Stakeholder Perspectives on The Pharmaceutical Industry in ...

1. Stakeholder Perspectives on The Pharmaceutical Industry in Transition Ian Morrison

3. The Ten Big Issues for the Pharmaceutical Industry Costs for everyone globally, focus on Prices in the U.S(and therefore importation) Losing the Value argument in the US and elsewhere Big Ugly Buyers and Tiering Coverage for the Elderly in the U.S. and Elsewhere AIDS in the Third World: Capitalism run Amok R&D productivity: Is bigger better or is it all a lottery $ 4 Billion Blockbusters or 40x $100 million Intellectual Property under assault Marketing practices as asset or liability: DTC, detailing, rebates and sales force productivity Losing Friends and gaining enemies Leadership finally coming out from the bunker of self-righteous, myopic, isolationism

4. How Consumers Rate Industries Attitudes toward hospitals have remained mostly stable and positive over the last few years. Pharmaceutical companies are being demonized in public debate. Drug companies have seen a dramatic decline in good will since 1997, including a large drop in the last year. Attitudes toward hospitals have remained mostly stable and positive over the last few years. Pharmaceutical companies are being demonized in public debate. Drug companies have seen a dramatic decline in good will since 1997, including a large drop in the last year.

5. Health Care Tops List of Industries Public Wants to See More Regulated

6. Medicare Drug Benefit

7. A Slight Majority Favor the New Medicare Plan�

8. �But Most Elderly are Disappointed with the Specifics

9. Disappointment over Expanded Private Sector Involvement and a Lack of a Reimportation Provision � in the short-term, few employers are actually focusing on this solution. Most are concerned with immediate cost control. � in the short-term, few employers are actually focusing on this solution. Most are concerned with immediate cost control.

10. Most Consumers Think the Medicare Bill will Benefit the Rx industry More than the Elderly

11. Medicare Bill as Three MoviesAs Good as it Gets Prohibition on Price Controls on drugs Medicare cannot use its raw naked purchasing power Prohibition on reimportation of pharmaceuticals from Canada Private Sector Handouts for corporations, health plans, PBMs (and doctors and hospitals) MSAs and HSAs enabled and encouraged for the elderly (The Warren Buffet PPO) No new Taxes for the rich And some fresh new coverage for the poor uncovered elderly who are not in states with rich PACE or Medicaid programs

12. Medicare Bill as Three MoviesThe World is Not Enough Wholly Inadequate Coverage when it finally arrives because most people will be paying for at least half their medications Price Transparency now and in the future (discount cards in the short run and donut holes in the long run) Drug industry will experience the coverage kicking in when many of the big blockbusters are off patent and when huge classes of drugs like statins will be both generic and OTC Huge incentive for corporate America to phase out retiree health benefits or make them Medicare Compatible (a euphemism for shitty) HMOs and HSAs will have to find a way to make money on anybody but the rich well elderly (all four of them) When it comes to healthcare for the elderly we are all poor Is this bill a platform for future Democrats to go after the drug industry when RX industry is at a low ebb, lacking innovation and subject to five years of public outrage about prices What would Hillary do with it in 2008?

13. Medicare Bill as Three Movies The Ten Commandments There shall be competition (Even if it is unpopular, doesn�t work and there are no willing HMOs or congressional districts willing to participate in it) There shall be liberty for seniors to be confused by a myriad of private health plan and drug coverage offerings There shall be skin in the game (consumer responsibility for payment through co-payments, deductibles and premium sharing) because it is good for consumers to pay at the point of care (it will stop them overusing the Medicare system for recreational purposes and it teaches seniors that they should look after themselves in their forties and fifties) There shall be no supplementary coverage because supplementary coverage nullifies skin in the game There shall be no new taxes for rich people, only raised premiums for all There shall be privatization because private is better than public (don�t argue, this is a commandment) There shall be unrestricted free choice of plans each of which has a restricted choice of doctors because choice is good There shall be no Canadian drugs in the veins of Americans even if the drugs are made in America and purchased by Americans There shall be big differences in coverage among seniors but thou shall not covet thy neighbor�s coverage There shall be no senior left behind���.. in traditional Medicare

14. The Argument For Consumer Responsibility for Payment Consumers have been progressively insulated from the cost of care for the last 40 years If they only knew how much healthcare cost and had to pay they would use it less If they were responsible for paying they would also take more responsibility to become healthy and cost the system less Consumers should have the right to choose and to trade up to better quality with their own money When they are make rational consumer choices the market will be working and whatever is spent will be appropriate like any other market or sector of the economy

15. The Argument Against Consumer Responsibility for Payment The 5/50 Problem: Most consumers that are heavy users have significant co-morbidity or serious illness like cancer, they didn�t choose this health status One day in an American hospital and they are over their maximum deductible, so�� Catastrophic coverage is a green light for excessive care by hospitals and procedure-oriented specialists While skin in the game can clearly move people around does it save money overall? The equity problems: A de facto reallocation of resources from poor to rich (my access to the collective social capital of health insurance is better because I can come up with the economic down payment for physician visits and tests) Poor people with chronic illnesses will be disproportionately affected by consumer responsibility for payment

16. Consumer Exposure to Health Care Costs is About to Increase As health insurance became more comprehensive, OOP costs declined through the 1980s and leveled off beginning in the 1990s. As health insurance became more comprehensive, OOP costs declined through the 1980s and leveled off beginning in the 1990s.

