INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.

Slides:



Advertisements
Similar presentations
The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.
Advertisements

Convenient Access to Retail Pharmacies - Analysis on Preferred Cost-Sharing Pharmacy Networks December 16 & 17, 2014 Division of Benefit Purchasing and.
Challenges of Serving Low-income Medicare Beneficiaries: Impact of Cost Sharing Cindy Parks Thomas Brandeis University Schneider Institute for Health Policy.
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.
Medicare Part D Nari Wang Health Law Unit 199 Water Street New York, NY Center for Independence of the Disabled, NY February 23, 2010.
Plantemoran.com JANUARY 27, (r) Final Regulations.
Subject Selection and Recruitment David Wendler Department of Clinical Bioethics NIH, USA.
Columbia University IRB IRB 101 September 21, 2005 George Gasparis, Executive Director, CU IRB Asst. V.P. and Sr. Asst. Dean for Research Ethics.
Long Term Care: Medicare Prescription Drug Coverage in Institutions and Our Communities Larry Kocot Vanessa Duran.
© 2005 National Mental Health Association The Medicare Drug Benefit: What Is It and What Does it Mean for Mental Health? Get Educated, Get Enrolled An.
TAYLOR MELANSON Providing Prescription Drug Coverage to the Elderly: America’s Experiment with Medicare Part D By Mark Duggan, Patrick Healy, and Fiona.
Medicare Part D Overview of Options, Creditable Coverage, Required Notices, COB and Health Care Reform.
Special Needs Plans Susan Nedza, M.D., M.B.A. Chief Medical Officer, CMS Chicago Regional Office March 23, 2006.
A Brief Introduction to GIC’s System of Retiree Health Insurance OPEB Commission April 5, 2012 Catharine Hornby, General Counsel, GIC.
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.
© 2005 National Mental Health Association The Medicare Drug Benefit: What Is It and What Does it Mean for Mental Health?
The AIDS Institute The Impact of Essential Health Benefits on People Living with HIV/AIDS Carl Schmid Deputy Executive Director ADAP Advocacy Association.
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.
Background Development of Anxiety Among Depressed Veterans After Antidepressant Usage Zhiguo Li, Paul Pfeiffer, Katherine Hoggatt, Kara Zivin, Karen Downing.
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.
Planned Emergency Research Exception from Informed Consent Requirements September 2007.
HIPAA – How Will the Regulations Impact Research?.
Analyzing NCHS Drug Data Amy B. Bernstein, Sc.D. Presented at the NCHS Board of Scientific Counselors Meeting January 28, 2005 U.S. DEPARTMENT OF HEALTH.
1 Department of Medical Assistance Services Stakeholder Advisory Committee October 22, 2014 Gerald A. Craver, PhD
Transitions: Moving Dual Eligibles to Medicare Prescription Drug Coverage Tony Culotta, Director, Appeals and Enrollment Group Babette Edgar, Director,
0 Beneficiary Choices in Medicare Part D and Plan Features in 2006 Supported by PhRMA September 13, 2006.
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.
Health Care Reform: 2012 and Beyond Summary of Benefits and Coverage –Effective for participants and beneficiaries who enroll or re- enroll beginning.
Draft Model Manufacturer Agreement Medicare Coverage Gap Discount Program Public Meeting June 1, 2010.
Arnold School of Public Health Health Services, Policy, and Management 1 Drug Treatment Disparities Among African Americans Living with HIV/AIDS Carleen.
