Horizon scanning: why & how to launch it in Lithuania?? 2018-10-13 Horizon scanning: why & how to launch it in Lithuania?? 2018-02-23 Per Troein, VP Strategic Partners

Europe saw 2015/16 a growth “bubble” HepC was the main driver - after the initial effect, HepC has declined through competition Traditional medicine show overall a steady volume increase but now value growth – thanks to ongoing savings from generics Specialty drugs shows a long term sustained growth ~10% Source: IQVIA MIDAS MAT Q3 2017; Recent Hep C launches included: SOVALDI, HARVONI, VIEKIRAX, DAKLINZA, EPCLUSA, EXVIERA, PEGASYS, SOVRIAD, COPEGUS, ZEPATIER

The value of innovation The promise is first a better medical outcome Comes at a cost - but It is also likely to change the mix of drug cost and other care cost Do we need more than one product in each class? Normally variations in effect/side effect between products – value differences for individual patients More products creates competition – competition leveraged reduces cost  Require early awareness and planning

What do we need to scan for? New break-through innovation Incremental innovation to be leveraged New indications Price shifts as from biosimilare competition

New break trough, examples of innovative product classes/ platforms 10/13/2018 Product class/platform Overview Impact on current treatment Volume of innovation Alzheimer’s therapies High unmet need means even a moderate efficacy would have a high impact on patients/HC system High Targeted + checkpoint comb. Combinations are showing step changes in patient benefits and will be high budget impact items CAR-Ts Offer step change in treatment and potentially a cure in indications where there is high unmet need Antibacterial mAbs Work by binding to bacteria and neutralising them; address need for novel solutions to resistance Gene therapy Offers symptomatic relief and potential cure within rare indications with poor prognosis and QoL Cell therapy Offers a step-change in treatment across a range of prevalent chronic diseases Moderate QI EFPIA Horizon Scan | July 2017

Incremental innovation New products in a class frequently offers some differentiation Different side effect profile More convenient dosing Etc The intensity in completion tend to require 3-4 product in a class Service differentiation Price or rebate agreements Etc Hep C is an example of the rapid development of alternatives daklatasvir (Daklinza) dasabuvir (Exviera) elbasvir/grazoprevir (Zepatier) glekaprevir/pibrentasvir (Maviret) ombitasvir/paritaprevir (Viekirax) simeprevir (Olysio) sofosbuvir (Sovaldi) sofosbuvir/ledipasvir (Harvoni) sofosbuvir/velpatasvir (Epclusa) sofosbuvir/velpatasvir/voxilaprevir (Vosevi)

New indications Case studies Anti TNF – Humira Cancer - Revlimid Rheumatology, Gastro, Psoriasis  moderate increase of patient population Cancer - Revlimid New cancer types, New combinations  each a small patient volume NOACs, Prostate cancer New indications of larger size  large patient volume

Biosimilare entries The largest biological products have/will shortly have Biosimilare competition Competition, well managed, drives down price/gives rebates What will the effect be/should be on usage? What is the effect on cost? Source: IQVIA MIDAS MAT Q3 2017; IQVIA Institute Jan 2018; *Approved by EMA / FDA and on market

The Swedish County Council collaboration model

Horizon Scanning new pharmaceuticals The Swedish model Preliminary evaluation Identification Filtering Experts + Filtering criteria Patient population Morbidity Clinical advantages Innovative way to treat the condition Budget impact Need to reorganize health care Effect on guidelines/recommendations Safety issues Media/patient interest Risk of to fast/slow introduction Legal/Ethical/Political interest Experts Pharmaceutical companies Agencies Organizations Media Etc. Experts

To be considered as a strategy Build knowledge Model Impact Take decision Need for local experts Standardize the format of what to asses Leverage other international work Aim for ”trails” Understand present cost Asses cost implication Consider issues with budget “silos” Get agreement on budget impact Leverage knowledge to all relevant prescribers Monitor outcome

Horizon scanning: why & how to launch it in Lithuania?? 2018-10-13 Horizon scanning: why & how to launch it in Lithuania?? 2018-02-23 Per Troein, VP Strategic Partners