Zoltan Kalo 1

Transcription

1 Most important health policy objective: improved health status of the population In developed healthcare systems, the most common medical treatment is pharmaceutical therapy Zoltán Kaló Professor of Health Economics Successful pharmaceutical innovation available generic in most common major diseases In chronic diseases with the greatest public health need (e.g. cardiovascular and central nervous system, diabetes mellitus etc.) generic are usually first line therapies CEMDC-PharmaTrain Module 8 kalo@tatk.elte.hu Conclusion: success of public health policies in improving the health status of total population highly depends on the success of generic policies Ref: Kaló Z, Holtorf AP, Alfonso-Cristancho R, Shen J, Ágh T, Inotai A, Brixner D. Need for Multicriteria Evaluation of Generic Drug Policies. Value in Health Policymakers - generic price erosion / lowest price - generic market share / penetration rate (1,2) (In Slovakia)... there is a fast-track reimbursement option for pharmaceuticals with a proposed price that is at least 10% lower than the reimbursed reference product with the same active ingredient. Innovative manufacturers and their advocates - evidence on translation of bioequivalence to therapeutic equivalence Consequences - policymakers prefer cheapest generics - often negative perception on generics This fast track option facilitates price erosion,... it results in frequent changes of the reference product (the product with the lowest price per DDD), allegedly having a negative influence on compliance with prescribing regimens for patients with chronic illnesses The relatively rapid generic price erosion may create negative incentives for the utilisation of generics. Changing the reference product every 3 months and the consequent switch in therapy that may entail stands to decrease patient compliance." 1. Dylst P et al.: Pharmacoeconomics. 2011:29: Kanavos P. Health Policy Aug 27 Ref: Kaló Z, Docteur E, Moïse P. Pharmaceutical pricing and reimbursement policies in Slovakia, OECD Health Working Paper, No. 31, Paris Zoltan Kalo (kalo@tatk.elte.hu) 1

2 generic price erosion reduced health care expenditure increased market share of generic reliable supply of preferred generic products Success criteria of generic drug policies no switch to other patented to prevent pharmacy substitution no increase in the utilisation of health care services equal or improved health outcomes (effectiveness) bio- and clinical equivalence at registration constant product quality maintained adherence & persistence improved patient access to therapy Treatment scenarios after patent expiry for those stable chronic patients who are persistent with their original maintenance drug therapy Potential savings in drug budget Potential effect on persistence with drug therapy Switch to other original Stay on original brand - ++ Switch to a generic drug with the same active ingredient + + Multiple switches among generic ++ - Discontinuation of reimbursed drug therapy Ref: Kaló Z, Holtorf AP, Alfonso-Cristancho R, Shen J, Ágh T, Inotai A, Brixner D. Need for Multicriteria Evaluation of Generic Drug Policies. Value in Health Ref: Kalo Z; Abonyi-Tóth Zs; Rokszin G; Katona L; Ágh T; Inotai A. Impact of Switching on Health Care Costs and Outcomes in Generic Drug Policies. VALUE IN HEALTH A537. Kostev et al. Int J Clin Pharmacol Ther. 2013; 51(5): Ref: Kalo Z; Abonyi-Tóth Zs; Rokszin G; Katona L; Ágh T; Inotai A. Impact of Switching on Health Care Costs and Outcomes in Generic Drug Policies. VALUE IN HEALTH A537. Zoltan Kalo (kalo@tatk.elte.hu) 2

3 Economic value of After patent expiry differential value of original products differential value of generic fulfilling multiple criteria policy objectives single switch to reference generic drug multiple switches to generic P value* Number of patients (N) Total Major Cardiovascular Events (AMI, sroke or death) 303 (9.77%) 350 (10.67%).247 Cost increase from baseline year Antihypertensive <0.001 Total annual treatment costs <0.001 Original lower R&D costs Generic fulfilling multiple criteria policy objectives substandard product quality (e.g. GMP) less stringent bioequvalence criteria lower value in use (i.e. persistence, adherence) inferior clinical outcomes increase in non-drug costs Generic fulfilling lowest price policy objective Ref: Kalo Z; Abonyi-Tóth Zs; Rokszin G; Katona L; Ágh T; Inotai A. Impact of Switching on Health Care Costs and Outcomes in TODAY S Generic RESEARCH Drug Policies. FOR TOMORROW S VALUE IN HEALTH. HEALTH A537. Ref: Kaló Z, Holtorf AP, Alfonso-Cristancho R, Shen J, Ágh T, Inotai A, Brixner D. Need for Multicriteria Evaluation of Generic Drug Policies. Value in Health Disinvestment aspect: Reduce health care expenditure without compromising health outcomes sustainability of health care financing Investment aspect: Increase population health gain by improved patient access without increasing health expenditure health improvement Ref: Kaló Z, Holtorf AP, Alfonso-Cristancho R, Shen J, Ágh T, Inotai A, Brixner D. Need for Multicriteria Evaluation of Generic Drug Policies, Value in Health In lower income countries the accessibility of patients to high cost biological medicines may be limited, because sustainability of health care financing is facilitated by implementing volume limits, influencing 1.prescribers: financing protocols to allow presciptions only for subgroup of patients volume limit for individual prescribers or health care institutions second-line reimbursement only after the first-line therapy fails prescription is limited to selected centers 2.patients: waiting lists limited treatment duration significant copayment for biological medicines signficant copayment for related services significant travel time and costs to prescribing centers 3.manufacturers: delayed reimbursement price-volume agreement Zoltan Kalo (kalo@tatk.elte.hu) 3

