Category Filter
- Advanced Imaging
- Autism Spectrum Mandate
- Behavioral Health
- Blue Advantage Policies
- Chronic Condition Management
- Genetic Testing
- HealthSmartRx Smart RxAssist Program
- Hemophilia Drugs
- Medical Policies
- Provider-Administered Drug Policies (Excluding Oncology)
- Provider-Administered Oncology Drug Policies
- Radiation Therapy
- Self-Administered Drug Policies
- Transgender Services
Asset Publisher
Hepatitis C Direct Acting Antivirals Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1120
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
|
Effective Date |
Date of Origin |
|
10/1/2022 |
|
FDA APPROVED INDICATIONS AND DOSAGE
|
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
|
Epclusa® (sofosbuvir/velpatasvir) Oral tablet |
|
|
1 |
|
Harvoni® (ledipasvir/sofosbuvir) Oral tablet/Oral pellets |
|
|
2 |
|
Mavyret® (glecaprevir/pibrentasvir) Oral tablet |
|
|
3 |
|
Sovaldi® (sofosbuvir) Oral tablet/Oral pellets |
|
|
4 |
|
Viekira Pak® (ombitasvir/paritaprevir/ritonavir co-packaged with dasavuvir) Oral tablet |
|
|
5 |
|
Vosevi® (sofosbuvir/velpatasvir/voxilaprevir) Oral tablet |
|
|
6 |
|
Zepatier® (elbasvir/grazoprevir) Oral tablet |
|
|
7 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
|
Hepatitis C |
Hepatitis C is an infection of the liver caused by the Hepatitis C virus (HCV), a blood-borne virus. Today, most people become infected with HCV by sharing needles or other equipment to inject drugs. Hepatitis C infection can either be acute or chronic. Acute HCV infection is defined as presenting within 6 months following exposure to the virus. In 2018, the reported acute hepatitis C case count in the United States corresponded to a rate of 1.2 cases per 100,000 population, an over 71% increase from the reported incidence rate in 2014. The infection is defined as chronic if the virus is present beyond 6 months following exposure. More than 50% of people who become infected with HCV develop chronic infection. Chronic hepatitis C is a serious disease that can result in cirrhosis, liver cancer, and death.(9)
The American Association for the Study of Liver diseases (AASLD) along with the Infectious Diseases society of America (IDSA) recommend the following:(8)
Risk activities:
Risk exposures:
Other conditions and circumstances:
|
|
AASLD/IDSA guidelines on when and in whom to initiate HCV therapy |
The goal of treatment of HCV-infected persons is to reduce all-cause mortality and liver-related health adverse consequences, including end-stage liver disease and hepatocellular carcinoma, by the achievement of virologic cure as evidenced by a sustained virologic response (SVR) (defined as the continued absence of detectable HCV RNA for at least 12 weeks after completion of therapy). According to the AASLD/IDSA guidelines, treatment is recommended for all patients with acute or chronic HCV infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy. Treatment should be initiated early because delaying therapy may decrease the benefits of SVR and increase the rates of liver-related mortality.(8)
Although the prevalence of chronic HCV is lower in children than adults, an estimated 3.5-5 million children worldwide have chronic HCV infection. Data from the National Health and Nutrition Examination Survey (NHANES) collected between 2003 and 2010 indicates that 0.2% of 6 to 11 year olds (31,000 children) and 0.4% of 12 to 19 year olds (101,000 adolescents) in the US are HCV antibody positive.(11)
Birth to an HCV-infected mother is a known risk for infection and these children should be evaluated and tested for HCV. The rate of mother-to-child transmission (MTCT) of HCV infection is approximately 5%, although rates are higher among women with inadequately controlled HIV co-infection, and women with higher HCV-RNA levels, or viral loads (greater than 6 log IU/mL). Identifying, following, and treating exposed children is recommended. The basis for evaluation early in life is HCV-RNA testing, as maternal antibodies and consequently anti-HCV assay positivity may persist for 18 months. About 25% to 50% of infected infants spontaneously resolve HCV infection (loss of previously detectable HCV RNA) by 3 years of age. HCV RNA is more expensive than an antibody-based test; and there is no intervention or treatment that will occur prior to age 3 because of lack of approved drugs for this age group and to allow for possible spontaneous clearance.(11) |
|
Simplified Treatment(12) |
Direct-acting antiviral agents (DAAs) offer the potential for highly effective, interferon-free (and in many cases, ribavirin-free) regimens for the majority of hepatitis C virus infected patients. Regimen selection varies by genotype and other patient factors, such as the presence of cirrhosis and treatment history. Patients who are co-infected with HCV and either hepatitis B or HIV should be treated as those mono-infected with HCV.
