Cancer is the second most common cause of death in the US1, and one of the most feared. Its effects can be devastating–physically, emotionally, and financially. Fortunately, we are learning more about prevention all the time, and many Americans are adopting lifestyles that will reduce their chance of developing cancer. Also, advances in medical science are changing the treatment landscape such that long-term remissions and even cures can be effected in more and more types of cancer. But treatments cannot work if patients do not get them.
This article will explore several key barriers to optimal cancer treatment, and ways that these barriers may be minimized.
Fact: Bankruptcy is an independent risk factor for mortality in cancer patients. Financial toxicity is real, and it is a major barrier to accessing cancer care.2, 3, 4 Drug product acquisition cost for cancer chemotherapy and immunotherapy continue to rise, year after year, and it is anticipated that this trend will continue. Although several of the older injectable products and a few oral agents are available generically, and biosimilars for biologic products like rituximab have been launched over the past couple of years, most oral and biologic cancer treatments have patent expirations that are years into the future.
It is not just the under-insured and uninsured who are affected.
- Patients whose treatment was covered by Medicaid have been found to have higher cancer-related mortality than those with managed care insurance, a statistic correlated with higher use of consensus guidelines in managed care patients.5 In addition, the type of insurance has also been associated with differences in cancer stage at diagnosis; those with government-sponsored or no insurance were more likely to have their cancer diagnosed at a late stage than patients who had private insurance.6 The situation may be improving for those with Medicaid, however; states that expanded Medicaid under the Affordable Care Act have been experiencing better mortality outcomes than states that did not do so.7
- One study published in 2013 demonstrated that chronic myeloid leukemia patients with commercial insurance and higher out of pocket costs for tyrosine kinase inhibitors (drugs such as Gleevec®, Sprycel®, Tasigna® and Bosulif®) were 42% more likely to be nonadherent to treatment than patients with lower costs, and 70% more likely to discontinue treatment altogether.8
It may seem that little can be done to reduce the cost of cancer treatment; however, there are existing and developing tactics designed specifically to reduce financial toxicity.
Payment assistance programs
The best-known tactic for breaking down the cost barrier for cancer treatments is referring the patient to manufacturer payment assistance programs (also known as copayment offset programs, copay cards or coupons). Typically, these programs are drug-specific, and they provide financial assistance to patients taking those drugs. These are good options for patients who do not have healthcare coverage and can also benefit those who have insurance coverage other than Medicare or Medicaid (which do not allow use of such programs).
Under usual circumstances, the payments via manufacturer payment assistance programs are treated by insurers as though they are being paid by the member, meaning that they are applied to the member’s deductibles and maximum out-of-pocket (MOOP) amounts. In these situations, the member generally benefits from assistance. However, many insurers have instituted copay adjustment programs that do not allow the payments to count towards deductibles or MOOP. Although there are variations, there are two major types of such programs:
- Copay accumulators, where payments from the manufacturer are not counted toward the member’s deductible or out-of-pocket maximum. Funds from the manufacturer are used to pay the member’s cost-share for prescriptions until the amount available through the copayment program is reached. After that, the member is responsible for paying their regular cost share and those costs then start accumulating towards their annual deductible and out-of-pocket maximum.
- Copay maximizers, also programs in which the manufacturer funds do not count toward the member’s deductible or out-of-pocket maximum. However, in these programs, the entire amount available from the manufacturer is spread throughout the year, and the member’s deductible is adjusted so that total annual cost share for the member equals the total funds available from the manufacturer. In this way, the member is not responsible for any cost share for the drug for the entire year.
