Real-World Experience with Taiho Oncology Patient Support for Lonsurf® (trifluridine and tipiracil)

Lisa A. Raedler, PhD, RPh

Patient Assistance Profiler December 2016 - Patient Support & Resources


Shifting the Cost Burden for Patients with Cancer

As the costs associated with cancer care continue to escalate, all key stakeholders—healthcare providers, private and government payers, and patients—strive to balance high-quality cancer care with cost efficiency. As insurance benefit designs continue to shift the cost burden of treatment, more patients with cancer and their families are both psychologically and financially invested in treatment decisions.

Market demand for affordable healthcare benefits has increased dramatically in the United States, in part due to passage of the Affordable Care Act in 2010. To meet the demand, many private payers offer and many employers prefer high-deductible health plans (HDHPs).1 However, these benefit designs have led to increased out-of-pocket costs for patients. A survey conducted by The Henry J. Kaiser Family Foundation among US employers from January to June 2015 shows that deductibles have increased 67% since 2010.2 Nearly one-quarter of workers are enrolled in an HDHP compared with 4% in 2006.2 Almost half of employees pay an annual deductible of $1000 or more per individual.2 Like high prescription drug copays, HDHPs are expected to become more commonplace in the near term until alternative benefit designs, such as value-based insurance design plans, are refined.1

Although future health plan designs may be more effective at minimizing unnecessary care while promoting appropriate preventive care,1 patients with cancer and other chronic conditions are likely to continue to assume a larger portion of healthcare costs. Thus, patients with cancer are not only required to navigate their disease from psychological and logistical perspectives, which is a sufficiently daunting task, they must also navigate complex aspects of insurance coverage and drug access. Is their treatment covered? Are they eligible for Medicare, Medicaid, or other supplemental insurance? Is copay assistance available under their pharmacy benefit? Do they qualify for drug manufacturers’ patient assistance programs? Are resources available to help with other cancer-related costs, such as travel? For patients and caregivers, as well as their cancer care providers, centralized sources of comprehensive information and support are critically valuable in order to answer these questions accurately and efficiently.

Unique Challenges for Patients with Advanced Colorectal Cancer

The prevalence and burden of colorectal cancer (CRC) are substantial. In the United States, CRC is the second leading cause of cancer death when data for men and women are combined.3 The American Cancer Society has estimated that, in 2016, approximately 134,500 Americans will be diagnosed with CRC and about 49,200 people will die of the disease.3

Improvements in both CRC screening and treatment have favorably affected outcomes associated with CRC, such that death rates have declined significantly over the past 20 years.3 Five-year survival for patients with stage I disease exceeds 90%.4 As with many other tumor types, CRC treatment and management can be costly.5 Of the more than $124 billion spent on cancer care in 2010 in the United States, CRC represented $14 billion or 11%.5 By 2020, costs associated with CRC among individuals aged 65 years and older are expected to increase by more than 50%.6

Systemic treatment options for patients with metastatic CRC that is not amenable to surgical resection or radiation include both cytotoxic and adjunctive targeted therapies. In the context of metastatic CRC, combinations of chemotherapy agents (ie, FOLFIRI: leuco­vorin, 5-fluorouracil [5-FU], irinotecan; FOLFOXIRI: leucovorin, 5-FU, oxaliplatin, irinotecan; FOLFOX: leucovorin, 5-FU, oxaliplatin; CapeOx: capecitabine, oxaliplatin) with or without targeted agents, such as bevacizumab and panitumumab, are all recommended initial treatment options for patients appropriate for intensive therapy.7 Later-line treatment options approved by the US Food and Drug Administration (FDA) for relapsed CRC include Lonsurf (trifluridine and tipiracil), Stivarga (regorafenib), and Zaltrap (ziv-aflibercept).7

Most treatments for metastatic CRC are administered via intravenous infusion. Unlike injectable chemotherapy, which is typically covered under private payers’ medical benefits and Medicare Part B, oral cancer treatments are usually covered by private payers’ pharmacy benefits and Medicare Part D. For patients, this often means a higher out-of-pocket financial liability for oral medications relative to infused drugs. To facilitate drug access, pharmaceutical manufacturers of oral medications approved for use in cancer routinely offer comprehensive support services through patient assistance programs.

