CONCLUSIONS (Random Thoughts and Take Home Questions) gianluigi casadei

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1 CONCLUSIONS (Random Thoughts and Take Home Questions) gianluigi casadei

2 IL SOLE 24 ORE (September 4, 2012)

3 Sustainability of health spending is a known issue for a long time The current crisis has dramatized it mainly in weak economies.

4 Appleby J. Can we afford the NIHS in future? BMJ 2011;343:d4321 doi: /bmj.d4321

5 The Burden of Health Care The ratio of total health expenditure (public and private) to GDP has at least doubled in countries with developed economy and welfare : more than half of the increase in primary expenditure (% of GDP) is attributable to health (G7: 57%) OECD and IMF: health expenditure expected to double in Pamolli F, Salerno NC. Sostenibilità e governance della spesa sanitaria. Roma, 6/12/2010

6 3 2 1 Biacker K, Chernew ME. The Economics of Financing Medicare. NEJM, 13/7/2011

7 Supporting Sustainability Increasing fiscal pressure Cost saving measures Cutting services (delayed/difficult access, outsourcing, ) Copayment

8 Out-of-pocket Health Expense pro capita ($ PPA) OECD Health Data

9 Italy: The Burden of Co-payment Sources: AIFA. Annual reports on national drug consumption.

10 Is this road feasible further? Is the end of the universal health coverage? Should we move toward a Bismarckian-like model?

11 o Three patients suffering from metastatic GI cancer o From 2001 enrolled in the imatinib phase III program o Sustained responses for 8 years. o Then, treatment discontinued due to economic downturn

12 Supporting Sustainability Avoid (minimize) waste This waste is more than 1.5 times the nation s total infrastructure investment in 2004, including roads, railroads, aviation, drinking water, telecommunications, and other structures. Source: Best Care at Lower Cost: The Path to Continuously Learning Health Care in America, Institute of Medicine.

13 Digital infrastructure 2012 Italian Investment pro capita: 22 (UK: 60; F: 40; D: 36) Payment-by-Performance Arch Intern Medicine September 4, 2012 Politecnico di Milano, 2012.

14 Decentralization: Looking for the Efficiency Pamolli F, Salerno NC. Le differenze regionali nella governance della spesa sanitaria ISQ Helath Quality Index (Outcome* 0,5 + Satisfaction * 0,17 + Medical Tourism * 0,17 + Hospitalization risk * 0,17)

15 Decentralization (Regionalism) Should (could) we still afford it? Region 2008 net expediture* Net cost per capita Mean standard cost Standard budget* Piemonte ,60 V. d Aosta ,60 Lombardia ,10 Pa Bolzano ,70 Pa Trento ,80 Veneto ,70 Friuli V.G ,10 Liguria ,30 Emilia R ,10 Toscana ,00 Umbria ,70 Marche ,90 Lazio ,50 Abruzzo ,50 Molise ,70 Campania ,00 Puglia ,40 Basilicata ,40 Calabria ,40 Sicilia ,60 Sardegna ,10 Standard vs. net* Total ,10 Pamolli F, Salerno NC. Le differenze regionali nella governance della spesa sanitaria. 2011

16 Innovation is There is no shortage of definitions of innovation. It will come as no surprise that, while everyone was content to use the word, and everyone agreed that it was a good thing, it was not easy to identify what was being discussed. In fact, as is common in policy-making, the absence of any hard centre of meaning allows people from all quarters to appear to be in agreement, without the need to nail down what it is that they were agreed on. Kennedy I: Appraising the value of innovation and other benefits. A short study for NICE Sir Ian Kennedy (2009)

17 Lack of an active arm (best available alternative) Add on therapy Primary efficacy criteria based on clinical assessment Follow-up (often) insufficient Additional benefit difficult to assess Simply new or innovative? Higher cost is the only certainty

