KV Pharmaceutical Ther-Rx Ther-Rx
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MakenaTM (hydroxyprogesterone caproate injection)
 

Cost of Bringing FDA-Approved Makena™ to Market

FDA-approved medications must meet high standards for effectiveness, safety and quality.1 Gaining FDA approval, maintaining FDA manufacturing standards and fulfilling FDA requirements requires significant upfront investments and ongoing costs.

Ther-Rx has made significant investments and commitments to advance Makena (hydroxyprogesterone caproate injection) through an FDA-approval process that began in 2006, and to ensure Makena’s availability. Ther-Rx has invested or committed over a quarter of a billion dollars to-date to bring Makena to market, including more than $60 million in research and clinical trial costs.

Makena™ Price

The pricing of Makena takes into consideration principal factors including: the cost associated with advancing Makena through the FDA approval process; the costs of manufacturing in a validated environment; the costs of investments going forward, including ongoing clinical studies; and various other factors to help ensure access to Makena.

Cost of Makena™

The safety and efficacy of Makena was evaluated based upon a clinical study of 463 women, which was sponsored by the National Institutes of Health (NIH) and served as part of the basis for FDA-approval. In addition to the NIH-funded study, the clinical requirements for approval of Makena include major, multi-year follow-on health studies of Makena involving 1,700 mothers and more than 500 infants. These studies, required by FDA as a condition for Makena’s approval, began enrolling patients in 2009 (prior to FDA approval) and are being funded by the company.2 These studies are approximately four times larger and approximately 12 times more expensive than the initial NIH trial submitted for FDA approval. These studies will help provide enhanced medical knowledge to patients, families, and society as a whole.

Manufacturing Costs

FDA-approved Makena—a sterile injectable—is manufactured in a facility compliant with current Good Manufacturing Practices (cGMPs). These FDA-enforced regulations help ensure the identity, strength, quality, and purity of the medication by requiring control and monitoring of the manufacturing process and facilities. This also helps ensure consistency from dose to dose and accurate potency according to the amount declared on the label.3 Adherence to these quality-management systems means patients will receive the FDA-approved formulation for this indication.4

Manufacturing a sterile injectable product, such as Makena, in an FDA-approved and regulated environment using approved ingredients will cost multiples of what it costs to simply compound a product as an individual prescription. Manufacturing a single five-dose vial of Makena includes costs associated with ingredients and direct manufacturing, and the personnel, overhead, and infrastructure costs associated with manufacturing using FDA-required quality procedures and validated processes.

Investment Costs

The Company remains committed to investing in clinical and scientific advances to create innovative products and services in women’s health.

Additional Factors

Another significant factor in pricing Makena is that relatively few patients are eligible for treatment – a fraction of the overall population for which most prescription drugs are developed and intended for use.

Makena is an “orphan drug,” defined by the FDA as a drug for a condition affecting less than 200,000 people a year.1 In the case of Makena, approximately three percent of pregnant women are estimated to be clinically indicated for treatment.5

As an FDA-approved medication, Makena is also subject to ongoing safety monitoring for adverse effects.

The company also made a significant investment in developing a network of specialty pharmacies, specialty distributors, and a customer support center to help facilitate prescriptions for Makena.

Patient Assistance Program

With our Patient Assistance Programs, clinically eligible patients can have affordable access to therapy. Financial assistance is available for clinically eligible insured and uninsured patients upon request.

The Makena Co-pay Assistance Program will reduce co-pay costs for insured patients whose health plan covers Makena™. Patients with a household income of up to $120,000* will pay between $0 and $20 per injection for Makena. Since there are no income caps, patients with a household income greater than $120,000 are also eligible for co-pay assistance.

The Makena Patient Assistance Program supports uninsured patients by offering the drug at no cost or reduced cost. Patients who are uninsured and have an annual household income less than $60,000 will receive Makena at no out-of-pocket cost.

Below is an overview of assistance provided through the program:

Coverage Income Level Copay/Financial Assistance†
Uninsured Up to $60,000 Receive Makena at no cost
Uninsured Above $60,000 Receive Makena at cost equivalent to what insured patients pay out-of-pocket under the Makena copay assistance program
Insured Up to $120,000
(represents 85 percent of household incomes based on 2009 census data) 		Copay of $0-$20 per injection for Makena
Insured Above $120,000
(represents 15 percent of household incomes based on 2009 census data) 		Copay of $40-$80 per injection for Makena
* This encompasses 85% of US household incomes. Source: 2009 US Census Data.
†Gross annual household income and insurance coverage are factors that determine the level of copay or financial assistance a patient is eligible for. There are additional eligibility requirements (i.e. have a Makena prescription, etc.) and these can be discussed on patient-by-patient basis with a representative from the Makena Care Connection, a program designed to help ensure access to Makena.