Dive Brief:

• A Medicare advisory panel has delivered an equivocal assessment of whether Novocure’s Optune device improves health and should be covered by the health insurance program.

• Medicare established a non-coverage policy for the tumor-treating field therapy in a form of brain cancer in 2015 but last year two Medicare Administrative Contractors (MACs) agreed to look at clinical data Novocure has generated since then.

• The data persuaded many panelists that tumor-treating field therapy provides net-positive health outcomes in newly-diagnosed glioblastoma but failed to quell all doubts.

Dive Insight:

Novocure designed Optune to deliver low-intensity, wave-like electric fields that interfere with the division of tumor cells. The interference may slow or stop the division of the cells or destroy them. In a 695-patient clinical trial, overall survival in glioblastoma subjects who received tumor-treating field therapy on top of chemotherapy was 20.9 months, compared to 16 months in the control cohort.

The data generated on Optune to date has enabled Novocure to win FDA approval and coverage by private payers but the company is yet to win over everyone. In November, Washington state's Health Technology Clinical Committee voted against covering Optune.

At this week’s Medicare review, the panelists were asked how confident they were about aspects of the evidence on a scale that ran from one, low-to-no confidence, to five, high confidence. Optune got scores ranging from 2.91 to 3.82, according to Cowen Washington Research Group analysts who reported on the event.

The 3.82 score covered whether there is enough evidence to say that the device yields net-positive outcomes in the Medicare-eligible population. However, panelists highlighted concerns about patient compliance and issues with the clinical data, leading to lower scores elsewhere. That mixed set of responses raised doubts about the likelihood of the panel backing widespread use of Optune.

“We continue to believe that a positive reconsideration of Medicare coverage of Optune is not a slam dunk and that any coverage expansion would likely be limited mainly due to recent independent technology assessments,” analysts at Cowen wrote in a policy note.

The limited coverage expansion envisaged by Cowen would be in line with National Comprehensive Care Network (NCCN) guidelines on Optune, although the fact NCCN backs the use of the device in some contexts does not mean Medicare will follow suit.

Cowen expects the MACs to publish a proposed Local Coverage Determination in the coming weeks or months. At that point, a 45-day comment period will open before the determination is finalized.  

The relevance of the determination to device companies other than Novocure is limited. Novocure has patents covering tumor-treating field delivery systems that it thinks will prevent the entry of competitors in the near term. The patents will expire between 2021 and 2035 but Novocure thinks the need for competitors to run clinical trials and seek approvals means it will have the field to itself for a while even after it loses its intellectual property.