Protecting Cancer Care: Improving Transparency and Patient Access
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Protecting Cancer Care: Improving Transparency and Patient Access A White Paper from the Oncology Therapy Access Physicians Working Group H istorically, cancer care has been protected from many of the insurance to instantly solve all of these problems, improvements in the areas of patient access and transparency are essential, issues that have beset other and thus these are good places to begin. diseases. The life threatening nature of cancer was IMPROVING PATIENT ACCESS TO recognized by physicians, CANCER TREATMENTS patients, and payers alike, The cost of cancer care in the United and the barriers to obtaining States exceeds $125 billion annually and payments from insurers CONTENTS is expected to increase nearly 40% by were minimal. Over the 2020.1 The escalating costs of treatment 1 Improving Patient past decade, however, this have been attributed to the aging Access to Cancer situation has changed. Policies population, increased diagnosis of cancer, Treatments dictated by insurers have and new state-of-the-art medications 2 Specialty Tiers begun to erode the protection targeted at specific molecules on cancer that formerly characterized 3 Prior cells.1 Many of these new medications coverage of cancer treatment. Authorization dramatically improve the treatment This trend is manifested by of cancer and it is often argued that 4 Coverage Parity reduced patient access to high solutions to the cost issues must also 5 Improving quality cancer care and a lack preserve the development of innovative Transparency of transparency regarding the therapies. in Cancer Care recommended treatments. In response to the demographic and 6 Transparency of As physicians, we are economic trends in cancer care, insurers Clinical Pathways committed to providing have devised a number of strategies the best care possible for 7 Conclusions designed to mitigate their costs. our patients. However, we Unfortunately, many of these policies face serious challenges in limit patient access to treatments from meeting this goal, including which they could benefit. Three of the the complex nature of cancer, main policies that must be amended involvement of multiple in order for patients to access cancer medical specialists, numerous therapies are (1) specialty tiers/high co- treatment options, a confusing pays, (2) prior authorizations, and (3) insurance system, and the parity of coverage not only for infusion inability of our patients to pay and oral therapies, but also for site of their sometimes outrageously care. Each of these policies is discussed high out-of-pocket expenses. in the following sections. Although it is not possible INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE OCTOBER 2014 1
of our patients cannot afford them— Patients Surviving At Least 5 Years After Being Diagnosed with or cannot do so without a significant Chronic Myeloid Leukemia financial hardship. For example, specialty tier medications cost $40,500-95,000 100% per patient per year4, and co-pays for 80% drugs on the specialty tier often range from 25% to 60% 33%.5 This means “I worry about the 40% that patients middle class. They who require a 20% make too much specialty tier drug 0% with an annual money to qualify Before Imatinib After Imatinib cost of $60,000 for pharmaceutical (1990-1992) (Today) company-sponsored would need to Sources: American Cancer Society, 20122 pay $15,000 assistance programs, and Druker et al, 20063 out of pocket but cannot afford the Specialty Tiers per year for cancer medications. Insurance plans typically incorporate their medication One of my patients several “tiers” that determine the level alone (based was a professional of patient cost sharing or the amount of on a typical whose cancer was medication cost that must be paid by 25% co-pay) in not improving with beneficiaries (i.e., co-pay). The lowest addition to their treatment. I just level of cost sharing, tier 1, usually other co-pays couldn’t figure out why. includes generic drugs. Tier 2, the next and deductibles After we lost him, I higher co-pay level, typically includes for office visits, preferred name-brand drugs, and tier found out that he had surgery, and 3 includes non-preferred, name-brand hospital care. This not taken his high-cost drugs. Tier 4, or the “specialty tier,” is an exorbitant medicine because he includes the more expensive drugs such amount of money didn’t want to bankrupt as those targeted toward specific types for most people. his family. It goes of cancer. without saying that such Further tragedies should not Typical Medication Tiers in complicating this Healthcare Benefit Plans scenario is the have to happen.” Tier 1 Generic drugs impact of cancer -Dr. Nadim Nimeh, MD on a person’s Tier 2 Preferred name brand drugs ability to work. Tier 3 Non-preferred name brand drugs Cancer and its Specialty Higher cost medications, treatment can Tier including many cancer therapies lead patients to The problem with this scheme is that quit or lose their co-insurance costs for the specialty tier jobs and hence drugs are typically so high that many their insurance, INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE OCTOBER 2014 2