The National Academies of Science, Engineering, and Medicine have proposed a strategy to reduce cases of chronic HCV infection by 90% by 2030. Data shows that HCV treatment can be effectively provided by a broad range of health care professionals with differing expertise – including specialists, primary care physicians, nurse practitioners, clinical pharmacy specialists, physician assistants, and registered nurses- without compromising treatment efficacy or safety. AASLD/IDSA has created simplified regimens to treat HCV in adults without cirrhosis or compensated cirrhosis who have not been previously treated for their infection to allow for the expansion of healthcare professionals who prescribe antiviral therapy and increase the number of persons treated. These simplified treatment algorithms are designed to be used by any health care provider knowledgeable about HCV disease and treatment, including those without extensive experience, who have timely access to a specialist. Any patients not included in the simplified treatment regimens should be seen by a specialist.
For patients without cirrhosis, the pretreatment evaluation should include:
The recommended treatment regimens are glecaprevir (300 mg)/pibrentasvir (120 mg) taken with food for 8 weeks or sofosbuvir (400 mg)/velpatasvir (100 mg) for a duration of 12 weeks.
For patients with compensated cirrhosis (Child-Turcotte-Pugh class A), the pretreatment evaluation should include:
The recommended regimens for genotype 1-6 are glecaprevir (300 mg)/pibrentasvir (120 mg) taken with food for 8 weeks or for genotypes 1, 2, 4, 5, or 6, sofosbuvir (400 mg)/velpatasvir (100 mg) for a duration of 12 weeks (note for sofosbuvir/velpatasvir: patients with genotype 3 require baseline NS5A resistance-associated substitution (RAS) testing. Those without Y93H can be treated with sofosbuvir/velpatasvir for a duration of 12 weeks). |
|
Efficacy |
Epclusa(1) Epclusa (sofosbuvir/velpatasvir) contains a hepatitis C nucleotide analog NS5B polymerase inhibitor (sofosbuvir) and a hepatitis C virus NS5A inhibitor (velpatasvir). Efficacy of this combination agent was evaluated in five phase 3 trials (ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4, and ASTRAL-5). All these trials included patients who were either treatment naïve or had previously been treated with an interferon based regimen (peginterferon plus ribavirin with or without a protease inhibitor). The primary endpoint for these trials was sustained virologic response at 12 weeks (SVR12) following completion of therapy.
ASTRAL-1 was a placebo controlled trial that enrolled patients with HCV infection genotype 1, 2, 4, 5, or 6. Overall, the SVR 12 rate was 99% in patients who received Epclusa and 0% in those receiving placebo (95% confidence interval, p less than 0.001).
ASTRAL-2 and ASRTAL-3 were randomized, open label trials evaluating efficacy in patients with HCV genotype 2 or 3 respectively. Those with HCV genotype 2 received either Epclusa for 12 weeks or sofosbuvir plus ribavirin for 12 weeks. The SVR12 rates for the two treatment arms were 99% and 94% respectively. Subjects with HCV genotype 3 were randomized to receive either Epclusa for 12 weeks or sofosbuvir plus ribavirin for 24 weeks. The SVR12 rates were 95% and 80% respectively.
ASTRAL-4 was an open label trial that evaluated efficacy of Epclusa in patients with decompensated cirrhosis. Patients were randomized to receive one of three treatment regimens: Epclusa for 12 weeks, Epclusa for 24 weeks, or Epclusa plus ribavirin for 12 weeks. SVR12 rates were 83%, 86%, and 94% respectively.
ASTRAL-5 was an open-label trial that evaluated 12 weeks of Epclusa in patients with genotype 1, 2, 3, 4, 5, or 6 hepatitis C infection who were coinfected with HIV-1. The patients were all on antiretroviral therapy of various regimens. The primary endpoint was SVR12. The SVR12 ranged from 92-100% depending on genotype and in genotype 1 the subtype. No patient had HIV-1 rebound during treatment and CD4+ counts were stable during treatment.
Trial 4062 was on open-label clinical trial that evaluated 12 weeks of treatment with Epclusa in 59 HCV-infected adults with end stage renal disease (ESRD) requiring dialysis. The overall SVR rate was 95%. Of the subjects completing 12 weeks of Epclusa, 1 subject experienced virologic relapse.
The efficacy of Epclusa once daily for 12 weeks was evaluated in an open-label trial (Study 1143) in 173 genotype 1, 2, 3, 4, or 6 HCV treatment-naïve or treatment-experienced pediatric subjects 3 years of age and older without cirrhosis or with compensated cirrhosis.
In patients 12 years to less than 18 years of age (genotypes 1, 2, 3, 4 and 6), the SVR rates were:
In patients 6 years to less than 12 years of age (genotypes 1, 2, 3, and 4) the SVR rates were:
In patients 3 years to less than 6 years of age the SVR rates were:
Trial 2104 was an open-label clinical trial that evaluated 12 weeks of treatment with Epclusa in 79 HCV-infected treatment-naïve and previously treated adult subjects who had undergone liver transplantation. The overall SVR12 rate was 96%.
Trial 4062 was an open-label clinical trial that evaluated 12 weeks of treatment with Epclusa in 59 HCV-infected adults with end stage renal disease (ESRD) requiring dialysis. The overall SVR rate was 95%.