FleetBoston Financial HIPAA Privacy Compliance Agnes Bundy Scanlan Managing Director and Chief Privacy Officer FleetBoston Financial.
HIV Care Continuum New Diagnoses, 2011, Fulton County, Georgia.
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.
HIV Care Continuum Persons Living With HIV, Georgia, 2012.
Medicaid Analytic eXtract (MAX) Presentation to the Academy Health Annual Research Meeting San Diego, California Dave Baugh, CMS/ORDI June 8, 2004.
Dual Eligibles with Mental Disorders and Medicare Part D: How are They Faring? Julie Donohue University of Pittsburgh Haiden Huskamp Harvard Medical School.
Avalere Health LLC | The intersection of business strategy and public policy Formulary Design: Balancing Cost and Access November 1, 2005 Presented By:
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.
Prescription Drug Expenditures and Healthcare Burdens in the Medicaid Population G. Edward Miller, Jessica S. Banthin and Thomas M Selden AHRQ Conference.
Medicaid Fee-for-Service: Prior Authorization Criteria & the Role of the DUR Board Charles Agte, Pharmacy Administrator Health Care Services June 19, 2013.
© 2004 Moses & Singer LLP HIPAA and Patient Privacy Issues Raised by the New Medicare Prescription Drug Program National Medicare Prescription Drug Congress.
Overview New Federal Regulations and Guidance David Panush Director, Government Relations March 22, 2012 California Health Benefit Exchange Board Meeting.
Pricing Under ASP Manufacturers submit quarterly ASP data by 11- digit National Drug Code (NDC) For multiple source drugs, the payment allowance limit.
Chapter 7: Medicare Part D Prescription Drug Coverage in Patients with Chronic Kidney Disease 2015 A NNUAL D ATA R EPORT V OLUME 1: C HRONIC K IDNEY D.
Overview of the New Medicare-Endorsed Prescription Drug Discount Card Program The Intersection of Business Strategy and Public Policy The Health Strategies.
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.
Initiatives Drive Pediatric Drug Development January 30, 2002.
HIV Care Continuum New Diagnoses, 2011, Georgia. Persons with HIV Engaged in Selected Stages of the Continuum of Care, United States Percent
Medication Therapy Management Part D Programs Presentation Developed for the Academy of Managed Care Pharmacy Updated: February 2014.
6 th Annual SNP Leadership Forum Danielle Moon, J.D., M.P.A. Director, Medicare Drug & Health Plan Contract Administration Group The Centers for Medicare.
Medicare Advantage Special Needs Plans CY 2012 Landscape and CY 2013 Application Review Preparation October 28, 2011 Deanna Greene, Acting Director Division.
Medicare Part C & D 2012 Plan Ratings SNP Leadership Forum October 28, 2011 Liz Goldstein, Ph.D. Centers for Medicare & Medicaid Services.
Promoting consumer access to affordable Prescription drugs
CMMI Enhanced Medication Therapy Management Model
Quality Improvement Program: Special Needs Plans
2016 Annual Data Report, Vol 1, CKD, Ch 7
FDA’s IDE Decisions and Communications
CMS and FDA The History and Horizon of Regulatory Coordination
Chapter 7: Prescription Drug Coverage in Patients with CKD
2016 Annual Data Report, Vol 2, ESRD, Ch 12
Medicare Risk Adjustment Update
Indian Policies and Procedures (IPPs) OASIS December 7, 2017
Healthcare Reform and Medicare Part D
HFMA Regulatory Overview
Jan Berger, M.D., M.J. Senior Vice President Chief Medical Officer
Medication Therapy Management Part D Programs
Overview of Tribes and Tribal Entities as Employers under the Patient Protection and Affordable Care Act.
Presentation transcript:

