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Pharmacoeconomic aspects of cancer drugs and pharmacoeconomic approach.
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Prof. Dr. F. Cankat Tulunay Honorary President of EACPT
TURKISH TYPE
PHARMACOECONOMY
• Clinical trials evaluate the efficacy and safety of therapies • Clinical trial focuses on medical indicators (eg. Blood pressure level) • Intensive monitoring is necessary
• Pharmacoeconomic evaluation is more concerned about what happens in “real life”. • Pharmacoeconomic study is more interested in effectiveness • Pharmacoeconomic study measure differnt outcomes (resource consumption, productivity, OoL etc)
Clinical trials
Pharmacoeconomic analysis
Can it work? = Efficacy (clinical trials) Does it work in reality? =
Effectiveness (observational studies) Is it worth doing it, compared to
other things we could do with the same money? = Cost-effectiveness = Efficiency =Value for money
6
PROBLEM: where is the threshold?
• HISTORICAL 50,000$ per QALY: = Annual cost of caring for a dialysis patient
• PUBLISHED THRESHOLDS – Vary between 10,000 and 100,000 $ per QALY
• WHO: GDP per capita (e.g. Belgium = €29000)
• TURKEY: 24.000 $ (2 GDP) (F.C.TULUNAY)
The criteria for adopting a technology or drug
• Reimbursing at a given price is generally based on 6 criteria a) Added therapeutical value b) Safety and tolerance c) Cost-effectiveness d) Budget impact e) Medical and therapeutical need f) Industrial policy
Value based pricing
8
Value based pricing?
ICER = (total cost A- total cost B) / rQALY (A –B) à rQALY (A –B)* ICER = tot cost A - tot cost B à rQALY (A –B)* ICER + tot cost B = tot cost A tot cost A = Drug cost A + Adm c A + AEc A .... Drug cost A = (rQALY (A –B)* ICER + tot cost B) -
Adm c A - AEc A .... 9
F. Cankat Tulunay, 2008
Drugs: " Same mechanisms of action " Mainly me too molecules
(AceIs, ARBs, Calcium CBs, Statins, PPIs, Biphosphonates, Cholinesterase inhibitors, SSRIs, etc)
" Same indication " Similar safety outcomes " Different price
F. Cankat Tulunay, 2008
Advantages: " Significant amount of saving
" Significant support to generic drugs.
" Industry will know the reimbursement band in advance.. " They will not try to push regulatory bodies " Especially small companies will not try to find “me too” molecules
• ACE INHIBITORS: (26) – Benazepril HCl – Delapril – Delapril HCl – Enalapril – Enalapril maleat – Fosinopril sodium – Imidapril – Imidapril HCl – Kaptopril – KinaprilHCl – Lisinopril – Lisinopril dihidrat
– Moeksipril HCl – Perindopril – Perindopril erbumin – Perindopril arginin – Ramipril – Silazapril – Spirapril – Spirapril HCl – Temokapril – Temokapril Hcl – Trandolapril – Zofenopril Ca. – Zofenopril
BRAND INN+DDD PACK.SIZE PACK. PRICE DDD TL kaptoril kaptopril25 50 5,9 0,11 kapril kaptopril25 48 5,63 0,12
sinopril lisinopril10 30 6,4 0,21 vasolapril enalapril10 20 4,62 0,23
enalap enalapril10 20 4,9 0,24 enapril enalapril10 20 4,91 0,24
konveril enalapril10 20 5,67 0,28 Blokace ramipril5 30 12,62 0,42 sandace ramipril5 28 11,74 0,42
delix ramipril5 28 13,87 0,49 kinateva kinapril20 20 9,04 0,52
rilace lisinopril10 28 15,38 0,55 Acuital kinalapril20 20 11,35 0,56 renitec enalapril10 20 12,86 0,64 zestril lisinopril10 28 17,86 0,64
forsace fosinopril20 20 14,67 0,73 inhibace silazapril2,5 28 21,05 0,75 gopten trandolapril2 28 23,52 0,84 univasc moeksipril15 20 17,49 0,87 cibacen benazepril10 28 25,06 0,9 monopril fosinopril20 20 18,33 0,91 coversil perindopril5 30 28,93 0,96 zoprotec zofenopril30 28 30,47 1,1
MEAN 0.55 TL
• Mean= 0.55 + 0.06 TL
• Mean+ SD= 0.55+0.29= 0.84 TL • Median= 0.55 TL
• Geometric mean= 0.46 TL
Reimbursement Band for
F.C. Tulunay, 2009
BRAND INN+DDD PACK.SIZE PACK. PRICE DDD TL IMS 2008 YTL kaptoril kaptopril25 50 5,9 0,11 364,573 kapril kaptopril25 48 5,63 0,12 772,131
sinopril lisinopril10 30 6,4 0,21 1,724,681 vasolapril enalapril10 20 4,62 0,23 120.512
enalap enalapril10 20 4,9 0,24 49,155 enapril enalapril10 20 4,91 0,24 2,114,173
konveril enalapril10 20 5,67 0,28 268,246 Blokace ramipril5 30 12,62 0,42 1,121,249 sandace ramipril5 28 11,74 0,42 ?
