BETHESDA, MD 18 September 2012—The government will pay acute care hospitals up to half the average cost of fidaxomicin or glucarpidase when given to Medicare-covered inpatients, the Centers for Medicare and Medicaid Services has decided for fiscal year 2013.

This decision, affecting discharges occurring on or after October 1, 2012, is the first time since 2002 that CMS has approved new technology add-on payments for a pharmaceutical.

Fidaxomicin. CMS set the maximum add-on payment for fidaxomicin tablets at $868 per case.

That amount, the agency said, covers half of the average cost of the antibacterial for the average number of days that a patient receives the drug while in an acute care hospital.

The FDA-approved labeling for the drug recommends it be taken twice daily for 10 days to treat Clostridium difficile-associated diarrhea.

CMS said Medicare Part A will pay for no more than 6.2 days of therapy.

In requesting approval of add-on payments, Optimer Pharmaceuticals Inc., which markets fidaxomicin as Dificid, told CMS that patients receive the product for 6.2 days on average while in a hospital.

These patients, on average, start fidaxomicin therapy once in the hospital for 6.7 days and stay a total of 13.9 days.

Processors of Medicare claims, CMS said, will identify fidaxomicin cases through the following combination of diagnosis and drug codes: International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code 008.45, indicating intestinal infection due to C. difficile; and National Drug Code (NDC) 52015-0080-01.

According to the NDC Directory, 52015-0080-01 represents the 20-tablet container of Dificid.

CMS said it will offer guidance on how hospitals should supply the NDC on the form for institutional health care claims.

Glucarpidase. The agency set the maximum add-on payment for glucarpidase injection, or Voraxaze, at $45,000 per case.

Manufacturer BTG International Inc., which requested approval of the add-on payments, told CMS that hospitals used an average of four 1,000-unit vials, at $22,500/vial, for every Medicare beneficiary who received the drug.

Glucarpidase lowers toxic plasma methotrexate concentrations in patients whose impaired renal function has delayed clearance of the antimetabolite.

According to the FDA-approved labeling for glucarpidase, patients receive one 50-unit/kg dose by i.v. injection.

CMS said processors of Medicare claims will identify glucarpidase cases by the presence of the ICD-9-CM procedure code 00.95, indicating injection or infusion of glucarpidase.

Criteria. To be eligible for add-on payments in the inpatient prospective payment system for acute care hospitals, CMS said, a new technology must

• Not be reflected in the data that establish the diagnosis-related groups,
• Cost so much that the payment rates for the relevant diagnosis-related groups are inadequate, and
• Provide a substantial clinical improvement over the existent technologies.

In the 11 years that CMS has been reviewing applications regarding new technologies, the agency had previously designated only one pharmaceutical—drotrecogin alfa (activated)—as eligible for the add-on payments.

The drug was eligible in fiscal years 2003 and 2004.

Eli Lilly and Company withdrew the drug from markets worldwide in 2011 after a company-funded study failed to show improvement in patients’ survival.