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 1 CMS 2012 Medicare Prescription Drug Benefit Symposium Part D Protected Class Drugs Monica Reed, Pharm.D., LCDR, USPHS, Medicare Drug Benefit and C&D Data Group, CMS (ARS Response Card: Channel 41)

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 2 Disclosure “I, Monica Reed, declare no conflicts of interest or financial interests in any product or service mentioned in this presentation, including grants, employment, gifts, stock holdings, or honoraria.”

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 3 Learning Objectives Identify the percentage of the Part D drug costs that were attributable to protected class drugs for 2010 Identify the percentage of all fills of protected class drugs represented by the top three most frequently prescribed protected drug classes for 2010

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 4 Discussion Topics Protected class drug requirement overview. Utilization rates Top classes and drugs by utilization and cost. Demographic data of Part D enrollees who utilized protected class drugs

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 5 Part D Protected Class Drug Requirement

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 6 Purpose of the Protected Class Policy Ensure beneficiaries reliant upon these drugs would not be substantially discouraged from enrolling in certain Part D plans Ensure access to vital drugs for vulnerable patient populations Limit the risks and complications associated with interruptions in therapy Ensure continued access for beneficiaries stabilized on therapy

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 7 Chapter 6 of the Part D Manual- Section Part D sponsor formularies must include all or substantially all drugs in the following six classes: Anticonvulsant Antidepressant Antineoplastic Antipsychotic Antiretroviral Immunosuppressant (for prophylaxis of organ transplant rejection)

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 8 MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Section 1860D 11(e)(2)(D)(i): Set forth the requirements for the approval of proposed plans and plan designs Gave CMS the responsibility to ensure beneficiaries receive clinically appropriate medications so that formularies are not discriminatory As a result, CMS has exercised its authority to ensure that Part D plan formularies and benefits do not discourage enrollment by certain part D eligible individuals under the plan

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 9 ACA Patient Protection and Affordable Care Act (ACA), Section 3307: Codified Part D formulary requirements with respect to certain categories or classes of drugs In general, a Part D sponsor is required to include all covered Part D drugs in the six clinical classes of concern. Exceptions may be established The Secretary shall establish the criteria for the identification of classes and categories of clinical concern and any exceptions through the promulgation of a regulation which includes a public notice and comment period

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 10 Chapter 6 of the Part D Manual- Section Protected class drug formulary requirements: Formularies must include substantially all drugs in the six categories that are FDA approved by the last CMS upload date for the upcoming contract year New drugs or newly approved uses for drugs in the six categories will be subject to an expedited P&T committee review The expedited review must occur within 90 days of the drug entering the market The drug must be added by the end of this 90 day period

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 11 Chapter 6 of the Part D Manual- Section Protected class drugs and utilization management: Are designed to encourage adherence and access to drugs that are especially important for beneficiaries Cannot be implemented to steer enrollees who are currently taking a protected class drug to preferred alternatives For HIV/AIDS drugs, utilization management tools such as prior authorization and step therapy are not allowed Part D sponsors may apply prior authorization to establish appropriate payment under Part B or Part D, even if the beneficiary is currently taking the drug Protected class drugs are not exempt from concurrent drug utilization review requirements outlined in 42 CFR (c)(2)

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 12 Protected Classes Formulary Review Initial formulary review occurs during Stage 1 of the formulary review process: Formularies are reviewed for drugs from the protected classes Monthly Submission Review: Formularies are reviewed to ensure that new protected class drugs are added to the formulary within the 90 day expedited review timeframe Consistent with the CY 2012 Formulary Information HPMS memo, failure to include a protected class drug during the required HPMS formulary submission window will result in the suppression of the formulary in Medicare Plan Finder (MPF)

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 13 Part D Protected Class Drug Utilization

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 14 Overview Approximately 40% of all Part D enrollees used at least one protected class drug in 2010 Protected class drugs accounted for 13% of all Part D fills and 18% of the total Part D drug costs in 2010 The top three protected classes (Antidepressants, Anticonvulsants, and Antipsychotics) accounted for 94% of fills for protected class drugs Most beneficiaries only used one drug within a specific protected class, with the exception of Antiretrovirals

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 15 Methodology Data Sources 2009 and 2010 Prescription Drug Event (PDE) data as of May 18, – 2011 PDE data as of January 30, 2012 (for yearly utilization trends) Drug information derived from Medi-Span and First Databank

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 16 Methodology (continued) Formulary Review Data and Medi-Span Identified reference National Drug Codes (NDCs) for drugs included in the protected class drug formulary review check Identified Generic Product Identifier 10 (GPI 10) for protected class drug reference NDCs Created a protected class drug NDC dataset by using GPI 10s to identify all possible protected class product NDCs

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 17 Methodology (continued) PDE Data Used to determine the following for protected class drugs: Number of utilizing beneficiaries Total gross drug cost Number of fills (adjusted for 30 day equivalents) Common Medicare Environment (CME) Beneficiary characteristics (e.g. gender, age, and race)

