BILL ANALYSIS Ó AB 383 Page 1 Date of Hearing: May 13, 2015 ASSEMBLY COMMITTEE ON APPROPRIATIONS Jimmy Gomez, Chair AB 383 (Gipson) - As Amended April 30, 2015 ----------------------------------------------------------------- |Policy |Health |Vote:|19 - 0 | |Committee: | | | | | | | | | | | | | | |-------------+-------------------------------+-----+-------------| | | | | | | | | | | | | | | | |-------------+-------------------------------+-----+-------------| | | | | | | | | | | | | | | | ----------------------------------------------------------------- Urgency: No State Mandated Local Program: NoReimbursable: No SUMMARY: This bill requires a primary care clinic (PCC) to offer specified patients receiving services a hepatitis C virus (HCV) screening or diagnostic test. AB 383 Page 2 FISCAL EFFECT: Based on conservative assumptions that this bill results in identification of 30,000 individuals affected by HCV in the first year: 1)Indirect cost pressure of $4.5 million (GF/federal) to Medi-Cal associated with increased testing in PCC clinics. Because clinics are reimbursed on a per-visit basis and the HCV test would likely be offered in combination with other services, testing cost would not be separately reimbursed. 2)For individuals who are diagnosed, counseling and follow-up care would result in increased visits costing Medi-Cal $1-2 million (GF/federal), depending on intensity of such care. 3)Cost pressure to Medi-Cal for increased drug treatment of HCV of $340 million (GF/federal), based on 38% of identified cases being among Medi-Cal eligible patients, and 75% of patients being linked to treatment at a one-time treatment cost of $40,000. These estimates are based on general public health surveillance data and data on clinic encounters reported by the Office of Statewide Health Planning and Development and is subject to significant uncertainty. Similar costs would be incurred in future years, although would taper off year by year as more people infected with HCV would be identified. Although HCV is the most common bloodborne pathogen among Americans, the infection is not rapidly spreading and thus widespread one-time testing would likely yield fewer and fewer positive results in each subsequent year. AB 383 Page 3 COMMENTS: 1)Purpose. According to the author, between 2.7 million and 3.9 million U.S. residents are infected with HCV and 500,000 Californians are living with the virus. Nevertheless, there is a significant lack of awareness of HCV, the threat that it poses to the public health, and current opportunities to control it. The author states this bill seeks to ensure that primary care clinics are proactive in testing high risk and baby boomer patients for HCV to increase community awareness. 2)Hepatitis C. Hepatitis is a virus, or infection, that causes liver disease and inflammation of the liver. Acute hepatitis C is a short-term infection with the hepatitis C virus. Symptoms can last up to six months. In about 15% of cases, the body is able to fight off the infection and get rid of the virus. Chronic hepatitis C is a long-lasting infection. Chronic hepatitis C occurs when the body can't get rid of the hepatitis C virus. People can become infected through sharing needles, needle-stick injuries in health care settings, or being born to a mother who has HCV. Receipt of donated blood and organs was once a common means of transmission as well, but modern screening has virtually eliminated this. According to the CDC, millions of Americans have HCV, but most don't know it, because people often have no symptoms and can live with an infection for decades without feeling sick. HCV is a leading cause of liver cancer and the leading cause of liver transplants. 3)Who is screened? This bill requires screening tests consistent with the United States Preventive Services Task Force (USPSTF) recommendations for screening and any federal Centers for Disease Control and Prevention (CDC) algorithms. The USPSTF and CDC recommend screening for HCV in persons at high risk for infection and 1-time screening for adults born between AB 383 Page 4 1945 and 1965, who account for 75% of individuals infected with HCV. 4)Treatment. Treatment for Hepatitis C has evolved rapidly in recent years. According to the Centers for Disease Control and Prevention, prior to 2013, medication was given for 24-48 weeks and cured 50%-80% of patients, sometimes with significant side effects. In late 2013, the federal Food and Drug Administration approved two new antiviral drugs, Sofosbuvir (Sovaldi) and Simeprevir (Olysio) to treat chronic HCV infection. Clinical trials have shown that these new "breakthrough" medications cure 80%-95% of patients after 12-24 weeks of treatment with fewer side effects. However, Gilead Sciences, the manufacturer of Sovaldi, has come under heavy fire for the price of the drug treatment; the 12-week treatment regimen has a retail price of $84,000. Gilead Sciences reported sales of $10.3 billion for Sovaldi in 2014. After a year of market exclusivity for Sovaldi, Abbvie gained FDA approval to market rival HCV treatment Viekira Pak in late 2014. Pharmacy benefit managers (PBMs), like ExpressScripts and CVS Caremark quickly signed deals that agreed to exclusive coverage for specific brand drugs, in return for a hefty price discount on the drug. Other competitor drugs are currently in final stages of clinical trials and could be on the market in the near future, and increased competition in the market is expected to bring costs down significantly. In early 2015, Gilead announced it would be offering rebates of up to 46% on Sovaldi now that multiple rival drugs have entered the market. 5)Related Legislation. AB 521 (Nazarian) requires patients who have blood drawn at a general acute care hospital emergency room to be offered an HIV test. AB 383 Page 5 6)Previous Legislation. a) SB 1303 (Torres) of 2013 required every "qualifying individual" who receives medical care to be offered a HCV test. SB 1303 was held in the Senate Health Committee. b) AB 446 (Mitchell), Chapter 589, Statutes of 2013, among other provisions, requires a patient between 12 and 65 years of age who has blood drawn at a primary care clinic to be offered an HIV test. Analysis Prepared by:Lisa Murawski / APPR. / (916) 319-2081