Sarcoma UK and GIST Cancer UK have expressed disappointment at the Scottish Medicines Consortium’s (SMC) decision not to approve Ripretinib (Qinlock®) for use within NHS Scotland for patients with advanced gastrointestinal stromal tumours (GISTs).
Ripretinib, developed by Deciphera Pharmaceuticals, would have provided a crucial fourth-line treatment option for GIST patients who have exhausted the currently available three lines of therapy (imatinib, sunitinib, and regorafenib). Clinical evidence indicates that Ripretinib can both extend life and improve quality of life for patients, with reduced side effects compared to existing treatments.
‘This decision is devastating for GIST patients in Scotland who have limited treatment options after progressing through the three currently approved therapies,’ said Richard Davidson, Chief Executive of Sarcoma UK. ‘After exhausting existing treatments, these patients may have on average just weeks to live. Ripretinib offered real hope for extended survival with fewer side effects. When the evidence shows a treatment can provide both extended survival and improved quality of life for patients with a rare cancer like GIST, we need approval systems that recognise this value. Our National Sarcoma Survey found that 95% of GIST patients reported that their diagnosis and treatment negatively affected their mental health and emotional wellbeing. A fourth-line treatment option would provide not just physical benefits but crucial psychological support in knowing further options exist.’
GIST is the most common form of soft tissue sarcoma, with approximately 43 people diagnosed in Scotland each year. These tumours develop in the gastrointestinal tract and can cause symptoms including fatigue, pain, and bleeding. The SMC’s primary reason for rejecting the treatment was cost, stating that the company’s “justification of the treatment’s cost in relation to its health benefits was not sufficient.” However, both patient organisations emphasise the significant unmet need that remains unaddressed with this decision.
GIST Cancer UK added: ‘People with GISTs experience significant challenges with existing treatments, including severe side effects that often require dose reductions, treatment resistance that develops over time, and disease progression. Knowing there was an effective fourth-line treatment available would have given patients hope and alleviated some of the emotional distress associated with limited treatment options.’
Both charities actively participated in the SMC’s appraisal process, submitting written evidence about patient experiences and testifying in person during assessment meetings.
The organisations have called for urgent action from the government and pharmaceutical industry to:
- Increase the development of new treatments and clinical trials for GIST patients
- Address cost barriers that prevent promising treatments for rare cancers from being approved
- Ensure evidence of clinical benefit is appropriately weighted in approval decisions
Sarcoma UK and GIST Cancer UK have committed to continue working with other charities, the manufacturer, and the NHS to push for GIST patients to have access to this drug in the future.
Ripretinib was approved for medical use in the United States and Australia in 2020 and in the European Union in 2021. While it was not approved by NICE in 2023, the company has resubmitted the drug for review in the coming months.
