Regulatory approval of cancer drugs under the US-led Project Orbis fast-track pathway does not necessarily translate to earlier patient access to more effective therapies, a UK study has found.
The retrospective analysis found that cancer drugs approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) under the scheme were not universally accessible to patients, with just 33% and 72% of drugs routinely available on the NHS in England or Scotland, respectively.
Furthermore, not all of the medicines approved by the MHRA under Project Orbis underwent health technology assessment, and among those that did, there were concerns over clinical and cost-effectiveness, the analysis concluded.
“We found that [regulators] seldom provided positive recommendations without highlighting substantial clinical and economic uncertainties, and in some cases did not recommend these drugs for reimbursement,” the authors noted in a paper published in The Lancet. (link here)
Australia has been a partner in Project Orbis since its inception in May 2019, with the TGA initially working with the FDA and Health Canada on the first submission to approve Lenvatinib in combination with pembrolizumab for the treatment of patients with advanced endometrial carcinoma.
Since then the TGA has approved more than 25 new medicines and 35 new indications through Project Orbis (link here).
In the UK, the MHRA participated in 18 drug approvals reviewed through Project Orbis between May 2019 and November 2023.
Fifteen of these were appraised by NICE, which issued positive recommendations for 40% and temporary approvals via the Cancer Drugs Fund for a further 33%.
Since joining Project Orbis, the time from regulatory approval to health technology assessment outcome increased in both England, from a median of 137 to 302 days between 2021 and 2023.
Crucially, the analysis also found no significant differences in overall and progression-free survival gains between cancer medicines that underwent the FDA’s normal regulatory processes and those selected for Project Orbis.
Of 244 cancer drugs approved by the FDA in the studied timeframe, 33% were channelled through Project Orbis The respective overall survival gains were 4.1 months and 2.7 months (p=0.11), while gains for progression-free survival were 2.6 months for each regulatory stream (p=0.44).
“Given modest clinical benefits, further transparency is needed to understand how the FDA identifies cancer drugs to be reviewed through the programme,” the study authors said.
“Maintaining high standards and transparent governance is particularly important as Project Orbis expands”.
“As spending on cancer drugs outpaces the rate of new cancer cases, future efforts to evaluate the success of international harmonisation efforts should extend beyond the number of approvals and review times to value metrics such as benefits and costs to elicit a comprehensive impact on health systems and patients globally,” they stressed.