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 18 Protected Class Drug Utilization & Costs Protected class drug utilization and costs were similar in 2009 and 2010: In 2009, 39% of all Part D enrollees used at least one protected class drug. These drugs accounted for 20% of all Part D drug costs and 12% of all Part D drug fills In 2010, 40% of all Part D enrollees used at least one protected class drug. These drugs accounted for 18% of the total Part D drug costs and13% of all Part D drug fills

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 19 Percent of Total Fills by Protected Drug Class

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 20 Percent of Total Gross Drug Cost by Protected Drug Class

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 21 Utilization of the Top Five Protected Class Drugs Utilization Ranked by Total Protected Class Drug Fills for the Top Five Protected Class Drugs Protected ClassDrug Name 2010 Number of Fills Percent of Total Protected Class Drug Fills AnticonvulsantsGabapentin30,027, % Antidepressants Citalopram Hydrobromide 22,399, % Antidepressants Sertraline Hydrochloride 19,464,4398.7% Antidepressants Fluoxetine Hydrochloride 12,078,5515.4% Antidepressants Paroxetine Hydrochloride 11,944,2085.4%

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 22 Utilization of the Top Five Protected Class Drugs Utilization Ranked by Total Protected Class Drug Cost for the Top Five Protected Class Drugs Protected ClassDrug Name 2010 Total Drug Cost Percent of Total Protected Drug Cost Antipsychotics Quetiapine Fumarate $1,749,620, % AntipsychoticsOlanzapine$1,587,515,4929.5% AntipsychoticsAripiprazole$1,184,940,1527.1% Antidepressants Duloxetine Hydrochloride $685,563,5144.1% AnticonvulsantsGabapentin$611,739,8843.6%

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law Trend of Total Gross Protected Class Drug Cost and Utilization Gross Drug Cost Number of Fills

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 24 Protected Class Drug Utilization by Gender & Race The distribution of protected class drug use by gender and race is consistent through time and proportional to gender and race distribution of enrollment: In 2009 and 2010 females accounted for 66% of protected class drug utilization In 2009 and 2010 white beneficiaries accounted for over 80% of protected class drug utilization Please see Table 1 and Table 2 in Appendix A for additional information

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 25 Protected Class Drug Utilization by Age Beneficiaries less than 65 years of age were the highest utilizers of protected class drugs: In 2009 and 2010 enrollees less than 65 accounted for approximately 40% of the total fills and over 30% of the total number of enrollees who utilized protected class drugs Please see Table 3 in Appendix A for additional information

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 26 Average Utilization Per Beneficiary Average utilization was consistent across years: Beneficiaries that used protected class drugs, on average used 1.7 distinct drugs (GPI 10) across all of the classes in 2009, and 1.8 in 2010 There were 11.8 fills (not unique drugs) for these drugs per beneficiary in 2009, and 11.7 fills in 2010

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 27 Number of Beneficiaries Who Used One or More Protected Class Drug With the exception of Antiretrovirals, in 2009 and 2010 most beneficiaries only used one drug within a specific protected class: In 2009: Anticonvulsants 84%, Antidepressants 77%, Antineoplastics 96%, Antipsychotics 78%, Antiretrovirals 19%, Immunosuppressants 83% In 2010: Anticonvulsants 84%, Antidepressants 77%, Antineoplastics 95%, Antipsychotics 79%, Antiretrovirals 21%, Immunosuppressants 84% Please see Table 4 and Table 5 in Appendix A for additional information

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 28 Limitations Protected class drugs have non-protected indications For example, gabapentin for post herpetic neuralgia The analysis to determine the number of beneficiaries who filled one or more protected class drug was completed at the GPI 10 level For example, combination drugs such as Antiretrovirals were counted as one drug since they have a unique GPI 10 The analysis to determine the number of beneficiaries who filled more than one protected class drug in a drug class is based on multiple fills at any point during the year

