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«Oxford UnitedHealthcare® Oxford Clinical Policy SODIUM HYALURONATE Policy Number: PHARMACY 059.32 T2 Effective Date: October 1, 2016 Table of ...»

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Oxford

UnitedHealthcare® Oxford

Clinical Policy

SODIUM HYALURONATE

Policy Number: PHARMACY 059.32 T2 Effective Date: October 1, 2016

Table of Contents Page Related Policies

INSTRUCTIONS FOR USE

CONDITIONS OF COVERAGE

BENEFIT CONSIDERATIONS

COVERAGE RATIONALE

APPLICABLE CODES

DESCRIPTION OF SERVICES

CLINICAL EVIDENCE

U.S. FOOD AND DRUG ADMINISTRATION

REFERENCES

POLICY HISTORY/REVISION INFORMATION................ 15

INSTRUCTIONS FOR USE

This Clinical Policy provides assistance in interpreting Oxford benefit plans. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage members. Oxford reserves the right, in its sole discretion, to modify its policies as necessary. This Clinical Policy is provided for informational purposes. It does not constitute medical advice. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies.

When deciding coverage, the member specific benefit plan document must be referenced. The terms of the member specific benefit plan document [e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan Description (SPD)] may differ greatly from the standard benefit plan upon which this Clinical Policy is based. In the event of a conflict, the member specific benefit plan document supersedes this Clinical Policy. All reviewers must first identify member eligibility, any federal or state regulatory requirements, and the member specific benefit plan coverage prior to use of this Clinical Policy. Other Policies may apply.

UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.

CONDITIONS OF COVERAGE

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BENEFIT CONSIDERATIONS

Before using this policy, please check the member specific benefit plan document and any federal or state mandates, if applicable.

Essential Health Benefits for Individual and Small Group For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”). Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to provide coverage for benefits which are deemed EHBs, the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is made on a state by state basis. As such, when using this policy, it is important to refer to the member specific benefit plan document to determine benefit coverage.

COVERAGE RATIONALE

Pre-certification is not required in the office for J7323, J7325, 20605 and 20610.

Initial Course of Administration/Treatment Intra-articular injections of sodium hyaluronate are proven and medically necessary for treating pain due to osteoarthritis of the knee when administered according to U.S. Food and Drug Administration (FDA) labeled indications.

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*Hyaluronic acid preparations for the treatment of pain due to osteoarthritis of the knee are deemed therapeutically equivalent. The UnitedHealth Group National Pharmacy and Therapeutics Committee has defined therapeutically equivalent, products that can be expected to produce essentially the same therapeutic outcome and toxicity.

–  –  –

Euflexxa, and Synvisc or Synvisc-One (J7323, J7325) Pre-certification is not required in the office for J7323 and J7325.

Intra-articular hyaluronan injections, Euflexxa (1% sodium hyaluronate), and Synvisc (Hylan G-F 20) or Synvisc-One (Hylan G-F 20), are proven and medically necessary for members with osteoarthritis of the

knee who meet all of the following criteria:

 The member has documented symptomatic osteoarthritis of the knee;

 The member reports pain which interferes with functional activities (e.g., ambulation, prolonged standing);

 The member has not responded adequately to conservative therapy which may include physical therapy or pharmacotherapy (e.g., non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen and/or topical capsaicin cream) or injection of intra-articular steroids and such therapy has not resulted in functional improvement after at least 3 months, or the member is unable to tolerate conservative therapy because of adverse side effects;

 The pain cannot be attributed to other forms of joint disease; and  There are no contraindications to the injections (e.g., active joint infection, bleeding disorder).

Hyalgan and Supartz (J7321), Orthovisc (J7324), Gel-One (J7326), Monovisc (J3490), Gel-Syn (J7328), and Genvisc 850 (Q9980), Hymovis (J3490) Pre-certification is required in all settings for J7321, J7324, J7326, J7328, Q9980 and J3490.





Intra-articular hyaluronan injections, Hyalgan (sodium hyaluronate) and Supartz (sodium hyaluronate), Orthovisc (high molecular weight form of hyaluronic acid), Gel-One (hyaluronan), Monovisc (crosslinked sodium hyaluronate), Gel-Syn (sodium hyaluronate), Genvisc 850 (sodium hyaluronate), and Hymovis (hyaluronic acid) are proven and medically necessary for members with osteoarthritis of the

knee who have met the criteria above and:

 The member has a history of failure, contraindication or intolerance documented trial and failure to Synvisc, Synvisc-One or Euflexxa.

Intra-articular injections of sodium hyaluronate are proven and medically necessary for treating temporomandibular joint (TMJ) disc displacement and osteoarthritis.

Sodium hyaluronate preparations are unproven and not medically necessary for treating any other

indication not listed above as medically necessary including but not limited to:

 Pain due to osteoarthritis in any joint other than the knee or TMJ  Any other form of arthritis [including rheumatoid arthritis (RA)  Patello-femoral syndrome  Chondromalacia of the knee  Following total or partial knee joint replacement Increase in viscoelasticity of synovial fluid after sodium hyaluronate injection has not been demonstrated in patients with rheumatoid arthritis, and it has not been determined whether sodium hyaluronate is protective in joints affected by rheumatoid arthritis. Further studies are needed to determine the safety and durability of such treatment for patello-femoral syndrome and chondromalacia of the knee and whether it significantly delays the need for more invasive treatment, e.g., surgery, joint replacement or arthroplasty. There are no clinical studies evaluating the use of sodium hyaluronate in persons following total or partial knee joint replacement surgery.

