Do Pharmaceutical Cost Control Policies Effective In Reducing Pharmaceutical Expenditure And Volume? A Systematic Review

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of DORDs; and there were relatively more negative versus positive reimbursement recommendations made for DURDs versus DORDs.  Conclusions: These findings suggest that DURDs and DORDs could be viewed as distinct categories of DRDs from an HTA perspective. This suggests that applying the same HTA standards to DURDs and DORDs might be inappropriate and could account for the higher rate of rejection of DURDs. Adaptation of HTA processes to accommodate DURDs could ameliorate inequity in access to treatments for extremely rare conditions. PHP43 Domestic Manufacturing In Russia: Measuring The Success Of The Pharma 2020 Program Privolnev Y Decision Resources Group, Toronto, ON, Canada

Objectives: Russia’s Pharma 2020 strategy, introduced in 2009, asserted the development of a strong domestic pharmaceutical industry as a top priority. One of the core goals of Pharma2020 is to have drugs manufactured in Russia account for a minimum 90% of drugs on the List of Vital and Essential Medicines (ZHNVLP) by 2020 - the country’s only national formulary and reimbursement list. This study will examine the methods, success and success factors of the Pharma 2020 program.  Methods: The ZHNVLP and accompanying regulations from 2009 onwards were examined to determine how many drugs were Russian-manufactured at the beginning of the strategy compared to how many drugs were Russian-manufactured in the 2016 list, and change throughout. Government strategies and external factors (economic growth, inflation, etc.) were analyzed to determine a correlation between factor and the change in the make-up of the ZHNVLP.  Results: 65% of the drugs on the 2016 list were Russian-manufactured or Russian-foreign partnership manufactured, an increase from the start of the Pharma2020 strategy. However, the 2014 list was 68% Russian-manufactured or Russian-foreign partnership manufactured. The decrease can be attributed to economic conditions in Russia since 2014. The overall increase compared to the program’s inception can be attributed to stricter government laws around selling and tendering foreign-manufactured drugs in Russia, as the majority of change in the ZHNVLP is a result of Russian-foreign partnerships and foreign companies manufacturing drugs in Russia.  Conclusions: Government regulations barring foreign companies from participating in public tendering in many circumstances has been the most effective tactic for Pharma 2020, resulting in an increase of foreign-domestic partnerships and companies manufacturing directly in Russia. As the regulations becomes stricter and expand to include the Eurasian Economic Union, foreign manufacturers will increasingly be pressured to commit to manufacturing in Russia or forego the market entirely. PHP44 Are We Indeed Fast Adopters As We Claim To Be? An Analysis Of The Time Interval From Regulatory Approval To Coverage And Reimbursement In The National List Of Health Services In Israel Ribalov R1, Morginstin T2, Greenberg D1 1Ben-Gurion University of the Negev, Beer-Sheva, Israel, 2Ministry of Health, Jerusalem, Israel

Objectives: Coverage and reimbursement of new drugs/indications in Israel is possible only if these have been approved by one of the major regulatory agencies worldwide (usually the FDA or EMA), and are registered in Israel. We assessed the time interval from regulatory approval to coverage of drugs in the National List of Health Services (NLHS) in order to identify if Israel is an “early adopter” that reimburses drugs soon after their international approval.  Methods: We reviewed all drugs included in the annual updates of the NLHS from 2008 through 2015. For each drug, we collected information on type of disease, specific indication, whether the drug is a chemical entity or a biological drug and the date of inclusion in the NLHS. Date of FDA and EMA drug’s initial/new indication approval was collected from the agencies’ websites. For EMA, we considered the date of CHMP’s positive opinion or authorization date. For each drug, we calculated the time interval from the earliest date of FDA or EMA approval until NLHS inclusion.  Results: A total of 471 drugs were reviewed of which 108(22.9%) were indicated for solid tumors, 61(13.0%) for hematological or hematology/oncology, 37(7.9%) for neurological, and 34(7.2%) for cardiovascular-related diseases. The median time lag was 1192 days; 17% of drugs were included in the NLHS within 1-year and 35% within 2-years of regulatory approval. Among the major disease areas, the median time to coverage was the shortest for hematology/oncology (664 days) and solid tumors (783 days) drugs (p= NS). The median time lag for biological and chemical drugs was 1024 and 1284, respectively (p= NS) but was substantially shorter for drugs covered during 2012-2015 compared to 2008-2011 (839 vs.1404 days, respectively; p< 0.001).  Conclusions: Israel is not a very fast adopter of new drugs. In recent years, however, the lag between regulatory approval to coverage has been substantially reduced. PHP45 Do Pharmaceutical Cost Control Policies Effective In Reducing Pharmaceutical Expenditure And Volume? A Systematic Review Lee KS1, Hendrie D2, Sunderland B2, Moorin RE3 1Ministry of Health Malaysia, Selangor, Malaysia, 2Curtin University, Western Australia, Australia, 3Curtin University, Perth, Australia

Objectives: To synthesise and compare methodologically the reported impacts of pharmaceutical cost control policies on drug utilisation, drug costs and public pharmaceutical expenditure.  Methods: We search major databases MEDLINE (Ovid), EMBASE (Ovid), EconLit and Google Scholar for randomised controlled trials (RCTs), non-randomised controlled trials (CCTs), repeated measures (RM) studies, interrupted time series (ITS) analyses, and before-after (BA) studies from 1 January 1991 to 31 December 2012. Combination of keywords covering four themes were used; Pharmaceuticals and Insurances, Cost Containment Measures, Health Care Policies, and Outcome Measures. Outcomes included drug volume (number of prescribed drugs, number of dispensed drugs) and drug expenditure (total drug expenditure, drugs cost or price). Studies evidence level were graded according to the Scottish Intercollegiate Guidelines Network (SIGN) grading system.  Results: We identified