Harvoni(2) Harvoni (ledipasvir/sofosbuvir) is a combination of an NS5A inhibitor (ledipasvir) and nucleotide analog NS5B polymerase inhibitor (sofosbuvir). Its efficacy was evaluated in several phase 2 and 3 clinical trials. These trials enrolled a broad range of patient populations including treatment naïve and treatment experienced patients, those without cirrhosis and with cirrhosis (compensated and decompensated), post-liver transplant patients, pediatric patients who were at least 3 years old or weighed more than 35 kg, as well as those with HIV/HCV co-infection. All the trials had a primary end point of sustained virologic response at 12 weeks (SVR12) following completion of treatment. Overall SVR12 was greater than 90% for the various patient populations. The treatment duration of this agent varies from 8 weeks to 24 weeks. Per the FDA labeling, treatment naïve patients with HCV genotype 1 with RNA of less than 6 million can be successfully treated with 8 weeks of Harvoni. This duration of treatment is not recommended in patients with cirrhosis, HIV, are post-liver transplantation, and/or black or African-American. Treatment experienced patients with cirrhosis may be treated with Harvoni alone for 24 weeks or in combination with ribavirin for 12 weeks. These two regimens are equally efficacious with SVR12 of 96% and 97% respectively.
Mavyret(3) Mavyret (glecaprevir/pibrentasvir) is a combination of an NS3/4A protease inhibitor (glecaprevir) and an NS5A inhibitor (pibrentasvir). Its safety and efficacy have been demonstrated in treatment naïve patients or patients previously treated with regimens containing peginterferon, ribavirin, and/or sofosbuvir (PRS) with HCV genotype 1, 2, 3, 4, 5 or 6 without cirrhosis or with compensated cirrhosis. Its safety and efficacy has also been demonstrated in patients who have previously been treated with a regimen containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both. Patients with prior treatment with both an NS5A inhibitor and NS3/4A inhibitor were at an increased risk of virologic failure when retreated with Mavyret.
The efficacy of Mavyret in treatment naïve or PRS treatment experienced adults with HCV genotype 1, 2, 4, 5, or 6 infection without cirrhosis was evaluated in the ENDURANCE-1, ENDURANCE-4, SURVEYOR-1 (part 2), and SURVEYOR-2 (part 2 and part 4) trials. The SVR12 ranged from 93% to 100% depending on genotype. The EDURANCE-1 trial demonstrated numerically similar efficacy in genotype 1 treatment naïve patients without cirrhosis treated for 8 weeks vs 12 weeks. The SURVEYOR-2 trial also demonstrated very high SVR12 for genotypes 2, 4, 5, or 6 after 8 weeks of treatment. Therefore, the recommended length of therapy for treatment naïve patients without cirrhosis is 8 weeks.
The efficacy of Mavyret in treatment naïve or PRS treatment experienced adults with HCV genotypes 1, 2, 4, 5, or 6 infection with compensated cirrhosis was evaluated in the EXPEDITION-1 trial. Patients received Mavyret for 12 weeks. The SVR12 was 99-100% depending on genotype.
The efficacy of Mavyret in treatment naïve or PRS treatment experienced adults with HCV genotype 3 infection without cirrhosis or with compensated cirrhosis was evaluated in the ENDURANCE-3 and SURVEYOR-2 (part 3) trial. For patients without cirrhosis the SVR12 was numerically similar for patients without cirrhosis and the recommendation for these patients is to treat for 8 weeks. The overall SVR12 for all patients in these trials ranged from 94.9-98% depending on cirrhosis status and previous treatment.
The efficacy of Mavyret in treatment naïve and PRS treatment experienced adults with genotype 2, 4, 5, or 6 without cirrhosis was evaluated in the SURVEYOR-2 (part 2 and part 4), ENDURANCE-4, and SURVEYOR-1 (part 2) trials. SVR12 ranged from 93-100% depending on genotype.
The efficacy of Mavyret in treatment naïve or PRS treatment experienced adults with HCV genotype 1, 2, 4, 5, or 6 infection with compensated cirrhosis was evaluated in the EXPEDITION-1 trial. The SVR12 ranged from 99-100% depending on genotype.
The EXPEDITION-4 trial evaluated treatment naïve and PRS treatment experienced adults with chronic kidney disease stage 4 and 5 and chronic HCV infection without cirrhosis or with compensated cirrhosis. The overall SVR12 was 98%.
The MAGELLAN-1 trial evaluated adults who were NS5A inhibitor or NS3/4A protease inhibitor experienced patients without cirrhosis or with compensated cirrhosis. The SVR12 ranged from 92-94% depending on previous treatment.
The MAGELLAN-2 trial evaluated patients who were treatment-naïve or PRS treatment-experienced who have had a liver or kidney transplant. The overall SVR12 rate was 98%.
The efficacy of Mavyret was evaluated in an open-label study (DORA Part 1) that evaluated adolescent subjects 12 years to less than 18 years without cirrhosis who received Mavyret for 8 or 16 weeks. Treatment duration was chosen to match approved adult durations based on HCV genotype and prior treatment experience. The overall SVR12 rate was 100%.
DORA part 2 enrolled patients aged 3 years to less than 12 years and used weight-based dosing of Mavyret. The overall SVR12 rate for the subjects who received the recommended dosage was 98.4%.
