Understanding Adherence to Oral Cancer Therapy
Understanding Adherence to Oral Cancer Therapy
Multiple Myeloma | Cancer of the Bone Marrow Understanding Adherence 12650 Riverside Drive, Suite 206 North Hollywood, CA 91607 USA Telephone: 800-452-CURE (2873) (USA & Canada) 818-487-7455 (worldwide) Fax: 818-487-7454 [email protected] myeloma.org © 2015, International Myeloma Foundation, North Hollywood, California (u-adher_g3_15) to Oral Cancer Therapy A publication of the International Myeloma Foundation Improving Lives Finding the Cure® Improving Lives Finding the Cure® Table of Contents About the International Myeloma Foundation Founded in 1990, the International Myeloma Foundation (IMF) is the oldest and largest myeloma-specific charity in the world. With more than 350,000 members in 140 countries, the IMF serves myeloma patients, family members, and the medical community. The IMF provides a wide range of programs in the areas of Research, Education, Support, and Advocacy: RESEARCH The IMF is the leader in globally collaborative myeloma research. The IMF supports lab-based research and has awarded over 100 grants to top junior and senior researchers since 1995. In addition, the IMF brings together the world’s leading experts in the most successful and unique way through the International Myeloma Working Group (IMWG), which is publishing in prestigious medical journals, charting the course to a cure, mentoring the next generation of innovative investigators, and improving lives through better care. EDUCATION The IMF’s educational Patient & Family Seminars, Medical Center Workshops, and Regional Community Workshops are held around the world. These meetings provide up-to-date information presented by leading myeloma specialists and researchers directly to myeloma patients and their families. Our library of more than 100 publications, for patients and caregivers as well as for healthcare professionals, is updated annually and available free of charge. Publications are available in more than 20 languages. SUPPORT Our toll-free InfoLine at 800-452-CURE (2873) is staffed by coordinators who answer questions and provide support and information via phone and email to thousands of families each year. The IMF sustains a network of more than 150 support groups and offers training for the hundreds of dedicated patients, caregivers, and nurses who volunteer to lead these groups in their communities. ADVOCACY The IMF Advocacy program trains and supports concerned individuals to advocate on health issues that affect the myeloma community. Working both at the state and federal level, the IMF leads two coalitions to advocate for parity in insurance coverage. Thousands of IMF-trained advocates make a positive impact each year on issues critical to the myeloma community. Learn more about the way the IMF is helping to improve the quality of life of myeloma patients while working toward prevention and a cure. Contact us at 800-452- CURE (2873) or visit myeloma.org. Improving Lives Finding the Cure® Introduction 4 What is adherence? 4 What can lead to poor adherence? 5 The most common obstacles to adherence 6 Patient-to-patient variations in adherence 6 Myths about adherence 6 Strategies for achieving successful adherence 8 Available resources 9 Introduction Understanding Adherence to Oral Cancer Therapy is intended to help myeloma patients and their healthcare providers work together to overcome any and all obstacles to adherence to safe and effective oral cancer therapy. This booklet is designed chiefly to provide support to patients and caregivers, and thus is part of Step 4, Supportive Care, in the IMF’s 10 Steps to Better Care® platform. The IMF hopes that this booklet will help you to understand and then overcome potential obstacles to complying with your doctor’s treatment plan. The IMF is here not only to help find a cure for myeloma, but to help you live longer and better as a myeloma survivor. Call the IMF at 800-452-CURE (2873) in the US and Canada, or 818-487-7455 worldwide, or email us at [email protected] We are here to help you. What is adherence? “Adherence” to an oral therapy means that in order to achieve the best results: You take the correct medicine. You take the correct dose. You take your medication in the correct manner. You take your medication for the prescribed length of time. No doses are taken in the wrong quantity. No doses are taken at the wrong time. No doses are missed. No extra doses are taken. currently in clinical trials. Oral therapy now plays, and will continue to play, an important role in treating myeloma. Adhering to the doctor’s treatment plan – and seeking help for any possible problems that could cause deviation from that plan – are crucial to achieving the best possible treatment outcome. A