CurrentCignaPolicy IP0263

Plegridy (peginterferon beta-1a)

Cigna drug coverage policy describing medical necessity criteria, covered indications, limitations, and billing-related requirements for Plegridy (peginterferon beta-1a) for treatment of relapsing forms of multiple sclerosis under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyPlegridy (peginterferon beta-1a)

Policy CodePolicy IP0263

Change TypeUpdates to definitions, prescribing, continuation, and preferred product rules

Effective DateDec 1, 2024

Next Review Date

Key ActionEnsure documentation and specialist involvement are provided when requesting initial or continuation coverage; prior authorization may be required for preferred product criteria.

POLICY UPDATE CHANGES

Added a definition for documentation.

Added a specialist prescribing requirement.

Added criteria for patient Currently Receiving Plegridy for ≥ 1 Year.

Removed Employer Plans preferred product requirements.

Updated Individual and Family Plans preferred product requirements.

Ocrevus Zunovo was added to the Appendix.

1Covered Indication (MS)

≥1yContinuation requirement (duration)

1yApproval duration

YesSpecialist involvement required

Coverage Summary

Plegridy (peginterferon beta-1a) is FDA-indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease. The policy aligns coverage to the FDA-approved indication and is applicable to Cigna-administered health benefit plans as described in the scope. Overall coverage stance: covered with criteria, requiring that medication be prescribed by or in consultation with a neurologist or physician who specializes in multiple sclerosis and that documented criteria are met for initial or continued therapy.

FDA-Approved Indication - Multiple Sclerosis

Approve for the duration noted below if the patient meets one of the following (A or B):

ANY of the following

A) Initial Therapy
- Documentation the patient has a relapsing form of multiple sclerosis
  Examples include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.
- Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis
- Preferred product criteria is met for the product(s) as listed in the Individual and Family Plans table
B) Patient is Currently Receiving Plegridy for ≥ 1 Year
- Patient has a relapsing form of multiple sclerosis
  Examples include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.
- Clinical response
  - Documentation the patient experienced a beneficial clinical response when assessed by at least one objective measure
    Examples include stabilization or reduced worsening in MRI activity (absence or decrease in gadolinium enhancing lesions, decrease in new or enlarging T2 lesions); stabilization or reduced worsening on EDSS; achievement of NEDA-3 or NEDA-4; improvement on FSIQ-RMS; reduction/absence of relapses; improvement/maintenance on six-minute walk test or 12-Item MS Walking Scale; improvement on MSFC; attenuation of brain volume loss.
  - Patient experienced stabilization, slowed progression, or improvement in at least one symptom such as motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling sensation
- Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

Applicable Codes

Drug (NDC) - PlegridyNDCCovered

No codes listed

Related products listed in Appendix (informational)mixed

Avonex	interferon beta-1a intramuscular injection (Preferred product referenced)
Ocrevus Zunovo	ocrelizumab and hyaluronidase-ocsq subcutaneous injection (added to Appendix)
Aubagio	teriflunomide tablets
Bafiertam	monomethyl fumarate delayed-release capsules
Betaseron	interferon beta-1b subcutaneous injection
Briumvi	ublituximab-xiij intravenous infusion
Copaxone	glatiramer acetate subcutaneous injection
Extavia	interferon beta-1b subcutaneous injection
Gilenya	fingolimod capsules
Glatopa	glatiramer acetate subcutaneous injection

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Provider Actions & Administrative Requirements

Prior Authorization

Prior authorization required per plan

Preferred product criteria for initial therapy may require prior authorization under Individual and Family Plans. When the criteria are met, approval duration is 1 year.

Documentation Required

Documentation of diagnosis and clinical response required

Documentation is required and may include the following to demonstrate relapsing MS diagnosis, specialist involvement, prior product failure/contraindication/intolerance (if applicable), or objective clinical benefit for continuation.

Chart notes
Laboratory tests
Claims records
Other information as required in criteria

Clinical Evidence & References

Evidence: Product prescribing information: Plegridy prescribing information, Biogen; July 2023; Guideline reference: A Consensus Paper by the Multiple Sclerosis Coalition, September 2019.

Background & Definitions

Background: Plegridy (peginterferon beta-1a) is indicated for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease. The policy explicitly aligns coverage to the FDA indication. The policy requires that the medication be prescribed by or in consultation with a neurologist or MS specialist, and continuation of Plegridy requires documentation of benefit (objective clinical response or stabilization) for approval when the patient has been receiving Plegridy for ≥ 1 year.

Term	Definition
Documentation
May include chart notes, laboratory tests, claims records, and/or other information as required in criteria.
Relapsing forms of multiple sclerosis
Includes clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.

Revision History

2024-12-01policy_effectiveLatest

Policy effective date set to 2024-12-01; revisions implemented as of this effective date (see Revision Details).

2024-12-01material_changeLatest

Added a specialist prescribing requirement: Medication must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis (applies to initial therapy and continuation).

2024-12-01

Policy Summary

PayerCigna

PolicyPlegridy (peginterferon beta-1a)

Policy CodePolicy IP0263

Change TypeUpdates to definitions, prescribing, continuation, and preferred product rules

Effective DateDec 1, 2024

Next Review Date

Key ActionEnsure documentation and specialist involvement are provided when requesting initial or continuation coverage; prior authorization may be required for preferred product criteria.

On This Page

Documentation Required

Specialist prescribing requirement

Medication must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis for both initial and continuation approvals.

Step Therapy

Preferred product requirement (Individual and Family Plans)

Initial therapy under Individual and Family Plans requires meeting ONE of the following: documentation of failure, contraindication, or intolerance to Avonex; OR currently receiving Plegridy.

Billing Rule

Samples do not satisfy coverage criteria

Receipt of sample product does not satisfy any criteria requirements for coverage.

Denial Risk

Non-relapsing MS excluded

Use of Plegridy for non-relapsing forms of multiple sclerosis (for example, primary progressive MS) is considered experimental/investigational/unproven and is not covered.

Added criteria for patients Currently Receiving Plegridy for ≥ 1 Year requiring documentation of clinical response (one objective measure or symptom stabilization/improvement) and specialist involvement; approval duration set to 1 year for continuation when criteria met.

2024-12-01updatedLatest

Updated Individual and Family Plans preferred product requirements: ONE of the following — documentation of failure, contraindication, or intolerance to Avonex; OR currently receiving Plegridy (may require prior authorization).

2024-12-01addedLatest

Added a definition for 'Documentation' (may include chart notes, laboratory tests, claims records, and/or other information).

2024-12-01addedLatest

Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq subcutaneous injection) was added to the Appendix listing related products.

2024-12-01removedLatest

Removed Employer Plans preferred product requirements.