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

Chloroquine^a

Hydroxychloroquine^a

^{a - generic equivalent available}

PROGRAM QUANTITY LIMITS

^{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. 1. 2. Lupus erythematosus

OR

1. 1. 3. Extraintestinal amebiasis

OR

1. 1. 4. Malaria (prophylaxis OR treatment)

AND

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

OR

1. 1. 2. 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

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

OR

1. 3. 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 DOSAGE^1,2

^{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 days^4,8
  • 600 mg twice daily on day one, then 400 mg daily on days 2-5⁴
  • 200 mg three times daily for 10 days^5,8
  • 400 mg twice daily for 2 days, then 200mg twice daily on days 2 – 5^6,7
  • 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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