Why to invest in capacity building in PE and HTA in CEE?

Doc. dr. Rok Hren, President, ISPOR Slovenia Regional Chapter

Agenda 1. How to value innovation in the presence of “me-too” products? 2. How to make PE/HTA a robust and meaningful tool?

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How to value innovation in the presence of “me-too” products?

What is a branded “metoo” drug? • A branded “me-too” drug is: – deemed having somewhat similar therapeutic effect as the “breakthrough” drug

• From an IPR perspective: – an equal status as the “breakthrough” drug

• Definition has yet to reach consensus – would be likely ferociously disputed by the branded firms

Hren R.. Review of economic principles of branded “me-too” drugs market. Poster at the ISPOR 16th Annual European Congress, November 2-6, 2013, Dublin. Value in Health vol 16: A491-492, 2013.

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What does the literature say about “me-too” drugs?

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Kaitin et al (1991) – Out of 218 drugs approved by FDA from 1978 to 1989, only 34 (15.6%) had important therapeutic gains

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Barral (1996) – Only 11% therapeutically and pharmacologically innovative

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Lu and Comanor (1998) – Among 144 drugs, only 13 deemed having no close substitutes – 1970s and 1980s portfolio

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Similar conclusion reached by Di Massi (2000) – 1995-1999 portfolio

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Schwabbe and Paffrath (2001) – Germany: “30% of the newly introduced substances classified as new and therapeutically significant”

What does the practice say about “me-too” drugs? • Between 2000 and 2010, FDA has granted “priority” review status to 44% of all new drugs – Is it due to companies‘ funding of the FDA‘s approval process?

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British Columbia: 80% of expenditure growth due to “me-too” drugs

Morgan SG et al (2005) Breakthrough drugs and growth in expenditure on prescription drugs in Canada. BMJ 331:816-816.

How to make PE/HTA a robust and meaningful tool?

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Health Technology Assessment requires analytical design • Elements of the design are many – – – – – – – – – – –

Type of economic assessment (e.g., cost-effectiveness) Evidence to classify product benefit (e.g., RCT) Choice of comparator (e.g., the least expensive therapy) Selection of the outcome variable (e.g., QoL) Costs included in the analysis (e.g., only direct costs) Discounting of costs and effects (e.g., 3.5 per cent) Use of CE threshold (e.g., 30,000 GPB) Sensitivity analyses (e.g., deterministic one-way) Missing and incomplete data Perspective Ex-ante or ex-post use? (e.g., cost-efficacy)

Hren R. The importance of sensitivity analyses in health technology assessments. Poster at the ISPOR 16th Annual European Congress, November 2-6, 2013, Dublin. Value in Health vol 16: A617-618, 2013.

How to assess sensitivity analysis?

L Andronis, P Barton and S Bryan (2009) Sensitivity analysis in economic evaluation: an audit of NICE current practice and a review of its use and value in decision-making. Health Technology Assessment Vol. 13: No. 29

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Key take-aways

Putting PE/HTA in the context of challenges in CEE • PE/HTA is an efficient tool in ranking/prioritizing/differentiating “me-too” products – Mandatory in times of financial crisis and with limited resources

• PE/HTA requires level of sophistication that is rarely achieved in the CEE markets – PE/HTA is not only ICER – ICER is not only a single number – PE/HTA should be established as universal methodology and not as a sophisticated marketing tool of pharmacoms

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Situation in Slovenia Academia -Faculty of Pharmacy (Prof. dr. Mitja Kos) -Institute of Economic Research (Dr. Valentina Prevolnik Rupel)

Excellence

Physicians Pharmacists Patients Lay public Thirst for knowledge

Authorities -National House of Insurance Understaffed

Pharmacoms -AmChamSlovenia Uneven capabilities

"Health technology assessment (HTA) has become an integral part in evaluating new health care technologies in Slovenia. Accordingly, there is a great need to increase the knowledge in the arena of health economics and to educate all stakeholders involved in the process of HTA. An ISPOR Chapter in Slovenia was established with a goal to serve as an advocate promoting health economics and outcomes research, encourage research in the field, and act as an impartial communication channel between governmental institutions, academia and industry. The mission of ISPOR Chapter Slovenia is to support public health care policies that maximize societal welfare and optimize diffusion of innovative health care technologies."

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