Peginterferon alfa-2b (PEG-Intron)

JCODE: J3490

Home health administration or 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 (> six months)
  • Positive HCV RNA titer
  • Obtain Genotype (1 or 2 or 3)

Approve for combination therapy

(Pegintron + Ribavirin) *

Intron A Naïve: No history of interferon alfa treatment

Intron A Relapser: Prior treatment with Intron A for six months with three 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 three months of Intron A therapy

Approve for monotherapy only if:

  • Contraindication to Ribavirin OR
  • Rebetron Failure Due to Ribavirin Adverse Effects

Pegintron + 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 peginterferon alfa-2b therapy is not indicated include:

  • Patients who do not have persistently elevated LFT’s (> six 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
  • Rebetol (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.

Administration:

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

Erythropoetin 40,000 U once weekly.

Monitor:

Baseline Labs: CBC, LFTs, HCV RNA PCR

Ongoing: CBC, LFTS, HCV RNA PCR q mo.

REBETOL(oral ribavirin) DOSING: Up to 1,200 mg/day are approvable.

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

PegIntron + 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. Western Health Advantage Pharmacy and Therapeutics Committee Approved/Revised: 3/17/2010 Reviewed: July 2011

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

Copegus is Roche’s version of Ribavirin.

All of the following must be met:

  • Diagnosis of Chronic Hepatitis C
  • Persistently elevated LFT’s (> six months)
  • Positive HCV RNA titer
  • Obtain Genotype (1 or 2 or 3) Western Health Advantage Pharmacy and Therapeutics Committee Approved/Revised: 3/17/2010 Reviewed: July 2011

Approve for combination therapy

(Pegasys + Ribavirin) *

PegIntron/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 (> six 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 1,200MG 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.

Administration:

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.

In anemia associated with Pegasys/Ribavirin Therapy

Erythropoetin 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.

Monotherapy:

Approve for 48 weeks


Western Health Advantage Pharmacy and Therapeutics Committee

Approved/Revised: 3/17/2010 Reviewed: December 2013