Plasminogen, human-tvmh (Ryplazim® )

Restricted Product(s)

• plasminogen, human-tvmh (Ryplazim® ) intravenous infusion for administration by a healthcare professional

FDA Approved Use

• For treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia)

Criteria for Medical Necessity

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval

1. The patient is 11 months of age or older; AND 
2. The patient has a diagnosis of plasminogen deficiency type 1 (hypoplasminogenemia) [medical record documentation required]; AND 
3. The patient has a baseline plasminogen activity level ≤ 45% prior to treatment [medical record documentation required]; AND 
4. The patient has a history of lesions and symptoms consistent with a diagnosis of congenital plasminogen deficiency [medical record documentation required]; AND 
5. The prescriber is a specialist in the area of the patient’s diagnosis or has consulted with a specialist in the area of the patient’s diagnosis [medical record documentation required]; AND 
6. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
7. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*
   
   Duration of Approval: 90 days (12 weeks)

Continuation Criteria for Approval

1. The patient was approved through Blue Cross NC initial criteria for approval; OR 
2. The patient would have met initial criteria for approval at the time they started therapy [medical record documentation required]; AND 
3. The patient has had a clinically significant response to treatment with the requested agent, as defined by one of the following [medical record documentation required]: 
   1. The patient has resolution or improvement of baseline lesions (if present) with no new or recurrent lesions; OR
   2. The patient has achieved or maintained a trough plasminogen activity level ≥ 10% above the initial baseline level; AND
4. The prescriber is a specialist in the area of the patient’s diagnosis or has consulted with a specialist in the area of the patient’s diagnosis [medical record documentation required]; AND 
5. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
6. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*
   
   Duration of Approval: 365 days (1 year) 

*Site of Care Medical Necessity Criteria

1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR 
2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met:
   1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR 
   2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR 
   3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR 
   4. Re-initiation of therapy, defined as ONE of the following:
      1. . First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR 
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR
   5. Requirement of a change in the requested restricted product formulation; AND
3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.

References

All information referenced is from FDA package insert unless otherwise noted below.

1. Shapiro AD, Nakar C, Parker JM, et al. Plasminogen replacement therapy for the treatment of children and adults with congenital plasminogen deficiency. Blood. 2018 Mar;131(12):1301-1310.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

July 2022: Coding update: Added HCPCS code J2998 to dosing reference table effective 7/1/2022, deleted C9399, J3490, and J3590 termed 6/30/2022.
September 2021: Original medical policy criteria issued.