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ONCOPHARMACOECONOMY-I, Prof. Dr. F. Cankat Tulunay


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Pharmacoeconomic aspects of cancer drugs and pharmacoeconomic approach.

Pharmacoeconomic aspects of cancer drugs and pharmacoeconomic approach.

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  • 1. Prof. Dr.F. Cankat TulunayHonorary President of EACPT
  • 3. Actual Reasons For Healthcare Expenses•  Ten reasons why it costs so much. Two of the ten add value: #1 and #2 improve the quality and length of our lives. Numbers 3 through 10 add no value. THAT is where you can save money without losing something we want. 1. Treatments available now that did not exist before 2. More people living longer 3. Action without evidence 4. Cost of regulations and compliance 5. Inefficiency 6. Perverse incentives 7. Defensive medicine 8. Adverse outcomes and errors 9. Profits taken out of healthcare system 10. Embezzlement and fraud (outright theft).
  • 4. USA•  USA spends $2 trillion on healthcare.•  $680billion (34%) "goes to" the doctors•  $600b (30%) to hospitals•  $340b (17%) to outpatient services•  $300b (15%) to for medications.
  • 5.   Costs of Cancer NIH estimated the 2008 overall annual costs of cancer were as follows:•  Total cost: $228.1 billion•  Direct medical costs (total of all health expenditures): $ 93.2 billion•  Indirect morbidity costs (cost of lost productivity due to illness): $ 18.8 billion•  Indirect mortality costs (cost of lost productivity due to premature death): $116.1 billion•  About 24% of Americans aged 18 to 64, 13% of children had no health insurance for at least part of the past year.•  This year, about 562,340 Americans are expected to die of cancer -- thats more than 1,500 people a day. Cancer is the second most common cause of death in the United States, exceeded only by heart disease. Cancer accounts for nearly 1 out of every 4 deaths in the United States American Cancer Society. Cancer Facts & Figures 2009. Atlanta, GA. 2009.
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  • 7. LIFE AFTER CANCER – costs of cancer care National Cancer Institute ● Cancer Trends Progress Report – 2005 Update ●
  • 8. Efficacy, safety, and cost of new anticancer drugs Silvio Garattini, director and Vittorio Bertele, head, regulatory policy laboratory Mario Negri Institute for Pharmacological Research, 20157 Milan, Italy Correspondence to: S Garattini BMJ. 2002 August 3; 325(7358): 269–271•  New anticancer drugs reaching the European market in 1995-2000 offered few or no substantial advantages over existing preparations, yet cost several times—in one case 350 times—as much•  The greatest changes have been 4500 fewer deaths from childhood tumours and 4000 fewer from lymphomas (Hodgkins disease) each year over the past four decades.•  Among solid tumours, advances have been made in treating breast cancer, in which tamoxifen increases 10 year survival by 6% for node negative and 11% for node positive tumours,3 and chemotherapy increases survival by 7% and 11%, respectively.4•  For most other common solid tumours such as those of lung, oesophagus, stomach, or pancreas, only limited survival gains have been achieved.2,5,6
  • 9. •  U.K. rejected NEXAVAR for liver cancer•  Nexavar was estimated to cost 65,900 pounds ($102,000) for every “quality adjusted year of life,”Not:•  NEXAVAR: 200 mg 112 tab: 8.270 TL ödenmez (SGK)
  • 10. Miracle Cancer Drug Extends Life With $48,720 Cost March 05, 2010  It was called SU11248 (SUTENT), and Pfizer Inc. had just acquired the company developing it. Tumors were shrinking in two thirds of the digestive tract cancer patients in the clinical trial Demetri had been running since February 2002. One dying man’s malignancy had stopped growing so suddenly after five doses that it was a “miracle,” the oncologist said.
  • 11. BMJ. 2002 August 3; 325(7358): 269–271
  • 12. •  Sunitinib is recommended, as a treatment option for people with unresectable and/or metastatic malignant gastrointestinal stromal tumours if:•  imatinib treatment has failed because of resistance or intolerance, and•  the drug cost of sunitinib (excluding any related costs) for the first treatment cycle will be met by the manufacturer.•  The use of sunitinib should be supervised by cancer specialists with experience in treating people with unresectable and/or metastatic malignant gastrointestinal stromal tumours after failure of imatinib treatment because of resistance or intolerance.
