Australia's Pharmaceutical Benefits Advisory Committee (PBAC) has issued eight positive recommendations during its July meeting, including acute lymphocytic leukaemia (ALL) drug Blincyto (blinatumomab Amgen, US).
Implications | However, the non-recommendation of HIV pre-exposure prophylaxis Truvada (tenofovir disoproxil fumarate + emtricitabine; Gilead Sciences, US) has been met with public fury from AIDS campaigners. |
Outlook | Given that a decision on an additional two HIV treatments from Gilead Sciences has been deferred by PBAC, public pressure is expected to increase on the company to continue pricing negotiations with PBAC. |
Several new listings were recommended during the July meeting of Australia's Pharmaceutical Benefits Advisory Committee (PBAC). PBAC's notification page for July can be accessed here.
Drug | Sponsor | Indication | PBAC Outcome |
Positive recommendations | |||
Blincyto (blinatumomab) | Amgen (US) | Acute lymphocytic leukaemia | Recommended on cost-effectiveness basis over standard-care chemotherapies, to be achieved in the context of a managed entry framework. PBAC considers that blinatumomab does improve survival, but evidence is comparatively weak. |
Boostrix (dTpa vaccine) | GlaxoSmithKline (GSK, UK) | Prevention of pertussis | Recommended a change to the circumstances under which combined diphtheria, tetanus, and acellular pertussis (dTpa) vaccine is made available as a designated vaccine for the National Immunisation Program (NIP) to include vaccination of women during each pregnancy to reduce pertussis disease in infants (prior to being vaccinated), and in mothers on the basis of cost effectiveness compared with no vaccination. PBAC noted that the states and territories currently fund dTpa vaccination during pregnancy, in line with the Australian Immunisation Handbook recommendation (section 4.12.7). PBAC considered that the introduction of dTpa for pregnant women on the NIP is warranted from a public health perspective as an additional measure to directly target the group with the highest burden of disease (i.e. infants). |
Brenzys (etanercept) | Merck Sharp & Dohme (MSD, US) | Rheumatoid arthritis; Psoriatic arthritis; Plaque psoriasis; Ankylosing spondylitis | Recommended on a cost-minimisation basis with Enbrel for all adult indications – rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic plaque psoriasis. |
Zepatier (grazoprevir + elbasvir) | MSD | Chronic hepatitis C (HCV) infection | Recommended treatment-naïve and treatment experienced genotypes 1, 4, and 6 patients, but not for treatment-naïve genotype 3 chronic HCV. |
Taltz (ixekizumab) | Eli Lilly (US) | Plaque psoriasis | Recommended for the treatment of severe chronic plaque psoriasis that is refractory to treatment with non-biological DMARDs. |
Xolair (omalizumab) | Novartis (Switzerland) | Paediatric severe allergic asthma | Recommended as treatment of severe allergic asthma in patients aged six years to less than 12 years, on the basis of sufficient evidence to demonstrate the effectiveness of omalizumab when compared with placebo plus optimised asthma therapy. |
Prevenar 13 (pneumococcal conjugate vaccine) | Pfizer (US) | Prevention of pneumococcal disease | Recommended a change to circumstances under which 13-valent pneumococcal conjugate vaccine (13vPCV) is made available as a designated vaccine on the NIP for the prevention of pneumococcal pneumonia and invasive pneumococcal disease (IPD) in adults, on the basis of cost-effectiveness compared with 23-valent pneumococcal polysaccharide vaccine (23vPPV, Pneumovax 23). PBAC recommended that a single dose of 13vPCV be made available to pneumococcal vaccine naïve non-indigenous adults aged 65 years and over, and to pneumococcal vaccine-naïve indigenous adults aged 50 years and over. |
Mekinist (trametinib) | Novartis (Switzerland) | Melanoma | Recommended continued listing of trametinib for use in combination with dabrafenib, for the treatment of patients with BRAF V600 mutation-positive unresectable stage III or metastatic (stage IV) malignant melanoma. |
First-time decisions not to recommend, major submissions | |||
Oralair (dactylis glomerata with poa pratensis, lolium perenne, anthoxanthum odoratum + phleum pratense) | Stallergenes (France) | Allergic rhinitis due to grass pollens | Not recommended as magnitude of clinical benefit was unclear and the cost-effectiveness of the requested listing was unknown. |
