QINLOCK (ripretinib)

QINLOCK (ripretinib)

SELF-ADMINISTRATION

Indications for Prior Authorization:

• Indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with ? 3 kinase inhibitors, including imatinib.

Patients must meet the following criteria for the indication(s) above:

• Diagnosis of gastrointestinal stromal tumor (GIST), AND
• Prescribed by or in collaboration with an oncologist, AND
• Patient is 18 years of age or older, AND
• Previously treated with ? 3 kinase inhibitors (e.g., Avapritinib, Sunitinib, Regorafenib), including Imatinib

Reauthorization Criteria:

• Chart note documentation confirming a positive clinical response to therapy and there is no evidence of unacceptable toxicity or disease progression while on current regimen

Additional Information:

• Risk of Tuberculosis (TB): patients should be tested for latent TB (e.g. TB skin test, QuantiFERON TB Gold test, or chest x-ray) before Humira® use and during therapy. Treatment for latent infection should be initiated prior to Humira® use.
• Do not administer live vaccines or attenuated vaccines concurrently with Humira®.

Dosing:

• 150 mg once daily

Warning/Precautions:

• Palmar-plantar erythrodysesthesia syndrome
• New primary cutaneous malignancies
• Hypertension: do not initiate if uncontrolled hypertension
• Cardiac dysfunction: permanently discontinue for grade 3 or 4 left ventricular dysfunction
• Risk of impaired wound healing: withhold for at least 1 week prior to elective surgery
• Embryo-fetal toxicity
• Avoid concomitant use of strong CYP3A inducers

Coverage Duration:

• Initial: 6 months
• Continuation: 1 year

Authorization is Not Covered for the Following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Review History:

• 5/15/2020 – New policy.

References:

• Ayvakit [package insert], Cambridge, MA: Blueprint Medicines Corporation; January 2020.
• Blay JY, Serrano C, Heinrich MC, et al. Ripretinib in patients with advanced GIST (INVICTUS): a double-blind, randomized, placebo-controlled, phase 3 trial [published online ahead of print, 2020 Jun 5]. Lancet Oncol. 2020;S1470-2045(20)30168-6. doi:10.1016/S1470-2045(20)30168-6.
• Blueprint Medicines Corporation. Blueprint Medicines announces PDUFA date extension for new drug application of avapritinib for the treatment of adults with fourth-line gastrointestinal stromal tumor (press release). February 6, 2020. Blueprint Medicines Web site. http://ir.blueprintmedicines.com/news-releases/news-release-details/blueprint-medicines-announces-pdufa-date-extension-new-drug. Accessed June 11, 2020.
• Clinicaltrials.gov Web site. https://clinicaltrials.gov. Identifiers: NCT03353753, NCT03673501. Accessed June 9, 2020.
• Drugs@FDA: FDA approved drug products. Food and Drug Administration website. 2020. http://www.accessdata.fda.gov/scripts/cder/daf. Accessed June 5, 2020.
• Food and Drug Administration. Multi-discipline review: Ayvakit. 2020. FDA Web site. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212608Orig1s000MultidisciplineR.pdf. Accessed June 11, 2020.
• Food and Drug Administration. Multi-discipline review: Qinlock. July 4, 2019. FDA Web site. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213973Orig1s000MultidisciplineR.pdf. Accessed June 24, 2020.
• Food and Drug Administration. FDA approves ripretinib for advanced gastrointestinal stromal tumor. May 15, 2020. FDA Web site. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-ripretinib-advanced-gastrointestinal-stromal-tumor. Accessed June 12, 2020.
• Gleevec [package insert], East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2020.
• Mazzocca A, Napolitano A, Silett M, et al. New frontier in the medical management of GIST. Ther Adv Med Oncol. 2019;11:1-13.
• Morgan J. Tyrosine kinase inhibitor therapy for advanced gastrointestinal stromal tumors. UpToDate Web site. Updated June 1, 2020. https://www.uptodate.com. Accessed June 11, 2020.
• Morgan J, Raut CP, Duensing A, et al. Epidemiology, classification, clinical presentation, prognostic features, and diagnostic work-up of gastrointestinal stromal tumors (GIST). UpToDate Web site. Updated October 23, 2018. https://www.uptodate.com. Accessed June 11, 2020.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Soft tissue sarcoma, version 2.2020. May 28, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf. Accessed June 10, 2020.
• Nexavar [package insert], Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; March 2020.
• Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.
• Qinlock [package insert], Waltham, MA: Deciphera Pharmaceuticals, LLC; May 2020.
• Sprycel [package insert], Princeton, NJ: Bristol-Myers Squibb Company; December 2018.
• Stivarga [package insert], Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; February 2020.
• Sutent [package instert], New York, NY: Pfizer Laboratories Div Pfizer Inc.: May 2019.
• Tasigna [package insert], East Hanover, NJ: Novartis Pharmaceuticals Corporation; September 2019.
• von Mehren M, Serrano C, Bauer S, et al. LBA87 - INVICTUS: A phase III, interventional, double-blind, placebo-controlled study to assess the safety and efficacy of ripretinib as ? 4th-line therapy in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior anticancer therapies (NCT03353753). Abstract LBA87. Presented at: 2019 ESMO Congress. Ann Oncol. 2019:30 (suppl_5): v851-v934. 10.1093/annonc/mdz394
• von Mehren M, Joensuu H. Gastrointestinal stromal tumors. J Clin Oncol. 2018;36(2):136-143.
• Votrient [package insert], East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2020.