17. Who Pays for Drugs?

18. The Five-Tier Formulary In June, Express Scripts unveiled a five-tier prescription drug benefit plan. The tiers range from $3 at the bottom to $50 at the top. This development may mean that in the future, consumers will have coverage for all drugs, regardless of their �preferred� status. However, the copay range will continue to expand. Therefore, pharmaceutical companies will have to make important decisions regarding where in the formulary each of their drugs should be placed. There will also be battles over what qualifies as a �look good/feel good� medication. Should drugs that relieve symptoms but do not extend life (e.g., non-sedating antihistamines) be placed in the fifth tier or do they belong in tiers 3 or 4?In June, Express Scripts unveiled a five-tier prescription drug benefit plan. The tiers range from $3 at the bottom to $50 at the top. This development may mean that in the future, consumers will have coverage for all drugs, regardless of their �preferred� status. However, the copay range will continue to expand. Therefore, pharmaceutical companies will have to make important decisions regarding where in the formulary each of their drugs should be placed. There will also be battles over what qualifies as a �look good/feel good� medication. Should drugs that relieve symptoms but do not extend life (e.g., non-sedating antihistamines) be placed in the fifth tier or do they belong in tiers 3 or 4?

19. James Brown and Fernando Lamas Effect

20. �Skin in the Game� Matters Trading down twice as often as trading up Rapid increase in generic and therapeutic substitution Poor, chronically ill most effected Starting to lead to adverse health outcomes like the uninsured Simple cost shifting without sophisticated disease management is not the right answer in the long-term

21. Big Increase in Trading Down on Drugs

22. Rx co-pay increase: More bargain-hunting since 2002. Low- and middle-income equally likely to �trade-down� What people did in response to increases in Rx cost-sharing varies considerably by income and tiered prescription drug coverage insurance.What people did in response to increases in Rx cost-sharing varies considerably by income and tiered prescription drug coverage insurance.

23. The Coming Challenges Price Reimportation Cost-effectiveness in formulary design Reference pricing World pricing Innovation Show me the molecules! Value The Cutler Defense: �Your Money or Your Life� The Danzon/Fujikawa Defense

24. The Value of Prescription Drugs

25. The Danzon/Fujikawa Defense The structure of the entire pharmaceutical market Brand, Branded Generic, Generic and OTC Prices Purchasing Power Parity Deflators Innovation: Novel large molecules Costs of distribution

26. Unit Volume for Branded vs. Generic drugs Varies by Country

27. Outside US Prices for Generics are Comparable or Higher than US prices

28. Based on Health PPPs, All countries Except France appear to have Higher Drug Prices than US

29. Per Capita Use of Newer Drugs is Lower in Other Countries Compared to US

30. The Missing One-Liners Hey you elderly, stop bitching that Lipitor is cheaper in Canada and learn how to use the proper purchasing power parity deflators Sure you pay more for brand name drugs but you�re getting young, long molecules OK, Brand name drugs are more expensive here but at least we aren�t screwing you on generics and aspirin like the Germans Who would you rather have the money, American drug companies or French pharmacists?

31. The Transformation of Pharmaceuticals Discover a unique white powder Search for a therapeutic action Establish safety and efficacy Make sure it�s better than available alternatives Promote to the profession Get a passive payer to pay for it Design a white powder with a predictable therapeutic action Establish safety, efficacy and cost-effectiveness Make sure it meets a previously unmet medical need or has an effect that is detectable to human beings Promote to all the Ps (patient, physician, PBM, payer, pharmacist, politician, press) Get an active payer to pay for it

32. Traditional Pharmaceuticals vs. Advanced Therapeutics

33. Happy Biotechnologist Scenario We have the best stuff Sure it�s expensive, but it works Because it works there are savings elsewhere This is complex � do not try this stuff at home As generic competition makes costs go down for some technologies, there will be more gross margin left for us Catastrophic drug coverage insulates consumers from caring about price

34. Biotechnologist�s Nightmare Scenario Public, physicians, policymakers could care less about large molecules; we don�t buy drugs by the atom It�s complex brewing not chemistry, but how hard could it be? Big ugly buyers and providers incensed about price of technology High efficacy focused on small sliver of needy, desperate patients Payers/purchasers Medicare inpatients � the stent effect Medicare hospital outpatient � the value case Administering Physicians e.g. oncologists zero-sum game on incomes �Plop, plop� vs clinical efficacy Consumers Co-insurance on top tier All drugs in CDHP Can you pass the NICE/Kaiser Test?

35. Meeting the Business Challenge Marketing Increased consumerism: reaching the patient Sales force Productivity Doctors as economic gatekeepers for patients Tiering will continue: positioning products in tiers Coverage and contracting: PBM negotiations become more complex Development Global role of payers in the development process e.g. NICE Embedding market understandings in go/no go decisions Regulatory and reimbursement hurdles become more complex Research New science versus traditional R&D R & D Productivity and the only 2 problem

36. Innovation Imperatives Consumers love new technology Innovation is you ace in price control debates But if you don�t truly innovate in a way consumers appreciate and pay for��. The new environment shifts responsibility for payment increasingly and transparency of pricing to consumers Delivering innovation to an end user consumer that has value they are willing to pay their own money for Do not overestimate (even) Americans willingness to trade up Are we comfortable with overt tiering?

37. Little R, Big D, Enormous M

38. Five Industry Giants 2014 The Initial Company GSKBMSJ&J The Latin Root Company AstraAventiNovarticus The Mother of All PBMs Advanced MedcoExpress Care-Scripts AmgenaMerck Biotech Baby eats an Adult Pfizer