Pharmacy Prior Authorization Criteria

Non-Formulary & Excluded Drug Exceptions Process for Drugs of Clinical Concern

Indications for Prior Authorization

Criteria

Brand Combivir, Brand Emtriva capsules, Brand Epivir, Brand Epzicom, Brand Intelence 100mg and 200mg tablets, Brand Kaletra, Brand Lexiva tablet, Brand Norvir tablets, Brand Retrovir, Brand Reyataz capsules, Brand Sustiva, Brand Symfi, Brand Symfi Lo, Brand Vimpat, Brand Viread 300mg tablets, Brand Ziagen [A]

Non Formulary

Length of Approval: 12 Month(s)

• Both of the following:
• One of the following:
• Both of the following:
• Submission of medical records (e.g., chart notes) documenting the patient has lack of adequate clinical response and related symptoms (e.g., allergy to excipient, worsening symptoms) with a formulary alternative that has the same active ingredient
AND
• One of the following:
• Submission of medical records (e.g., chart notes) or paid claims documenting the patient has tried and failed at least 2 additional formulary alternatives within the same therapeutic class. If only 1 formulary alternative within the therapeutic class is available, the patient must have tried the formulary alternative within the therapeutic class AND 1 additional formulary alternative. If there are no formulary alternatives within the same therapeutic class, the patient must have failed or had contraindication or intolerance to 2 formulary alternatives.
OR
• For continuation of prior therapy
OR
• If the requested drug is a fixed-dose combination product with each individual ingredients available on formulary, one of the following:
• Both of the following:
• Submission of medical records (e.g., chart notes) documenting the patient has lack of adequate clinical response and related symptoms (e.g., allergy to excipient, worsening symptoms) with the individual ingredients in the combination product
AND
• Submission of medical records (e.g., chart notes) or paid claims documenting the patient has tried and failed at least 2 additional formulary alternatives
OR
• For continuation of prior therapy
OR
• One of the following:
• If formulary alternatives are available and do not meet above scenarios, submission of medical records (e.g., chart notes) or paid claims documenting patient has tried and failed, or has contraindication or intolerance to at least 3 formulary alternatives. If only 1 or only 2 alternatives are available, the patient must have failed or had contraindications or intolerance to all available formulary alternatives (Refer to Table 1 for examples of equivalent formulary alternatives)
OR
• For continuation of prior therapy
OR
• No formulary alternative is available to treat the patient's condition
AND
• One of the following:
• Both of the following:
• Requested drug is FDA-approved for the condition being treated
AND
• Additional requirements listed in the "Indications and Usage" sections of the prescribing information (or package insert) have been met (e.g., first line therapies have been tried and failed, any testing requirements have been met, etc.)
OR
• If requested for an off-label indication, the off-label guideline approval criteria have been met

Aplenzin, Aptiom, Auvelity, Ayvakit, Brukinsa, Caplyta, Citalopram 30mg capsule, Delstrigo, Elepsia XR, Emsam, Eprontia, Esperoct, Fintepla, Forfivo XL, Bupropion HCL 450mg ER (XL), Genvoya, Ilumya, Jivi, Kcentra, Lexiva solution, Lybalvi, Norvir capsule/packet/solution, Nubeqa, Nuplazid, Brand Oxtellar XR, Generic oxcarbazepine extended - release, Rebinyn, Rylaze, Savaysa, Secuado, Sertraline capsules, Siliq, Spritam, Stribild, Trizivir, Trogarzo, Venlafaxine 112.5mg tablet, Xembify, Zonisade [B]

Non Formulary

Length of Approval: 12 Month(s)

• Both of the following:
• One of the following:
• For continuation of prior therapy
OR
• Both of the following:
• Submission of medical records (e.g., chart notes) documenting the patient has lack of adequate clinical response and related symptoms (e.g., allergy to excipient, worsening symptoms) with a formulary alternative that has the same active ingredient
AND
• Submission of medical records (e.g., chart notes) or paid claims documenting the patient has tried and failed at least 2 additional formulary alternatives within the same therapeutic class. If only 1 formulary alternative within the therapeutic class is available, the patient must have tried the formulary alternative within the therapeutic class AND 1 additional formulary alternative. If there are no formulary alternatives within the same therapeutic class, the patient must have failed or had contraindication or intolerance to 2 formulary alternatives.
OR
• If the requested drug is a fixed-dose combination product with each individual ingredients available on formulary, both of the following:
• Submission of medical records (e.g., chart notes) documenting the patient has lack of adequate clinical response and related symptoms (e.g., allergy to excipient, worsening symptoms) with the individual ingredients in the combination product
AND
• Submission of medical records (e.g., chart notes) or paid claims documenting the patient has tried and failed at least 2 additional formulary alternatives
OR
• If formulary alternatives are available and do not meet above scenarios, submission of medical records (e.g., chart notes) or paid claims documenting patient has tried and failed, or has contraindication or intolerance to at least 3 formulary alternatives. If only 1 or only 2 alternatives are available, the patient must have failed or had contraindications or intolerance to all available formulary alternatives (Refer to Table 1 for examples of equivalent formulary alternatives)
OR
• No formulary alternative is available to treat the patient's condition
AND
• One of the following:
• Both of the following:
• Requested drug is FDA-approved for the condition being treated
AND
• Additional requirements listed in the "Indications and Usage" sections of the prescribing information (or package insert) have been met (e.g., first line therapies have been tried and failed, any testing requirements have been met, etc.)
OR
• If requested for an off-label indication, the off-label guideline approval criteria have been met