Sovaldi (sofosbuvir)(4) Sovaldi is a nucleotide analog NS5B polymerase inhibitor. It is indicated for use in combination with other DAAs including daclatasvir and simeprevir. It may also be used in combination with peg-interferon and ribavirin. To date, sofosbuvir is the only oral DAA indicated for treatment of patients with hepatocellular carcinoma secondary to chronic HCV infection.
The safety and efficacy of Sovaldi was evaluated in five Phase 3 trials in a total of 1724 HCV mono-infected subjects with genotypes 1 to 6 chronic hepatitis C virus, one Phase 3 trial in 223 HSC/HIV-1 coinfected subjects with genotype 1, 2, or 3 HCV, and one trial in 106 pediatric subjects 3 years of age and older with genotype 2 or 3 HCV. The efficacy of Sovaldi (SVR12) is dependent on the combination regimen in which it is used, the patient’s genotype, and patient’s treatment history (range 82% - 100%).
The most common adverse events of sofosbuvir when used with ribavirin include fatigue headache and insomnia. Nausea, insomnia, and anemia were the most common adverse events when sofosbuvir was used in combination with ribavirin and peg-interferon.
Viekira Pak(5) Viekira Pak (ombitasvir/paritaprevir/ritonavir co-packaged with dasabuvir) is a combination therapy containing a hepatitis C virus NS3/4A protease inhibitor (paritaprevir), a CYP3A inhibitor (ritonavir), a hepatitis C virus NS5A inhibitor (ombitasvir), and a hepatitis C NS5B palm polymerase inhibitor (dasabuvir). Safety and efficacy of this combination was evaluated in trials including treatment naïve, previous failures, cirrhotic and non-cirrhotic genotype 1 patients. The studies (SAPPHIRE-1, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV, TURQUOISE-II, AND TURQUIOISE-III) all had a primary efficacy endpoint of SVR12.
Patients with genotype 1a infection without cirrhosis were evaluated in the SAPPHIRE-I, SAPPHIRE-II, and PEARL-IV trials. The SVR12 ranged from 95-97% depending on previous treatment.
Patients with genotype 1b infection without cirrhosis were evaluated in the PEARL-II and PEARL-III trials. SVR12 for both of these studies was 100%.
Patients with genotype 1a and genotype 1b infection with compensated cirrhosis were evaluated in the TURQUOISE-II and TURQUOISE-IV trials. The SVR12 ranged from 89-100% depending on genotype subtype and length of treatment.
Treatment guidelines recommend that patients that have failed a previous protease inhibitor containing regimen receive ledipasvir/sofosbuvir. Ombitasvir/paritaprevir/ritonavir + dasabuvir is not a recommended regimen in previous protease inhibitor failures due to risk of resistance.
Vosevi(6) Vosevi (sofosbuvir/velpatasvir/voxilaprevir) is a fixed-dose combination of a hepatitis C virus nucleotide analog NS5B polymerase inhibitor (sofosbuvir), an HCV NS5A inhibitor (velpatasvir), and an HCV NS3/4A protease inhibitor (voxilaprevir). Efficacy of this combination agent was evaluated in two phase 3 trials. The primary endpoint in both trials was SVR12.
The efficacy of Vosevi in patients with hepatitis C genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis who were treatment experienced with a NS5A inhibitor (POLARIS-1 trial). The SVR12 ranged from 91-100% depending on genotype.
The efficacy of Vosevi in patients with hepatitis C genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis who previously failed a hepatitis C direct acting antiviral (POLARIS-4 trial). The SVR12 ranged from 94-100% depending on genotype and in genotype 1, the subtype. Additional benefit of this combination agent over sofosbuvir/velpatasvir has not been shown in patients with genotype 1b, 2, 4, 5, or 6 infection who were previously treated with sofosbuvir without an NS5A inhibitor.
Zepatier(7) Zepatier (elbasvir/grazoprevir) is a combination regimen of an NS5A replication inhibitor (elbasvir) and an NS3/4A protease inhibitor (grazoprevir). Its efficacy was evaluated in several phase 2 and 3 clinical trials. All the trials had a primary end point of sustained virologic response at 12 weeks (SVR12) following completion of treatment.
Efficacy of Zepatier in treatment naïve patients with HCV genotype 1 with or without cirrhosis was evaluated in the C-EDGE TN and C-EDGE COINFECTION trials. Subjects in both trials received Zepatier for 12 weeks. SVR12 was 95% in both trials. There were no significant differences in SVR12 between cirrhotic and non-cirrhotic patients. The C-EDGE TE trial evaluated efficacy of this combination in treatment experienced HCV genotype 1 patients with or without cirrhosis who had previously failed peginterferon plus ribavirin. Subjects received Zepatier monotherapy for 12 weeks or Zepatier with ribavirin for 16 weeks. SVR12 rates in the two treatment groups were 94% and 97% respectively.
Efficacy in HCV genotype 1 patients with or without cirrhosis who had previously failed peginterferon, ribavirin, plus a protease inhibitor was evaluated in the C-SALVAGE trial. This was an open label, single arm trial. All subjects received Zepatier plus ribavirin for 12 weeks. Overall SVR12 was 96%.
