The Centers for Medicare & Medicaid Services will use coverage with evidence development only when an agent is highly likely to show benefit in a broader patient population than its labeled indication, CMS Senior Advisor Peter Bach said Dec. 5.

"We would contemplate a coverage under evidence development decision where we think there is a high likelihood of benefit for our beneficiaries with that device or drug based on the available data," Bach said during a Food & Drug Law Institute conference in Washington, D.C.

In addition to available data, CMS will consider the underlying mechanism of action and other "scientific inputs" in attempting to determine whether a product is likely to show benefit, he said.

Furthermore, coverage with evidence development (CED) would be used only when a drug is "incredibly promising, particularly in an extended population beyond that which is covered without restrictions," Bach said.

CED ties formal data gathering to reimbursement: CMS's draft guidance on the initiative, released in April, included a broad range of circumstances under which the agency proposed to link data collection with coverage (¹ Also see "CMS Proposes Broad Criteria For Linking Reimbursement To Data Collection" - Pink Sheet, 11 April, 2005., p. 24).

Subsequent to issuance of the draft, CMS said that it plans to use CED in a relatively limited number of circumstances. Nevertheless, stakeholders requested that CMS more clearly define when CED would be used.

During the FDLI meeting, Bach reiterated that the agency plans to release another draft guidance to further clarify the scope and function of the program (² Also see "CMS To Give More Specifics For Use Of Coverage With Evidence Development" - Pink Sheet, 25 July, 2005., p. 25).

Bach explained that CED is really intended for agents that already have "a foot in the door - already covered for some indication and we see this expanded population as very promising."

He emphasized that the agency would not use CED to disprove the utility of a therapy in a setting for which available data suggest it is unlikely to demonstrate benefit.

"It would be relatively unlikely - if we were looking at something where it looked very negative or unlikely to be helpful - that we would move forward with coverage under evidence development," he explained.

"It's case by case, obviously, but I don't think we would look at this and say 'here is something that probably won't work, let's do a CED,'" he said. The motivation is the "exact opposite," he said; if a drug is "likely to have a huge benefit, let's not wait."

CMS' decision not to use CED as part of its national coverage determination for Johnson & Johnson's heart failure therapy Natrecor appears to reflect the policy of only using CED when the agency believes a drug has a high likelihood of showing benefit in a certain off-label indication (see ³ Also see "Medicare Proposes To Cover J&J’s Natrecor For Labeled Indication Only" - Pink Sheet, 12 December, 2005.).

CED's purpose is to "extend the coverage, gather more data, get the best out of this innovation that we can in a hurry. Don't let the marketplace necessarily pursue these ideas piecemeal or pursue these ideas driven to some extent by market decisions, which may not perfectly parallel the needs of our beneficiaries," Bach said.

The agency employed a coverage with evidence development approach in its NCD for four colorectal cancer therapies - Genentech's Avastin (bevacizumab), Bristol-Myers Squibb/ImClone's Erbitux (cetuximab), Sanofi-Aventis' Eloxatin (oxaliplatin) and Pfizer's Camptosar (irinotecan) (⁴ Also see "Colorectal Cancer Policy Will Not Limit Current Off-Label Coverage, CMS Says" - Pink Sheet, 7 February, 2005., p. 15).

During the FDLI conference, Arnold & Porter Senior Policy Advisor Kathy Means indicated that drug cost played a key role in the NCD process for the colorectal cancer agents. Means previously served on the senior executive staff at CMS.

During the NCD process, "CMS explicitly asked for price concessions in terms of pricing those drugs in the marketplace," Means said.

"A couple of the companies did in fact grant price concessions, another manufacturer did not," she said. "The companies granted them in the context of fearing a negative coverage determination."

While all companies eventually succeeded in receiving coverage, CMS "was exceeding its authority" in requesting the concessions, she said.

CMS To Use Coverage With Evidence Development When Rx Benefit Is Likely

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