Diabetic medication formulary and prior authorization guidance
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Policy provides formulary preferences, step therapy and prior authorization directions for insulin and diabetic medications for Kern Family Health Care providers and pharmacies.
No material clinical or coverage changes in this revision.
Coverage Criteria and Formulary Preferences
Formulary preferences and step therapy
Coverage preferences and step therapy rules apply as follows:
Prescribers are encouraged to write 'insulin lispro' to allow formulary selection.
Adlyxin is noted as a lower-cost GLP-1 and a component of Soliqua.
Documentation examples: labs, history of MI, or medication regimen indicative of CVD.
Documentation examples: ejection fraction measurement or relevant medications (diuretics, selective beta-blockers, ACE/ARB).
No additional exclusions are specified beyond the formulary preference statements. Pharmacies may select the preferred manufacturer when a prescription is written generically for the ingredient (for example, insulin lispro), and the plan designates the most cost‑effective manufacturer as formulary (for insulin lispro, Admelog is preferred). Brand‑for‑brand substitution is not permitted without provider approval in accordance with FDA rules; therefore, a prescriber must explicitly authorize substitution if a specific branded product is required.
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Provider Submission, Documentation, and Step Therapy Actions
Submit TAR via provider portal
Submit all TAR (prior authorization) requests through the Kern provider portal as the required submission channel.
Step therapy requirements for Soliqua and Adlyxin
Follow step therapy requirements: Soliqua requires prior use of Basaglar or a GLP-1 agent; Adlyxin is permitted only after 90 days of SGLT-2 therapy.
- Soliqua: prior use of Basaglar or a GLP-1 is required.
- Adlyxin: allowed only after 90 days of SGLT-2 therapy.
Clinical justification required (labs, history, diagnostics, meds)
Provide clinical documentation to justify use of non-preferred agents, including relevant labs, history (e.g., prior MI), diagnostic results (e.g., ejection fraction), and medication history that indicates CVD or CHF.
- Examples: positive labs, history of MI, ejection fraction measurement.
- Medication history consistent with CVD (for SGLT-2 exceptions) or CHF (for DPP-4 exceptions), e.g., diuretics, selective beta-blockers, ACE/ARB.
Denial risk when documentation absent for non-preferred agents
Coverage for non-preferred manufacturers or non-preferred agents may be denied if adequate positive clinical documentation is not provided to support a preference exception.
- Examples: Steglatro is preferred unless documentation of atherosclerotic disease is provided to justify Jardiance or Farxiga.
- Alogliptin is preferred unless documentation of CHF is provided to justify Tradjenta.
Background
This policy provides formulary preferences and utilization management rules for insulin and non‑insulin diabetic agents to promote cost‑effective prescribing while allowing documented clinical exceptions. It designates preferred agents (for example, Admelog for insulin lispro), specifies step therapy requirements (for example, Soliqua requires prior use of Basaglar or a GLP‑1, and Adlyxin is allowed only after 90 days of SGLT‑2 therapy), and details documentation expectations when non‑preferred agents are requested (positive clinical documentation for cardiovascular or heart‑failure indications to permit alternatives to the preferred SGLT‑2 or DPP‑4 choices). Quantity limits for supplies are included (maximum 200 pen needles or syringes per 40 days), and substitution rules follow FDA guidance such that brand substitution requires provider approval.
Definitions and Formulary Notes
Initial Therapy Constraints
Initial therapy constraints
Step Therapy Details
| Drug | Prior use / step requirement | Timing / duration required | Coverage status |
|---|---|---|---|
| Soliqua | Prior use of Basaglar (basal insulin) or a GLP-1 receptor agonist required | Not specified (step therapy required before initiation) | Covered with criteria |
| Adlyxin | Must have prior SGLT-2 therapy | 90 days of SGLT-2 therapy required before Adlyxin is allowed | Covered with criteria |
Quantity Limits
Biosimilar and Manufacturer Preferences
Preferred insulin lispro manufacturer and pharmacy selection
When a prescription is written for insulin lispro generically, pharmacies are expected to select the preferred manufacturer (Admelog). Brand-to-brand substitution between Admelog and Humalog requires provider approval per FDA rules.
- Admelog is the preferred insulin lispro manufacturer.
- Pharmacies may select any manufacturer only if the prescription is written as 'insulin lispro'; otherwise provider approval is required for brand substitution.
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