Actinic Keratosis - Score (Diclofenac Sodium GEL 3% and related step therapy policies)
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Defines product-specific utilization management (step therapy) requirements for actinic keratosis topical therapy (Diclofenac Sodium GEL 3%) and several listed specialty drugs; impacts prescribers and pharmacy prior authorization reviewers.
No material clinical or coverage changes in this revision.
Coverage Criteria
Diclofenac Sodium GEL 3% — Initial coverage
Covered when ALL of the following are met
Required prior to approval of Diclofenac Sodium GEL 3%
Invega Hafyera — Initial coverage for new starts
Covered when ALL of the following are met
Continuation of prior therapy is approved
Relistor — Initial coverage
Covered when ALL of the following are met
Required prior to approval of Relistor
Zonisade Suspension — Initial coverage
Covered when ALL of the following are met
Continuation of prior therapy is approved
No explicit exclusions for Diclofenac Sodium GEL 3% are listed in this policy. The product is included under the Actinic Keratosis policy but the document does not enumerate any conditions or populations that would be specifically excluded from consideration.
The policy does not identify any conditions as explicitly not medically necessary. Instead, it defines step therapy requirements that must be met for coverage (for example, documentation of a trial of specified topical agents prior to approval).
Initial Therapy Criteria
inv-23: Diclofenac Sodium 3% initial therapy
Initial therapy requirements for Diclofenac Sodium GEL 3%
Specified in Details section
Continuation Criteria
inv-24: Continuation approvals
Continuation of prior therapy
As stated for respective products
Provider Actions and Documentation Requirements
Prior trial required for Diclofenac 3%
Diclofenac Sodium GEL 3% requires documentation that the patient has tried either topical fluorouracil or topical imiquimod before the product will be approved.
Topical step required before Diclofenac
For actinic keratosis, step therapy requires a trial of either topical fluorouracil or topical imiquimod before Diclofenac Sodium GEL 3% will be approved.
Document trial of topical fluorouracil or imiquimod
To meet the coverage criterion for Diclofenac Sodium GEL 3%, documentation must show a trial of either topical fluorouracil or topical imiquimod.
Step trial required for new Invega Hafyera starts
New starts for Invega Hafyera must have a documented trial of either Invega Sustenna or Invega Trinza; members already on Invega Hafyera may be approved to continue prior therapy.
Invega Hafyera step: alternate Invega product required
Step therapy for Invega Hafyera mandates a trial of an alternate Invega product (Invega Sustenna or Invega Trinza) for new starts; continuation of prior therapy is approved.
Document trial of Sustenna or Trinza for Invega Hafyera
For new starts of Invega Hafyera, documentation must confirm a trial of Invega Sustenna or Invega Trinza; continuation of prior Invega Hafyera therapy may be approved without re‑stepping.
Laxative trial required for Relistor
Approval of Relistor requires a prior trial of listed laxatives before authorization will be granted.
Relistor step: try listed laxatives first
Step therapy for Relistor requires a trial of one of the listed laxatives (lubiprostone, Constulose, Enulose, Generlac, or lactulose) prior to approval.
- Lubiprostone
- Constulose
- Enulose
- Generlac
- Lactulose
Document laxative trial for Relistor
Documentation for Relistor requests must show a trial of one of the specified laxatives (lubiprostone, Constulose, Enulose, Generlac, or lactulose).
- Lubiprostone
- Constulose
- Enulose
- Generlac
- Lactulose
Generic zonisamide trial required for new Zonisade starts
New starts of Zonisade Suspension require a trial of a generic zonisamide capsule before Zonisade will be approved; members already receiving Zonisade may continue therapy.
Zonisade step: generic zonisamide required for new starts
Step therapy for Zonisade Suspension mandates a trial of a generic zonisamide capsule for new starts; continuation of prior therapy is approved without requiring the step.
Document trial of generic zonisamide for Zonisade
For Zonisade suspension new starts, documentation must demonstrate a trial of a generic zonisamide capsule; prior therapy continuation may be approved without this requirement.
Denial risk if topical trial not documented
If a trial of either topical fluorouracil or topical imiquimod is not documented, authorization for Diclofenac Sodium GEL 3% for actinic keratosis may be denied.
Denial risk for missing step therapy documentation
For the specialty products listed (Invega Hafyera, Relistor, Zonisade), lack of documented trials of the specified alternative agents for new starts may result in denial of the requested product.
- Invega Hafyera — trial of Invega Sustenna or Invega Trinza required for new starts
- Relistor — trial of lubiprostone, Constulose, Enulose, Generlac, or lactulose required
- Zonisade — trial of generic zonisamide capsule required for new starts
Step Therapy Table
| Drug | Step requirement |
|---|---|
| Diclofenac Sodium GEL 3% | |
| Trial of either topical fluorouracil or topical imiquimod must be documented prior to approval |
| Drug | Step requirement | Applies to |
|---|---|---|
| Invega Hafyera | ||
| Trial of one of the following: Invega Sustenna or Invega Trinza must be documented | ||
| New starts only; continuation of prior therapy approved |
| Drug | Step requirement |
|---|---|
| Relistor | |
| Trial of lubiprostone, Constulose, Enulose, Generlac, or lactulose must be documented prior to approval |
| Drug | Step requirement | Applies to |
|---|---|---|
| Zonisade Suspension | ||
| Trial of a generic zonisamide capsule must be documented prior to approval | ||
| New starts only; continuation of prior therapy approved |
Definitions
Background
Actinic keratosis is a common sun-related precancerous skin lesion treated with topical field therapies. This policy notes that first-line topical field agents include topical fluorouracil and topical imiquimod, and it requires a documented trial of one of these agents before approving alternative topical therapy such as Diclofenac Sodium GEL 3%.
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