Obtain PA and document preferred‑product trials

Submit a prior authorization request and ensure the patient meets the referenced standard Inflammatory Conditions prior authorization policy; when clinically appropriate, document trials of the Preferred Product(s) per the policy table before requesting approval of a Non‑Preferred product.

• Continuation of Non‑Preferred subcutaneous/oral products requires verification via claims or prescriber if claims unavailable (see continuation verification rules).
• If preferred‑product trial requirement not met, the reviewer will offer review for a Preferred/Step product per the step table.

Meet standard PA and step‑therapy rules

All requests must meet the respective standard Prior Authorization Policy criteria and indicate any required step‑therapy trials per the policy table; if step requirements are unmet, the requestor should be offered review for the listed Step/Preferred products.

• Non‑Preferred approvals are often directed to one or more Step 1 (Preferred) or Step 2 products.
• Some Step 3 Non‑Preferred agents require documentation of trials of two Step 1 or 2a products.

PA approvals are time‑limited (initial and continuation)

Authorization approvals are time‑limited: initial approvals are commonly 3 or 6 months (varies by agent/indication) and continuation approvals are typically for 1 year when standard PA and any indication‑specific continuity requirements are met.

• Examples: Cimzia plaque psoriasis initial approval = 3 months (when criteria met).
• Cimzia initial approvals for many indications = 6 months; continuation approvals (patients currently receiving) = 1 year.

Verify established‑on‑therapy (often ≥90 days) for continuation

For continuation approvals based on being established on therapy, verify the patient has been on therapy for the required period (often ≥90 days) and provide claims or prescriber verification per the policy to support a 1‑year renewal.

• Example: Simponi continuation — established ≥90 days and claims show a 90‑day supply within the past 130 days or prescriber verification.
• If claims history (130 days) is unavailable, prescriber must verify at least 90 days of paid use (no samples/coupons).

Care Value approvals conditional on meeting PA and step criteria

Care Value approvals are conditional: the reviewer must confirm standard PA criteria plus any Care Value additional prior‑therapy or establishment requirements for the product/indication before granting the specified approval duration.

• If Care Value additional conditions are not met, offer review for specified Preferred/Step products per the standard PA policies.
• Durations vary by product and indication (e.g., initial 3–6 months; continuation typically 1 year).

Follow the referenced standard PA policy for each drug

Follow the referenced standard Prior Authorization Policies for each agent; the Care Value document cross‑references product‑specific PA policies (e.g., Tocilizumab SC policy) that must be satisfied in the request.

• Refer to the Inflammatory Conditions – [product] Prior Authorization Policy for agent‑specific clinical criteria.
• Prescribers must provide any documentation the referenced PA policy requires.

Document meeting standard PA criteria and prior trials

Requests must include documentation that the patient meets the referenced 'standard Inflammatory Conditions' prior authorization policy criteria and any specified prior‑therapy trials; initial approvals commonly issued for 6 months and continuation for 1 year when requirements are documented.

• Examples: Rinvoq/Xeljanz initial approvals often 6 months when standard PA and trial requirements met; continuation approvals generally 1 year.
• Document prior trials as noted (number and acceptable agents vary by indication).

PA is required and must cite standard PA criteria

Prior authorization is required for initial and continuation therapy and the request must document meeting the referenced standard PA criteria; provide required prior‑therapy documentation as noted in each product section.

• Initial Rinvoq approvals: patient must meet the Rinvoq/LQ PA criteria and the indication‑specific prior therapy requirement.
• If prior therapy trial requirement is not met, offer review for listed Preferred Products.

Rinvoq initial PA: meet Rinvoq/LQ PA + prior‑therapy rule

For initial Rinvoq therapy, confirm the patient meets the standard Rinvoq/LQ prior authorization criteria and the indication‑specific prior therapy requirement (e.g., specified biologic trial) before requesting a 6‑month initial approval.

• Example: nr‑axSpA initial Rinvoq requires prior trial of Cimzia (or specified alternatives).
• If prior trial not met, offer review for Preferred Product (Cimzia or Taltz).

Rinvoq continuation PA: verify prior use or prior biologic trial

For patients currently receiving Rinvoq/Rinvoq LQ, request prior authorization for continuation by confirming standard Rinvoq/LQ PA criteria and one of the indication‑specific continuity conditions (including prior biologic trial or verification of ≥90 days Rinvoq use with claims), to qualify for a 1‑year approval.

