Providing key policy setters and decision makers in the global health sector with unique and transformational insights into healthcare dynamics derived from granular analysis of information. February 2014 Patient Savings Program Use Analysis IMS Institute for Healthcare Informatics Patient Savings Program Impact Analysis 11 Waterview Boulevard, Parsippany, NJ 07054, USA
IMS Institute for Healthcare Informatics February 2014 Background A large number and variety of patient savings programs have been established over the past twenty years by pharmaceutical manufacturers in an effort to reduce financial barriers to patients and enable them to receive the medicines prescribed to them by healthcare professionals. This has occurred even as generic drugs have risen to comprise 84% of all dispended prescriptions in 2012 (see Exhibit 1). The extent to which these programs are used, the type of medicines typically involved, and the way in which patient savings programs are used to support patient treatment has not been well analyzed or documented. The purpose of this report is to summarize the findings of a study undertaken by IMS Health and which was funded by Pfizer, Inc. The interpretation of the study results and preparation of this summary was undertaken independently by a team from the IMS Institute for Healthcare Informatics which is part of IMS Health but operates separately and according to its own mission, research agenda and guiding principles 1. This research was conducted by the Institute independently and without industry or government funding. EXHIBIT 1 Generics share of total prescriptions 54% 57% 60% 63% 67% 72% 74% 78% 80% 84% 43% 46% 50% 54% 58% 63% 66% 70% 73% 77% 11% 11% 10% 9% 9% 9% 8% 8% 7% 7% 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Branded Generics Unbranded Generics Source: IMS Health, National Prescription Audit, Dec 2012 1 See page 11 of this report, or visit the IMS Institute website www.theimsinstitute.org. 2
Approach and Sources The analysis utilized IMS Health longitudinal anonymized patient-level prescription data as gathered from retail pharmacies. Coverage of all retail pharmacy transactions is estimated by IMS Health to be 74%, and 68% of individual prescriptions are able to be linked longitudinally at the patient level. This level of coverage provides comprehensive and detailed understanding of the 3.5 billion retail prescriptions filled through chain store, independent and food store retail pharmacies in 2012 2. Retail prescriptions filled through mail-order or specialty pharmacies are not included in this analysis. Prescriptions filled by patients using a co-pay card or voucher that are part of a Patient Savings Program are identified in the retail information provided by retail pharmacies and assigned to the specific Program under which they are filled. A minimum number of 100 unique patients is required for a Patient Savings Program to be included in this analysis. Prescriptions covered by third party commercial payers are included in this analysis. Prescriptions filled under a Patient Savings Program are included regardless of the level of deductible, co-insurance or co-payment that may have been required. Prescriptions reimbursed under Medicaid or Medicare Part D programs are not included as patient subsidies are not permitted under these programs. Methodology Retail prescriptions, as captured by the IMS Health National Prescription Audit and filled between November 1, 2011 and October 31, 2012, were included in this analysis. Patients are counted once only in this analysis for each Patient Savings Program under which they have filled one or more prescriptions. All of the prescriptions filled by that patient under the Patient Savings Program are included in the analysis. Patients filling prescriptions under multiple Patient Savings Programs are counted each time they use a different Patient Savings Program. Almost all of these programs are for branded pharmaceuticals, with only 23 of the 549 programs covering generic drugs. Analysis in this report is based on all programs. 2 IMS Institute for Healthcare Informatics, Declining Medicine Use and Costs: For Better or Worse? May 2013 3
