Subject:
Pegloticase (Krystexxa®)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Pegloticase (Krystexxa) is a PEGylated uric acid specific enzyme that consists of recombinant modified mammalian urate oxidase. It functions by catalyzing the oxidation of uric acid to allantoin which in turn lowers serum uric acid.
Pegloticase is marketed as Krystexxa by Crealta Pharmaceuticals LLC.
In September 2010, the FDA approved Krystexxa for the treatment of chronic gout in adult patients who are refractory to conventional therapies. These patients have not achieved serum uric acid normalization and continue to exhibit signs and symptoms of gout despite xanthine oxidase inhibitor therapy or those who cannot tolerate of or are contraindicated to such therapies.
[INFORMATIONAL NOTE: The FDA-approved Krystexxa (pegloticase) package insert has the following black box warnings:
· Anaphylaxis and infusion reactions have been reported to occur during and after administration of Krystexxa
· Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported.
· Krystexxa should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions
· Patients should be premedicated with antihistamines and corticosteroids
· Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of Krystexxa.
· Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
Policy:
NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance
I. Pegloticase (Krystexxa) is medically necessary for the FDA-approved indication of chronic gout in adult patients refractory to conventional therapy who meet the following criteria:
· Refractory patients are defined as those who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors (allopurinol, febuxostat/Uloric) AND with a combination therapy with uricosuric agent (probenecid) and xanthine oxidase inhibitor at the maximum medically appropriate dose or for whom these drugs are contraindicated (documentation of medical records required)
· Patient has one of the following (documentation of medical records required):
o At least 3 gout flares in the previous 18 months that were inadequately controlled by colchicine and/or nonsteroidal anti-inflammatory drugs (NSAIDS) or oral/injectable corticosteroids; OR
o At least 1 gout tophus or has chronic gouty arthritis; AND
· Baseline serum uric acid level > 8 mg/dL (current lab reports are required for renewal; documentation of medical records required); AND
· Patient is NOT concurrently receiving other urate lowering therapies such as allopurinol, febuxostat, probenecid, lesinurad, etc. AND
· The prescriber is a specialist in the area of the patient’s diagnosis (e.g. rheumatologist, nephrologist) or has consulted with a specialist in the area of the patient’s diagnosis
[INFORMATIONAL NOTE: 2012 American College of Rheumatology guidelines for gout recommends certain diet and lifestyle measures for the majority of patients to decrease the risk and frequency of acute gout attacks and lowering serum urate levels. Recommendations include limiting consumption of purine-rich meat and seafood as well as high fructose corn syrup-sweetened soft drinks and energy drinks, and encouraging the low-fat or nonfat daily product consumption. ]
II. Eligible members must not have documented Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
[INFORMATIONAL NOTE: Pegloticase is contraindicated in G6PD deficiency due to the risk of hemolysis and methemoglobinemia. Before starting pegloticase, patients at higher risk for G6PD deficiency (e.g. those of African and Mediterranean ancestry) should be screened due to the risk of hemolysis and methemoglobinemia.]
III. When medical necessity criteria are met, pegloticase (Krystexxa) will be approved for six (6) months at the FDA approved dose of 8 mg every two weeks by intravenous infusion.
[[INFORMATIONAL NOTE: As per the FDA approved package insert, pegloticase should be given as an intravenous infusion over no less than 120 minutes via gravity feed, syringe-type pump, or infusion pump. Patients should receive pre-medication with an antihistamine and corticosteroid to minimize the risk of anaphylaxis and infusion reactions. Administer pegloticase in a healthcare setting and observe patients for an appropriate period of time after administration. Patients should discontinue oral urate-lowering medications and should not be instituted on therapy with oral urate-lowering agents while on pegloticase.
As per the FDA approved package insert, gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of Krystexxa therapy and lasting at least 6 months, unless medically contraindicated or not tolerated. Krystexxa does not need to be discontinued because of a gout flare.]
IV. Continued therapy with pegloticase (Krystexxa) will be considered biannually based if the following criteria are met:
· Disease response with treatment (e.g., reduction of symptoms, reduction of tophi); AND
· Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: anaphylaxis; infusion reactions; exacerbation of congestive heart failure; AND
· Serum uric acid level <6 mg/dL prior to scheduled infusion (documentation of medical records required)
[INFORMATIONAL NOTE: The optimal treatment duration with pegloticase has not been established. The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response. Monitoring of serum uric acid levels prior to infusions may be warranted to determine if treatment should be continued. According to the FDA approved labeling, if 2 consecutive levels are above 6 mg/dL, treatment discontinuation should be considered.]
V. Other uses of pegloticase (Krystexxa) are considered investigational, including, but not limited to the treatment of asymptomatic hyperuricemia and youth onset type 2 diabetes.
[INFORMATIONAL NOTE: Per FDA approved labeling, Pegloticase is not recommended for the treatment of asymptomatic hyperuricemia.]
Medicare Coverage
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon Policy.
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Pegloticase (Krystexxa®)
Krystexxa® (Pegloticase)
References:
1. Krystexxa® (Pegloticase) Prescribing Information. Crealta Pharmaceuticals LLC. Glendale, WI: 07/2015. January 2020.
2. MICROMEDEX® 1.0 (Healthcare Series). DRUGDEX® Evaluations. Pegloticase. Available at: http://www.thomsonhc.com. Accessed March 9, 2015.
3. Sundy JS, Baraf HS, et al. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA. 2011 Aug 17;306(7):711-20.
4. Khanna, D. et al. 2012 American College of Rheumatology Guidelines for Management of Gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care & Research Vol. 64, No.10, October 2012, pp 1431-1446.
5. Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Annals of the Rheumatic Diseases 2017;76:29-42. Qaseem A, Harris RP, Forciea MA, et al. Management of Acute and Recurrent Gout: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017;166(1):58-68.
6. Krystexxa . ClinicalTrials.gov Available at clinicaltrials.gov/ct2/results?cond=&term=krystexxa&cntry=&state=&city=&dist=.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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