UPDATE: July 19, 2019: Medicare’s durable medical equipment contractors finalized a local coverage determination and 2019 monthly fee schedule amount Thursday for Novocure's Optune tumor-treating field therapy in cases of newly diagnosed glioblastoma (GBM). The policy goes into effect Sept. 1.

Following publication of the proposed policy in May, several commenters requested extending coverage to patients with recurrent GBM, but CMS didn’t budge.

“Novocure did not submit any new clinical evidence to support their request to extend coverage to recurrent disease, and thus, the reconsideration request for recurrent disease was deemed invalid,” the agency explained in response to summarized comments.

Medicare contractors loosened language from the initial policy requiring patients undergo maximal debulking surgery, instead saying the procedure should occur “when feasible.”

The final policy eliminates a mandate that care be received at a National Cancer Institute-designated facility. Additionally, treating practitioners will be allowed to judge clinical benefit of the treatment after commenters spoke against initial plans requiring demonstration of benefit by radiographic measures within 60 to 90 days.

Dive Brief:

• Medicare contractors are proposing narrow coverage criteria for Novocure's tumor treatment field therapy, called Optune, for a type of brain cancer called glioblastoma multiforme.
• The policy limits reimbursement to newly diagnosed cases of the disease when certain coverage requirements are met.
• Comments for the local coverage decision will be accepted through June 24. A public meeting to discuss the policy is scheduled for June 20.

Dive Insight:

It's common for draft coverage policies to be stricter at the outset and then loosened in the final local coverage determination based on stakeholder comments, according to analysts at Cowen Washington Research Group.

While the draft local coverage determination for the Novocure treatment may be more restrictive than some expected, it's an improvement from the prior blanket non-coverage policy from durable medical equipment Medicare administrative contractors Noridian and CGS, the analysts said in a note to clients.

The two contractors, which process claims for all four regions of the country, last year accepted a reconsideration request for a 2015 non-coverage determination for the Optune treatment.

The device delivers low-intensity 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.

At a March advisory meeting to discuss Medicare coverage for the tumor treatment, an expert panel gave a mixed assessment of whether the device improves health and should be covered. According to the Cowen report, panelists at the meeting asked pointed questions about the clinical trial data, dosage issues and patient compliance. Based on new clinical data from Novocure, many panelists ultimately were persuaded the therapy led to positive health outcomes.

Novocure's data has enabled it to win FDA approval and coverage by private payers. According to the company, Medicare was the sole remaining large U.S. payer that had denied coverage. More than 2,600 patients were receiving the Optune treatment as of March 31, the company said earlier this month.

Gaining coverage is a bigger challenge than how Medicare will price Optune, the Cowen analysts said. A recent policy change in how the agency determines pricing of advanced durable medical equipment could help the treatment receive an adequate payment level, they said.

The Medicare coverage policy will likely be finalized by late summer or early fall and go into effect after a 45-day notice period, the analysts said.