Cathflo is a thrombolytic agent that gives you a viable treatment option for central venous access device (CVAD) occlusions as assessed by the ability to draw blood. It is a human tissue plasminogen activator (alteplase) produced by recombinant DNA technology. In the clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis.⁸

Cathflo is the only FDA-approved thrombolytic agent for restoration of function to CVADs as assessed by the ability to withdraw blood.⁸

Cathflo binds to fibrin in the thrombus, converting entrapped plasminogen to plasmin, initiating local fibrinolysis.⁸

As with native tissue-plasminogen activator, Cathflo is highly fibrin-specific. It therefore acts specifically on fibrin-rich clots in the occluded catheter. The clinical significance of fibrin specificity is unknown.⁸

Cathflo has proven efficacy.⁸ In COOL-1, Cathflo restored function to 88% (112/127) of central lines after up to 2 doses using a 120-minute dwell time for each in catheters with occlusions present for up to 24 hours.⁸ In COOL-1 and COOL-2, Cathflo restored function to 68% (796/1043) of central lines after 1 dose and 88% (902/1043) of central lines after 2 doses in catheters with occlusions present for less than 14 days.⁸

COOL-1 was a double-blind, randomized, placebo-controlled study of 150 patients to evaluate the efficacy of Cathflo 2 mg/2 mL, in up to 2 doses, with function assessed at 120 minutes.⁸ COOL-2 was a phase III, single-arm, open-label, multicenter study of 995 patients to evaluate the safety of serial administration of up to 2 doses of Cathflo. Secondary objectives included assessing success rates at 30 minutes and 120 minutes.⁸

The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding.⁸

Adverse events seen in the largest clinical trial involving Cathflo included sepsis (0.4%), a major hemorrhage (0.4%), gastrointestinal bleeding (0.3%), and venous thrombosis (0.3%).¹⁰ There were no instances of intracranial hemorrhage (ICH) or embolic events.⁸

Cathflo should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation. It should be used with caution in the presence of known or suspected infections in the catheter. Using Cathflo in patients with infected catheters may release a localized infection into the systemic circulation.⁸

The Cathflo Activase Pediatric Study (CAPS) was designed to evaluate the safety profile in 310 pediatric patients 17 years of age and younger.² In CAPS, Cathflo restored function in 83% (257/310) of central lines after up to 2 doses using a 120-minute dwell time for each.² Adverse events that occurred in the study included catheter-related complications (1.3%),^a sepsis (1.0%), and fever/lethargy (<1.0%).² There were no reports of intracranial hemorrhage or embolic events with Cathflo in clinical trials, including infants as young as 2 weeks of age. Sepsis developed in 3 patients; each of these patients had evidence of infection prior to administration of Cathflo.²

CAPS was an open-label, single-arm trial that evaluated the safety of Cathflo in 310 patients between the ages of 2 weeks and 17 years.⁸ Cathflo was evaluated in a maximum of 2 doses at ≤2 mg per dose. The primary objective was to evaluate safety, as measured by the incidence of intracranial hemorrhage (ICH). Secondary objectives included assessing restoration rates at 30 minutes and 120 minutes, and serious adverse events within 48 hours.²

When administered for restoration of function to CVADs according to instructions, circulating plasma levels of alteplase are not expected to reach pharmacologic concentrations. If a 2-mg dose of Cathflo was administered by bolus injection into the circulation, the concentration of circulating drug would be expected to return to endogenous levels of 5 to 10 ng/mL within 30 minutes.⁸

Medicare does not have a specific national coverage policy on Cathflo for the treatment of occluded CVADs, but local coverage determinations (LCDs) for some Medicare Administrative Contractors (MACs) support use of Cathflo.²³ Additionally, the absence of a coverage policy does not mean noncoverage. In general, Medicare covers a drug used in the outpatient setting if it is not usually self-administered and its use is reasonable and necessary for treatment of the patient's condition.²³

Most private payers do not have coverage policies related to the use of Cathflo for the treatment of occluded CVADs, but the absence of a coverage policy does not mean noncoverage. Please contact individual payers as necessary to determine their specific coverage guidelines.

Reimbursement for all services, supplies, and drugs furnished to a Medicare beneficiary during an inpatient hospitalization is bundled into a single prospective payment under the Medicare Severity Diagnosis Related Group (MS-DRG) system. Cathflo is not separately reimbursed.

Cathflo is reimbursed at Average Sales Price (ASP) plus 6% when administered to Medicare beneficiaries in the outpatient hospital setting (ASP is published quarterly by the Centers of Medicare and Medicaid Services).

Cathflo is reimbursed at Average Sales Price (ASP) plus 6% when administered to Medicare beneficiaries in a physician’s office or freestanding clinic (ASP is published quarterly by the Centers of Medicare and Medicaid Services).

Genentech has established the Access to Care Foundation for each of its marketed products. The program is designed to provide products to patients who are uninsured or rendered uninsured due to payer denial and who meet the program's medical and financial criteria. For information on Genentech's Access to Care Foundation, please visit GenentechAccessSolutions.com