Taiho Oncology Patient Support for Patients with Metastatic CRC

Taiho Oncology Patient Support is an example of a comprehensive patient and provider program developed by a pharmaceutical manufacturer to simplify the process of obtaining drug access for patients with cancer. The program was designed by healthcare professionals (HCPs) at Taiho Oncology to help patients with metastatic CRC and their care providers navigate drug access. Its goal is to quickly investigate each patient’s coverage for Lonsurf, regardless of insurance status, and help patients access the treatment that their physician has prescribed.8 Introduced in September 2015, Taiho Oncology Patient Support is a “one-stop, comprehensive, and fully integrated” patient assistance program.9

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co, Ltd, is a specialty pharmaceutical firm focused on oncology, allergies and immunology, and urology. In the field of oncology, Taiho Oncology is a leader in developing innovative medicines. In other therapeutic areas, the company creates quality products that effectively treat medical conditions and enhance people’s quality of life. Taiho’s oral oncology pipeline consists of both novel antimetabolic agents and selective targeted agents.10

On September 22, 2015, the FDA approved Lonsurf, an oral agent, for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF biological therapy; and, if RAS wild-type, an anti-EGFR therapy.11,12

The approval of Lonsurf for patients with metastatic CRC was based on the results of a randomized, placebo-controlled, double-blind, multinational, phase 3 trial known as RECOURSE.10 This study compared the efficacy and safety of Lonsurf plus best supportive care (BSC) with placebo plus BSC in 800 patients whose metastatic CRC was refractory to antitumor therapy or who had experienced clinically significant adverse events that precluded readministration of those therapies.12,13

In the RECOURSE trial, Lonsurf resulted in a statistically significant 1.8-month improvement in median overall survival compared with placebo and BSC (hazard ratio = 0.68 [95% confidence interval, 0.58 – 0.81]; P <0.001).12,13 The oral combination agent was associated with few serious adverse events.13

To facilitate drug access and reimbursement, enrollment in Taiho Oncology Patient Support is offered to eligible patients with metastatic CRC for whom Lonsurf has been prescribed. The comprehensive and customizable services that are included in the Taiho Oncology Patient Support program are summarized in Table 1.

Table

Spotlight on Practices with Taiho Oncology Patient Support Experience

John Theurer Cancer Center

Dedicated to the diagnosis, treatment, management, research, screenings, preventive care, and survivorship of patients with cancer, John Theurer Cancer Center (JTCC) is New Jersey’s largest and most comprehensive cancer center. Fourteen specialized divisions feature teams of medical, research, nursing, and support staff who provide advanced focused care for each patient. Located in Hackensack, NJ, JTCC is differentiated by comprehensive multidisciplinary care, state-of-the-art technology, and access to clinical trials.14

Patients with metastatic CRC obtain cancer care from medical oncologists and other HCPs affiliated with JTCC’s gastrointestinal (GI) cancer division. This program specializes in the evaluation, treatment, and comprehensive care of patients with GI tumors, including CRC, esophageal cancer, and liver cancer. The multidisciplinary team of specialists at JTCC includes medical oncologists, surgeons, pathologists, and radiation oncologists. JTCC physicians partner with oncology nurses, nurse navigators, pharmacists, advanced practice professionals, and administrative staff who support patients with services that address medical, physical, and emotional needs.14

Healthcare providers at JTCC work with the specialists of Taiho Oncology Patient Support to assist patients with metastatic CRC who are undergoing treatment with Lonsurf. Joanna P. Mohney, BSN, OCN, RN, Oncology Nurse Navigator in JTCC’s GI division, describes the Taiho Oncology Patient Support program as highly valuable for a large cancer center such as JTCC. “We use programs like these because they have experts who perform these [drug access] tasks day in and day out. They are a good resource for financial assistance and co-pay help for our patients. They coordinate with specialty pharmacies, which saves us time. Taiho personnel tell us what the patient can expect [financially] and how they can help in terms of assistance. They help us develop a financial plan for the patient.”

