ModifiedCignaPolicy N/A

Contraceptives - Oral, Patch, and Vaginal Ring Products Step Therapy Policy

Step therapy policy listing brand and generic combined hormonal contraceptive oral, patch, and vaginal ring products and grouping them by formulation for coverage/step requirements; affects providers prescribing or requesting authorization for these contraceptives.

Policy Summary

PayerCigna

PolicyContraceptives - Oral, Patch, and Vaginal Ring Products Step Therapy Policy

Policy CodePolicy N/A

Change TypeAdded productsrevised preventive coverage language

Effective Date

Next Review DateJul 16, 2025

Key ActionRequire trial of a Step 1 product before approving a Step 2 contraceptive; document supporting rationale for exceptions.

SourceLink

POLICY UPDATE CHANGES

Femlyv was added as a Step 2 product.

Policy statement updated to remove the word 'primarily' and to add 'or for the improvement of birth outcomes.'

Generic Haloette and generic EnilloRing vaginal rings were added as Step 1 products.

9document pages (partial)

20+product listing chunks

brands & genericsproduct types listed

BMI ≥30patch BMI contraindication

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BMI 25–29Twirla reduced effectiveness

Coverage Criteria

Initial Step Therapy

Covered when the Step Therapy requirement is met

Step therapy flow: Patient must try a Step 1 Product prior to Step 2 Product; if the patient has tried one Step 1 Product, approve the Step 2 Product.

Approvals are for 1 year.

Preventive Services Exception

Exception for preventive services

Preventive service exception: When ACA/HRSA/PHS§2713 coverage is required and criteria are not met, approval is granted if the requested drug is used for prevention of pregnancy or improvement of birth outcomes and the prescriber states Step 1 Products would not be as medically appropriate.

Approvals are for 1 year when granted under this exception.

Transdermal contraceptive patches (including Ortho Evra® generics, Xulane®, Zafemy™, and Twirla®) carry specific BMI- and weight-based limitations. Use of transdermal patches is contraindicated in women with a BMI ≥ 30 kg/m2 (Boxed Warning). Generic Ortho Evra products include a limitation noting possible reduced effectiveness in women weighing > 198 pounds (90 kg). In addition, Twirla® labeling recommends consideration of reduced effectiveness for patients with a BMI ≥ 25 to < 30 kg/m2.

The policy requires adherence to the listed Step Therapy criteria; any exception that is not explicitly listed in the Step Therapy criteria is ruled out. Any other exception outside the listed Step Therapy criteria is considered not medically necessary and will not be approved under this program.

Requests for Step 2 products must meet the Step Therapy requirements to be covered. If the patient has not met the Step Therapy criteria (trial of a Step 1 Product as specified by policy) and the request does not qualify for the ACA/HRSA/PHS §2713 preventive-services exception, the request will not meet criteria for coverage. Requests for Step 2 products without meeting the Step Therapy criteria and not meeting the ACA/HRSA exception are considered not medically necessary.

Clinical & Coding Notes

inv-06: BMI contraindication for transdermal patches

BMI contraindicationTransdermal patches (Xulane/Zafemy and Twirla) are contraindicated for use in women with BMI ≥ 30 kg/m2 (boxed warning).

Twirla reduced effectiveness noteTwirla labeling advises consideration of reduced effectiveness in women with BMI ≥ 25 to < 30 kg/m2.

Generic Ortho Evra weight warningGenerics for Ortho Evra may be less effective in women who weigh > 198 pounds (90 kg).

inv-07: BMI contraindication threshold

BMI threshold>= 30 kg/m2

ContextBoth Xulane/Zafemy (norelgestromin/ethinyl estradiol) and Twirla (levonorgestrel/ethinyl estradiol) are contraindicated at this BMI per boxed warning.

What Providers Need to Do

Step Therapy

Step Therapy Applies to Listed Contraceptives

Step therapy applies to the contraceptives listed in this policy. This Step Therapy Policy groups contraceptives by formulation and brand/generic status and requires following the step rules before a Step 2 Product will be covered.

Step therapy applies to listed contraceptives (see product list)
Document is titled a Step Therapy Policy

Prior Authorization

Prior Authorization and Coding Requirements

Prior authorization and documentation must be submitted in accordance with the Coverage Policy criteria. Reimbursement will only be provided when services are submitted with the covered diagnosis and/or procedure codes required by the applicable Coverage Policy.

