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CMAC 2011 Presentation
 

CMAC 2011 Presentation

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  • Joke about answering to Gus Gavone or VinneBoombotsGround rules – yell questions whenever (or raise hand) mention dinner conversation
  • Mention Imperial March Theme
  • Talk about the 5 deadliest sins of business.
  • Talk about the 5 deadliest sins of business.
  • During a restructuring, this is a prime opportunity
  • Discuss aligning decision making across all Phases of drug development
  • To sum up the first five trends, the pipeline trends: the pipeline has grown and become targeted to the same targets in ever smaller patient populations further narrowed by biomarkers. You can see how this leads—as though by design—to increasing competition. It’s tempting to think this competition is down the road and something to worry about when it comes. This would be a mistake, because competition is already hitting the clinical trials—competition for patients, competition for the best investigators, competition for clinical trial sites. Competition also makes clinical trials longer and riskier. First of all, the control arms are simply better than they used to be, so you have to take the trials farther out to see a separation if you see one at all. This is a big issue, because trials may have been designed assuming a lower efficacy from the control arm, so the trials may not be properly powered. Second, who knows how long progression-free survival (PFS) will be acceptable as a primary endpoint. If the FDA suddenly finds overall survival (OS) the only acceptable endpoint, at a minimum trials will be longer, and trials designed with PFS endpoints may have to be redone. The implication of this competition is that flawless commercialization efforts will become vital in order to succeed in a “me too,” “me three,” “me the twentieth VEGF inhibitor” market.Do you have any questions on the first five trends? Time for the last five trends: The commercial trends.
  • We have described 10 trends that are transforming the oncology marketplace. These trends begin with structural changes in the oncology pipeline that lead directly to intense competition. At the same time, changes in underlying oncology economics have prompted an ongoing change in the most effective oncology commercialization strategies. The days of “if you build it, they will come” are over. Competition is precisely the environment where companies need to be able to differentiate. However, at this same moment, customers and their needs are changing. This means outdated strategies are not matched to today’s commercial realities.We are at an inflection point. Going forward, winning oncology companies will recognize the new reality and organize their portfolios, launch planning, and customer-facing resources to meet this new reality head on.

CMAC 2011 Presentation CMAC 2011 Presentation Presentation Transcript

  • Preparing For A Specialty Launch: What You Need To Know Nathan White, CPC • Executive Director, Access and Reimbursement CBI „s 2nd Annual Commercialization and Market Access Congress Philadelphia, PA • December 7, 2011 WE’RE WAITING FOR YOU AT THE GLOBAL CROSSROADS. WE KNOW THE WAY IN HEALTHCARE.™1 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • World’s leading provider of sales, marketing, and communications The leading management One of the industry’s consulting group specializing top global CROs solutions for the healthcare industry in biopharma Services include: Services include: Consulting practices include:  Phase I-II  Outsourced sales teams and  Brand management (FIH or bioequivalence studies) sales support  Business development  Phase IIb – Phase IV studies  Advertising, branding and PR  Clinical development  Strategic partnerships  Digital and closed loop marketing  Medical affairs  Bioanalytical services  Patient outcomes, REMS and  Pricing and market access  Clinical data services/technology Rx access/adherence  Sales  Medical education  Staffing services2 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • The Payer Strikes Back!“If the pharmaceutical industry‟s principle challenge of thelast 10 years has been reinventing the R&D model toaddress declining productivity, the next 10 years couldvery likely be termed „the rise of the payer.‟”- Lujing Wang, Ryan Richardson - Campbell Alliance TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • 4 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Industry Megatrends Specialty trend (spend) gaining lots of attention • By 2016, 8 of top 10 worldwide drugs will be specialty Pharma companies will move toward developing more targeted and tailored therapies and more personalized medicine • About 70% of current pipeline drugs have biomarkers associated with them. Pipeline for specialty is substantial • 600 new drugs in pipeline (40% oncology and 30% of these infused)SOURCE: Accredo Keynote Address, Armada Summit, May 20115 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Industry Megatrends Legislative and regulatory activity will shape our future • Many of today’s Indigent patients will become insured (underinsured) The co-pay card tipping point • The government has already restricted commercial co-pay activity and private payers are nextSOURCE: Accredo Keynote Address, Armada Summit, May 20116 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • The beginning of the end… CVS Caremark Corp.s pharmacy-benefit business is recommending customers stop covering more than 30 drugs next year, including