BILL ANALYSIS Ó AB 219 Page 1 ASSEMBLY THIRD READING AB 219 (Perea) As Introduced February 4, 2013 Majority vote HEALTH 15-2 APPROPRIATIONS 15-0 ----------------------------------------------------------------- |Ayes:|Pan, Ammiano, Atkins, |Ayes:|Gatto, Harkey, Bigelow, | | |Bonilla, Bonta, Chesbro, | |Bocanegra, Bradford, Ian | | |Gomez, | |Calderon, Campos, Eggman, | | |Roger Hernández, Rendon, | |Gomez, Hall, Holden, | | |Maienschein, Mitchell, | |Linder, Pan, Quirk, | | |Nazarian, Nestande, V. | |Ammiano | | |Manuel Pérez, Wieckowski | | | | | | | | |-----+--------------------------+-----+--------------------------| |Nays:|Wagner, Wilk | | | | | | | | ----------------------------------------------------------------- SUMMARY : Requires health plan contracts and health insurance policies that cover prescribed, orally administered anticancer medications to limit an enrollee or insured's total cost share to no more than $100 per filled prescription. FISCAL EFFECT : According to the Assembly Appropriations Committee: 1)According to the California Health Benefits Review Program (CHBRP), the provisions of this bill would likely have a negligible impact on the state because the programs affected, the California Public Employees' Retirement System and Medi-Cal, already provide coverage with cost-sharing below the amounts in this bill. 2)This bill would have minor costs to the Department of Managed Health Care and the Department of Insurance for plan filings. COMMENTS : The author states that this bill is needed to ensure that cancer patients who are prescribed oral anticancer medications to treat their cancer can afford these treatments when covered by their health plan or insurance. According to the author, innovations in the pharmaceutical industry have resulted in the routine availability of new oral pills that work AB 219 Page 2 better and have fewer side effects than older intravenous or injectable medications. The author notes that oral anticancer medications are covered as a pharmacy benefit by health plans or insurance so the terms of coverage are different and can include co-insurance instead of flat rate co-pay. The author maintains that since oral drugs are new and currently often under patent, they can be much more expensive than patients expect to pay for a pill, with prices as high as $10,000 for a prescription, meaning a patient responsible for a 30% co-insurance payment could need to pay $3,000 for a single prescription of oral anticancer medication. The author asserts that out-of-pocket costs for oral anticancer medications are a de facto denial of access and cites a 2010 study done by Prime Therapeutics, a pharmacy benefit management company, which found one in six cancer patients with high out-of-pocket costs abandons their medication. Lastly, the author points out that 21 other states have already passed legislation to address high out-of-pocket costs for these treatments. According to an analysis by CHBRP, oral anticancer medications (usually pills) are used to treat frequently diagnosed cancers, such as breast, lung, prostate, and colorectal cancers, and they are also used for rare cancers, such as cancer of the adrenal gland, cancer of the dermis layer of skin, and retinoblastoma (an eye cancer). CHBRP indicates that the roles of oral anticancer medications in cancer treatment vary. Some oral anticancer medications are used to reduce the likelihood of recurrence of cancer in patients with early stage cancers who were previously treated with surgery, radiation, and/or intravenous anticancer medications, while others are taken on an ongoing basis to prevent the growth of cancer cells. Still others are used to treat metastatic cancers, recurrent cancers, or cancers that cannot be surgically removed. Oral anticancer medications may be used as "first-line" treatments for persons newly diagnosed with cancer or as "second-line" treatments for persons who do not respond to "first-line" treatments. Although oral anticancer medications have been available for many years, CHBRP notes that the number of oral anticancer medications approved by the federal Food and Drug Administration (FDA) has grown dramatically over the past decade. To date, the FDA has approved 54 oral anticancer medications used to treat 50 AB 219 Page 3 different types of cancer. According to CHBRP, approximately 100 oral anticancer medications are currently under development, and only nine of the 54 oral anticancer medications approved by the FDA have intravenous or injected equivalents. Only 11 of the 54 approved by the FDA have generic equivalents. According to CHBRP, coverage for anticancer medications can differ in a number of ways, depending on provisions of a person's health plan contract or health insurance policy. Anticancer medications may be covered as pharmacy plan benefits or as medical plan benefits, and most plans and insurers depend on the dispensing site to determine which will be the form of coverage. For example, intravenous anticancer medication, which is usually provided in a hospital or