CurrentAvMedPolicy N/A

Tiopronin (Thiola) prior authorization

This form governs prior authorization and step-edit requests for tiopronin products for AvMed members; it outlines required documentation, clinical criteria for initial and reauthorization, and administrative submission instructions affecting prescribers and specialty pharmacy.

Policy Summary

PayerAvMed

PolicyTiopronin (Thiola) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign and print name on the PA/step-edit request form and fax to AvMed; requests missing required information may be delayed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

12 moReauthorization duration

>500 mg/dayInitiation urine cystine

≥20 kgPediatric minimum weight

<250 mg/LMaintenance target

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization - All criteria: Provider requesting this medication is a nephrologist or has experience in treating/monitoring members with homozygous cystinuria (documentation attached); member has a confirmed diagnosis of homozygous cystinuria with supporting documentation including family history, history of nephrolithiasis, kidney stone collection analysis, and metabolic testing/24-hour urinalysis; urine cystine level > 500 mg/day (laboratory results attached); prevention of recurrent cystine stones has NOT been achieved with increased fluid intake, restriction of sodium/protein intake, and urinary alkalinization (documentation of trials and failures attached); a baseline urinary protein level has been measured and there are no signs of proteinuria (laboratory results attached); a lower dose will be initiated for members with prior severe D-penicillamine toxicity; for pediatric patients, current weight is ≥ 20 kg (tiopronin will NOT be approved for members < 20 kg or for doses > 50 mg/kg).see node texts

Initial authorization duration: 6 months

Continuation / Reauthorization

Reauthorization covered when ALL of the following are met:

Policy Summary

PayerAvMed

PolicyTiopronin (Thiola) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign and print name on the PA/step-edit request form and fax to AvMed; requests missing required information may be delayed.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Reauthorization - All criteria: Member does NOT have signs of proteinuria (most recent urinalysis attached); provide the most recent urinary cystine measurements (laboratory results attached); maintenance dose has been adjusted to reduce urinary cystine concentration to < 250 mg/L; improvement or reduction in cystine crystalluria has been observed and documented with follow-up chart notes attached.see node texts

Reauthorization duration: 12 months; renal function, 24-hour urinary protein and urinalysis should be measured at baseline and every 3-6 months; urinary cystine measured 1 month after initiation and every 3 months thereafter.

Tiopronin (Thiola) will NOT be approved for members whose current weight is 20 kg. In addition, tiopronin will not be approved for dosing that exceeds 50 mg/kg.

Coding and Clinical Thresholds

Urine cystine level for initiation and maintenance

Initiation thresholdUrinary cystine > 500 mg/day (laboratory results must be attached)

Maintenance targetMaintenance dose should be adjusted to reduce urinary cystine concentration to < 250 mg/L

Monitoring frequencyUrinary cystine measured 1 month after initiation and then every 3 months thereafter

Pediatric minimum weight

Minimum pediatric weightCurrent weight ≥ 20 kg (tiopronin will NOT be approved for members < 20 kg)

Weight documentationCurrent weight measurement and date must be provided on the request

Dose restriction noteTiopronin will NOT be approved for doses greater than 50 mg/kg

Initial Authorization criteria (definition)

DefinitionInitial authorization: treatment for prevention of recurrent cystine stones in confirmed homozygous cystinuria when urine cystine >500 mg/day and conservative measures have failed; request must include diagnostic documentation and labs.

Provider requirementProvider requesting therapy should be a nephrologist or have experience treating/monitoring homozygous cystinuria

Initial durationInitial authorization period: 6 months

Initial Therapy Criteria

Initial therapy

Covered when ALL of the following are met for initial authorization:

Initial: Provider expertise: provider requesting medication is a nephrologist or has experience treating/monitoring homozygous cystinuria (documentation attached); confirmed diagnosis of homozygous cystinuria with required documentation (family history, nephrolithiasis history, kidney stone analysis, metabolic testing/24-hour urinalysis); urine cystine > 500 mg/day with laboratory results attached; failure of conservative therapies (increased fluids, sodium/protein restriction, urinary alkalinization) with documentation of trials and failures; baseline urinary protein measured with no signs of proteinuria (laboratory attached); lower dose to be initiated if prior severe D-penicillamine toxicity; pediatric patients must have current weight ≥ 20 kg (tiopronin not approved < 20 kg or for doses > 50 mg/kg).see texts

