The rising costs of medicines worldwide have resulted in many healthcare systems struggling to make these costly therapies available for patients. This is particularly true of the UK’s National Health Service (NHS) when it comes to cancer medicines, such as those for ovarian cancer.
In the UK, drugs have to go through an appraisal process by the National Institute for Health and Care Excellence (NICE), and only drugs that have been approved by NICE are available to patients on the NHS. Drugs that are not deemed by NICE to be sufficiently cost-effective or clinically beneficial, and which are therefore not made available on the NHS, may still be accessed via the Cancer Drugs Fund (CDF). The CDF is a source of funding in England that allows access to new, costly therapies via managed access schemes with the drugs developers, while further clinical data is collected.
AstraZeneca / Merck Sharp & Dohme’s (MSD’s) PARP inhibitor Lynparza (olaparib) has shown impressive data in the maintenance setting for platinum-sensitive ovarian cancer patients regardless of BRCA status. In January 2020, NICE recommended Lynparza for use in the NHS for BRCA-positive patients in the second-line, post-platinum-chemotherapy treatment setting for ovarian cancer.
Given that final overall survival (OS) data is not yet available from the clinical trial, cost-effectiveness is yet to be accurately determined in this treatment setting. Therefore, AstraZeneca opted for a managed access agreement with the CDF that applies to the tablet formulation of Lynparza and will allow the drug to be available on the NHS for patients who harbour BRCA mutations.
Notably, Lynparza was first launched as a capsule in the third-line treatment setting, where it has met NICE’s end-of-life criteria and was deemed to be cost-effective. NICE, therefore, recommended Lynparza for use based on the clinical data from Study-19, and the capsule formulation was made available via a patient access scheme.
Lynparza has also been evaluated as a monotherapy in Phase III SOLO-1 study and in combination with bevacizumab in the Phase III PAOLA study. The European Commission approved the monotherapy for use in the first-line setting following platinum chemotherapy in June 2019 and a NICE recommendation quickly followed suit in August 2019, whereby the companies offered yet another managed access scheme with the CDF to allow NHS use. Furthermore, AstraZeneca announced in August 2019 that the PAOLA study evaluating the combination with bevacizumab in this setting met its primary endpoint.
Treating physicians and key opinion leaders (KOLs) are particularly excited about the clinical data for Lynparza as a maintenance treatment in the first-line treatment setting, especially for those with BRCA mutations. Data from SOLO-1 and PAOLA have generated much interest, and GlobalData expects Lynparza will see steep uptake as an upfront treatment, displacing use in later lines of therapy.