CurrentCentenePolicy CP.PMN.79

Clinical Policy: Doxycycline Hyclate (Acticlate, Doryx), Doxycycline (Oracea)

Defines medical necessity criteria, prior authorization and continuation requirements, dosing limits, covered indications (rosacea, acne vulgaris, malaria prophylaxis, FDA-approved acute infections) and exclusions for doxycycline formulations across commercial, HIM/ICHRA, and Medicaid lines of business for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyClinical Policy: Doxycycline Hyclate (Acticlate, Doryx), Doxycycline (Oracea)

Policy CodePolicy CP.PMN.79

Change TypeAnnual review and targeted updates (additions/revisions)

Effective DateJun 1, 2017

Next Review Date

Key ActionProvider must submit documentation (office notes, labs or other clinical information) supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

Added ICHRA line of business and references to doxycycline hyclate (generic Acticlate).

Added step therapy bypass for Illinois HIM per IL HB 5395.

For rosacea, added requirement that member must use delayed release doxycycline (generic Oracea).

Doryx MPC 60 mg strength added to policy.

2Q 2026 annual review: references updated; no significant clinical changes.

4Covered Indications (major categories)

3Formulations covered

>=1Step therapy required (varies by indication)

State-specific bypass (IL HIM per IL HB 5395)

Coverage Summary

Policy stance: covered_with_criteria for doxycycline formulations including Acticlate (doxycycline hyclate), Doryx / Doryx MPC (doxycycline hyclate delayed-release), and Oracea (doxycycline delayed‑release capsule). Coverage is aligned to indication, formulation, dosing limits, and step therapy requirements per the approval criteria: Oracea is covered only for adult rosacea with inflammatory lesions at a maximum of 40 mg/day (1 capsule/day); Acticlate/Doryx are covered for acne and FDA‑approved acute infections with dosing limits up to 200 mg/day (Doryx MPC up to 240 mg/day); malaria prophylaxis dosing limits are 100 mg/day for Acticlate/Doryx and 120 mg/day for Doryx MPC. Approvals require supporting documentation and prior authorization, with continuation and duration limits applied (e.g., Oracea not authorized for >16 weeks continuous daily use). Effective date: 2017-06-01. Last review / P&T approval: 2026-05-26. For Illinois HIM requests, the policy includes a statutory step therapy bypass per IL HB 5395 effective 2026-01-01, so the usual step therapy requirements do not apply for that state/line of business.

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Dose and Duration Thresholds

Oracea dose limit40 mg/day and 1 capsule per day

Oracea duration limitMember has not received Oracea daily for > 16 weeks

Acticlate/Doryx dose limits200 mg/day

Doryx MPC limits240 mg/day

Malaria prophylaxis limitsActiclate/Doryx: 100 mg/day; Doryx MPC: 120 mg/day

Initial Therapy Criteria

Initial Approval Criteria

Provider must submit documentation supporting that member has met all approval criteria. Approvals vary by indication and formulation.

A. Rosacea (must meet all)

Diagnosis of rosacea with inflammatory lesions (papules and pustules)
Request is for doxycycline delayed release capsule (Oracea)
Age ≥ 18 years
If request is for brand Oracea, member must use doxycycline delayed release capsule (generic Oracea), unless contraindicated or clinically significant adverse effects are experienced

Continuation Therapy (Re-authorization) Criteria

Continued Therapy (Re-authorization) Criteria

Continuation criteria differ by indication; re-authorization not permitted for some indications.