major benefit of oral cancer therapy is that it is easier, faster, and more painless to swallow a pill than to have an intravenous infusion or an injection, the customary ways that chemotherapy has been administered. Another benefit of oral agents to treat cancer is their convenience, since they do not require a trip to the doctor’s office for each dose. Quality of life improves when patients have the flexibility to carry out their daily activities (whether on the job or at home) and plan travel without having to factor in visits to the clinic or doctor’s office at frequent intervals. Because myeloma is a chronic disease – one that cannot usually be cured but can be controlled over a long period of time – the best treatment model for many patients is ongoing, long-term therapy with an oral drug that gives them the ability to have good quality of life with more control over their time. Long-term followup on use of an oral therapy for myeloma for greater than 10 months indicated that In the case of myeloma, there are currently three US Food and Drug Association (FDA) approved treatments available to myeloma patients that are taken orally: Thalomid® (thalidomide), Revlimid® (lenalidomide), and Pomalyst® (pomalidomide). Several other oral therapies for myeloma are 4 800-452-CURE (2873) there was significantly improved overall survival (OS), especially when careful dose adjustment was done to prevent side effects. Despite its obvious benefits to patients, however, oral cancer therapy requires a shift in responsibilities that can be challenging. Whereas intravenous (IV) or subcutaneous (SQ) chemotherapy is administered and monitored by the healthcare team, oral chemotherapy requires that the patient (or caregiver, in some cases) assume these responsibilities. Patients and their caregivers must be up to the task of understanding and complying with the treatment plan, and finding help to remove obstacles that stand in the way of adherence. With oral cancer therapy, the success or failure of treatment can hinge on a patient’s ability to acquire a drug, take it according to the doctor’s orders, and communicate quickly and accurately with the healthcare team if any problems or side effects occur. What can lead to poor adherence? A number of issues pose obstacles for patients. Here are some common problems patients experience: D ifficulty getting to an appointment If a patient misses a doctor’s appointment, he or she may not get the needed prescription for that month, delaying access to treatment. L ack of adequate insurance Some patients have no insurance and others have inadequate coverage. These patients need help finding out how to initiate an application process with the assistance team of the pharmaceutical firm that makes the therapy, or a nonprofit foundation that subsidizes cancer therapy, to supply the drug at low or no cost. myeloma.org C omplicated insurance plans Some patients who do have health insurance coverage might have complicated insurance plans. It is important to find out if the insurer pays for the drug in part or in full, and if approval from the insurance company is necessary before starting therapy. N eed for co-pay or co-insurance assistance Many patients need co-pay or co-insurance assistance, and are not aware that non-profit foundations are available to help them. U ltimately, cost is still too high Many patients find that their share of the cost burden for treatment is still overwhelming, and they either “stretch” their treatment supply to last longer than the prescribed period, or forego treatments altogether. A number of adherence issues stem from poor communication between doctors and their patients. For example: T he patient might be too ill to focus on correct prescription therapy When discussing oral therapy at a doctor visit or when being discharged from the hospital, patients may be feeling ill or may be suffering from stress or from some level of cognitive impairment that is a barrier to understanding the treatment, the means of accessing it, and the schedule for taking it. T he patient might forget or intentionally skip doses Some patients who feel well and have good quality of life while on oral chemotherapy either forget to take their treatment or believe that they can skip days or go off treatment altogether without impairing their prognosis. Patients may not understand the nature of a chronic disease or the need for continuous therapy. 