Sovaldi (sofosbuvir) coverage criteria
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Defines prior authorization, approval duration, quantity limits, and medical necessity criteria for Sovaldi (sofosbuvir) for treatment of chronic hepatitis C virus (HCV) infection for Amerigroup members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Sovaldi (sofosbuvir)
Initial therapy — covered with criteria
Requests for Sovaldi (sofosbuvir) may be approved when ALL of the following general criteria are met and the regimen-specific criteria are satisfied:
Supports AASLD/IDSA 2017; see policy chunks 5
Regimen-specific authorization (one of the following)
- A. Sovaldi + ribavirin: 1. Age 12–17 (or <12 and ≥35 kg) with compensated cirrhosis or without cirrhosis and Genotype 2 or 3
chunk 6
- B/C. Sovaldi + Olysio (simeprevir): 1. Age ≥18 and treatment‑naïve or dual P/R 2b treatment‑experienced without cirrhosis and Genotype 1; OR for post‑liver transplant recipients (with or without compensated cirrhosis) Genotypes 1 or 4 with prior trial and inadequate response to Mavyret or exceptions (currently completing same regimen; documented hypersensitivity to Mavyret ingredient not in Sovaldi/Olysio; concurrent non‑substitutable contraindicated agent)
chunks 7
- G/H/I/J/K. Sovaldi + Daklinza (daclatasvir) ± ribavirin: Multiple branches by genotype/cirrhosis/transplant status including: treatment‑naïve or dual P/R 2b experienced without cirrhosis Genotype 1; Genotype 2 or 3 scenarios; Genotype 3 with/without cirrhosis and Y93H polymorphism considerations; decompensated cirrhosis or ribavirin‑ineligible patients — most branches require prior trial and inadequate response to Epclusa (sofosbuvir/velpatasvir) OR Mavyret, or exceptions (currently completing regimen; documented hypersensitivity to Epclusa/Mavyret ingredient not in Sovaldi/Daklinza; concurrent non‑substitutable contraindicated agent; post‑liver transplant recipient)
chunks 8,9,10,11,12,13,14
- Post‑transplant and other combinations: Post‑liver or post‑kidney transplant branches (various genotypes) require prior trial and inadequate response to Mavyret or Epclusa as specified, or the exceptions listed (currently completing regimen; documented hypersensitivity to preferred agent ingredient; concurrent non‑substitutable contraindicated agent)
chunks 14,15,16
See repeated clauses in chunks 7–16
Not eligible: Re-treatment after NS5A inhibitor failure
Sovaldi (sofosbuvir) may not be approved when the following condition is met:
Per policy non‑approval condition (chunk 18)
Hypersensitivity or contraindicated concomitant use
Coverage considerations related to hypersensitivity and concomitant medications:
Allows exception to prior‑trial requirement when true hypersensitivity is documented (see chunks 7,8,9,12,14,15)
Policy notes concurrent non‑substitutable contraindicated agents as a reason for exception or denial (chunks 7–16,19)
Requests for Sovaldi (sofosbuvir) may not be approved when one or more of the following constraints apply. Individuals with severe or end‑stage CKD (requiring dialysis) are not eligible. Do not approve when Sovaldi is being used in combination with daclatasvir if a known NS5A polymorphism is present. Concurrent use with certain contraindicated or not‑recommended agents (examples include amiodarone, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St John’s Wort, tipranavir/ritonavir) is a basis for non‑approval. Non‑approval also applies when Sovaldi is combined with a non‑nucleoside NS5B polymerase inhibitor (e.g., dasabuvir), or with an NS3/4A protease inhibitor other than simeprevir or elbasvir/grazoprevir, or with an NS5A 2a inhibitor other than daclatasvir or elbasvir/grazoprevir. Additionally, re‑treatment scenarios involving simeprevir combinations after prior failure (failure to achieve SVR defined as HCV RNA ≥25 IU/mL or relapse) are listed as non‑approval conditions.
Re‑treatment requests that include Sovaldi in combination with daclatasvir are not approved when the individual previously failed to achieve a sustained virologic response (SVR)—defined in this policy as a lower limit HCV RNA of 25 IU/mL—or relapsed after achieving SVR during a prior completed regimen that contained an NS5A 2a inhibitor.
Retreatment combinations are excluded from approval when there is documented prior failure to achieve SVR or documented relapse after prior SVR on specified prior regimens. Examples include prior failure with regimens containing NS3/4A 2c protease inhibitors, NS5B non‑nucleoside polymerase inhibitors, or other listed agent classes; such prior failures typically preclude approval of the same or closely related retreatment combinations except in limited transplant‑related scenarios described elsewhere in the policy.
When evaluating requests to re‑treat with daclatasvir‑containing regimens after prior therapy with an NS5A‑containing regimen, the policy specifies non‑approval if the prior course resulted in failure to achieve SVR (HCV RNA ≥25 IU/mL) or a subsequent relapse. Such requests should be denied per the documented exclusion unless an exception in the policy (for example, certain transplant circumstances) explicitly allows reconsideration.
Coding Thresholds and Clinical Scores
Provider Actions, Requirements, and Denial Triggers
Prior authorization required; quantity limit 1 tablet/day
Prior authorization is required for Sovaldi (sofosbuvir). The plan enforces a quantity limit of 1 tablet per day. Approval durations vary by genotype, cirrhosis, transplant, and other clinical-status factors per the approval criteria.
- Quantity limit: 1 tablet per day.
- Approval duration determined by genotype and clinical status (see regimen-specific criteria).