delix ramipril5 28 13,87 0,49 17,746,026 kinateva kinapril20 20 9,04 0,52 ?
rilace lisinopril10 28 15,38 0,55 1,147,843 Acuital kinalapril20 20 11,35 0,56 2,381,412 renitec enalapril10 20 12,86 0,64 199,995 zestril lisinopril10 28 17,86 0,64 0
forsace fosinopril20 20 14,67 0,73 ?2008 inhibace silazapril2,5 28 21,05 0,75 7,584,019 gopten trandolapril2 28 23,52 0,84 5,995,584 univasc moeksipril15 20 17,49 0,87 8,727 cibacen benazepril10 28 25,06 0,9 104,720 monopril fosinopril20 20 18,33 0,91 3,461,346 coversil perindopril5 30 28,93 0,96 36,664,923 zoprotec zofenopril30 28 30,47 1,1 12,687,519
MEAN 0.55 TL 68,706,833
45 MİL. DOLAR
27.810.000 18.5 mil dolar
Total: 96.516.867 64.3 mil dolar
F.C. Tulunay, 2009
İlaç Etken Doz Fiyat tablet no DDD/TL Vegabon Alendronat 70 mg/hafta 78,36 12 0,93 Vegabon Alendronat 70 mg/hafta 27,99 4 1,00 Bonacton Ibandronic asid 70 mg 31.94 4 1,14 Bonemax Alendronat 70 mg/hafta 31,94 4 1,14 Andante Alendronat 70mg/hft 31,94 4 1,14 Osalen Alendronat 70mg/hft 31,94 4 1,14 Osteomax Alendronat 70mg/hft 31,94 4 1,14 Andante Alendronat 10mg/gün 32,86 28 1,17 Andante Alendronat 70mg/hft 99,72 12 1,18 Vegabon Alendronat 10 mg/gün 33,07 28 1,18
Osalen Alendronat 70 mg/hafta 99,74 12 1,19 Fosamax Alendronat 10 mg/gün 39,92 28 1,43 Fosamax Alendronat 70mg/hft 39,92 4 1,43 Arilex Risendronate 35 mg 126.68 12 1,51 Arilex Risendronate 35 mg 45,22 4 1,62 Bonviva İbandronik asit 150 mg 154,66 3 1,72 Goyart Risendronate 35 mg/hafta 50,43 4 1,80 Actonel Risendronate 150mg/ay 173.25 6 1,93 Actonel Risedronate 5 mg/gün 55,50 28 1,98 Actonel Risendronate 35mg/hafta 56.73 4 2,02
AVERAGE 1,39
BİPHOSPHANATE
REIMBURSMENT BAND
F.C. Tulunay, 2009
Critical Drug Evaluation of New Cancer Drugs
The Scottish Experience
Prof Ken Paterson Chair – Scottish Medicines Consortium
Berlin – 18 February 2010
New Anti-Cancer Medicines
► Considerable pent-up demand § Patients § Clinicians
► Much media interest § “miracle drugs”, “life-saving treatment”
► Often political interest § …especially if threat not to make drug available
► Legitimate interest from pharma § Keen to sell drug and boost share price/profile
Does some ‘Hype’ Matter?
► May raise false hopes ► Often fails to represent the downside of
treatment ► May distort priority setting in health-care
§ Use of ineffective therapy § Failure to adopt new, effective therapy
► Subverts true evidence-based practice ► How good are new anti-cancer drugs?
§ …and how hard is it to know this?
Scottish Medicines Consortium
► Rapid health technology assessment of all new drugs – established 2002 § Unique position in world new-drug HTA
► Manufacturer makes the case for use – § Clinical effectiveness § Cost-effectiveness
► Cost-utility analysis (cost per QALY) the preferred approach
► Analysis of QALYs only (not cost)
Why QALYs?