• Continuation verification: ≥90 days on Rinvoq and claim history showing a 90‑day supply within past 130 days, or prescriber verification if claims unavailable.
• If continuity conditions unmet, offer review for specified Preferred alternatives.

Xeljanz/XR initial PA: meet Xeljanz PA + prior biologic trial

For initial Xeljanz/XR requests, document that the patient meets the standard Xeljanz/XR PA criteria and has tried the specified alternative biologic (often Enbrel or an adalimumab product) per the indication to receive a 6‑month initial approval.

• Example: Psoriatic arthritis initial Xeljanz/XR requires trial of Enbrel or an adalimumab product.
• If step criterion not met, offer review for Step 1 Preferred products.

Xeljanz/XR continuation PA: verify prior use or prior biologic trial

For continuation of Xeljanz/XR, provide documentation that the patient meets the standard PA criteria and the indication‑specific condition (e.g., prior biologic trial or established Xeljanz/XR use with claims or prescriber verification) to obtain a 1‑year approval.

• Established use verification: ≥90 days on Xeljanz/XR and claims showing a 90‑day supply within past 130 days, or prescriber attestation if claims unavailable.
• If not met, offer review for Preferred alternatives per step table.

Sotyktu: follow standard Sotyktu PA for initial and continuation

Sotyktu approvals require meeting the standard Sotyktu Prior Authorization Policy criteria for the indication (initial per that PA policy or 1 year for continuation); include required documentation and step‑therapy information when applicable.

• If Care Value additional conditions are not met for requested product, offer review for specified Preferred/Step products per the standard PA policies.

Trial Preferred product(s) per step table before Non‑Preferred

This program requires trials of Preferred Product(s) (Step 1) per the policy table before approval of Non‑Preferred Products, when clinically appropriate; document trials as required by the step table.

• A trial of more than one adalimumab product counts as one Preferred Product trial where noted.
• Exceptions and situations allowing Non‑Preferred trials are described in product‑specific criteria.

Step therapy structure: Step 1 before Non‑Preferred steps

Step structure: require Step 1 (Preferred) trials before advancing to Non‑Preferred (Step 2a/2b/3a/3b); many Non‑Preferred approvals are directed to one Step 1 product or require documented trials of two Step 1/2a products for some Step 3 approvals.

• Some indications specifically direct Non‑Preferred agents to a single Step 1 product (see step table).
• Step 3a Non‑Preferred often requires documentation of trials of TWO Step 1 or 2a products.

Offer review for Preferred/Step products when trials undocumented

If required prior therapy trials are not documented, the policy requires offering review for the listed Preferred/Step products for that indication using the respective standard PA criteria.

• Examples: For Cimzia plaque psoriasis, if two prior agents are not documented, offer review for Preferred products including Enbrel and listed adalimumab products.
• For Simponi indications, offer Step 1/Step 2a product review when prior trials are unmet.

Offer alternative Preferred/Step products when criteria unmet

If the patient has not met the specific trial requirements, the reviewer should offer to review for preferred or step‑product alternatives listed for the indication using their standard PA criteria.

• Example: Entyvio SC initial — if prior‑therapy condition not met, offer review for Step 1 or Step 2a products (adalimumab biosimilars, Omvoh SC, Skyrizi SC, etc.).

Refer to listed Preferred/Step alternatives when trials missing

If required prior trial(s) are not met, direct the reviewer to evaluate a Preferred Product or Step product listed for the indication (specific alternatives enumerated in the policy) under the respective standard PA policy.

• Adalimumab‑ryvk NDCs starting with 82009 are included in preferred lists; trials of multiple adalimumab products count as one where noted.

Offer alternate Preferred/Step products if Care Value conditions fail

When Care Value additional conditions for a requested product are not satisfied, require the reviewer to offer review for specified Preferred or Step products using their standard PA criteria as alternative options.

• Examples: Cosentyx or Siliq Care Value sections instruct offering review for multiple Preferred products when Care Value conditions are unmet.

Offer Step 1/2a alternatives when core criteria unmet

If core criteria are not met for a requested product, the reviewer should offer to review for Step 1 or Step 2a products (extensive lists of biologic or targeted alternatives are provided) using their standard PA criteria.

