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Chloroquine, Hydroxychloroquine Quantity Limit Criteria

Policy Number: PH-1125

Chloroquine, Hydroxychloroquine Quantity Limit Criteria

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

Chloroquine, Hydroxychloroquine Quantity Limit

The program quantity limit is set to allow for one course of therapy for COVID-19 infection.  Use beyond the program quantity limit will require prior authorization. Those previously on therapy prior to start of the program will be able to continue therapy. New start therapies beyond the quantity limit will require prior authorization.

TARGET AGENTS

Chloroquinea

Hydroxychloroquinea

a - generic equivalent available

PROGRAM QUANTITY LIMITS

Brand (generic)

GPI

Multisource Code

Quantity Limit

Chloroquinea

250 mg tablet

13000010200305

M, N, O, or Y

40 tablets / 90 days

500 mg tablet

13000010200310

M, N, O, or Y

20 tablets / 90 days

Hydroxychloroquinea

200 mg tablet

13000020100305

M, N, O, or Y

40 tablets / 90 days

a – generic equivalent available

QUANTITY LIMIT AUTHORIZATION CRITERIA FOR APPROVAL

Requests above the set quantity limit will be approved when ONE of the following is met:

  1. BOTH of the following:
    1. The patient is using the requested agent for ONE of the following:
      1. Rheumatoid arthritis

OR

      1. Lupus erythematosus

OR

      1. Extraintestinal amebiasis

OR

      1. Malaria (prophylaxis OR treatment)

AND

    1. ONE of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

OR

      1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND the prescriber has provided information in support of therapy with a higher dose for the requested indication

OR

  1. The requested agent is being used for COVID-19 AND ONE of the following:
    1. The prescriber has provided information that the patient requires an additional course of therapy for treating COVID-19

OR

    1. The prescriber has provided information in support of using the requested agent for therapy in COVID-19 beyond 10 days of therapy

OR

    1. The prescriber has provided information for COVID-19 dosing that is above the set limit (clinical references needed)

Length of Approval: 

1 month for COVID 19, extraintestinal amebiasis, malaria treatment

Up to 12 months for malaria prevention

12 months for all other indications

FDA APPROVED INDICATIONS AND DOSAGE1,2

Agent

Indication

Dosage & Administration

Chloroquinea

Tablets

Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P. ovale, and P.vivax.

Adults:

An initial dose of 1 g salt (= 600 mg base) followed by an additional 500 mg (= 300 mg base) after six to eight hours and a single dose of 500 mg (= 300 mg base) on each of two consecutive days. This represents a total dose of 2.5 g chloroquine phosphate or 1.5 g base in three days.

Infants and Children:

In infants and children, the recommended dose is 10 mg base/kg followed by 5 mg based/kg at 6, 24 and 36 hours (total dose 25 mg based/kg). The pediatric dose should never exceed the adult dose regardless of weight.

The dosage for adults of low body weight and for infants and children should be determined as follows:

First dose: 10 mg base per kg (but not exceeding a single dose of 600 mg base).

Second dose: (6 hours after first dose) 5 mg base per kg (but not exceeding a single dose of 300 mg base).

Third dose: (24 hours after first dose) 5 mg base per kg.

Fourth dose: (36 hours after first dose) 5 mg base per kg.

P. vivax and P. ovale: Concomitant therapy with an 8-aminoquinoline compound is necessary for treatment of the hypnozoite liver stage forms of the parasites.

Prophylaxis of malaria in geographic areas where resistance to chloroquine is not present.

Adult Dose: 

The dosage for prophylaxis is 500 mg (= 300 mg base) administered once per week on exactly the same day of each week.
 

Pediatric Dose:

The dosage for prophylaxis is 5 mg calculated as base, per kg of body weight, administered once per week on exactly the same day of each week. The pediatric dose should never exceed the adult dose regardless of weight.
 

If circumstances permit, suppressive therapy should begin two weeks prior to exposure. However, failing this in adults, an initial double (loading) dose of 1 g (= 600 mg base), or in children 10 mg base/kg may be taken in two divided doses, six hours apart. The suppressive therapy should be continued for eight weeks after leaving the endemic area.

Treatment of extraintestinal amebiasis.

1 g salt (600 mg base) daily for two days, followed by 500 mg (300 mg base) daily for at least two to three weeks. Treatment is usually combined with an effective intestinal amebicide.

Hydroxychloroquinea

Tablets

Treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax.

Adults:

800 mg (620 mg base) followed by 400 mg (310 mg base) at 6 hours, 24 hours and 48 hours after the initial dose (total 2000 mg hydroxychloroquine sulfate or 1550 mg base).

