CurrentHawaii Medical Service Association (HMSA)Policy N/A

Prior authorization request form for specialty gout therapy (Krystexxa reference)

Prior authorization form used by CVS Caremark for HMSA Medicare Advantage members that defines clinical and administrative information required for initial and continuation coverage of specialty injectable therapy for chronic gout.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyPrior authorization request form for specialty gout therapy (Krystexxa reference)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionFax the completed prior authorization form and supporting clinical information to CVS Caremark at 1-866-237-5512.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1-866-237-5512submission fax number

1-808-254-4414prior authorization contact

CaremarkConnect 1-800-237-2767specialty customer care

Krystexxa 1/2024document footer

Coverage Criteria

Initial Therapy Criteria

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyPrior authorization request form for specialty gout therapy (Krystexxa reference)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionFax the completed prior authorization form and supporting clinical information to CVS Caremark at 1-866-237-5512.

SourceLink

On This Page

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Initial therapy requirements: 1) Diagnosis of chronic gout; 2) Request documents whether drug will be used concomitantly with oral urate-lowering therapies; 3) Member is refractory to conventional therapy (e.g., allopurinol, febuxostat) at the maximum medically appropriate dose OR there is a documented clinical reason to avoid conventional therapies; 4) Will co-administer weekly oral methotrexate plus folic/folinic acid supplementation OR there is a documented contraindication/clinical reason to avoid methotrexate.

Form branches based on answers to questions #5–#9; provider must supply clinical reasons when indicating avoidance or contraindication.

Continuation Therapy Criteria

Covered when documentation supports benefit and lab criteria are met

Continuation therapy requirements: 1) Member is receiving benefit from the requested drug therapy (examples include serum uric acid < 6 mg/dL, reduction of tophi, reduction of symptoms and/or flares) AND 2) Medical records (e.g., chart notes, lab test results) documenting response to therapy are available upon request.serum uric acid < 6 mg/dL

Form asks whether the member has had two consecutive serum uric acid levels above 6 mg/dL since starting therapy (if yes, no further questions).

Initial Therapy Criteria

Initial — Detailed Requirements

Initial use requires demonstration of refractoriness to or contraindication for conventional oral urate‑lowering therapies and consideration of concomitant therapies.

Diagnosis and concomitant therapy: 1) Diagnosis: chronic gout; 2) Indicate whether the requested drug will be used concomitantly with oral urate‑lowering therapies (Yes/No).

Refractoriness or clinical avoidance of conventional therapy

Refractory to conventional therapy: Member is refractory to conventional therapy (e.g., allopurinol, febuxostat) at the maximum medically appropriate dose.
Clinical reason to avoid conventional therapies: Documented clinical reason to avoid therapy with all conventional therapies (provider must provide clinical rationale in the space provided on the form).

Methotrexate co‑administration or contraindication: Will the requested drug be co‑administered with weekly oral methotrexate plus folic acid or folinic acid supplementation? If No, document whether the patient has a contraindication to or clinical reason to avoid oral methotrexate (examples: liver disease, breastfeeding, blood dyscrasias, intolerance, hypersensitivity, renal impairment).

Continuation Therapy Criteria

Continuation — Ongoing Approval and Monitoring Requirements

Continuation requests must document continued benefit and appropriate laboratory monitoring.

Demonstration of clinical benefit: Member demonstrates benefit from therapy (examples: serum uric acid < 6 mg/dL, reduction of tophi, reduction in symptoms/flares).

Documentation availability: Medical records (e.g., chart notes, lab test results) documenting response to therapy must be available upon request for review by CVS Caremark or the benefit plan sponsor.

Laboratory monitoring question: Indicate whether the member has had two consecutive serum uric acid levels above 6 mg/dL since starting treatment with the requested drug; if Yes, the form indicates 'No Further Questions'.two consecutive serum uric acid > 6 mg/dL

Continuation therapy — definitions, benefit examples, and monitoring thresholds

DefinitionOngoing treatment where documentation must show the member is receiving benefit (examples: serum uric acid < 6 mg/dL, reduction of tophi, reduction of symptoms and/or flares).

Required documentationMedical records (e.g., chart notes, lab test results) demonstrating response to therapy must be available upon request.

Monitoring questionForm asks whether the member has had two consecutive serum uric acid levels > 6 mg/dL since starting the requested drug (affirmative response ends further questions).

Clinical benefit examplesSerum uric acid < 6 mg/dL; reduction of tophi; reduction of symptoms and/or gout flares.

Coding

Diagnosis code fieldICD-10

ICD-10 code (blank field on form)

Serum uric acid — laboratory thresholds and interpretation

Primary laboratory thresholdSerum uric acid < 6 mg/dL is cited as an example of clinical benefit.

Trigger for additional reviewThe form asks whether the member has had two consecutive serum uric acid levels above 6 mg/dL since starting treatment; two consecutive > 6 mg/dL is queried.

Use of levels in decisionsSerum uric acid levels and trends are used to document continued benefit for continuation requests; documentation must be available upon request.

Provider Actions & Submission Requirements

Prior Authorization

Prior Authorization Submission

Prior authorization is required for certain specialty medications administered through the CVS Caremark pharmacy benefit. Submit the completed prior authorization form and supporting clinical documentation to CVS Caremark Specialty Programs for HMSA Medicare Advantage members. Fax submissions toll-free to 1-866-237-5512. For prior authorization questions call CVS Caremark at 1-808-254-4414. For patient eligibility, copay, or medication delivery questions contact CaremarkConnect® at 1-800-237-2767.

