In an era of changing economic times and health care uncertainty, patients are increasingly facing the challenge of how to pay for the rising costs of their medications. In 2009, it was estimated that more than 43 million people were living in poverty and 50 million did not have health insurance.1 The high cost of pharmaceutical care, coupled with an uninsured patient population, has created a large group of patients who cannot afford optimal health care; this portends a particularly worrisome outlook for patients requiring high-cost drug therapies.

Pharmaceutical companies are shifting the focus of new drug research. Historically, these organizations have relied on blockbuster therapies that treat many people for common chronic disease states, such as cardiovascular disease and diabetes mellitus. While research is continuing in these areas, pharmaceutical companies are increasingly shifting their focus to highly sophisticated, targeted therapies that serve smaller groups of patients. The field of targeted oncology drugs is growing exponentially compared with other classes of drugs.2,3 Although it is absolutely necessary to develop these new drugs if we are to advance the treatment of cancer, this advancement comes at an enormous price: In 2009, the average cost of brand-name drugs increased by 8% to 9%, with generic drugs showing a smaller increase in price (Figure).3-5

The patient’s share of costs associated with health care and medications has been increasing at a disproportionate rate to most patients’ incomes. This increased cost is being passed on to patients in the form of increased cost or copayments.1 In some cases, these costs can be exorbitant. For example, one course of sipuleucel-T (Provenge, Dendreon) used for metastatic prostate cancer treatment can cost $93,000, with a resulting life extension averaging 4 months. Malignant melanoma treatment employing ipilimumab (Yervoy, Bristol-Myers Squibb) costs as much as $120,000 for an estimated benefit of 3.5 months. Dasatinib (Sprycel, Bristol-Myers Squibb/Otsuka) is an oral chemotherapy medication taken daily for the treatment of chronic myelogenous leukemia; one month of treatment can cost over $10,000, and therapy is usually continued until disease progression or the development of unacceptable toxicity. Depending on the specific insurance plan, patient copayments may be derived from tiered drug levels or percentages of the total drug cost. While some patients have access to affordable insurance coverage, in many cases, the end result of copayments seems to have changed from one that prevents inappropriate medication use to one that prohibits the continuation of optimal patient care.

Patient Assistance Programs

To continue the treatment of patients on high-cost medications, including chemotherapy, health care professionals are increasingly turning to the aid of pharmaceutical manufacturer patient assistance programs (PAPs). PAPs provide brand-name medications at no cost or reduced cost to patients who meet specific program criteria, including income, prescription coverage, and residence. Oral, injectable, and infused medications are available through PAPs. For intravenous medications, there are programs that supply medications for use in the outpatient infusion clinic; there also are limited PAPs that replace medications used by uninsured patients during an inpatient admission (Table, page 39).

Table. Selected Industry-Sponsored Patient Assistance Programs
Patient Assistance Program(s) Sponsoring Organization Examples of Covered Drugs
AZ&Me Prescription Savings Program AstraZeneca www.astrazeneca-us.com/help-affording-your-medicines Arimidex, Faslodex, Zoladex
ASAP Program Allos Support for Assisting Patients Allos www.getasapinfo.com Folotyn
The Safety Net Foundation Amgen www.amgenassistonline.com Aranesp, Epogen, Neulasta, Neupogen, Vectibix, Xgeva
NexCCAP Bayer http://nexavar-us.com/scripts/pages/en/rcc/patient-assistance-and-support/nexccap/ Nexavar
Destination Access Bristol-Myers Squibb http://www.destinationaccess.com/index.aspx Erbitux, Ixempra, Sprycel, Yervoy
Celgene Patient Support Celgene www.celgenepatientsupport.com Abraxane, Istodax, Revlimid, Thalomid, Vidaza
CORE: Cephalon Oncology Reimbursement Expertise Cephalon www.cephalononcologycore.com Treanda, Trisenox
The Eisai Reimbursement Resources Eisai www.eisaireimbursement.com Aloxi, Dacogen, Fragmin, Gliadel, Halaven, Ontak
Lilly Patient One Eli Lilly www.lillytruassist.com Alimta, Gemzar
Genentech Access Solutions Genentech, Inc. www.genentechaccesssolutions.com Avastin, Herceptin, Rituxan, Pegasys, Pulmozyme, Tarceva, Xeloda
Genzyme Patient Assistance Genzyme Corporation www.genzymeoncology.com http://www.genzyme.com/healthcare/ services_reimbursement.asp Aldurazyme, Cerezyme, Fabrazyme, Hectoral, Renagel/Renvela, Campath, Clolar, Fludara, Leukine, Mozobil, Thyrogen
Commitment to Access, CARES by GSK GlaxoSmithKline http://www.commitmenttoaccess.com/ index.html http://www.caresbygsk.com/hcp.html Arranon, Arzerra, Bexxar, Hycamtin, Promacta, Tykerb, Votrient
The ACT Program Merck & Co. www.merck.com/merckhelps Emend, Intron A, Gardasil, Noxafil, Pegintron, Sylatron, Temodar, Zolinza
Velcade Reimbursement Assistance Program Millennium Pharmaceuticals, Inc www.velcade.com/payingfortreatment.aspx Velcade
Novartis Patient Assistance NOW, EPASS Prescription and Reimbursement Novartis Pharmaceuticals http://www.patientassistancenow.com/ index.jsp Affinitor, Exjade, Gleevec, Sandostatin LAR Depot, Tasigna, Zometa
First Resource, Pfizer Pfriends Pfizer www.pfizerhelpfulanswers.com Aromasin, Camptosar, Ellence, Emcyt, Idamycin, Neumega, Sutent, Torisel, Xalkori, Zinecard
PACT+Provider Portal Sanofi Patient Assistance Programs www.pactplusonline.com Eligard, Elitek, Eloxatin, Taxotere

