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Peginterferon alfa-2b (PEG-Intron, Pegasys)

JCODE: J3490

SELF ADMINISTRATION

Oral ribavirin is covered under the Pharmacy Benefit

All of the following must be met:

Diagnosis of Chronic Hepatitis C
Persistently elevated LFT’s (> 6 months)
Positive HCV RNA titer
Obtain Genotype (1 or 2 or 3)

Approve for combination therapy:

(Peg Intron/Pegasys + ribavirin)*

Naïve: No history of interferon alfa treatment
Relapser: Prior treatment with interferon alfa for 6 months and patient has a complete biochemical remission and then a relapse
Non-Responders: ALT remains abnormal & serum HCV RNA remains detectable after three months of Intron A therapy

Approve for monotherapy only if:

Contraindication to ribavirin OR
Failure Due to ribavirin Adverse Effects
Interferon alfa + ribavirin relapsers (if completed course of therapy)
Allow another full course of Pegasys + Ribavirin + boceprevir/telaprevir

* Highest response rates seen with combination therapy in Hepatitis C Patients

Patients for whom peginterferon alfa-2b therapy is not indicated include

Patients who do not have persistently elevated LFT’s (> 6 months)
Patients with decompensated cirrhosis (ascites, GI bleed, encephalopathy)
Patients w/o significant inflammation or fibrosis on liver biopsy (if biopsy available)
Hepatitis C Prophylaxis Post-Liver Transplant
Patients who have a documented relapse of Hepatitis C post-transplant may be eligible for treatment for up to 1 year in duration. Refer PA requests to Medical Director
Other Viral Conditions: Acute Hepatitis B or C, Epstein-Barr Virus, cytomegalovirus, Hepatitis D or E
oral ribavirin dosing higher than 1,200MG per day

Pegasys/Pegintron + Ribavirin Non-Responders

If completed course of therapy and no response is seen: Needs medical director review. There is no literature to support continued use of combination therapy in non-responders

Dosing:

Administer SQ once weekly. The dose should be given on the same day of each week

Dose Reduction:

If a serious adverse reaction develops, DC or the dosage of PEG-Intron to 1/2 the starting dosage until the adverse event stops or decreases in severity. If intolerance is persistent or reoccurs despite dosage adjustment, DC treatment with PEG-Intron
In the event of neutropenia and thrombocytopenia, the following dose modifications are recommended by the manufacturer:
- ANC < 750 cells/mm3: dose as above
- ANC < 500 cells/mm3: permanent DC
- Platelet count <80 x 109/L: dose as above
- Platelet count <50 x 109/L: permanent DC
In anemia associated with Peginterferon/ribavirin Therapy
- Erythropoietin 40,000 U once weekly

Monitor:

Baseline Labs: CBC, LFTs, HCV RNA PCR
Ongoing: CBC, LFTS, HCV RNA PCR q mo. oral ribavirin dosing: Up to 1,200 mg/day are approvable

***This includes weight-based dosing***

Peg Intron/Pegasys + ribavirin:

Assess whether patient is genotype 1 or genotype 2 or 3
Genotype 1, 4, 6 or 7 or any genotype and HIV co-infection: Approve for 12 weeks and obtain viral load to assess response (2 log10 drop or negative HCV RNA) Approve for 36 additional weeks once response is documented
In Genotype 1, 4 , 6 or 7 or any genotype and HIV co-infection patients with no response at 12 weeks, medical director will discuss discontinuing therapy
Genotype 1, 4, 6, 7 or any genotype and HIV co-infection with a detectable viral load and a 2 log reduction at 12 weeks a total of 72 weeks can be authorized if viral load is undetectable at 24 weeks
For Genotype 2/3: approve for 24 weeks**

**Literature states that 24 weeks is adequate to see a sustained virological response in Genotype 2/3 patients.

Triple therapy for genotype 1only: peg-interferon + ribavirin+ boceprevir/telaprevir
Boceprevir is WHA’s preferred agent for triple therapy

Monotherapy:

Approve for 48 weeks

Monotherapy (PEG-Intron)

Body Wt. (kg)	PEG Intron Strength	PEG Intron (ug)	PEG Intron (ml)
<40	50 ug/0.5 ml	50	0.5
40-50	60 ug/0.5 ml	64	0.4
51-60	60 ug/0.5 ml	80	0.5
61-75	120 ug/0.5 ml	120	0.4
76-85	120 ug/0.5 ml	120	0.5
>85	150 ug/0.5 ml	150	0.5

Combination therapy (PEG Intron + Ribavirin)

Body Wt. (kg)	PEG Intron Strength	PEG Intron (ug)	PEG Intron (ml)
<45	50 ug/0.5 ml	40	0.4
40-50	50 ug/0.5 ml	50	0.5
57-72	80 ug/0.5 ml	64	0.4
73-88	80 ug/0.5 ml	80	0.5
89-106	120 ug/0.5 ml	96	0.4
107-136	120 ug/0.5 ml	120	0.5