  • 13. SUTENT•  Costs•  Sunitinib is marketed by Pfizer as Sutent, and is subject to patents and market exclusivity as a new chemical entity until February 15, 2021•  Sutent is one of the most expensive drugs widely marketed. Doctors and editorials have criticized the high cost, for a drug that doesnt cure cancer but only prolongs life.•  In the U.S., insurance companies have refused to pay for all or part of the costs of Sutent.•  In the UK NICE refused (late 2008) to recommend suntinib for late stage renal cancer (kidney cancer) due to the high cost per QALY, estimated by NICE at £72,000/QALY and by Pfizer at £29,000/ QALY.[21] It was also refused by NICE in 2008 for the treatment of kidney cancer.[22] This refusal/guidance was updated Feb 2009 after negotiations on price for the first course of treatment•  TÜRKİYEDE BİR SİKLÜS İLAÇ GİDERİ: 17.346 TL
  • 14. Well sell our house for this drug (sutent)•  The treatments are used for advanced kidney cancers•  A row has broken out over the funding of four drugs for advanced kidney cancer after the drugs advisory body NICE said they should not be available on the NHS.•  Andrew Crabb, from Abingdon in Oxfordshire, got the news on the first anniversary of his diagnosis with the disease - but says he will do everything he can to carry on receiving his drug. BBC news, 7 August 2008
  • 15. •  FOLOTYN is a folate analogue metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. (FDA Prospektüs)•  The drug was approved by the Food and Drug Administration in late September as a treatment for peripheral T-cell lymphoma, 30.000 dolar/month•  In the clinical trial, the median duration of use was 70 days, which would cost roughly $70,000 to $80,000. But some patients used the drug for many months.•  Folotyn has not yet shown an effect on longevity. In the clinical trial that led to approval of the drug, 27 percent of the 109 patients experienced a reduction in tumor size. The reductions lasted a median of 9.4 months.•  But considering all the patients in the trial, only 12 percent had a reduction in tumor size that lasted for more than 14 weeks. The trial did not compare Folotyn to another drug or a placebo.•  Genzyme’s Clolar for pediatric leukemia costs about $34,000 a week, though the company says that only two weeks of treatment are typically needed.•  GlaxoSmithKline is charging up to $98,000 for a six-month treatment course of Arzerra, a drug approved in late October for chronic lymphocytic leukemia•  The colon cancer drug Erbitux, for instance, costs $10,000 a month and the drug Avastin about $8,800 when used to treat lung cancer.
  • 18. Charles Nemeroff caught with his hands in the Glaxo till…• “…From 2000 through 2006, Dr. Nemeroff received just over $960,000 from Glaxo….”
  • 19. GSK  COURT EXPOSED GSK/RESEARCHERS FRAUD The court documents released as a result of one of the lawsuits in October 2008 indicated that GSK "and/or researchers may have suppress  MISLEADING PUBLIC For 10 years, GlaxoSmithKlines marketing of the drug stated that it was "not habit forming". In 2002, the U.S. Food and Drug Administration published a new product warning about the drug, and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) declared GSK guilty of misleading the public about paroxetine on US television. ed or obscured suicide risk data during clinical trials"
  • 20. Drugs Giants GlaxoSmithKline In Iraq Probe•  Pharmaceutical companies GlaxoSmithKline and AstraZeneca have been linked to an investigation into bribes allegedly paid to Saddam Husseins former regime.•  The oil-for-food programme was supposed to allow the Iraqi government to sell limited amounts of oil to buy foreign food and medicines.
  • 21. Is there an EVİDENECE-BASED pharmacotherapy? PHARMACOTHERAPY
  • 24. 7U RATIONAL DRUG USE 7Rl  Uygun endikasyon l  Right indicationl  Uygun ilaç l  Right drugl  Uygun yol, doz ve süre l  Right route, dosage, durationl  Uygun hasta l  Right patientl  Uygun hasta bilgilendirilmesi l  Right patient informationl  Uygun değerlendirme l  Rigtht evaluationl  Uygun fiyat l  Right price Hastaların klinik ihtiyaçlarına “Patients receive medications göre, ihtiyaç duyduğu dozda, appropriate to their clinical sürede ve kendisi ve toplum needs, in doses that meet için en ucuz maliyette ilaç their own individual bulabilmesidir. requirements, for an adequate period of time, and at the (WHO 1985) lowest cost to them and their community.” (WHO, 1985).
