Pharmacy Prior Authorization Criteria

Alfa Interferons

Indications for Prior Authorization

Intron A (interferon alfa-2b)

• For diagnosis of Hairy Cell Leukemia
  Indicated for the treatment of patients 18 years of age or older with hairy cell leukemia.

• For diagnosis of Malignant Melanoma
  Indicated as adjuvant to surgical treatment in patients 18 years of age or older with malignant melanoma who are free of disease but at high risk for systemic recurrence, within 56 days of surgery.

• For diagnosis of Follicular Lymphoma
  Indicated for the initial treatment of clinically aggressive follicular Non-Hodgkin's Lymphoma in conjunction with anthracycline-containing combination chemotherapy in patients 18 years of age or older. Efficacy of Intron A therapy in patients with low-grade, low-tumor burden follicular Non-Hodgkin's Lymphoma has not been demonstrated.

• For diagnosis of Condylomata Acuminata
  Indicated for intralesional treatment of selected patients 18 years of age or older with condylomata acuminata involving external surfaces of the genital and perianal areas.

  The use of this product in adolescents has not been studied.

• For diagnosis of AIDS-Related Kaposi's Sarcoma
  Indicated for the treatment of selected patients 18 years of age or older with AIDS-Related Kaposi's Sarcoma. The likelihood of response to Intron A therapy is greater in patients who are without systemic symptoms, who have limited lymphadenopathy and who have a relatively intact immune system as indicated by total CD4 count.

• For diagnosis of Chronic Hepatitis C
  Indicated for the treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease who have a history of blood or blood-product exposure and/or are HCV antibody positive. Studies in these patients demonstrated that Intron A therapy can produce clinically meaningful effects on this disease, manifested by normalization of serum alanine aminotransferase (ALT) and reduction in liver necrosis and degeneration.

  A liver biopsy should be performed to establish the diagnosis of chronic hepatitis. Patients should be tested for the presence of antibody to HCV. Patients with other causes of chronic hepatitis, including autoimmune hepatitis, should be excluded. Prior to initiation of Intron A therapy, the physician should establish that the patient has compensated liver disease. The following patient entrance criteria for compensated liver disease were used in the clinical studies and should be considered before Intron A treatment of patients with chronic hepatitis C:

  - No history of hepatic encephalopathy, variceal bleeding, ascites, or other clinical signs of decompensation - Bilirubin less than or equal to 2 mg/dL - Albumin stable and within normal limits - Prothrombin time less than 3 seconds prolonged - WBC greater than or equal to 3,000/mm3 - Platelets greater than or equal to 70,000/mm3.

  Serum creatinine should be normal or near normal.

  Prior to initiation of Intron A therapy, CBC and platelet counts should be evaluated in order to establish baselines for monitoring potential toxicity. These tests should be repeated at Weeks 1 and 2 following initiation of Intron A therapy, and monthly thereafter. Serum ALT should be evaluated at approximately 3-month intervals to assess response to treatment.

  Patients with preexisting thyroid abnormalities may be treated if thyroid-stimulating hormone (TSH) levels can be maintained in the normal range by medication. TSH levels must be within normal limits upon initiation of Intron A treatment and TSH testing should be repeated at 3 and 6 months.

  Intron A in combination with Rebetol is indicated for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with alpha interferon therapy and in patients 18 years of age and older who have relapsed following alpha interferon therapy. See Rebetol prescribing information for additional information.

• For diagnosis of Chronic Hepatitis B
  Indicated for the treatment of chronic hepatitis B in patients 1 year of age or older with compensated liver disease. Patients who have been serum HBsAg positive for at least 6 months and have evidence of HBV replication (serum HBeAg positive) with elevated serum ALT are candidates for treatment. Studies in these patients demonstrated that Intron A therapy can produce virologic remission of this disease (loss of serum HBeAg), and normalization of serum aminotransferases. Intron A therapy resulted in the loss of serum HBsAg in some responding patients.

  Prior to initiation of Intron A therapy, it is recommended that a liver biopsy be performed to establish the presence of chronic hepatitis and the extent of liver damage. The physician should establish that the patient has compensated liver disease. The following patient entrance criteria for compensated liver disease were used in the clinical studies and should be considered before Intron A treatment of patients with chronic hepatitis B:

  - No history of hepatic encephalopathy, variceal bleeding, ascites, or other signs of clinical decompensation

  - Bilirubin normal

  - Albumin stable and within normal limits

  - Prothrombin Time - adults < 3 seconds prolonged, pediatrics less than or equal to 2 seconds prolonged

  - WBC greater than or equal to 4,000/mm^3

  - Platelets - adults greater than or equal to 100,000/mm^3, pediatrics greater than or equal to 150,000/mm^3.

  Patients with causes of chronic hepatitis other than chronic hepatitis B or chronic hepatitis C should not be treated with Intron A. CBC and platelet counts should be evaluated prior to initiation of Intron A therapy in order to establish baselines for monitoring potential toxicity. These tests should be repeated at treatment Weeks 1, 2, 4, 8, 12, and 16. Liver function tests, including serum ALT, albumin, and bilirubin, should be evaluated at treatment Weeks 1, 2, 4, 8, 12, and 16. HBeAg, HBsAg, and ALT should be evaluated at the end of therapy, as well as 3- and 6-months post-therapy, since patients may become virologic responders during the 6-month period following the end of treatment.