Fax: 1-866-237-5512 (toll-free)
PA questions: 1-808-254-4414
CaremarkConnect (eligibility/cost/delivery): 1-800-237-2767

Denial Risk

Submission Requirement — Complete Documentation Required

Failure to submit the required prior authorization form and all requested clinical information (including diagnoses, prior therapy details, and relevant labs) may result in denial of coverage. Ensure the prescriber signs and dates the form and that documentation supporting clinical statements is available upon request.

Include prescriber signature and date
Attach relevant clinical records (chart notes, labs)
Incomplete submissions may be denied

Step Therapy

Step Therapy / Prior Failure Requirements

For initial requests, document trial and failure or intolerance to conventional oral urate-lowering therapies (e.g., allopurinol, febuxostat) at maximum medically appropriate doses, or provide a clinical rationale for avoidance. Indicate whether the requested agent will be used concomitantly with oral urate-lowering therapy and whether methotrexate prophylaxis will be co-administered when applicable.

Document trials of allopurinol and febuxostat (doses and dates)
If avoiding conventional therapy, provide specific clinical reason
State whether methotrexate + folic/folinic acid will be co-administered

Documentation Required

Supporting Documentation for Continuation

For continuation requests, clinical benefit must be documented. Medical records (chart notes, laboratory results such as serum uric acid levels, and other relevant documentation) must be available upon request to support ongoing benefit from therapy.

Document response to therapy (e.g., serum uric acid < 6 mg/dL, reduction of tophi or flares)
Provide two consecutive serum uric acid levels when requested
Maintain copies of chart notes and lab results for review

Site of Care

Note

Specify site of care (dispensing and administration)

Indicate where the drug will be dispensed and where it will be administered by selecting the appropriate setting(s) on the form.

Dispensed setting options include: Office, Outpatient Hospital, Ambulatory Surgical, Inpatient Hospital, Pharmacy, Other.
Administration setting options include: Ambulatory surgical, Home, Inpatient Hospital, Office, Outpatient Hospital, Pharmacy.

Step Therapy / Prior Failure

Required documentation	Details / examples
Documentation of failure or intolerance to conventional oral urate‑lowering therapies (e.g., allopurinol, febuxostat)	Form asks: 'Is the member refractory to conventional therapy (e.g., allopurinol, febuxostat) at the maximum medically appropriate dose?' — provider must indicate Yes and may supply clinical notes, dosing history, or evidence of adverse effects
Clinical reason to avoid conventional therapies	Form asks: 'Does the member have a clinical reason to avoid therapy with all conventional therapies? (Please provide the clinical reason in the space provided.)' — provider must document the specific clinical rationale (for example, contraindication, intolerance, comorbidity) in the space provided on the form
Planned concomitant urate‑lowering therapy and methotrexate prophylaxis documentation	Form asks whether the requested drug will be used with oral urate‑lowering therapies and whether weekly oral methotrexate plus folic/folinic acid supplementation will be co‑administered or if there is a contraindication to methotrexate — provider must document responses and any contraindications or clinical reasons to avoid methotrexate (e.g., liver disease, breastfeeding, blood dyscrasias, intolerance, hypersensitivity, renal impairment)
Supporting medical records for continuation	For continuation requests, the form requires documentation that the member is receiving benefit (e.g., serum uric acid < 6 mg/dL, reduction of tophi, reduction of symptoms/flares) and that medical records documenting response are available upon request

Definitions

Initial therapy — definition and considerations

Definition of initial therapyA request for new treatment — the form directs 'Initial therapy' responses to the initial therapy section and related questions (see concomitant therapies, refractoriness, methotrexate use).

Refractoriness requirementInitial use requires documentation whether the member is refractory to conventional therapy (e.g., allopurinol, febuxostat) at the maximum medically appropriate dose or has a clinical reason to avoid them.

Concomitant therapy considerationThe form asks whether the requested drug will be used concomitantly with oral urate-lowering therapies and whether weekly oral methotrexate plus folic/folinic acid supplementation will be co-administered or is contraindicated.

Routing on the formIf 'Initial therapy' is selected on the diagnosis/questions screen, the form instructs the provider to continue to the initial therapy question set (items #5–#9).

Continuation therapy — what constitutes continuation and clinical benefit examples

What constitutes continuationOngoing treatment in which the member demonstrates benefit (e.g., serum uric acid < 6 mg/dL, reduction of tophi, reduction of symptoms/flares) and for which records documenting response are available upon request.

Examples of documented clinical benefitMeasured serum uric acid below 6 mg/dL; objective reduction in tophi; fewer or less severe gout flares or symptoms recorded in clinical notes.

Laboratory monitoringThe form specifically asks whether the member has had two consecutive serum uric acid levels above 6 mg/dL since starting treatment — an affirmative response halts further questions.

Background

This prior authorization form is used to request specialty injectable therapy for treatment of chronic gout. It separates requests for initial therapy versus continuation therapy and asks for objective measures of response — notably whether the member is receiving benefit (e.g., serum uric acid < 6 mg/dL, reduction in tophi, or fewer flares) and whether two consecutive serum uric acid levels have been >6 mg/dL since starting the drug. The form also stops the gout-specific workflow if the selected diagnosis is Other.