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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-J1000-65

Original Effective Date: 04/15/12

Reviewed: 03/12/14

Revised: 11/01/15

Subject: Pyridoxine HCl Injection (vitamin B6)

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.

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

DESCRIPTION:

Pyridoxine is one of three naturally occurring, chemically unique compounds that comprise vitamin B6.1,2 To become physiologically active, pyridoxine is converted to the coenzyme pyridoxal phosphate in a process requiring riboflavin.1,2 Pyridoxal phosphate is required for myelin formation and activates several pathways in the synthesis of amino acids, neurotransmitters (e.g., serotonin, norepinephrine, GABA), and sphingolipids.1-3 Because of this, vitamin B6 can influence cognitive function and is critical for normal development of the central nervous system. Individuals with a deficiency of vitamin B6 may present with symptoms of nervous system dysfunction such as irritability, confusion, peripheral neuropathy, or seizures.1,4

While dietary sources of vitamin B6 are available and able to provide recommended intakes (Recommended Daily Allowance for adults: 1.3-2 mg), supplementation is indicated for treatment of pyridoxine-dependency syndromes (e.g., pyridoxine-dependent seizures in infants, homocystinuria, pyridoxine-responsive anemia, and hyperoxaluria) and prophylaxis or treatment of pyridoxine deficiencies related to diseases, diet, or pharmacological agents.4-6 Deficiencies may occur in conjunction with other vitamin B complex deficiencies, such as in chronic alcoholism or malabsorption syndromes.4,6 Pharmacological agents capable of causing pyridoxine deficiency include isoniazid, hydralazine, penicillamine, cycloserine, ethionamide, theophylline, and possibly oral contraceptives.4

Pyridoxine is well absorbed from the gastrointestinal tract following oral administration; however, pyridoxine can be administered as an intravenous, intramuscular, or subcutaneous injection.3-5 The parenteral route is only indicated when gastrointestinal absorption is impaired or when oral administration is not feasible.3 In cases of acute isoniazid toxicity, intravenous pyridoxine rapidly terminates seizures, corrects metabolic acidosis, and reverses coma.7,8 The U.S. Food and Drug Administration (FDA) has designated pyridoxine orphan drug status for the treatment of pyridoxine dependent seizures.9

POSITION STATEMENT:

Pyridoxine injection meets the definition of medical necessity for members meeting ALL of the following criteria:

1. Oral administration of pyridoxine tablets is contraindicated or not feasible

2. Indication for use is ONE of the following:

a. Adverse reaction to drug causing Vitamin B6 deficiency

b. Pyridoxine dependency syndrome

c. Treatment or Prophylaxis of Vitamin B6 deficiency

3. Dose is less than 600 mg/day

Duration of approval: 1 year

Pyridoxine injection meets the definition of medical necessity for the following designated orphan drug indication (http://www.fda.gov/orphan/designat/list.htm):

1. Treatment of pyridoxine dependent seizures

Duration of approval: 1 year

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.

Dosing

1. Adverse reaction to drug causing Vitamin B6 deficiency

100 mg/day for 3 weeks, followed by 30 mg/day maintenance dose

2. Pyridoxine dependency syndrome

10 to 250 mg/day up to 600 mg/day

3. Treatment and Prophylaxis of Vitamin B6 deficiency

5 to 25 mg/day for 3 weeks, followed by maintenance therapy with 1.5 to 5 mg/day in a multivitamin preparation

Dose Adjustments

None

Drug Availability

Pyridoxine is supplied as a 100 mg/1 mL solution for injection.

PRECAUTIONS:

Parenteral pyridoxine solutions contain varying concentrations of aluminum. Patients with renal impairment, especially as seen with neonatal prematurity, are at risk of aluminum accumulation which may result in toxicity. Limit intravenous pyridoxine therapy and consider the cumulative aluminum content among all therapies under administration in patients with renal impairment.

Peripheral sensory neuropathy or neuropathic syndromes have been associated with prolonged use of oral pyridoxine.4 Although these syndromes were initially observed following administration of high doses (2 to 6 grams daily), more recent reports have described peripheral neuropathy with lower doses (50 to 500 mg daily).4 Neuropathic symptoms generally subside after withdrawal of pyridoxine.

BILLING/CODING INFORMATION:

HCPCS Coding

J3415

Injection, pyridoxine HCl, 100 mg

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

E53.1

Pyridoxine deficiency

D64.3

Pyridoxine-responsive sideroblastic anemia

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) or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Thiamine HCl Injection (vitamin B-1), 09-J1000-64
Vitamin B-12 Injections, 09-J0000-10

OTHER:

None

REFERENCES:

  1. Snell, EE. Vitamin B6 and decarboxylation of histidine. Ann N Y Acad Sci. 1990;585:1-12.
  2. National Center for Biotechnology Information. PubChem BioAssay Database; CID=1054, Source=Scripps Research Institute Molecular Screening Center [cited 2013 Jan 31]. Available from: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=1054#x281/.
  3. Pyridoxine. Clinical Pharmacology [Internet Database]. Gold Standard, Inc., 2013 [cited 2014 Jan 31]. Available from: http://www.clinicalpharmacology-ip.com/.
  4. Pyridoxine. In: DRUGDEX® System [Internet Database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically [cited 2014 Jan 31]. Available from: http://www.thomsonhc.com/.
  5. Pyridoxine HCl injection, USP. Schaumburg (IL): APP Pharmaceuticals, LLC; 2008 April. Package insert. NDC 63323-180-01.
  6. Dietary Reference Intakes: RDA and AI for Vitamins and Elements [Internet]. Food and Nutrition Board, Institute of Medicine [cited 2013 Jan 31]. Available from: http://fnic.nal.usda.gov/dietary-guidance/dietary-reference-intakes/dri-tables/.
  7. Wason S, Lacouture PG, Lovejoy F. Single high-dose pyridoxine treatment for isoniazid overdose. JAMA. 1981;246:1102-1104.
  8. Howland MA, editors. Goldfrank's Toxicologic Emergencies [Internet]. 9th ed. New York: McGraw-Hill; 2011. Antidotes in Depth (A15): Pyridoxine [cited 2013 Jan 31]. Available from: http://www.accesspharmacy.com.lp.hscl.ufl.edu/content.aspx?aID=6536739/.
  9. Orphan Drug Designations and Approval [Internet Database]. U.S. Food and Drug Administration, 2013 [cited 2014 Jan 31]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 03/12/14.

GUIDELINE UPDATE INFORMATION:

04/15/12

New Medical Coverage Guideline.

04/15/13

Review and revision to guideline; consisting of position statement, dosage, administration, and precautions sections, decision tree, and references

04/15/14

Review and revision to guideline; consisting of references, NLR status

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: December 18, 2017: 03:34 PM