Remicade RA Therapy Meets Medicare Criteria For Infused Drug - Centocor

Centocor has been communicating with the Health Care Financing Administration regarding Medicare coverage for the newly approved rheumatoid arthritis indication for Remicade.

Upon its Nov. 10 approval, Centocor announced that Remicade (infliximab), meets current criteria for Medicare reimbursement of infused drugs.

About 50% of the estimated 2.5 mil. U.S. patients who may be appropriate candidates for Remicade therapy will be eligible for Medicare benefits, Centocor said.

Centocor will likely use Remicade's HCFA status to leverage its drug against Immunex' competing biologic response modifier Enbrel (etanercept), which had sales of $102 mil. in the third quarter. A self-injected biologic, Enbrel is currently ineligible for Medicare.

Immunex is working with the Washington state delegation in support of legislation, introduced by Washington Rep. Dunn (R), that would extend Medicare coverage to self-injected biologics (¹ (Also see "Hatch Bill Would Restrict HCFA Payment System; Enbrel Coverage Sought" - Pink Sheet, 27 Sep, 1999.)). With a list price of $110 per shot, administered twice weekly, Enbrel's annual price tag is $11,440.

Remicade's average wholesale price is $611.33 per 100 mg vial. The average patient needs two to three vials per infusion, making the first year of therapy $9,000 to $10,000. Subsequent annual cost is about $7,300.

Remicade must be infused by a physician, which creates an additional administrative cost of about $1,000 per year. The expense could be greater if administered in a hospital setting, Centocor noted. The company has hired "infusion specialists" to assist rheumatologists who want to add infusion centers in their offices.

In the U.S., Centocor will co-promote Remicade for RA with its J&J sister subsidiary Ortho-McNeil.

Centocor is currently enrolling patients in Prompt, an open-label pharmacoeconomic study of Remicade that will evaluate patients' cost of care, ability to continue work and other economic data. The one-year study currently has 90 investigators, who are each seeking to enroll 10 patients.

Dosing is 3 mg/kg given as an intravenous infusion at zero, two and six weeks, and every eight weeks thereafter. "The infusion solution must be administered over a period of not less than two hours," labeling states.

Enbrel, on the other hand, can be administered at home with a 25 mg dose, given twice weekly as a subcutaneous injection 72-96 hours apart. The injection takes a "matter of seconds," Immunex said.

The two products have similar safety profiles, and both labels have a bolded warning against the risk of infections. Immunex sent a "Dear Doctor" letter in May addressing reports of serious infections associated with Enbrel use (² (Also see "Immunex Preparing Enbrel Infection Risk Study And BLA For RA Progression" - Pink Sheet, 17 May, 1999.)). Common adverse events for Remicade and Enbrel are injection site reactions, respiratory infections, particularly sinusitis, and headaches.

Infliximab was approved for use with the current RA standard of care methotrexate for treatment of RA patients who have had inadequate response to methotrexate alone, while Enbrel is indicated for a more narrow population with "moderately to severely active" RA. Immunex estimates that half a million RA patients are appropriate candidates for Enbrel. Immunex submitted an sBLA for use of Enbrel in early RA and disease modification in July (³ (Also see "Immunex Enbrel" - Pink Sheet, 19 Jul, 1999.)).

Enbrel is also approved for treatment of active polyarticular-course juvenile RA in patients age four to 17, a 70,000 patient population, Immunex said. Remicade has not been evaluated for pediatric use.

Remicade approval is based on data from the ATTRACT trial. In the 428 patient, double-blinded study, 50% of Remicade and methotrexate treated patients, compared to 20% of patients receiving methotrexate alone, experienced an ARC20 reduction in signs and symptoms of RA at 30 weeks.

Remicade is also approved for short-term management of Crohn's disease. Possible additional indications for Remicade include congestive heart failure and psoriasis. Centocor submitted an infliximab sBLA Oct. 18 for prevention of joint damage in RA patients, based on one-year radiographic data from the ATTRACT trial. That study will be presented Nov. 15 at the American College of Rheumatology.