BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 219
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          ASSEMBLY THIRD READING
          AB 219 (Perea)
          As Introduced February 4, 2013
          Majority vote 

           HEALTH              15-2        APPROPRIATIONS      15-0        
           
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          |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  








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          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  








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          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,  








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          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  








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          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 


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