  • 25. WHO advocates 12 key interventions to promote more rational use:1 Establishment of a multidisciplinary national body to coordinate policies on medicine use.....NO2. Use of clinical guidelines.....NO3. Development and use of national essential medicines list...NO4. Establishment of drug and therapeutics committees in districts and hospitals...NO5. Inclusion of problem-based pharmacotherapy training in undergraduate curricula...NO6. Continuing in-service medical education as a licensure requirement:7. Supervision, audit and feedback...NO8. Use of independent information on medicines...NO9. Public education about medicines...NO10. Avoidance of perverse financial incentives...NO11. Use of appropriate and enforced regulation...NO12. Sufficient government expenditure to ensure availability of medicines and staff...NO
  • 26. Factors affecting irrational drug use Rule and Regulations Industry Regulatory agencies Physician Patient • Unethical • Inadequate graduate •  Political pressure practice by •  Inadequate and post all means• Wrong bgraduateeducation registration system information • Fraud •  Inadequate • No drug information • Corruption reimbustment• False informatin source • No-oto system • Press, TV • Over loaded patient control •  No tratement duty guidelines• False beliefs • Prescription •  No rational drug• Unable explane pressure: Pharmacist policy problems •  No • Industry• No relaible pharmacoeconomy information • Patients • Inadequate •  No..No..No..!!!! source • Promotions education• Self medication • Corruption • Unethical drug business!! • Unethical• Komşusunun practice ilacını kullanma • Corruption • No prescription• Economical! control Tulunay 2008
  • 27. Outcomes of irrational drug useDegenerationof treatment Increased Psycho-socialquality Waste of risk of outcomes resources adverse effect risk • morbidity • mortality • Unneeded • Adverse reactions expectations from • Decrease drugs availability • Bacterial resistans • Feeling of unhealing • Increased price • Suicite ECONOMICAL LOSTS COST OF HUMAN BEING? SHAME OF 21st CENTURY Tulunay 2008
  • 28. Medical journals and pharmaceutical companies: uneasy bedfellows Richard Smith, editor BMJ 2003;326:1202-1205 (31 May) •  Free newspapers for doctors depend completely on income from pharmaceutical advertising, but many journals also depend heavily on such advertising •  The advertising is often misleading •  Editorial coverage is much more valuable to drug companies than advertising, and scientific studies can be manipulated in many ways to give results favourable to companies •  Many medical journals have a substantial income from supplements and reprints paid for by drug companies •  In one sense, all journals are bought by the pharmaceuticalHADİ RICHARD...BİZ BİRBİRİMİZE MUHTAÇIZ industry. The industry dominates health care, and most doctors have been wined and dined by it.
  • 29. Future European health care: Cost containment, health care reform and scientific progress in drug research G.Emilien, Int.J.Health Plan.Manag. 12:81-101, 1997•  A= Terapoetic efficacy Top 25 products Top 50 products internationally proven•  B= Second choise, open Not for abuse A B C A B C necessary•  C= Non-effective drugs ** (1993) Italy 11 7 7 25 15 10 21.2•  In Germany 4.128 billion dolar worth suspicious drug (1992) France 16 4 5 26 14 10 20.5 Germany 19 5 1 35 9 6 11.9 UK 24 1 0 46 4 0 NA ** % of total drug use
  • 30. Another !GARDASİL.... 806 TLCERVARIX.... 734 TL
  • 31. 8 October 2009, BMJ 2009;339:b3884 Cost effectiveness analysis of including boys in a human papillomavirus vaccination programme in the United States Jane J Kim, assistant professor, Sue J Goldie, professor 1 Harvard School of Public Health, Department of Health Policy and Management, Center for Health Decision Science, 718 Huntington Avenue, Boston, MA 02115, USA•  Given currently available information, including boys in an HPV vaccination programme generally exceeds conventional thresholds (QALY over 100.000$) of good value for money, even under favourable conditions of vaccine protection and health benefits
  • 32. Hysteria over genital warts? New York Times,2008•  In a New York Times article published last year, Dr. Harper spoke about the fear-based marketing of Gardasil by Merck: "Merck lobbied every opinion leader, womens group, medical society, politicians, and went directly to the people -- it created a sense of panic that says you have to have this vaccine now..." This behavior by drug companies -- using fear tactics to promote a particular disease in order to sell the "treatment" -- is called disease mongering. Most of the pharmaceutical profits generated today are based on precisely this tactic: Spread the fear, then sell the treatment. Why is disease mongering so important to the profits of the drug companies? They figured out many years ago that selling drugs only to those people who are sick was a very limited income opportunity. To rake in the real profits, they needed to devise a way to sell drugs to healthy people (i.e. people who dont need them). Thats what cervical cancer vaccines really are: A scheme to sell vaccines to people who arent suffering from any disease at all. That one of the industrys own researchers is willing to speak out against this is not just highly unusual; its also highly courageous. It makes you wonder: Who, exactly, is this Dr. Harper? Dr. Diane Harper•  Dr. Harper is a graduate of the Massachusetts Institute of Technology. She studied additional courses at Stanford and received her medical degree from the University of Kansas. She was a key researcher in both Gardasil and Cervarix vaccines, and shes one of the most experienced researchers in the world on HPV-related diseases. Shes done work for both Merck and GlaxoSmithKline.
