We understand having access to PBS-subsidised medicines can be critical to patient care. That’s why it’s important to ensure you use the most recently published written authority application form. To align with PBS listing changes, forms are updated on the first of the month. Using the most recent form will help avoid delays in obtaining authority approval.
Visit servicesaustralia.gov.au/hpwrittenauthoritydrugs on the Services Australia website to find the most up to date authority application form for each drug, program or condition.
Use the Health Professional Online Services (HPOS) upload function to submit your completed written authority application forms and any supporting documents or evidence. You’ll get a faster processing response using HPOS and will avoid any postage delays.
For more information go to servicesaustralia.gov.au/hpos
Kind regards,
PBS Authorities
Pharmaceutical Benefits Branch
Services Australia
Email: Authorities.comms.change@servicesaustralia.gov.au
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Good Afternoon,
To assist providers to understand and meet their obligations and responsibilities under legislation that governs the Pharmaceutical Benefits Scheme (PBS), the Benefits Integrity and Digital Health Division has developed the following educational factsheet:
- Prescribing PBS Medicines; What Prescribers need to know: This factsheet is primarily aimed at providers who have prescribing responsibilities under the PBS; primarily doctors, dentists, optometrists, nurse practitioners and midwife practitioners.
A copy of this factsheet is available at Prescribing Pharmaceutical Benefits Scheme medicines – what prescribers need to know | Australian Government Department of Health and Aged Care
To help us promote a greater understanding and assist providers to ensure compliance in prescribing PBS medicines, we would be grateful if you could please share this resource more broadly with your members.
If you have any questions or concerns in relation to this resource, please contact us via email at Compliance.Education@health.gov.au
Thank you.
Regards,
Compliance Education
Compliance Audit and Education Branch
Benefits Integrity & Digital Health Division | Health Resourcing Group
Australian Government, Department of Health and Aged Care
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.
"Important: This transmission is intended only for the use of the addressee and may contain confidential or legally privileged information. If you are not the intended recipient, you are notified that any use or dissemination of this communication is strictly prohibited. If you receive this transmission in error please notify the author immediately and delete all copies of this transmission."
The AIR042A report is available to vaccination providers to generate through the AIR site. It identifies individuals who have:
- not received any doses of a COVID-19 vaccine;
- partially completed their COVID-19 primary course (i.e. have received one of their two dose course); or
- completed their COVID-19 primary course and are due for their first booster.
From 3 December 2022 the AIR042A report will be temporarily unavailable whilst enhancements are made to improve usability and to future proof the report so that it is aligned with evolving clinical advice regarding multiple boosters and new COVID-19 vaccines. Vaccination providers will still be able to access and view reports that they’ve requested prior to 3 December 2022.
It is anticipated the enhanced AIR042A report will be available for vaccination providers to use from March 2023.
Further information regarding the report will be distributed in early 2023.
Kind Regards,
Nicholas Stoney - Assistant Secretary Immunisation Branch Population Health Division
Primary and Community Care Group Australian Government Department of Health and Aged Care
Please see the below important information about Pharmaceutical Benefits Scheme listings.
We’re increasing the PBS medicines that can be approved online
Services Australia has been working with the Department of Health and Aged Care to increase the number of PBS items that can be approved in ‘real time’ using the Online PBS Authorities System (the system).
From 1 July 2022, prescribers can submit certain Authority Required ‘Written’ (written) PBS medicines on the schedule using the system. Over time, more written PBS medicines across broader medicine groups will be added to the system for ‘real time’ approval.
We will continue to work with the Department of Health and Aged Care to update the relevant PBS listings and will continue to share this information with you as it becomes available.
Over the next 2 years, we will also be improving the system’s digital capability to support the transition of Authority Required (Written) medicines for online access.
How you can help
When there are changes to the PBS listings, we’ll email you a summary of the changes in a table (please see attached).
We would appreciate your assistance by sharing this with your members via your available channels.
We welcome any feedback on the information we provide or if you have any suggestions on how we can improve the delivery of our messages, please reply to this email.
Additional information
Can PBS authority approval be submitted by post?
Prescribers can still submit applications for authority to prescribe by:
- mailing the application
- uploading applications in HPOS.
Updated versions of application forms will remain available on our website.
How will prescribers know what the changes are?
Whenever there are changes, we’ll send you a summary table to let you know what’s changed.
We’ll explain what the change is, for what condition, and the drugs that treat it.
Kind regards,
PBS Authorities
Pharmaceutical Benefits Branch
Services Australia
Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st December 2022. Frequently Asked Questions (FAQs) relating to access and use of the Online PBS Authorities system is also attached. This information may be of interest to your members.
This information relates to the administration of these listings by Services Australia. For further information on broader PBS changes, please visit the PBS website. Relevant information and authority application forms have been updated and can be accessed through the Services Australia website.
Paroxysmal nocturnal haemoglobinuria
Pegcetacoplan (Empaveli®) (solution for subcutaneous infusion 1080 mg in 20 mL) is now listed on the PBS for the treatment of paroxysmal nocturnal haemoglobinuria. Authority applications for initial and continuing treatment can be made in writing.
Pulmonary arterial hypertension
Ambrisentan, bosentan, epoprostenol, iloprost, macitentan, riociguat, sildenafil and tadalafil (various brands) have had a change to the available dual therapy and triple therapy combinations and to the authority level for the treatment of pulmonary arterial hypertension. Authority applications for initial monotherapy, dual therapy or triple therapy treatment of pulmonary arterial hypertension in an untreated patient can be made either in real time using the Online PBS Authorities system or in writing. For previously treated patients, all treatment applications including changing from monotherapy to dual or triple therapy can be made either in real time using the Online PBS Authorities system or by telephone.
