Policy Positions

Ensuring Access and Availability to High Quality Treatment and Care

OCRA is working hard to ensure that ovarian cancer patients are able to receive the best care possible regardless of geographic, financial or other barriers. This care may include participating in clinical trials, and we are working with Congress and Federal agencies to make sure that the opportunities are understood by and available to patients in need.

  • OCRA believes that all women deserve the best quality treatment and care available, and supports policies that allow all women to access standard of care treatment.
  • OCRA believes that patients should be able to receive the best possible care without experiencing financial hardship.
  • OCRA supports efforts to increase the availability of ovarian cancer clinical trials and supports efforts to increase patient participation rates.
  • OCRA supports legislation to allow patients access to all FDA-approved cancer treatment regimens, regardless of the delivery method, by ensuring patients don’t face dramatically higher out-of-pocket costs because of how medicine is classified.

OCRA works with a variety of stakeholders, including health care practitioner societies, patients and federal partners, to ensure that all women receive standard of care treatment for ovarian cancer. We support policies that ensure all women with ovarian cancer: have access to a gynecologic oncologist for surgery; receive standard of care chemotherapy regimens and targeted therapies outlined by the National Comprehensive Cancer Network (NCCN); and that all women are offered the chance to participate in clinical trials.

Unfortunately, research shows that almost 2 out of 3 women do not receive standard of care treatment. Typically, women treated at large, high-volume hospitals receive standard of care, whereas those treated at low-volume hospitals often do not. Additional research has shown that women from low-income or minority backgrounds typically have poorer survival rates.

Over the past several years, access to health insurance coverage has improved. While this is an important development, we believe these plans must provide adequate coverage for women with ovarian cancer and those at high risk of developing the disease. Specifically, these plans should include access to preventative services, diagnostic tests, the best possible drug therapies, clinical trials, and palliative care. Insurance networks should include access to gynecologic oncologists, as research clearly shows improved outcomes for women treated by these specialists.

Ovarian cancer is an expensive disease to treat, with estimated costs ranging up to $200,000 for care in the first year post-diagnosis. In order to limit patient out-of-pocket expenditures, OCRA closely monitors the benefits design of health insurance plans and promotes policies that seek to protect patients from financial hardships.

Clinical Trials

Clinical trials are essential to the discovery of new and better therapies in the fight against ovarian cancer. In addition to advancing science by participating in a clinical trial, patients may also have the chance to receive the latest and most innovative investigational medicines to fight their cancer. Unfortunately, clinical trial participation rates are extremely low (around 3%) and recently, we have seen a decline in the availability of gynecologic clinical trials.

A recent report found that since 2011, we have seen a 90% decline in patient enrollment in phase III gynecologic clinical trials sponsored by NCI. Several factors likely contributed to this decline including uncertainty over year-to-year federal funding, increasingly narrowing eligibility restrictions, and geographic and financial constraints.

OCRA is working to address this decline. We have been working with Members of Congress, the National Cancer Institute (NCI), and other organizations and stakeholders to develop concrete steps to broaden the availability of clinical trials and encourage robust participation.

Promoting a Strong Commitment to Research and Education Funding

As the world’s largest private funder of ovarian cancer research grants, OCRA understands the importance of a robust commitment to life-saving scientific research. At every opportunity, we work to increase the federal government’s investment in research and educational programs.

  • OCRA believes that public investments in ovarian cancer research, awareness, and education are critical in the fight against ovarian cancer.
  • OCRA recognizes that instability and uncertainty around funding opportunities slows scientific progress and hamstrings researchers – particularly those early in their careers who depend heavily on grant support.
  • OCRA believes that research into high mortality cancers – like ovarian cancer and others with survival rates of less than 50 percent – should be among the highest-ranking priorities at National Cancer Institute (NCI) and funded accordingly.