5 T he patient might not adhere to prescribed therapy due to side effects Some of those who may be experiencing side effects, or fear they will experience side effects of treatment, skip doses without consulting the doctor in the hope that the side effect will either not occur or improve. T he patient might be hesitant to discuss questions and concerns. Patients may be afraid to contact their doctors to clarify treatment issues or to complain of side effects because they don’t want to be perceived as troublesome. Others may have given up on communicating with an overburdened healthcare team that has a poor track record on returning calls. The most common obstacles to adherence Factors that are obstacles to adherence can be social, economic, disease-related, therapy-related, or related to problems in the healthcare system. A survey among the nurses of the IMF Nurse Leadership Board (NLB) ranked the top five barriers, in order of frequency, as 1) cost and income, 2) treatment complexity, 3) medication side effects, 4) difficulty in getting prescriptions filled, and 5) disease symptoms. A survey of 20,000 patients with chronic diseases published in the journal Health Expectancy in September 2010, listed 1) financial hardship, 2) side effects, 3) concerns about medications, and 4) lack of perceived need as the four key reason for non-adherence. Many patients need help and support in the following areas: Learning about resources that help patients access and pay for their treatments; 6 Receiving good instructions and follow- up support on taking their medications in the proper way, at the proper time; Having information at hand on what side effects to expect and when and how to reach the doctor or a nurse at the office, in the evening, and on a weekend or holiday; Having support at home and/or through a social worker or nurse to help manage treatment when a patient is feeling too ill to manage on their own. Patient-to-patient variations in adherence Not only are there variations in adherence between different patients, but individuals themselves may vary in adherence depending on where they are in the course of treatment and how they are feeling physically and emotionally at that time. Patients make and change decisions about their medications based on their beliefs about their treatment, disease, and prognosis. Myths about adherence Myth #1: Forgetfulness is the primary reason for poor adherence. Forgetfulness occurs randomly, causing occasional slips and lapses in taking medications, but long-term adherence involves a conscious decision-making process that each patient makes based on beliefs and experiences. Only 12% of the 20,000 patients in the Health Expectancy survey responded that problems remembering to take medication were an obstacle to longterm adherence. Myth #2: Healthcare providers satisfy patient medication information needs. Patients often complain that not enough information is provided to them about their oral prescription medications. 800-452-CURE (2873) Patients need and want information about the benefits as well as the side effects of treatment. Multiple studies have demonstrated that patients receive variable information on the purpose, frequency, timing, dose, and strength of their treatments, and poor information about side effects, risks, costs, efficacy, duration, and barriers to the use of their medications. Doctors may have limited time to discuss these issues or may believe that the information will “frighten” patients and make them less adherent. The facts indicate that patients want to be empowered with information, and that the better informed they are about their treatments, the more likely they are to discuss benefits and side effects with their healthcare providers, address problems early, and survive longer. Myth #3: Providers and patients routinely discuss adherence. Doctors mistakenly assume that their patients are adherent, but the majority of patients do not communicate with their doctors when they do not want to take a drug at all or decide to take it less frequently. Myth #5: Simplifying instructions/ regimens solves the problem of non-adherence. In fact, reviews show that simplifying regimens or using calendar/reminder packaging only marginally improves adherence to oral therapy. The real issue is how well the treatment fits in with the individual patient’s routine, expectations, and beliefs. Myth #6: Side effects automatically reduce adherence. A common misconception is that patients who suffer side effects of a particular treatment are those who are most likely to stop taking it. On the contrary, patients who suffer side effects and report those problems to the healthcare team are most likely to have adjustments made in the dose and/or schedule of their medications. Once the adjustments have been made and the most tolerable and effective dose has been established, these patients are most likely to adhere to, and benefit from, long-term therapy. Myth #4: There is a typical non-adherent patient type. Surprisingly, adherence to prescription medications has been proven to be unrelated to a patient’s level of self-care and