P & T Revisions

2024-10-24, 2024-10-02, 2024-09-05, 2024-08-21, 2024-07-30, 2024-07-01, 2024-06-24, 2024-06-20, 2024-06-17, 2024-04-24, 2024-03-11, 2024-01-31, 2023-12-01, 2023-11-28, 2023-11-08, 2023-08-22, 2023-07-28, 2023-06-12, 2023-05-11, 2023-04-26, 2023-02-08, 2022-11-02, 2022-03-15, 2022-02-02, 2022-01-03, 2021-12-15, 2021-10-26, 2021-06-24, 2021-05-26, 2021-05-21, 2021-04-29, 2021-03-15, 2021-03-15, 2021-03-01, 2020-12-01, 2020-12-01, 2020-11-13, 2020-07-15, 2020-06-02, 2020-04-28, 2020-04-01, 2020-03-16, 2020-01-23, 2019-11-15, 2019-10-29, 2019-07-09

References

---

End Notes

1. Target drugs are brand drugs with AB-rated generics available. Continuation of prior therapy is not required for the switch between brand and its AB-rated generic since pharmacies can automatically switch to the generic at point of sale level.
2. Target drugs are brand drugs without AB-rated generics available. Continuation of prior therapy is allowed for target drugs.

---

Revision History

• 2024-10-24: Annual review, no changes.
• 2024-10-02: update guideline to include generic oxcarbazepine extended -release
• 2024-09-05: Two criteria sections created to separate target drugs with/without true generics. Criteria update to clarify COT is not required for target drugs that have true generics. Background updates.
• 2024-08-21: Added EHB formulary and associated target drugs. Updated background table.
• 2024-07-30: Removal of Vocabria and Cabenuva as these drugs have drug specific NF criteria
• 2024-07-01: Removal of Rubraca
• 2024-06-24: Background update
• 2024-06-20: Removed Descovy and brand Truvada as targets from program.
• 2024-06-17: Removal of Vemlidy
• 2024-04-24: Updated target drugs. Removed EHB formulary.
• 2024-03-11: Criteria update.
• 2024-01-31: Program update to clarify Non-Formulary review scenarios.
• 2023-12-01: Background updates.
• 2023-11-28: GPI updates.
• 2023-11-08: Annual review: Removed obsolete product (Viramune) from guideline.
• 2023-08-22: update background section
• 2023-07-28: Updated Background section
• 2023-06-12: Added Trogarzo to guideline (excluded on EHB).
• 2023-05-11: Addition of Bupropion HCL ER (XL) (MSC M) product as a target
• 2023-04-26: Added Auvelity as target to guideline.
• 2023-02-08: Per PA inquiry, added Lybalvi to guideline
• 2022-11-02: Annual review: Added new Caplyta GPIs and removed Zytiga GPI.
• 2022-03-15: Removed therapy stage field.
• 2022-02-02: Removed Treanda and Zytiga.
• 2022-01-03: Removed Treanda and Zytiga.
• 2021-12-15: Removed Herzuma, Ogivri, Ontruzant, Asceniv, Panzyga, Cutaquig, Rebif, Extavia, Plegridy, Sevenfact, Tazverik, Yonsa, and Erleada from guideline.
• 2021-10-26: Update to add additional targets that will be excluded for 1/1/2022.
• 2021-06-24: Removed Cosentyx, Olumiant, Truxima from guideline.
• 2021-05-26: Added 'non-form' and 'non-formulary' as searchable terms in RxWeb per PA team request. No change to clinical criteria.
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-29: Addition of Esperoct
• 2021-03-15: Added Plegridy IM formulation to guideline.
• 2021-03-15: Removed notes from criteria.
• 2021-03-01: Added Aplenzin, Aptiom, Ayvakit, Brukinsa, Cabenuva, Caplyta, Brand Combivir, Generic efavirenz-lamivudine-tenofovir DF, Brand Epzicom, Fintepla, Ilumya, Jivi, Brand Kaletra oral solution, Kcentra, Mononine, Nubeqa, Nuplazid, Rebinyn, Rexulti, Savaysa, Sevenfact, Siliq, Spritam, Brand Trizivir, Xeljanz oral solution, Xembify, and Zykadia to guideline
• 2020-12-01: Added Forfivo XL and Rebif to guideline.
• 2020-12-01: Annual review: No updates required.
• 2020-11-13: Added Erleada to guideline.
• 2020-07-15: Added Yonsa, Zytiga 500mg and Tazverik to guideline
• 2020-06-02: Added Temixys and Treanda to guideline.
• 2020-04-28: Added Herzuma and Ontruzant to guideline.
• 2020-04-01: Added Asceniv to guideline.
• 2020-03-16: Added Ogivri and Truxima to guideline.
• 2020-01-23: Added "Cosentyx", "Non-formulary drug", and "Excluded drug" as search terms. No changes to criteria.
• 2019-11-15: Removed Taltz from guideline as will no longer be excluded; Added Cosentyx to guideline as will be excluded.
• 2019-10-29: Cutaquig added to guideline.
• 2019-07-09: Remicade removed from throughout guideline (product search, criteria, background section). Grandfathering exception no longer needed since Inflectra and Renflexis now have the pediatric ulcerative colitis indication.

---