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The Policy VaultThe Policy Vault

Tykerb (lapatinib)United Healthcare

Colon Cancer

Initial criteria

  • Diagnosis of colon cancer
  • AND Disease is HER2-amplified and RAS and BRAF wild-type
  • AND One of the following:
  • Disease is proficient mismatch repair/microsatellite-stable (pMMR/MSS)
  • OR
  • Disease is positive for deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) or polymerase epsilon/delta (POLE/POLD1) mutation
  • AND One of the following:
  • Ineligible for or progressed on checkpoint inhibitor immunotherapy [e.g., Opdivo (nivolumab), Keytruda (pembrolizumab), Jemperli (dostarlimab-gxly)]
  • OR Has a contraindication to checkpoint inhibitor immunotherapy
  • AND One of the following:
  • Used as initial therapy for unresectable metachronous metastases AND previous therapy with FOLFOX or CapeOX within the past 12 months
  • OR Intensive chemotherapy with oxaliplatin, irinotecan, or capecitabine is not recommended
  • OR Used as second-line or subsequent therapy for progression of advanced/metastatic disease
  • AND Used in combination with trastuzumab
  • AND Patient has not previously been treated with a HER2 inhibitor [e.g., trastuzumab, Perjeta (pertuzumab), Nerlynx (neratinib)]

Reauthorization criteria

  • Patient does not show evidence of progressive disease while on Tykerb therapy

Approval duration

12 months