Drug Channel’s Adam Fein, after describing examples for each scenario, stated that “When compared with the accumulator scenario, the maximizer scenario is equivalent for the manufacturer, worse for the plan, and much better for the patient”.9
While plan sponsors favor accumulator programs, the potential negative effects have drawn attention. First, patients may end up paying more out of pocket in plans with one of these programs than in plans without. These programs are for expensive brand name products; if a generic alternative exists, patients in plans with copay accumulator programs may miss out on the lower-cost generic copayment when (if) the program funds run out (some benefit plans mitigate this effect, however). Second, a General Accounting Office report from 2016 found that at least 18 such programs drove the effective market price of the related products up.10
The 2020 Notice of Benefit and Payment Parameters (NBPP) Final Rule that allowed plan sponsors to exclude manufacturer funds from members’ MOOP and deductible limited this practice to drugs for which a generic equivalent was available. Unfortunately, this legislation was never enforced; and in May of 2020, CMS published a similar regulation in the 2021 NBPP Final Rule which does not include the stipulation related to generic drugs.11
A recent survey by the Business Group on Health revealed the 34% of surveyed employers used copay accumulator or maximizer programs, 4% were planning to add one and 15% more were considering adding one in the next 2 years.12
In addition to copay assistance, pharmaceutical manufacturers also sponsor patient assistance programs (PAPs) that provide financial assistance or free drug product (through in-kind product donations) to low-income individuals to augment any existing prescription drug coverage
There are some funds available from sources other than pharmaceutical manufacturers, which unlike manufacturer copayment programs, may be available to Medicare beneficiaries. These can also be important to those who do not meet manufacturer requirements for assistance. Several organizations such as the Cancer Financial Assistance Coalition, Cancer.net , the American Cancer Society and the Centers for Disease Control provide information about these on their websites.
So-called “self-injectable” drugs are ones that most (but not all) patients may be able to administer to themselves in the home setting. Self-administration is generally encouraged because it is almost always more cost effective and more convenient for the patient than having a healthcare professional administer the drug. In fact, the cost savings may make the difference between a patient being able to receive treatment or foregoing it due to cost being a barrier.
However, despite starter kits, videos from manufacturers, live video tools and the like, some patients may need assistance from a healthcare professional for initial administration of “self-injectables”. In addition, some products are available only as infusions or injections that must be administered by healthcare professionals. There are several options for care settings in these situations. Although the order may vary due to individual plan designs and contracted rates, a general rule is that the available care settings for non-self-injectables rank as follows in terms of cost (low to high):
- Professional Office
- Home Infusion
- Infusion Center/Specialty Condition Center
- Hospital Outpatient Facility
Care setting may drive dispensing channel for the drug (e.g., physician office “buy and bill” vs. specialty pharmacy dispensing).
Both the setting itself and the dispensing channel for the drug will influence cost for payer; and depending on benefit parameters, these may also affect member cost-share–again, potentially causing an access issue.
Care setting influences access in other ways than just cost, however. In two recent analyses, it was found that patients receiving chemotherapy in the physician’s office received more chemotherapy than those treated in hospital outpatient departments.13, 14 Regardless of whether relative cost was a factor in this, site of care matters for patient access to cancer treatment.
Novel approaches for improving access
One unique approach to helping cancer patients afford their treatments was recently instituted in Ohio. The State of Ohio Board of Pharmacy and the Ohio State University Comprehensive Cancer Center collaborated to create a drug repository where patients, families, pharmacies, hospitals, and nonprofit clinics can deposit unused drugs for use by those who cannot afford to buy them. Precautions are taken to ensure that the drugs are not degraded or otherwise unsuitable for patient use. While unique at this time, this program may stimulate other institutions to adopt similar practices.15
Another strategy targets patients for financial guidance through the Comprehensive Score for financial Toxicity (COST) measure, and tailors interventions to those patients’ needs. In one study, patients who scored 5 or less on two of the COST questions met with a nurse navigator and a clinical pharmacist to identify gaps in care and explore opportunities for grants, copay assistance and other resources to help pay for gas, food, and transportation. Targeted patients were also given an opportunity to meet with a financial planner at no cost. The study revealed that those who received these interventions to improve treatment access had quality-of-life scores afterwards that were statistically significantly higher than scores for those who did not.16
Social determinants of health
Race and Culture
Race and culture are often misunderstood barriers to cancer treatment.