Texas Oncology

Texas Oncology (TxO) delivers high-quality cancer care with leading-edge technology and advanced treatments to help patients with cancer to achieve “More breakthroughs. More victories.®15 A pioneer in community-based cancer care, TxO is an independent network of oncology practices with sites of service throughout Texas and Oklahoma. TxO is affiliated with US Oncology, one of the nation’s largest community-based cancer treatment and research networks.15

Margaret Harville, RCPhT, manages a relatively new group within TxO Pharmacy Services, Inc, known as the Prior Authorization and Patient Assistance (Rx PA_PAS) team. This group of pharmacists, technicians, and financial counselors is focused on connecting patients to their oral oncology therapy, handling all pharmacies’ prior authorization and patient assistance needs. The team removes these burdens from nurses employed by TxO, freeing their time to focus on patients’ clinical needs. The Rx PA_PAS team also minimizes financial hurdles that patients face as they try to obtain treatments that have been prescribed. Ms Harville explained, “We solicit all available programs to help our patients access their prescribed therapy in a timely and seamless fashion, regardless of where their prescription is being filled. Our mail order and on-site pharmacies are hands-on with our patients. They utilize our team’s services because we are expeditious. We treat every patient as a member of our own family.”

Benefits of Taiho Oncology Patient Support for Providers and Patients

Ms Mohney and Ms Harville stated that virtually all patients who receive Lonsurf apply for enrollment in the Taiho Oncology Patient Support program. Ms Mohney explained, “We enroll all patients who are deemed to be candidates for Lonsurf into their support program. [Taiho Oncology Patient Support representatives] take on the enrollment, work through financial obstacles with payers, move the baton to the appropriate specialty pharmacy, and then follow up with the patient to learn about symptoms and compliance. They do all the legwork for you. Why reinvent the wheel when it’s already been done?”

Ms Harville agreed, “Our pharmacy team gets 1 or 2 referrals for Lonsurf patient assistance per week. I just spoke with a Taiho representative yesterday about an approval for patient assistance. We get to know them very well; we know each other by name….I think some nurses and administrators feel that they have to do a lot of follow-up with programs like these. In reality, the patient communicates with Taiho and the specialty pharmacy, which minimizes the need for nurses to be involved.”

In addition to financial and copay support, Ms Mohney highlighted the value of the personalized counseling and support that the nurses affiliated with Taiho Oncology Patient Support provide to patients with metastatic CRC and their caregivers (Table 2). “One of the key things that the Lonsurf [Taiho Oncology Patient Support] program offers is nursing support to patients. I receive faxes from a Taiho nurse in which she describes a given patient’s symptoms or tells me about issues that the patient is experiencing. This is important because I can then be on the lookout to determine whether this is a side effect of the drug or a disease-related problem. The Taiho nurses also share information about each patient’s timing of medication refills. That’s a unique feature of Lonsurf patient support compared with other assistance programs.”

Table

The Taiho Oncology Patient Support program benefits both patients with metastatic CRC and HCPs who care for them. Ms Mohney predicted that as healthcare and insurance models continue to evolve, a growing proportion of cancer patients will require help with access and copays. “We see many underinsured and uninsured patients, and Taiho Oncology does provide support to help them get the prescription for Lonsurf.”

Ms Harville and the Rx PA_PAS team believe that representatives from Taiho Oncology Patient Support add unique value by communicating directly with patients. “In general, the process of getting assistance applications together can be long, in part because patients do not complete the form fully or do not understand the questions. The Lonsurf program communicates directly with patients, more so than any other program. After obtaining permission, they contact the patient and confirm the information that they have received from us, the Rx PA_PAS team. We sometimes have conference calls with all parties—us [the Rx PA_PAS team member], the patient, and the Lonsurf representative—to ensure that patients understand this process and why they are sharing their financial and other information. That is unique to Lonsurf, and I appreciate it. It moves the application process along. And it puts more responsibility on patients, an approach that I have advocated for years.”

For oncology nurses associated with TxO, Ms Harville explained that Taiho Oncology Patient Support reduces worries about patients’ financial challenges. “Rather than the nurse having to track the patient assistance application and the insurance card, and the financial information, the patient works directly with Lonsurf for that. The patient sends information directly to Lonsurf. That does help relieve time for nursing. It allows nurses to focus on counseling and the disease, rather than paperwork. It really isn’t a nurse’s business what the patient’s income is. I think it’s important to keep this information separate.”