Findings Among the key findings regarding the use and impact of Patient Savings Programs are summarized in the following areas: Number and characteristics of Patient Savings Programs (see Exhibit 2) A total of 549 Patient Savings Programs were identified, covering medicines for the treatment of a range of disease areas, including dyslipidemia, asthma, diabetes and sleep disorders. A relatively small number of prescriptions are filled through Patient Savings Programs: only 1.2% of total prescriptions and 6.1% of branded prescriptions are filled through these programs during the time period studied. Of total prescriptions dispensed during the 12 month period studied, 80.4% were dispensed as generics, 18.4% were dispensed as brands and were not part of a Prescription Savings Program, while 1.2% were dispensed as part of a brand s Program. Over the course of the 12 month period, 14 million patients benefited from participation in these programs, of whom 90% used one program and 10% used multiple programs. EXHIBIT 2 Number and Characteristics of Patient Savings Programs Patient Savings Program (PSP) Prescription Usage PSP Programs Used By 14 Million Patients 1.2% 18.4% 10% 80.4% 90% Branded Non PSP Prescriptions Generic Non PSP Prescriptions Total Prescriptions using PSPs Used 1 Program Used More than 1 Program 4
TOP 10 PSP THERAPEUTIC AREAS Top Therapeutic Areas for Patient Savings Programs (see Exhibit 3) Patient Savings Programs are available for medicines used in the treatment of a broad range of large therapeutic areas, including cholesterol management, hypertension, asthma and diabetes, each of which affect millions of Americans and is of major public health importance. Most of the top therapeutic areas for patient savings programs are for chronic conditions where patient adherence to their healthcare professional s recommended therapy is important and conditions are often asymptomatic. The top therapeutic areas include many treatment options, including both generic and branded medicines. Across the top 10 therapeutic areas for Patient Savings Programs, the number of prescriptions filled ranged from 9.2 million to 1.1 million, and the share of prescriptions filled under these programs ranged from 1% to 9% of total prescriptions for that class. EXHIBIT 3 Top Therapeutic Areas for Patient Savings Programs Top 10 Therapeutic Areas by number of prescriptions using PSP Programs Rx Share by Branded PSP, Generic PSP and non PSP scripts Top 10 PSP Therapeutic Areas PSP Rx Counts (in Millions) PSP Patient Counts (in Millions) No. of Programs CHOLESTEROL 7% 93% CHOLESTEROL 9.2 2.5 26 GERD 9% 91% GERD 4.7 1.3 13 CONTRACEPTIVE ADHD HYPERTENSION 5% 6% 1% 95% 94% 99% CONTRACEPTIVE 3.8 1.0 12 ADHD 3.5 1.1 13 ASTHMA 3% 97% HYPERTENSION 3.1 0.8 29 DIABETES ALLERGIES PAIN 2% 6% 1% 98% 94% 99% ASTHMA 2.9 1.5 26 DIABETES 2.5 0.8 34 SLEEP DISORDER 2% 98% ALLERGIES 1.9 1.1 11 0% 20% 40% 60% 80% 100% PAIN 1.8 0.6 37 Branded PSP Scripts Scripts without PSP SLEEP DISORDER 1.1 0.2 5 5
Level of initial co-pays (see Exhibit 4) Of the 1.2% of total prescriptions filled using Prescription Savings Programs, 93% were for products with an initial co-pay of more than $20, including 34% that were prescriptions with co-pays in excess of $50. The share of prescriptions filled under a Patient Savings Program in each therapy area with co-pays in excess of $50 range from 14% in the case of allergies to 48% in the pain therapy area. A wide range of initial co-pays are observed for prescriptions filled using Prescription Savings Programs, with initial co-pays ranging as high as several hundred dollars. In the case of diabetes treatments, for example, 13% of prescriptions filled had an initial copay of $100 or more, including 5% with initial co-pays in excess of $200 per prescription. EXHIBIT 4 Level of Initial Co-Pays PSP Usage by Therapeutic Area and Initial Co-Pay (Top 10 by Number of Total Rx s Supported by Programs) ALL MARKETS 7% 59% 34% CHOLESTEROL 7% 68% 26% GERD 2% 57% 41% CONTRACEPTIVE 6% 60% 34% ADHD 6% 59% 35% HYPERTENSION 2% 59% 39% ASTHMA 12% 61% 27% DIABETES 10% 57% 32% ALLERGIES 16% 70% 14% PAIN 4% 48% 48% SLEEP DISORDER 5% 52% 43% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% $0 - $20 (Rx: 3.2M) $20.01 to $50 (Rx: 25.3M) $50.01+ (Rx: 14.6M) 6