• Many product sections list Step 1/2a alternatives (adalimumab biosimilars, Enbrel, Skyrizi, Taltz, etc.) that may be reviewed as substitutes.

Offer Preferred/Step alternatives when secondary criteria unmet

If secondary or indication‑specific criteria are not met, offer review for Step 1 or Step 2a / Preferred Products (lists vary by indication) using the respective standard Inflammatory Conditions PA criteria.

• Example: Orencia and other agents list Step 1/2a preferred alternatives when prior‑therapy rules are unmet.
• Lists differ by indication—follow the product section for specifics.

Prior trial of Enbrel/Cimzia/adalimumab commonly required

Many indications require prior trial of specific preferred agents (commonly Enbrel, Cimzia, or an adalimumab product) before approval; if those trials are not documented, the request should be referred for review of a Preferred Product using standard PA criteria.

• Example: Rinvoq and Xeljanz indications commonly require trial of Enbrel or an adalimumab product.
• If trial requirement not met, offer review for listed Preferred alternatives.

Offer review for Step/Preferred products when step criteria unmet

When step criteria (e.g., prior Enbrel or adalimumab trial) are not met, the requestor must be offered review for listed Step 1 or Preferred products and the reviewer must assess those products under their standard PA policies.

• Product lists include multiple adalimumab biosimilars and other preferred agents; document trials per the listed PA criteria when reviewing alternatives.

Check the referenced PA policies for step sequencing details

Refer to the selected standard Prior Authorization Policies for any agent‑ and indication‑specific step therapy sequencing or detailed step requirements.

• The Care Value policy cross‑references product‑specific PA policies which contain detailed sequencing and clinical criteria.

Provide written documentation of prior trials when requested

Prescribers must provide written documentation supporting prior trials when documentation is required (chart notes, prescription claims records, prescription receipts), and include patient identifiers.

• Documentation examples: chart notes, prescription claims, receipts.
• All documentation must include patient‑specific identifying information.

Types of acceptable documentation for prior trials

Acceptable documentation includes chart notes, prescription claims records, and prescription receipts to confirm prior trials; the prescriber must supply these records when the criteria indicate [documentation required].

• Documentation must evidence the agent trialed and dates/duration where possible.
• If claims history is unavailable for continuation, prescriber verification attesting to paid use (no samples/coupons) is required.

Document trials of specified prior therapies (examples provided)

Document trials of the specific prior therapies listed in the criteria (e.g., Enbrel, adalimumab products, Rinvoq, Taltz, Xeljanz/XR, ustekinumab products); note that multiple products of the same molecule class may count collectively as a single trial per policy rules.

• Examples: multiple adalimumab products count as ONE product for meeting trial requirements.
• Document which exact products were used and provide supporting records when requested.

Examples of acceptable trial documentation

When prior‑trial documentation is requested, provide examples such as chart notes, prescription claims records, and prescription receipts to substantiate trials of the named products; note that multiple products within a molecule family may count collectively as one trial.

• Examples listed include Enbrel, adalimumab biosimilars, Rinvoq, Taltz, Xeljanz/XR, Skyrizi, Tremfya, etc.
• Ensure documentation aligns with the trial counting rules described in the policy.

Verify continuation with claims history (90‑day supply within 130 days)

For continuation requests, verify prior use via prescription claims history showing at least a 90‑day supply dispensed within the past 130 days, or provide prescriber verification when claims are unavailable, to meet established‑therapy continuation rules.

• This verification supports a 1‑year continuation approval when other criteria are met.
• If 130 days of claims history is unavailable, prescriber must attest to paid use and duration (no samples/coupons).

Document prior medication trials and claims history for PA

Provide documentation of prior trials of the specified agents (names/examples appear in the policy) and include claims history or prescriber verification to demonstrate prior dispensing when required.

• Documentation must show agent names, dates, and evidence of trial duration where applicable.
• If claims unavailable, prescriber attestation may be used per the policy rules.

Verify prior Cimzia dispensing (≥90‑day supply within 130 days)

To verify established on Cimzia for continuation, provide prescription claims history showing at least a 90‑day supply dispensed within the past 130 days, or obtain prescriber verification if claims are not available.

