Rare medullary thyroid cancer treatment gets nod from NICE

Ipsen has announced that adult patients in England and Wales with medullary thyroid cancer (MTC) could now benefit from treatment with Cometriq^® (cabozantinib).

Following a successful period of negotiation and collaboration, the National Institute for Health and Care Excellence (NICE) has recommended Cometriq^® for reimbursement via the NHS. Cometriq was previously available via the Cancer Drugs Fund, and under the new-look NICE appraisal system, successfully demonstrated cost-effectiveness to the NHS and clinical value in a real-world setting. Ipsen is currently working with healthcare authorities to ensure that all eligible patients across the UK will have access to Cometriq^®.

Cometriq^® is recommended, within its marketing authorisation, as an option for treating progressive MTC in adults with unresectable, locally advanced or metastatic disease.¹ It is a rare cancer, accounting for 3-12% of all thyroid cancers, and can spread to the lungs or bone. Approximately 25% of MTCs are the result of an inherited faulty gene that runs in the family.²

Ewan McDowall, General Manager, Ipsen UK & Ireland commented on today’s announcement by NICE saying: “Patients with medullary thyroid cancer typically have a poor prognosis and currently have limited treatment options available. We are therefore delighted that NICE has approved Cometriq^® for use via the NHS for eligible patients in England after previously being available via the Cancer Drugs Fund. We believe that any medicine that has the potential to improve the life of a patient with cancer, should be treated as an absolute priority, regardless of whether it is a rare cancer that affects only a few or one that affects many. We are grateful for the opportunity to work collaboratively with health authorities including NICE, as we recognise resources are finite, yet often patients do not have time to wait. Ipsen remains committed to achieving the best outcome for patients across the UK & Ireland.”

Cometriq^® is administered daily (as 2 to 4 capsules) that targets multiple pathways involved in tumour growth.¹ It is licensed for adults with MTC and has been shown to significantly improve median progression free survival (PFS) in patients (estimated median PFS 11.2 months versus 4.0 months for placebo HR, 0.28; 95% CI, 0.19 to 0.40; P < .001).³

“Today’s announcement by NICE marks the first day a licensed treatment has been routinely available via the NHS for all eligible patients with progressive medullary thyroid cancer in England. NICE’s decision to reimburse Cometriq is so important for people living with medullary thyroid cancer and for clinicians managing their care,” said Dr Jonathan Wadsley, Consultant Clinical Oncologist, Sheffield Teaching Hospitals NHS Foundation Trust. “Cometriq has demonstrated significant improvements in median progression free survival in clinical trials of patients with advanced disease. It is one of only two licensed treatment options to help clinicians treat this rare and difficult to treat form of cancer and ensure patients maintain a good quality of life for as long as possible.”

Cometriq^® is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. For patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.¹ The NICE recommendation states: Cabozantinib is recommended, within its marketing authorisation, as an option for treating progressive medullary thyroid cancer in adults with unresectable, locally advanced or metastatic disease only if the company provides cabozantinib with the discount agreed in the patient access scheme.⁴

The use of Cometriq^® in MTC is supported by data from the EXAM trial, an international, multi-centre, randomised double-blinded controlled Phase III clinical trial conducted in 330 patients with progressive, unresectable locally advanced or metastatic MTC, in which Cometriq^® met its primary efficacy endpoint of improving PFS as compared to placebo.^3,5 The most common adverse events experienced with Cometriq^® are consistent with other VEGF receptor tyrosine kinase inhibitors (TKIs) in patients with MTC. These included diarrhea, palmar-plantar erythrodysesthesia, decreased weight and appetite, nausea, and fatigue.³

References

1. Cometriq SmPC. Available at: https://www.medicines.org.uk/emc/medicine/32559. Last accessed: February 2018
2. Cancer Research UK. Types of thyroid cancer. Available at: http://www.cancerresearchuk.org/about-cancer/thyroid-cancer/stages-types…. Last accessed: February 2018
3. Elisei R, et al. Cabozantinib in Progressive Medullary Thyroid Cancer. Clin Oncol. 2013. 31:3639-3646
4. National Institute for Health and Care Excellence. Cabozantinib and vandetanib for treating unresectable locally advanced or metastatic medullary thyroid cancer [ID56]. Final Appraisal Document.
5. Schlumberger M et al. Overall survival analysis of EXAM, a phase III trial of cabozantinib in patients with radiographically progressive medullary thyroid carcinoma. Ann Oncol. 2017;28(11):2813-2819.