How do Payers utilize the AMCP edossier System for pre-approval information and could it qualify as a safe harbor?

Transcription

1 How do Payers utilize the AMCP edossier System for pre-approval information and could it qualify as a safe harbor? Jackie Gladman Vice President, Sales and Marketing, Dymaxium Elizabeth Sampsel, Pharm.D, MBA, BCPS Senior Consultant, Payer Engagement and Partner Collaborations, Dymaxium Alan Pannier, Pharm.D, MBA Director of Clinical Services, Veridicus Health Webinar Objectives Discuss recent research on how US payers are utilizing the AMCP edossier System for preapproval information Share current AMCP edossier System insights regarding the information exchange, tracking and usage Provide Payer perspective on drug evaluation process, the need for pre-approval information and discussion on the attributes of a safe harbor Consider how AMCP edossier System could be a potential safe harbor mechanism for preapproval information and support the decision-making process 1

2 AMCP edossier Evidence Horizon and Resources Library Product Evaluation Apps and Interactive Tools FD Focus newsletter AMCP edossier System for US Formulary Decisions US P&T Competition Manufacturer Value edossiers BIM / CE Templates. Manufacturer emodels Evidence Comparison and Drug class reviews Global Future HCDMs P&T monographs and presentation templates HTA Review and Peer Insights A central source of Evidence, Insights and P&T Tools to support formulary decision makers with starting their product evaluation. A central erequest tool. Interactive edossier. Integrated P&T Tools - saving time and improving efficiencies. Pipeline Survey #1 Overview Conducted Jan % When do Payers Initiate the Majority of Pipeline Research? Responses: % actively involved in pipeline research 20% 10% 22% 22% 15% 18% 8% 15% Survey Demographic 46% MCO 27% PBM 19% Hospital/Health Systems 7 % Other 0% Within 6 months prior to approval 6-12 months prior to approval months prior to approval months prior to approval 24+ months prior to approval Other (I don't know, postapproval, etc...) 85% prior to approval Earlier review required for formulary positioning and budget forecasting 2

3 Decision Process Factors Accounted for When Determining Pipeline Research Timing Used in the P&T Committee review process Payer use of Pipeline Research 73% Therapeutic area 86% Used to develop predictive comparative cost-effectiveness models 30% Cost implications 86% Used to inform organization financial and operational strategies 54% Competitive landscape 69% Used to inform product reimbursement status/tier placement Used in product price negotiations/risk share agreement discussions 32% 32% Your specific covered population 51% Used to develop prior authorization programs 55% Other 7% Used to develop pharmacy and medical management systems to monitor utilization 38% Other 5% Respondents: 87 They (health plans) are going to start forming a decision matrix fairly early on. Payer AMCP Focus Group AMCP Annual Meeting, 2016 Data Around the Exchange Do Payers Request Manufacturer Information during the Product Pipeline Research Process? 13% 8% 79% Yes, we request information from manufacturers No, we don't request information from manufacturers Don't know Manufacturers Response to HCDMs Request for Pipeline Information 100% 75-99% 50-74% Less than 50% Don't know 13% 13% 18% 22% 34% 0% 10% 20% 30% 40% Timeliness of Response was rated highly as a limiting factor: 41% of those requesting info 45% of those that do not request info PAYERS frustrated at inconsistent manufacturer response only 13% respond all the time. 3

4 How do Payers Describe the System? 47% indicated AMCP edossier System is a central source for dossiers and other information What can the AMCP edossier System do to further support your product evaluation and formulary decision-making process? Survey Jan 2016 N=49 #1 Provide preliminary product information prior to FDA approval (48%) #2 Increase the number of dossiers in the System (46%) #3 Provide pipeline product tracking including PDUFA dates (42%) So What Have We Learned HCDMs are: Conducting pipeline reviews up to 24 months in advance Using the System for pipeline research See the System as a central source for information Challenged by the manufacturer response HCDMs want MORE! 4

