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New Prior Authorization Criteria for Patisiran Effective March 1, 2019

Last updated on 2/1/2019

Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to eligible clients. Administrative procedures such as prior authorization, pre-certification, referrals, and claims/encounter data filing may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the client's specific MCO for details.

Effective for dates of service on or after March 1, 2019, prior authorization criteria for patisiran (procedure code C9036) will change for Texas Medicaid.

Patisiran is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

Prior authorization requests for procedure code C9036 must be submitted with a Special Medical Prior Authorization (SMPA) Request Form and may be approved for 12 months per prior authorization request.

The Special Medical Prior Authorization (SMPA) Request Form must be completed, signed, and dated by the prescribing provider. The completed Special Medical Prior Authorization (SMPA) Request Form must be maintained by the prescribing provider in the client's medical record and is subject to retrospective review. The Special Medical Prior Authorization (SMPA) form will not be accepted later than 90 days after the date of the prescribing provider’s signature.

For initial therapy, the following criteria must be met:

  • The client is 18 years of age or older.
  • The client has a diagnosis of hATTR amyloidosis (diagnosis code E851), supported by the following:
    • Transthyretin (TTR) mutation proven by genetic testing
    • Clinical signs and symptoms of the disease (e.g., peripheral/autonomic neuropathy, motor disability)
  • The client will not receive patisiran therapy in combination with other polyneuropathy hATTR amyloidosis therapies (e.g., inotersen or tafamidis meglumine).
  • The client has not had a liver transplant.

For renewal or continuation of therapy, the following criteria must be met:

  • The client has previously received treatment with patisiran without an adverse reaction.
  • The client has a positive clinical response to patisiran (e.g., improved neurologic impairment, improved motor function, slowing of disease progression).

Documentation of the client’s dosage, administration schedule, number of injections to be administered during the prior authorization period, requested units per injection, and the dosage calculation must be submitted in Section C of the Special Medical Prior Authorization (SMPA) Request Form under Statement of Medical Necessity.

For more information, call the TMHP Contact Center at 800-925-9126.