Weight based dosage in adults and pediatric patients: 

13 mg/kg (10 mg/kg base), not to exceed 800 mg (620 mg base) followed by 6.5 mg/kg (5 mg/kg base), not to exceed 400 mg (310 mg base), at 6 hours, 24 hours and 48 hours after the initial dose.

Hydroxychloroquine Sulfate film-coated tablets cannot be divided, therefore they should not be used to treat patients who weigh less than 31 kg.

For radical cure of P. vivax and P. malariae infections, concomitant therapy with an 8-aminoquinoline compound is necessary.

Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.

Adults: 

400 mg (310 mg base) once weekly on the same day of each week starting 2 weeks prior to exposure, and continued for 4 weeks after leaving the endemic area.

Weight-based dosing in adults and pediatric patients: 

6.5 mg/kg (5 mg/kg base), not to exceed 400 mg (310 mg base), once weekly on the same day of the week starting 2 weeks prior to exposure, and continued for 4 weeks after leaving the endemic area.

Treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults.

Adults:

200 to 400 mg (155 to 310 mg base) daily, administered as a single daily dose or in two divided doses.

Doses above 400 mg a day are not recommended.

Treatment of acute and chronic rheumatoid arthritis in adults.

Initial adult dosage:

400 mg to 600 mg (310 to 465 mg base) daily, administered as a single daily dose or in two divided doses. In a small percentage of patients, side effects may require temporary reduction of the initial dosage.

Maintenance adult dosage:

When a good response is obtained, the dosage may be reduced by 50 percent and continued at a maintenance level of 200 mg to 400 mg (155 to 310 mg base) daily, administered as a single daily dose or in two divided doses.

Do not exceed 600 mg or 6.5 mg/kg (5 mg/kg base) per day, whichever is lower, as the incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded.

Corticosteroids and salicylates may be used in conjunction with hydroxychloroquine sulfate tablets, and they can generally be decreased gradually in dosage or eliminated after a maintenance dose of hydroxychloroquine sulfate tablets has been achieved.

a – generic equivalent available

CLINICAL RATIONALE

While not FDA approved for use in COVID-19, chloroquine and hydroxychloroquine are being used in treating patients with the infection. Dosing for each product in COVID-19 varies but the following have been reported and/or studied in small patient populations:

  • Chloroquine
    • 500 mg twice daily for 10 days3
  • Hydroxychloroquine
    • 400 mg twice daily on day one, then daily for 5 days4
    • 400 mg twice daily on day one, then 200 mg twice daily for 4 days4,8
    • 600 mg twice daily on day one, then 400 mg daily on days 2-54
    • 200 mg three times daily for 10 days5,8
    • 400 mg twice daily for 2 days, then 200mg twice daily on days 2 – 56,7
    • 200 mg twice daily for 5-20 days8

Safety

Chloroquine is contraindicated in those with the following:1

  • Presence of retinal or visual field changes of any etiology.
  • Known hypersensitivity to 4-aminoquinoline compounds.

Hydroxychloroquine is contraindicated in those with hypersensitivity to 4-aminoquinoline compounds.2

REFERENCES

  1. Chloroquine prescribing information. Rising Pharmaceuticals Inc. October 2018.
  2. Hydroxychloroquine prescribing information. Dr.Reddy’s Laboratories Inc. July 2019.
  3. Expert consensus on chloroquine phosphate for the treatment of novel coronavirus pneumonia. Chinese Medical Association Publishing House. Feb 2020. Available at https://pubmed.ncbi.nlm.nih.gov/32075365/.
  4. Information for clinicians on therapeutic options for COVID-19 patients. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html. Accessed 03/23/2020.
  5. Gautret et al. (2020) Hydroxychloroquine and azithromycin as a treatment of  COVID‐19: results of an open‐label non‐randomized clinical trial. International Journal of Antimicrobial Agents – In Press 17 March 2020 – DOI: 10.1016/j.ijantimicag.2020.105949
  6. UCSF inpatient adult COVID-19 interim management guidelines. UCSF Health. Available at: https://infectioncontrol.ucsfmedicalcenter.org/sites/g/files/tkssra4681/f/UCSF%20Adult%20COVID%20draft%20management%20guidelines.pdf. Accessed 03/23/2020.
  7. UMMC COVID-19 treatment guidelines. The University of Mississippi Medical Center. Available at: https://www.umc.edu/CoronaVirus/Mississippi-Health-Care-Professionals/Clinical-Resources/UMMC-COVID-19-Treatment-Guidelines.html. Accessed 03/23/2020.
  8. Hydroxychloroquine. Clinical Pharmacology. Accessed 03/23/2020.

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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