lifestyle. Trained athletes such as swimmers and marathon runners, or those who religiously follow healthy diets and exercise routines, may not adhere to oral medication prescriptions, while those who are overweight, who regularly smoke and drink, and who rarely exercise may completely adhere to their oral therapy. myeloma.org 7 Strategies for achieving successful adherence What are the costs? Myeloma is a chronic illness which, for many patients, can be well-controlled in the long term with careful, continuous therapy. The keys to successful adherence are based in part on excellent communication between healthcare providers and their patients. Doctors, nurses, and patients can work together to overcome obstacles to adherence. Here are some suggestions that may be helpful: What is the timing? (i.e., in the morning? Talk to your healthcare team! How can uninsured patients access Bring a caregiver, spouse, or friend to your doctor visits. Make sure you understand why and how you should be taking your medication. Make sure you understand your insurance coverage, and any co-pay issues. Every member of the healthcare team should be able to discuss and answer the following questions: Key questions What is the dose? with meals? at bedtime?) What is the schedule? (i.e., every day? every other day? days 1-14?) What is the time to response? What is the duration of a particular treatment? Uninsured treatment through insurance assistance programs? Underinsured How can underinsured patients (those who cannot afford their co-payments) access treatment through co-pay assistance programs? Transportation needs Is there help for patients who need transportation or other assistance to get their medication? What are the benefits of therapy? Other resources What are the side effects? What other important resources are What are the potential side effects and how are they managed? available to patients, such as pharmacies, nutritionists, social workers, information specialists, and support groups? Safety aspects What are treatment safety recommendations, including which baseline and follow-up tests to use to monitor potential side effects such as fatigue, low white count, gastrointestinal problems, and blood clots? Rapid start to therapy How can patients receive their therapy as quickly as possible and enroll in any required safety programs as quickly as possible? 8 800-452-CURE (2873) It is critically important that healthcare providers and patients communicate with each other effectively. Doctors must be able to discuss all aspects of treatment thoroughly. In turn, patients and caregivers must be encouraged to discuss their fears, concerns, financial issues, and any other obstacles to adherence at the time a drug is prescribed and throughout treatment. Patients must rapidly and effectively describe any and all side effects to the healthcare team so that measures can be taken to ensure that they can continue therapy safely and effectively. A well-informed, proactive patient is best armed to overcome obstacles to successful and safe treatment. Patients must not be reluctant to tell their doctors that they have taken themselves off medication or regularly skip doses. Doctors can’t fix what they don’t know is broken. Patients who do not or cannot take the steps to access treatment, or decide not to take it for any reason, cannot expect to benefit from it. As former Surgeon General of the United States C. Everett Coop famously said, “Drugs don’t work in patients who don’t take them.” The IMF’s 10 Steps to Better Care, a stepby-step guide to your care from diagnosis through the latest clinical trials, is available on our website myeloma.org, complete with publications that can be viewed or downloaded. The IMF InfoLine team is here to help you with information about treatments, side effects, and the resources available to you as a patient or caregiver. We can be reached by calling 800-452-CURE (2873), toll-free in the US and Canada, or 818-487-7455 from other parts of the world, or by writing to us at [email protected] We are here to help, and we look forward to hearing from you. myeloma.org Available resources International Myeloma Foundation myeloma.org, 800-452-CURE (2873), publications, support groups (including an on-line group), InfoLine information specialists, advocacy for oral parity legislation (making sure that each state passes a law to ensure that oral cancer treatments are covered by insurance at the same level as injectable treatments) IMF Nurse Leadership Board (NLB) Guidelines Publications from the Clinical Journal of Oncology Nursing on Survivorship Care Plan for Multiple Myeloma, Side Effects Fact Sheets, Guidelines for Management of Side Effects of Novel Therapies, available at myeloma.org IMF International Myeloma Working