4 Clopidogrel consumption was strongly affected by affordability constraints before the generic entry This effect decayed after generic clopidogrel entered the market After controlling for other variables, utilization had a substantially larger trend increase in lower-income European countries than in the higher-income ones. - No significant effect for the highest-income countries - Around 30 per cent for the average-income country - More than 100 per cent for the lowestincome country Ref: Elek P, Harsányi A, Zelei T, Csetneki K, Kaló Z. Policy objective of generic medicines from the investment perspective: the case of clopidogrel, Health Policy, (5): Originator is reimbursed without access limits to patients savings in drug budget Originator is reimbursed with access limits to patients no increase in drug budget improved patient access health gain Originator is not reimbursed potential increase in drug budget health gain Conditions: health care sustainability or improved patient access Treatment naive patients: in the financing protocols biosimilars are first line therapies (even before other patented originator biologicals) Maintenance patients: switch to biosimilars under medical supervision Zoltan Kalo (kalo@tatk.elte.hu) 4

5 Not really, because. for treatment naive patients physicians prefer prescribing therapies with no biosimilar alternative - due to hypothetical concerns related to indication extrapolation - to avoid risk of switching patients to biosimilars - as biosimilars and other patented biologicals are in the same treatment line in financing protocols (i.e. first line therapy) in maintenance therapy physicians prefer continuing the original therapy due to hypothetical risks of immunogeneicity related to switching to biosimilars Systematic literature review to identify evidence on consequences of switching from original biologics to biosimilars. After title-, abstract- and full text screening out of the 230 hits 58 papers were included. 32 of the non-empirical papers implied an increased risk of switching or substituting to biosimilars, however these statements were not substantiated by clinical evidence. On the contrary, none of the systematic reviews, nor the original clinical trials concluded that switching to biosimilars was associated with increased risks for patients. Preventing patients on biologic medicines from switching to biosimilars due to anticipated risks seems to be disproportional compared to the expected cost savings and/or improved patient access as societal benefits. Ref: Inotai A, Prins CPJ, Csanádi M, Vitezic D, Codreanu C, Kaló Z. Real concern or just hype? A systematic literature review of clinical consequences of switching from originator biologics to biosimilars. Manuscript in submission, 2017 Policy approach General policy INN related Systematic analysis of available evidence in the scientific literature Awaiting results of larger ongoing clinical studies on consequences of switching to biosimilars PLANETAS PLANETRA NOR-SWITCH etc. Ex post: analysing available real world data drug utilisation data in payers dispensing database, registries Ex ante: health economic models overestimating potential risks applying sensitivity analyses/scenario analyses () Reconsider objectives of biosimilar drug policies in lower income countries: - Inappropriate to limit the value proposition of biosimilar medicines only to cost-savings - Most important public policy objectives of biosimilars is increased patient access to reduce health inequalities in Europe More research is needed to improve the evidence base of biosimilar pharmaceutical policies Zoltan Kalo (kalo@tatk.elte.hu) 5

6 Disinvestment decisions, especially in difficult economic periods, are rarely substantiated with convincing scientific evidence. The evidence base of generic drug policies (not generic!) is limited and controversial. Therefore generics - in the way they are currently used - may not deliver expected savings without compromising health outcomes. Off-patent medicines have vital importance in meeting public health objectives and sustainability of health care financing Inappropriate to limit the value proposition of generics only to cost-savings Multicriteria decision analysis may be appropriate to evaluate generic and drug policies Zoltan Kalo (kalo@tatk.elte.hu) 6