Until there is an efficient method for providing complete health care coverage for all patients, it will be important for members of the health care team to be aware of patient access to medications through these programs. The first step to providing uninsured patients with the optimal therapy is to match the PAP with the patient’s current financial and insurance situation. Enrolling patients in these programs can be time-consuming because of wide variations in eligibility requirements. Depending on the source of funding for the PAP, eligibility criteria for specific medications are established by either the manufacturer or charitable organizations.

The process of enrolling patients may include the completion of application forms, reporting of a patient’s health insurance coverage, assets, salary, liabilities, Social Security benefits, and proof of income such as federal tax returns or W-2 forms. Once the enrollment paperwork is completed and submitted to the PAPs, the turnaround time will vary. In some cases, it can be as quick as the same day, but most programs take from 5 business days to 6 weeks to process and receive medications. The downside of many of these programs is that the application process can be rather nebulous. Furthermore, as health care costs rise and these programs increase in number, it is likely that navigation of program loopholes will become more difficult, especially because a uniform application process does not exist.

In some cases, application to a PAP can be initiated by the patient; however, action by the prescribing physician or the health care team is required to complete the application. While oncology practices would undoubtedly jump at the chance to provide the necessary therapy to their patients at a reduced and affordable cost, most have not yet created a systematic, organized approach to identifying the PAP that will provide the most assistance to each patient. Some oncology practices that have taken this step have identified a point person in the pharmacy department or have outsourced this role to a PAP manager to streamline the process. In many community oncology offices, a nurse has been assigned the responsibility of assisting patients with PAPs. In other cases, PAPs may be delegated to companies, such as McKesson and Cardinal, that run the program for a percentage of the reimbursed amount. Whatever the approach, heightened awareness of such programs is crucial for the optimal provision of treatment in the face of ever-rising health costs.

Conclusion

As drug development increasingly shifts to targeted therapies, response rates will continue to improve; but at the same time, health care costs will rise. The effect of current health care reform on the individual patient remains to be seen. It seems reasonable to assume that widespread and affordable access to vital drugs will not be secured by government agencies in the near future. It will remain the responsibility of the health care team to ensure that patients have access to the drugs they need for optimal treatment. PAPs can be a valuable tool to facilitate that access.

References

     

  1. Kaiser Family Foundation. Family health premiums rise 3 percent to $13,770 in 2010, but workers’ share jumps 14 percent as firms shift cost burden. http://www.kff.org/insurance/090210nr.cfm. Accessed November 15, 2011.
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  3. The costly war on cancer. New cancer drugs are technically impressive. But must they cost so much? The Economist. http://www.economist.com/node/18743951?story_id=18743951. Accessed November 15, 2011.
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  5. Medco R&D Directions. 2010 Drug Trend Report. http://www.drugtrend.com/art/drug_trend/pdf/DT_Report_2010.pdf. Accessed November 28, 2011.
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  7. US Government Accountability Office. Report to Congressional Requesters. Brand-name prescription drug pricing. Lack of therapeutically equivalent drugs and limited competition may contribute to extraordinary price increases. http://www.gao.gov/new.items/d10201.pdf. Accessed November 28, 2011.
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  9. US Department of Labor. Bureau of Labor Statistics. Consumer Price Index All Urban Consumers U.S. City Average, All Items 1982-84=100. ftp://ftp.bls.gov/pub/special.requests/cpi/cpiai.txt. Accessed November 28, 2011.
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