Truvada (tenofovir disoproxil fumarate + emtricitabine) | Gilead Sciences (US) | HIV pre-exposure prophylaxis | Not recommended on the basis of unacceptable and uncertain cost effectiveness in the proposed population and at the proposed price. PBAC considered that the cost-effectiveness estimates were unreliable, and that attempts to restrict the eligible population by quantifying an individual's future risk of HIV infection based on self-reported future behaviour, and limiting access to those with a predicted annual risk of infection of 3% or higher, may not be feasible or acceptable to clinicians and consumers. |
Actair (house dust mite American + house dust mite European) | Stallergenes (France) | Allergic rhinitis due to house dust mites | Not recommended as PBAC considered that the magnitude of clinical benefit was unclear, and the estimate of cost-effectiveness as presented in the submission was unknown. |
Imlygic (talimogene laherparepvec) | Amgen (US) | Melanoma | Not recommended on basis of highly uncertain magnitude of clinical benefit, and thus highly uncertain cost effectiveness compared with its nominated comparators (pembrolizumab, nivolumab and ipilimumab). |
Esmya (ulipristal) | Vifor Pharma (Switzerland) | Moderate to severe symptoms of uterine fibroids | PBAC decided not to recommend that ulipristal be listed on the PBS for the treatment of moderate to severe uterine fibroids on the basis that the clinical place of treatment was not adequately established; the nominated comparator, goserelin, is not PBS-listed for the treatment of uterine fibroids and its use in clinical practice was not substantiated; the comparative effectiveness and safety of ulipristal compared with goserelin was not established; and no evidence was presented assessing the impact of ulipristal on surgical outcomes. |
Revlimid (lenalidomide) | Celgene (US) | Relapsed or refractory mantle-cell lymphoma | Not recommended on the basis of uncertain effectiveness, with no overall survival gain demonstrated in the trial, and uncertain cost-effectiveness. PBAC took the view that many assumptions used in the estimation of the cost-effectiveness were optimistic, and that the incremental cost-effectiveness ratio (ICER) was therefore likely to be higher than estimated in the submission. |
Fycompa (perampanel) | Eisai (Japan) | Epilepsy | Not recommended on the basis of a lack of clinical data for use in the relevant PBS population, and unknown cost-effectiveness. |
Briviact (brivaracetam) | UCB (Belgium) | Epilepsy | Not recommended on the basis of a lack of clinical data for use in the requested PBS population, and lack of a comparison with levetiracetam, or other similarly listed anti-epileptic drugs, which the PBAC considered would be replaced by brivaracetam. |
Deferrals | |||
Zinbryta (daclizumab) | Biogen (US) | Relapsing-remitting multiple sclerosis | |
Odefsey (emtricitabine + rilpivirine + tenofovir) | Gilead Sciences | HIV | |
Descovy (tenofovir + emtricitabine) | Gilead Sciences | HIV | |
Source: The Pharmaceutical Benefits Scheme (Australian Government Department of Health), August 2016© 2016 IHS | |||
Outlook and implications
PBAC's July meeting resulted in a somewhat smaller number of recommendations than previously; however, noteworthy decisions include Amgen's ALL treatment Blincyto (blinatumomab), which follows its recommendation in June by the Scottish Medicines Consortium (SMC; see United Kingdom: 14 June 2016: SMC's May and June recommendations include Humira, Genvoya, Avastin, Blincyto, Duodopa, and Nucala).
However, a notable flashpoint has been PBAC's decision not to fund HIV pre-exposure prophylaxis (PrEP) treatment Truvada, due to "unacceptable and uncertain cost effectiveness in the proposed population and at the proposed price". In addition, PBAC has also deferred making a reimbursement decision on Gilead's HIV treatments Odefsey (emtricitabine + rilpivirine + tenofovir) and Descovy (tenofovir + emtricitabine), the latter of which recently received a decision of no additional benefit by Germany's Institute for Quality and Efficiency in Healthcare (IQWiG; see Germany: 19 August 2016: Germany's IQWiG decides HIV treatment Descovy shows no additional benefit). According to the Sydney Morning Herald, AIDS campaigners in Australia have expressed dismay at the non-recommendation of Truvada, with the Australian Federation of AIDS Organisations saying the decision would limit patient access to effective prevention, and urging Gilead Sciences to "urgently submit a new application for Truvada and do whatever it takes to ensure the next submission is successful".
Also of note is PBAC's recommendation of MSD's Brenzys as a biosimilar of Enbrel (etanercept); this decision is in line with Australia's strategy of increasing patient access to more affordable biosimilars and generics, and reining in healthcare expenditure.