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Evidence-Based Oncology
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The advocacy affiliate of the American Cancer Society, the American Cancer Society Cancer Action Network, is working across the country to pass and implement strong oral chemotherapy fairness laws to help ensure cancer patients have access to the recommended course of treatment without added out-of-pocket costs based on how their drug is administered.
A cancer diagnosis can generate a host of fears, including fear about the availability and cost of the recommended treatment for a particular diagnosis. Cancer patients and their families, although rightly concerned about whether a treatment has been discovered for their particular cancer, also worry about their ability to afford those lifesaving cancer treatments.
To reduce death and suffering from cancer, we need a balanced approach that fosters continuous innovation in the development of cutting-edge cancer treatments that will save more lives and is affordable for those who need it. With increasing attention being paid to the rising cost of prescription medicines, one aspect of this issue that has seen visible progress in terms of accessibility is oral chemotherapy fairness.
Historically, the majority of frontline cancer chemotherapy treatments were administered intravenously to patients in their physician’s office. However, scientific advancements over the past several years have brought forth effective oral medications for cancer that are convenient to self-administer, require less time off from work and less travel time to and from medical facilities, and, in some cases, come with fewer side effects (see Sidebar). Today, oral chemotherapies account for about 10% of available chemotherapies and roughly 25% of the medications in the oncology development pipeline, indicating a growing role for oral chemotherapy in cancer treatment.1
Although intravenous (IV) medications are typically covered under a health plan's medical benefit, health plans have often required higher cost-sharing for oral cancer medications rather than those administered intravenously by a doctor because they are included in the plan’s drug benefit. This disparity can influence patient and physician decision making about treatment options and may lead patients to forgo the best treatment for their situation in favor of a treatment they can afford. In addition, research suggests high cost-sharing for oral chemotherapy medications may lead patients to abandon treatment altogether.1
ORAL PARITY, THE AFFORDABLE CARE ACT, THE AMERICAN CANCER SOCIETY CANCER ACTION NETWORK
The Affordable Care Act (ACA) mandates the inclusion of prescription drug coverage as an essential health benefit that must be offered in new insurance plans; however, it does not dictate the specific details of that coverage other than the number of drugs per therapeutic class that must be offered.2 Many cancer drugs are placed on “specialty” tiers, which typically have the highest patient out-of-pocket (OOP) costs, some as high as 50% of a drug’s cost.
A 2014 analysis of drug formularies in marketplace plans revealed, for example, that Tarceva, a treatment for advanced-stage non-small cell lung cancer and advanced-stage pancreatic cancer, although included on all health insurance marketplace plans evaluated, was listed on the highest tier between 50% and 100% of the time.3 In the case of drugs that are offered in both oral or IV form, the difference in OOP costs can influence a patient’s decision to choose the IV version of a therapy even though doing so could be significantly more burdensome from a nonfinancial standpoint in terms of time away from work, transportation, etc.
Under the ACA, states must also pick a benchmark for the minimum level of coverage all healthcare plans must provide in that state—most states select the largest small group insurance plan as the benchmark. If a state passes a mandate that goes above and beyond the benefits included in the benchmark plan, then the state is responsible for footing the bill for that extra coverage.
A guidance issued by HHS in 2012 states that oral chemotherapy fairness policies did not constitute an additional benefit beyond the established essential health benefit package. Thus, if plans already cover the IV counterpart medication as part of their essential benefit, parity policies limiting OOP costs for oral chemotherapy can be applied without the state incurring additional costs. Eliminating this state budget implication opened the floodgates for states to pass oral chemotherapy fairness laws that include oral chemotherapy medications under the state’s benchmark health plan and, in many cases, eliminated the disparity with IV medications. The American Cancer Society Cancer Action Network (ACS CAN) has been a driving force in helping 40 states pass oral chemotherapy fairness laws since 2007.
There are 3 types of laws that states have passed to address oral chemotherapy fairness:
1. The first type creates parity for OOP costs for IV chemotherapies and oral chemotherapies. These laws fix the problem on the surface. However, insurers in some states (eg, Hawaii) have been quick to react by increasing the cost of IV medications, forcing organizations like ours to work to tighten the laws.
2. The second type of law caps the monthly OOP costs for oral chemotherapy medications. Whereas this action might control costs, it could also fail to create true parity with IV medications, which may continue to carry lower OOP costs.
3. The most recent laws mandate coverage with capped co-payments or coinsurance per prescription per month for specialty tier drugs, which includes medications for other conditions in addition to chemotherapies.