Other indications should be evaluated on a case-by-case basis

Peginterferon alfa-2A (Pegasys)

JCODE: J3490

Home health administration or self administration

**oral ribavirin is covered under the Outpatient Benefit

All of the following must be met:

Diagnosis of Chronic Hepatitis C
Persistently elevated LFT’s (> 6 months)
Positive HCV RNA titer
Obtain Genotype (1 or 2 or 3)

Approve for combination therapy (Pegasys + ribavirin) *

Peg Intron/Intron A Naïve: No history of interferon alfa treatment
Intron A Relapser: Prior treatment with Intron A for 6 months with 3 MU TIW and pt. has a complete biochemical remission and then a relapse
Intron A Non-Responders: ALT remains abnormal & serum HCV RNA remains detectable after 3 months of Intron A therapy

Pegasys + Ribavirin Relapsers (if completed course of therapy)

Allow another full course of Pegasys + Ribavirin

*Highest response rates seen with combination therapy in Hepatitis C Patients

Patients for whom Pegasys therapy is not indicated include:

Patients who do not have persistently elevated LFT’s (> 6 months)
Patients with decompensated cirrhosis (ascites, GI bleed, encephalopathy)
Patients w/o significant inflammation or fibrosis on liver biopsy (if biopsy available)
Hepatitis C Prophylaxis Post- Liver Transplant
Patients who have a documented relapse of Hepatitis C post-transplant may be eligible for treatment for up to one year in duration. Refer PA requests to Medical Director.
Other Viral Conditions: Acute Hepatitis B or C, Epstein-Barr Virus, Cytomegalovirus

Hepatitis D or E

Ribavirin Dosing higher than 1.200 mg per day

PEGASYS/PEGINTRON + RIBAVIRIN NONRESPONDERS

If completed course of therapy and no response is seen: Needs medical director review. There is no literature to support continued use of combination therapy in non-responders

Dosing:

Administer 180 mcg SQ once weekly. The dose should be given on the same day of each week

Dose Reduction with Pegasys:

ANC < 750 cells/mm3: dose to 135 mcg
ANC < 500 cells/mm3: Stop treatment and restart 90 mcg when ANC > 1000 cells/mm3
Platelet count < 50,000 cells/mm3: 90 mcg dose
Platelet count< 25000 cell/mm3: D/C Pegasys
ESRD requiring dialysis: 135 mcg weekly
Progressive increases in ALT: 90 mcg weekly
ALT levels increase with increased bilirubin, despite dose reduction: D/C therapy STAT
Hepatic decompensation: D/C therapy STAT
Mod-Severe adverse reactions: dose to 135 mcg or 90 mcg or 45 mcg (depending on severity) and dose when adverse reactions improve. Western Health Advantage Pharmacy and Therapeutics Committee Approved: 5/25/2004

?In anemia associated with Pegasys/Ribavirin Therapy

Erythropoietin 40,000 U once weekly

Dose Reduction with Ribavirin without cardiovascular disease and Hgb <10g/dL or stable CV disease with in Hgb by more than 2g/dL during any 4 weeks of T

Treatment: dose of ribavirin to 200 mg QAM and 400 mg QPM

W/O cardiovascular disease and Hgb <8.5g/dL or stable CV disease with Hgb value < 12g/dL despite reduced ribavirin dosages for 4 weeks

D/C treatment of ribavirin. Restart at 600 mg/day and increase to 800 mg/day based on physician judgment

Monitor:

Baseline Labs: CBC, LFTs, HCV RNA PCR
Ongoing: CBC, LFTS, HCV RNA PCR q month

Oral Ribavirin Dosing:

Approve ribavirin dose of 1000 mg for patients < 75 kg
Approve ribavirin dose of 1200 mg for patients > 75 kg

This coverage position on ribavirin dosing is based on the opinions of regional hepatology experts, the VA Guidelines on the diagnosis and treatment of Hepatitis C: OCT 2001, and on the recommendation of the Western Health Advantage P & T Committee

Pegasys + ribavirin:

Assess whether patient is genotype 1 or genotype 2 or 3

Genotype 1 , 4, 6, 7 or any genotype and HIV co-infection: Approve for 12 weeks and obtain viral load to assess response (2 log10 drop or negative HCV RNA) Approve for 36 ADDITIONAL weeks once response is documented
In Genotype 1 and 4 patients with no response at 12 weeks, medical director will discuss discontinuing therapy
Genotype 1, 4, 6, 7 or any genotype and HIV co-infection with a detectable viral load and a 2 log
reduction at 12 weeks a total of 72 weeks can be authorized if viral load is undetectable at 24 weeks
For Genotype 2/3: approve for 24 weeks**

**Literature states that 24 weeks is adequate to see a sustained virological response in Genotype 2/3 patients