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Drug Category: Vitamin supplementation and management

Medication Class/Individual Agents: Vitamins and Nutrients

I. Prior-Authorization Requirements

 Nutrients, Vitamins, and Vitamin Analogs – Not Otherwise Classified

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

glucose products PA   - ≥ 19 years
l-glutamine-Nutrestore Nutrestore PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

 

Vitamin D and Vitamin D Analogs:

  • In patients with stage 3-5 CKD not on dialysis with intact parathyroid hormone (PTH) progressively rising or persistently above the upper normal limit of the assay, it is suggested to evaluate for hyperphosphatemia, hypocalcemia, high phosphate intake, and vitamin D deficiency.1
  • In adults with stage 3-5 CKD not on dialysis, it is suggested to not routinely use calcitriol and vitamin D analogs. It is reasonable to reserve the use of calcitriol and vitamin D analogs for adults with CKD G4–G5 with severe and progressive hyperparathyroidism. The use in children may be considered to maintain serum calcium levels in the age-appropriate normal range.1
  • Excessive administration of vitamin D compounds may lead to over suppression of parathyroid hormone (PTH), hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease.2

calcifediol:

  • FDA-approved for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 CKD and serum total 25-hydoxyvitamin D levels less than 30 ng/mL.

doxercalciferol:

  • FDA-approved for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 CKD or with CKD and on dialysis.

paricalcitol:

  • FDA-approved for the treatment of secondary hyperparathyroidism in adults and children 10 years or older with stage 3 or 4 CKD or CKD and on dialysis.

Nascobal:

  • FDA-approved for the maintenance of normal hematologic status in pernicious anemia in patients in remission following intramuscular vitamin B-12 therapy with no nervous system involvement.
  • FDA-approved as a supplement for various other vitamin B-12 deficiencies.

1 Kidney Disease Improving Global Outcomes. KDIGO Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) [guideline on the Internet]. Kidney international supplements, 2017 [cited 2018 May 31]. Available from: https://kdigo.org/wp-content/uploads/2017/02/2017-KDIGO-CKD-MBD-GL-Update.pdf.
2 Zemplar [package insert on the internet]. North Chicago (IL): AbbVie, Inc.; 2016 Oct [cited 2016 Dec 14]. Available from: www.zemplar.com.

 

 

 Nutrients, Vitamins, and Vitamin Analogs – Vitamin D Analogs

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

calcifediol Rayaldee PA  
calcitriol Rocaltrol # test  
calcitriol injection test  
doxercalciferol capsule Hectorol PA  
doxercalciferol injection Hectorol ^ test  
paricalcitol capsule Zemplar PA  
paricalcitol injection Zemplar ^ test  

 Nutrients, Vitamins, and Vitamin Analogs – Vitamins

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

ascorbic acid vitamin C * test  
calcium replacement * test  
cyanocobalamin vitamin B-12 o test  
cyanocobalamin / folic acid Foltrate PA  
cyanocobalamin-Nascobal Nascobal PA  
ergocalciferol capsule test  
folic acid * test  
multivitamin-Dekas Essential Dekas Essential PA  
multivitamins * test  
multivitamins / minerals / coenzyme Q10-Aquadeks Aquadeks PA  
multivitamins / minerals / coenzyme Q10-Dekas Plus Dekas Plus PA  
multivitamins / minerals / folic acid / coenzyme Q10-Aquadeks Aquadeks PA  
multivitamins / minerals / folic acid / coenzyme Q10-Dekas Bariatric Dekas Bariatric PA  
multivitamins / minerals / folic acid / coenzyme Q10-Dekas Plus Dekas Plus PA  
niacin vitamin B-3 * test  
niacinamide * test  
pediatric multivitamins * test  
prenatal vitamins * test  
pyridoxine vitamin B-6 * test  
retinol vitamin A * test  
riboflavin vitamin B-2 * test  
thiamine vitamin B-1 * test  
vitamin B complex * test  
vitamin D * test  
vitamin E, oral * test  
vitamins, multiple * test  
vitamins, multiple / minerals * test  
vitamins, pediatric * test  
vitamins, prenatal * test  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.
 
o Prior-authorization status depends on the drug's formulation.
 
^ This drug is available through the health care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Secondary hyperparathyroidism in chronic kidney disease (CKD)
  • Short bowel syndrome
  • Vitamin deficiency

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All prior-authorization requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon the member's condition and requested medication (see below).

 

Aquadeks, Dekas Bariatric, Dekas Essential, and Dekas Plus

  • Documentation of the following is required:
    • appropriate diagnosis (e.g., cystic fibrosis, short gut syndrome, malabsorption syndrome).

SmartPA: Claims for Aquadeks will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for Aquadeks within the most recent 90 days, or if the member has a history of MassHealth medical claims for cystic fibrosis, malabsorption syndrome, or short gut syndrome.

SmartPA: Claims for Dekas Bariatric, Dekas Essential, and Dekas Plus will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for Dekas Bariatric, Dekas Essential, or Dekas Plus within the most recent 90 days, or if the member has a history of MassHealth medical claims for cystic fibrosis, malabsorption syndrome, or short gut syndrome.

  

doxercalciferol capsule and paricalcitol capsule

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • appropriate age (for doxercalciferol capsule member is ≥ 18 years of age, for paricalcitol capsule member is ≥ ten years of age); and
    • an inadequate response to 90 days of therapy, adverse reaction, or contraindication to vitamin D; and
    • an inadequate response to 90 days of therapy, adverse reaction, or contraindication to calcitriol.

 

Foltrate and Nascobal

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to all other comparable generic vitamins.

 

glucose products for members 19 years of age

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for the requested agent above age limit.

 

Nutrestore

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is currently on growth hormone therapy.

 

Rayaldee

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • total 25-hydroxyvitamin D is < 30 ng/mL; and
    • an inadequate response to 90 days of therapy, adverse reaction, or contraindication to vitamin D; and
    • an inadequate response to 90 days of therapy, adverse reaction, or contraindication to calcitriol; and
    • an inadequate response to 90 days of therapy, adverse reaction, or contraindication to doxercalciferol or paricalcitol; and
    • appropriate dosing.

 Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 03/2006

Last Revised Date: 08/2019


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Last updated 08/29/19