Meeting date: 7 August 2025 |
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Medicine: pegylated liposomal irinotecan (Onivyde®) Indication: in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas License status: Licensed for the indication under consideration Scrutiny Panel decision: Pegylated liposomal irinotecan (Onivyde®) is suitable for a full HTA assessment via the Licensed Medicines One Wales Medicines Assessment Group (LOWMAG). A Welsh Patient Access Scheme (WPAS) has already been agreed through the Commercial Arrangement Scheme Wales Group (CASWG). Clinicians highlighted the unmet clinical need for this medicine. This medicine is not routinely available across other UK countries and there is no UK clinical guidance available, it was therefore deemed suitable for full HTA assessment. A full submission will be requested from the company. |
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Medicine: pegylated liposomal irinotecan (Onivyde®) Indication: for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine-based therapy License status: Licensed for the indication under consideration Scrutiny Panel decision: Pegylated liposomal irinotecan (Onivyde®) in conjunction with chemotherapy after progression on gemcitabine-based therapy is not suitable for assessment via the Licensed Medicines One Wales Medicines Assessment Group (LOWMAG). There are no significant new factors which would change the original NICE decision. |
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Medicine: Progesterone (Prometrium®) Indication: Prevention of miscarriage in women presenting with bleeding in the first trimester of pregnancy and have a history of recurrent miscarriages License status: Licensed for the indication under consideration Scrutiny Panel decision: Prometrium® is suitable for a limited assessment via the Licensed Medicines One Wales Medicines Assessment Group (LOWMAG). This is the first licensed progesterone product for this patient group and will replace off-label preparations used in NHS Wales. There is national clinical guidance from NICE and the Royal College of Obstetrics and Gynaecology available recommending use of progesterone products for this indication. The clinical effectiveness and cost-effectiveness have been sufficiently established from published clinical and economic studies according to NICE in the development of their guidelines. |
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Medicine: vericiguat (Verquvo®) Indication: Treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy. License status: Licensed for the indication under consideration Scrutiny Panel decision: Vericiguat (Verquvo®) is not suitable for assessment via the Licensed Medicines One Wales Medicines Assessment Group (LOWMAG). Unmet clinical need has not been established. As the company are not able to submit to AWMSG, a full HTA assessment would be required using evidence in the public domain. However, there is a paucity of clinical data due to a change in clinical pathway on which to undertake a meaningful assessment by AWMSG. |
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Medicine: bimekizumab (Bimzelx®) Indication: Moderate to severe Hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy. License status: Licensed for the indication under consideration Scrutiny Panel decision: Bimekizumab (Bimzelx®) is suitable for a full HTA assessment via the Licensed Medicines One Wales Medicines Assessment Group (LOWMAG). Unmet clinical need has been identified . There are no UK clinical guidelines currently recommending this treatment and this medicine has not been appraised by NICE (NICE terminated). |
Meeting date: 19 June 2025 |
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Medicine: venetoclax (Venclyxto®) plus azacitidine Indication: treatment of relapsed / refractory (R/R) acute myeloid leukaemia (AML) following at least one line of intensive chemotherapy – this includes scenarios of molecular relapse, and relapse following allogeneic haematopoietic stem cell transplant [HSCT]) in situations where:
License status: Off-label for the indication under consideration Scrutiny Panel decision: Venetoclax with azacitidine is suitable for assessment via One Wales Medicines Assessment Group (OWMAG). This is an off-label indication for a specified cohort of patients where current unmet need has been demonstrated by continuing IPFR submissions. There is relevant evidence available for OWMAG to consider in order to make a recommendation. |
Meeting date: 10 April 2025 |
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Medicine: blinatumomab (Blincyto®) Indication: For first line treatment for paediatric patients aged 1 month to 17 years diagnosed with CD19 positive, B-cell precursor acute lymphoblastic leukaemia (ALL) alongside standard chemotherapy. License status: Off-label for the indication under consideration Scrutiny Panel decision: Decision deferred pending further information being supplied by AWTTC. Application to be re-considered at a future meeting. |
Meeting date: 6 March 2025 |
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Medicine: infliximab Indication: For the off-label treatment of Immune Checkpoint Inhibitor (ICI) induced grade 3-4 myocarditis that has not responded to first line immunosuppression with corticosteroids. License status: Off-label for the indication under consideration Scrutiny Panel decision: Infliximab is suitable for assessment via One Wales Medicines Assessment Group (OWMAG). This is an off-label indication for a specified cohort of patients where there is perceived to be a current unmet need. There is some, albeit very limited, evidence available for OWMAG to consider in order to make a recommendation. |