Efficacy of Zepatier in patients with HCV genotype 1 with or without cirrhosis and who had Chronic Kidney Disease (CKD) stage 4 (eGFR 15-29 mL/min/1.73 m2) or CKD Stage 5 (eGFR less than 15 mL/min/1.73 m2), including patients on hemodialysis was evaluated in the C-SURFER trial. Patients were randomized to receive either Zepatier for 12 weeks or placebo for 12 weeks followed by 12 weeks of Zepatier (deferred treatment group). Overall SVR12 was 99%. There were no significant differences with regard to safety in the Zepatier group versus placebo group.
These trials found that presence of NS5A amino acid polymorphisms in patients with HCV genotype 1a was associated with reduced efficacy of Zepatier regardless of treatment history or cirrhosis status. It is recommended to test for NS5A polymorphisms in HCV genotype 1a patients prior to starting treatment with this combination. If the polymorphism is present, addition of ribavirin to the treatment regimen and extension of the duration of treatment to 16 weeks is recommended.
Efficacy of Zepatier in HCV genotype 4 patients was evaluated in the C-SCAPE, C-EDGE TE, C-EDGE TN, and C-EDGE COINFECTION trials. Treatment naïve patients in these trials received Zepatier for 12 weeks while those who were treatment experienced received Zepatier plus ribavirin for 12 to 16 weeks. SVR12 in the treatment naïve and treatment experienced patients was 97% and 100% respectively. |
|
Safety(1-7) |
|
|
Risk of Hepatitis B infection reactivation with HCV Direct Acting Antivirals(10) |
In October of 2016, the FDA issued a safety alert concerning risk of reactivation of hepatitis B viral (HBV) infection in patients treated with HCV direct acting antivirals (DAA). At the time of the alert, the FDA had identified 24 cases of HBV infection reactivation in patients who had been treated with an HCV DAA. In a few of these cases, the HBV reactivation resulted in serious liver problems or death. As a result, the FDA has required labeling for all HCV DAAs to include a boxed warning for HBV infection reactivation. In addition, the FDA has recommended that all patients be screened for evidence of current or prior HBV infection before starting treatment with HCV DAAs and be monitored for HBV reactivation during and after treatment with an HCV DAA. |
REFERENCES
|
Number |
Reference |
|
1 |
Epclusa prescribing information. Gilead. June 2021. |
|
2 |
Harvoni prescribing information. Gilead. March 2020. |
|
3 |
Mavyret prescribing information. AbbVie. September 2021. |
|
4 |
Sovaldi prescribing information. Gilead. March 2020. |
|
5 |
Viekira Pak prescribing information. Abbvie Inc. December 2019. |
|
6 |
Vosevi prescribing information. Gilead. November 2019. |
|
7 |
Zepatier prescribing information. Merck. January 2022. |
|
8 |
AASLD/IDSA HCV Guidance: Recommendations for Testing, Managing, and Testing Hepatitis C. Available at www.hcvguidelines.org. |
|
9 |
The center for Disease Control and Prevention. Viral Hepatitis Statistics and Surveillance. Available at http://www.cdc.gov/hepatitis/statistics. |
|
10 |
Direct-Acting Antivirals for Hepatitis C: FDA Drug Safety Communication-Risk of Hepatitis B Reactivation. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm523690.htm |
|
11 |
|
|
12 |
AASLD-IDSA Hepatitis C Guidance Panel. Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection. Hepatology, Vol. 71, No.2, 2020. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
|
Agent Names |
Strength |
Targeted MSC |
Available MSC |
Effective Date |
|
|
||||
|
EPCLUSA*sofosbuvir-velpatasvir pellet pack ; EPCLUSA*sofosbuvir-velpatasvir tab ; SOFOSBUVIR/VELPATASVIR*sofosbuvir-velpatasvir tab |
150 MG ; 200 MG ; 400 MG |
M ; N ; O ; Y |
M ; N |
|
|
HARVONI*ledipasvir-sofosbuvir pellet pack ; HARVONI*ledipasvir-sofosbuvir tab ; LEDIPASVIR/SOFOSBUVIR*ledipasvir-sofosbuvir tab |
33.75 MG ; 45 MG ; 90 MG |
M ; N ; O ; Y |
M ; N |
|
|
MAVYRET*glecaprevir-pibrentasvir pellet pack ; MAVYRET*glecaprevir-pibrentasvir tab |
100 MG ; 50 MG |
M ; N ; O ; Y |
N |
|
|
VOSEVI*sofosbuvir-velpatasvir-voxilaprevir tab |