Hyaluronic acid gel preparations to improve the skin's contour and/or reduce depressions due to acne, scars, injury or wrinkles are considered cosmetic.

The use of sodium hyaluronate preparations to improve the skin's contour and/or reduce depressions in the skin due to acne, scars, injury or wrinkles improves physical appearance but does not remove or improve a functional impairment of the skin.

Subsequent Course of Administration/Treatment Repeated courses of intra-articular sodium hyaluronan injections of the knee may be considered proven

and medically necessary under the following conditions:

 Documentation of significant pain relief achieved with the prior course of injections; and  Pain has recurred; and  At least six (6) months have passed since the prior course of treatment.

APPLICABLE CODES

The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non

–  –  –

Coding Clarification: Sodium Hyaluronate is unproven and not medically necessary for any other diagnosis not listed as proven. This also includes any other form of arthritis other than osteoarthritis of the knee and TMJ or for any other condition not included in this policy.

–  –  –

DESCRIPTION OF SERVICES

Sodium hyaluronate also referred to as hyaluronic acid (HA) or hyaluronan is a viscoelastic substance that occurs naturally in synovial fluid and is thought to play an important role in lubricating, protecting, and maintaining the health of articular cartilage. Sodium hyaluronate preparations are used as an intra-articular treatment for relief of pain associated with osteoarthritis (OA), with the potential for disease modification through improvement of synovial fluid quality and/or quantity. (Hayes, 2012, updated 2015) HA preparations have been approved by the FDA as a device for the treatment of pain in osteoarthritis of the knee in patients who have not responded to exercise, physical therapy and non-prescription analgesics. HA gels have also been approved by the FDA for treatment of wrinkles and other facial contouring disorders.

CLINICAL EVIDENCE

Numerous randomized controlled trials have investigated the utility of sodium hyaluronate for osteoarthritis of the knee as well as for temporomandibular joint arthritis and disc displacement. There is growing literature regarding the use of Synvisc® Hylan G-F 20 for the treatment of osteoarthritis (OA) of the hip. However, current FDA labeling for sodium hyaluronate is limited to osteoarthritis of the knee.

Knee Osteoarthritis A systematic review and meta-analysis by Bannuru et al.(2009) compared the effectiveness of intra-articular hyaluronic acid (n=312 patients) with corticosteroids (n = 294 patients) for knee osteoarthritis (OA). Of 1238 studies evaluated, 7 studies were included for meta-analysis. The authors found that intra-articular corticosteroids appeared more effective for pain relief through week 4.At week 4 both treatments appeared equal. However, treatment effects at 8 weeks and beyond showed greater effectiveness in the hyaluronic acid group.

Goldberg and Buckwalter's (2005) meta-analysis of the use of hyaluronans in the treatment of OA concluded that there is clinical evidence to support that in addition to relieving the symptoms of OA, they also modify the structure of the disease joint and the rate of OA disease progression.

Chevalier et al.(2010) conducted a prospective double-blind study of 253 patients to compare the use of a single 6ml intra-articular injection of hylan G-F 20 (n = 123) with placebo (n = 130) in patients with symptomatic knee Sodium Hyaluronate Page 5 of 15 UnitedHealthcare Oxford Clinical Policy Effective 10/01/2016 ©1996-2016, Oxford Health Plans, LLC osteoarthritis. Outcomes were measured by the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, Likert and patient global assessment (PGA) questionnaires as well as a blinded evaluator completed by the clinical observer global assessment (COGA).Patients were followed up 1, 4, 8, 12, 18 and 26 weeks after injection.

Patients receiving hylan G-F 20 had greater improvements in WOMAC A pain scores and several of the secondary outcome measures (WOMAC A1, PGA and COGA), than patients receiving placebo treatment. The authors concluded that a single 6 ml intra-articular injection of hylan G-F 20 provided better pain relief over 26 weeks than placebo.

In a prospective, naturalistic study by Petrella (2005), 537 patients received a 3 intra-articular injection series with Suplasyn over 3 weeks. The cohort group was followed for 6.7 years. Patients returned for consideration of a repeat injection series based on their perception of symptom severity and were eligible if their resting visual analog scale pain was 45 mm. The three-injection series and data collection were repeated, and again, patients were given similar instructions regarding consideration of a third injection series. The mean time between first and second series was 27 +/- 7 wks. Duration of symptom control was about 6 months. These data support the potential role of intraarticular hyaluronic acid as an effective long-term therapeutic option for patients with osteoarthritis of the knee.

Conrozier et al. (2009) conducted a prospective, multi-center, randomized study of 100 patients to evaluate the safety and efficacy of five dosing regimens of viscosupplementation with hylan G-F 20 in patients with symptomatic tibio-femoral osteoarthritis. Patients were randomized to receive varying dosing regimens of hylan G-F 20 (1 x 6 mL, 1 x 4 mL, 2 x 4 mL 2 weeks apart, 3 x 4 mL 1 week apart, or 3 x 2 mL 1 week apart).Patients in the 3 x 4 mL group reported the highest percentage of device-related local adverse events (30%) while patients in the 1 x 6 mL and 3 x 2 mL groups reported only 10%.Patients in the 1 x 6, 3 x 4 and 3 x 2 mL treatment groups showed the greatest improvements in the patient-rated knee osteoarthritis pain assessment visual analog score. The authors concluded that a single 6 mL injection of hylan G-F 20 may be as efficacious, and as well tolerated, as 3 x 2 mL one week apart;

however, a double-blind, controlled trial is needed to confirm these data.



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