Patient Savings and Out-of-Pocket Costs (see Exhibit 5) The average patient savings per prescription filled under a Patient Savings Program was $40, and ranged from $24 on average per contraceptive prescription filled under a Patient Savings Program to $46 per ADHD prescription. The range of savings per prescription is wide: for example, the average savings per diabetes prescription is $42 but over 10% of prescriptions saved the patient in excess of $100. Patients using Patient Savings Programs were left with an average final out of pocket cost of $26 per prescription. EXHIBIT 5 Patient Savings and Final Out of Pocket Costs Average Patient Savings per Rx Using PSPs ALL MARKETS CHOLESTEROL GERD CONTRACEPTIVE ADHD HYPERTENSION ASTHMA DIABETES ALLERGIES ALLERGIES PAIN PAIN SLEEP DISORDER SLEEP DISORDER $40 $34 $43 $24 $46 $46 $32 $30 $42 $42 $28 $28 $35 $35 $37 $37 0 10 20 30 40 50 10 20 30 40 50 CONTRACEPTIVE SLEEP DISORDER Average Patient Out of Pocket Costs per Rx after PSP Program ALL MARKETS CHOLESTEROL GERD ADHD HYPERTENSION ASTHMA DIABETES ALLERGIES PAIN $21 $24 $24 $25 $25 $24 $26 $26 $25 $28 $35 0 10 20 30 40 Average Patient Savings Average Final Patient Out Of Pocket Costs 7
PROGRAM LENGTH IN MONTHS Longevity of Patient Savings Programs (see Exhibit 6) Almost all Patient Savings Programs continue to run for many years. Only three programs that were launched prior to 2009 had been terminated by the end of October 2012 Of the 296 existing brands with Patient Savings Program programs launched prior to 2009, 80% had programs running for more than two years as of the end of October 2012. EXHIBIT 6 Longevity of Patient Savings Programs Number of Brands by Length of Days (Excluding Products Launched 2009+) 43 to 45 Months 40 to 42 Months 37 to 39 Months 34 to 36 Months 31 to 33 Months 28 to 30 Months 25 to 27 Months 22 to 24 Months 19 to 21 Months 16 to 18 Months 13 to 15 Months 10 to 12 Months 7 to 9 Months 4 to 6 Months 1 to 3 Months 25 18 10 9 10 7 11 12 6 3 9 9 5 4 151 0 20 40 60 80 100 120 140 160 Only three of these brands ended all programs during study period Count of Brands Note: Search for start date ended on January 2009 which results in the majority of programs starting this month Brands launched from 2009 and after are not included in the length of program analysis above Results include data for third party payers only 8
Use of branded patient savings programs when generic products are available (see Exhibit 7) Of the 526 Patient Savings Programs for branded drugs, 459 programs are for brands which do not have an AB equivalent 3 generic product also available in the market. The 67 branded programs where AB equivalent generic products are available accounted for 0.05% of the total number of prescriptions filled during the 12 months period analyzed. EXHIBIT 7 Use of Branded Patient Savings Programs when Generic Products are Available 526 Branded Programs with or without AB Equivalents (Molecular Level) 67 459 Percent of Total Prescriptions where Brands are competing with AB Equivalent at Molecule Level: 0.05% Branded Programs Do not compete with AB Equivalent Compete with AB Equivalent Study Limitations This analysis is based on IMS Health anonymized patient longitudinal prescription data as reported by retail pharmacies and captured in the IMS Health National Prescription Audit. As a result, Patient Savings Programs that operate through mail order or other non-retail pharmacies are not covered, including certain orphan, specialty and oncology product programs. In addition, the Patient Savings Programs analyzed in this report are limited to those having 100 or more unique patients assisted during the 12 month period ending October 31, 2012. While Patient Savings Programs are only utilized to offset the patient costs for prescriptions purchases entirely by the patient (i.e. cash purchases) or in part by third party commercial payers, this analysis only considers prescriptions filled under third party commercial payer plans. 3 AB equivalent drugs are products meeting necessary bioequivalence requirements as specified by the Food and Drug Administration 9
Co-insurance payments and insurance deductibles are not included in calculations of patient total out of pocket costs; only deductibles paid at the point of prescription dispensing are included and the impact of Patient Savings Programs on those amounts. Discussion Patient Savings Programs have been introduced in part to provide support for patients who may otherwise be deterred from treatment options due to high out-of-pocket costs associated with their use. These programs are for medicines covering a broad range of important therapy classes associated with diseases affecting large patient populations. This study is intended to describe the magnitude, extent and impact of