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Navigating the Quagmire of Immunosuppressant Drug Coverage and Affordability in the United States


Laura Lourenço Jenkins, PharmD
Laura.Lourenco@uchospitals.edu

Lisa Potter, PharmD, BCPS, FAST, FCCP
Lisa.Potter@uchospitals.edu
University of Chicago Medicine
Chicago, IL, USA



The Quagmire

Immunosuppressive medications are essential for the prevention of organ transplant rejection. Transplant recipients occasionally encounter barriers in obtaining appropriate insurance coverage. Additionally, even with appropriate insurance that includes coverage for medications, high or unaffordable copays can prevent patients from obtaining their lifesaving medications.

Initial concerns were addressed in 1985 by the Task Force on Organ Transplantation following the approval of cyclosporine in 1983 [1,2]. Subsequently, between 1986 and 2000, changes were made in Medicare coverage and reimbursement policies to enhance access to these life-sustaining therapies [3-8]. Those changes led to immunosuppressive coverage under the Medicare Part B benefit. In 2006, Medicare expanded coverage to include prescription drugs through the Medicare Part D program. Despite these changes in legislation, and regardless of whether a patient carries Medicare or some other type of insurance, many patients remain unable to afford their immunosuppressive medications. Missing these medications can lead to premature and avoidable graft loss [1,2,6,7,9-12].

In 2010, the American Society of Transplantation, in cooperation with the United Network for Organ Sharing (UNOS) and the North American Pediatric Renal Trials and Collaborative Studies, undertook a survey of adult and pediatric transplant centers in an effort to establish the scope and magnitude of immunosuppressive medication cost-related non-adherence [13]. Over 83% of transplant programs reported that patients frequently contact them with concerns about the high cost of their immunosuppressive medications. In fact, 43% of all programs report that more than 10% of their patients are not taking their immunosuppressive drugs as prescribed because of difficulties associated with their ability to pay for them. This nonadherence can have devastating consequences, with 68% of the participating centers reporting deaths and graft losses directly attributable to cost-related immunosuppressive medication nonadherence. As such, it is imperative that we as a multidisciplinary team are equipped to assist our patient population navigate their insurance benefit as well as overcome the variety of financial obstacles that may present post-transplant.

Tips for Securing Drug Coverage

In the United States, insurance coverage may come via private plans provided by employers, private plans that individuals purchase through national exchanges or on their own, public plans for those with low incomes (i.e. Medicaid), or public plans for those who meet certain conditions (i.e. Medicare). All plans use strategies such as provider networks, medication formularies, prior authorization requirements, quantity limits, step therapy, and restricted pharmacy dispensing to control costs. An important part of a transplant evaluation, as well as long-term transplant management, is ensuring patients carry adequate coverage, ensuring they understand how to use their coverage, and helping them navigate plan restrictions.

One current and alarming problem centers around immunosuppressant drug coverage under Medicare Part D plans. Affected transplant recipients are any who received their transplant while covered by insurance other than Medicare, then later become eligible for Medicare. As currently written, the Medicare Part D regulations do not obligate plans to cover any medication unless it is used per FDA-approved labeling or for indications deemed appropriate by the Centers for Medicare and Medicaid Services (CMS)-approved compendia (AHFS-DI® or Drugdex®). Beginning in 2016, some Medicare D plans have begun applying this option and have denied immunosuppressant drug coverage for lung transplant recipients, or everolimus/sirolimus coverage for heart transplant recipients. These denials are allowed, since use is off label and not supported by the compendia, and thus they are upheld through multiple levels of appeal. To address this concern, members of the transplant community are proposing revisions to the CMS-approved compendia, as well as lobbying Congress to enact legislation requiring Part D plans to consider peer reviewed literature when making decisions regarding coverage of off label immunosuppression.

Tips for Overcoming Financial Hurdles

When gaps exist between cost and coverage there remains a variety of resources available for transplant centers to offer those who require assistance. A few grants and foundations exist as a resource to patients with insurance that are experiencing coverage gaps, high premiums, and/or high co-payments (see Table 1.). These funds exist through donations and strict criteria may apply. Additionally, programs may close when insufficient funds are available. Manufacturer assistance programs are available to bridge these gaps but have a variety of eligibility requirements (see Table 2). Voucher or sample programs, where available, offer a free short-term supply to serve as a bridge to longer-term assistance. Longer-term assistance may include co-pay cards, which can often be applied retroactively 120 days. These copay card programs exclude patients with publicly funded insurance programs, exclude Massachusetts residents, and require renewal over time. Other forms of long-term assistance include the aforementioned grants, foundations, and manufacturer assistance.

