Marc Claussen, Chiesi USA, Director, Market Access. Donna White, Chiesi USA, Sr. Director, Contracting and Compliance

Transcription

1 Marc Claussen, Chiesi USA, Director, Market Access Donna White, Chiesi USA, Sr. Director, Contracting and Compliance

2 The views/observations expressed in this presentation are the personal views/observations of the speakers and do not reflect the views/observations of Chiesi USA.

3 Understand Commercial Contracting Segments Contract Life Cycle Management and Maintenance Commercial Pricing Calculations and Payments Measure Contract Success and Recognize ROI WHATEVER YOU WANT TO DISCUSS

4 Who has been working in the Contracts space for Less than 2 years? Less than 1 year? Less than 6 months? Less than 1 month?

5 What is your company s contracting structure? Multiple Teams Multiple People Small group of people Island of One

6 What types of Contracts do you manage? Government Commercial GPO Hospital Trade Wholesaler Specialty Pharmacy

7 In which department does your contracting team reside? Legal Finance Sales Market Access Other Are there other contracting teams in different departments?

8 Has your company entered into an outcomes-based agreement?

9 The U.S. Health Care System: An International Perspective DPE Research Department 9

10 In 2015, Pharmaceuticals represent roughly 13% of the US Healthcare dollar Fastest growing segment of US Health care dollar 11% in 2009 Medicines are the most visible and relatable to the public and non-healthcare professionals Patient cost share has increased dramatically in the last 2-3 years largely due to the ACA (Affordable Care Act)/Obama Care Medicine spend grew 8.5% in 2015 outpacing growth since 2010* However Net Price growth slowed in 2015 as price concession by manufacturers rose sharply (2.4% on protected brands) In the US list price is rarely the final price as rebates and price concessions are provided in each segment * Source Medicines Use and Spend in 2015 IMS 10

11 Survey asked respondents: Which stakeholder has been the most influential in the past five years? Which will be the most important going forward? Moved to most influential Second most influential Very little influence Specialists were the most influential year ending 2006 Payers jumped 20% to take the lead Source: Monitor April 2011

12 Access to affordable Healthcare is a hot topic Recent Pharmaceutical Pricing pressures are here to stay Payers and providers are moving away from open formularies with weak incentives Traditional Managed Care formularies are moving to exclusion formularies Hospitals and institutions are placing tighter controls on utilization Contracting is a key component of a successful Market Access Strategy

13 Everybody wants to do it Some have done it Regardless It s Here to Stay!

14 Changes to Medicare (Government Insurance for citizens 65 and older) Part A reimbursement to hospitals over the last several years are driving a trend towards shared risk and value verses volume commercial payers are beginning to follow suit APM (Alternative Payment Models) per defined events are taking the bundled payment reimbursement system to the next level incorporating reimbursement impacts based on patient satisfaction, re-hospitalizations, hospital acquired infections, use of EHR, and other outcomes measurements. These risk sharing reimbursement arrangements intend to incentivize quality of outcomes verses volume of treatments preformed 14

15 Contracting is a tactical implementation of an overall brand position and corporate objectives

16 Where does your brand want to play? Where is your brand with the its lifecycle? How is your brand performing today against the plan verses where you want it to preform tomorrow? What is important to your brand s success? What resources do you have available to implement a contracting tactic? How do the Payers perceive your brand?

17 Commercial Medicaid Medicare GPO IDN 340B Specialty Pharmacies

18 Health Insurance Coverage in the United States 2% 13% Employer 15% 48% Other Private Medicaid Medicare 16% 6% Other Public Uninsured In April 2015 Government Payer Enrollment has grown to 33% of the population with estimates as high as 50% in 2018

19 Increased Volume through Increased Access Ability to Build Business Relationships Spillover Potential Increased Profitability Product Uptake

20 Who is the internal driver? For what Product(s)? Bid due? Customer Request? Renewal? Maintain existing business or new business? Financial implications? (G2N, Revenue Contribution, Contractual obligations) Formulary Structure? (Payers and Hospitals) Access Only? Price Protection? Best Price Implications?

21 Supply Chain availability? Tier Structure? Restrictions? All key stakeholders involved? Routing for approval and signature? Clear understanding of end goal? Pick up the phone? Face-toface?

22 The US Market Access Team s core function is to secure favorable and profitable reimbursement for outpatient drugs Prescribers see payers and product reimbursement has a Hassle Factor Prescribers are influenced by a product s perceived ease of prescribing Most drugs are covered by payers how they are covered determines the ease of prescribing US Market Access Team selectively targets payers across all segments to create a general perception that a product is well reimbursed by payers

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25 Non-government owned and largely for profit health insurance companies Two main components of Health Insurance for US patients with commercial insurance Medical Benefit 86% of the Health Care dollar Pharmacy Benefit Products 14% of Health Care Dollar PBM s (Pharmacy Benefit Managers) have become a driving factor for obtaining product access on commercial payer formularies

26 Health Insurance Companies United Health Care 14M Lives Aetna 7.5 M Lives Cigna 6M Lives Anthem 14M Lives Blue Cross Blue Shield of MA 1.5M Lives Highmark 1.1M Lives Wellcare 1.6M Lives PBM s (Pharmacy Benefit Managers) Express Scripts (ESI) - 44M Lives CVS/Caremark 24M Lives

27 The predominant pharmacy benefit design for commercial insurance patients is a Open Tiered Benefit The most common benefit design is a 3 tier open formulary Formulary Tier 1 generics - $5 - $25 Co-pay for patients Formulary Tier 2 preferred brands - $25 - $50 Copay for patients Formulary Tier 3 Non Preferred Brands - $50-$75 Co-pay for patients In the past all products were covered but recent trending includes excluded products Conceived and built during a period when the average cost of a prescription was $150 Manufacturers negotiate discounts (rebates) for formulary position Tiered formularies are designed to use patient cost sharing to drive consumer like behavior

