Access To Anti-Infective Medicines For Systemic Use In Armenia

A442

VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6

was obtained, the submodels were ranked and the final ensemble was compiled on the basis of the forecasts from a weighted average of the submodels.  Results: The comparison of models revealed an association between consumption of antibiotics and changes in resistance. For the pair Escherichia coli – penicillins + inhibitor the forecast accuracy is 89% for parametric model and 49% for nonparametric.  Conclusions: The optimal resistance model should include antibiotic consumption as an independent parameter. There is evidence of a relationship between antibiotic consumption and resistance, although the model should be further examined with more data and across different datasets. PHP16 Biosimilars: Market Access and Market Penetration – A Comparison of France and Germany Freiberg M1, Schwarz R1, Khoury C2 Commercial Germany GmbH, Mannheim, Germany, 2Quintiles Advisory Services, Saint Ouen, France

1Quintiles

Objectives: Biosimilars are approved in Europe since 10 years, representing an opportunity to generate cost savings for the healthcare systems. The market access and penetration differs among products and countries. The objective of the analysis is to understand the current access and penetration of Biosimilars in France and Germany. Different drivers for chances and challenges are identified and assessed.  Methods: 1) Review of rules and regulations for access of Biosimilars: National and subnational rules and regulations Impact of physician associations & patient associations Medical guidelines 2) Review of market uptake and penetration.  Results: By February 2016, 20 Biosimilars were approved by EMA. Under German national regulations Biosimilars do not have to undergo the additional benefit assessment. On subnational level the ASHIPs implement quotas to increase prescriptions of Biosimilars. Also for some Biosimilars fixed reference groups do exist. Moreover, SHIs started open house contracts which allow manufacturers of Biosimilars as well as original Biologics to join the contract by offering a rebate on their selling price, making both economically efficient. The French healthcare system is promoting the prescription of less expensive drugs and is discussing about the implementation of cost-effectiveness assessment of Biosimilars (especially for rheumatoid arthritis). Besides cost savings French physicians seem to be influenced by national guidelines.  Conclusions: In France and Germany, there is a high market penetration for specific Biosimilars (eg Epo, Filgrastim) mainly driven by tender and price-driven competition. There is limited penetration of Somatropin, mainly due to the specifics of the indication of a differentiated market with complex stakeholder landscape and competition. Also physicians in Germany have freedom of therapy and remain reluctant to prescribe Biosimilars based on treatment area and safety questions. Further reasons besides rules and regulations can be seen in the complexity of the new monoclonal antibody Biosimilars and the affected indications.

HEALTH CARE USE & POLICY STUDIES – Drug/Device/Diagnostic Use & Policy PHP17 How Real Is “Free Pricing” In The Uk? Furniss J1, Auluck J2 Mowbray, UK, 2GfK, London, UK

1GfK, Melton

Objectives: A key benefit for companies as members of the voluntary Pharmaceutical Price Regulation Scheme (PPRS) is freedom to launch new branded products at a price of their choice. However, there are increasing restrictions on the price the National Health Service (NHS) is willing to pay. This research reviews drugs launched in the UK in 2014 and 2015 to explore how many were entitled to free pricing, and how many achieved it.  Methods: Publicly available data on new drug launches during 2014 and 2015 was collated using the UK Medicines Information database. Products were filtered to identify ‘new molecular entities’ (NMEs), entitled to freedom of pricing under the PPRS. Licence extensions, new formulations, generics and biosimilars were excluded. NMEs were checked against NICE technology appraisals, Cancer Drugs Fund (CDF) outcomes and tendering requirements for restrictions impacting price.  Results: In total 35 NMEs were launched in 2014 and 31 in 2015. In 2014, 15 of the 35 were reviewed by NICE, of which 6 were subject to tenders, 6 were recommended with a patient access scheme (in each case a confidential discount), 1 was recommended with a simple discount and 1 was referred to the CDF. Fourteen products launched in 2015 were reviewed by NICE of which 3 were subject to tenders, 4 were recommended with a patient access scheme (confidential discount) and 3 were referred to the CDF for consideration. Of the products considered by the CDF, one was subjected to a negotiated price reduction in 2014.  Conclusions: Not all products that qualify for freedom of pricing are able to achieve it. Whether through tenders, Patient Access Schemes, simple discounts or managed entry agreements, prices are often subject to negotiation, and the headline “free” price is not what the NHS is paying. PHP18 Pharmaceutical Policies In Eurasian Economic Union Countries Kostyuk A1, Nurgozhin T2, Akanov A3 1Kazakh Agency for Health Technology Assessment, Astana, Kazakhstan, 2Nazarbayev University, National Laboratory Astana, Astana, Kazakhstan, 3Astana Medical University, Astana, Kazakhstan

Objectives: Eurasian Economic Union (EAEU) is an international integration economic union established by a treaty which was signed on 2014. The union includes Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan. By 2017, the EAEU will form a common pharmaceutical market. Markets for medical equipment will also be integrated. Our objective is to analyze which pharmaceutical policies EAEU countries applied during the financial crisis.  Methods: We undertook a survey with officials from public authorities for pharmaceutical pricing and reimbursement of 5 countries represented in EAEU based on a questionnaire. The survey was launched in November 2015 and repeated in March 2016 to obtain updated information. 