Both of these patient advocates touted the time-savings associated with use of the Taiho Oncology Patient Support program. According to Ms Mohney, “I would recommend the Taiho program to other providers. It alerts me on how the patient is feeling. Like other practices, we have several patients who do not tell us about symptoms that they are experiencing. With the Taiho program, I can see something on the fax and then call and ask the patient directly, which is a real benefit.” Ms Harville concurred, focusing on the time-savings that pharmacy staff, nurses, and practice administrators can achieve by working with Taiho Oncology Patient Support, “If you haven’t yet used the Taiho program, sit down, take 2 minutes to complete the Lonsurf application, fax it in, and let Lonsurf take the wheel. Let them drive the process.…The application is simple and straightforward, and most importantly, the representatives at Taiho completely relieve our nurses from pharmacy-related tasks, allowing them to focus on patient care.”

Conclusion

Although they are demonstrably effective and convenient, oral cancer treatments can also be expensive and difficult to access. Health insurers often require considerable medical documentation before allowing access to drugs, and many health plan designs feature multitiered drug formularies that require substantial cost-sharing by patients. Without support and copay supplementation, many people with cancer are unable to navigate these requirements and afford their medications. As Ms Mohney and Ms Harville have described, oncologists, oncology nurses, nurse navigators, pharmacists, pharmacy technicians, and office administrators play a critical role in facilitating access to these important medications, partnering with patients and the patient assistance programs of pharmaceutical firms. Taiho Oncology Patient Support is an example of a comprehensive and customizable program that streamlines these challenging and time-consuming steps, so that oncology professionals are better able to focus on optimizing patient care.




References

  1. Dolan R. High-deductible health plans. Robert Wood Johnson Foundation. Health Policy Brief. http://healthaffairs.org/healthpolicybriefs/brief_pdfs/healthpolicybrief_152.pdf. Published February 4, 2016. Accessed August 17, 2016.
  2. Henry J. Kaiser Family Foundation and Health Research and Educational Trust. Employer Health Benefits: 2015 Summary of Findings. http://files.kff.org/attachment/summary-of-findings-2015-employer-health-benefits-survey. Published September 2015. Accessed August 17, 2016.
  3. Key statistics about colorectal cancer. American Cancer Society website. www.cancer.org/cancer/colonandrectumcancer/detailedguide/colorectal-cancer-key-statistics. Revised January 20, 2016. Accessed August 17, 2016.
  4. What are the survival rates for colorectal cancer, by stage? American Cancer Society website. www.cancer.org/cancer/colonandrectumcancer/detailedguide/colorectal-cancer-survival-rates. Revised January 20, 2016. Accessed August 17, 2016.
  5. Mariotto AB, Yabroff KR, Shao Y, et al. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011;103(2):117-128.
  6. Yabroff KR, Mariotto AB, Feuer E, Brown ML. Projections of the costs associated with colorectal cancer care in the United States, 2000-2020. Health Econ. 2008;17(8):947-959.
  7. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Colon Cancer. Version 2.2016. www.nccn.org/ professionals/physician_gls/pdf/colon.pdf. Accessed August 17, 2016.
  8. Taiho Oncology Patient Support website. www.taihopatientsupport.com. Accessed August 17, 2016.
  9. Taiho Oncology. Taiho Oncology, Inc announces comprehensive access support program for LONSURF® (trifluridine and tipiracil) [press release]. www.taihooncology.com/us/newsroom/press-releases/2015-09-26-Taiho-Oncology-Inc-Announces-Comprehensive-Access-Support-Program-for-LONSURF; September 29, 2015. Accessed August 17, 2016.
  10. Taiho Oncology. Taiho Oncology, Inc announces FDA approval of LONSURF® (trifluridine and tipiracil) for refractory metastatic colorectal cancer (mCRC) [press release]. www.taihooncology.com/us/newsroom/press-releases/2015-09-22-Taiho-Oncology-Inc-Announces-FDA-Approval-of-LONSURF-for-Refractory-Metastatic-Colorectal-Cancer; September 22, 2015. Accessed August 18, 2016.
  11. US Food and Drug Administration. FDA approves new oral medication to treat patients with advanced colorectal cancer [press release]. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463650.htm; September 22, 2015. Accessed August 17, 2016.
  12. Lonsurf (trifluridine and tipiracil) tablets [prescribing information]. Princeton, NJ: Taiho Oncology, Inc; September 2015.
  13. Mayer RJ, Van Cutsem E, Falcone A, et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015;372(20):1909-1919.
  14. John Theurer Cancer Center website. www.jtcancercenter.org. Accessed August 18, 2016.
  15. Texas Oncology website. www.texasoncology.com. Accessed September 22, 2016.