A. Rosacea (must meet all)

Member meets one of: currently receiving medication via Centene benefit or previously met initial approval criteria; or currently receiving medication and enrolled in a state/product with continuity of care regulations
Request is for doxycycline delayed release capsule (Oracea)
Member is responding positively to therapy
If request is for brand Oracea, member must use doxycycline delayed release capsule (generic Oracea), unless contraindicated or clinically significant adverse effects are experienced

Other Diagnoses / Exclusions

Other diagnoses/indications

Pathway if request is for uses not covered in sections above or recent label changes

ANY of the following

If drug underwent a label change within last 6 months not reflected in this policy, follow formulary/no coverage or non-formulary policies depending on formulary status (lists CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If requested use is not listed under section III and criterion 1 above does not apply, refer to off-label use policy for relevant line of business: CP.CPA.09, HIM.PA.154, CP.PMN.53

Diagnoses/Indications not authorized

Coverage exclusions

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety per off-label policies or evidence of coverage documents is provided

Applicable Codes

Product availability / strengths (informational drug codes not provided)NDC|mixed

Acticlate tablets strengths	Tablets: 75 mg, 150 mg; Generic: 20 mg, 50 mg, 75 mg, 100 mg, 150 mg
Doryx delayed-release tablets strengths	Delayed-release tablets: 50 mg, 80 mg, 200 mg; MPC: 60 mg, 120 mg; Generic: 50, 75, 80, 100, 150, 200 mg
Oracea strength	Delayed-release capsule: 40 mg

Product availability / strengths (informational drug codes not provided)NDC|mixed

Acticlate tablets strengths	Tablets: 75 mg, 150 mg; Generic: 20 mg, 50 mg, 75 mg, 100 mg, 150 mg
Doryx delayed-release tablets strengths	Delayed-release tablets: 50 mg, 80 mg, 200 mg; MPC: 60 mg, 120 mg; Generic: 50, 75, 80, 100, 150, 200 mg
Oracea strength	Delayed-release capsule: 40 mg

Provider Actions

Documentation Required

Submit supporting documentation

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

Office notes
Laboratory results
Other clinical information demonstrating criteria met (diagnosis, prior trials, dosing)

Prior Authorization

Prior authorization required with indication-specific criteria

Requests require prior authorization and must meet the listed initial or continuation criteria for the requested indication and formulation. Approvals are limited to specified durations where noted (e.g., malaria prophylaxis: up to 4 months or duration of travel plus up to 4 weeks; acute infections: up to 60 days).

Clinical Evidence & Supporting References

Evidence references noted in the brief: prescribing information updates for Acticlate, Doryx, and Doryx MPC (March 2025) and Oracea (April 2025) are cited, along with clinical guideline sources for rosacea and acne and the CDC Yellow Book for malaria. The brief does not provide detailed study metrics or trial data within the summary; it references prescribing information and guideline documents for supporting evidence.

Background

Background: Doxycycline is a tetracycline‑class antibiotic available as Acticlate, Doryx (including Doryx MPC), and Oracea. Oracea is a delayed‑release doxycycline formulation indicated only for treatment of inflammatory lesions (papules and pustules) of rosacea in adults and is not indicated for antibacterial use; its labeling warns against using Oracea to treat or prevent infections to avoid development of drug‑resistant bacteria. The policy aligns coverage to the specific FDA‑approved indications, formulation, dosing limits (e.g., Oracea ≤ 40 mg/day and 1 capsule/day; Acticlate/Doryx ≤ 200 mg/day; Doryx MPC ≤ 240 mg/day), and step therapy expectations (trials of immediate‑release doxycycline and additional preferred tetracyclines where required), with the noted Illinois HIM step therapy bypass per IL HB 5395.

Definitions

OraceaDoxycycline delayed-release capsule indicated for inflammatory lesions (papules and pustules) of rosacea in adults; not for antibacterial use.

Doryx MPCDoxycycline delayed-release tablets, multiparticulate customized (MPC) formulation available in specified strengths.

Revision History

2026-03-26 / P&T 2026-05-26annual_reviewLatest

2Q 2026 annual review: added ICHRA/line of business and references to doxycycline hyclate (generic Acticlate); references reviewed and updated; no significant clinical changes.

2025-07-14policy_change

Added step therapy bypass for Illinois HIM per IL HB 5395; effective 2026-01-01 (Illinois HIM exempt from step therapy requirements).

