Peginterferon alfa-2b (PEG-Intron)
JCODE: J3490
HOME HEALTH / SELF ADMINISTRATION
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)
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 / 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
Last review date: December 2, 2013