Eliminating Hepatitis C in the United States Treatment Access for All! Ryan Clary Executive Director December 7, 2016

Transcription

1 Eliminating Hepatitis C in the United States Treatment Access for All! Ryan Clary Executive Director December 7, 2016

2 History The cure arrives! Sovaldi (Dec. 2013) List price: $84,000 Immediate payer outrage/restrictions AIDS Healthcare Foundation letter to Medicaids (Feb. 2014) Media blitz: $1,000/pill (Spring, 2014) Viekira Pak enters market/competition leads to lower prices/open access in Express Scripts (Dec. 2014) CMS Guidance to state Medicaids (Nov. 2015) Zepatier enters market/$54,600 list price Significantly lower prices result in minimal expansion of access

3 Advocacy Successes Community sign-on letter (Sept. 2014) Meeting with HHS officials (Dec. 2014) Meeting with CMS (March 2015) PACHA resolution/letter (May 2015) CMS Guidance (Nov. 2015) HHS Summit/Access to High Price Meds (Dec. 2015) HHS Meeting (Sept. 2016) State Medicaid victories: CA, WA, CO, MA, CT, DC, PA, FL, DE, HI, IL (pending) Private insurance, VA, Medicare significant expansion of access

4 CMS Guidance to State Medicaids November 5, 2016 CMS is concerned that some states are restricting access to DAA HCV drugs contrary to the statutory requirements in section 1927 of the Act by imposing conditions for coverage that may unreasonably restrict access to these drugs. the effect of such limitations should not result in the denial of access to effective, clinically appropriate, and medically necessary treatments using DAA drugs for beneficiaries with chronic HCV infections. States should, therefore, examine their drug benefits to ensure that limitations do not unreasonably restrict coverage of effective treatment using the new DAA HCV drugs.

5 The State of Medicaid Access November 14, 2016 Robert Greenwald Clinical Professor, Harvard Law School; Director, Center for Health Law and Policy Innovation Ryan Clary Executive Director, National Viral Hepatitis Roundtable

6 The Current Big Picture The advent of new treatments to combat HCV is a major development in treating the deadliest infectious disease in US Unfortunately, despite the potential of curative medications, many state Medicaid programs limit access due to cost concerns Limitations run counter to clear guidance from CMS and are in direct opposition to AASLD and IDSA treatment guidelines Failure to provide appropriate access to HCV treatment threatens the health of millions of our most vulnerable residents in the US #StateofHepC

7 The Research Hepatitis C: The State of Medicaid Access, updates and expands upon initial 2014 Medicaid fee-for-service (FFS) surveys, and documents the current state of Medicaid FFS and managed care organization (MCO) HCV treatment access through October 2016 The preliminary report provides an evaluation of treatment access in each state s Medicaid program focusing on liver disease and sobriety restrictions and prescriber limitations highlighting successes in access expansion as well as ongoing challenges since 2014 providing a first-time national assessment of MCO coverage #StateofHepC

8 Methods Evaluated Medicaid reimbursement criteria for available DAAs for all 50 states and the District of Columbia 2014 research from Annals of Internal Medicine survey 2016 research of state Medicaid reimbursement criteria from publically available Medicaid documents, official press or media releases, or official communication with Medicaid rep, between 5/1/16 and 10/31/16 State classified as Restrictions Unknown for both 2014 and 2016 in this report if it failed to provide treatment criteria through any method outlined above or if criteria was unclear or ambiguous Data for 2016 were crosschecked by CHLPI and NVHR staff with differences resolved by consensus Multiple MCOs may operate in a state and restrictions expressed in a range #StateofHepC

