1. Sheldon Toubman, Staff Attorney New Haven Legal Assistance Association stoubman@nhlegal.org (203) 946-4811, ext. 1148 June 17, 2016 STRATEGIES FOR CONVINCING STATE MEDICAID AGENCIES TO FULLY COVER NEW GENERATION HCV MEDICATIONS

2. In May, 2015, CT Medicaid Reversed Several Severe Restrictions on Access to Sovaldi Imposed in November of 2014, without Litigation Being Commenced. Restrictions Included: Requirement of Metavir score of F3 or F4 Absolute bar if pregnant Absolute bar if patient has any type of cancer

3. Prohibition on being treated more than once Absolute bar on use if patient taking other drugs which may reduce effectiveness of Sovaldi Prohibition on any use outside of narrow FDA-approved indications Only certain specialists allowed to prescribe Not allowing providers even to request prior authorization unless they certify above restrictive criteria are met

4. Multi-faceted strategy to try to persuade agency to reverse course without litigation :  Legal aid and Yale Law School/Public Health School clinic wrote to agency in February 2015 laying out state and federal law violations inherent in the new policies  Coalition of advocates formed and wrote to state agency two weeks later, on Feb. 19, 2015, advising of all of the legal and policy problems with restrictions, including incorporation of legal analysis in first legal letter from advocates  Advocates coordinated with HCV clinicians experiencing access problems for patients

5.  HCV clinicians reached out to agency’s medical director to try to persuade to advocate internally for reversal, emphasizing high cost of not treating with Sovaldi  Use of media to call attention to severe access issue  Encouragement for state to negotiate with manufacturers  Advocates’ two letters available at http://nvhr.org/hepatitis-c- treatment-access/advocacy-resources#samplehttp://nvhr.org/hepatitis-c- treatment-access/advocacy-resources#sample

6. Violations of federal law cited in legal advocates’ Feb. 3, 2015 letter to agency: Federal law requirement that states must provide all FDA-approved medications subject to a rebate agreement (except for certain narrow categories of excludable medications, not applicable to HCV drugs), unless a drug has no significant, clinically meaningful therapeutic advantage over other medications, 42 U.S.C. § 1396r-8(d)(4)(C) and (D). Federal law requirement that states must provide FDA-approved medications not only for all FDA-approved usages but also for recognized off-label usages, 42 U.S.C. § 1396r-8(d)(4)(C).

7. Federal law requirement that all categories of Medicaid services must be provided in sufficient amount, duration, and scope to achieve their purpose, 42 C.F.R. § 440.230. Federal law requirement that all covered services, including prescription drugs, must be provided with reasonable promptness, 42 U.S.C. § 1396a(a)(8). Federal law requirement that there is a right to a written notice and hearing whenever any service requested under Medicaid is denied, 42 U.S.C. § 1396a(a)(3), 42 C.F.R. § 431.200 et seq.

8. Violations of state law cited in legal advocates’ Feb. 3, 2015 letter to agency:  State law requirement that broad medical necessity statutory standard must be applied to all categories of Medicaid services, including the provision of services to prevent medical conditions from occurring  State law requirement barring denial of a requested treatment in favor of different treatment unless substitute is “at least as likely to produce equivalent therapeutic or diagnostic results” to requested treatment -Conn. Gen. Stat. Section 17b-259b(a)

9. Problems with state position identified in advocate coalition’s Feb. 19, 2015 letter to agency:  Legal issues identified in earlier letter  Restrictions on access will interfere with public health goals of (a) reducing transmission of HCV and (b) providing treatment prior to permanent harm which may require long-term expensive treatment  Restrictions on access undermine state legislation passed the previous year mandating screening for HCV, for the propose of determining whether individuals, including those who are asymptomatic, should receive curative treatment

10.  Restrictions on access specifically for Medicaid enrollees threaten to exacerbate health disparities, in that these enrollees are disproportionately African-American and Latino  Restrictions on access will cost state more compared with older treatments, which also are expensive, have a high incidence of expensive complications, and are far less likely to bring a permanent cure eliminating need for further treatment

11. CT News Junkie: http://www.ctnewsjunkie.com/archives/entry/advocates_urge _easier_access_to_expensive_drug_for_medicaid_patients/ (March 19, 2015) Hartford Courant: http://www.courant.com/politics/hc-sovaldi-more-accessible- 0516-20150515-story.html (May 15, 2015) http://www.courant.com/opinion/letters/hc-expensive- hepatitis-c-cure-is-a-bargain-20150521-story.html (May 21, 2015)