400 MG |
M ; N ; O ; Y |
N |
|
|
SOVALDI*sofosbuvir pellet pack ; SOVALDI*sofosbuvir tab |
150 MG ; 200 MG ; 400 MG |
M ; N ; O ; Y |
N |
|
|
VIEKIRA*dasab-ombit-paritap-riton tab er ; VIEKIRA*ombitas-paritapre-riton & dasab tab pak |
12.5 MG ; 200 33.33 MG |
M ; N ; O ; Y |
N |
|
|
ZEPATIER*elbasvir-grazoprevir tab |
50 MG |
M ; N ; O ; Y |
N |
|
POLICY AGENT SUMMARY QUANTITY LIMIT
|
Target Agent GPI |
Agent Names |
Strength |
QL Amount |
Dose Form |
Days Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
Effective Date |
|
|
||||||||||
|
123599026530 |
EPCLUSA*sofosbuvir-velpatasvir pellet pack |
150 MG ; 200 MG |
28.0 |
PACKTS |
28 |
Days |
|
|
|
|
|
123599026503 |
EPCLUSA*sofosbuvir-velpatasvir tab ; SOFOSBUVIR/VELPATASVIR*sofosbuvir-velpatasvir tab |
200 MG ; 400 MG |
28.0 |
TABS |
28 |
Days |
|
|
|
|
|
123599024030 |
HARVONI*ledipasvir-sofosbuvir pellet pack |
33.75 MG ; 45 MG |
28.0 |
PACKTS |
28 |
Days |
|
|
|
|
|
123599024003 |
HARVONI*ledipasvir-sofosbuvir tab ; LEDIPASVIR/SOFOSBUVIR*ledipasvir-sofosbuvir tab |
45 MG ; 90 MG |
28.0 |
TABS |
28 |
Days |
|
|
|
|
|
123599023530 |
MAVYRET*glecaprevir-pibrentasvir pellet pack |
50 MG |
140.0 |
PACKTS |
28 |
Days |
|
|
|
|
|
123599023530 |
MAVYRET*glecaprevir-pibrentasvir pellet pack |
50 MG |
140.0 |
PACKTS |
28 |
Days |
|
|
|
|
|
123599023503 |
MAVYRET*glecaprevir-pibrentasvir tab |
100 MG |
84.0 |
TABS |
28 |
Days |
|
|
|
|
|
123530800030 |
SOVALDI*sofosbuvir pellet pack |
150 MG ; 200 MG |
28.0 |
PACKS |
28 |
Days |
|
|
|
|
|
123530800003 |
SOVALDI*sofosbuvir tab |
200 MG ; 400 MG |
28.0 |
TABS |
28 |
Days |
|
|
|
|
|
1235990460B7 |
VIEKIRA*ombitas-paritapre-riton & dasab tab pak |
12.5 MG |
1.0 |
PACK |
28 |
Days |
|
|
|
|
|
123599038003 |
VOSEVI*sofosbuvir-velpatasvir-voxilaprevir tab |
400 MG |
28.0 |
TABS |
28 |
Days |
|
|
|
|
|
123599023003 |
ZEPATIER*elbasvir-grazoprevir tab |
50 MG |
28.0 |
TABS |
28 |
Days |
|
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
|
Agent Names |
Strength |
Client Formulary |
|
EPCLUSA*sofosbuvir-velpatasvir pellet pack ; EPCLUSA*sofosbuvir-velpatasvir tab ; SOFOSBUVIR/VELPATASVIR*sofosbuvir-velpatasvir tab |
150 MG ; 200 MG ; 400 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
HARVONI*ledipasvir-sofosbuvir pellet pack ; HARVONI*ledipasvir-sofosbuvir tab ; LEDIPASVIR/SOFOSBUVIR*ledipasvir-sofosbuvir tab |
33.75 MG ; 45 MG ; 90 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
MAVYRET*glecaprevir-pibrentasvir pellet pack ; MAVYRET*glecaprevir-pibrentasvir tab |
100 MG ; 50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
SOVALDI*sofosbuvir pellet pack ; SOVALDI*sofosbuvir tab |
150 MG ; 200 MG ; 400 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
VIEKIRA*dasab-ombit-paritap-riton tab er ; VIEKIRA*ombitas-paritapre-riton & dasab tab pak |
12.5 MG ; 200 33.33 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
VOSEVI*sofosbuvir-velpatasvir-voxilaprevir tab |
400 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
ZEPATIER*elbasvir-grazoprevir tab |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
|
Agent Names |
Strength |
Client Formulary |
|
EPCLUSA*sofosbuvir-velpatasvir pellet pack |
150 MG ; 200 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
EPCLUSA*sofosbuvir-velpatasvir tab ; SOFOSBUVIR/VELPATASVIR*sofosbuvir-velpatasvir tab |
200 MG ; 400 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
HARVONI*ledipasvir-sofosbuvir pellet pack |
33.75 MG ; 45 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
HARVONI*ledipasvir-sofosbuvir tab ; LEDIPASVIR/SOFOSBUVIR*ledipasvir-sofosbuvir tab |
45 MG ; 90 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
MAVYRET*glecaprevir-pibrentasvir pellet pack |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
MAVYRET*glecaprevir-pibrentasvir pellet pack |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
MAVYRET*glecaprevir-pibrentasvir tab |
100 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
SOVALDI*sofosbuvir pellet pack |
150 MG ; 200 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
SOVALDI*sofosbuvir tab |
