Iressa Coverage Under Part D Should Be Consistent With On-Label Use – WLF

AstraZeneca's oncology drug Iressa should be reimbursed under Medicare Part D for lung cancer patients who are already benefiting from it, the Washington Legal Foundation urges in Aug. 19 comments to the Centers for Medicare & Medicaid Services.

The comments request that CMS reverse its recently published policy statement that Iressa (gefitinib) will not be required on Part D formularies (¹ 'The Pink Sheet' June 27, 2005, In Brief).

The drug was singled out as an exception in a CMS guidance telling Part D plans to include "all or substantially all" drugs in six categories, including anticancer agents (² (Also see "Medicare Part D Formularies May Omit Lexapro Or Celexa, CMS Says" - Pink Sheet, 20 Jun, 2005.), p. 21).

"Iressa should remain fully accessible under Part D to non-small cell lung cancer Medicare patients for whom it may represent the best available care, particularly patients who have already benefited from treatment with it," WLF said.

The group was joined in the submission by three patient advocacy organizations: the Abigail Alliance for Better Access to Developmental Drugs; Lorenzen Cancer Foundation and Lung Cancer Alliance.

Omitting Iressa from formulary requirements would represent "the first occasion ever on which CMS has acted to block patients' access to an FDA-approved oncologic for an on-label use," WLF asserts.

The CMS policy statement on Iressa preceded FDA's conclusion that the oncologic could remain on the market but that its use be restricted to those already benefiting from the drug (³ (Also see "Iressa Relabeling Reflects Competing Risk/Benefit Interests – CDER’s Galson" - Pink Sheet, 27 Jun, 2005.), p. 17).

FDA's decision was based on Iressa's failure to demonstrate a statistically significant survival benefit in the overall study population of a confirmatory trial.

However, WLF points out that "oncologists who use this drug report that it works well, and sometimes dramatically, for a small percentage of patients....The statistics do not reflect that direct observational data."

In support of a policy reversal, AstraZeneca also cited the disconnect between FDA's action on Iressa and the current CMS approach.

"We would hope that CMS would revisit this situation now that the label has been finalized and it has been determined by the FDA that patients that are currently on Iressa and benefiting from it may remain taking it," said Mary Lynn Carver, AstraZeneca's director of external communications for oncology.

To accommodate the new CMS requirement that "all or substantially all" drugs in certain classes be included on Part D formularies, PDP sponsors have been given a two-week window to make changes to formularies already submitted to the agency.

In a recent question & answer guidance, CMS said that "organizations will be permitted to update conditionally approved formularies from September 1, 2005 through 5:00 pm EDT September 15, 2005."

This timeframe "will provide the last opportunity to incorporate updates into the formulary until 60 days after the beginning of the contract year," CMS said.

The agency "expects that organizations will use the September open period to add any drugs within the six classes of clinical concern (including the older agents)...that are not presently contained within the formulary," the guidance notes.

The open period will allow companies to make minor changes, such as "adding new drugs or enhancing the formulary in other ways."

"It is our expectation that there will not be negative changes to the formulary, both in regard to the drug list (removal of drugs without substitution within the same class or category), as well as the addition of utilization management tools," the agency added.

Formulary updates submitted during the September period must be approved by CMS before a plan can begin marketing on Oct. 1.

Inappropriate changes to a formulary "could potentially jeopardize the conditionally approved status and lead to non-approval of your formulary," CMS said.

The agency said it is developing additional guidance on the process for making monthly formulary updates after the benefit begins in 2006.