12. Developments Since May 2015 Which Enhance Threat of Litigation as a Strategy: 1.CMS guidance issued Nov. 5, 2015, including applicability to managed care organizations, https:/www.medicaid.gov/Medicaid-CHIP-Program- Information/By-Topics/Benefits/Prescription- Drugs/Downloads/Rx-Releases/State-Releases/state-rel- 172.pdf https:/www.medicaid.gov/Medicaid-CHIP-Program- Information/By-Topics/Benefits/Prescription- Drugs/Downloads/Rx-Releases/State-Releases/state-rel- 172.pdf 2.Litigation success in Washington state, see B.E. v. Teeter, Case No. C16-227-JCC (W.D. Wash. May 27, 2016) 3.Increasing number of states which are eliminating restrictions in response to threats to sue (e.g., Delaware, New York, Florida)

14. Emalie Huriaux Director of Federal & State Affairs, Project Inform Chair, California Hepatitis Alliance June 17, 2016 Hepatitis C Treatment Access Advocacy in California

16. Californians with Hepatitis C Estimate of Californians living with the hepatitis C virus (HCV) = 750,000

17. State Public Payers Rationing Care  In 2014, the state of California had treatment utilization policies that limited access to new medications.  Our position is that these types of requirements are purely rationing and cost-containment measures and many of them are illegal  Not based on the FDA-approved labels, clinical evidence, or guidance developed by the American Association for the Study of Liver Diseases/Infectious Diseases Society of America

18. FY 14-15 Policies in Medi-Cal & ADAP  Medi-Cal (state Medicaid program):  Authorized treatment ONLY for people with advanced liver disease (i.e., F3-F4) or certain extrahepatic conditions.  Prohibited treatment for people who use drugs or alcohol unless they they have six months of abstinence or are “actively engaged in drug treatment”  The AIDS Drug Assistance Program (ADAP):  Authorized treatment ONLY for people with advanced liver disease (i.e., F3-F4) or certain extrahepatic conditions.

19. Medi-Cal Managed Care Issues  1 out of 3 Californians has Medi-Cal (11 million)  75%-80% are in “managed care” plans, rather then “fee-for-service”  Medi-Cal managed care (MMC) plans instituted additional restrictions beyond the treatment utilization policy  e.g., limiting to one specialist in a large county, requiring abstinence only, denying every initial request, refusing to allow infectious disease or primary care docs to prescribe

20. Positive Changes Spurred by Advocacy  Medi-Cal: Updated policy, effective July 1, 2015:  Allows for treating F2-F4  Allows for treating many people regardless of “F score” Including people w/ certain extrahepatic conditions and co- occurring conditions (e.g., HIV, HBV, diabetes, debilitating fatigue due to HCV). Including populations at high risk for transmitting the virus (e.g., people who inject drugs, women of childbearing age who wish to become pregnant, gay men who have “high-risk sex”)  ADAP: Updated policy for FY 15-16, allows for treatment of all regardless of “F score”

21. How We Advocated for Improved Tx Access  Public Comment to Department of Health Care Services (Medi-Cal) and Office of AIDS (ADAP)  We coordinated and submitted sign-on letters in response to DHCS and ADAP proposed HCV treatment utilization policies. Included public comment with suggestions for how the policies could be improved and aligned with clinical best practices and professional guidelines.  To inform these comments, we consulted with experts in the field, including hepatologists, infectious disease specialists, and primary care providers who have been treating HCV for a number of years.

22. Sign-on letters to state agencies

23. How We Advocated for Improved Tx Access  Consulted with clinicians about “on the ground” access issues, including issues with MMC plans and connected clinicians and their patients to legal aid through the Health Consumer Alliance (HCA).  Partnered with legal groups  Such as the National Health Law Program (NHeLP) and the Health Consumer Alliance (HCA), to track these issues and work to have them reported to DHCS. This is an ongoing area of advocacy.

24. How We Advocate for Improved Tx Access  Meetings with DCHS  Started in response to original policy  Brought clinicians to these meetings  Now an ongoing area of advocacy as we bring clinicians to DHCS to explain the issues they are seeing on the ground  Participation on Advisory Committees  Governor’s High-Cost Drugs Work Group  Medi-Cal Managed Care Advisory Group

25. How We Advocate for Improved Tx Access  Talk with the press directly and connect journalists to providers and patients.