Despite major advancements in ovarian cancer research and understanding in the past two decades, significant gaps remain. Ovarian cancer involves multiple layers of complexity, which further complicates its diagnosis and treatment. Distinct subtypes exist with different origins, risk factors, genetic mutations, biological behaviors, and prognoses; the progression of each subtype is not fully understood. A 2016 review of the state of science in ovarian cancer by the National Academy of Medicine (formerly the Institute of Medicine) reaffirms that “there remain surprising gaps in the fundamental knowledge about and understanding of ovarian cancer.” Closing these gaps and unraveling the complexities of ovarian cancer depends on ongoing public and private investments in research.

As the largest non-governmental funder of ovarian cancer research, OCRA is doing its part. To date, OCRA has awarded over $97 million in private ovarian cancer research to 79 leading universities, medical schools, and other research institutions.

The federal government distributes ovarian cancer funding through the National Institutes of Health (NIH), which houses National Cancer Institute (NCI), the Centers for Disease Control and Prevention (CDC), and the Department of Defense (DoD). Each agency is unique in its area of focus and grant-making approach but all employ a rigorous peer-review process, ensuring federal investments are meritorious and non-duplicative. Funding levels are determined annually through the congressional appropriations process.

OCRA works with its grassroots base of patient and survivor advocates, as well as other similarly aligned organizations to influence congressional decision-making throughout the appropriations process and ensure ovarian cancer programs continue to receive adequate support and funding.

National Cancer Institute (NCI) at the National Institutes of Health (NIH)

The National Cancer Institute (NCI) is the leading federal agency for cancer research and oversees the national cancer research agenda. NCI’s investments account for the majority of federal funding for ovarian cancer research and include basic, translational, and clinical biomedical research on myriad topics including early detection, imaging technologies, risk assessment, immunosuppression and novel therapeutic approaches.

Federal Funding History

Ovarian Cancer Federal Funding History 2020
  • After a vigorous grassroots campaign led by OCRA, Congress agreed to a major increase in funding for the OCRP in FY 2020. The $15 million increase (from $20 million to $35 million) represents the first major increase in funding for the program in more than a decade.

Ovarian Cancer Research Program at the Department of Defense

The Ovarian Cancer Research Program (OCRP) is part of the Department of Defense’s (DoD’s) Congressionally Directed Medical Research Program (CDMRP). OCRP invests in cutting-edge research that’s high-impact, high risk and high reward and may not qualify for funding from other federal agencies. In particular, OCRP focuses on translational research – which aims to “translate” findings in basic research into clinical the patient community. The research pipeline moves slowly and the progression from bench to bedside can take years, or even decades. Translational research is further along in the pipeline and for today’s patient community, offers the best hope for accelerating progress toward long-term survival.

Centers for Disease Prevention and Control (CDC)

Johanna’s Law

Johanna’s Law – also referred to as The Gynecologic Cancer Education Act – was signed into law in 2007 to raise public awareness of gynecologic cancer symptoms and reduce rates of late-stage diagnosis. The legislation is named for Johanna Silver Gordon, who died of ovarian cancer in 2000. Johanna’s Law supports CDC’s Inside Knowledge Campaign, which develops and disseminates fact sheets, brochures, and posters, as well as broadcast, print, and digital public service advertisements to raise awareness of ovarian and other gynecologic cancers. Inside Knowledge uses varied platforms and evidence-based strategies to ensure messaging is effective and reaches target populations.

  • Ads produced for the Inside Knowledge campaign were seen or heard around 6.5 million times and were worth a total of $175 million in donated ad value between 2010 and 2016.
  • Across all of CDC’s cancer pages, the Inside Knowledge and gynecologic cancer pages consistently receive the most visits every month, with the Inside Knowledge home page receiving over 500,000 page views in 2016.
  • Throughout 2016, Inside Knowledge supported a consistent level of targeted paid outreach via digital display, Facebook, and YouTube ads. During 2016, the display and Facebook ads generated more than 300,000 clicks to the campaign website and related pages. YouTube ads generated more than 1.9 million, with an average view-rate of nearly 20 percent.

Johanna’s Law also supports ongoing education about gynecologic cancers and symptom among health care providers and offers free Gynecologic Cancer Curriculum for Continuing Medication Education (CME) credits.