In the United States, racial discrepancies have been identified in access and adherence to cancer therapy. One study found that black women more frequently delayed breast cancer treatment, and had greater treatment prolongation than white women of similar age and economic status.18 Another reported that black patients were less likely than white patients to receive cancer treatment consistent with consensus guidelines. Treatment not led by guidelines was, in turn, associated with increased incidence of death related to breast, colon, liver, gastric, ovarian, and cervical cancers.5 (p 1) Some of the factors causing these issues are discussed in this section.
Cultural norms, such as beliefs and attitudes associated with a patient’s nationality or religion, are sometimes difficult to discern for a given patient, and as such, are sometimes overlooked by healthcare providers. But myths and stigma about cancer are a part of many cultures, and these can interfere with a patient’s access to cancer screening, therapy, symptom alleviation, follow up, social services, etc.
Differing beliefs about healing practices in general (“eastern” vs. “western” medicine, role of native healers, reliance on faith healing, etc.) are among the more obvious cultural influences on access at any point in the continuum of cancer detection and treatment. But studies have revealed other, more specific causes and effects related to cancer treatment access.
Specific cultural norms were identified through surveys as barriers to breast cancer screening among Jordanian and Somali women.4 (p 1) In contrast, culture was not found to be a significant barrier to mammography or cervical cancer screening in Asian women.19, 20
Communication and language were found to be barriers to effective cancer symptom treatment in Native Americans.21 In fact, language issues (including lack of, or difficulties with, interpreters3 (p 602)) were found to be barriers in virtually all the reports examined in conjunction with this paper.
There are several factors to consider when attempting to ameliorate cultural barriers to care. For example, in some cultures, family involvement is critical to treatment success,22 and an environment that is welcoming to family members can improve adherence to care, if not outcomes in general. In other cultures, however, the stigma of having cancer is so great that patients may wish to conceal their condition from family members.23 To help overcome attitudes and beliefs that foster shame or isolation of those with cancer, emotional and cultural support can be key. In addition to simply recognizing and respecting the patient’s culture, healthcare professionals can help by letting the patient take the lead in decisions about involving or not involving family members in their care. In some cases, connecting patients with their respective spiritual leaders or peer or survivor support groups can help.
Infrastructure measures that can alleviate cultural barriers include:
- Use of well-screened interpreters or care navigators where appropriate.
- Discreet signage and inconspicuous entrances in and around healthcare settings, to accommodate those who do not wish to reveal their diagnosis.
- Waiting and changing areas that feature measures to protect privacy such as curtains, frosted glass, and the like, for individuals whose culture values modesty and gender separation.
In addition, communications that emphasize positive factors related to cancer may reduce the fear and stigma that families and friends may associate with the disease. These factors include:
- Declining cancer incidence
- Improvements in screening and early detection
- Improved cancer survivorship
- Lifestyle changes that can reduce risk
Health literacy is the degree to which a person can obtain, understand, and apply basic health information and services so they can make proper decisions about their own health and care.
Education level, which will affect health literacy, may correspond with adherence to prescribed treatment. One study compared cancer survivors who reported receiving all necessary cancer care to those who did not and found that among those who reported not receiving all necessary cancer care, a smaller proportion had received at least some college education (557 of 1088 [59%] vs 26 of 70 [42.3%]).17
Measures to help overcome a lack of formal education could include provision of information related to the patient’s cancer and treatment via written, verbal and/or electronic media (tailoring the approach based on the patient’s access to and ability to understand these media).
When treatment requires travel to a clinic or other healthcare facility, transportation difficulties can have a significant negative impact on access to care. In a study of colon cancer patients, those who traveled 50 or more miles to receive adjuvant treatment were significantly less likely to receive that therapy, regardless of whether local oncologists were readily available.24 Similarly, researchers found that duration of treatment for breast cancer patients was significantly prolonged for patients with transportation issues, regardless of whether that treatment was surgery plus chemotherapy, surgery plus radiation therapy or all three.18 (p 4962)
Limitations due to age and health, as well as lack of access to public or private transportation, can be impediments to travel. The demise of rural treatment centers, necessitating long commutes for treatment, also contributes to the difficulty of accessing cancer care for many.
