Provider Notice issued 08/08/14

​Prior Authorization of Sovaldi and Other Medications for the Treatment of Chronic Hepatitis C

Hepatitis C-Risk Factors and Usual Course

Hepatitis C, a blood borne viral infection which targets the liver, was discovered in 1989. Baby boomers born between 1945 and 1965, veterans, males, people in low income groups, prisoners, and African American and Latino populations seem to be at a higher risk of infection. Some people may never know how they were infected, however, the most common risk factors are:

• a blood transfusion before 1992 (in hemophilia, hemodialysis and organ transplant patients);
• sharing needles/syringes for injecting drugs; or, needle stick injuries in healthcare settings;
• use of potentially infected body art tools and ink for tattoos or unsterile equipment for body piercing;
• a child born of a Hepatitis C infected mother; and,
• unprotected or high risk sex with multiple partners, etc.

The majority of infected patients have no symptoms and may never know they are infected; 75-85% may develop a chronic or lifelong infection with no or few symptoms such as fatigue; in 30-40 years, some patients may develop cirrhosis, liver failure, liver cancer or death. Alcohol and substance abuse appear to enhance the rate of liver disease progression.

Screening

The Centers for Disease Control and Prevention (CDC) and the United States Preventive Services Task Force recommend a onetime Hepatitis C Virus antibody test for those born between 1945 and 1965 regardless of risk factors. Sixty-six percent (66%) of those living with Hepatitis C belong to this age group and 75% of Hepatitis C related deaths occur in this population. The Illinois Medicaid program allows and pays for Hepatitis C testing anytime when ordered by a physician or other authorized practitioner.

Treatment

Newer medications for treatment of Hepatitis are considered more effective for most Hepatitis C patients but come at a significant expense ($1,000 a day for Sovaldi or $84,000 for a usual 12-week course); however, the available research studies leave many unanswered questions.

For example, Sovaldi trials did not include:

• Medicaid population specifically or enough minorities;

• head to head comparison with standard treatments that were available prior to Sovaldi;

• patients who had received prior therapy for Hepatitis C or failed on previous treatments; or,

• enough patients with Genotype 1, the most common form of Hepatitis C.

In addition, these studies did not include enough patients prescribed Sovaldi with multiple medical, psychiatric or substance abuse problems and those who were receiving multiple other prescription medications. 

Further, Sovaldi is not indicated for use as a stand-alone drug. At least one or two other medications must be prescribed at the same time depending on the Genotype, therefore, those who cannot use these other products precludes the use of Sovaldi. Thus, Sovaldi will not benefit every patient with Hepatitis C and in some cases may be harmful or less effective if prescribed for a patient with other untested disease state or in combination with other medications and in the context of active and current substance abuse. Long term effects and benefits of taking Sovaldi are as yet not available. With several newer medications, hopefully better tested, more effective, requiring a shorter course of treatment, and less expensive waiting to be released in the next 18-24 months, it may be prudent and safer for the patients we are committed to serve, to wait to be treated unless there are immediate threats to their well-being or advanced liver disease.

Summary

All of this information guided the collaborative work at the HFS to develop a responsible yet compassionate policy on the utilization of Sovaldi, which remains available with appropriate controls including prior authorization, to eligible patients who are likely to benefit, and not be harmed, from this therapy. In addition, these criteria were presented for consideration by the Hepatitis C Legislative Task Force on July 9, 2014. Their suggestions have been incorporated in these final criteria which are listed below:

1. Patient is 18 years of age or over and enrolled in IL Medicaid.
2. Patient must have diagnosis of Chronic Hepatitis C infection genotype 1, 2, 3, or 4 confirmed by HCV RNA level and a metavir score ≥ 4 or equivalent.
3. The patient has not been denied Sovaldi from another insurance carrier for an acceptable cause. If approved for coverage by another carrier, HFS will only pay as a secondary payer after the primary payer has paid.
4. If patient is female, she must not currently be pregnant and may not become pregnant while taking Sovaldi. A negative pregnancy test must be obtained within the previous 30 days, and monthly thereafter during treatment with Sovaldi.
5. If patient is male, patient must not have a female partner who is currently pregnant, and agrees to use adequate contraception to avoid pregnancy during treatment.
6. The patient is mentally competent, able to make appropriate decisions about this treatment, comply with dosing and other instructions, and is capable of completing therapy.
7. The patient does not have end stage renal disease requiring dialysis.
8. The patient does not have glomerular filtration rate < 30 mL/minute/1.73m2.
9. The patient, if Genotype 1, is not considered interferon-ineligible.
10. The patient does not have evidence or known diagnosis of malignancy of any body organ diagnosed within the last 12 months, or currently receiving or planning to receive chemotherapy or radiation therapy. Exceptions will be made for hepatocellular carcinoma if patient has been cleared by HFS for liver transplant.
11. The patient does not have evidence of known terminal disease, with life expectancy < 12 months.
12. The patient is not currently enrolled in hospice.
13. The patient is not taking rifampin, anticonvulsants, St. John’s Wort or other prescribed or over-the-counter products known to be harmful while taking Sovaldi.
14. The treatment with Sovaldi is NOT for an indication outside of the FDA approved labeling and is prescribed with FDA-approved combination therapy. Further, no contraindications for use of Sovaldi exist as specified in the product labeling.
15. The patient does not have evidence of substance abuse diagnosis or treatment (alcohol, illicit drugs or prescription opioids and other drugs listed on the schedule of controlled drugs maintained by the Drug Enforcement Administration) in the past 12 months based on department claims records, prescriber’s knowledge, medical record entry, state’s narcotic prescription registry database, reports from a hospital, an Emergency Department visit, an urgent care clinic, a physician’s office or practice or another setting.
16. The patient has a documented negative standard urine drug screen report within 15 days prior to submission of prior approval request.
17. The patient has no history of a full or incomplete course of Sovaldi treatment (“Once in a lifetime” treatment policy).
18. A full course of Sovaldi will usually consist of 12 weeks of therapy. The prescriber will submit additional information to justify a request for more than 12 weeks of therapy.
19. Sovaldi will be dispensed for 2 weeks at a time with further refills being available every 2 weeks for a total of 12 weeks (or longer if indicated).*
20. Non-compliance with the regimen or patient’s failure to obtain refills every 2 weeks will result in discontinuation of previous prior approval, and no further therapy with Sovaldi will be approved by the department.
21. Lost or misplaced Sovaldi will not be replaced, and further treatment with Sovaldi will not be approved. Exceptions will be made only in cases of an extreme hardship such as a house fire.
22. The prescriber can be any physician who holds a current unrestricted license to practice medicine and is currently enrolled as an Illinois Medicaid Provider. If the prescriber is NOT a board-certified gastroenterologist, transplant hepatologist or infectious disease specialist, a one-time written consultation report from a board-certified gastroenterologist, transplant hepatologist or infectious disease specialist will be required within the past 3 months. This consulting specialist must have recommended Sovaldi therapy prior to approval. Requests will not be accepted from mid-level practitioners and pharmacies.
23. The prescriber agrees to obtain all FDA recommended tests and to monitor therapy with Sovaldi for the entire duration of therapy.
24. The prescriber agrees to submit progress notes and HCV RNA level to HFS on patients prescribed Sovaldi within the first 8 weeks of treatment, upon completion of therapy, and at 12 months post-treatment.
25. Provider must provide a copy of a signed patient commitment letter for Sovaldi treatment.

* Product stability testing suggests the medication is stable for 45 days and should be protected from light

Sovaldi Criteria for Prior Approval and Prior Authorization Request Forms

Prior authorization requests must be submitted using the Prior Authorization request forms Prior Authorization Request Form - INITIAL Chronic Hepatitis C (pdf) and Prior Authorization Request Form-RENEWAL Chronic Hepatitis C Regimen (pdf).

Questions

Questions regarding this notice may be directed to the Bureau of Professional and Ancillary Services at (877)782-5565, option 7.

Theresa A. Eagleson, Administrator
Division of Medical Programs