which in turn can lead to insurmountable Clearly, specialty tiers that require high financial burdens, including bankruptcy.6 co-pays are unaffordable for most To help minimize the financial burden, patients. One potential solution is for many patients do not take their insurers to raise their co-pays on lower- medications as prescribed,7 which of tier (i.e., less expensive) drugs to offset course reduces or even negates the the costs of specialty tier medications. effectiveness of treatment. Other solutions are also possible, and it is imperative that stakeholders work Financial Distress Associated together to identify policies that With Cancer Treatment preserve the needs of insurers while • Cancer patients are 2.65 times more likely increasing patient access to specialty tier to go bankrupt than people without cancer therapies. cancer.6 • A random sample of people who filed for Prior Authorization bankruptcy in the US found that >60% filed because of medical bills—even though Another policy that limits patient ¾ had insurance at the time of their illness.8 access to cancer treatments is prior • In a study of 300 insured adults with authorization. Prior authorization is the cancer:7 approval of a therapy by insurers before - 16% reported high or overwhelming financial distress it is given to a patient. The concept of - 27% did not adhere to their medication pre-approval is not, in itself, a problem. regimen However, problems arise when insurers - 14% skipped doses to make the take a prolonged time to approve medication last longer therapies, particularly when they are - 11% took less medication than pre- scribed to make medication last longer urgently needed to help reduce cancer - 22% did not fill a prescription because growth or, in the case of supportive care of cost drugs such as hematopoietic growth factors, reduce the risk of serious Hundreds of advocacy groups have complications of treatment. Some states alleged that the high patient costs for have passed legislation that requires specially tier medications discriminate insurers to respond to prior authorization against those with cancer, multiple requests within 48 hours or the request is sclerosis, AIDS, and other chronic automatically approved.10,11 Moreover, due diseases—the ones who require specialty to variation in the forms physicians must tier medications.9 Under many insurance fill out for pre-approval, the legislation plans, these patients are required to requires that all prior authorization pay percentages rather than flat co- requests be standardized, with electronic pays and higher overall dollar amounts submissions allowed. These steps greatly for their medications than patients with improve the prior authorization system other diseases. This is true even for and should be implemented by all states. insurance plans sold through exchanges Prior authorization policies could be developed under the Affordable Care Act, further improved with several additional in which non-discrimination was a major common sense amendments. First, if provision.9 INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE OCTOBER 2014 3
insurers pre-authorize therapies, they was to increase patient access by making should pay for them. Pre-authorized needed medications available to more claims should not be up for re-review patients.11 There is general agreement after they have been approved and that this program is very effective when the patient has already received the applied as intended. therapy. Although this seems intuitive, If this program were misused by eligible it is not uncommon for insurers to deny institutions, however, it could have an pre-authorized claims after the fact. unforeseen consequence of contributing Moreover, if the drug is being used in to the closure of local community cancer line with its Prescribing Information as centers. These closures may prove approved by the US Food and Drug problematic in rural areas where patients Administration, physicians should be may have to drive many miles for care. able to treat patients prior to receiving Commuting to the city is difficult for pre-approval. patients with limited income and for Coverage Parity seniors, who may have trouble navigating Parity for Site of Service urban roadways and parking lots or Coverage parity refers to comparable must rely on family members or friends insurance coverage for comparable to drive them. Furthermore, seniors may services and medicines. Several parity feel more comfortable at local centers issues are at the forefront of cancer and may therefore be better able to care today, one of the most notable of explain their symptoms, which in turn which involves the site of cancer care. In will result in better care. Experts agree the United States, cancer treatment is that local cancer centers are in danger of available at various locations, including extinction, with a study by the American community clinics, hospitals affiliated Society of Clinical Oncology (ASCO) with universities, and private hospital finding that 63% of small oncology outpatient centers. practices were likely to merge, sell, or close operations in the coming year.13 Although it seems logical for insurers to provide comparable coverage for Infused Versus Oral Medications medicines and services at all of these Another notable parity issue in cancer locations, certain treatment sites tend is the preference that insurers give to to have a disproportionate number of medications (i.e., chemotherapies) that uninsured or underinsured patients— must be injected or infused over those often in populous inner city areas. In taken orally in the form of pills. Oral order to make it possible for physicians agents have a number of advantages and institutions to treat these patients, over injection and infusion therapies, federal programs such as 340B Drug such as being more convenient— Pricing Program were implemented. swallowing a pill is easier than traveling The 340B program mandates that to a treatment center for a prolonged drug manufacturers sell medicines to intravenous infusion and minimizes qualifying institutions at significantly disruptions in work and everyday life. reduced prices.12 The goal of this program Moreover, many of the recently approved, INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE OCTOBER 2014 4