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Medicine: tocilizumab Indication: As an alternative to infliximab for the off-label treatment of Immune Checkpoint Inhibitor (ICI) induced grade 3-4 myocarditis that has not responded to first line immunosuppression with corticosteroids in patients with a left ventricular ejection fraction of less than 40%. License status: Off-label for the indication under consideration Scrutiny Panel decision: Although there was recognition of an unmet clinical need, Scrutiny Panel is of the opinion that there is currently insufficient evidence available for OWMAG to consider and issue advice on an All-Wales basis. Scrutiny Panel feel, at present, it is more appropriate for clinicians to request access to this medicine via their local processes. Clinicians are urged to collate outcome data for any requests and present these as evidence to support a re-submission of this medicine to Scrutiny Panel for future consideration. |
Meeting date: 6 February 2025 |
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Medicine: trametinib (Mekinist®) Indication: For the off-label treatment of recurrent low grade serous ovarian carcinoma (LGSOC) which has progressed following at least 1 previous platinum-based regimen. License status: Off-label for the indication under consideration Scrutiny Panel decision: Trametinib is suitable for assessment via One Wales Medicines Assessment Group (OWMAG). This is an off-label indication for a specified cohort of patients where there is perceived to be a current unmet need. |
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Medicine: teriparatide Indication: Treatment of osteoporosis in men at increased risk of fracture License status: Licensed for the indication under consideration Scrutiny Panel decision: Teriparatide for use in men is suitable for limited assessment via the Licensed Medicines One Wales Medicines Assessment Group (LOWMAG). The medicine is recommended by the National Osteoporosis Guideline Group UK and is commissioned by NHS England and therefore the case for clinical effectiveness is established. The panel noted that due to All Wales Drug Contract pricing for biosimilars, the cost of the medicine is reduced relative to the price in 2008 when AWMSG appraisal took place. |
Meeting date: 9 January 2025 |
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Medicine: guanfacine (Intuniv®) Indication: Treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Intuniv® must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures. License status: Licensed for the indication under consideration Scrutiny Panel decision: Guanfacine is suitable for a limited assessment via the Licensed Medicines One Wales Medicines Assessment Group (LOWMAG). The anticipated budget impact is considered to be low and there is national clinical guidance from NICE available. Clinical effectiveness has been established. |
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Medicine: abiraterone (generic) Indication: With prednisolone for the treatment of newly-diagnosed high-risk, metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT). License status: Licensed for the indication under consideration Scrutiny Panel decision: Abiraterone acetate (generic) in combination with prednisone or prednisolone and androgen deprivation therapy (ADT) is suitable for a limited assessment via the Licensed Medicines One Wales Medicines Assessment Group (LOWMAG). This treatment is commissioned in Scotland and England. Advice will be interim to NICE assessment. This treatment is deemed to be cost saving when compared to other doublet therapies. |
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Medicine: cetuximab (Erbitux®) Indication: For the off-label third line or later treatment of metastatic colorectal cancer (mCRC) as a re-challenge after previous successful first-line use of an epidermal growth factor receptor inhibitor (EGFRi). License status: Off-label for the indication under consideration Scrutiny Panel decision: Cetuximab is not suitable for assessment via One Wales Medicines Assessment Group based on lack of available evidence. The clinical study includes patients on cetuximab in combination with irinotecan therapy which does not meet the scope of assessment for monotherapy. AWMSG Scrutiny Panel noted that clinical preference is for panitumumab for this patient population and that the evidence base for this medicine in this patient population is stronger. |
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Medicine: panitumumab (Vectibix®) Indication: For the off-label third line or later treatment of metastatic colorectal cancer (mCRC) as a re-challenge after previous successful first-line use of an epidermal growth factor receptor inhibitor (EGFRi). License status: Off-label for the indication under consideration Scrutiny Panel decision: Panitumumab is suitable for assessment via One Wales Medicines Assessment Group. This is an off-label indication for a specified cohort of patients where there is perceived to be a current unmet need. |