Download NM HSD HCV Checklist for Sovaldi

HCV Checklist
PATIENT NAME:
CLINICAL CRITERIA
DOB:
1. Please indicate desired treatment regimen (including medications, dose of each medication, duration of therapy)
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
2. DIAGNOSIS:
Chronic Hepatitis C Infection
a. Genotype _______ Subtype (if applicable)_______( please attach results)
b. HCV RNA Level within the past 12 months: Level:______________ Date:____/_____/____(attach results)
3. Yes
No
Yes
Patient with current alcohol or illicit drug use
No
If yes to above question, is patient receiving or has been offered counseling/treatment
4. Yes
No
Prescribed by gastroenterologist, infectious disease specialist, hepatologist, primary care provider
experienced in treating hepatitis C infection or primary care provider with treatment recommendation from any
aforementioned specialist (to include recommendations received via Telemedicine or phone)
a. If consultation occurred, provide name of specialist who was consulted:
Name________________________, Phone______________________
5. Yes
No
Is patient treatment experienced? (If ‘Yes’ answer a, b & c If no go to Liver Assessment ))
a. List regimen patient has received including duration of therapy:
_______________________________________________________________________________________
b. Yes
No
Did Patient complete regimen? If not, reason for discontinuation of therapy
_______________________________________________________________________________________
c. What was patient’s response to therapy?
Relapser.
Non-responder (Includes null responders (serum HCV
RNA levels declined less than 2 log10 IU/ml by week 12) and partial responders (≥ 2 log10 IU/ml response whose
virus remained detectable by week 24)
LIVER ASSESSMENT
1. Yes
No
Does the patient have one of the following extra-hepatic manifestation of HCV Infection:
Lymphoma, Vasculitis, or Renal Disease
2. Yes
No
Does the patient have APRI > 1.0, METAVIR Score >= F3 (Bx. Date ________), Transient
Elastography Score >= 9.5 kiloPascals, FibroTest >= 0.58, radiographic imaging consistent with cirrhosis or
physical examination findings consistent with cirrhosis
3. Yes
No
Does the patient have decompensated liver disease
4. Yes
No
Is treatment to be co-managed with a gastroenterologist, infectious disease specialist or
hepatologist
PATIENT NAME:
DOB:
6. Yes
No
Has patient previously had a liver transplant?
7. Yes
No
Does patient have hepatocellular carcinoma awaiting liver transplantation
a. If answered Yes above, please answer a) through c) below:
a) Anticipated transplant date: ____/____/____
b) Does patient meet Milan criteria? Please indicate which of the following criteria is met:
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HCV Checklist
Single hepatocellular carcinoma, presence of tumor 5cm or less in diameter, OR Multiple tumors
with each being 3cm or less in diameter.
No extrahepatic manifestations of cancer or evidence of vascular invasion of tumor
Neither of the above apply
c) Yes
No
Prescriber received an authorization for liver transplant per plan policy?
INTERFERON INTOLERANCE (Does the patient have clinical intolerance or contraindication to interferon
documented by at least one of the following?)
8. Yes No
a. If answer is ‘Yes’, please check all that apply and provide documentation:
Known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, anaphylaxis, or
Stevens-Johnson syndrome to alpha interferon, including PEGASYS, or any of its components
Hepatic decompensation (Child-Pugh score > 6 [class B and C]) in cirrhotic patients before treatment or ≥6 in
cirrhotic CHC patients co-infected with HIV before treatment
Uncontrolled psychiatric condition (i.e. schizophrenia, schizoaffective disorder, bipolar disorder, major
depressive disorder)
Suicidal behavior within the past 12 months
Severe concurrent medical disease (uncontrolled diabetes, significant ischemic heart disease, obstructive
pulmonary disease)
Autoimmune hepatitis or autoimmune disorder (eg, dermatomyositis, immune[idiopathic]
thrombocytopenia purpura, inflammatory bowel disease, interstitial lung disease, interstitial nephritis,
polymyositis, psoriasis, rheumatoid arthritis, sarcoidosis, and systemic lupus erythematosus).
Uncontrolled seizures
Moderate or severe retinopathy
Symptomatic hepatitis C induced cryoglobulinemia
Uncontrolled hyper/hypothyroidism
Hepatocellular cancer awaiting transplant
Baseline platelet count ≤70,000 cells/mm3
Baseline absolute neutrophil count (ANC) ≤1,500 cells/mm3
Baseline hemoglobin ≤10 g/dL
REQUIRED LABS (Must be within 6 weeks of request- please attach laboratory results)
AST,
ALT,
Bilirubin,
Albumin,
INR,
Platelet count,
ANC,
Hgb,
SCr
REQUIRED SCREENING
HIV Screening,
Hepatitis A and B screening including: HBsAg, anti-HBs, anti-HBc, HAV Ab
REQUIRED VACCINATIONS
Patient has completed or initiated Hepatitis A and Hepatitis B vaccination series
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