1.1 Olaratumab, in combination with doxorubicin, is recommended for use within the Cancer Drugs Fund as an option for advanced soft tissue sarcoma in adults, only if:
they have not had any previous systemic chemotherapy for advanced soft tissue sarcoma
they cannot have curative treatment with surgery or their disease does not respond to radiotherapy
the conditions in the managed access agreement for olaratumab are followed.
1.2 This recommendation is not intended to affect treatment with olaratumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
People with advanced soft tissue sarcoma having doxorubicin alone are expected to live for 12 to 16 months after starting treatment. Evidence suggests that having olaratumab plus doxorubicin increases the length of time people live by 11.8 months. This amount of survival gain in advanced sarcoma is unprecedented and potentially represents a step-change in its treatment. However, there are not enough long-term data to know the overall length of time people having olaratumab plus doxorubicin live compared with doxorubicin alone because a confirmatory phase III trial (ANNOUNCE) is still ongoing.
Olaratumab plus doxorubicin met NICE's criteria to be considered a life-extending treatment at the end of life. The criteria are that life expectancy for people with the condition should be less than 24 months and that the treatment should extend life by more than 3 months.
The estimate of the cost effectiveness of olaratumab plus doxorubicin varied primarily because of the uncertainties in the data. The incremental cost-effectiveness ratios (ICERs) ranged between £46,000 and £60,000 per quality-adjusted life year (QALY) gained. The most plausible ICER is likely to be close to £60,000 per QALY gained. This is not cost effective based on what NICE normally considers acceptable for end-of-life treatments.
More long-term data would reduce uncertainty in the clinical effectiveness of olaratumab plus doxorubicin and allow a more certain cost effectiveness estimate. The ongoing ANNOUNCE trial is expected to address the uncertainty in the data. Olaratumab is therefore recommended for use within the Cancer Drugs Fund while further data are collected.