Ordering and stocking FDA-approved Makena for your office

Makena® (hydroxyprogesterone caproate injection) may be purchased directly from a specialty distributor or wholesaler and stocked in the healthcare provider's office

  • Purchase directly from one of the following specialty distributors:
    Click here for billing resources. Please call the specialty distributor for specific ordering instructions
  • Order via drop shipment from your preferred wholesaler: Please contact them directly for more information
Makena prescription support

Can you buy-and-bill for Makena?

eMakena also offers assistance with investigating patient benefits for those who are interested in purchasing Makena and billing the insurance company directly for weekly injections.

Committed to helping ensure cost is not a barrier to acceptance of therapy

Makena copay assistance

Financial assistance is available with no upper-level income caps for eligible insured and uninsured patients in need. Learn more

Committed to helping patients adhere to their weekly injection schedule

A free nurse-led program designed to provide education, support, and empowerment throughout the patient's pregnancy journey. Learn more

Billing and coding for Makena (J1725)

Below is billing and coding information that is required for Makena when completing the CMS 1500 claim form. Please note, code and claim information requirements may vary by insurer and benefit plan. Patient coverage and codes should be verified before purchasing and billing.

Makena CMS 1500 Makena CMS 1500

*National Drug Code (payer requirements regarding 10-digit and 11-digit NDC may vary).

†Current Procedural Terminology.

‡International Classification of Diseases–9th Revision–Clinical Modification.

§International Classification of Diseases–10th Revision–Clinical Modification.

||Healthcare Common Procedure Coding System.

Important information about reimbursement for J1725

When calculating reimbursement for J1725, it is important to record the appropriate billable unit.

Makena J code Makena J code
  • There are 250 mg in one weekly dose (1 mL) of Makena
  • 1 mg = 1 billable unit; thus each Makena injection equals 250 billable units
  • J code calculation: 250 mg x (reimbursement rate per billable unit)

The reimbursement per billable unit may vary based on your contracted rate; check with the payer to ensure that your claim is recorded correctly.

Patient Information and Coding Worksheet

Patient Information and Coding Worksheet

Helps you keep track of your patients' insurance information and codes needed for reimbursement for Makena

Download
Makena Billing Guide

Makena Billing Guide

Use for assistance when completing the CMS 1500 claim form.

Download
Makena patient story

Tools for managing financial responsibility

Volume discount

Offices purchasing Makena may receive a volume discount from their specialty distributor.

Please contact:
CuraScript 1-877-599-7748,
or
TheraCom 1-888-214-8313
directly for more information.

Makena Returns Policy

Under certain circumstances, Makena may be returned when purchased through a specialty distributor. A Makena Returns Request Form must be completed.

Makena Returns Policy

Makena Returns Request Form

Frequently asked questions about ordering and stocking Makena

How is Makena ordered?

Makena can be ordered through the following specialty distributors. Please call for specific ordering instructions.

Makena is also available via drop shipment through your preferred wholesaler. If you prefer to receive your order via drop shipment, please contact your wholesaler directly for more information.

Obtain the correct claim requirements in writing from the patient's insurer before submitting a claim for each weekly dose of Makena.

What is the return policy?

Under certain circumstances, for both the single-dose and multi-dose vials, Makena may be returned for credit when purchased through CuraScript, Inc., through McKesson Plasma and Biologics, through TheraCom, or via drop shipment. The policy has certain limitations and applies to expired doses that are not billable.*

Makena Returns Policy

Makena Returns Request Form

For the multi-dose vial (5 weekly injections), keep the storage guidelines noted in the Makena prescribing information in mind. All doses need to be used within 5 weeks after the first use. Under certain circumstances, Makena can be returned for credit.

*Product that is returned without a completed and approved Returns Request Form will be destroyed without credit.

Is 340B/PHS pricing available?

Yes. 340B-eligible hospitals and other eligible facilities can obtain Makena through CuraScript, Inc., McKesson Plasma and Biologics, or TheraCom.

Are drop shipments available?