Patient Savings Program currently available in the U.S. market. While prescriptions filled using Patient Savings Programs represent only 1.2% of total scripts and 6.1% of branded scripts, over 14 million patients received some benefit over the course of a twelve month period from lower out of pocket copay costs provided by these programs across a broad range of therapy areas. This reflects the finding that while these programs cover a large part of the market, their overall level of use is modest relative to the total medicines market. The average co-pay for a patient after applying the Patient Savings Program savings was $26, providing an average savings per prescription of $40. The range of savings varies considerably and patient savings in some cases exceed $100 or more per prescription. The study also finds that the vast majority of programs are for branded medicines for which no AB equivalent generic product is available. Patient Savings Programs run for long time spans, providing continuous support to eligible patients who are able to anticipate ongoing assistance with co-pay levels over many years. Overall, this study suggests that Patient Savings Programs play a selective and meaningful role in addressing patient concerns about co-pay levels and out of pockets costs, enabling them to receive the benefits from medicines prescribed by their healthcare professional. Further study is required to assess the impact of these programs on patient health outcomes and utilization of health services. 10
About the Institute The IMS Institute for Healthcare Informatics leverages collaborative relationships in the public and private sectors to strengthen the vital role of information in advancing healthcare globally. Its mission is to provide key policy setters and decision makers in the global health sector with unique and transformational insights into healthcare dynamics derived from granular analysis of information. Fulfilling an essential need within healthcare, the Institute delivers objective, relevant insights and research that accelerate understanding and innovation critical to sound decision making and improved patient care. With access to IMS Health s extensive global data assets and analytics, the Institute works in tandem with a broad set of healthcare stakeholders, including government agencies, academic institutions, the life sciences industry and payers, to drive a research agenda dedicated to addressing today s healthcare challenges. By collaborating on research of common interest, it builds on a long-standing and extensive tradition of using IMS Health information and expertise to support the advancement of evidence-based healthcare around the world. Research Agenda The research agenda for the Institute centers on five areas considered vital to the advancement of healthcare globally: The effective use of information by healthcare stakeholders globally to improve health outcomes, reduce costs and increase access to available treatments. Optimizing the performance of medical care through better understanding of disease causes, treatment consequences and measures to improve quality and cost of healthcare delivered to patients. Understanding the future global role for biopharmaceuticals, the dynamics that shape the market and implications for manufacturers, public and private payers, providers, patients, pharmacists and distributors. Researching the role of innovation in health system products, processes and delivery systems, and the business and policy systems that drive innovation. Informing and advancing the healthcare agendas in developing nations through information and analysis. Guiding Principles The Institute operates from a set of guiding principles: The advancement of healthcare globally is a vital, continuous process. Timely, high-quality and relevant information is critical to sound healthcare decision making. Insights gained from information and analysis should be made widely available to healthcare stakeholders. 11
Effective use of information is often complex, requiring unique knowledge and expertise. The ongoing innovation and reform in all aspects of healthcare require a dynamic approach to understanding the entire healthcare system. Personal health information is confidential and patient privacy must be protected. The private sector has a valuable role to play in collaborating with the public sector related to the use of healthcare data. 12