Subject: tiopronin products 2991-A SGM P2024b
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THIOLA
(tiopronin)
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THIOLA EC
(tiopronin delayed-release tablets)
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tiopronin
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tiopronin delayed-release tablets
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Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are
considered a covered benefit provided that all the approval criteria are met and the member
has no exclusions to the prescribed therapy.
FDA-Approved Indication
Thiola and Thiola EC are indicated, in combination with high fluid intake, alkali, and diet
modification, for the prevention of cystine stone formation in adult and pediatric patients 20 kg
and greater with severe homozygous cystinuria who are not responsive to these measures
alone.
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
A. Initial requests:
1. Genetic testing results, stone analysis, or urine microscopy supporting diagnosis; and
2. Lab results documenting baseline urinary cystine levels.
B. Continuation of therapy requests: lab results or chart notes documenting a benefit from
therapy.
III. CRITERIA FOR INITIAL APPROVAL
Cystinuria
Authorization of 12 months may be granted for prevention of cystine stone formation in a
member with severe homozygous cystinuria when all of the following criteria are met:
A. Diagnosis of cystinuria was established by one or more of the following:
1. Biallelic mutations/variants in the SLC3A1 or the SLC7A9 gene confirmed by genetic
testing.
2. Stone analysis revealing 100 percent cystine calculi.
3. Presence of pathognomonic hexagonal cystine crystals visualized on urine microscopy.
B. The requested medication is being used as an adjunct to high fluid intake, alkali, and diet
modification.
C. The member has elevated urinary cystine levels at baseline.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for an indication listed in Section III who are experiencing benefit from therapy
(e.g., a decrease in urinary cystine levels compared to pretreatment baseline, reduction in
stone formation/growth).
Place of Service:
Outpatient
The above policy is based on the following references:
- Thiola [package insert]. San Antonio, TX: Mission Pharmacal Company; January 2021.
- Thiola EC [package insert]. San Antonio, TX: Mission Pharmacal Company; March 2021.
- Biyani CS, Cartledge JJ. Cystinuria- diagnosis and management. Eur Urology. 2006; 4:175-183.
- Pearle MS, Goldfarb DS, Assimos DG, et al: Medical management of kidney stones: AUA Guideline. J Urol 2014; 192: 316.
- Goldfarb DS, et al. Cystinuria and cystine stones. UpToDate, Lam, AQ (Ed), Waltham, MA, 2023. URL: www.uptodate.com. Accessed February 2, 2024.
- Tiopronin [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; February 2021.
- Tiopronin delayed release [package insert]. Basking Ridge, NJ: Torrent Pharma Inc.; February 2024.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
June 16, 2024