  • 33. Top researcher who worked on cervical cancer vaccine warns about its dangers 8.10.2009•  One of the key researchers involved in the clinical trials for both Gardasil and Cevarix cervical cancer vaccines has gone public with warnings about their safety and effectiveness. Dr. Diane Harper openly admitted the vaccine doesnt even prevent cervical cancer, stating, "[The vaccine] will not decrease cervical cancer rates at all." Dr. Harper also warned that the cervical cancer vaccine was being "over-marketed" and that parents should be warned about the possible risk of severe side effects from the vaccine. She even concluded that the vaccine itself is more dangerous than the cervical cancer it claims to prevent! Dr. Harpers warnings about cervical cancer vaccines are especially relevant considering her expertise in the cost/benefit analysis of vaccines. Her conclusion is that cervical cancer vaccines arent worth the risks, nor are they worth all the effort being put into hyping them to the public. "This may not be the best use of our resources at this time," she said in a Washington Post article. So why do cervical cancer vaccines continue to be pushed by doctors and health authorities across the US, UK and other first-world nations? Because Big Pharma is the great corporate puppeteer thats pulling the strings of legislators. With enough money and lobbyists, you can always overcome scientific thinking with fear-based marketing and under-the-table deal-making. Science-based medicine has no place in a world where disease is big business.
  • 34. Press Release For immediate release 9th October 2009 ALLIANCE FOR NATURAL HEALTH CALLS FOR AN URGENT SCIENTIFIC INQUIRY INTO THE HPV VACCINE USED IN THE UK The Alliance for Natural Health (ANH) today calls for anindependent Inquiry into the safety of HPV vaccine, and appeals to all Members of Parliament to press for this.•  Reports of serious and even lethal adverse reactions to the Human Papilloma Virus (HPV) vaccine, Cervarix, manufactured by GlaxoSmithKline, raises grave concern over the safety of the vaccine. While its closely related vaccine, Gardasil, manufactured by Merck, is recognised by the US Centers for Disease Control (CDC) to trigger severe reactions, namely hospitalisation, permanent disability, life-threatening illness or death, equivalent data in the UK appears not to be publicly available.
  • 35. NEXAVAR?? (1month cost is 8.270 TL=5.500 USD) Which one is wright!!?? Bayer•  Bayer, Onyx Pill Doesn’t Slow Breast •  Wednesday - September 23, 2009 Phase II Cancer in Study Study in Advanced Breast Cancer: Sept. 30 (Bloomberg) -- Bayer AG and Onyx Pharmaceuticals Inc.’s Nexavar cancer •  Nexavar® in Combination with drug failed to slow the progression of breast Chemotherapy Demonstrates 74 cancer in the second of four studies that Percent Improvement in combine the medicine with different types of chemotherapy. Progression-Free Survival•  September 30, 2009 •  First presentation of results at joint ECCO- ESMO congress in Berlin, Germany Mid-stage breast cancer trial of •  Abstract # 3LBA Bayer, Onyxs Nexavar misses Berlin, September 23, 2009 – Bayer primary endpoint HealthCare AG and Onyx Pharmaceuticals, Inc. today announced the full results from Last Updated:September 30, 2009 00:30 their first collaborative group-sponsored Preliminary results showed that a Phase II trial randomized, double-blind, placebo controlled of Bayer and Onyx’s Nexavar (sorafenib) in Phase II trial showing that Nexavar® combination with paclitaxel in patients with (sorafenib tablets) in combination with the advanced breast cancer did not meet its oral chemotherapeutic agent, capecitabine, primary endpoint of progression-free survival, significantly extended progression-free the companies announced on Wednesday. Dimitris survival in patients with advanced breast Voliotis, vice president of global clinical cancer by 74 percent. The data were development oncology at Bayer, said the “data presented at the joint 15th European CanCer require further analysis and interpretation before Organisation (ECCO) and 34th European we determine the appropriate path forward." Society for Medical Oncology (ESMO)•  Multidisciplinary Congress in Berlin, Germany.
