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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-48

Original Effective Date: 1/15/16

Reviewed: 12/14/16

Revised: 01/15/17

Next Review: 12/13/17

Subject: Pyrimethamine (Daraprim)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates   Previous Version
           

DESCRIPTION:

Pyrimethamine (Daraprim), a synthetic antiparasitic agent, was approved by the U.S. Food and Drug Administration (FDA) in 1953 for the treatment of malaria and toxoplasmosis and for the prophylaxis of malaria. Pyrimethamine is chemically and pharmacologically similar to trimethoprim, a component of co-trimoxazole. Pyrimethamine should not be used alone to treat acute malaria. Due to widespread resistance and availability of faster acting agents, use of pyrimethamine for both the treatment and prophylaxis of malaria is no longer recommended by the CDC.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, or emergency facility is not considered medically necessary.

Initiation pyrimethamine (Daraprim) meets the definition of medical necessity when used for one of the following indications and ALL of the following criteria are met:

1. Treatment of toxoplasmosis

a. Member is diagnosed with toxoplasmosis – documentation from the medical record must be provided

b. Dose does not exceed (dosage will be achieved using the fewest number of tablets per day):

i. Loading dose: 200 mg (1 dose)

ii. Maintenance dose: 75 mg/day

2. Prophylaxis of toxoplasmosis

a. Member is immunocompromised (e.g., HIV-positive, solid organ transplant receipt/donor) – documentation from the medical record must be provided

b. ONE of the following:

i. Use is for secondary prophylaxis

ii. Member had persistent, intolerable adverse effects with use of trimethoprim-sulfamethoxazole

iii. Member has a contraindication to trimethoprim-sulfamethoxazole

c. Dose does not exceed (dosage will be achieved using the fewest number of tablets per day):

i. If dosing daily: 25 mg/day

ii. If dosing weekly: 75 mg/week

3. Prophylaxis of pneumocystis pneumonia (PCP)

a. Member is immunocompromised (e.g., HIV-positive, solid organ transplant receipt/donor) – documentation from the medical record must be provided

b. ONE of the following:

i. Member had persistent, intolerable adverse effects with use of trimethoprim-sulfamethoxazole

ii. Member has a contraindication to trimethoprim-sulfamethoxazole

c. Dose does not exceed (dosage will be achieved using the fewest number of tablets per day):

i. If dosing daily: 25 mg/day

ii. If dosing weekly: 75 mg/week

Approval duration: 6 months

Continuation of pyrimethamine (Daraprim) meets the definition of medical necessity when ALL of the following criteria are met:

1. Authorization/reauthorization has been previously approved by Florida Blue in the past two years, OR the member has previously met all indication-specific initiation criteria

2. Dose does not exceed 75 mg/day – dosage will be achieved using the fewest number of tablets per day

Approval duration: 6 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

For Treatment of Toxoplasmosis

Dose Adjustments

Drug Availability

PRECAUTIONS:

Boxed Warning

Contraindications

Precautions/Warnings

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J8499

Prescription drug, oral, non-chemotherapeutic, Not Otherwise Specified

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

B58.00 – B58.0

Toxoplasma oculopathy

B58.1

Toxoplasma hepatitis

B58.2

Toxoplasma meningoencephalitis

B58.3

Pulmonary toxoplasmosis

B58.81 – B58.89

Toxoplasmosis with other organ involvement

B58.9

Toxoplasmosis, unspecified

P37.1

Congenital toxoplasmosis

Z92.25

Personal history of immunosupression therapy

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

None

RELATED GUIDELINES:

None

OTHER:

None

REFERENCES:

  1. Centers for Disease Control and Prevention. CDC Health Information for International Travel 2016. New York: Oxford University Press; 2016. Available from: http://wwwnc.cdc.gov/travel/yellowbook/2016/infectious-diseases-related-totravel/malaria#4904
  2. Centers for Disease Control and Prevention. Treatment of Malaria (Guidelines For Clinicians). Accessed 11/30/16]. Available from: http://www.cdc.gov/malaria/resources/pdf/clinicalguidance.pdf/
  3. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016-11-23]. Available from: http://www.clinicalpharmacology.com/.
  4. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2016-11-23]. Available from: http://clinicaltrials.gov/.
  5. Department of Health and Human Services. Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents; 2015-10-19 [cited 2016-11-23]. Available from: https://aidsinfo.nih.gov/guidelines/html/4/adult-and-adolescent-oi-prevention-andtreatment-guidelines/322/toxo
  6. Department of Health and Human Services. Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children; 2015-10-29 [cited 2016-11-23]. Available from: https://aidsinfo.nih.gov/guidelines/html/5/pediatric-oi-prevention-and-treatmentguidelines/418/toxoplasmosis
  7. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016-11-23]. Available from: http://www.thomsonhc.com/.
  8. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2016 [cited 2016-11-23]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  9. Turing Pharmaceuticals. Daraprim (pyrimethamine) tablet. 2016 [cited 2016-11-23]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=5420/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 12/14/16.

GUIDELINE UPDATE INFORMATION:

01/15/16

New Medical Coverage Guideline.

01/15/17

Review and revision to guideline consisting of updating position statement and references.

Date Printed: December 17, 2017: 04:23 PM