a physician's office, is generally covered as a medical benefit, while oral anticancer pills dispensed by a pharmacy are usually covered as a pharmacy benefit. CHBRP notes that payers employ a host of strategies to promote appropriate utilization and cost controls for both medical and pharmacy benefits. These strategies include creation of formularies; maximization of manufacturer rebates; quantity restrictions; use of prior authorization; development of clinical guidelines; and, implementation of patient cost sharing, such as deductibles, coinsurance, and copayments. Cost sharing for medications is frequently complicated by tiered pricing in which plans and insurers assign drugs to tiers (generic drugs in the lowest and very expensive drugs in the highest) and apply varying copayments and coinsurance rates to different tiers. As with cost sharing in general, the impact of tiers (if any) depends on the specifics of a person's plan contract or insurance policy. Lastly, CHBRP states that the variety of cost sharing provisions currently used in California makes it difficult to generalize about the ways in which a cancer patient may be required to pay out-of-pocket for any anticancer medication. Fixed copayments are a common form of cost sharing for medications delivered through a pharmacy. However, some carrier contracts and policies require coinsurance for one or more medications or the terms of coverage may or may not include a deductible. Coverage of medications delivered as medical benefits also varies. CHBRP was created in response to AB 1996 (Thomson), Chapter 795, AB 219 Page 4 Statutes of 2002, which requests the University of California to assess legislation proposing a mandated benefit or service, and prepare a written analysis with relevant data on the public health, medical, and economic impact of proposed health plan and health insurance benefit mandate legislation. The sponsors of this bill, Susan B. Komen for the Cure California Affiliates and Carrie's TOUCH, Inc., state that this bill will make oral cancer chemotherapy treatments more affordable and therefore more accessible to cancer patients in California. Supporters, representing patient advocacy groups, providers, and biomedical research companies, among others, point to research showing that a $100 cap on cost-sharing requirements for orally administered anticancer medications per filled prescription increases patient compliance with their doctor prescribed therapy and reduces the likelihood of treatment abandonment that is associated with higher cost-sharing amounts. The American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society note in support that, typically, orally administered chemotherapy is covered under a health plan's pharmacy benefit and oral chemotherapy medications are often classified in the highest tier of a plan's cost-sharing system. They maintain that this requires patients to pay a high percentage of the drug's cost and potentially results in thousands of dollars in out-of-pocket costs each month. The Association of Northern California Oncologists writes in support that the emergence of safe, effective, orally administered anticancer medications has dramatically improved the quality of life for cancer patients and this bill will make these medicines, which are often more advanced therapies with fewer side effects than traditional chemotherapy, more affordable and accessible. Lastly, biomedical research companies, such as the California Healthcare Institute and BIOCOM, add that remarkable breakthroughs in orally administered cancer treatments are only effective when patients have access to them. Health plans and health insurers object to this bill because they argue that it threatens the efforts of all health care stakeholders to provide consumers with meaningful health care choices and affordable coverage options. America's Health Insurance Plans notes in opposition that cost sharing is a crucial part of controlling health care costs and setting an arbitrary cost sharing limit for those who are using oral chemotherapy medication means more of the cost of these AB 219 Page 5 expensive medications will need to be borne by other enrollees and insureds in the form of higher premiums. The California Association of Health Plans (CAHP) contends that this bill does nothing to control the high underlying cost of pharmaceuticals, nor does it do anything to encourage drug makers to be more efficient and lower costs. CAHP further believes that the Affordable Care Act provides a more comprehensive solution to lowering consumer costs without favoring one drug class over another and still allows for appropriate utilization and benefit management by health plans. Blue Shield of California adds in opposition that this bill attempts to carve out special cost sharing rules for a particular line of pharmaceutical company drugs and will only exacerbate the affordability crisis by giving special treatment to certain drug company products. Analysis Prepared by : Cassie Royce / HEALTH / (916) 319-2097 FN: 0000215