diabetes treatments and an erectile-dysfunction pill, to save money and combat drug- maker coupons that promote brand-name medicine over cheaper alternatives WSJ, November 19th, 2011 Drug-company coupons that promote brand-name medicine over cheaper alternatives could hike drug costs by $32 billion over the next decade, according to a study from the industry that manages pharmacy benefits WSJ, November 3rd, 20117 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Industry Megatrends Legislative and regulatory activity will shape our future • Many of today’s Indigent patients will become insured (underinsured) The co-pay card tipping point • The government has already restricted commercial co-pay activity and private payers may be next The demonstration of value is becoming more critical • Payers are already demonstrating resistance to high cost specialty products w/o a value propositionSOURCE: Accredo Keynote Address, Armada Summit, May 20118 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • What should we care about in a specialty product launch? VALUE PATIENT ACCESS DATA 1. 2 3. Clinical & Cost Effectiveness To Therapy To support value claims9 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • 1. Define Your Goals10 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Step 1: Define Your Goals! DEMONSTRATE FOSTER GENERATE 1. 2 3. Value Patient access to therapy Data to support value demonstration11 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Company with some US commercialization experience Mid-size Biotech launched a lyo-formulated SQ injectable biologic for a Company chronic disease into a very crowded market. Co. had label restricting administration by a HCP in a market where most competitors were self- administered This caused payers to cover the product under the medical benefit in most cases. Prescriber adoption was poor due to the hassles with reimbursement when alternatives were easily accessible with fewer access hurdles. Results & Lessons Learned Better integration with the clinical and regulatory teams could have yielded better Phase III studies with the commercial environment in mind. They also could have considered a pro-active risk management program to mitigate concern with patient education and altered the label pre-approval.12 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • 1. Define 2. Build Your Goals Your Team13 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • 2. Build Your Team!14 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Define the Market Access Function Market Access Functional Consolidation Activities Integrated into Previous Functional Area Market Access Function Overseeing Activity Payer Marketing / Payer Market Development Brand Management/Marketing Pricing and Contracting Finance Account Management/Field Operations Sales Health Economics and Outcomes Research Medical AffairsSOURCE: Lujing Wang, Ryan Richardson; Campbell Alliance15 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Your Internal Team: Current vs. Consolidated Current Consolidated • Various budget holders • Single budget holder • Non-aligned management • Aligned management and incentives VS. and incentives • Turf conflicts • Reduced in-fighting • Decision by committee • Accountable decision making16 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Steps to Create the Market Access Function • Increase internal core competencies: › Understand payer needs and translate into tactics with clinical team › Influence marketing strategy and create tactics to achieve goals › Work with new product planning, business development to ensure payer perspective is taken into consideration • Restructure infrastructure and operations › E.g. HOER contributing at all levels of decision making process Global VS. Local Global – large evidence generation, stakeholder management software, prioritization Local – on-the-ground perspective, knowledge of local politics, institutions, stakeholdersSOURCE: Lujing Wang, Ryan Richardson; Campbell Alliance17 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Considerations for Strategic Partnerships Aligned values Long-Term growth Open communication and innovation and objectives › Don’t underestimate the › This includes the › Is the supplier innovating alignment of values breakdown of typical for 5+ years from now? client-vendor game › Objectives and risks playing › Is reimbursement and should be shared access their core • E.g. price padding, competency? • E.g. Stock brokers who exaggeration get paid by the trade vs. › Do their business groups your portfolio’s work together to produce performance results? • Are they willing to share in financial risk?18 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Key Considerations For Specialty Pharmacy Evaluation • Disease management expertise • Payer and employer relationships • Technology platforms • Pharma (customized) • Ownership • Linkage to copay assistance • Legal flexibility in program design • Risk sharing (performance- foundations • Field resources based) • Price for data • Training Programs Contracts Data19 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Organizational Requirements The right value evidence needs to be delivered to the right audience at the right time by the right people. Stakeholder mapping and engagement is pivotal in rolling out the study outputs efficiently and effectively. Hypothesis Evidence Value Validation Generation Communication Strategic Visionary Rigorous Scientist Credible Ambassador20 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • 1. Define 2. Build 3. Refine Your Your Your Goals Team Strategy21 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Who cares about value?22 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • What is evidence-based medicine? ―The conscientious, explicit, and judicious use of current evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.