Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Metastatic high grade pleomorphic sarcoma. 
Treatment: Lynparza 100 milligram (mg) OR TABS. 
The insurer denied coverage for Lynparza 100 mg OR TABS. 
The denial is upheld. 

The treating provider has diagnosed the patient with high grade soft tissue sarcoma. The patient has tried and failed surgery, radiation and pembrolizumab. It is stated that there is a poor prognosis and no available standard options left. The treating provider has requested Lynparza based on Next Generation Sequencing (NGS) panel testing. 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. 

There is no literature to support the use of Lynparza to treat pleomorphic high grade sarcoma or soft tissue sarcoma in general. Case reports in leiomyosarcoma are not considered acceptable evidence of efficacy. 

Per El-Deiry, W. S., et al., (2019), "The world of molecular profiling has undergone revolutionary changes over the last few years as knowledge, technology, and even standard clinical practice have evolved. Broad molecular profiling is now nearly essential for all patients with metastatic solid tumors. New agents have been approved based on molecular testing instead of tumor site of origin. Molecular profiling methodologies have likewise changed such that tests that were performed on patients a few years ago are no longer complete and possibly inaccurate today. As with all rapid change, medical providers can quickly fall behind or struggle to find up-to-date sources to ensure he or she provides optimum care. In this review, the authors provide the current state of the art for molecular profiling/precision medicine, practice standards, and a view into the future ahead." 

Lynparza 100 mg OR TABS does not have final approval from the appropriate regulatory bodies for this diagnosis. Specifically, Lynparza is not approved by the Food and Drug Administration (FDA) to treat pleomorphic sarcoma. 

This patient is not a good candidate for Lynparza 100 mg OR TABS. 

There is no evidence that Lynparza will be of benefit to this individual. The use of NGS panel testing as a means to select anti cancer therapy in advanced cancer remains an area of active research with ongoing studies of TPUR and MATCH. The concept of this approach is that all cancers are unique and each cancer has a specific individual molecular driver, which can be identified using this testing. Once identified, specific therapy can be given to the patient directly treating their tumor. The majority of studies of this approach are fraught with methodological design issues, such as lack of randomization and inclusion of large numbers of patients with established molecular drivers, and then claiming that the identification and targeting of said known drivers contributes to benefit. There has been only one well designed trial of this approach, SHIVA which demonstrated that this testing approach does not improve clinical outcomes for patients with advanced cancer. 

Lynparza 100 mg OR TABS is not the best available treatment for this patient at this time. 

It is unclear if the adverse risks are increased over standard treatment. As there is no literature that has studied olaparib in soft tissue sarcoma, adverse risk cannot be determined. 

In summary, the denial of Lynparza 100 mg OR TABS should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are unknown over standard treatments.