Obvious ways of addressing transportation-related issues include eliminating the need to travel or making travel easier.
In addition to the growing number of oral cancer medications, the availability of injectable products that can be self-administered subcutaneously has made treatment at home more feasible. This eliminates the need for a patient with reduced mobility to try to walk short distances, transport walkers or canes, or submit to cumbersome transfers to and from wheelchairs for every treatment.
For those who do need to make clinic visits, app-based ride services are stepping to the plate. Health systems have been collaborating with services such as Uber and Lyft to provide rides that are easy to arrange and can be billed directly to the facility.
Medication adherence is the extent to which a patient’s behavior (e.g., taking medications correctly with respect to timing, dosage, and frequency) corresponds with agreed-upon recommendations from a health-care provider. Studies have evaluated the impact of regimen adherence on response to therapy. One such study, for example, found that there is a strong correlation between adherence and response: among patients taking Imatinib for chronic myeloid leukemia, those with less than 91% adherence had a lower response rate than those whose adherence rate was 91% or greater–a statistically significant difference.25 Clearly, there is a need to optimize medication adherence.
Barriers to adherence include the following:
Anyone receiving drug therapy for cancer will, at some point, be concerned about side effects. These concerns are not unfounded, since traditional chemotherapy drugs are intended to kill human cells. The difference between their effective dose and the dose at which they can cause serious side effects is generally quite small. Unfortunately, effectiveness and toxicity both tend to increase with increasing dose, so these drugs are often given at doses as high as patients can tolerate. If these factors do not cause patients’ oncologists to discontinue therapy, they may be troublesome enough that the patients simply stop taking them.
There is good news, however. Since chemotherapy started gaining traction in the 1950s and 1960s, treatments for side effects have steadily improved; and experience has taught health care professionals the timing, dose and route of administration that works best for most patients. Recently, the FDA launched a website, Project Patient Voice, that is specifically designed to document patient-reported symptom data from cancer treatments that are already approved.26 This is something that has not been well-reported in the past, and having this information will improve the ability to predict and prepare for side effects.
In addition, tests are now available for many cancer types that allow doctors to know with much higher accuracy which drugs are likely to be effective—and ineffective. This testing can reduce use of therapy that is ineffective, reducing the overall number and duration of treatments and therefore reducing side effects.
Even better is the advent of a new type of anti-cancer drugs, known as “biologics”. These products are highly effective at limiting effects to just cancer cells. Although they have their own set of side effects, they tend to have fewer, less serious side effects than traditional chemotherapy.
Cognitive factors that can impact adherence include the patient’s understanding of directions for use and goal of therapy, their ability to remember to take doses, and their motivation to adhere to therapy
It has been shown that clinical pharmacy services which include regimen simplification can improve adherence and outcomes.27 And educational counseling by a nurse or pharmacist has been shown to improve adherence as well. A study evaluating medication therapy management services to elderly cancer patients showed a statistically significant improvement in satisfaction with their treatment—including their understanding of their goals of therapy and medication use (based on a 5-question before-and-after survey) compared to baseline. Educational and informational services for caregivers, as well as the availability of written materials, will provide resources for the patient to reinforce their understanding.28
Physical reminders and accountability measures will enhance adherence as well. One genre of tools, electronic applications, was the subject of a recent survey. This survey revealed that patients value the inclusion of educational and behavioral interventions in adherence apps.29 Other tried and true measures are daily pill boxes, pill counts by a third party, and dose tracking and reporting such as use of a medication diary. Digital medicines, where a cancer drug is taken orally in a capsule with a sensor, can also support tracking of doses taken and dose reminders through an associated mobile application.30
Payer role in breaking down barriers
Payers can break down barriers to cancer treatment access and adherence by working with their medical and pharmacy benefit managers to help ensure that:
- Coverage restrictions do not inappropriately limit selection of drug route of administration, dispensing channel or administration setting.