Growth hormone deficiency (Adult)
Somatropin (Genotropin Goquick®, Norditropin FlexPro®, NutropinAq®) has had amendments made to the prescriber instructions. Authority applications for somatropin for initial treatment of growth hormone in adults can be made either in real time using the Online PBS Authorities system or in writing. Continuing treatment applications can be made either in real time using the Online PBS Authorities system or by telephone.
Rheumatoid arthritis and severe active juvenile idiopathic arthritis
Tocilizumab (Actemra®) has had the temporary listings due to critical shortage removed as the critical shortage has been resolved. Patients wishing to change biological drugs under these programs must qualify under the change or recommencement criteria of the relevant drug.
Primary mediastinal B-cell lymphoma, Hodgkin lymphoma, urothelial cancer and colorectal cancer
Pembrolizumab (Keytruda®) (solution concentrate for I.V. infusion 100 mg in 4 mL) has had an amendment to the existing listings for the treatment of primary mediastinal B-cell lymphoma, Hodgkin lymphoma, urothelial cancer and colorectal cancer. Authority applications for pembrolizumab for initial and continuing treatment of primary mediastinal B-cell lymphoma and Hodgkin lymphoma is streamlined. Authority applications for pembrolizumab for initial and continuing treatment of urothelial cancer and colorectal cancer can be made either in real time using the Online PBS Authorities system or by telephone.
Hereditary angioedema Types 1 or 2
Lanadelumab (Takhzyro®) (300 mg/2 mL syringe) has had a change to remove the grandfather restriction.
Chronic heart failure
Vericiguat (Verquvo®) (tablet 2.5 mg, tablet 5 mg, tablet 10 mg) is now listed on the PBS for the treatment of chronic heart failure. Authority applications for vericiguat for initial treatment of chronic heart failure can be made either in real time using the Online PBS Authorities system or by telephone. Continuing treatment is streamlined.
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer
Lorlatinib (Lorviqua®) (tablet 25 mg, tablet 100 mg) has had an amendment to the existing listing. Authority applications for lorlatinib for initial and continuing treatment of Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer can be made either in real time using the Online PBS Authorities system or by telephone.
Hypercholesterolaemia
Evolocumab (Repatha®) (injection 140 mg in 1 mL single use pre-filled pen, injection 420 mg in 3.5 mL single use pre-filled cartridge) has had an amendment to the existing listing. Authority applications for evolocumab for initial treatment of hypercholesterolaemia can be made either in real time using the Online PBS Authorities system or by telephone.
Multiple sclerosis
Natalizumab (Tysabri®) (solution concentrate for I.V. infusion 300 mg in 15 mL) has had an amendment to the existing listing. Authority application for natalizumab for treatment of multiple sclerosis is streamlined.
Treatment of bacterial infections
Amoxicillin and clavulanic acid USP (Aurobindo) (875 mg/125 mg tablets 20 pack) is now listed on the PBS for the current supply shortage under section 19A. Authority applications for amoxicillin and clavulanic acid for treatment of bacterial infections is streamlined.
Amoxicillin (Kent) (250 mg/5 mL oral powder for suspension 100 mL) is now listed on the PBS for the current supply shortage under section 19A as an unrestricted benefit.
Central precocious puberty
Leuprorelin acetate (Eligard®) (suspension for subcutaneous injection (modified release) containing 45 mg of leuprorelin acetate) is now listed on the PBS for the treatment of central precocious puberty. Authority applications for initial and continuing treatment is listed as a restricted benefit.
Detrusor overactivity
Oxybutynin (Niche Generics Limited) (5 mg tablets 84 pack) is now listed on the PBS for the current supply shortage under section 19A as a restricted benefit.
Unrestricted benefit
Bevacizumab (Abevmy®) (solution for I.V. infusion 100 mg in 4 mL, solution for I.V. infusion 400 mg in 16 mL) is now listed on the PBS as an unrestricted benefit.
1 December 2022 delisted PBS listings
Hypertension
Pindolol (Barbloc®) (5 mg tablet) has been delisted from the PBS with “Supply Only” arrangement until 1 June 2023.
Multiple sclerosis
Interferon Beta-1A (Rebiff 44®) has been delisted from the PBS with “Supply Only” arrangement until 1 April 2023.
Anticoagulant
Dipyridamole with aspirin (Diasp SR®) has been delisted from the PBS with “Supply Only” arrangement until 1 June 2023.
Heparin (Pfizer Australia) (5000 IU in 5 mL 50 pack) has been delisted from the PBS with “Supply Only” arrangement until 1 December 2023.
Treatment of bacterial infections
Ampicillin (Alphapharm) (1 g vials) has been delisted from the PBS with “Supply Only” arrangement until 1 June 2023.
Depression
Doxepin (Deptran®) (10 mg and 25 mg capsules, 50 mg tablet) has been delisted from the PBS with “Supply Only” arrangement until 1 June 2023.
Selecting the correct restriction in the Online PBS Authorities system
Balance of Supply (BoS) restrictions are available through the Online PBS Authorities system. New questions and answers (Q&As) have been applied against BoS restrictions for multiple medicines listed on the PBS for multiple Authority Required (Written) programs to ensure prescribers are selecting the correct restriction and treatment phase to determine their patient’s eligibility. These Q&As will also ensure prescribers are using the correct authority submission channel for the required treatment phase to avoid post compliance activities.
Kind regards,
PBS Authorities Pharmaceutical Benefits Branch