2023-07-12policy_change

Policy Summary

PayerCentene

PolicyClinical Policy: Doxycycline Hyclate (Acticlate, Doryx), Doxycycline (Oracea)

Policy CodePolicy CP.PMN.79

Change TypeAnnual review and targeted updates (additions/revisions)

Effective DateJun 1, 2017

Next Review Date

Key ActionProvider must submit documentation (office notes, labs or other clinical information) supporting that member has met all approval criteria.

On This Page

Failure of immediate-release doxycycline, unless contraindicated or clinically significant adverse effects are experienced

For Illinois HIM requests, the step therapy requirement does not apply as of 2026-01-01 per IL HB 5395

Failure of ≥ 4-week trial of one additional preferred oral tetracycline antibiotic (e.g., immediate-release minocycline), unless contraindicated or clinically significant adverse effects are experienced

For Illinois HIM requests, the step therapy requirement does not apply as of 2026-01-01 per IL HB 5395

Dose limits

Dose does not exceed 40 mg per day40 mg/day
Dose does not exceed 1 capsule per day1 capsule/day

B. Acne Vulgaris (must meet all)

Diagnosis of acne vulgaris
Request is for doxycycline hyclate (Acticlate), doxycycline hyclate delayed-release tablets (Doryx), or Doryx MPC
Member must use immediate-release doxycycline, unless contraindicated or clinically significant adverse effects are experienced
For Illinois HIM requests, the step therapy requirement does not apply as of 2026-01-01 per IL HB 5395
Failure of a ≥ 4-week trial of one additional preferred oral tetracycline antibiotic (e.g., immediate-release minocycline), unless clinically significant adverse effects are experienced or all are contraindicated
For Illinois HIM requests, the step therapy requirement does not apply as of 2026-01-01 per IL HB 5395
Dose limits
- Doxycycline hyclate (Acticlate), doxycycline hyclate delayed-release tablets (Doryx): dose does not exceed 200 mg per day200 mg/day
- Doryx MPC: dose does not exceed 240 mg per day240 mg/day

C. Prophylaxis of Malaria (must meet all)

Prescribed for malaria prophylaxis
Request is for doxycycline hyclate (Acticlate), doxycycline hyclate delayed-release tablets (Doryx), or Doryx MPC
Member must use immediate-release doxycycline, unless contraindicated or clinically significant adverse effects are experienced
For Illinois HIM requests, the step therapy requirement does not apply as of 2026-01-01 per IL HB 5395
Dose limits
- doxycycline hyclate (Acticlate), doxycycline hyclate delayed-release tablets (Doryx): dose does not exceed 100 mg per day100 mg/day
- Doryx MPC: dose does not exceed 120 mg per day120 mg/day
Approval duration: 4 months or duration of travel and up to 4 weeks after member leaves the malarious area, whichever is less

D. FDA-Approved Acute Infection Indications for Acticlate, Doryx, Doryx MPC (must meet all)

Prescribed for the treatment of one of the listed FDA-approved conditions (see Appendix D): rickettsial infections; sexually transmitted infections; respiratory tract infections; specific bacterial infections; ophthalmic infections; anthrax (including inhalational anthrax post-exposure); selected infections when penicillin is contraindicated; acute intestinal amebiasis
Request is for doxycycline hyclate (Acticlate), doxycycline hyclate delayed-release tablets (Doryx), or Doryx MPC
Member must use immediate-release doxycycline, unless contraindicated or clinically significant adverse effects are experienced
For Illinois HIM requests, the step therapy requirement does not apply as of 2026-01-01 per IL HB 5395
Failure of one additional preferred oral tetracycline antibiotic (e.g., immediate-release minocycline), unless clinically significant adverse effects are experienced or other preferred tetracyclines are not indicated for the diagnosis
For Illinois HIM requests, the step therapy requirement does not apply as of 2026-01-01 per IL HB 5395
Dose limits
- doxycycline hyclate (Acticlate), doxycycline hyclate delayed-release tablets (Doryx): dose does not exceed 200 mg per day200 mg/day
- Doryx MPC: dose does not exceed 240 mg per day240 mg/day
Approval duration: 60 days or duration of request, whichever is less