  • 36. FDA probe of Pfizers anti-smoking drug continues April 6 2009•  The FDA is investigating reports of injury, visual impairment and other problems connected with the medication, which is designed to ease smokers withdrawal symptoms. The agency began probing the problems last fall.•  The Federal Aviation Administration last year banned the use of Chantix by pilots after a spike in patients reporting blackouts, some of which led to traffic accidents
  • 37. Innovation worries the decision makerR&D Activity in Main Therapeutic Areas R&D Activity in Main Therapeutic Areas 20%Growth of sales 2004-2009* 18% Innovative approaches Oncology (L1, L2) set to drive strong CNS (N3A, N5A, N6A) 16% growth in oncology Osteoporosis (M5B, G3H, H4A, H4V) HIV antivirals (J5D) 14% Oral antidiabetics (A10B) 12% Cardiovascular (C8, C9, C10A) Epoetins (B3C) 1% A large number of innovative PPIs (A2B2) candidate makes the oncology Anti-platelet inhibs (B1C) 8% pipeline the largest in the industry 6% 4% Size of bubble: 2% Forecast sales 2009 0% -50 0 50 100 150 200 250 300 350 400 450 500 # phase II & onwards pipeline products Source: IMS Management Consulting analysis
  • 38. e.g. New drug vs. current care(health care payer perspective) Current New Current Net SavingsNew New CurrentCost of drug +TreatmentOther Average Costs = Total Cost physicians hospital surgery other drugs 41 tests
  • 39. e.g. New drug vs. current care (2) New Current Current New New Current Cost of drug +TreatmentOther = Average Costs Total Cost physicians hospital surgery other drugs 42 tests
  • 40. e.g. New drug vs. current care (3) New ts Cos Net Current New Current New Current Cost of drug +TreatmentOther = Average Costs Total Cost physicians hospital surgery other drugs 43 tests
  • 41. How do we value innovation?•  Steve Pearson, President of the Institute for Clinical and Economic Review at Harvard, identified two options for judging innovation.•  The first is by setting criteria for success before the innovation has been introduced, such as measuring whether an intervention works. Mr Pearson said this would be “difficult to do in a way which makes sense”, as it is hard to define criteria for an innovation’s success before the innovation itself has been created.•  Another method of judging innovation would be to assess its performance once introduced. This again poses difficulties, as it depends on an agreed definition of “value”. Suggested definitions include the speed of penetration of the innovation into a healthcare system, or the destination of venture capital - which he said could be cosmetic surgery in the case of the US.•  9 December 2009 44
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  • 44. Evidence to support chronic myeloid leukaemia drugs "very poor"•  NICE is unable to recommend the use of dasatinib and nilotinib for the treatment of chronic myeloid leukaemia in patients who cannot tolerate the first-line treatment imatinib, after finding that the evidence to support their use is “very poor”.•  Neither of the drugs fits the NICE end-of-life criteria, introduced to allow Appraisal Committees to consider expensive medicines licensed for terminal illnesses, as the available evidence on life extension is too weak.•  But even if the end-of-life criteria had been met, the exceptionally high costs of dasatinib and nilotinib, taken together with poor quality evidence on the drugs’ effectiveness, would not allow NICE to consider the drugs a cost-effective use of NHS resources.•  This latest draft guidance comes after the independent Appraisal Committee met, last month, to discuss issues around the cost-effectiveness modelling raised during the first public consultation.•  Professor Peter Littlejohns, clinical and public health director at NICE, said: “The Committee heard from clinical specialists that in their opinion dasatinib and nilotinib are clinically effective. However, the evidence available to support this was very poor, with no studies comparing either drug to other treatments.•  “The cost of the drugs is also extremely high and before committing limited NHS resources to fund them, we need to be sure they are effective. It would be heartening to hear that the pharmaceutical company manufacturers are prepared to share some of the very high cost of the drugs with the NHS.”•  The independent committee will next met on 9 March 2010 to consider any further evidence before issuing the next draft guidance.•  9 February 2010 47
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