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Florida-Medicaid HCV Criteria/Sovaldi .....August 8, 2014 pdf attached
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Sovaldi criteria pdf:
http://ahca.myflorida.com/Medicaid/Prescribed_Drug/drug_criteria_pdf/Sovaldi_Criteria.pdf
Download the PDF here
Excerpts:
for Gt1
1 - Prescribed by a hepatologist, gastroenterologist, infectious disease specialist or transplant physician
2 - Patient has abstained from the use of illicit drugs and alcohol for a minimum of one month as evidenced by negative urine or blood confirmation tests collected within the past 30 days, prior to initiation of therapy (results must be submitted with request);
If the test results submitted is positive the reviewer must review claims history or medical records to determine if medications are prescribed. If so proceed to next step (#5).
OR
Patient is receiving substance or alcohol abuse counseling services or seeing an addiction specialist as an adjunct to HCV treatment and it is documented in the medical records;
3 - HCV & HCV/HIV-1 Co-Infection - Genotype 1 or 4 (Interferon Ineligible)
Evidence of Stage 3 or Stage 4 hepatic fibrosis including one of the following:
· Liver biopsy confirming a METAVIR score of F3 or F4; OR
· Transient elastography (Fibroscan) score greater than or equal to 9.5 kPa; OR
· FibroTest score of greater than or equal to 0.58; OR
· APRI score greater than 1.5; OR
· Radiological imaging consistent with cirrhosis (e.g., evidence of portal hypertension); OR
· Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician.
4 - For HIV-1 co-infected patients, patients must have the following:
· Documented HIV-1 diagnosis, AND
· CD4 count greater than 500 cells/mm3, if patient is not taking antiretroviral therapy; OR
· CD4 count greater than 200 cells/mm3, if patient is virologically suppressed (e.g., HIV RNA < 200 copies/mL)
5 - Lab results (HCV RNA) collected two or more weeks after the first prescription fill date must indicate a response to therapy (≥ 2 log reduction in HCV RNA or HCV RNA < 25 IU/ml). Copy of results must be submitted.
a. Subsequent reauthorization is contingent upon subsequent HCV viral load results
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