Member has not received doxycycline delayed release capsule (Oracea) daily for > 16 weeks

Dose increase limits

If request is for a dose increase, new dose does not exceed 40 mg per day40 mg/day
If request is for a dose increase, new dose does not exceed 1 capsule per day1 capsule/day

B. Acne Vulgaris (must meet all)

Member meets one of: currently receiving medication via Centene benefit or previously met initial approval criteria; or currently receiving medication and enrolled in a state/product with continuity of care regulations
Request is for doxycycline hyclate (Acticlate), doxycycline hyclate delayed-release tablets (Doryx), or Doryx MPC
Member is responding positively to therapy
Dose increase limits
- If request is for a dose increase, new dose does not exceed doxycycline hyclate (Acticlate) or Doryx: 200 mg per day200 mg/day
- If request is for a dose increase, new dose does not exceed Doryx MPC: 240 mg per day240 mg/day

C. Prophylaxis of Malaria and FDA-Approved Acute Infection Indications

Re-authorization is not permitted. Members must meet the initial approval criteria
Approval duration: Not applicable

Prior authorization required for requested indication and formulation
Approvals limited to specified durations (see malaria and acute infection criteria)

Step Therapy

Step therapy requirements

Most indications require step therapy: trial/failure of immediate‑release doxycycline and an additional preferred oral tetracycline (e.g., a ≥4‑week trial of immediate‑release minocycline) before approval unless contraindicated or clinically significant adverse effects occur. Exception: Illinois HIM requests are exempt from the step therapy requirement as of 2026‑01‑01 per IL HB 5395.

Trial/failure of immediate‑release doxycycline required unless contraindicated
Failure of a ≥4‑week trial of one additional preferred tetracycline (e.g., immediate‑release minocycline)
IL HIM step therapy bypass effective 2026‑01‑01 (IL HB 5395)

Billing Rule

Dose and duration limits enforceable on claims

Claims exceeding indicated daily dose limits or duration limits may be denied. Dose thresholds enforced by claims include formulation- and indication-specific maximums (examples below).

Oracea (rosacea): limit 40 mg/day and 1 capsule per day; continued therapy not permitted beyond 16 weeks of daily use
Acticlate/Doryx (acne/acute infections): limit 200 mg/day
Doryx MPC: limit 240 mg/day
Malaria prophylaxis: Acticlate/Doryx 100 mg/day; Doryx MPC 120 mg/day

Denial Risk

Non-covered uses and off-label requests

Non–FDA-approved indications not addressed in this policy will be denied unless sufficient documentation is provided per the applicable off‑label use policies or evidence of coverage. Refer to the line-of-business off‑label policies listed in the criteria (CP.CPA.09, HIM.PA.154, CP.PMN.53) when considering off‑label requests.

Off‑label requests require documentation of efficacy/safety per off‑label policies
Applicable off‑label policies: CP.CPA.09 (commercial), HIM.PA.154 (HIM/ICHRA), CP.PMN.53 (Medicaid)

For rosacea, added requirement that member must use delayed-release doxycycline (generic Oracea) prior to brand Oracea unless contraindicated or adverse effects.

2022-08-30policy_change

Template changes applied to diagnoses/indications and continued therapy; Doryx MPC 60 mg strength added to policy.

2025-01-22 / P&T 2025-05annual_review

2Q 2025 annual review: no significant changes; added references to generic Oracea and Doryx; references reviewed and updated.

2024-01-10 / P&T 2024-05annual_review

2Q 2024 annual review: no significant changes; references reviewed and updated.

2023-02-14 / P&T 2023-05annual_review

2Q 2023 annual review: no significant updates; references reviewed and updated.

2022-02-14 / P&T 2022-05-22annual_review

2Q 2022 annual review: no significant changes; references reviewed and updated.