Download
1 / 17
170 likes | 249 Views
In-depth overview of France's drug pricing and reimbursement, impact of agreement on sales, role of Economic Committee, and members involved. Details on objectives, implementation, and measures to regulate pharmaceutical industry effectively.
E N D
The framework agreement between the french authorities and the industry: a tool to adjust drugs expenditure Chrystelle Gastaldi-Ménager Direction of the Social Security
Overview • rapid overview of the price and reimbursement procedure in France • implementation of the Agreement • presentation of the agreement : main objectives and key points • Impact of the agreement on sales expenditures • conclusion
The economic committee: role • major role in the reimbursement/price procedures : • price negotiation (price/volume agreement) • regulation of drug expenditures based in particular on the framework agreement • drugs : ambulatory and hospital ones • but also medical devices
The economic committee: members • a chairman and a vice-chairman • representatives of the directors of the social security and of the general health (Ministry of health ) • representative of the director of hospital admission and the organization of health care (Ministry of health) • representatives from the Ministry of economic, finance and industry in charge of industry, technology, competition, consumption… • representatives of national health insurance bodies • representative of complementary health insurance
Implementation of the framework agreement • Social Security Finance Law for 2003 • new article in the social security code • open the possibility for an accord to specify the framework for conventions establishing relations between the Economic Committee and each drug company • 6 month negotiations with representatives of drug companies • 12 meetings • Initially for the 2003-2006 period • initially only for ambulatory drugs • modified and reinforced twice : october 2006 and january 2007
Framework agreement: objectives • rapid access by patients to innovative drugs • improved efficiency and rationality in drugs expenditures • sustained effort to avoid all abuse in consumption • promote proper use of drugs a regulation tool which respects the importance attached to maintaining and developing a strong and competitive pharmaceutical industry
Several measures/clauses about • exchange of information • monitoring of reimbursed expenses • acceleration of price/reimbursement procedures • specific advantages for innovative drugs, orphan drugs and pediatric ones • monitoring of new drugs (post-marketing studies) • development of generics and reference prices • information for prescribers, promotion and publicity • multiannual company conventions and annual financial regulation
Exchange of information • desire of transparency in both sides • improving and sharing information about consumption and prescription of reimbursable drugs • pharmaceutical company are responsible to maintain the GERS database • monthly sales: volume/value, ambulatory/hospital drugs • used by the Economic Committee for its forecasts • on trends in sales of reimbursable drugs • with regards to the application of the regulatory mechanisms • information relating to prices charged in other European countries, reimbursement conditions and volume of sales • creation of a joint monitoring group
Acceleration of price/reimbursement procedures (1) • preliminary investigation for centralized marketing authorization drugs • only for drugs with a positive opinion from the EMEA/CPMP • does not exempt the company from making an official application for admission for reimbursement
Acceleration of price/reimbursement procedures (2) • price notification procedure for innovative drugs • Company must ask to benefit from a fast-track procedure only • If they have signed multiannual convention • for drugs with a added therapeutic value (level1 to 3, but also level 4 under specific conditions) • pricing application submitted by company must be consistent with prices accepted in Germany, Spain, Italy and UK (updates) • if the Economic Committee has not informed the company of its objection (explicit reasons) within 2 weeks, the application is deemed to be accepted • Commitments to be undertaken by the companies • regarding prices, sales volume, new scientific data, post-marketing studies…)
multiannual company conventions and annual financial regulation: principles • Would exempt company from the “safeguard” contribution • “Safeguard” contribution is required when annual sale growth is superior to the growth rate (K rate) voted each yean by the parliament (ex: 1% in 2006) • In exchange company will have to pay rebates • rebates paid must be less than the “safeguard” contribution that company would have paid in the absence of agreement
multiannual company conventions and annual financial regulation: 2 types of rebates • rebates by pharmacotherapeutic aggregate • For each aggregates in which the trend in annual sales is greater than the rate determined by the economic committee according to the K rate (fixed by the parliament) • One part of the rebate is paid only by companies whose annual sales trend is greater than the rate set by the Economic Committee • rebates on turnover: • based on any disparity found between their turnover and the threshold set each year by codicil to the agreement • rebates rate is equal to 10%
multiannual company conventions and annual financial regulation: main rebate exemptions • Total or partial exemption for innovative drugs • Ex: for drug with added therapeutic value (ATV) level 1, total exemption for 36 months • Total exemption for orphan drugs unless otherwise stated in the agreement • Total or partial exemption for pediatric drugs • Idem innovative drugs but based on ATV level -1 • Ex: pediatric drug with ATV level 3, same condition tha innovative drug with ATV level 2.
Impact of the agreement on sales expenditures • Total growth for ambulatory sales: • 6.1% in 2003 (15.8 billion €) compared to 0.7% in 2006 (18 billions €) • no rebates paid in 2006 • Total growth for hospital sales • +7% in 2006 (4.6 billions €) • Hospital drugs concerned by the agreement only since june 2006 • amount of rebates: 60.6 millions € before exemptions, 15 millions € after exemptions (and specific credits).
conclusion The framework agreement had permit • To develop and improve the exchange of information between health authorities and companies • To regulate drug expenditures in a way that encourages innovative drugs but also orphan and pediatric ones.