200 MG ; 400 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
VIEKIRA*ombitas-paritapre-riton & dasab tab pak |
12.5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
VOSEVI*sofosbuvir-velpatasvir-voxilaprevir tab |
400 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
ZEPATIER*elbasvir-grazoprevir tab |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PREFERRED AGENTS
|
Disease State |
Disease Name |
Drug Name |
Preferred Level |
# of Preq Necessary |
Required Preq Levels |
Required Preferred Level 1 Agent |
Required Preferred Age Limit |
Required Preferred Age Limit Units |
|
Hepatitis C |
||||||||
|
Hepatitis C |
Genotype 1 |
Sovaldi (Sovaldi is non-preferred for patients without hepatocellular carcinoma.), Viekira PAK, Zepatier |
Non-Preferred |
|
|
|
|
|
|
Hepatitis C |
Genotype 1 |
Epclusa, Harvoni, Ledipasvir/Sofosbuvir, Sofosbuvir/Velpatasvir , Mavyret, Vosevi |
Preferred |
|
|
|
|
|
|
Hepatitis C |
Genotype 2 |
Sovaldi (Sovaldi is non-preferred for patients without hepatocellular carcinoma.) |
Non-Preferred |
|
|
|
|
|
|
Hepatitis C |
Genotype 2 |
Epclusa, Sofosbuvir/Velpatasvir , Mavyret , Vosevi |
Preferred |
|
|
|
|
|
|
Hepatitis C |
Genotype 3 |
Sovaldi (Sovaldi is non-preferred for patients without hepatocellular carcinoma.) |
Non-Preferred |
|
|
|
|
|
|
Hepatitis C |
Genotype 3 |
Epclusa, Sofosbuvir/Velpatasvir, Mavyret, Vosevi |
Preferred |
|
|
|
|
|
|
Hepatitis C |
Genotype 4 |
Sovaldi (Sovaldi is non-preferred for patients without hepatocellular carcinoma.), Zepatier |
Non-Preferred |
|
|
|
|
|
|
Hepatitis C |
Genotype 4 |
Epclusa, Harvoni, Ledipasvir/Sofosbuvir, Sofosbuvir/Velpatasvir, Mavyret, Vosevi |
Preferred |
|
|
|
|
|
|
Hepatitis C |
Genotype 5 |
Epclusa, Harvoni, Ledipasvir/Sofosbuvir, Sofosbuvir/Velpatasvir , Mavyret, Vosevi |
Preferred |
|
|
|
|
|
|
Hepatitis C |
Genotype 6 |
Epclusa, Harvoni, Ledipasvir/Sofosbuvir, Sofosbuvir/Velpatasvir, Mavyret , Vosevi |
Preferred |
|
|
|
|
|
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
|
Module |
Clinical Criteria for Approval |
||||||||||||||||||||||||||||||||||||||||||||||||
|
Epclusa and Sofosbuvir/Velpatasvir |
PRIOR AUTHORIZATION CRITERIA FOR APPROVAL Epclusa and Sofosbuvir/Velpatasvir Evaluation Epclusa or Sofosbuvir/Velpatasvir will be approved when ALL of the following are met:
Length of approval: Up to the duration of treatment as determined in Tables 1 or 2. NOTE: If Quantity Limit Applies, please see Quantity Limit criteria Table 1: Epclusa or Sofosbuvir/Velpatasvir Treatment Recommendations based on FDA labeling
Table 2: Epclusa or Sofosbuvir/Velpatasvir Decompensated Cirrhosis Treatment Recommendations based on AASLD/IDSA Guidelines for unique populations
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
Harvoni and Ledipasvir/Sofosbuvir |
Harvoni and Ledipasvir/Sofosbuvir Evaluation Harvoni or Ledipasvir/Sofosbuvir will be approved when ALL of the following are met:
Length of approval: Up to the duration of treatment as determined in Table 3 or 4. NOTE: If Quantity Limit applies, please see Quantity Limit criteria Table 3: Harvoni or Ledipasvir/Sofosbuvir Treatment Recommendations based on FDA labeling
Table 4: Harvoni or Ledipasvir/Sofosbuvir Decompensated Cirrhosis Treatment Recommendations based on AASLD Guidelines for unique populations
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
Mavyret |
Mavyret Evaluation Mavyret will be approved when ALL of the following are met:
Length of approval: Up to the duration of treatment as determined in Table 5. NOTE: If Quantity Limit applies, please see Quantity Limit criteria Table 5: Mavyret Treatment Recommendations based on FDA labeling
*HCV/HIV-1 co-infection, follow recommendations in the table above + Patients with any degree of kidney impairment (including those on hemodialysis), follow recommendations in the table above
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
Sovaldi |
Sovaldi Evaluation Sovaldi will be approved when ALL of the following are met:
Length of approval: Up to the duration of treatment as determined in Table 6 or 7.
