Peginterferon

Peginterferon alfa-2b (PEG-Intron)

JCODE: J3490

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Oral Ribavirin is covered under the Pharmacy Benefit

All of the following must be met as a condition(s) for coverage:

• 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

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
  • 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)

Combination Therapy (Peg-Intron + Ribavirin)

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

Peginterferon alfa-2A (Pegasys)

JCODE: J3490

HOME HEALTH / SELF ADMINISTRATION

Oral Ribavirin is covered under the Outpatient Benefit

Copegus is Roche’s version of Ribavirin

All of the following must be met as a condition(s) for coverage:

• 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

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
• 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