Yes. Drop shipments from wholesalers are available. Drop shipment capabilities must be established between the wholesaler and the specialty distributor (CuraScript, Inc., McKesson Plasma and Biologics, or TheraCom). Payment terms are governed by the customer/wholesaler agreement, independent of the Makena specialty distributors.

What codes are needed to submit claims for Makena?

Refer to the billing and coding procedures. When verifying a patient's insurance benefits, confirm the codes required by the payer, as the required codes may vary. Confirm patient benefits and the correct payer-specific codes for each patient to help prevent errors and ensure timely reimbursement.

If Makena is purchased and stocked by a healthcare provider or institution, do patients still have access to financial assistance?

Yes. If a patient cannot afford her out-of-pocket expense, she should contact the Makena Care Connection (1-800-847-3418) directly to assess her eligibility. The patient should let the Makena Care Connection know that she is receiving Makena and is in need of copay assistance (applies to copays, coinsurance, and deductibles).

How is Makena insurance coverage determined for a specific patient?

If Makena is ordered and stocked in the office, contact the individual's payer/insurer and inquire about the patient's benefits. This coding worksheet will assist in verifying the correct billing codes.

What happens if a patient does not have insurance?

We are committed to helping ensure cost is not a barrier to acceptance of therapy. If the patient is uninsured, a Makena Prescription Form should be submitted to the Makena Care Connection with the "Patient does not have insurance" box checked in Step 1. She will immediately be assessed for participation in the Makena Patient Assistance Program, which offers eligible patients Makena at no cost.

Have a question that is not here? Please call or email the Makena Care Connection:

Monday–Friday, 7 AM – 7 PM (CT)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication

Makena (hydroxyprogesterone caproate injection) is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.

Important safety information for Makena (hydroxyprogesterone caproate injection)
  • Do not use Makena in women with any of the following conditions:
    • Current or history of thrombosis or thromboembolic disorders
    • Known or suspected breast cancer, other hormone-sensitive cancer or history of these conditions
    • Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
    • Cholestatic jaundice of pregnancy
    • Liver tumors, benign or malignant, or active liver disease
    • Uncontrolled hypertension
  • Makena should be discontinued if thrombosis or thromboembolism occurs
  • Allergic reactions, including urticaria, pruritus and angioedema have been reported with use of Makena or with other products containing castor oil
  • Women receiving Makena should be monitored if they:
    • Are prediabetic or diabetic
    • Have conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction
    • Have a history of clinical depression; Makena should be discontinued if depression recurs
    • Develop jaundice; consider whether benefit of use warrants continuation
    • Develop hypertension
  • Certain pregnancy-related fetal and maternal complications or events were numerically increased in Makena-treated subjects as compared to placebo subjects, including miscarriage (2.4% vs. 0%) and stillbirth (2% vs. 1.3%), admission for preterm labor (16% vs. 13.8%), preeclampsia or gestational hypertension (8.8% vs. 4.6%), gestational diabetes (5.6% vs. 4.6%), and oligohydramnios (3.6% vs. 1.3%)
  • The most common adverse reactions reported in ≥2% of subjects and at a higher rate in the Makena group than in the control group were injection site reactions (pain [35% vs. 33%], swelling [17% vs. 8%], pruritus [6% vs. 3%], and nodule [5% vs. 2%]), urticaria (12% vs. 11%), pruritus (8% vs. 6%), nausea (6% vs. 5%), and diarrhea (2% vs. 1%)

Please see full prescribing information for Makena.

References: 1. American Medical Association. Current Procedural Terminology 2014: Professional Edition. Chicago, IL: American Medical Association; 2013. 2. Buck CJ. 2014 ICD-9-CM Volumes 1, 2 & 3: For Hospitals. St. Louis, MO: Saunders Elsevier; 2014. 3. American Medical Association. ICD-10-CM The Complete Official Draft Code Set. Chicago, IL: American Medical Association; 2014. 4. PMIC. HCPCS: Health Care Procedure Coding System, National Level II Medicare Codes 2014. Los Angeles, CA: Practice Management Information Corporation; 2013.

Important safety information and Indication
INDICATION
IMPORTANT SAFETY INFORMATION
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