18 Costs in Cancer Care Direct costs in US $ 104 billion in 2006 $ 173 billion in due to increases of: number of treated patients, therapies per each patients, cost per treatment. Sales of cancer drugs ranks 2 nd after cardiovascular drugs Monthly cost $ Smith TJ, Hillner BE. Bending the cost curve in cancer care. N Eng J Med 2011; 364:2060-5

Costs in Cancer Care Their continued growth is no longer sustainable We must find ways to reduce the costs of everyday care to allow more people and advances to be covered without bankrupting the

19 Costs in Cancer Care Their continued growth is no longer sustainable We must find ways to reduce the costs of everyday care to allow more people and advances to be covered without bankrupting the health care system. Medical oncologists directly or indirectly control or influence the majority of cancer care costs, including the use and choice of drugs, the types of supportive care, the frequency of imaging, and the number and extent of hospitalizations. Smith TJ, Hillner BE. Bending the cost curve in cancer care. N Eng J Med 2011; 364:2060-5

20 Behaviour Approach Practice Diagnostic only when FU is beneficial Sequential monotheraphy in 2 nd and 3 rd line Chemio only if performance status is high 4 th line only with investigational drugs Set realistic targets - expectations Cognitive approach Palliative care Know and accept current limits Improve Resource Allocation Elaborato da: Smith TJ, Hillner BE. Bending the cost curve in cancer care. N Eng J Med 2011; 364:2060-5

21 Profitability Always target a high price Should (could) profitability balanced with sustainability?

22 Pollack A. New drugs fight prostate cancer, but at high cost. The New York Times, 27/6/2011

23 Pollack A. New drugs fight prostate cancer, but at high cost. The New York Times, 27/6/ May I afford it?

ICER 93.825 per QALY gained Survival extended for less than 2.

24 Lapatinib NICE (2010) Appraising treatments that may extend the life of patients with a short life expectancy and that are licensed for indications that affect small numbers of people with incurable illnesses Lapatinib ICER per QALY gained Survival extended for less than 2.4 months No evidence of any subgroup of patients who may have an incremental benefit. F. Hoffmann-La Roche Ltd., Group Communications NICE Guidance (6/2010) Lapatinib

25 4 CONSIDERATION OF THE EVIDENCE 4.2 The Committee heard from the clinical specialists that ipilimumab represents a step change in the treatment of advanced melanoma and is the first new treatment available in 30 years that may offer significant palliation and possible survival gain for people with advanced, unresectable disease that has progressed after first-line therapy. 4.3 The Committee heard from the clinical specialists that approximately 30% of people treated with ipilimumab will have improved survival, and about 10% of people may have longterm benefits. The clinical specialists indicated that melanoma may have an unpredictable clinical course and that late recurrences are well recognised. fewer than 1% of patients in the ipilimumab arms showed a complete disease response.

26 Sobrero A, Bruzzi P. Incremental advance or seismic shift? The need to raise the bar of efficacy for drug approval. J Clin Oncol Dec 10;27(35): Epub 2009 Oct 13.

27 Progression Free Survival PFS x 2 Modified from Sobrero A, Bruzzi P. J Clin Oncol Dec 10;27(35): PFS +50% 10 mos 5 mos Breast, ovary, colonrectum PFS 5-10 months MST 2 years MST +30% Pancreas, Gastric, NSCLC PFS 2-4 mos MST < 1 year MST +50% Median Survival Time years

28 Value-Based Pricing The setting of a product or service's price, based on the benefits it provides to consumers. Have Health Authorities the right (and duty) to set thresholds to define what progress (innovation) is? Should the EMA assess also the expected additional benefit of a new (innovative) drug? Garattini S, Chalmers I. Patients and the public deserve big changes in evaluation of drugs. BMJ 2009; 338:b1025

29 Gracias por su atención

The Italian decision to mandate. children vaccinations. Fortunato D Ancona, MD Italian Ministry of Health

The Italian decision to mandate children vaccinations Fortunato D Ancona, MD Italian Ministry of Health The ASSET FINAL EVENT Share and move for mobilization and mutual learning at local, national and