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AWMSG Scrutiny Panel decisions

 

Meeting date: 6 February 2025

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.

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

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.

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.

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.

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.

 

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