Results: In most countries the prices of medicines are controlled at the stage of manufacture or wholesale. All surveyed countries run a reference price system, i.e. a reimbursement policy based on clusters of identical or similar medicines for which a fixed amount of reimbursement is granted. During the survey period, 17 measures were identified in countries surveyed which were implemented to contain public medicines expenditure. Price reductions, changes in the co-payments, in the VAT rates on medicines and in the distribution margins were among the most common measures. The largest number of measures were implemented in Kazakhstan and Russia.  Conclusions: Cost-containment has been an issue for better-income countries in EAEU – no matter if hit by the crisis or not. Changes in pharmaceutical policies were reported from 3 EAEU countries. Measures which can be implemented rather swiftly (e.g. price cuts, changes in co-payments and VAT rates on medicines) were among the most frequent measures. While the “crisis countries” (e.g. Kyrgyzstan, Armenia) reacted with a bundle of measures, reforms in other countries (e.g. Kazakhstan, Russia) were not directly linked to the crisis, but also aimed at containing public spending. Since further reforms are under way, we recommend that the monitoring exercise is continued. PHP19 Access To Anti-Infective Medicines For Systemic Use In Armenia Sevikyan A Yerevan State Medical University, Yerevan, Armenia

Objectives: Аnti-infective medicines are widely used in Armenia. However, a national reimbursement system covers cost of medicines only for patients from some vulnerable groups. The objective of this work was to study availability and affordability of anti-infectives for systemic use for outpatients in Armenia.  Methods: In May-June 2015 data on availability and prices of 10 tracer anti-infectives (all from the Armenian List of Essential Medicines) were collected in 60 pharmacy outlets from 10 different regions of Armenia and the capital - Yerevan. Affordability of medicines was calculated using methodology developed by World Health Organization and Health Action International: assessing the number of days for worker with the minimal salary to work in order to pay for one course of treatment with a particular medicine.  Results: Tracer anti-infectives were available at more than 90 % of all the community pharmacies studied. Originator brands (OB) were found for 4 pharmaceuticals, generics - for all medicines. OBs for 3 of 4 medicines were much higher priced than lowest-priced generics (LPGs), however for 1 of 4 anti-infectives price for OBs is the same as price of highest priced generics (HPGs). Using matched medicine pairs (OBs:LPGs ratio), OBs were from 3.7 to 29 times the price of LPGs. One (Sulfamethoxazole + trimethoprim) medicine is affordable (OB and generics), generic products of Ceftriaxone, Aciclovir and Clarithromycin were affordable only if prescribed at low doses and unaffordable at higher doses; only generic products of Amoxicillin, Azithromycin, Ciprofloxacin and Doxycycline were affordable.  Conclusions: Anti-infectives for systemic use are mainly available at pharmacy outlets in Armenia. There is a large difference in prices of OBs and LPGs. Due to high prices treatment of effective diseases can be unaffordable for many patients who pay for medicines out-of-pocket. A new policy on medicines reimbursement system could improve the situation. PHP20 The assessment of advanced medicinal products (atmp) in germany: is the practice to define atmp drugs as procedures in compliance with european legislation? Volmer T, Bakker K SmartStep Consulting GmbH, Hamburg, Germany

Objectives: The EU Regulation no. 1394/2007 of the European Parliament on ATMP was adopted in 2007 – and with some procedural exemption implemented in full consequence up to 2012. All medicinal products based on gene therapy, somaticcell therapy or tissue engineering launched in Germany since 2007 are by definition drugs – and should therefore fall since 2011 under the AMNOG process. The objective of this study is to assess how ATMP products have been evaluated by the German Federal Joint committee (Gemeinsamer Bundesausschuss – G-BA). Methods: All ATMP products launched in Germany have been analyzed to understand: (1) how many ATMP products went through a regular drug evaluation process defined by the §35a SGBV (AMNOG)? (2) In how many cases has the G-BA decided to use a different way of assessment (e.g. prior or during AMNOG times)?  Results: In June 2016, 15 ATMP products in Germany have received either a valid centralized marketing authorization for the EU(7) or a national authorization pursuant to the special provisions of section 4bAMG (8 products). Two somatic cell therapy medicinal products are tumor vaccines and excluded. Of the remaining 13 products, 6 products have not been classified as drugs – and the evaluation is not completed: the reimbursement status of these products is unclear. One product (ChondroCelect) is covered under §135SGBV regulation since 1999 – and still on temporary status. Three products (Provenge, Glybera, Strimvelis) are covered within the AMNOG process. One assessment (Strimvelis) has only started June 2016. Two (one Orphan: Glyera), received a non-quantifiable benefit rating. Three products (MACI, Holoclar, C-Cure) are covered by §135/§137cSGB< span”> V regulation, though the AMNOG should be applied. Conclusions: Although the EU regulation defines ATMP products as drugs, the German HTA evaluation process follows only in some cases the drug procedures of the AMNOG process (§35aSGBV). This might be in conflict with EU regulation No. 1394/2007.

PHP21 Access To Orphan Drugs In Poland - Is Change In Health Technology Assessment Approach Required? Caban A1, Lach S1, Rémuzat C2, Toumi M3 1Creativ-Ceutical, Cracow, Poland, 2Creativ-Ceutical, Paris, France, 3Faculté

Laboratoire de Santé Publique, Aix-Marseille Université, Marseille, France

de Médecine,