Prior authorization required when applicable per Coverage Policy
Use most appropriate codes as of the submission effective date
Claims without covered diagnosis or procedure codes will be denied

Clinical Background

Combined oral contraceptives (COCs) contain both estrogen and progestin and prevent pregnancy primarily by suppressing ovulation (the estrogen component) and by altering cervical mucus and the endometrium (progestin effects). COCs are available in multiple formulations — monophasic, biphasic, triphasic, and four-phasic — with monophasic regimens maintaining the same hormone dose throughout the active cycle. Progestin-only products (oral or other formulations) provide an alternative when estrogen is contraindicated, such as in patients with a history of venous thromboembolism or those who are breastfeeding.

Definitions

inv-23: Monophasic COC

DefinitionMonophasic combined oral contraceptive (COC): formulation that maintains the same dose of estrogen and progestin throughout the cycle.

Typical dosing patternTypically 21 days of active pills followed by 7 days of placebo (21/7).

Clinical noteAll COCs have similar efficacy irrespective of monophasic or multiphasic regimens; monophasic regimens provide consistent hormone exposure across the cycle.

inv-24: Extended-cycle (84-day) regimen

DefinitionExtended-cycle (84-day) regimen: a monophasic regimen providing 84 days of active hormone followed by 7 days of placebo.

PurposeReduces the frequency of withdrawal bleeding compared with traditional 21/7 regimens.

Initiation Guidance

Initiation guidance

General clinical considerations for initiating therapy

Initiation considerations: Select combined oral contraceptive (COC) type (monophasic vs multiphasic/extended-cycle) based on patient preference and symptom profile; consider progestin-only products for patients with contraindications to estrogen (e.g., history of venous thromboembolism, breastfeeding).

Consider drospirenone-containing progestin-only products contraindications (risk of hyperkalemia) in patients with renal disease, hepatic dysfunction, or adrenal insufficiency; document rationale for product selection in prior authorization requests.

Step 1 Products

Step 1 products: Generic oral contraceptives; transdermal Xulane; transdermal Zafemy; etonogestrel-ethinyl estradiol vaginal ring (and generics EluRyng, EnilloRing, Haloette).

These products are the required first step before coverage of Step 2 products; trial of one Step 1 product is sufficient to approve a Step 2 product.

Step Therapy Listings

Step Group	Products / Examples	Coverage Note
Step 1
Generic oral contraceptives; transdermal Xulane; transdermal Zafemy; etonogestrel-ethinyl estradiol vaginal ring and generics (EluRyng, EnilloRing, Haloette)
Covered when Step Therapy requirement is met (trial of a Step 1 Product). Approvals provided for 1 year.

Formulary / Listing	Applies To	Notes
Generic combination hormonal contraceptives (multiple monophasic, biphasic, triphasic and extended‑cycle products listed)
Multiple generic oral products listed across monophasic/biphasic/triphasic and extended‑cycle formulations (examples in formulary listing)
Formulary listings and step therapy distinctions apply across the listed generic products; specific product examples are in the formulary tables.

Step Requirement	Provider Action	Decision Rule
Minimum trial requirement
Patient must have tried one Step 1 Product before a Step 2 Product will be approved
If the patient has tried one Step 1 Product, approve a Step 2 Product; approvals are for 1 year. Exceptions per ACA/HRSA/PHS§2713 apply for prevention of pregnancy or improvement of birth outcomes if prescriber attests Step 1 products are not as medically appropriate.

Policy Summary

PayerCigna

PolicyContraceptives - Oral, Patch, and Vaginal Ring Products Step Therapy Policy

Policy CodePolicy N/A

Change TypeAdded productsrevised preventive coverage language

Effective Date

Next Review DateJul 16, 2025

Key ActionRequire trial of a Step 1 product before approving a Step 2 contraceptive; document supporting rationale for exceptions.

SourceLink

On This Page

ImplicationPatients with BMI ≥ 30 kg/m2 should not be prescribed transdermal patches listed due to reduced safety/efficacy.

inv-08: Twirla reduced effectiveness consideration

Twirla BMI considerationLabeling notes reduced effectiveness to be considered for BMI ≥ 25 to < 30 kg/m2.

ProductTwirla is a levonorgestrel/ethinyl estradiol transdermal patch (30 mcg EE / 120 mcg levonorgestrel per 24 h).

Clinical actionConsider alternative contraceptive methods for patients in this BMI range due to potential reduced effectiveness.

inv-09: Weight consideration for generic Ortho Evra

Weight threshold> 198 pounds (90 kg)

ApplicabilityGeneric Ortho Evra products may be less effective in preventing pregnancy in women weighing more than 198 lb (90 kg).

