Transcript Zaltrap
Zaltrap (ziv-afilbercept) Zaltrap 4 mg/kg q2wk $11,000/month $5,500/dose Zaltrap 42 days Worth and Medicine Senior Grand Rounds Jacob Sadik, MD PGY3 Objectives • Improve awareness and understanding of US pharmaceutical pricing and the balance between cost and value in medicine • Reinforce the importance of tailoring treatment to patients and not simply their disease processes • Recognize how patient advocacy by physicians may evoke change even in complex systems, such as pharmaceutical drug pricing What’s in a Word… • Pricing – the base price of a drug – Prior to negotiations, rebates and discounts • Cost – the actual dollar amount paid by patients, health plans or government • Value – the benefit of a drug relative to its cost Prescription Drug Costs: A Growing Problem • 7 in 10 Americans take at least one prescription med • Effects of dealing with the cost (data from 2012) – – – – – 18% retail drugs were paid for out of pocket 7.8% patients were non-compliant* 15% patients negotiated with their physician 4.2% patients resort to alternative therapies 1.6% patients sought out-of-country prescriptions • Speciality Drugs – 1% of all prescription drugs – 25% ___ of the $297 billion dollars spent on prescriptions drugs Prescription Drug Costs: A Growing Problem $297.7 billion The Cheese Stands Alone Barriers to Reducing Prescription Drug Costs • Lack of pricing transparency • Regulatory barriers • Lack of clinical data showing cost-effectiveness and value of a drug • Health plan benefit structure • Loopholes – Extension of brand-name drug monopolies – Exclusion of low-cost alternatives Lack of Transparency • Drug expense attributed to the cost of research, development and innovation Lack of Transparency • Tufts Center for Study of Drug Development estimate of drug development/approval (2014) – $2.6 billion dollars = price of a drug – Results were cited to justify pharm drug prices – 10 unnamed drug makers – 106 unnamed investigational “self-originated” compounds – Numbers not available for transparent review Lack of Transparency • NEJM Perspective article ($1.4 for R&D) – Highest profit amounts held overseas • Pfizer ($69 billion) • Merck ($57 billion) • Another 8 drug companies ($173 billion) – Large public subsidies (e.g. R&D tax credits) – Core of many research leading to drug discovery found in (largely) publicly-funded research at nonprofit, university-affiliated centers Challenges to Price Reduction • Lack of pricing transparency • Regulatory barriers • Lack of clinical data showing cost-effectiveness and value of a drug • Health plan benefit structure • Loopholes – Extension of brand-name drug monopolies – Exclusion of low-cost alternatives Clinical Data Poorly-Reflects Balance Between Cost and Value • High cost = perceived high value • FDA Approval limitations • Statistical significance = clinical/societal benefit? Generic drug name (trade name; manufacturer, location) Cancer Typical treatment schedule Cumulative drug $ for 1 yr Comments Duration not well defined; currently, physicians have been going past the 4 doses if patients have achieved a good response Ipilimumab (Yervoy; BristolMyers Squibb, New York, NY) Melanoma Once every 3 wk for 4 doses 120,000 Sipuleucel-T (Provenge; Dendreon Corp, Seattle, WA) Prostate cancer Three doses over 1 mo 90,000 for 3 doses Bevacizumab (Avastin; Genentech Inc, South San Francisco, CA) Various cancers, including lung and colon cancer Once every 3-4 wk 90,000 Can be continued >1 y until disease progression Paclitaxel, protein-bound (Abraxane; Celgene Corp, Summit, NJ) Breast cancer Three times a month 80,000 Continued until disease progression Lenalidomide (Revlimid; Celgene Corp) Multiple myeloma Daily for 3 wk of each month 90,000 In frontline and maintenance, duration of therapy can exceed 3 y; in relapsed disease, duration is approximately 1 y Bortezomib (Velcade; Millennium Pharmaceuticals, Cambridge, MA) Multiple myeloma Once weekly 60,000 Can be continued >1 y until disease progression Imatinib mesylate (Gleevec; Novartis Pharmaceuticals Corp, East Hanover, NJ) Chronic myeloid leukemia Once daily 70,000 Lifelong until progression Alemtuzumab (Campath; Genzyme Corp, Cambridge, MA) Chronic leukemias Three times a week for 3 mo 70,000 Could be used for >1 y Twelve doses over 3-4 mo 120,000 Could be used for >1 y Ofatumumab (Arzerra; Lymphomas and chronic GlaxoSmithKline, Philadelphia, lymphoid leukemias PA) Brentuximab vedotin (Adcetris; Seattle Genetics Inc, Bothell, WA) Hodgkin lymphoma Once every 21 d for 8 cycles 100,000 Approximately 6-8 cycles in a year Dasatinib (Sprycel; BristolMyers Squibb) Chronic myeloid leukemia Once daily 110,000 Lifelong until progression Challenges to Price Reduction • Lack of pricing transparency • Regulatory barriers • Lack of clinical data showing cost-effectiveness and value of a drug • Health plan benefit structure • Loopholes – Extension of brand-name drug monopolies – Exclusion of low-cost alternatives FDA Protection • Patents – Lasts 20 years – More flexible than market exclusivity • Market exclusivity – Other drugs are prevented from attaining FDA approval and entering the market before that period ends – Lasts 5 years for chemical drugs – Lasts 7 years for orphan drugs – Lasts 12 years for biologics OxyContin Legal Anti-Competition • Evergreening (or product-hopping) – Loophole in drug design to keep competitors out of the market • Pay-for-delay agreements – Patent holder pays off generic companies for their absence in the market – Estimated cost to the healthcare system is $35 billion between 2010-2020 – Mandating illegality would cut the federal deficit by $4.8 billion over 10 years Pro-Competition Efforts • Hatch-Waxman Act of 1987 – Aimed to increase availability of generic drugs after patent expiration – Less stringent clinical testing for generics • Biologics Price Competition and Innovation Act (BPCIA) – Part of the ACA – Expedited approval pathway for biosimilar products – Prevents “evergreening” What do you do when you have a really expensive drug, but it’s really really good? Hepatitis C • Affects >3.2 million people in the US (70% genotype 1) • Patients who achieve SVR…are considered cured – Undetectable HCV RNA in 99% of persons for >5 years – HCC risk reduction of >74%5 – HCV-related morbidity and mortality reduction of >54%6 • A long time ago in a galaxy far far away…. – 48-week course of PEG-IFN-alpha2beta PLUS ribavirin – SVRs between 42-52% – Not to mention intolerance and toxicity SAPPHIRE-1 SAPPHIRE-2 Treatment of HCV Infection Sovaldi (sofosbuvir) 84,000$ 8 weeks 95,000$ 12 weeks Harvoni (sofosbuvir/lepidasvir) Does Cure Justify Cost? • Without a cure, 350,000 more patients would be living with advanced HCV between 20152025 at a cost of $115 billion9 CHRONIC HEPATITIS C HCC CIRRHOSIS TRANSPLANT Objectives • Improve awareness and understanding of US pharmaceutical pricing and the balance between cost and value in medicine • Reinforce the importance of tailoring treatment to patients and not simply their disease processes • Recognize how patient advocacy by physicians may evoke change in complex systems, such as pharmaceutical drug pricing What Can We do As Healthcare Providers to Best Treat Our Patients? • Asking the right questions – HRQoL tools – Understand your patients’ values and goals FACT-GWELL-BEING (Version 4) EMOTIONAL FACT-G HRQoL Not at all A little bit Somewhat Below is a list of statements that other people with your illness have said are important. Please circle GE1 I feel sad .............................................................................. 0 1 2 or mark one number per line to indicate your response as it applies to the past 7 days. GE2 I am satisfied with how I am coping with my illness.......... 0 I feel nervous....................................................................... Very much 3 4 1 2 3 4 Very 1 much 2 3 4 0 1 2 3 4 Not A little Some- Quite GE3 I am losing hope in the fight against my illness.................. 0 PHYSICAL WELL-BEING at all bit what a bit GE4 Quite a bit GP1 GE5 I have a lack of energy ....................................................... 0 1 2 I worry about dying ............................................................. 03 14 2 3 4 GP2 GE6 I have nausea ...................................................................... 0 1 2 I worry that my condition will get worse ............................ 03 14 2 3 4 GP3 Because of my physical condition, I have trouble meeting the needs of my family ......................................... 0 1 2 GP4 I have pain .......................................................................... 0 1 2 Somewhat Quite a bit Very much GP5 I am bothered by side effects of treatment ......................... 0 1 2 GP6 GP7 FUNCTIONAL WELL-BEING 3 Not at all 3 3 4 GF1 I am able to work (include work at home) .......................... I feel ill ............................................................................... 0 1 2 0 3 1 4 2 3 4 GF2 My work (include work at home) is fulfilling..................... I am forced to spend time in bed ........................................ 0 1 2 0 3 1 4 2 3 4 0 1 2 3 4 Quite Very 1 much 2 3 4 I am sleeping well ............................................................... I feel close to my friends.................................................... 0 1 2 GF6 I am enjoying the things I usually do for fun ...................... I get emotional support from my family ............................ 0 1 2 GF7 I am content with the quality of my life right now.............. I get support from my friends............................................. 0 1 2 0 3 0 3 0 3 1 4 1 4 1 4 2 3 4 2 3 4 2 3 4 My family has accepted my illness .................................... 3 4 GF3 I am able to enjoy life.......................................................... SOCIAL/FAMILY WELL-BEING GF4 Not A little Some- I have accepted my illness................................................... at all bit what a0bit GF5 GS1 GS2 GS3 GS4 4 A little bit 4 0 1 2 GP4 I have pain .......................................................................... 0 1 2 3 4 GP5 I am bothered by side effects of treatment ......................... 0 1 2 3 4 GP6 I feel ill ............................................................................... FACT-G HRQoL 0 1 2 3 4 GP7 I am forced to spend time in bed ........................................ 0 1 2 3 4 Not A little Somewhat Quite a bit Very much I feel close to my friends .................................................... 