- Coverage criteria for cancer drugs and related genetic tests keep pace with medical advances. Coverage should not be provided solely for FDA-approved indications; rather, consensus guidelines such as those promulgated by National Comprehensive Cancer Network (NCCN) or the American Society for Clinical Oncology (ASCO) should be used to determine what uses are medically accepted.
- Medication adherence is optimized through deployment of programs such as those sponsored by PBMs, health plans, pharmaceutical manufacturers, etc.
- Members are introduced as appropriate to drug company-sponsored patient assistance programs, both those that offer financial aid as well as those that provide support for patients’ emotional and drug procurement/administration needs (the client may need to opt in to a PBM program to leverage these).
- Relative cost between care settings (including both drug cost and administration charges) is understood by:
- Plan case managers and member customer service team members, to assist in decision-making about care setting; and
- Plan administrators, so that coverage of individual drugs may be limited to pharmacy or medical benefit as appropriate
- A team approach is used in treating cancer patients, including side effect mitigation, emotional and social support and education about their disease and treatment.
- Providers promote general health literacy and offer culturally sensitive treatment environments.
When a cancer patient’s treatment regimen is not followed, their cancer is more likely to progress and get worse or recur. And while cancer treatment is often expensive and/or unpleasant, an actively growing cancer is even less desirable from both perspectives.
Breaking down treatment, access and adherence barriers can go a long way in reducing financial, physical, and emotional toxicity of cancer treatment. While healthcare providers are at the front lines for removing barriers to cancer care, payers, medical benefit administrators and pharmacy benefit managers can also make a positive impact.
- Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin 2021; 71, 7-33.
- De Souza JA, Yap BJ, Wroblewski K, et. al. Measuring financial toxicity as a clinically relevant patient‐reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer 2016; 123(3), 476-484.
- DeJesus M, Miller E. Examining Breast Cancer Screening Barriers Among Central American and Mexican Immigrant Women: Fatalistic Beliefs or Structural Factors? Health Care for Women International 2015; 36: 593-607.
- Kawar L. Barriers to Breast Cancer Screening Participation Among Jordanian and Palestinian American Women. European Journal of Oncology Nursing 2013; 17(1): 88-94.
- Fitzgerald K. Socioeconomic Status Impacts Receipt of Guideline-directed Cancer Care. Report on Disparities by race, socioeconomic status, and insurance type in the receipt of NCCN guideline concordant care for select cancer types in California, Abstract 7031. Presented during 2020 ASCO Virtual Scientific Program, May 29-31, 2020. Authors: Clair K, Change J, Ziogas A et. al.
- Fitzgerald K. Insurance Type Impacts Cancer Stage at Diagnosis and Survival. Report on Health insurance status and cancer stage at diagnosis and survival in the United States, Abstract 7026. Presented during 2020 ASCO Virtual Scientific Program, May 29-31, 2020. Authors: Zhao J, Han X, Nogueira L et. al.
- Fitzgerald K. Study Links Affordable Care Act Medicaid Expansion to Improved Cancer Mortality Outcomes. Report on Changes in cancer mortality rates after the adoption of the Affordable Care Act, Abstract 2003. Presented during 2020 ASCO Virtual Scientific Program, May 29-31, 2020. Authors: Lee A, Shah K, Chino JP et. al.
- Dusetzina SB, Winn AN, Abel GA et. al. Cost sharing and adherence to tyrosine kinase inhibitors for patients with chronic myeloid leukemia. J Clin Oncol 2013; 32:306-311.
- Fein AJ. Copay accumulator update: Widespread adoption as manufacturers and maximizers limit patient impact. Drugchannels.net. Accessed January 25, 2021. https://www.drugchannels.net/2018/09/copay-accumulator-update-widespread.html
- GAO.gov. Accessed January 27, 2021. https://www.gao.gov/assets/680/678690.pdf.
- CMS.gov. Accessed January 27, 2021. https://www.cms.gov/files/document/final-2021-hhs-notice-benefit-and-payment-parameters-fact-sheet.pdf.