Table 6: Sovaldi Treatment Recommendations in Adult Patients with Genotype 1, 2, 3, or 4 Based on FDA Labeling
Table 7: Sovaldi and Ribavirin with or without Peg-interferon Treatment Recommendations for Pediatric Patients 3 Years of Age and Older Based on FDA Labeling
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
Viekira Pak |
Viekira Pak Evaluation Viekira PAK will be approved when ALL of the following are met:
Length of approval: Up to the duration as determined in Table 8. NOTE: If Quantity Limit applies, please see Quantity Limit criteria Table 8: Viekira PAK Treatment Recommendations based on FDA labeling:
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
Vosevi |
Vosevi Evaluation Vosevi will be approved when ALL of the following are met:
Length of approval: Up to the duration of treatment as determined in Table 9. NOTE: If Quantity Limit applies, please see Quantity Limit criteria Table 9: Vosevi Treatment Recommendations based on FDA labeling
+ - Sofosbuvir with or without any of the following: peginterferon alfa/ribavirin, ribavirin, HCV NS3/4A protease inhibitor (simeprevir) |
||||||||||||||||||||||||||||||||||||||||||||||||
|
Zepatier |
Zepatier Evaluation Zepatier will be approved when ALL of the following are met:
Length of approval: Up to the duration of treatment as determined in Table 10 NOTE: If Quantity Limit applies, please see Quantity Limit criteria Table 10: Zepatier Treatment Recommendations based on FDA labeling
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
ZZZ New to Market Hepatitis C Agents |
New to Market Hepatitis C Agents Evaluation New to market Hepatitis C agents will be approved when ALL of the following are met:
Length of approval: Up to the duration of treatment as determined in Table 11. NOTE: If Quantity Limit Applies, please see Quantity Limit criteria Table 11: Treatment Recommendations based on FDA labeling
|
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
|
Module |
Clinical Criteria for Approval |
||||||||||||||||||||||||||||||||||||||||||||||||
|
Epclusa and Sofosbuvir/Velpatasvir |
Quantity Limit for the Requested Agent(s) will be approved when ONE of the following is met:
Length of approval: Up to the duration of treatment as determined in Tables 1 or 2. Table 1: Epclusa or Sofosbuvir/Velpatasvir Treatment Recommendations based on FDA labeling
Table 2: Epclusa or Sofosbuvir/Velpatasvir Decompensated Cirrhosis Treatment Recommendations based on AASLD/IDSA Guidelines for Unique populations
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
Harvoni and Ledipasvir/Sofosbuvir |
Quantity Limit for the Requested Agent(s) will be approved when ONE of the following is met:
Length of approval: Up to the duration of treatment as determined in Table 3 or 4. Table 3: Harvoni or Ledipasvir/Sofosbuvir Treatment Recommendations based on FDA labeling
Table 4: Harvoni or Ledipasvir/Sofosbuvir Decompensated Cirrhosis Treatmetn REcommendations based on AASLF Guidelines for unique populations
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
Mavyret |
Quantity Limit for the Requested Agent(s) will be approved when ONE of the following is met:
Length of approval: Up to the duration of treatment as determined in Table 5. Table 5: Mavyret Treatment Recommendations based on FDA labeling
+Patients with any degree of kidney impairment (including those on hemodialysis), follow recommendations in table above |
||||||||||||||||||||||||||||||||||||||||||||||||
|
Sovaldi |
Quantity Limit for Requested Agent(s) will be approved when ONE of the following is met:
Length of approval: Up to the duration of treatment as determined in Table 6 or 7. Table 6: Sovaldi Treatment Recommendations in Adult Patients with Genotype 1, 2, 3, or 4 Based on FDA Labeling
Table 7: Sovaldi and Ribavirin with or without Peg-interferon Treatment Recommendations for Pediatric Patients 3 years of Age and Older Based on FDA labeling
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
Viekira Pak |
Quantity Limit for the Requested Agent(s) will be approved when the requested quantity (dose) does NOT exceed the program quantity limit Length of approval: Up to the duration as determined in Table 8. Table 8: Viekira PAK Treatment Recommendations based on FDA labeling
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
Vosevi |
Quantity Limit for the Requested Agent(s) will be approved when the requested quantity (dose) does NOT exceed the program quantity limit Length of approval: Up to the duration of treatment as determined in Table 9.
Table 9: Vosevi Treatment Recommendations based on FDA labeling
+ - Sofosbuvir with or without any of the following: peginterferon alfa/ribavirin, ribavirin, HCV NS3/4A protease inhibitor (simeprevir)
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
Zepatier |
Quantity Limit for the Requested Agent(s) will be approved when the requested quantity (dose) does NOT exceed the program quantity limit Length of approval: Up to the duration of treatment as determined in Table 10. Table 10: Zepatier Treatment Recommendations based on FDA labeling
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
ZZZ New to Market Hepatitis C Agents |
Quantity Limit for the Requested Agent(s) will be approved when ONE of the following is met:
Length of approval: Up to the duration of treatment as determined in Table 11. Table 11: Treatment Recommendations based on FDA labeling
|
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, and Health Insurance Marketplace formularies.
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment
BCBSAL _ CS _ Hepatitis C Direct Acting Antivirals Prior Authorization with Quantity Limit _ProgSum_ 10/1/2022 _