IN THE TRENCHES
ACS CAN and the Leukemia & Lymphoma Society recently led a coalition of public health groups in Mississippi to pass a law that would create fairness between oral chemotherapy medications and IV chemotherapies. The successful, coalition-driven campaign is a prime example of the power of advocacy. The bill, first introduced in January 2015 by Rep. Charles Busby (R-Pascagoula), received great bipartisan support from the start, passing the House with a vote of 117:1. However, once the legislation reached the state Senate, the opposition geared up its fight.
ACS CAN and the coalition intensified their campaign to ensure that this bill passed and gave patients equal access to the chemotherapies they need. ACS CAN hosted a Day at the Capitol during which volunteers from across the state met with their legislators and discussed the oral chemotherapy fairness legislation. In collaboration with its coalition partners, ACS CAN hosted a press conference and had volunteers send in letters and e-mails to their legislators throughout the campaign to remind them of the importance of this legislation. All of this hard work paid off and the bill passed the full Senate and was eventually signed into law by Governor Phil Bryant on April 23, 2015.4
Passing state laws is only one part of a 3-pronged approach to ensuring oral chemotherapy fairness. We must ensure these laws are implemented and enforced appropriately so they work as intended. Although some are concerned that parity will lead to increased costs for insurance plans, data show that health benefit plan prices increase less than one-tenth of 1%.5 In spite of the evidence, efforts to find loopholes in oral chemotherapy fairness laws continue so these medications will not have to be covered on the same level as IV chemotherapies. ACS CAN is committed to working to tighten any regulations that would guarantee equal, affordable access to oral chemotherapy medications for patients with cancer.
Because of the variability in the state laws, there is strong desire for a federal bill that would set a level playing field among the states.
Sen. Mark Kirk (R-IL), Sen. Al Franken (D-MN), Rep. Leonard Lance (R-NJ,) and Rep. Brian Higgins (D-NY) have taken up the charge and earlier this year introduced the Cancer Treatment Parity Act of 2015.6 Like much of the state legislation, the federal bill would require private health insurance plans that cover traditional chemotherapy to provide equally favorable coverage for orally administered anticancer medications. It would set a national maximum OOP cost for patients with private insurance on oral chemotherapy medications. By removing barriers to critical treatments, this bill has the potential to ensure that patients and their oncologists can choose a course of treatment based on what is in the best health interest of the patient, rather than by what a patient will have to pay under an insurance plan.
The larger issue of drug costs needs a balanced, comprehensive approach that could take some time to develop; however, oral chemotherapy fairness is one issue we can tackle now. It’s an issue that is important in the states, with 40 states having passed legislation to address it. It’s an issue that is important to lawmakers on both sides of the aisle, with federal legislation introduced in both the House and the Senate. Most importantly, it’s an issue that is important to patients because it can mean a significantly improved quality of life while dealing with one of the most feared diseases.
EBO
We’ve achieved significant strides in developing oral chemotherapy regimens that are improving survivorship along with the patient’s quality of life and ability to continue working. However, the advances in research mean nothing if patients lack access to these life-saving treatments. Oral chemotherapy fairness should be the standard practice in every insurance plan, not a luxury based on where a patient lives or what they can afford.
Christopher Hansen is the president of the American Cancer Society Cancer Action Network.REFERENCES
1. Streeter SB, Schwartzberg L, Husain N, Johnsrud M. Patient and plan characteristics affecting abandonment of oral oncolytic prescriptions. J Oncol Pract. 2011;7(suppl 3):46s-51s.
2. Patient Protection and Affordable Care Act; standards related to essential health benefits, actuarial value, and accreditation. Fed Regist. 2012;77(227):70643-70676. To be codified as 45 CFR §147,155,156.
3. Cancer drug coverage in health insurance marketplace plans. American Cancer Society Cancer Action Network website. http://www.acscan.org/content/wp-content/uploads/2014/03/Marketplace_formularies_whitepaper.pdf. Published March 2014. Accessed October 22, 2015.
4. Health plans & policies; prohibit higher copayments for patient-administered anti-cancer medications. Mississippi Legislature website. http://billstatus.ls.state.ms.us/2015/pdf/history/HB/HB0952.xml. Accessed October 22, 2015.
5. Starner CI, Gleason PP, Gunderson BW. Oral oncology prescription abandonment association with high out-of-pocket member expense. J Manag Care Pharm. 2010;16(2):161-162.
6. Oral parity bill will help limit the out-of-pocket costs of cancer care [press release]. Washington, DC: American Cancer Society; June 12, 2015. http://www.acscan.org/content/media-center/oral-parity-bill-will-help-limit-the-out-of-pocket-costs-of-cancer-care/. Accessed October 22, 2015.