0 1 2 3 4 GS3 I get support from my friends............................................. 0 1 2 3 4 GS4 My EMOTIONAL family has accepted myWELL-BEING illness .................................... 0 1 I am satisfied with family communication about my illness.................................................................................. 0 1 SOCIAL/FAMILY WELL-BEING GS1 FACT-G (Version at all bit 4) Please circle or mark one number per line to indicate your response as it applies to the past 7 1 2 3 4 days.I get emotional support from my family ............................ 0 GS2 GS5 GS6 GE1 GE3 2 A little 3 bit 3 Some4 what Quite a bit Very much 2 3 4 4 I feel .............................................................................. I feel closesad to my partner (or the person who is my main support) .............................................................................. 0 1 0 I am satisfied with how I am coping with my illness.......... 0 1 2 3 4 0 1 2 3 4 2 3 4 GE2 Q1 Not 2 at all Regardless of your current level of sexual activity, please answer the following question. If you prefer not to answer it, I am fight against my illness.................. please marklosing this boxhope in andthe go to the next section. 2 1 3 4 I feel nervous....................................................................... 0 GE5 I worry about dying ............................................................. 0 1 2 3 4 GE6 I worry that my condition will get worse ............................ 0 1 2 3 4 Quite Very GE4 I am satisfied with my sex life ............................................ GS7 0 1 2 English (Universal) Copyright 1987, 1997 1 3 4 16 November 2007 Page 1 of 2 FUNCTIONAL WELL-BEING Not A little Some- What Can We do As Healthcare Providers to Best Treat Our Patients? • Asking the right questions – Determining and managing patient expectations • 67% - very or somewhat likely to help with symptoms related to their lung cancer • 78% - thought it was somewhat likely to help them live longer • 43% - felt that it was very or somewhat likely to cure their cancer What Can We do As Healthcare Providers to Best Treat Our Patients? • Asking the right questions – Guideline (n) – a general rule/principle or piece of advice • Patient-centered care Objectives • Improve awareness and understanding of US pharmaceutical pricing and the balance between cost and value in medicine • Reinforce the importance of tailoring treatment to patients and not simply their disease processes • Recognize how patient advocacy by physicians may evoke change in complex systems, such as pharmaceutical drug pricing Zaltrap (ziv-afilbercept) Better or Newer? Rationing or Rational? “Ignoring the cost of care is no longer tenable” ”Soaring spending has presented the medical community with a new obligation. When choosing treatments for patients, we have to consider the financial strains they may cause alongside the benefits they may deliver.” “However, we recognize that there was some market resistance to the perceived relative price of Zaltrap in the U.S. — especially in light of low awareness of Zaltrap in the U.S. market. As such, we are taking immediate action across the U.S. oncology community to reduce the net cost of Zaltrap.” “It was the first time physicians have stood up and said, ‘enough is enough’, and I think that was a watershed moment”. -Dr. Lee Newcomer, senior vice president for oncology at United Healthcare Food for Thought What happens to the market when a single oral agent is discovered to be the cure for…. • Diabetes? • High blood pressure? • Aging? In Summary… • Think about where cost meets value in all aspects of medicine • Practice patient-centered care • Patient advocacy even in the smallest circumstances can evoke change in complex systems, such as pharmaceutical drug pricing Questions? References 1) Collins SR, Rasmussen PW, Doty MM, Beutel S. The rise in health care coverage and affordability since health reform took place. Issue Brief (Commonw Fund). 2015;2:1-16. 2) Jones, G., et al. Strategies that delay or prevent the timely availability of affordable generic drugs in the United States. Blood. March 17, 2016. Issue 127 (11) 3) Bach, P., Saltz, L., Wittes, R., In Cancer Care, Cost Matters. New York Times Opinion Pages. Oct 14, 2012. 4) Pollack, A. “Sanofi Halves Price of Cancer Drug Zaltrap After Sloan-Kettering Rejection” New York Times. Nov 8, 2012. 5) Morgan, L. et al. “Eradication of Hepatitis C Virus Infection and the Development of Hepatocellular Carcinoma: A MetaAnalysis of Observational Studies.” Annals of Internal Medicine. March 2013. 329-337. 6) Backus et al., “A Sustained Virologic Response Reduces Risk of All-Cause Mortality in Patients with Hepatitis C.” Clinical Gastroenterology and Hepatology. June 2011. Volume 9, Issue 6, 509-516.e1. 7) Daniel H, for the Health and Public Policy Committee of the American College of Physicians. Stemming the Escalating Cost of Prescription Drugs: A Position Paper of the American College of Physicians. Ann Intern Med. [Epub ahead of print 29 March 2016] doi:10.7326/M15-2768 Pollack, A. “Sanofi Halves Price of Cancer Drug Zaltrap After Sloan-Kettering Rejection” New York Times. Nov 8, 2012.