Ovarian Cancer Control Initiative

CDC’s Ovarian Cancer Control Initiative (OCCI) CDC monitors demographic and other factors at the population-level around ovarian cancer diagnosis, treatment, and survival. These include patient knowledge, perceived risk, treatment and decision-making, as well as physician awareness of and adherence to guidelines regarding clinical assessment and treatment of ovarian cancer. This information is then used to inform strategies for population screening and risk reduction.

Protecting Patient Safety in the Era of Precision Medicine and Advanced Diagnostics

As new ovarian cancer therapies and diagnostic tools come to the market, OCRA is working to make sure that patient safety is protected. New therapy approvals should consider the patient voice throughout the process and diagnostic tools must be tested to ensure clinical validity. We are also engaging in efforts to increase the availability of genetic testing and closely monitor any efforts that threaten the privacy of genetic data.

  • OCRA believes that all diagnostic tests – regardless of whether they are developed by a laboratory in-house or by a manufacturer offsite – should be independently verified to ensure safety and clinical validity, and support regulatory reform to that end.
  • OCRA believes that patient voices should be heard at the regulatory level and encourages patient advocate representation on panels that consider the safety of new and advancing drug therapies.
  • OCRA believes that genomic tumor profiling and other applications in precision medicine have ushered in a new era of oncology care and will accelerate progress toward ensuring long-term survival for every woman diagnosed with ovarian cancer.
  • OCRA believes that in accordance with National Cancer Center Network (NCCN) guidelines, all women diagnosed with ovarian cancer should receive genetic testing and supports for policies that lift barriers to these services.
  • OCRA believes that requirements for insurance coverage of genetic counseling and testing are incomplete unless they also include provisions for the necessary and appropriate risk-reducing interventions in the event of positive results.
  • OCRA supports the Genetic Information Nondiscrimination Act (GINA) and similar policy proposals that provide protections against discrimination on the basis of genetic information.

Medical treatments have historically been designed as “one-size fits all” for the “average patient” – which is effective for some but not all. “Precision medicine” shifts away from this paradigm and uses a tailored approach to disease prevention and treatment that takes into account an individual variability in genes, environment, and lifestyle for each person. Advancements in diagnostic testing technologies have been key to the evolution of precision medicine in oncology; enabling earlier detection through screening for high-risk genetic mutations and creating a path forward for individualized treatments that are tailored to a tumor’s specific genetic alterations. These new, targeted therapies are less toxic and associated with improved patient outcomes. Roughly 21 percent of ovarian cancer patients have tumors that are driven by certain genetic mutations that could be targets for specific drugs.

Diagnostic tests are critical tools in clinical decision-making, providing a wealth of information that is used by doctors and patients to make critical decisions at every stage of care.

Currently, a diagnostic test produced by a manufacturer and sold to a laboratory must first obtain pre-market clearance or approval from the FDA to support the safety and effectiveness of the test. These tests are also subject to comprehensive quality system requirements from design through distribution, as well as post-market oversight that includes mandatory adverse event reporting and FDA’s recall authority. Labs that develop, manufacture, and use their own similar tests (laboratory developed tests or LDTs) are not, however, are under the regulatory authority of CMS, not FDA, and as such, are not subject to the same rigorous standards to certify reliability, safety, and effectiveness as FDA-cleared diagnostic tests developed offsite by a manufacturer.

LDTs have proliferated the health care ecosystem in the last two decades, and are widely used interchangeably with FDA-approved or cleared diagnostics. Often patients or even doctors are unaware of the regulatory status of the test being used to make critical treatment decisions.

Evidence showing the harmful repercussions of unregulated LDTs has amassed, and several disease areas have been adversely impacted, including the ovarian cancer community. In January 2017, FDA issued Discussion Paper on Laboratory Developed Tests that outlines an effective case for the need for regulation.