- Andrews M. With Federal Nod, Consumers Could Lose the Boost They Get from Drug “Coupons”. Kaiser Health News, April 16, 2020.
- Hayes J, Hoverman J, Brow M, et. al. Cost Differential by Site of Service for Cancer Patients Receiving Chemotherapy. Am J Manag Care 2015; 21(3): e189-e196.
- Kalidindi Y, Jung J, Feldman R. Differences in Spending on Provider-Administered Chemotherapy by Site of Care in Medicare. Am J Manag Care 2018; 24(7): 328-333.
- New program in Ohio accepting oral cancer drug donations. Associated Press. Published February 4, 2020. Accessed January 25, 2021. https://apnews.com/article/828502f369ed6b1f8048d6d73b4f81d
- Fitzgerald K. Reducing Financial Toxicity for Patients with Cancer Improves Quality of Life. Report on Financial Toxicity Intervention Improves Quality of Life in Hematologic Malignancy patients, Abstract 430. Presented during the 62nd American Society of Hematology Annual Meeting & Exposition, Dec 2-11, 202. Authors: Knight TG, Ahguiar M, Robinson M et. al.
- De Moor J, Virgo K, Li C, et. al. Access to Cancer Care and General Medical Care Services Among Cancer Survivors in the United States: An Analysis of 2011 Medical Expenditure Panel Survey Data. Public Health Reports 2016; 131 (6): 783-790.
- Emerson MA, Golightly YM, Aiello AE et. al. Breast cancer treatment delays by socioeconomic and health care access latent classes in Black and White women. Cancer 2020; 126 (22): 4957-4966.
- Wu T, Hsieh H, West BT. Demographics and perceptions of barriers toward breast cancer screening among Asian-American women. Women & Health, 2008; 48(3): 261-281.
- McPhee SJ, Ha N, Bird JA et. al. Barriers to breast and cervical cancer screening among Vietnamese-American Women. Am J Prev Med 1997; 13:205-13.
- Itty T, Hodge F, Martinez F. Shared and Unshared Barriers to Cancer Symptom Management Among Urban and Rural American Indians. The Journal of Rural Health 2014; 30:206-213.
- Daher M. Cultural Beliefs and Values in Cancer Patients. Annal Oncol 2012; 23(suppl 3): iii66-iii69.
- Lagnado L. In Some Cultures, Cancer Stirs Shame. The Wall Street Journal. October 4-5, 2008.
- Lin C, Bruinooge S, Kirkwood M, et. al. Association Between Geographic Access to Cancer Care, Insurance, and Receipt of Chemotherapy: Geographic Distribution of Oncologists and Travel Distance. J Clin Oncol 2015; 33: 3177-3185.
- Marin D, Bazeos A, Mahon F, Eliasson L, Milojkovic D, Bua M, et. al. Adherence is the Critical Factor for Achieving Molecular Responses in Patients with Chronic Myeloid Leukemia Who Achieve Complete Cytogenetic Responses on Imatinib. J Clin Oncol 2010; 28:2381-2388.
- Office of the Commissioner. Project Patient Voice. Fda.gov. Published September 11, 2020. Accessed January 25, 2021. https://www.fda.gov/about-fda/oncology-center-excellence/project-patient-voice
- Kavookjian J, Wittayanukorn S. Interventions for Adherence with Oral Chemotherapy in Hematological Malignancies: A Systematic Review. Research in Social and Administrative Pharmacy 2015; 11: 303-314.
- Yeoh T, Si P, Chew L. The Impact of Medication Therapy Management in Older Oncology Patients. Support Care Cancer 2013; 21:1287-1293.
- Ali E, Leow J, Chew L, Yap K. Patients’ Perception of App-based Educational and Behavioral Interventions for Enhancing Oral Anticancer Medication Adherence. J Canc Educ 2017; published online 14 July 2017.
- New breakthrough brings digital medicines to cancer care. Mhealth.org. Accessed January 28, 2021. https://www.mhealth.org/blog/2019/jan-2019/new-breakthrough-brings-digital-medicine-technology-to-cancer-care