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32 ITS and 7 BA, carried out in 15 different countries. Policies found were grouped into two categories, namely policies influencing either the supply or the demand of pharmaceuticals. Most policies influenced pharmaceuticals demand whereby 17 of the studies investigated patient cost sharing polices, which included fixed co-payments (2), proportional co-payments (1), ceilings (2) and a combination of cost sharing policies (12). 4 studies analysed either positive or negative list policies, 10 studies on prescription controls and duration limits, one study each on budget policy and generic substitution. Policies influencing the supply were mainly on reference pricing policy (9) and price cut measures (3). All studies in the review fell into Level 3 (non-analytic studies) of the SIGN grading system.  Conclusions: This review suggest that price cuts and reference pricing measures have been effective in reducing total drug expenditure mainly by reducing drugs cost, with limited changes observed in drug volume. Cost sharing, positive and negative lists and prescription controls and duration limits, were found to have reduced drug volume or drug cost but their impact on total drug expenditure was inconclusive. PHP46 International Reference Pricing: Measuring Country Influence Privolnev Y Decision Resources Group, Toronto, ON, Canada

Objectives: International reference pricing (IRP) is used by countries to benchmark prices, in order to minimize drug prices. Reference countries can make or break a drug’s launch, and are thus very influential on pricing worldwide. This study will seek to categorize and analyze countries across three metrics to establish levels of and reasons for IRP influence, to assist the drug industry to better launch drugs.  Methods: Reference baskets worldwide were examined for inclusion of 55 of the largest pharmaceutical markets in the world. The 55 countries were then analyzed for degree of influence (how often they appear in reference baskets) and range of influence (how many different geographic regions they are referenced in). The countries were then segmented into levels of influence – top influencers (influential in range and degree), moderate influencers (influential in range or degree) and low influencers. The countries were then examined for a third metric (market size) and for similarities, in order to determine which factors (health technology assessment, cost-containment strategies, demographics, geography, economy, etc.) are common to which segments.  Results: Of the 55 nations examined, 3 were top influencers (influential in range and degree), 28 moderately influential (only 5 in terms of range, 23 in terms of degree) and the remaining were deemed not influential. High influencers, and moderate influencers to a lesser extent, tend to be regional powers, relatively wealthier, have strong health technology assessment (HTA) structures and employ many costcontainment strategies. Uninfluential nations tend to not use HTA or have high costs, free pricing or unusual demographics.  Conclusions: The four resulting segments feature distinct profiles that affect international reference pricing, with many similarities between the countries in each group. Through the use of this influence-ranking system, the drug industry can understand which nations are influential in what contexts, and develop a strategy for successfully launching new drugs. PHP47 The Future Of Uk Drug Pricing: The 2014 Pprs (An Interim Review) Macaulay R Parexel Access Consulting, London, UK

Objectives: The Pharmaceutical Price Regulation Scheme (PPRS) is a voluntary agreement between industry and government to control pharmaceutical expenditure that regulates profit rather than prices directly. A new inclusion in 2014 PPRS was the industry “austerity commitment” to ensure the NHS branded medicines bill stayed within “affordable limits” (0% change 2014–2015, < 2% annual growth 2016– 2018); this was rebated if exceeded. There are exemptions; notably new launches: included in the measured spend but rebates are not paid on their revenues. This research evaluates medicine expenditures/rebates realised versus forecasts under this PPRS and implications of its 2018 expiry.  Methods: Publically available DoH PPRS documentation (to 11/04/16) was screened for forecast and realised expenditures/rebates.  Results: The PPRS covered ~75% of branded medicines sales in 2014 (~£8.3 billion). £310 million in rebates were paid in 2014, rising to £619 million in 2015 (excluding Q4). The 2014 rebate represented 3.74% of sales covered by the PPRS payment. This was based upon a forecast measured spend growth rate of 3.87% in 2014, which was substantially exceeded (6.03%). Hence, the 2015 annual rebate was increased from 7.13% (forecast) to 10.36% (actual) and the 2016–2018 annual forecasts were raised from 9.92% to 15.0%. In 2015, the growth rate of 0.90% was significantly lower than the 4.55% forecast. Hence, the 2016 annual rebate (and the 2017 and 2018 forecasts) was reduced to 7.80% from the forecast 15.0%.  Conclusions: The 2014 PPRS has undoubtedly helped to control NHS medicinal expenditure, with over £1 billion rebated to date (expected to reach £3 billion). In 2018, this scheme expires and, against the backdrop of continued economic growth, there may be industry reluctance to renew this “austerity commitment”. This may require substantial governmental investment to make up the shortfall or may potentially be used by the government to drive new pricing and reimbursement reforms. PHP48 The Transparency Of Published Recommendations On Reimbursement Of Health Technologies In Poland Bochenek T1, Kocot E1, Rodzinka M1, Godman B2, Maciejewska K1, Kamal S3, Pilc A4 of Health Sciences, Jagiellonian University Medical College, Krakow, Poland, 2Division of Clinical Pharmacology, Karolinska Institutet, Stockholm, Sweden, 3School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, 1211 Geneve 4, Switzerland, 4Institute of Pharmacology, Polish Academy of Sciences, Krakow, Poland 1Faculty

Objectives: The Polish state agency for health technology assessment (AOTM/ AOTMiT) serves as an advisory body to the Minister of Health, to whom it issues the HTA-based recommendations on reimbursement of new health technologies. The recommendations are being partly blinded before making them available to the general public. Nevertheless, it was assumed that the citizens of a democratic