  • In 2008, OvaSure was introduced, marketed as an early detection test for ovarian cancer. The test was not independently verified to insure clinical validity. It was soon discovered that the test did not accurately predict ovarian cancer cases, leading otherwise healthy women to have their ovaries removed based on bad information.
  • More recently Abcodia released the ROCA Test and marketed it directly to consumers as an effective “early detection” test for ovarian cancer. Prior to wide release, OCRA convened a group of experts over the course of two scientific meetings which produced a white paper published in American Family Physician which concluded that the findings of the related studies did not demonstrate the necessary results needed to warrant screening the general public. Despite the challenge, Abcodia moved forward and expanded access to the test throughout the country. The company finally pulled the test only after FDA issued a safety alert to consumers.

Due to the incredible importance of diagnostic accuracy and patient safety, it is essential that LDTs are properly regulated. OCRA is working closely with Members of Congress and FDA to promote a regulatory mechanism to ensure that LDTs are independently tested to verify their clinical validity and safety.

Genetic Testing as Tool for Cancer Prevention and Risk Reduction

In addition, genetic testing and other applications in precision medicine have created new opportunities in cancer prevention and risk management through screening and early identification of inherited cancer-causing genetic mutations. Asymptomatic women carrying these genes may opt for risk-reducing interventions like prophylactic surgery and increased surveillance.

  • The most common inherited genetic mutation that can cause ovarian cancer is an inherited mutation in one of two genes called breast cancer gene 1 (BRCA1) and breast cancer gene 2 (BRCA2). Mutations in these genes increase a woman’s risk of breast, ovarian and other cancers. In the general population, BRCA mutations are rare, but may account for up to 15-20% of all cases of ovarian cancer. It is estimated that about 44% of women who inherit a harmful BRCA1 mutation and about 17% of women who inherit a harmful BRCA2 mutation will develop ovarian cancer by the age of 80. Women of Ashkenazi Jewish descent are at higher risk of carrying BRCA1 or BRCA2 mutations than the general public; however, people of other ancestries also carry these mutations. People who have no known family history of ovarian cancer can also acquire these mutations, though those with a family history of the disease are at highest risk.
  • Another known hereditary genetic link to ovarian cancer is called Lynch Syndrome. Lynch Syndrome increases a woman’s risk for colorectal, endometrial, ovarian and other cancers. Lynch Syndrome is found in about 1 in 33 women with ovarian cancer.

Coverage and access

There is broad variation in how payers reimburse and cover genetic screening and testing services. In many cases, health insurance plans will cover genetic testing and services when recommended by a physician, but that isn’t always the case and often coverage is incomplete.

Under the Affordable Care Act’s preventive health benefit, all health insurance plans must cover BRCA testing and genetic counseling for women with a family history of breast and ovarian cancer at no out-of-pocket cost to the patient. The provision is narrow in scope and does not cover several high-risk segments of the population, nor make any specifications about coverage for risk-management services in the event of a positive genetic test. In addition, the requirement only applies to BRCA 1 and BRCA 2 mutations and does not extend to other known cancer-causing mutations.

Protections Against Genetic Discrimination

The Genetic Information Nondiscrimination Act (GINA), passed in 2008, prohibits genetic discrimination in employment and health insurance. GINA prohibits employers from using genetic information in hiring, firing and promotion decisions. Employers also are barred from requesting their employees submit to genetic testing. GINA bans health insurers from rejecting coverage or raising premiums for healthy individuals based on their genetic information. Notably, GINA’s protections do not extend to life, disability and long-term care insurance.

Several states have passed laws that bolster GINA’s protections in life, disability and long-term care insurance. You can find information on whether your state offers additional protections.

  • There are other federal laws that offer additional legal and privacy protections to patients:
  • The Privacy Act of 1974 allows for some privacy protection for medical records.
  • The Americans with Disabilities Act (ADA) addresses similar issues regulating medical information about disabilities by protecting both privacy and discrimination (employment, public services and public accommodations; genetic illnesses are not specifically referenced, however).
  • The Health Insurance Portability and Accountability Act, passed in 1996, upholds some restrictions on the use of genetic information in setting premiums and determining eligibility for benefits in health insurance.
  • The Patient Protection and Affordable Care Act, passed in 2010, states that health insurance providers cannot deny coverage or set rates based upon any pre-existing medical condition.