‖SOURCE: Sackett DL, Straus S, Richardson S, Rosenberg W, Haynes RB. Evidence-based Medicine: how to practice and teachEBM, ed 2. London: Churchill Livingston, 200023 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Number of Occurrences of Value Terminology by Year in Core Clinical JournalsSOURCE: Reich, S., & White, N. (2010). Speaking of Value in Healthcare: The Need for Common Understanding of Terminology.Poster Session, International Society for Medical Publication Professionals.24 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Percent of Increase of Occurrences of Value Terminology from 2006 to 2009 in Core Clinical JournalsSOURCE: Reich, S., & White, N. (2010). Speaking of Value in Healthcare: The Need for Common Understanding of Terminology.Poster Session, International Society for Medical Publication Professionals.25 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • How do we define value? THE PLAYERS AHRQ NIH PCORI Payers Patients and providers26 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • ONC Landmark Study: Pipeline Trends Increased Pipeline Overlap The oncology Implications pipeline has grown…  Clinical trials will become increasingly difficult to complete …and become highly because of competition for patients, investigators, and sites. targeted to…  Regulatory approval will likely become more challenging as the …the same molecular standard of care fills with ―me-too‖ oncology products that pathways in… improve the standard of care on control arms. …ever narrower  Commercialization efforts will become increasingly vital as patient populations… companies struggle to differentiate themselves in the oncology marketplace. …further fractured by biomarkers. The oncology market has matured, and new oncology products will be launched in the face of direct competition from similar products. Commercialization will become increasingly important in the decade to come.SOURCE: Campbell Alliance27 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • ONC Landmark Study: Commercial Trends New Commercial Realities Oncology is now a Implications blockbuster machine…  Oncology commercialization is at an inflection point. ...saturated with sales representatives.  In the world of 2000, there were fewer reps, few access issues, and few concerns about reimbursement. All these have Oncologists are no changed in 2010, and this implies the need for the following: longer the sole arbiters  Proactive portfolio management of therapy…  Pricing and access preparation early in development …and payers are  Flawless launch restricting access.  Best-in-industry sales representatives There may be a  Patient co-pay programs and direct-to-consumer outreach bursting oncology  Medical Affairs investment asset bubble. Winning oncology companies will recognize the new reality, and will organize their portfolios, launch planning, and customer-facing resources to meet this new reality head on.SOURCE: Campbell Alliance28 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Innovative Contracting: The Future of Payer-Pharma Relationships Innovative Contracting Contract Types 1 2 3 Performance-Based Contracts Risk-Sharing Agreements Traditional With a “Twist”  An outcome or behavior is  Manufacturer assumes some risk  A standard contract with a rebate measured and tied to the based on anticipated is tied to another factor besides structure of the contract. utilization, adverse market share or volume. events, performance, or some other  For example, the manufacturer factor.  This can include a price increase can commit to an outcome or the cap, escalating rebates, rewards  Variation to the expected level will plan can commit to programs to for loyalty, portfolio contracts, or require payment or concessions by support behaviors such as a one of the parties. anything that is in addition to the adherence. standard contract.  For example, the manufacturer can  The rebate level can be tied to commit to effectiveness within 10 whether the outcome or behavior doses and cover the costs for is achieved. patients requiring more than 10 doses—the manufacturer takes on the risk.29 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Benefit Design Shift Correlates To Goals Of Innovative Contracts •Risk (and cost) shift •Both short and long- to manufacturer. term costs considered. Cost Cost Shifting Reduction Budget Value Focus Predictability •Focus shifts to •Some contracts have outcomes vs. potential benefits. utilization. Several trends in benefit management are aligned with the objectives stated for implementing an innovative contract. As these trends continue, they create an environment where stakeholders are more open to innovative contracts.30 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • A Glimpse Into the Future: Prime Therapeutics CareCentered™ Contracting • PT is a large national pharmacy benefit manager covering 17M lives for 12 BCBS affiliates • New PBM-manufacturer outcomes-based contracting initiative launched Fall 2011 • Under agreement, in the event therapy does not ―work as expected,‖ manufacturer agrees to either: › Refund cost of therapy › Pay for cost of event treatment (such as a bone fracture in osteoporosis) • Goes beyond outcomes to include: › Cost of care › Adherence › Patient education31 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • 4. 