Initial authorization duration: 6 months

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization requirements

Reauthorization: No proteinuria on urinalysis (most recent results attached); recent urinary cystine measurements provided (laboratory results attached); maintenance dose adjusted to achieve urinary cystine < 250 mg/L; documented reduction in cystine crystalluria with follow-up chart notes attached.see texts

Reauthorization duration: 12 months; renal function, 24-hour urinary protein and urinalysis should be measured baseline and every 3-6 months; urinary cystine measured 1 month after initiation and every 3 months thereafter.

Step Therapy Requirements

Required prior step	Documentation required
Increased fluid intake and dietary modification (sodium/protein restriction)	Chart notes documenting trial and failure of conservative measures (dates, duration, response)
Urinary alkalinization therapy trial	Chart notes documenting trial and failure of urinary alkalinization (including doses and duration)
Measurement of urine cystine level prior to treatment	Laboratory results showing urine cystine > 500 mg/day (must be attached)
Verification of prior therapies and medication history	Pharmacy claims or submitted chart notes verifying prior medication use; note that use of samples to initiate therapy does not meet step edit/preauthorization criteria

Provider Actions and Submission Requirements

Prior Authorization

Submission and Signature Requirement

The prescribing physician must sign and clearly print their name on the prior authorization/step-edit request (pre-printed stamps are not valid). Office staff may complete other fields. Fax the completed request to 1-305-671-0200. Incomplete, incorrect, or illegible information — including missing phone/fax numbers — may delay the authorization process.

Note

Drugs Covered by This PA

Drugs covered by this prior authorization: tiopronin products (Thiola® generics and formulations).

tiopronin (generic Thiola)
tiopronin delayed-release tablets (Thiola EC)
venxxiva (Thiola generic)

Documentation Required

Samples and Verification

Samples do not meet step edit/prior authorization criteria and cannot be used to initiate therapy. Prior therapies will be verified through pharmacy paid claims or submitted chart notes.

Documentation Required

Required Supporting Documentation

All required supporting documentation must be attached or the request may be denied. Required items include: family history and history of nephrolithiasis, kidney stone collection analysis, metabolic testing/24-hour urinalysis, urine cystine level laboratory results, baseline urinary protein and urinalysis, documentation of prior therapy trials (fluid/sodium/protein restriction and alkalinization) and follow-up chart notes showing improvement/reduction in cystine crystalluria. For pediatric patients include current weight and date.

Family history and history of nephrolithiasis
Kidney stone collection analysis
Metabolic testing / 24‑hour urinalysis
Urine cystine level laboratory results (>500 mg/day for baseline)
Baseline urinary protein and urinalysis (no proteinuria)
Documentation of trials/failures of fluid intake, sodium/protein restriction, urinary alkalinization
Follow-up chart notes showing improvement/reduction in cystine crystalluria
For pediatrics: current weight and date (must be ≥ 20 kg)

Denial Risk

Incomplete or Missing Documentation — Risk of Delay/Denial

Incomplete, incorrect, or illegible requests — or missing required laboratory results, diagnostics, or documentation of diagnoses/prior therapies — may result in delays or denial of authorization.

Site of Care and Dispensing

Note

Specialty Pharmacy dispensing and plan coverage caveat

Medication is provided by the Specialty Pharmacy Proprium Rx; coverage depends on the member's plan and non‑formulary drugs may require medical necessity documentation.

Medication being provided by Specialty Pharmacy - Proprium Rx.
Not all drugs may be covered under every plan; non‑formulary drugs require documentation of medical necessity.

Background

Tiopronin is a cysteine‑binding agent used to prevent recurrent cystine kidney stones in patients with homozygous cystinuria. Management includes measurement of urine cystine and urinary protein, dietary measures (increased fluid intake, sodium/protein restriction) and urinary alkalinization; tiopronin is prescribed when conservative measures fail and urine cystine remains elevated. Prescribers must complete and sign the prior‑authorization/step‑edit request form for tiopronin products (including generic Thiola, delayed‑release Thiola EC and related formulations) when requesting coverage.