Krystexxa (pegloticase)

POLICY NUMBER

L.5.01.462

Krystexxa (pegloticase)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Gout is a type of arthritis that occurs when uric acid builds up in the joints. Symptoms develop suddenly and can involve only one or a few joints, most commonly the big toes, knees, or ankle joints. The joint is usually very tender and appears warm and red. An acute gout flare typically affects one joint and lasts several days. Chronic gout is repeated episodes of pain and inflammation which may involve one or more joints. Those with chronic gouty arthritis may develop joint deformities and loss of motion in the joints.

There is no cure for gout, but it can be managed. Acute flares are most commonly treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine. Lifestyle changes such as losing weight, limiting alcohol, and eating less purine-rich food (i.e., red meat or organ meat) may help prevent future attacks, and medications that lower uric acid levels in the blood, such as allopurinol, febuxostat, or Krystexxa (pegloticase), can be used as prophylactic therapy for people with frequent acute flares or chronic gout.

Krystexxa (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult individuals refractory to conventional therapy.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy for purposes of Medical Policy review.

Krystexxa (pegloticase) will be considered medically necessary when ALL of the following criteria are met:

1. The individual is ≥18 years old;

2. The individual has a documented diagnosis of gout and ALL of the following:

   1. History of at least 2 gout flares in the previous 12 months;

   2. At least 1 gouty tophus;

   3. Chronic gouty arthropathy;

3. The individual has failed (see Medication Failure in Policy Guidelines) allopurinol AND febuxostat (≥3 months) defined as BOTH of the following:

   1. serum uric acid level >6mg/dL;

   2. continued signs/symptoms of gout despite treatment with xanthine oxidase inhibitors at the maximally tolerated dose for at least 6 months, AND

4. The individual does not have glucose-6-phosphate dehydrogenase (G6PD) deficiency;

5. The individual is not currently taking any oral urate-lowering medications and will not take any oral urate-lowering medication concurrently;

6. The prescriber is a specialist or has consulted with a specialist in an area of the individual's diagnosis (i.e., rheumatologist, nephrologist);

7. The medication will be administered in a healthcare setting by a healthcare provider prepared to manage anaphylaxis;

8. The prescribed quantity (dose) does not exceed FDA labeled dose of 8mg given as IV infusion every two weeks.

Length of Approval: 6 months

Renewal Criteria

Krystexxa (pegloticase) may be approved for renewal when ALL of the following criteria are met:

1. The individual has been previously approved for Krystexxa (pegloticase) through the BCBSMS Prior Authorization process;

2. The individual continues to meet all initiation criteria;

3. The individual has documented clinical improvement (i.e. serum uric acid level <6mg/dL, tophus reduction, etc.);

4. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent;

5. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

 Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Medication failure is defined as disease progression despite maximally tolerated dose (≥3 months use) as appropriate for disease state being treated. Experience of common side effects of medication will not be considered medication failure for the purpose of this review.

BCBSMS determines individual medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If individual is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the individual and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

11/04/2011: Policy added.

04/01/2014: Policy reviewed; no changes.

08/03/2015: Code Reference section updated for ICD-10.

05/31/2016: Policy number L.5.01.462 added. Policy Guidelines updated to add medically necessary definition.

06/13/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

05/16/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

03/27/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

08/03/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title changed from "Pegloticase (Krystexxa®)" to "Krystexxa (pegloticase). Added drug name to the top of the policy. Added statement to perform a formulary drug search on the patient's member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member's benefit plan. Policy description revised. Policy section updated to add that the use of samples by a member will not be considered current or stable therapy for purposes of Medical Policy review. Medically necessary policy statement criteria revised. Added renewal evaluation criteria. Policy Guidelines updated to define medication failure. Sources updated.

10/29/2020: Code Reference section updated to add HCPCS code J2507.

07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy section updated to revise medically necessary criteria and renewal criteria. Added statement that services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Added information regarding BCBSMS request for medical records. Sources updated. Code Reference section updated to remove HCPCS code J3590.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.

10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy language updated to change "member" to "individual." Sources updated.

SOURCE(S)

1. FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology Guideline for the Management of Gout [published correction appears in Arthritis Care Res (Hoboken). 2020 Aug;72(8):1187]. Arthritis Care Res (Hoboken). 2020;72(6):744-760.

2. Gout. Centers for Disease Control and Prevention. https://www.cdc.gov/arthritis/basics/gout.html

3. Krystexxa prescribing information. Horizon Therapeutics USA, Inc. November 2022. Last accessed July 2024.

4. Qaseem A, Harris RP, Forclea MA. Management of acute and recurrent gout: A clinical practice guideline from the American College of Physicians. Ann Intern Med. 2017;166(1):58-68.

5. Richette P et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis. 2017 Jan;76(1):29-42.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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