RYPLAZIM (plasminogen, human-tvmh)
Medical Administration - intravenous
Diagnosis considered for coverage:
- Indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia).
Coverage Criteria:
For diagnosis of plasminogen deficiency type 1:
- Dose does not exceed 6.6 mg/kg administered intravenously every 2 to 4 days (initiate at a frequency of every three days), AND
- Prescribed by or in consultation with a hematologist, AND
- Chart note documentation is provided showing the diagnosis of plasminogen deficiency type 1 (hypoplasminogenemia) is confirmed by the following:
- Deficiency of plasminogen activity evidenced by a level of less than or equal to 50%, as confirmed by a chromogenic assay, AND
- Abnormal plasminogen antigen plasma level of less than 9 mg/dL, as confirmed by an enzyme-linked immunosorbent assay, AND
- Presence of clinical symptoms and signs of the disease (e.g., ligneous conjunctivitis, ligneous gingivitis or gingival overgrowth, occlusive hydrocephalus, vision abnormalities, respiratory distress/obstruction, abnormal wound healing)
Reauthorization Criteria:
For diagnosis of plasminogen deficiency type 1:
- Dose does not exceed 6.6 mg/kg administered intravenously every 2 to 4 days, AND
- Documentation of positive clinical response to therapy (e.g., plasminogen activity trough level increased by at least 10 percentage points from baseline, improvement or resolution of lesions)
Coverage Duration:
- Initial: 6 months
- Reauthorization: 1 year
Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Additional Information:
• The dosing frequency is individualized based on the patient’s trough plasminogen activity level and lesion resolution (see the Prescribing Information for detailed recommendations).
• Warnings and precautions include:
- Bleeding
- Tissue Sloughing
- Transmission of infectious agents
- Hypersensitivity reactions
- Neutralizing antibodies
- Laboratory abnormalities
Policy Updates:
- 5/17/2022 – New policy approved by P&T.
References:
- Mehta R and Shapiro AD. Plasminogen deficiency. Haemophilia. 2008; 14:1261-1268. doi: 10.1111/j.1365-2516.2008.01825.x
- Ryplazim [package insert], Laval, Quebec, Canada: Prometic Bioproduction Inc.; June 2021.
- Schuster V, Hügle B, Tefs K. Plasminogen deficiency. J Thromb Haemost. 2007;5(12):2315-2322. doi:10.1111/j.1538-7836.2007.02776.x
- Schuster V, Seregard S. Ligneous conjunctivitis. Surv Ophthalmol. 2003;48(4):369-388. doi:10.1016/s0039-6257(03)00056-0
- Shapiro AD, Nakar C, Parker JM, et al. Plasminogen replacement therapy for the treatment of children and adults with congenital plasminogen deficiency. Blood. 2018;131(12):1301-1310. doi:10.1182/blood-2017-09-806729
Last review date: May 17, 2022