• This verification supports a 1‑year continuation approval for patients currently receiving Cimzia.
• If claims not available, prescriber must verify the patient has been receiving paid Cimzia for the required period.

Provide claims history or prescriber attestation for established therapy

Document prior medication trials and provide prescription claims history to verify prior dispensing (e.g., 90‑day supply within past 130 days) or prescriber attestation if claims are unavailable; include examples of acceptable agents per the product sections.

• Examples shown across product sections (Entyvio, Orencia, Kineret, etc.) list acceptable prior agents and the documentation required.
• Claims verification exceptions allow prescriber attestation when 130 days of claims history cannot be accessed.

Follow trial counting rules when documenting prior trials

Count trials per the policy's trial‑counting rules: multiple products of the same molecule class (e.g., multiple adalimumab biosimilars) count collectively as a single prior‑product trial; document trials accordingly.

• Policy explicitly notes trials of multiple adalimumab, ustekinumab, tocilizumab, Xeljanz/Rinvoq products count as ONE product where specified.
• Ensure documentation indicates which product family was trialed and how counting rules apply.

Verification requirement for continuation based on prior Rinvoq dispensing

To verify prior Rinvoq therapy for continuation approvals, provide claims history demonstrating at least a 90‑day supply dispensed within the past 130 days; if claims are not available, the prescriber must verify established paid use.

• This verification supports a 1‑year continuation approval under the Rinvoq/LQ section.
• Prescriber verification must attest to paid claims (no samples/coupons) when claims history is unavailable.

Claims or prescriber verification required for Xeljanz/XR continuation

For continuation of Xeljanz/XR, submit prescription claims history showing at least a 90‑day supply dispensed within the past 130 days; if claims are unavailable, include prescriber verification attesting to paid use and duration.

• This evidence supports a 1‑year continuation approval when other PA criteria are met.
• If claims history is incomplete, prescriber attestation must confirm paid dispensing and duration.

Cite the required PA policy (Sotyktu note) when submitting

Include the required standard product PA policy reference when submitting requests; for Sotyktu, be aware that Sotyktu approvals follow its standard Sotyktu Prior Authorization Policy and any Care Value additions.

• Providers must follow the referenced standard PA policies for indication‑specific criteria.
• If Care Value adds prior‑trial requirements, they must be documented in addition to the standard PA criteria.

Risk: missing verification prevents continuation approval

Failure to provide verification of prior use of a Non‑Preferred product (claims showing 90–120 days within a 130‑day lookback or prescriber verification when claims unavailable) may result in non‑approval of continuation requests.

• Claims must show the specified duration within the 130‑day lookback; if not available, prescriber must verify paid use (no samples/coupons).

Risk: lack of continuation verification may trigger denial

If required claims history or prescriber verification for continuation of a Non‑Preferred product is lacking (i.e., failure to verify 90 or 120 days within a 130‑day lookback), the request may be denied.

• This applies to Non‑Preferred subcutaneous and oral products seeking continuation under Care Value rules.
• Prescriber attestation can be used only when claims history is unavailable and must confirm paid use.

Denial risk: Cimzia plaque psoriasis without required trials

Requests for Cimzia for plaque psoriasis will be denied if the requestor does not meet BOTH the standard Cimzia PA criteria and documentation of TWO specified prior therapies as listed for plaque psoriasis.

• Cimzia plaque psoriasis initial requires two prior agents (examples provided) and [documentation required].
• If 5Ai is met but 5Aii is not, reviewer should offer to review for Preferred products.

Claims verification risk for established therapy continuation

If prescription claims history cannot verify the required 90‑day supply within the past 130 days for continuation, the continuity criteria may not be met unless prescriber verification and paid claims evidence are provided, risking non‑approval.

• Examples: Simponi and Bimzelx continuation sections require claim verification of a 90‑day supply within a 130‑day lookback or prescriber verification.
• Prescriber verification must confirm paid dispensing (no samples/coupons).

Denial risk: insufficient Bimzelx prior‑trial history

Failure to meet both the standard Bimzelx PA criteria and the required prior biologic/trial history for the indication will render the request ineligible for approval under the Bimzelx Care Value pathway.

• Example: Bimzelx ankylosing spondylitis initial requires trying one of Enbrel, an adalimumab product, or Taltz.
• If criterion not met, offer review for Preferred Products per the policy.

