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NICE Recommends Lynparza, Avastin Combination in Ovarian Cancer Through Cancer Drugs Fund

NEW YORK – The UK's National Institute for Healthcare Excellence (NICE) on Friday recommended that the National Health Service provide AstraZeneca's olaparib (Lynparza) in combination with Roche's bevacizumab (Avastin) for certain ovarian cancer patients through the Cancer Drugs Fund (CDF).

In a draft guidance, NICE specifically recommended the olaparib-bevacizumab combination for patients with advanced, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer characterized by homologous recombination deficiency (HRD). Patients eligible to receive the PARP and VEGF inhibitor combo must have had a complete or partial response to first-line platinum-based chemotherapy and bevacizumab.

NICE issued the draft recommendation after reviewing data suggesting that olaparib plus bevacizumab improves progression-free survival to 37.2 months compared to 17.7 months on placebo. However, NICE noted in a statement that it was unable to determine based on the submitted evidence whether the treatment was cost effective, since it was unclear if the regimen improves overall survival compared to placebo. NICE's review committee, however, recognized that the regimen may be cost effective, and therefore recommended that the NHS make it available to patients through the CDF.

The NHS provides drugs through the CDF for a period of time while the sponsors gather more evidence for NICE to appraise. Using that data, NICE issues a final decision as to whether a particular treatment is cost effective and should be available through the NHS.

"Olaparib with bevacizumab has shown the potential to improve the lives of hundreds of individuals," Meindert Boysen, director of the NICE Centre for Health Technology Evaluation, said in a statement. "We don’t yet know whether the benefits on disease progression translate in longer-term outcomes, and we look forward to seeing what the time spent on the CDF will uncover about its benefits for the future."

Olaparib monotherapy is already available through the CDF as a maintenance treatment for advanced ovarian cancer patients with BRCA1/2 mutations after they've responded to first-line, platinum-based chemo. More evidence is being collected on this indication until 2023. Advanced ovarian cancer patients without a BRCA1/2 mutation, meanwhile, have to wait until their cancer comes back in order to gain access to a PARP inhibitor.

The new recommendation would give more ovarian cancer patients earlier access to the olaparib-bevacizumab combo with the help of HRD testing, which gauges biomarkers associated with DNA damage repair beyond BRCA1/2 mutations. The agency estimated that approximately 1,100 women will be eligible for this treatment in England.

According to NICE, in order to implement the new recommendation, clinicians will need to introduce HRD testing and provide bevacizumab and platinum-based chemo in the first-line setting. "Clinical experts confirmed it would be possible to implement these changes and the committee took account of the associated costs and consequences in its decision making," NICE said.

The US Food and Drug Administration last year approved the olaparib-bevacizumab combo as a maintenance regimen for advanced ovarian cancer patients who have HRD and are responding to first-line platinum-based chemotherapy. Simultaneously, the agency also approved Myriad Genetics' myChoice CDx as a companion diagnostic for identifying women with HRD who are likely to benefit from treatment.