New listings of asthma treatment bioequivalents and an extended age range for cystic fibrosis drug ivacaftor were among PBAC’s recommendations.
Patients on therapies that may lead to immunocompromise are potential beneficiaries of the expanded eligibility criteria for free Shingrix announced at the November 2023 PBAC meeting.
Many such patients missed out when the varicella zoster virus recombinant vaccine (Shingrix, GSK) was first listed on the National Immunisation Program in November last year. PBAC has now expanded eligibility under the NIP to include people on a broad range of immunosuppressant medications, including biologics such as dupilumab, conventional immunosuppressants, cancer treatments and cellular therapies.
PBAC also recommended the streamlined authority listing of two new bioequivalent asthma/COPD inhaler preparations from Orion Pharma: Bufomix Easyhaler (budesonide + formoterol) and Salflumix Easyhaler (fluticasone propionate + salmeterol).
Cystic fibrosis drug Ivacaftor (Kalydeco, Vertex) got the nod for expanded age eligibility. The treatment is currently PBS listed for infants aged 12 months and older with a gating (Class III) CFTR gene mutation or at least one CFTR gene mutation. In recommending the extension of eligibility to children from four months of age, the PBAC noted that while there’s little evidence of efficacy in 4–12-month-olds, it also acknowledged the difficulty in obtaining efficacy data in this age group.
November 2023 PBAC meeting outcomes
Among the PBAC outcomes, the following are relevant to allergy, respiratory and/or immunology specialists. Note that recommendation does not mean immediate PBS listing.
Budesonide + formoterol (Bufomix Easyhaler, Orion Pharma)
Request General Schedule streamlined authority listing for the treatment of asthma and COPD under the same circumstances as the reference drug Symbicort Turbuhaler (AstraZeneca). Recommended.
PBAC noted the TGA considered Bufomix Easyhaler to be bioequivalent to Symbicort Turbuhaler, and advised the equi-effective doses were: Bufomix Easyhaler 200/6 = Symbicort Turbuhaler 200/6, and Bufomix Easyhaler 400/12 = Symbicort Turbuhaler 400/12.
Fluticasone propionate + salmeterol (Salflumix Easyhaler, Orion Pharma)
Request General Schedule streamlined authority listing for the treatment of asthma and COPD under the same circumstances as the reference drug Seretide Accuhaler (GSK). Recommended.
The PBAC noted the TGA considered Salflumix Easyhaler to be bioequivalent to Seretide Accuhaler, and advised the equi-effective doses were: Salflumix Easyhaler 250/50 = Seretide Accuhaler 250/50, and Salflumix Easyhaler 500/50 = Seretide Accuhaler 500/50.
Ivacaftor (Kalydeco, Vertex)
Request written authority listing under Section 100 (Highly Specialised Drugs Program) for the treatment of infants aged 4-12 months with cystic fibrosis (CF) with the CF transmembrane conductance regulator (CFTR) gene mutation. Recommended.
Pneumococcal conjugate vaccine, 20-valent (Prevenar 20, Pfizer)
Request National Immunisation Program (NIP) listing for paediatric populations currently recommended for 13-valent and 15-valent pneumococcal conjugate vaccine. Recommended.
Varicella zoster virus recombinant vaccine (Shingrix, GSK)
PBAC recommended an expanded eligibility for free Shingrix under the National Immunisation Program, including people likely to be immunocompromised due to the following treatments:
- B and T-cell targeted monoclonal antibody therapies
- some conventional immunosuppressive agents (including high dose methotrexate, mercaptopurine, azathioprine, mycophenolate, calcineurin inhibitors, mTOR inhibitors, cladribine)
- some biologic therapies (including TNF-a inhibitors, abatacept, dupilumab, mepolizumab, tocilizumab)
- immunomodulatory drugs (including sphingosine-1-phosphate inhibitors)
- some oral small molecule targeted therapies (including JAK inhibitors, BTK inhibitors, BCR-ABL inhibitors)
- cancer treatments, cellular therapies and anti-organ rejection therapy.
The full list of November 2023 PBAC outcomes can be found here.
PBAC March 2024 agenda
The following are among the items on the March 2024 agenda. The full agenda can be found here.
Amino acid formula supplements with prebiotics, probiotics and long chain polyunsaturated fatty acids (Neocate Syneo, Nutricia Australia)
Request that a new formulation of Neocate Syneo continue to be listed on the PBS under the existing conditions for infants with cows’ milk enteropathy, proven combined immunoglobulin E (IgE) mediated allergy to cows’ milk protein and soy protein or combined intolerance to cows’ milk protein, soy protein and protein hydrolysate formulae.
Beclometasone + formoterol (Fostair, Chiesi Australia)
Request a General Schedule streamlined authority listing as a maintenance and reliever treatment for asthma.
Dupilumab (Dupixent, Sanofi-Aventis)
To request a Section 100 (Highly Specialised Drugs Program) written authority listing for the treatment of uncontrolled severe asthma in patients aged six to 11 years (currently listed for patients 12 years and older).
Elexacaftor + tezacaftor + ivacaftor, & ivacaftor (Trikafta, Vertex Pharmaceuticals)
To request a Section 100 (Highly Specialised Drugs Program) written authority listing for the treatment of cystic fibrosis in patients aged two to five years with at least one F508del mutation on the cystic fibrosis transmembrane conductance regulator (CFTR) gene (currently listed for patients six years and older).
Influenza vaccine (Flucelvax Quad, Seqirus)
Request inclusion on the National Immunisation Program for prevention of influenza in people aged from six months (the current minimum is five years).
Influenza vaccine (Flublok Quadrivalent, Sanofi-Aventis)
Request a National Immunisation Program listing for the prevention of influenza in patients aged 65 years and over.
Mepolizumab (Nucala, GSK)
Request changes from written authority required to phone/online for initial treatment and streamlined for continuing treatment of uncontrolled severe asthma.
Respiratory syncytial virus vaccine (Abrysvo, Pfizer)
Request a National Immunisation Program listing for the prevention of RSV-related lower respiratory tract illness in infants from birth through to 6 months of age by active immunisation of pregnant individuals.
Tadalafil (Tadalis, Cipla)
To request listing of a new pack size of the 20mg tablets for pulmonary arterial hypertension.
Tiotropium (Tiotropium Lupin, Generic Health)
To request a General Schedule Restricted Benefit listing of a new form of tiotropium for the treatment of COPD.