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 29 Summary Review There were over 130 million fills for protected class drugs accounting for 13% of all Part D drug fills and 18% of total Part D drug costs in 2010 In 2010, 40% of all Part D enrollees used at least one protected class drug Antineoplastics, antiretrovirals, and immunosuppressants account for less than 6% of fills for protected class drugs The top 5 protected class drugs by fills account for over 40% of fills for protected class drugs in 2010 The top 5 protected class drugs by cost account for over 30% of cost for protected class drugs in 2010

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 30 Assessments

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 31 Assessment Question 1 What percentage of all fills of protected class drugs are represented by the top 3 most frequently prescribed protected drug classes for 2010? 94% 64% 87% 76%

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 32 Assessment Question 2 What percentage of the Part D drug costs were attributable to protected class drugs In 2010? 30% 18% 24% 11%

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 33 Questions?

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 34 Contact Information For more information please contact: LCDR Monica Reed (410) Part D Formulary Questions

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 35 Presentation Evaluation Please get your ARS Response Card ready

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 36 APPENDIX A

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 37 Table 1 Number of Fills and Protected Class Drug Utilizing Beneficiaries by Gender Gender Number of Fills Percent of Total Fills Number of Beneficiaries Percent of Total Beneficiaries 2009 Female86,506, %6,774, % Male45,983, %3,527, % Unknown23, %1, % 2010 Female91,039, %7,148, % Male48,466, %3,764, % Unknown2, % %

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 38 Percentage of Fills and Protected Class Drug Utilizing Beneficiaries by Race Race Percent of Total Fills Percent of Total Beneficiaries Percent of Total Fills Percent of Total Beneficiaries White83.42%82.07%83.11%81.81% Black10.38%10.91%10.50%11.00% Asian1.27%1.59%1.32%1.64% Hispanic3.08%3.50%3.18%3.57% North American Native 0.53%0.50%0.54%0.50% Other/ Unknown 1.32%1.44%1.36%1.49% Table 2

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 39 Table 3 Percentage of Fills and Protected Class Drug Utilizing Beneficiaries by Age Group Age Group Percent of Total Fills Percent of Total Beneficiaries Percent of Total Fills Percent of Total Beneficiaries < %30.70%40.79%30.98% %31.25%27.20%31.64% %24.04%20.00%23.60% %12.49%10.75%12.28% ≥ %1.51%1.26%1.50%

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 40 Table 4 Number of Beneficiaries Who Used One or More Protected Class Drug (GPI 10) by Protected Drug Class in 2009 Protected Drug Class % of Beneficiaries with 1 Drug % of Beneficiaries with 2+ Drugs % of Beneficiaries with 3+ Drugs Beneficiaries with 1 Drug Beneficiaries with 2 Drugs Beneficiaries with 3 Drugs Anticonvulsants 83.72%16.28%2.94% 3,226,445514,204 91,976 Antidepressants 77.07%22.93%4.17% 5,435,5031,322, ,660 Antineoplastics 95.54%4.46%0.22% 684,17730,365 1,503 Antipsychotics 78.47%21.53%5.15% 1,891,539394,986 89,632 Antiretrovirals 18.55%81.45%57.00% 21,37128,172 36,118 Immunosuppressants 83.30%16.70%1.05% 75,32614, Note: % of enrollees with 2+ and 3+ drugs are not mutually exclusive.

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 41 Table 5 Number of Beneficiaries Who Used One or More Protected Class Drug (GPI 10) by Protected Drug class in 2010 Protected Drug Class % of Beneficiaries with 1 Drug % of Beneficiaries with 2+ Drugs % of Beneficiaries with 3+ Drugs Beneficiaries with 1 Drug Beneficiaries with 2 Drugs Beneficiaries with 3 Drugs Anticonvulsants 83.85%16.15%2.93% 3,547,979559,057100,698 Antidepressants 76.80%23.20%4.23% 5,746,2341,419,869261,063 Antineoplastics 94.96%5.04%0.28% 701,10035,1981,945 Antipsychotics 78.72%21.28%5.14% 1,943,368398,50691,104 Antiretrovirals 20.69%79.31%56.33% 25,74028,57439,263 Immunosuppressants 84.24%15.76%0.90% 83,96114, Note: % of enrollees with 2+ and 3+ drugs are not mutually exclusive.