  In clinical studies in adults, 39% (15/38) of responding patients lost HBeAg 1 to 6 months following the end of Intron A therapy. Of responding patients who lost HBsAg, 58% (7/12) did so 1 to 6 months post-treatment.

  A transient increase in ALT greater than or equal to 2 x baseline value (flare) can occur during Intron A therapy for chronic hepatitis B. In clinical trials in adults and pediatrics, this flare generally occurred 8 to 12 weeks after initiation of therapy and was more frequent in Intron A responders (adults 63%, 24/38; pediatrics 59%, 10/17) than in non-responders (adults 27%, 13/48; pediatrics 35%, 19/55). However, in adults and pediatrics, elevations in bilirubin 3 mg/dL (2 times ULN) occurred infrequently (adults 2%, 2/86; pediatrics 3%, 2/72) during therapy. When ALT flare occurs, in general, Intron A therapy should be continued unless signs and symptoms of liver failure are observed. During ALT flare, clinical symptomatology and liver function tests including ALT, prothrombin time, alkaline phosphatase, albumin, and bilirubin, should be monitored at approximately 2-week intervals.

Pegasys (peginterferon alfa-2a)

• For diagnosis of Chronic Hepatitis C
  1) Indicated for the treatment of Chronic Hepatitis C (CHC) in combination therapy with other hepatitis C virus drugs for adults with compensated liver disease. PEGASYS monotherapy is indicated only if patient has contraindication or significant intolerance to other HCV drugs. 2) indicated for the treatment of Chronic Hepatitis C (CHC) in combination with ribavirin for pediatric patients 5 years of age and older with compensated liver disease.

  Limitations of use: Pegasys alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for treatment of patients with CHC who previously failed therapy with an interferon-alfa. - Pegasys is not recommended for treatment of patients with CHC who have had solid organ transplantation.

• For diagnosis of Chronic Hepatitis B
  Indicated for the treatment of adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication and liver inflammation.

  Indicated for the treatment of HBeAg-positive CHB in non-cirrhotic pediatric patients 3 years of age and older with evidence of viral replication and elevations in serum alanine aminotransferase (ALT).

Criteria

Intron A

**Defined as Child-Pugh Class B or C

Prior Authorization

Length of Approval: 48 Week(s)
For diagnosis of Chronic Hepatitis C

• Diagnosis of chronic hepatitis C
AND
• Patients without decompensated liver disease**
AND
• For patients who have not previously been treated with interferon
AND
• One of the following:
• Contraindication or intolerance to ribavirin
• Used in combination with ribavirin
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• HIV specialist certified through the American Academy of HIV Medicine

Pegasys

**Defined as Child-Pugh Class B or C

Prior Authorization (Initial Authorization)

Length of Approval: 28 Week(s)
For diagnosis of Chronic Hepatitis C

• Diagnosis of chronic hepatitis C infection
AND
• Patient without decompensated liver disease**
AND
• One of the following:
• Used in combination with one of the following:
• Sovaldi (sofosbuvir)
• Ribavirin
OR
• Contraindication or intolerance to all other HCV agents (e.g., Sovaldi [sofosbuvir], ribavirin)
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• HIV specialist certified through the American Academy of HIV Medicine

Pegasys

Prior Authorization (Reauthorization)

Length of Approval: 20 Week(s)
For diagnosis of Chronic Hepatitis C

• Patient has an undetectable HCV RNA at week 24
AND
• Additional treatment weeks of peginterferon are required to complete treatment regimen
AND
• Patient has not exceeded 48 weeks of therapy with peginterferon
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• HIV specialist certified through the American Academy of HIV Medicine

Intron A or Pegasys

**Defined as Child-Pugh Class B or C

Prior Authorization

Length of Approval: 48 Week(s)
For diagnosis of Chronic Hepatitis B

• Diagnosis of chronic hepatitis B infection
AND
• Patients without decompensated liver disease**

Intron A

Prior Authorization

Length of Approval: 6 Week(s)
For diagnosis of Condylomata acuminata

• Diagnosis of condylomata acuminata (genital or perianal)

Intron A

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Diagnoses other than hepatitis and condylomata acuminata

• One of the following:
• Diagnosis of hairy cell leukemia
OR
• Diagnosis of AIDS-related Kaposi's sarcoma
OR
• Both of the following:
• Diagnosis of metastatic renal cell carcinoma
• Used in combination with Avastin (bevacizumab)
OR
• Diagnosis of malignant melanoma
OR
• Diagnosis of Stage III or IV follicular Non-Hodgkin's Lymphoma
OR
• As maintenance therapy for the treatment of multiple myeloma (non-FDA approved indication)

P & T Revisions

2024-07-03, 2023-06-22, 2023-06-08, 2022-06-08, 2021-09-30, 2021-08-02, 2021-05-10, 2020-05-14

References

1. Pegasys Prescribing Information. Genentech, Inc. South San Francisco, CA. March 2021.
2. Intron A Prescribing Information. Merck & Co. Whitehouse Station, NJ. November 2021.

---

Revision History

• 2024-07-03: Annual Review - GPI update
• 2023-06-22: Removed Oncology specialist requirement
• 2023-06-08: Annual Review - no criteria changes. PegIntron removed from criteria as product is obsolete.
• 2022-06-08: Annual Review
• 2021-09-30: GPI replication update for Pegasys. No changes to clinical criteria.
• 2021-08-02: 2021 UM Annual Review.
• 2021-05-10: 2021 UM Annual Review.
• 2020-05-14: Annual Review

---