Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.
Blue Cross and Blue Shield of Montana (BCBSMT) may consider human fibrinogen concentrate, pasteurized (HFCP) (RiaSTAP™) medically necessary for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (CFD) Factor I bleeding disorder, including afibrinogenemia and hypofibrinogenemia, when the following criteria are met:
- Confirmed CFD by prothrombin time, partial thromboplastin time, thrombin clotting time, and reptilase time; AND
- Failed response to substitution with a cryoprecipitate or substitution with fresh frozen plasma.
BCBSMT considers all other use of human fibrinogen concentrate (RiaSTAP™) experimental, investigational and unproven, including but not limited to dysfibrinogenemia.
The FDA orphan product designation was based upon a study of 15 patients with afibrinogenemia who achieved the target level of fibrinogen expected to prevent bleeding after they received 70 milligrams/kilograms of the drug. In addition, plasma from 14 of the 15 patients showed increased maximum clot firmness, a surrogate marker likely to predict clinical benefit. (1)
This was a phase II multinational, multicenter (ten centers in the United States and Italy), prospective, open-label, and uncontrolled design clinical trial, conducted in subjects with CFD manifested as afibrinogenemia, in a non-bleeding state. Of the 15 subjects, ten were males, with 11 in an age range of 16 to <65 years and the balance between 8 and 14 years. Plasma fibrinogen activity and antigen screening had to be undetectable (<20 mg/dL). Human fibrinogen concentrate, pasteurized (HFCP) was administered as a single intravenous infusion of 70 milligram/kilogram body weight. Blood samples were drawn at pre-dose and at 0.5, 1, 2, 4, 8, 24, 96, 144, 216, and 312 hours post-dosing. Fourteen patient’s laboratory results were evaluated (one subject’s plasma samples thawed during transport). The pharmacokinetics of HFCP, in terms of plasma fibrinogen activity and antigen screening, indicate that HFCP has a long half-life and is slow clearance drug. The results indicated no difference between females and males. In children younger than 16 years, the half-life and clearance of HFCP were 11% shorter and 32% faster than in adults. However, due to the small study size of children younger than 16 years, it is difficult to make any outright conclusion. (2, 3)
Clinical trials will be conducted in the United Kingdom to determine whether HFCP has a role in major vascular surgery to reduce the necessity of blood component transfusions. Additional phase III clinical trials are being completed in the United States as part of the FDA orphan drug approval process. (1)
A search of peer reviewed literature through May 2012 identified no new clinical trial publications or any additional information (including the results from phase III clinical trials) that would change the coverage position of this medical policy.
Disclaimer for coding information on Medical Policies
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.