5 Decision Maker/Manufacturer Exchange of Information Pre-Approval - What Works? AMCP edossier System User Survey Conducted November 2016 Survey Purpose Understand the exchange of pre-approval information In response to the FDA hearings what is the physical mechanism of exchange No FDA sanctioned system for the exchange How to support the need for safe harbor? 5

6 Survey #2 Response 172 Participants Registered users of the AMCP edossier System 75% are actively involved or familiar with the pre-approval formulary decision making process within their organization (N=172). Over 85% have been involved in making a request for pre-approval product information from manufacturers 1-10 times in the last year (N=106). Is the System Working for the Information Exchange Between Payer and Manufacturers? 92% 80% 97% 86% said that the unsolicited request process within the AMCP edossier System met or exceeded their need to support the information exchange between manufacturers and decision makers pre approval (N=106). stated that the System is easy to use and 64% said that within the System it is easy to specify what is needed from manufacturers (N=66). responded positively to the ease of use of the erequest Tool within the AMCP edossier System to request pre approval information from manufacturers (N=109). said that the System currently provides sufficient tools and information for pre approval product review (N=107). The AMCP edossier System supports the Information Exchange. 6

7 What should AMCP edossier System do better to support the exchange of pre-approval information between manufacturers and payers? 77% Make it easier to understand what information is available from manufacturers (Response N=31 are those that felt that exchange could be improved) Manufacturer Response Payer Perception 40% Better 26% Same Manufacturer response rate is better (40%) or the same (26%) for those participating in the AMCP edossier System versus those who are not (N=106). Manufacturers are responding to requests in the AMCP edossier System. 7

8 Manufacturer Information Requested by Payers Information requested by Payers Clinical 93% Safety 69% Therapeutic area 60% Health Economic 56% (N=108) 100% said that it would be helpful to have ready access to a manufacturer curated information repository within the AMCP edossier System (information that does not require an unsolicited request e.g. disease information, publicly available information, etc.) (n=106) Payers receive requested information but would prefer more readily available information from manufacturers. Timeliness of manufacturer response to payer requests for pre-approval product information (whether or not they participate in the edossier System) 40% 30% 37% 36% 20% 18% 10% 6% 3% 0% Immediately Within 1 week Within 2 weeks No real consistency with respect to response time Most don t respond/other N=107 8

9 Since AMCP Format 4.0 (Updated April 2016 with guidance on exchange of pre-approval information) the Exchange of Information is: 45% Easier 49% Same (N=105) Survey Summary Pre-approval exchange is happening now o V4.0 guidance has facilitated improvement System works to support the exchange Opportunity for increasing manufacturer participation and timeliness of information 9

10 Payer Perspective Drug Evaluation Process Pharmacy Benefits Manager Therapeutic Assessment Committee (TAC) Pharmacy and Therapeutics Committee (P&T) Value Assessment Committee (VAC) Compile all available medical literature Evaluate clinical impact of FDA approval Compare medication to currently available products Typically internal PBM clinicians Review evaluations and recommendations from TAC Make final clinical determination Evaluate medical policy and step therapy clinical appropriateness Formulary placement recommendations based on financial considerations Evaluates medications based on net cost Decisions made based on evaluating utilization patterns, cost implications, and potential member disruption 10

11 Need for Early Information Pipeline management Formulary management planning Budget forecasting Actuarial analysis Increase timeliness of reviews Meet regulatory timelines Pre-approval Information Exchange Current Process Legal restrictions on communication prior to FDA approval Limited information available No consensus on type of information Inability of current state to meet demands of the market What is safe harbor? Restricted to population health decision makers to prevent unintended use of information Allows bi-directional communication for information exchange Promotes transparency in available clinical and economic data available for the requested product The AMCP edossier System meets safe harbor requirements for pre-approval information exchange. 11

12 Conclusion HCDMs are conducting pipeline reviews up to 24 months in advance AMCP edossier System is viewed as a central source for evidence and information AMCP Format v4.0 guidance has facilitated improvement in pre-approval exchange Challenges include manufacturer participation and timeliness of information Pre-approval exchange is happening now AMCP edossier System functionality supports payer pre-approval drug evaluation activities and meets safe harbor requirements Questions? 12