Cystine Depleting Agents Prior Authorization (Cystadrops, Cystaran, Cystagon, Procysbi)
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Defines prior authorization requirements for ocular and systemic cysteamine products for Georgia Medicaid Fee-for-Service members, including preferred status, age limits, G-tube and medical necessity requirements, and 1-year approvals.
No material clinical or coverage changes in this revision.
Coverage Criteria for Cystine-Depleting Agents
Cystadrops and Cystaran (ocular)
Approvals for ocular cysteamine products
Preferred products but require prior authorization
Procysbi (systemic)
Approvals for Procysbi (systemic delayed-release cysteamine)
Procysbi is non-preferred; alternatives preferred when appropriate
Exceptions to coverage conditions are not handled by blanket policy exclusions; instead, they are evaluated on a case-by-case basis through the prior authorization process. Providers seeking coverage exceptions must initiate the PA process as specified by the plan.
Initial Therapy Criteria
Initial therapy
Length of authorization: 1 year
Provider Actions and Prior Authorization Requirements
Prior authorization required for all listed cysteamine products
Prior authorization is required for Cystadrops, Cystaran, Cystagon, and Procysbi. Approvals are issued for 1 year and are contingent on meeting the product-specific clinical criteria (age and diagnosis) described in the policy.
- Approval duration: 1 year
- PA must demonstrate the member meets age and diagnosis criteria for the requested product
Preferred systemic product and exception process for Procysbi
Cystagon is the preferred systemic agent. Procysbi is non‑preferred and will only be approved if the member has a gastrostomy (G) tube or the prescriber submits a written letter of medical necessity explaining why Cystagon is not appropriate.
- Preferred systemic product: Cystagon
- Non‑preferred Procysbi requires G‑tube or letter of medical necessity as exception process
Required supporting documentation for Procysbi without G‑tube
When Procysbi is requested for a member without a gastrostomy tube, the prescriber must submit a written letter of medical necessity that explains why the preferred product Cystagon is not appropriate for the member. The PA process may be initiated by calling OptumRx.
- Written letter of medical necessity required if no G‑tube
- PA initiation: call OptumRx at 1‑866‑525‑5827
Denial risk when clinical or administration criteria are not met
Requests may be denied if they do not meet the policy’s diagnosis, age, or administration criteria — for example, ocular agents (Cystadrops or Cystaran) require corneal cystine crystal deposits and systemic Procysbi requests require a G‑tube or an adequate letter of medical necessity.
- Ocular agents approvable only for members ≥1 year with corneal cystine crystal deposits
- Procysbi approvable only for members ≥1 year with G‑tube or with letter of medical necessity
Step Therapy / Product Preference
| Step | Preferred product | Non-preferred product — exception requirement |
|---|---|---|
| 1 | Cystagon (cysteamine bitartrate capsules) — preferred systemic agent | Procysbi (cysteamine bitartrate delayed‑release capsules and granules) — Non‑Preferred. Approvable for members ≥ 1 year with a gastrostomy (G) tube; if no G‑tube, prescriber must submit a written letter of medical necessity documenting why Cystagon is not appropriate. |
Site of Care Considerations
Procysbi approval pathway when G‑tube present
Procysbi approval includes an explicit pathway for members who have a gastrostomy (G) tube, indicating enteral administration at home is an accepted setting when a G‑tube is present.
Quantity Limits
Definitions
Background
Cystinosis is managed with topical and systemic cysteamine formulations. Ophthalmic products (Cystadrops, Cystaran) are intended for members with corneal cystine crystal deposits, while systemic oral agents (Cystagon, Procysbi) are used for nephropathic cystinosis. The policy distinguishes these product groups and applies product-specific prior authorization criteria.
For systemic therapy, Procysbi (delayed-release cysteamine) is considered non-preferred compared with Cystagon and has specific approval pathways: members must be ≥ 1 year of age with nephrotic cystinosis and either have a gastrostomy (G) tube for enteral administration or the prescriber must provide a written letter of medical necessity documenting why Cystagon is not appropriate.
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