Group (IMWG) Guidelines Capsule summaries of IMWG publications on a wide range of treatment- and side effect-related topic, available at myeloma.org American Cancer Society cancer.org, 800-227-2345, rides to treatment, lodging, patient navigator program Association of Cancer Online Resources acor.org, a network of online communities, including one for myeloma CancerCare cancercare.org, 800-813-4673, individual counseling, patient education, insurance information, financial assistance, transportation assistance Cancer Legal Resource Center 866-843-2572, legal information and resources for cancer patients Cancer Support Community cancersupportcommunity.org (merger of The Wellness Community and Gilda’s Club), provides support helpline, emotional support, referral to counseling, online support, distress screening, 9 referrals to local Cancer Support Communities around the US and among international affiliates Celgene Patient Support celgene.com/patient-support, 800-931-8691 Center for Medicare Advocacy medicareadvocacy.org, helps older adults with Medicare and health insurance choices Chronic Disease Fund cdfund.org, 877-968-7233, financial assistance for oral myeloma treatments Clinical Trials clinicaltrials.gov, the most comprehensive search program for clinical trials around the globe, provided by the National Cancer Institute (NCI); clinical trials provide experimental drugs at no cost to patients Diplomat Specialty Pharmacy diplomatpharmacy.com, 877-977-9118, the nation’s largest privately owned specialty pharmacy, they help patients with chronic and serious diseases, including myeloma, to quickly and seamlessly access their prescription medications; also help patients who are in need of copay assistance by working with foundations to secure funding for them Leukemia & Lymphoma Society Co-Pay Assistance Program lls.org, 877-557-2672 Meals to Heal meals-to-heal.com, registered oncology dietician, referrals to nutrition professionals, nutrition information, nutritious meals customized and delivered to cancer patients Medicare Consumer Guide medicareconsumerguide.com, unbiased educational materials pertaining to Medicare and related insurance programs Millennium Pharmaceuticals millennium.com, 866-835-2233, Velcade Reimbursement Assistance Program can help with understanding health insurance, Medicare, and Medicaid My Medicare Matters mymedicarematters.org, sponsored by the National Council on the Aging, helps Medicare enrollees choose a Part D prescription program Needy Meds 978-865-4115, financial assistance, insurance information Onyx 360 onyx.com, 855-669-9360, a comprehensive patient and caregiver support and services program Partnership for Prescription Assistance pparx.org, 888-477-2669 Patient Access Network Foundation (PANF) 866-316-7263, financial assistance Patient Advocate Foundation Co-Pay Relief copays.org, 866-512-3861 Patient Services, Inc. (PSI) patientservicesinc.org, bone disease from myeloma is included in the list of areas covered for co-pay assistance R x Assist Patient Assistance Program rxassist.org, list of free drug programs for patients in need that is run by pharmaceutical companies State Health Insurance Assistance Programs (SHIP) 800-633-4227, resource for health insurance questions, particularly Medicare and Medicaid The printing of this patient education booklet was supported by a grant from Celgene Corporation. 10 800-452-CURE (2873) 10 STEPS TO BETTER CARE® A UNIQUE TOOL FOR DIAGNOSTIC AND TREATMENT INFORMATION One of the most daunting aspects of being diagnosed with multiple myeloma (MM) is learning about – and understanding – an unfamiliar disease that is quite complicated. From diagnosis to long-term survival, the 10 Steps to Better Care® will guide you through the MM journey: 1. Know what you’re dealing with. Get the correct diagnosis. 2. Tests you really need. 3. Initial treatment options. 4. Supportive care and how to get it. 5. Transplant: Do you need one? 6. Response Assessment: Is treatment working? 7. Consolidation and/or maintenance. 8. Keeping Track of the Myeloma: Monitoring without mystery. 9. Relapse: Do you need a change in treatment? 10. New Trials: How to find them. Visit 10steps.myeloma.org to gain a better understanding of the disease and diagnosis, and proceed through the steps to learn the best tests, treatments, supportive care, and clinical trials currently available. As always, the International Myeloma Foundation (IMF) urges you to discuss all medical issues thoroughly with your doctor. The IMF is here to equip you with the tools to understand and better manage your MM. Visit the IMF website myeloma.org or call the IMF InfoLine at 800-452-CURE (2873), which is staffed by trained information specialists, with your questions or concerns. The IMF is here to help.