Hyaluronate Derivatives

Coverage Summary

Medical-benefit prior authorization policy for hyaluronate derivatives used to treat pain from knee osteoarthritis. The policy covers initial and continued therapy criteria, required documentation, contraindications, dosing and treatment cycles, HCPCS J-codes, and program-specific exceptions. For Health Insurance Marketplace (HIM) members, hyaluronates are excluded from the HIM pharmacy benefit and the criteria are applicable to the HIM medical benefit. Per Illinois law (IL HB 5395) effective 01.01.2026, step therapy requirements for Illinois HIM requests are bypassed. Policy status: covered_with_criteria. Effective date: 10.01.08; Last review / P&T approval date: 11.25 (documented 07.10.25 annual review adding IL HIM step therapy bypass).

Key Thresholds

NSAID trial duration>= 4 weeks of continuous therapeutic (prescription strength) dosing

Allowed treatment frequency per kneeOne treatment cycle per knee per 6 months

Continued therapy retreatment interval>= 6 months since last treatment cycle

Approval duration6 months (one treatment cycle per knee)

Initial Therapy Criteria — Osteoarthritis of the Knee

I. Initial Approval Criteria - Osteoarthritis of the Knee

Covered when ALL of the following are met:

ALL of the following

Diagnosis of OA of the knee supported by imaging (e.g., X-ray, MRI)
Prescribed by or in consultation with a rheumatologist, orthopedist, physiatrist, or sports medicine physician
Inadequate response to physical therapy as directed by a physical therapist
ALL of the following
- ONE of

Initial Therapy — Other Diagnoses / Indications

I. Initial Approval Criteria - Other diagnoses/indications

Must meet ONE of the following:

ANY of the following

If the drug has had a label change within the last 6 months not yet reflected in this policy, follow appropriate no-coverage or non-formulary policy depending on formulary status (see referenced policy numbers)within 6 months
Refer to CP.CPA.190, CP.PMN.255, HIM.PA.33, CP.PMN.16 as applicable
If requested use is NOT listed under section III and label-change criterion does not apply, refer to the off-label use policy for the relevant line of business (see referenced policy numbers)
Refer to CP.CPA.09 (commercial), HIM.PA.154 (HIM medical), CP.PMN.53 (Medicaid)

Continuation Therapy Criteria — Osteoarthritis of the Knee

II. Continued Therapy - Osteoarthritis of the Knee

Covered when ALL of the following are met:

ALL of the following

Member meets one of the following: currently receiving medication via Centene benefit or previously met initial approval criteria; OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy as evidenced by at least one of: decrease in pain (e.g., VAS), improvement in ambulation or range of motion, improvement in stiffness, decrease in rescue pain medication use
Member has not had total knee arthroplasty in the targeted knee
At least 2 of the following

Continuation Therapy — Other Diagnoses / Indications

II. Continued Therapy - Other diagnoses/indications

Must meet ONE of the following (same routing as Initial Other diagnoses):

ANY of the following

If recent label change not reflected, follow no-coverage or non-formulary policy as appropriatewithin 6 months
Refer to CP.CPA.190, CP.PMN.255, HIM.PA.33, CP.PMN.16 as applicable
If requested use not listed in section III and label-change criterion does not apply, refer to off-label use policy
Refer to CP.CPA.09 (commercial), HIM.PA.154 (HIM medical), CP.PMN.53 (Medicaid)

Diagnoses / Indications Not Authorized

III. Diagnoses/Indications Not Authorized

Not covered unless criteria in off-label policies are met:

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents

Refer to CP.CPA.09 (commercial), HIM.PA.154 (HIM medical), CP.PMN.53 (Medicaid)

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for hyaluronate derivatives. Providers must submit documentation demonstrating that the member meets all approval criteria.

Office chart notes documenting diagnosis and imaging
Imaging (e.g., X-ray, MRI) supporting knee OA
Documentation of trials of therapies (physical therapy, ≥4-week oral NSAID or topical NSAID when applicable)
Documentation of at least one intra-articular glucocorticoid injection with a documented positive but inadequate response (or contraindication/intolerance)
PA must demonstrate all criteria are met for approval
Affected HCPCS codes: J7318, J7320, J7321, J7322, J7323, J7324, J7325, J7326, J7327, J7328, J7329, J7331, J7332

Applicable Codes

HCPCS J-codes for hyaluronan derivatives (informational)HCPCS

J7318	Hyaluronan or derivative, Durolane, for intra-articular injection, 1 mg
J7320	Hyaluronan or derivative, GenVisc 850, for intra-articular injection, 1 mg
J7321	Hyaluronan or derivative, Hyalgan, Supartz, or VISCO-3, for intra-articular injection, per dose
J7322	Hyaluronan or derivative, hymovis or hymovis one, for intra-articular injection, 1 mg
J7323	Hyaluronan or derivative, Euflexxa, for intra-articular injection, per dose
J7324	Hyaluronan or derivative, Orthovisc, for intra-articular injection, per dose
J7325	Hyaluronan or derivative, Synvisc or Synvisc-One, for intra-articular injection, 1 mg
J7326	Hyaluronan or derivative, Gel-One, for intra-articular injection, per dose
J7327	Hyaluronan or derivative, Monovisc, for intra-articular injection, per dose
J7328	Hyaluronan or derivative, Gelsyn-3, for intra-articular injection, 0.1 mg

1–10 of 13

1/2

Clinical Evidence & Rationale

3Guideline citations (AAOS, ACR, OARSI)

Knee-onlyEvidence supports use for knee OA; not appropriate for other joints

Hip/Ankle negHip and ankle trials showed no consistent benefit vs placebo

Background evidence supports that hyaluronate derivatives are FDA-indicated only for knee osteoarthritis in patients who have not responded to conservative non-pharmacologic therapy and simple analgesics. Guideline and trial evidence cited show lack of consistent benefit for hip and ankle OA versus placebo/saline and recommend limiting use to the knee. Referenced guideline sources include AAOS (2021), ACR (2019), and OARSI (2019). Appendix D includes examples of a documented positive but inadequate response to intra-articular glucocorticoid injections used in the approval criteria.

Background

Hyaluronate derivatives are FDA-indicated for treatment of pain in knee osteoarthritis for patients who have failed conservative non-pharmacologic therapy and simple analgesics. The policy lists covered products and HCPCS J-codes, specifies dosing and product-specific treatment cycles (e.g., Euflexxa = 3 injections; Durolane = 1 injection; Monovisc = 1 injection), and details contraindications (including known hypersensitivity and injection-site infection). The rationale for limiting coverage to knee OA is supported by guideline recommendations and trial data showing no consistent efficacy in hip or ankle OA.

Definitions: - Treatment cycle: Product-specific injection course as listed in Section V (e.g., Euflexxa = 3 injections; Durolane = 1 injection; Monovisc = 1 injection). - OA: Osteoarthritis. - NSAID: Non-steroidal anti-inflammatory drug.

Revision History

07.20.21material

2021-07-20 material: Added allowable treatment number per duration to initial and continued criteria (4Q 2021 annual review; P&T Approval Date 11.21)

01.06.24revised

2024-01-06 non-material: (4Q 2022/2024 updates reflected ongoing HCPCS and template changes; HCPCS J7321 description updated and obsolete codes removed)

02.12.24material

2024-02-12 material: Revised HIM line of business to HIM medical benefit (hyaluronates excluded from HIM pharmacy benefit)