9 Comparing 2014 & 2016 Medicaid FFS Liver Disease Requirements 2014 FFS Medicaid Liver Disease Requirements 2016 FFS Medicaid Liver Disease Requirements * Includes states that were characterized as none indicated and unknown in the Annals of Internal Medicine 2014 analysis. In the 2016 analysis, only includes states whose stage of liver disease restrictions are unknown data from Barua S., Greenwald, R., Grebely, J., Dore, G., Swan, T., and Taylor, L. Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infections in the United States, Ann Intern Med. 2015; 163: #StateofHepC F1 F2 No Restrictions Chronic HCV F3 F4 Restrictions Unknown*

10 Comparing 2016 Medicaid FFS & MCO Liver Disease Requirements 2016 FFS Medicaid Liver Disease Requirements 2016 MCO Medicaid Liver Disease Requirements With MCOs, where restrictions varied color denotes low end of the restriction range. No Restrictions Chronic HCV F F2 F3 1 #StateofHepC Restrictions Varied No MCO Programs F4 Restrictions Unknown

11 Comparing 2014 & 2016 Medicaid FFS Sobriety Requirements 2014 FFS Medicaid Sobriety Requirements 2016 FFS Medicaid Sobriety Requirements * Includes states that were characterized as none and unknown in the Annals of Internal Medicine 2014 analysis. In the 2016 analysis, only includes states whose sobriety restrictions are unknown data from Barua S., Greenwald, R., Grebely, J., Dore, G., Swan, T., and Taylor, L. Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infections in the United States, Ann Intern Med. 2015; 163: No Restrictions Abstain (6 mos.) Screening & Counseling #StateofHepC Abstain (12 mos.) Abstain (1 mo.) Restrictions Unknown* Abstain (3 mos.)

12 Key Findings Overall, from transparency as to state Medicaid program HCV treatment access restrictions has increased Access to HCV treatment has improved, primarily in reduction/elimination of FFS liver disease or fibrosis restrictions Access restrictions related to sobriety and prescriber limitations have decreased to a far lesser extent While there are some MCOs with low levels of restrictions, many follow their states fee-for-service (FFS) Medicaid restrictions, and others impose more onerous restrictions Variation in MCO coverage within a state is not uncommon #StateofHepC

13 Conclusion Progress has been made, yet too many restrictions remain There is a consensus emerging that restrictions will eventually be removed, voluntarily or by courts, but we must hold Medicaid programs accountable now, as some states see a budgetary incentive in dragging their feet as long as possible To build on progress to date, people living with HCV and their allies must hold federal and state Medicaid officials accountable for monitoring and enforcing nondiscriminatory HCV treatment access State Medicaid directors must make all HCV treatment access criteria publically available and detail immediate plans to meet HCV treatment obligations under the law With changing political environment collaborative advocacy more important than ever #StateofHepC

14 Next Steps Formal surveys being sent to Medicaid Directors/final opportunity to provide information Final report will be issued in first quarter of 2017 Report card with grades/ranking will be based on final report/issued second quarter of 2017 Launch event, Congressional briefing, Administrative/Legislative visits Tools for state advocates Ongoing project/maps and data will be updated and hosted on website #StateofHepC

15 Challenges Threats to ACA and health care safety net Medicaid expansion Medicaid block grants Medicare Stigma Limited advocacy capacity/stretched thin with new challenges New HHS/CMS leadership unknowns Disease specific legislation not popular in Congress Many states continue to have fiscal challenges

16 2017 Advocacy Unwavering push: access for all. All stakeholders must do everything in their power Our message must include new arguments and the moral argument Connect with overdose/opioid epidemics NAS elimination report Emphasis on sobriety/substance use restrictions? Litigation: MO, VT let s have more! Address prisons/jails, Indian Health Service Don t forget screening- cure means nothing to people who don t know their status Don t forget prevention we can t treat our way to elimination Our efforts will pave the way for HBV treatment advocacy

17 How Can You Help? You are the eyes and ears in your state! Provide information/data to advocates Connect state advocates with one another and to national campaign Disseminate final report/report card Identify media contacts in your state Join HCV treatment access listserv: How can we help you?

18 Thank You Ryan Clary Executive Director National Viral Hepatitis Roundtable