April 19th, 2018
The CMS National Coverage Decision on NGS
New Insights: As a result of the recent CMS National Coverage Decision on NGS, the MolDX® program of Palmetto GBA® is now actively considering cover...
Number of Citations in Google
Familiarity with the concept of Personalized Healthcare
Stakeholders: regulators, policy makers, payers, patient organisations
Physicians: oncologists, pathologists, virologists, laboratory heads
Today the majority of oncologists primarily responsible for test prescribing are familiar with personalized medicine.
Payer and stakeholder awareness still needs to improve so that personalized medicine's full potential can be realized.
Oncology remains the leading therapy area for personalized medicine, with 2013 seeing an increase in cancer-associated biomarkers in FDA-approved tests (thanks to the approval of Prosignia, Nanostring with 45 novel biomarkers).
Today, nearly three-quarters of all Phase 3 pipeline from 12 leading pharma companies can be considered as personalized medicine, which is up from just over a half in 2011.
|Bosutinib (Bosulif®)||BCR-ABL1||Leukemia: The molecular response measured by BCR-ABL1 RT-qPCR assists in identifying suboptimal responses and can help inform the decision to switch to alternative therapies that may be more efficacious (or to pursue more stringent monitoring). Furthermore, the tyrosine kinase inhibitor–mediated molecular response provides valuable risk stratification and prognostic information on long-term outcomes.||2012|
|Pertuzumab (Perjeta®)||HER2 / neu receptor||Breast cancer: Indicated in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.||2012|
|Trametinib (Mekinist®); Dabrafenib (Tafinlar®)||BRAF||Melanoma: Indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.||2013|
|Ponatinib (Iclusig®)||BCR-ABL1||Leukemia: The molecular response measured by BCR-ABL1 RT-qPCR assists in identifying suboptimal responses and can help inform the decision to switch to alternative therapies that may be more efficacious (or to pursue more stringent monitoring). Ponatinib is a kinase inhibitor, which inhibits the in vitro tyrosine kinase activity of ABL and T315I mutant ABL.||2013|
|Drug||Therapeutic Area*||Biomarker||Referenced Subgroup||Labelling Sections|
|Afatinib||Oncology||EGFR||EGFR exon 19 deletion or exon 21 substitution (L858R) positive||Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies|
|Bosutinib||Oncology||BCR/ABL1||Philadelphia chromosome positive||Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies|
|Ado-Trastuzumab Emtansine||Oncology||ERBB2||HER2 protein overexpression or gene amplification positive||Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies|
|Vemurafenib||Oncology||BRAF||BRAF V600E mutation positive||Indications and Usage, Warning and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counselling Information|