Table 2.
Cpic Level | Clinical Context | Level of Evidence | Strength of Recommendation |
---|---|---|---|
A | Genetic information should be used to change the prescribing of the affected drug. | The preponderance of the evidence is high or moderate in favor of changing prescribing. | At least one moderate or strong action (change in prescribing) is recommended. |
A/B | Preliminary review indicates it is likely that the definitive CPIC level will be either A or B. | Full evidence review is needed to assess the level of evidence, but prescribing actionability is likely. | Full review by expert guideline group to assign strength of recommendation. |
B | Genetic information could be used to change prescribing of the affected drug because alternative therapies/dosing are extremely likely to be as effective and as safe as non-genetically based dosing. | The preponderance of the evidence is weak with little conflicting data. | At least one optional action (change in prescribing) is recommended. |
B/C | Preliminary review indicates it is likely that the definitive CPIC level will be either B or C. | Prescribing actionability based on genetics is not clear without further evidence review. | Full review by expert guideline group to assess the strength of recommendation. |
C | There are published studies at varying levels of evidence, some with mechanistic rationale, but no prescribing actions are recommended because (a) dosing based on genetics makes no convincing difference; (b) alternatives are unclear, possibly less effective, more toxic, or otherwise impractical; or (c) few published studies or mostly weak evidence and clinical actions are unclear. Most important for genes that are subject to other CPIC guidelines or genes that are commonly included in clinical or DTC tests. | Evidence levels can vary. | No prescribing actions are recommended. |
C/D | Preliminary review indicates it is likely that the definitive CPIC level will be either C or D. | Evidence levels can vary. | No prescribing actions are recommended. |
D | There are few published studies, clinical actions are unclear, little mechanistic basis, mostly weak evidence, or substantial conflicting data. If the genes are not widely tested clinically, evaluations are not needed. Criteria for “widely tested” includes: 1) College of American Pathologists (CAP) proficiency testing is available; 2) gene is in disease-specific panels (e.g., pain, psychiatric, cancer, etc.); or 3) evidence exists for implementation of the gene into clinical practice (CPIC member feedback, publications, etc.). | Evidence levels can vary. | No prescribing actions are recommended. |
Adopted from cpicpgx.org/.