commercialize theone-year vaginal contraceptive system, if approved. We intend to add a dedicated marketing team exclusively focused on theone-year vaginal contraceptive system. We also believe that we are uniquely positioned to market theone-year vaginal contraceptive system, if approved, to the more than 60,000 annual vitaMedMD prenatal customers, who may proceed to contraception following pregnancy.
We currently intend to price theone-year vaginal contraceptive system at parity or discount to current prescription contraceptive pricing levels and anticipate an annual wholesale acquisition cost, or WAC, of between $1000 and $1400, which reflects a 40% decrease to the annual WAC of NuvaRing. We believe that the unique characteristics of theone-year vaginal contraceptive system will assist us in pursuing favorable commercial payor coverage, including only one pharmacy fill fee per year, an estimated savings of $33 annually per patient, and no office visit or procedure fees, an estimated savings of several hundred dollars annually per patient. However, obtaining and maintaining favorable reimbursement can be a time-consuming and expensive process, and there is no guarantee that we will be able to negotiate or continue to negotiate reimbursement or pricing terms for our products, including theone-year vaginal contraceptive system, with payors at levels that are profitable to us, or at all.
In addition, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or the ACA, mandates that private health plans provide coverage for women’s preventative services, without imposing patient cost-sharing requirements, as recommended by the Health Resources and Services Administration, or HRSA. HRSA Guidelines require private health plans to cover, without cost-sharing, at least one form of contraception, or product, in each of the methods, or classes, identified by the FDA for women in its Birth Control Guide, which currently includes 18 separate classes. For classes with more than one type of treatment, private payors need only provideno-cost coverage for one product in each class, and may use reasonable medical management to determine whether and to what extent to cover other products in the class. We believe that if theone-year vaginal contraceptive system is classified by the FDA as a “vaginal system,” and if the FDA determines that a “vaginal system” constitutes a new class of birth control, this designation could allow for coverage of theone-year vaginal contraceptive system by private health plans with noout-of-pocket cost for patients. However, the FDA may not designate theone-year vaginal contraceptive system as a new class, and, even if the FDA does designate it as a new class, it is possible that otherFDA-approved products could also be included in this new class. To the extent theone-year vaginal contraceptive system is not the onlyFDA-approved product in a designated class of contraception, private payors may choose not to cover ourone-year vaginal contraceptive system, or may require patient cost-sharing obligations.
As part of the Council License Agreement, we have agreed to provide significantly reduced pricing to federally designated Title X family planning clinics serving underrepresented women.
The Population Council has previously entered into a supply agreement with Crystal Pharma SAU for the supply of Nestorone, one of the active pharmaceutical ingredients for theone-year vaginal contraceptive system, and a letter agreement with QPharma AB for the optimization of the commercial manufacturing process for theone-year vaginal contraceptive system. We intend to enter into agreements Crystal Pharma SAU and QPharma AB for the supply of Nestorone for, and the manufacturing of, theone-year vaginal contraceptive system, respectively, and the Population Council has agreed to use commercially reasonable efforts to assist us in doing so. However, either or both of these contract manufacturers could decline to enter into similar agreements with us on the terms we anticipate, or at all.
Amendment to MidCap Credit Agreement
On July 30, 2018, we entered into Amendment No. 1 to that certain Credit and Security Agreement, or the Credit Agreement, by and among our company, as borrower, our company’s subsidiaries party thereto from time to time, each as a borrower, MidCap Financial Trust, as agent and as lender, and the additional lenders party thereto from time to time, in order to permit our entry into the