26. Covered California & Commercial Payers  Covered California is state exchange  Tiering of drug formularies, Tiers 1-4 Tier 1 is low-cost generics Tier 4 is “specialty” or high-cost drugs Cost-sharing up to 30% on “specialty” medications  In 2015, all new HCV drugs were tier 4 in every Covered California plan. In 2016, this is still largely true, with a few exceptions.  Many Covered California and private payers are engaged in similar rationing as the public programs

27. Addressing Cost-Sharing in Covered CA  Encouraged Covered California to institute a cap on “specialty” drugs  Worked in coalition with other healthcare advocacy groups through participation in the Covered California Specialty Drug Work Group  Since January 2016, most people now pay $250 per drug per month  Platinum plan pays $150 per drug per month  Bronze plan pays $500 per drug per month

28. Work Remains

29. Medi-Cal Access Challenges Remain  Utilization of HCV drugs in Medi-Cal is low  Est. ~200,000 Medi-Cal beneficiaries with HCV and only 4% have been treated *  Still reports of disparate fidelity to the state policy by MMC plans, which translates into inequitable access for MMC beneficiaries around the state.  Discussion with legal advocates about whether to continue administrative advocacy approach or engage in legal advocacy. * There may be some overlap between individuals treated in 2014 and 2015, so the total number treated may be less than 7,965. MMCFFS 20141719430 20155255561

30. Other Challenges  Getting a handle on what is happening in the private marketplace.  Numerous plans.  Difficult to get access to their prior authorization forms.  Difficult to get data to know how many Californians total have been treated for HCV in recent years.  Understanding treatment access in the state prisons.  State prisons still have F3-F4 restriction.  Don’t know what utilization has been.

31. Advice for Other Advocates

32. Suggestions for Advocacy  Stay on message  Everyone with HCV deserves a cure  Work in coalition  With other organizations and individuals affected by HCV  Collaborate with legal and medical experts  Don’t recreate the wheel  Talk to folks on this call and in other states to get examples of letters and other materials  Talk to journalists  They may not quote you, but they often use what you say to direct their reporting and use you as a resource for referrals to patients and providers  Be invovled with the bureacuracy  Go to your Medicaid program’s meetings, get on email lists  Ask state leadership the hard questions and be tenacious

33. Thank you for being part of the movement to cure all* *Thanks to Daniel Raymond at Harm Reduction Coalition for coming up with this phrase

34. Contact Information Emalie Huriaux Director of Federal & State Affairs, Project Inform Co-Chair, California Hepatitis Alliance (415) 580-7301 ehuriaux@projectinform.org www.projectinform.org www.calhep.org

35. Hepatitis C Treatment Access: State-Level Advocacy Successes Dawn Fishbein, MD, MS Scientific Director, Viral Hepatitis Research MedStar Health Research Institute June 17, 2016

36. Disclosures Advisory Boards: BMS, Gilead Grant Funding: Gilead Stock ownership: Gilead, Abbvie

37. MedStar TLC Navigation

38. Approach Living in Washington, DC has its advantages … Staying involved with local and national government efforts and advocacy organizations – HAHSTA – HHS – Action Plan (stakeholder from NVHR and IDSA) – AfPA's (Alliance for Patient Access) Hepatitis Therapy Access Physician's Working Group – NVHR Best Practices Workgroup – Collaborations through research – PCORI, CTSA, Gilead FOCUS – DC Health Finance and DC Medicaid; MedStar Medicaid Not sure what this approach would be considered?

39. Process for change Ongoing process Got involved when DC Medicaid was not spending as much as they planned in 2015 DC Medicaid did not approve Harvoni until 2-13-15 DC Health Finance had a meeting for HAHSTA, NIH and clinicians DC not as restrictive as other states, small and reasonable Prior: F2 and greater (including HIV/HBV patients), urine drug screen (including marijuana), LMN for all patients Now: providers will work with patients on adherence and abstinence F1-F2, HIV and HBV at any stage, no urine tox, no LMN if for preferred drug

40. Current Status & Future Efforts New PBM – Magellan – Dramatic improvement over Xerox – Website; approvals in 48-72 hours Continue to attend the DURB meetings; send emails with any changes from other states – discuss new medications Managed Medicaid – conversations with MedStar MCO Future: – Universal testing – ED testing and linkage to care – Goal towards elimination

41. Lessons Learned: Physicians/Providers Get involved! Other Physician Advocates: – Cami Graham, Lynn Taylor, Stacey Trooskin, others? Give the patient prospective … be their clinician expert Pharmacy Benefit Managers make a difference address your concerns with the State Medicaid team not PBM Get invited and GO to drug utilization review board meetings Go regularly Other: P&T, quarterly approval, HHS Stakeholder Put in the PA packet regardless Advocate for all patients and providers Not solely your own