► Can (should) capture all the benefits and adverse effects of the medicine in question § Survival gain (or loss) § Improvement in quality of life from treatment § Reduction in quality of life from adverse events § Impact on quality of life of treatment protocol § Appropriate modelling very sensitive to change
► Allows comparison across (and within) disease areas
Oncology Assessments
► Fewer RCTs per drug (median 1 v 2) ► Longer follow-up (52 wks v 12 wks) ► Acceptance rate - 67%
§ About half with some restriction, usually to specialist use
► Higher cost per QALY (£15K v £8.5K)
Special Cancer Issues - 1
► Often scanty phase 3 clinical data ► Complex regimens with poly-pharmacy make
comparators hard to define § RCTs often use comparators different from
current Scottish practice § May require indirect comparison
► Survival benefits often unclear § Overall v ‘progression-free’ survival § Extrapolation not clear-cut § Cross-over after “benefit proven” a problem
Special Cancer Issues - 2
► Quality of life assessment difficult § Impact of adverse events a problem § ? revaluation of QoL near life’s end § ? special benefit with low expectancy
► Increased niching by indication § …more (ultra-)orphan drugs
► …with expectations of “special case”
► Rule of Rescue - a rule??
Quality of Life
► Are the impacts of adverse events limited to when they occur?
► With 3 months to live, if you say your QoL is 90%, is that true? § Are time-trade off/standard gamble useful?
► Is 3 months extra life worth more if you’ve had the diagnosis for 3 months rather than 5 years? § ? discriminates against certain cancers?
Clinical Trial v Real World
► Are the patients similar? § ? older in real world § ? less good performance status § ? more co-morbidities
► Does the drug perform equally well? § ? effectiveness < efficacy § ? toxicity greater in real world
► Does this really all matter? § … only if benefit - risk - cost finely balanced!
SMC and Anti-Cancer Medicines
► 61 cancer medicines reviewed § 36 for advanced/metastatic cancer § 25 for earlier/adjuvant treatment
► Median QALY gain (over current treatment) § 0.38 for advanced cancer § 0.30 for earlier/adjuvant treatment
► Mean QALY gain (over current treatment) § 0.52 for both groups
What does this Mean?
► Median health gain § 6 months with quality of life 70% of normal
► Mean health gain § 8-9 months with QoL 70%
► Only 6 drugs (10%) offered ≥1 QALY ► 22 drugs (36%) offered ≤0.2 QALY
§ = ≤3 months at 70% of normal QoL § Note NICE ‘end-of-life’ decision-making
Is There No Good News- 1?
► Some of the greatest health-gains are with really innovative drugs – § Trastuzumab – 2.4 QALYs § Nilotinib – 2.1 QALYs § Bortezomib – 1.1 QALYs
► Even if these are expensive, they offer good ‘value-for-money’
Is There No Good News – 2?
► Anti-cancer drugs are much like other drugs § Musculoskeletal (11) – 0.66 QALY § Infections (33) – 0.11 QALY § Endocrine (24) – 0.07 QALY § Cardiovascular (33) – 0.05 QALY § CNS and pain (55) – 0.04 QALY
► New drugs in general are not as valuable as many would like to think!
How Good are New Drugs?
► 22% offer no health gain (=me too!)
Ø 28% offer >0 – 0.1 QALY
Ø 25% offer >0.1 – 0.5 QALY
Ø 13% offer >0.5 – 1.0 QALY
Ø 12% offer >1 QALY
Median health gain (n = 281) = 0.1 QALY!!
Caveats and Criticisms
► Health gain is as presented by pharma § May over-estimate true gain by a factor of 2!! § SMC did not always accept the QALY given
► QALY may not adequately capture benefits § Responder v non-responder § Problems with QoL assessment
► Clinical trial ≠ clinical practice § ?possible to maximise benefit & minimise S/E
► … targeted therapy the ‘Holy Grail’!
Conclusions - 1
► Assessing the real benefits of new cancer medicines is not easy
► New medicines generally are rarely as valuable as they might like to appear
► Health-gain from many new cancer medicines is modest § …and often over-stated in media etc
► Some innovative new drugs are breaking the mould
Conclusions - 2
► The introduction of new medicines needs to be managed to maximise risk:benefit
► Real world data on new cancer medicines are urgently needed § … to see whether targeting really works! § … to get real advances to patients quickly § … to minimise burden on (or harm to) patients
► … and costs to health-care systems
► Real innovation has nothing to fear from such assessment!
WHAT DO WE NEED! • A system without corruption • A transperant system • To prevent waste / wastefulness • To be rational • To realize that we all are sailing the same
boat • To trust each other • Harmonization on all subjects (patient
handout forms, education, etc.)
WHAT DO WE NEED! • Pharmacoeconomic analysis of a treatment • Not to have reimburse “drug is not a drug” • Appropriate pricing according to the purchasing
power • Medications to be available to everyone (EQUITY) • Standardized diagnosis-treatment guidelines • Standardized education at all universities • Clinical, pharmacological and epidemiological research • Independent "Govermental Drug Institution” and
“independent reimbursment institution”