Related productOrtho Evra generics (Xulane/Zafemy are related transdermal generics).

Step Therapy

Step Therapy Requirement

A trial of at least one Step 1 Product is required before a Step 2 Product will be approved. Requests for Step 2 products that do not meet the Step Therapy criteria will be evaluated per the Step Therapy criteria and are subject to denial if the step requirements are not met.

Step requirement: trial of one Step 1 Product prior to Step 2 Product
Requests for Step 2 products when criteria not met will be evaluated per Step Therapy criteria
Failure to follow step requirements may result in coverage denial

Note

Step Therapy / Formulary Application

Formulary distinctions and step rules apply across monophasic, biphasic, and other combination hormonal contraceptive products as listed in the policy. Providers should reference the product list when submitting prior authorization requests.

Step therapy/formulary application spans monophasic, biphasic, and other products
Providers should reference the policy product list when requesting prior authorization

Step Therapy

Step 1 and Step 2 Product Examples

Step 1 products include generic oral contraceptives and specific transdermal and vaginal ring generics listed in the policy (for example: generic oral contraceptives, transdermal Xulane, transdermal Zafemy, etonogestrel-ethinyl estradiol vaginal ring, and listed generic rings). Step 2 products include listed brands (for example: brand oral contraceptives, Twirla, NuvaRing, Annovera, Femlyv).

Step 1 example list: generic oral contraceptives; transdermal Xulane; transdermal Zafemy; etonogestrel-ethinyl estradiol vaginal ring; Eluryng; EnilloRing; Haloette
Step 2 example list: brand oral contraceptives; transdermal Twirla; NuvaRing; Annovera; Femlyv

Note

Approval Duration and ACA/HRSA Note

All approvals under this Step Therapy Policy are provided for 1 year in duration. When ACA/HRSA/PHS §2713 compliance applies and criteria for preventive coverage are not met, approval may still be granted for contraception used for pregnancy prevention or improving birth outcomes if the prescriber documents that Step 1 Products would not be medically appropriate.

Approvals are valid for 1 year
ACA/HRSA/PHS §2713 considerations may allow approval for preventive use when criteria not met, per prescriber statement

Documentation Required

Documentation and Review Considerations

Provide documentation consistent with the member's benefit plan and the Coverage Policy. Coverage determinations are based on the documentation submitted; medical directors may exercise clinical judgment. Coverage Policies do not replace the member's benefit plan document; in case of conflict the plan document controls.

Submit documentation consistent with the applicable benefit plan and supported diagnosis/procedure codes
Coverage determinations rely on submitted documentation; exceptions not meeting criteria are considered not medically necessary

ExampleProducts such as Seasonale (generic available) utilize the 84/7 extended-cycle format.

inv-25: Transdermal patch BMI limitation

SummaryCertain transdermal contraceptive patches are contraindicated or have reduced effectiveness at higher BMI values (boxed warning at BMI ≥ 30 kg/m2).

SpecificsGenerics for Ortho Evra/Xulane/Zafemy and Twirla carry BMI/weight-related limitations in labeling; consider alternatives for higher-BMI patients.

Clinical implicationAssess BMI and weight prior to prescribing transdermal patches due to labeled contraindications and reduced effectiveness considerations.

inv-26: Transdermal Patches

Product descriptionsXulane and Zafemy: transdermal patches delivering ethinyl estradiol and norelgestromin (35 mcg EE / 150 mcg norelgestromin per 24 h).

Twirla detailsTwirla: transdermal patch delivering ethinyl estradiol and levonorgestrel (30 mcg EE / 120 mcg levonorgestrel per 24 h).

Regulatory notesOrtho Evra brand discontinued in 2015; generics remain available with labeling warnings regarding BMI/weight and higher estrogen exposure.

inv-27: Vaginal Rings

NuvaRing and genericsDisposable vaginal rings (etonogestrel-ethinyl estradiol, e.g., NuvaRing, EluRyng, EnilloRing, Haloette): one ring used continuously for 3 weeks followed by a 1-week ring-free interval.

Annovera reusable ringAnnovera is a reusable vaginal ring providing contraception for 13 cycles (each cycle: 3 weeks in, 1 week out).

Active ingredientsVaginal rings release ethinyl estradiol with a progestin (Annovera contains ethinyl estradiol and segesterone acetate).