Prior auth required for re-treatment; controls for prior NS5A exposure
Prior authorization is required for re-treatment requests; requests may be subject to additional controls when there is prior NS5A exposure or other contraindicated concomitant medications. Re-treatment with daclatasvir after prior NS5A-containing regimen failure is specifically listed as a non-approved scenario.
- Prior authorization required for re-treatment requests when prior NS5A exposure is present.
- Re-treatment in combination with daclatasvir after prior NS5A failure (SVR ≥25 IU/mL or relapse) may not be approved.
Step therapy: prior trial of Epclusa or Mavyret required
Many Sovaldi regimen approvals require a documented prior trial and inadequate response to preferred agents (authorized generic Epclusa/sofosbuvir-velpatasvir or Mavyret) before approval of Sovaldi-based regimens, unless specified exceptions apply.
- Medication samples, coupons, and discount cards are excluded from consideration as a prior trial.
- Exceptions to prior trial requirement include currently completing the requested regimen, documented hypersensitivity to preferred agents, contraindicated concomitant agents that cannot be substituted or stopped, or transplant recipient status as specified in regimen branches.
Preferred regimens and permitted substitutions; non-preferred combinations may be disallowed
Preferred regimens (e.g., Epclusa or Mavyret) should be used when appropriate; use of non-preferred combinations or combinations with contraindicated concomitant agents may be disallowed or require documentation of intolerance or hypersensitivity to preferred options.
- Documented hypersensitivity to preferred agents or inability to substitute/stop a concomitant agent supports consideration of Sovaldi regimen.
- Non-preferred combinations may be denied if contraindicated agents cannot be changed.
Required documentation: CHC diagnosis, genotype, HCV RNA, liver disease status
Provide documentation of chronic hepatitis C infection including genotype and a positive HCV RNA result, evidence of compensated or decompensated liver disease, and enrollment in a substance abuse program if the individual abuses alcohol or IV drugs.
- Document genotype and positive HCV RNA (AASLD/IDSA 2017, CDC 2013).
- If active alcohol or IV drug abuse, document enrollment in a substance abuse program.
- Document compensated vs decompensated liver disease per approval criteria.
HBV testing and monitoring plan required (HBV reactivation risk)
Obtain and document evidence of current or prior HBV infection before initiating DAA therapy and provide a monitoring plan for HBV reactivation during and after therapy, because DAA agents have a black box warning for HBV reactivation.
- Test for evidence of current or prior HBV infection prior to DAA initiation.
- Document monitoring plan and management approach for HBV reactivation during and following HCV DAA therapy.
Child‑Pugh scoring documentation required
Document liver disease status using Child‑Pugh components and calculate the total Child‑Pugh score to establish Class A, B, or C (compensated versus decompensated) as required for regimen selection.
- Record total bilirubin, serum albumin, prothrombin time/INR, presence of ascites, and hepatic encephalopathy.
- Calculate total points and interpret Class A (5–6), B (7–9), or C (10–15).
Denial triggers: severe/ESKD and NS5A polymorphism or contraindicated drugs
Requests may be denied for individuals with severe (eGFR 15–29 mL/min) or end‑stage CKD (eGFR <15 mL/min) requiring dialysis; for use with daclatasvir when a known NS5A polymorphism is present; or for concurrent use with listed contraindicated agents (e.g., amiodarone, carbamazepine, phenytoin, rifampin, St John's Wort, tipranavir/ritonavir).
- Severe CKD (Stage 4) defined as eGFR 15–29 mL/min and End‑Stage CKD (Stage 5) as eGFR <15 mL/min.
- Known NS5A polymorphism with daclatasvir-containing regimen is a denial trigger.
- Concurrent contraindicated agents listed in the policy can lead to non-approval.
Re‑treatment with daclatasvir after NS5A failure is not approvable
Re-treatment requests that include daclatasvir for individuals who previously failed to achieve SVR (defined as HCV RNA ≥25 IU/mL) or who relapsed after prior SVR on an NS5A‑containing regimen are not eligible for approval under this policy.
- SVR failure threshold specified as HCV RNA ≥25 IU/mL.
- This re-treatment exclusion applies to prior NS5A 2a inhibitor failures as described.
Non‑approval risk when contraindicated concomitant medication cannot be stopped or changed
If a concurrent medication is contraindicated with preferred regimen(s) and cannot be substituted or temporarily discontinued, the Sovaldi request may not be approved unless documentation shows inability to change the concomitant agent.
- Examples of contraindicated concomitant agents are provided in the policy and include strong inducers and other listed drugs.
- Document inability to substitute or stop the agent to support approval consideration.
Hypersensitivity to preferred agent ingredients affects regimen choice/approval
Documented hypersensitivity manifested by a severe allergic reaction to any ingredient in Mavyret (or other preferred agents) that is not present in Sovaldi or Daklinza may support approval of a Sovaldi‑based regimen as an alternative.
- Provide evidence of severe allergic reaction to the preferred agent ingredient not shared with Sovaldi or Daklinza.
- Hypersensitivity is an exception to prior trial requirements in several regimen branches.
Definitions and Background
Sovaldi (sofosbuvir) is an oral NS5B polymerase inhibitor used as part of combination antiviral regimens to treat chronic hepatitis C across multiple genotypes, cirrhosis statuses, and transplant settings. Regimens and durations vary by genotype, presence of compensated or decompensated liver disease, transplant status, age, and presence of viral polymorphisms (for example, Y93H). Sovaldi is typically administered in combination with other direct‑acting antivirals or ribavirin according to AASLD/IDSA guidance, and co‑infection with HIV‑1 is permitted per those recommendations.
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