1. Define 3. Refine 2. Build Implement Your Your Your Team Your Goals Strategy Program32 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Key Components Of A Patient Access Program Nursing Support Patient Reimburse- Reported ment and Outcomes Access Call Center & Web Copay Specialty Portal Foundation Pharmacy and Alternate Coordination Coverage Assistance Patient Site of Care Adherence Coordination33 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Does Investment Result in Perceived Leadership?SOURCE: Market Strategies International, ―Good Business and Good Will Go Hand in Hand‖, Oncology Business Review, May 200834 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Well respected medical device manufacturer had Medical Device Firm challenges with spinal surgeon utilization of artificial (Co. C) disc replacement due to negative US coverage policies (CMS NCD) and technology assessments (BCBS TEC) Due to high number of initial PA denials, spine surgeons opted for spinal fusion or other interventions In spite of negative coverage policies, Co C possessed many positive case reviews, positive economic models, 15 years of European peer rev. lit. and a positive NICE tech. assessment Co C launched an appeals support program that collected QoL information from the patient and submitted a personalized appeal package with supporting case studies and NICE TA to the payer on Results & Lessons Learned behalf of the surgeon and patient Co. C saw increased utilization of product due to lower administrative burden on the spine surgeon‟s office. Additionally, patients who may have been denied the procedure obtained approval and were treated.35 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Focusing On the Patient: Patient Reported Outcomes • Helps to develop evidence of effectiveness outside an artificial controlled environment (RCT) • ―Self-reports‖ by a patient • Data collected through self-administered questionnaires or interviews (ex. EQ-5D or SF-36) › Generic › Disease specific • Attempts to assess: › Impairments to well-being › Disabilities › Health perceptions › Quality of Life (QoL) › Other healthcare ratings36 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • US Payers Likely To Use Patient Reported Outcomes (PRO) In Future Decisions How likely are you to use PRO to make coverage and reimbursement policy decisions in the future? (on a scale of 1 to 7 where # of lives = 4,353,435 1=Not likely, 7= Very likely) 5% # of lives = 19,701,655 26% n=22 68% Very Likely # of lives = 51,127,435 Likely Mean 4.5 Not LikelySOURCE: 2011 inVentiv Health Payer Study37 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • US Payers Likely To Follow CMS Lead If CMS publicly leverages the resultsof these studies, how likely are you to follow CMS‟ lead in utilizing PRO to guide your coverage decisions? (on a scale of 1 to 7 where 1=Not likely, 7= Very likely) 1% 14% n=22 Very Likely Likely Not Likely 86%SOURCE: 2011 inVentiv Health Payer Study38 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Company with some US commercialization experience Small Specialty wanted to create and demonstrate value to payers in Pharmaceutical light of loss of patent exclusivity Company (Co. D) Post-approval RCT sought to demonstrate superior effectiveness of buprenorphine medication-assisted therapy paired with Patient Reported Outcomes (in opioid-dependent patients) CAC and trained registered nurses conducted telephonic surveys designed to encourage appropriate compliance & persistency The study concluded that patients were more likely to take their therapy every day and less likely to abuse, compared to controls Results of study presented at AMCP satellite symposia Results & Lessons Learned Better patient support leads to better patient outcomes, reducing overall payer spend; additional messaging to payers on total value of package (product + program) was critical39 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Evidence Development: Pre- and Post-Approval • Prospective › Clinical study data • May include PRO endpoints and cost-benefit analysis › FDA approved label • Retrospective › Pharmacy claims analysis › Chart review › Budget impact modeling › Cost effectiveness analysis (limited use in US) › Registry › Phase IV outcomes study with PRO › Commercial marketing programs40 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Payer Communication of Value Evidence Successful communication with payers requires following three principles. Principles of Payer Communication I Simplicity II Transparency III Credibility  A complete story that  Avoidance of ―black  Well-accepted can be told in a box‖ design and methodology and definite time window subjective validated design assumptions  Concise and crisp  Third-party takeaways that can  Key foundations for endorsement and stay in memory audience to interpret KOL partnership study results41 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Summary VALUE ACCESS Build endpoints into studies early DATA Access programs are Prepare Phase IV worth the investment initiatives PRO can be your Design with data friend Innovative contracts collection in mind don’t have to be SP and HUB data scary Partner with vendors can guide your who will grow with strategy you42 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
  • Thank You!Nathan White, CPCnwhite@inventivhealth.com TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™