state-of-the-art medications that target or not covered by their insurance, and molecules associated with cancer cells the out-of-pocket expenses for which are available only in oral formulations. they are responsible. Insurance-related However, traditional infusion therapies costs are typically hidden in verbose are preferred for some patients due policies that are difficult for patients to personal and cancer-specific to understand, and cancer centers considerations. studiously avoid publicizing the costs of their services and procedures. However, In many states, insurers still differ in patients want to know these costs and the extent to which they cover infusion to discuss them with their healthcare therapies and oral therapies for the providers, as indicated by a recent survey same types of cancer. For traditional of men with advanced prostate cancer.16 chemotherapy administered via infusion into the vein, patients must typically pay a set fee for the medication and its “Reducing price variation infusion.14 Annual out-of-pocket costs are for the 108 million Americans usually capped as part of the medical with employer sponsored benefit of the patient’s insurance plan. In contrast, oral agents to treat cancer insurance could save the are typically covered under patients’ nation as much as $36 billion pharmacy benefit plan, which requires per year.” them to pay a percentage of the drug’s cost—which can run into the tens of Thomson Reuters, 201217 thousands of dollars annually if the drug is classified by the pharmacy benefit In addition to the high costs of cancer plan as “specialty tier.” Moreover, there care, several other developments are is often no out-of-pocket limit for nudging the system toward greater these medications.14 transparency. These include patient access to electronic information and The good news is that 33 states and studies showing that healthcare costs the District of Columbia have now for the same procedure in the same passed laws requiring insurers to geographic area can vary by more than provide coverage parity for oral cancer 100%. Indeed, it has been estimated therapies.15 Extending these laws to that reducing price variation for insured the remaining states is a priority for individuals could save the US $36 improving patient access to cancer care. billion annually.17 To improve transparency, insurance plans IMPROVING TRANSPARENCY IN should include clear formulary lists and CANCER CARE provider networks. They should include Transparency of Costs, Coverage, the tiers and co-pays with real-world and Co-Pays examples of amounts that patients Cancer patients are frequently surprised would need to pay for some of the by the costs of care, the items covered most common diseases. The costs of INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE OCTOBER 2014 5
therapies, including diagnostics, imaging, • Initially, payments should be increased and medications, along with other fees, for practices using pathways; increases should be made apparent to patients. should be large enough to cover the cost and time of acquiring and implementing Transparency of Clinical Pathways pathways. Clinical pathways specify which • CMS should develop a certification process for care pathways. treatments patients should receive • After certified pathways have been and in which order. They are typically developed, practices should be expected developed by physicians working with to use and adhere to them, and payments should be reduced if pathways insurers who consider both available are not used. evidence and cost; in this way, clinical • Payers and providers should collaborate pathways can help reduce costs and to evaluate the effectiveness of pathways in improving patient outcomes and even improve cancer care.18 Many clinical controlling costs. pathways are well designed and accepted by physicians. Unfortunately, however, some do not rely as heavily on evidence Following the development of clinical and are designed based on cost of care cancer pathways, insurers typically instead of professional consensus. The offer financial incentives to physicians American Society of Clinical Oncology or physician practices for adhering to has outlined guiding principles for the them a certain percentage of the time. development and use of cancer care According to the US Oncology Network, pathways, as listed in the following table. this percentage is ideally about 80%— meaning that about 80% of patients are suitable for the pathways.20 This leaves ASCO Guiding Principles for the room for flexibility 20% of the time to Development and Use of Oncology Care Pathways19 accommodate patients with special circumstances. For instance, if the clinical • Pathways should be developed with the pathway specifies a treatment that can input of oncologists. cause severe skin reactions, patients with • Pathways should describe all aspects of cancer care, not just anti-cancer treatment. a history of such reactions may be better • Pathways should give appropriate suited to a different medication that consideration to costs of alternative provides comparable benefits but with approaches to care. less risk of skin reactions. • Oncology practices should be able to use the same pathways with all payers. Perhaps more disconcerting are the • Efficient methods of using pathways and of documenting and auditing adherence insurers who pay physicians for each to pathways should be developed. patient they keep on their pathways. For • 100% adherence to pathways is likely example, WellPoint, the second largest impossible and undesirable; deviations should be used to advance knowledge insurer in the US, pays oncologists $350 about appropriate care. per patient per month to remain on one • Standards for adherence to pathways of their clinical pathways.21 In this case, should be established in advance based there is a financial incentive for physicians on evidence and experience. continued to place each individual patient on a INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE OCTOBER 2014 6