28 Payer also include several other UM (Utilization Management) tools to influence prescribers and patients towards preferred formulary products Prior Authorization providers are required to get prior approval before a product can be dispensed PA s are often used to create more work for a provider and their staff this is often seen as a hassle and can dampen prescribing behaviors For some payers PA s are used on all expensive products (>$600) Step Edit requires a patient to have tried and failed on preferred formulary options In some cases manufacturers will pay rebates to reduce restrictions or influence Prior Authorization approval criteria

29 Rebates Market Share Volume Access Restrictions PA Criteria Risk Sharing Price Protection Tiers Bundled Administration Fees Best Price Implications

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31 Originally launched in 1965 as a retirement medical insurance benefit All citizens over 65 years of age are eligible Until 2006, only covered hospitalization (Medicare Part A) and physician services (Medicare Part B) In 2003, the US congress passed the Medicare Modernization Act (MMA) As of 2006, coverage of outpatient drugs for Medicare beneficiaries (Medicare Part D)

32 Growing at Medicare is funded by the federal government but the pharmacy benefit is administered by commercial entities The Medicare pharmacy benefit is structured in the same way as the commercial pharmacy benefits with a few minor differences Source: Kaiser Family Foundation Website

33 The most common benefit design for Medicare patients includes a 4- Tier benefit design Formulary Tier 1 generics - $5 - $25 Co-pay for patients Formulary Tier 2 preferred brands - $40 - $75 Co-pay for patients Formulary Tier 3 Non Preferred Brands - $75-$100 Co-pay for patients Formulary Tier 4 Specialty Brands- 20%-30% Co-Insurance for patients Any drug not listed on a formulary is largely considered not covered

34 Initial Deductible - $400 Initial Coverage Limit - $3,700 Out of Pocket Threshold - $4,950 Coverage Gap (Donut Hole) - $3,700 - $4,950 Catastrophic Coverage - $7,425

35 Negotiating for Medicare formulary placement is much like the commercial segment and many of the commercial plans also act as a Medicare Plan. Strategy Differences Best Price Implications - None

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37 Nearly all of the states have transitioned form a completely open benefit to a Preferred Drug List (PDL) All pharmaceutical manufacturers can participate in Medicaid if they sign a CMS agreement which requires a non-negotiable discount calculation - minimum of 23.1%. Requires participation in FSS and PHS Most States have little to no co-pay associated with the drug benefit and therefore they rely heavily on utilization management tools Medicaid programs are much more aggressive than commercial plans at forcing utilization of preferred products through the use of Prior Authorization and Step Edit tools.

38 Most states utilize bid (tender) processes and there is very little negotiating Formularies are typically set annually Medicaid formularies are the most restrictive in the US system making the Medicaid segment a key function of the ease of prescribing Restricted access means better pricing for the states but less choice for patients and providers In most therapeutic categories bids pit products against one another for formulary positions

39 Bids to the states for Medicaid formulary inclusion come in the form of supplemental rebates added on to the mandatory rebates discussed previously Mandatory rebates are shared between the federal and state governments Supplemental rebates are reserved solely by the states For most products the discounts provided in mandatory and supplemental rebates constitute the highest discounts provided any segment

40 Baseline AMP (Average Manufacturer Price) AMP BP (Best Price) CPI-U Penalties Supplemental Rebates URA (Unit Rebate Amount)

41 URA Calculation = 23.1% $ $ = $ AMP URA Medicaid Price AMP minus BP Calculation = (AMP less BP) > (23.1% * AMP) $ $ = $ AMP Best Price Additional URA based on Baseline AMP/Baseline CPI-U * current quarter CPI-U; if current AMP is greater then additional URA URA

42 Drug s Best Price (40% of WAC) + CPI (Consumer Price Index Penalty) + Supplemental Rebate = Actual Medicaid Price $ ($ $ $240) = $120 WAC (AMP for Example) Best Price CPI Penalty Supplemental Medicaid Price Rebate

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44 Safe Harbor 3% Admin Fee Most Favored Nations Clause Product Mix Class of Trade Added Value Tier Based Volume Based Market Share Incentives Mergers and Acquisitions Regional Purchasing Coalitions

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46 Customer Goal Product Mix Added Value Tier Based Volume Based Market Share Incentives Relationship to GPO Watch for Best Price Implications

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48 Policies and Guidelines Product Mix Services Fair Market Value Open or Closed AMP is calculated off sales to Retail Community Pharmacies

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50 Cross-functional Pricing Committee Review Life Cycle Management Launch End of patent life Off-patent Generic launch Average Manufacturer Price (AMP) Medicare Part B/Average Sales Price (ASP) Best Price (BP) Implications Market Now Future

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52 How do you measure the return on investment on your contract? Pre-Contract Analysis Post-Contract Analysis

53 Product Specific Spillover to other payer types Spillover to other Products Term of Contract Amendment or New Contract

54 Units Affected Customer Share of Product Gross Revenue Financial Impact Involve other stakeholders when needed Total Effect on Net

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56 Involve Key Stakeholders Early Teams Individuals Don t wait until the product is approved Educate early and often Create a set process Open or Closed

57 Look for improvements in efficiencies Communication tools Review tools Contract Management Systems/Repositories Be proactive Create guidelines and process documents

58 Create guidelines and process documents Establish go/no-go language Prepare for the pullthrough after execution And don t forget Price