Table 1. Grants and Foundations:

American Transplant Foundation

Healthwell Foundation

Patient Acces Network Foundation

Eligibility Requirements

Insurance

Required

Required

Required

Household Income

Reviewed

Up to 500% Poverty Level

Up to 500% Poverty Level

Sample Funds

Premiums, copays

Maximum Grant: $400

Cystic Fibrosis

Maximum Grant: $15,000 for copays

Gout

Maxiumum Grant: $12,000 for copays or premiums

Heart Failure

Maximum Grant: $1,500 for copays

Hepatitis C

Maximum Grant: $30,000 for copays

Maximum Grant: $15,000 for copays

Hyperkalemia

Maximum Grant: $4,000 for copays

Pediatric Assistance

Maximum Grant: $5,000 for copays

Decision Timeframe

1 week

Immediate - 72 hours

Immediate - 72 hours

Disbursement

Vendor

Pharmacy Card or Patient Reimbursement

Pharmacy Card or Patient Reimbursement

Link to Program

American Transplant Foundation

Healthwell Foundation

Patient Access Network Foundation

As of August 19, 2016



Table 2. Manufacturer Patient Assistance:

Manufacturer

Copay Cards

Patient Assistance Program

30-Day Voucher

Link to Program

Astellas

Prograf, Astagraf XL

Prograf, Astagraf XL

AstagrafXL

Astellas

Veloxis

Envarsus XR

Envarsus XR

Envarsus XR

Veloxis

Genentech

Valcyte, Cellcept

Valcyte, Cellcept

No voucher; Valcyte samples

Genentech

Novartis

Myfortic, Neoral, Sandimmune, Zortress

Myfortic, Neoral, Zortress

Myfortic, Neoral, Zortress

Novartis

Pfizer

Rapamune

Rapamune

None

Pfizer

Bristol-Myers Squibb

Belatacept

Belatacept

None

Bristol-Myers Squibb


Additional resources are available to aid in identifying potential assistance programs for patients in need. These include: RxOutreach, NeedyMeds, RxAssist Patient Assistance, Sav-Rx Prescription Services, the Partnership for Prescription Assistance, RxHope, GoodRx, and more. The multidisciplinary transplant team must collaborate in order to optimize each patient's access to coverage through his or her prescription benefit program, identify resources for coordinators, social workers, and other transplant staff, facilitate patient assistance applications, and work with outpatient pharmacies to utilize vouchers and co-pay programs. The transplant pharmacist might be the most appropriate team member to determine when a formulary alternative is reasonable, frame prior authorization arguments, and triage medication access problems. Collaboration of all members of the interdisciplinary team is essential to ensure the coverage and affordability of these life-sustaining therapies. ■

Disclosure Statement: The authors have no conflicts of interest to disclose in relation to this topic. Laura Lourenço Jenkins receives financial support for research from Organ Recovery Systems. Lisa Potter receives financial support for research and educational initiatives from Novartis, Astellas, Organ Recovery Systems, and Centers for Disease Control and Prevention.


References:

  1. Task Force on Organ Transplantation: Report to the Secretary and the Congress on Immunosuppressive Therapies. Rockville, MD, Office of Organ Transplantation, Health Resources and Services Administration, Department of Health and Human Services, October 1985.
  2. Task Force on Organ Transplantation: Organ Transplantation: Issues and Recommendations. Rockville, MD, Office of Organ Transplantation, Health Resources and Services Administration, Department of Health and Human Services, April 1986.
  3. Rettig RA, Levinsky NG, eds: Kidney Failure and the Federal Government, Washington, D.C., National Academy Press, 1991.
  4. Levinsky NB, Rettig RA: The Medicare End-Stage Renal Disease Program: A report from the Institute of Medicine. N Engl J Med 1991;324:1143-1148.
  5. U.S. Congress, Office of Technology Assessment: Outpatient Immunosuppressive Drugs Under Medicare. Report No. OTA-H-452. Washington, D.C., U.S. Government Printing Office, September 1991.
  6. Kasiske BL, Cohen D, Lucey MR, et al.: Payment for immunosuppression after organ transplantation. JAMA 2000;283:2445-2450.
  7. Field MJ, Lawrence RL, Zwanziger L, eds: Extending Medicare Coverage for Preventive and Other Services, Washington, D.C., National Academy Press, 2000.
  8. Ekstrand L: End-Stage Renal Disease: Characteristics of Kidney Transplant Recipients, Frequency of Transplant Failures, and Cost to Medicare. Report No. GAO-07-1117. Washington, D.C., United States Government Accountability Office, 2007.
  9. Evans RW, Kitzmann DJ: An economic analysis of kidney transplantation. Surg Clin North Am 1998;78: 149-174.
  10. Eggers P: Comparison of treatment costs between dialysis and transplantation. Semin Nephrol 1992;12: 284-289.
  11. Perovic S, Jankovic S: Renal transplantation vs hemodialysis: Cost-effectiveness analysis. Vojnosanit Pregl 2009;66: 639-644.
  12. Klarenbach S, Manns B: Economic evaluation of dialysis therapies. Semin Nephrol 2009;29: 524-532.
  13. Evans RW, Applegate WH, Briscoe DM, et al. Cost-related immunosuppressive medication nonadherence among kidney transplant recipients. Clin J Am Soc Nephrol 2010;5:2323-2328.
  14. www.medicare.gov/coverage/prescription-drugs-outpatient.html. Accessed August 14, 2016.
  15. www.cms.gov/Medicare/PrescriptionDrugCoverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefits-Manual-Chapter-6.pdf. Accessed August 14, 2016.



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