pathway. If physicians deviate from to rein in their own costs, insurers may the pathway, which will certainly occur require exorbitant co-pays/co-insurance in selected cases, they will still get for state-of-the-art medications, reimbursed.22 However, the physician fail to respond to requests for prior will not receive $350 per month for authorization in a timely manner, and, those patients. unbeknownst to the patient, pay doctors to place them on a clinical pathway Moreover, clinical pathways can be designed to utilize treatments that different for each insurer, forcing combine efficacy with lower cost. physicians into a “treatment by insurance” routine where the treatment patients Part of the solution to the cost challenges receive varies by which insurance they may lie in greater transparency across the have.21 Many experts believe that it should entire healthcare system. When costs of be the practice or hospital that develops procedures and medications are readily the pathways and insurance companies accessible and insurance policies written that agree to abide by them rather than in an approachable manner, patients will the other way around. engage in informed healthcare choices. Regardless of which clinical pathway These issues are especially critical in is followed, however, patients have cancer given the serious nature of the a right to know what care is being disease. It is unfair for people who have recommended for them and what they paid their insurance premiums and/ are scheduled to receive—that is, the or Medicare payroll taxes for decades pathway and the financial incentives to be surprised by lack of adequate must be transparent. Although many coverage when they need help paying might decry the inability of patients to for a life-and-death illness. Policymakers understand such information, there is and citizens must work to protect clearly a trend toward greater patient patient access to cancer therapies by engagement in cancer care and a call promoting transparency and rectifying from the Institute of Medicine to provide patient unfriendly insurance practices information that patients can understand.1 such as specialty tiers, prolonged prior authorizations, and lack of equal CONCLUSIONS coverage for comparable services The cost of cancer care continues to rise, and treatments. compromising our patients’ ability to access needed therapies. In an attempt ONCOLOGY WORKING GROUP MEMBERS Robert Miller, M.D. Rachel Brem, M.D. Lucy Langer, M.D. David Charles, M.D. Alan Marks, M.D. Emily Chan, M.D. Nadim Nimeh, M.D. Please note that the views expressed in this document do not necessarily reflect those of the institutions with which the Working Group Members are affiliated. Join AfPA’s Oncology Therapy Access Physician Working Group Established in 2014, the Oncology Therapy Access Physicians Working Group is a home for oncologists interested in health policy issues relating to access to cancer therapies. Working Group members collaborate in development of educational resources such as white papers, policy briefs and videos to be utilized in encouraging informed policymaking, while ensuring the physician’s perspective is shared as policymakers consider how to balance access and costs. Physicians interested in joining the working group or participating in an upcoming meeting should contact AfPA at www.AllianceforPatientAccess.org or call 202-499-4114. INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE OCTOBER 2014 7
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Bill number SB 866 Amended in Senate supported by McKesson Specialty Health. Clinical April 11, 2011; Introduced by Senator Hernandez, February pathways: are we there yet? Commun Oncol. 2013;10:96-8. 18, 2011. An act to add Section 1367.241 to the Health and Safety Code, and to add Section 10123.191 to the Insurance 21. Mathews AW. Insurers Rush to Rein in Spending on Cancer Code, relating to health care coverage. Available at: http:// Care. The Wall Street Journal. May 27, 2014. Available at: www.leginfo.ca.gov/pub/11-12/bill/sen/sb_0851-0900/ http://online.wsj.com/articles/insurer-to-reward-cancer- sb_866_bill_20110411_amended_sen_v98.html. Accessed doctors-for-adhering-to-regimens-1401220033. Accessed June 23, 2014. June 23, 2014. 11. State of Vermont. 2013 Vermont Statutes Title 18 Health 22. American Journal of Managed Care. AJMC.com. AJMC Chapter 221 Health Care Administraiton § 9418b Prior panel asks: does it pay to use pathways? July 3, 2014. authorization. Available at: http://law.justia.com/codes/ Available at: http://www.ajmc.com/newsroom/AJMC- vermont/2013/title-18/chapter-221/section-9418b. Panel-Asks-Does-It-Pay-to-Use-Pathways- . Accessed Accessed June 23, 2014. August 27, 2014. This white paper is authored by the members of the Oncology Therapy Access Physicians Working Group and sponsored by the Institute for Patient Access. I f PA Institute for Patient Access www.InstituteforPatientAccess.org The Institute for Patient Access • 2000 M Street NW Suite 850 • Washington, DC 20036 The Oncology Therapy Access Physicians Working Group is a project of the Alliance for Patient Access. The working group is supported by educational donations from: Astellas Pharma US, Inc., Millennium Pharmaceuticals, Inc., Bristol-Myers Squibb and the Institute for Patient Access. INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE OCTOBER 2014 8
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