Denial triggers: missing prior‑therapy or established‑therapy evidence

Failure to meet listed prior‑therapy or established‑therapy requirements (e.g., not documenting required prior trials or established use) will prevent approval under Care Value pathways and may prompt offering review for alternative preferred products.

• Denial triggers include missing documentation of required prior agents or lack of claims verification for established therapy.
• When Care Value criteria are unmet, the reviewer should offer Preferred/Step alternatives.

Denial risk: prior therapy not documented

Failure to document trials of required prior agents (for example, two adalimumab products or other specified alternatives) may result in denial of an initial therapy request for indications that list such requirements (e.g., ulcerative colitis).

• Ensure documentation of the named prior agents and apply trial counting rules when multiple biosimilars were used.
• If not documented, offer review for the listed Preferred products.

Denial risk: unable to verify prior therapy for continuation

For continuation approvals, inability to verify prior use (e.g., 90‑day prior use) via prescription claims or prescriber verification may trigger denial of the continuation request.

• This applies across multiple agents (Entyvio, Ilumya, Siliq examples).
• If claims history is incomplete, prescriber must attest to paid use and duration to avoid denial.

Denial risk: missing required prior‑trial documentation

Failure to document required prior trials of specified therapies (for example, required two prior agents for some psoriatic arthritis adult initial therapy rules) may lead to denial of the initial request.

• Policy sections (Orencia, Cosentyx, Cimzia, etc.) require documentation of specified numbers of prior agents for initial approvals.
• If not met, offer to review for Step 1 or Preferred products.

Denial risk: missing 90‑day prior‑use verification for continuation

For continuation approvals, lack of verification of a 90‑day prior use period (or inability to verify claims history within past 130 days) risks denial unless prescriber verification is provided documenting paid use.

• Examples: Orencia, Olumiant continuation sections require claims proof of 90‑day supply within past 130 days or prescriber verification.
• Prescriber verification must confirm paid claims (no samples/coupons).

Denial risk: failure to meet PA and step therapy requirements

Initial therapy requests may be denied if the patient has not met the standard product‑specific prior authorization criteria or has not trialed the specified preferred biologic(s) required by the step therapy rules (e.g., Rinvoq/LQ indications).

• Example: Rinvoq initial approvals require meeting Rinvoq/LQ PA criteria and specified prior biologic trials; lacking those may prevent approval.
• When unmet, offer review for Preferred alternatives.

Denial risk: Xeljanz/XR initial requests without required trials

Initial Xeljanz/XR requests will be denied if the patient does not meet the standard Xeljanz/XR PA criteria and has not tried required alternative biologic(s) (e.g., Enbrel or an adalimumab product) specified for the indication.

• Example: Xeljanz/XR psoriatic arthritis and ulcerative colitis initial rules require trial of Enbrel or an adalimumab product; lacking this triggers denial.
• If unmet, offer review for Preferred products per the step table.

Denial risk: non‑adherence to referenced standard PA criteria

Requests that do not meet the selected standard Prior Authorization Policy criteria for the specific patient population may be denied; ensure the submitted request adheres to the referenced standard PA policy for that agent and indication.

• Cross‑reference the product‑specific PA policy cited in the Care Value document before submission.
• Provide all required documentation and claims verification as described to reduce denial risk.

Adalimumab‑ryvk NDC prefix noted for preferred listings

NDCs beginning with 82009 (adalimumab‑ryvk) are identified in policy tables as preferred/Step 1 adalimumab products; when documenting trials of adalimumab products include the product/NDC as applicable.

Multiple adalimumab products count as one trial

A trial of multiple adalimumab products counts collectively as one prior trial for meeting step requirements; document the adalimumab family trial accordingly rather than counting each brand separately.

Adalimumab products listed as Preferred/Step options (NDC prefix noted)

Adalimumab products (including adalimumab‑ryvk NDCs starting with 82009) are listed among Preferred or Step options to review when initial criteria are not met; document trials of these specific products as indicated.

Infliximab (Remicade/biosimilars) may count toward prior‑therapy requirement

A trial of an infliximab product (e.g., Remicade or biosimilars) may count toward required prior therapy for several indications — include documentation when relying on an infliximab trial.