CurrentCignaPolicy N/A

Hepatitis C - Sovaldi Drug Quantity Management Policy - Per Days • Sovaldi ® (sofosbuvir tablets and oral pellets - Gilead)

Cigna drug quantity management policy specifying annual maximum quantities and clinical criteria for coverage of Sovaldi (sofosbuvir) tablets and pellet packets in pediatric patients with chronic Hepatitis C genotype 3 when used in combination with ribavirin; approvals are for 1 year and quantity limits are per 365 days.

Policy Summary

PayerCigna

PolicyHepatitis C - Sovaldi Drug Quantity Management Policy - Per Days • Sovaldi ® (sofosbuvir tablets and oral pellets - Gilead)

Policy CodePolicy N/A

Change TypeAnnual revision — clarified (no criteria changes)

Effective Date

Next Review Date

Key ActionIf the Drug Quantity Management rule is not met at point of service, confirm the patient meets the specified pediatric genotype 3 clinical criteria (age <18, not decompensated cirrhosis, prescribed with ribavirin) for a 1-year approval and applicable quantity limits.

POLICY UPDATE CHANGES

Annual Revision dated 10/07/2024 indicates 'No criteria changes.'

2Pediatric genotype indications covered (150/400 mg and 200 mg formulations)

24 weeksMaximum treatment duration represented

1 yearApproval duration

Coverage Summary

Initial Therapy Criteria

Sovaldi 150 mg pellet packet and 400 mg tablet - Genotype 3 (pediatric)

Approve 168 tablets per 365 days at retail or home delivery if the patient meets ALL of the following (A, B, and C):

ALL of the following

A: Patient is < 18 years of age
B: The patient does not have decompensated cirrhosis (Child-Pugh B or C)
Coverage is provided for patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).
C: The medication will be prescribed in combination with ribavirin
This is a quantity sufficient to treat with one pellet packet or one tablet once daily for 24 weeks.

Completion: For an indication or condition addressed as an approval in the above criteria section, approve the quantity requested, not to exceed 168 tablets to complete a course therapy.

For example, if the patient has received 84 tablets (12 weeks), approve 84 tablets to complete a total of 24 weeks of treatment (total of 168 tablets).

Sovaldi 200 mg pellet packet and 200 mg tablet - Genotype 3 (pediatric)

Approve 336 tablets per 365 days at retail or home delivery if the patient meets ALL of the following (A, B, and C):

ALL of the following

A: Patient is < 18 years of age
B: The patient does not have decompensated cirrhosis (Child-Pugh B or C)
Coverage is provided for patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).
C: The medication will be prescribed in combination with ribavirin
This is a quantity sufficient to treat with two pellet packets or two tablets once daily for 24 weeks.

Completion:

Continuation Therapy / Completion of Course

General completion-of-course quantity approvals

For an indication or condition addressed as an approval in the above criteria sections, approve the quantity requested to complete a course of therapy, not to exceed the stated annual maximums.

ANY of the following

150/400 mg regimen completion: If patient has received 84 tablets (12 weeks) for 150 mg/400 mg regimen, approve up to 84 tablets to complete total of 24 weeks (total 168 tablets)
200 mg regimen completion: If patient has received 168 tablets (12 weeks) for 200 mg regimen, approve up to 168 tablets to complete total of 24 weeks (total 336 tablets)

Definitions & Background

Sovaldi is an NS5B polymerase inhibitor indicated as part of combination antiviral therapy for chronic HCV in adults and, for pediatric patients ≥3 years, for genotypes 2 or 3 in combination with ribavirin. Pediatric dosing and duration for genotypes 2 and 3 are weight-based, with pellets available for children who cannot swallow tablets; genotype 3 pediatric treatment with Sovaldi + ribavirin is given for 24 weeks. This policy specifically addresses pediatric genotype 3 use in combination with ribavirin and implements drug quantity limits to prevent stockpiling and waste, with point-of-service quantity management and 1-year approvals.

Decompensated cirrhosis: Child-Pugh class B or C (patients with these classifications are excluded from the pediatric coverage criteria).

Provider Actions

Prior Authorization

Quantity management rule and criteria check at point of service

If the Drug Quantity Management rule is not met for the requested medication at point of service, coverage will be determined by the specified clinical criteria; approvals are provided for 1 year.

Billing Rule

Dispensing limits per fill

Dispensing is limited to 28 packets/tablets per dispensing for 150 mg and 400 mg strengths (maximum annual quantities defined); 56 packets/tablets per dispensing for 200 mg strength. Annual maximums: 150 mg pellet packets — 84 packets per 365 days (28 packets per dispensing); 400 mg tablets — 84 tablets per 365 days (28 tablets per dispensing); 200 mg pellet packets — 168 packets per 365 days (56 packets per dispensing); 200 mg tablets — 168 tablets per 365 days (56 tablets per dispensing).

Documentation Required

Clinical documentation for pediatric genotype 3

Provider must document patient age (<18), cirrhosis status (not decompensated; Child-Pugh classification), and that Sovaldi will be prescribed in combination with ribavirin.

Patient age (< 18 years)
Cirrhosis status — patient does not have decompensated cirrhosis (exclude Child-Pugh B or C); note coverage includes patients without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Documentation that Sovaldi will be prescribed in combination with ribavirin

Applicable Codes

drug products and forms covered (quantity limits apply)NDC|mixedCovered

Sovaldi 150 mg pellet packets	Unit-dose packets; maximum 84 packets per 365 days (28 packets per dispensing)
Sovaldi 200 mg pellet packets	Unit-dose packets; maximum 168 packets per 365 days (56 packets per dispensing)
Sovaldi 200 mg tablets	Bottles of 28 tablets; maximum 168 tablets per 365 days (56 tablets per dispensing)
Sovaldi 400 mg tablets	Bottles of 28 tablets; maximum 84 tablets per 365 days (28 tablets per dispensing)