42. Questions

43. Dude, Where’s My Cure? Getting to Universal Coverage for HCV June 17, 2016 Michael Ninburg Executive Director Hepatitis Education Project www.hepeducation.or g

44. Efforts in Washington State Q1 2014 - MCO’s start denying coverage for SOF, SOF/SIM; most commercial payors will follow suit by Q3/Q4 1.Individual advocacy 2.Appeal letter for cirrhotic patients 3.Work with WA Medicaid on HCV carve-out www.hepeducation.or g

45. January 1, 2015 – HCV carve-out starts Summer, 2015 - White paper for regulators, including WA OIC Begin work with Washington State Insurance Commissioner Letter from CMOs and leading specialists to OIC Q1-Q3 2015

46. Q4 2015 – Q1 2016 In late 2015, successfully persuaded the Washington State OIC to survey national and regional insurance carriers that operate in Washington State regarding their HCV coverage policies and forward latest update to IDSA/AASLD HCV Guidance to carriers. Subsequent to OIC survey of insurers, several carriers removed fibrosis restrictions consistent with HCV Guidelines effective January 1, 2016 including e.g., Aetna, United, Anthem, and Premera Blue Cross Large commercial plans in WA now have polices consistent with HCV Guidance. (Some smaller plans still holding out.)

47. Early 2016 - Other States, Nat’l Carriers Letters to United Health Care and Cigna regarding discriminatory HCV coverage restrictions, cc’ing several state insurance departments (WA, Illinois, Texas, NY, CA, NM) and U.S. Dept. of Labor (EBSA) As result of letter to carriers, NY, Illinois, and NM Departments of Insurance requested more info on coverage restrictions. Held tele-conference with the United Health Medical Director and their Legal and Regulatory team regarding our argument that their sobriety restrictions constitutes illegal and unethical discrimination. To date, no change. Cigna informed us that effective March 1, 2016 they had removed abstinence requirement.

48. Q1-Q2 2016 - New York and Illinois In early 2016, successfully persuaded the Illinois Department of Insurance to formally review the HCV access issues In early 2016, successfully persuaded the NY Department of Financial Services to actively initiate an investigation and survey insurance carriers that do business in NY state regarding their HCV coverage policies and practices In June 2016, Illinois Department of Insurance informed us that they were in conversations with HCSC (BCBS Illinois, Texas, Montana, NM) and HCSC had updated their HCV prior authorization policy and removed the reference to fibrosis levels as a condition for authorization; the forwarded policy also did not include any sobriety restrictions.

49. Q1-Q2 2016 - Florida In early 2016, drafted and submitted requests to Large non-profit Blue Cross Blue Shield carriers (Health Care Service Contractor and Florida Blue) to remove inappropriate HCV coverage restrictions based on F2 fibrosis or greater, copying insurance regulators In spring 2016, continued discussions with Florida Department of Insurance regarding concerns regarding HCV access Turnover at FL OIR; we were contacted to discuss requirements for commercial plans’ coverage of HCV drugs in Florida. Recommendations to OIR include guidelines consistent with HCV guidance and consideration of out-of-pocket max for patients.

50. U.S. Dept. of Labor In Winter 2015-2016, drafted letters and correspondence with Department of Labor (Employee Benefits Security Agency) regarding HCV access issues including White Paper In early 2016, successfully persuaded the Department of Labor to formally review HCV access issues In Spring 2016, at their request, provided suggested language to Department of Labor regarding guidance to carriers stating that HCV abstinence and sobriety restrictions illegally violate ERISA’s non-discrimination provisions Next call with DOL is June 22, 2016

51. Washington State Lawsuits Coordinated with Washington State plaintiff’s attorney on class action lawsuit filed against two major northwest regional insurance carriers (Regence and Group Health) in early 2016. Lawsuit resulted in Regence and Group Health reversing their position and updating their coverage criteria consistent with HCV Guidelines. Coordinated with Washington State plaintiff’s attorney on lawsuit against WA HCA (PEBB). To date, not settled. Hearing on motion for preliminary injunction (and motion to dismiss) on June 17, 2016.

52. Washington State Lawsuits - Medicaid Coordinated with Washington State plaintiff’s attorney and CHLPI on lawsuit against WA HCA (Medicaid). In May 2016, a federal Court in Washington granted plaintiff’s motion for a preliminary injunction barring the HCA from denying coverage for HCV drugs to Washington state Medicaid patients based on their fibrosis scores.

53. Washington State Lawsuits - Medicaid 60 days to report back on compliance with court order First updated protocol non-starter, substituted fibrosis for other restrictions Plaintiff’s attorney will not settle until HCA meets its obligation