MANAGEMENT ENTRY STRATEGIES: SPAIN S CASE

Transcription

1 7th European Pharma Licensing Symposium 23rd & 24th September 2014 MANAGEMENT ENTRY STRATEGIES: SPAIN S CASE

2 GENERAL OVERVIEW MARKET ARMONIZATION: DECLARED AS A PRIORITY. CENTRAL GOVERNMENT INTENDS TO PROVIDE EQUAL ACCESS TO A PORTFOLIO OF SERVICES ALL AROUND SPAIN: 1.FREE OF CHARGE A NUMBER OF BASIC HEALTH INTERVENTIONS (PRIMARY CARE, SPECIALIST MEDICINE, SURGICAL INTERVENTIONS and MEDICINES PROVIDED TO PATIENTS WHILE IN THE HOSPITAL) 2.OTHER INTERVENTIONS SUBJECTED TO CO-PAYMENT: MEDICINES (10% to 50%) CERTAIN SURGICAL INTERVENTIONS CONSIDERED NON CRITICAL, FERTILITY TREATMENTS ETC 3.AUTONOMOUS REGIONS CAN SUPPORT INTERVENTIONS SUBJECTED TO CO- PAYMENT (OTHER THAN MEDICINES) IF APPROVED BY HEALTH COUNCIL AND DEMONSTRATE THAT THEY HAVE ENOUGH BUDGET TO FUND THEM. 4.MANDATORY PRESCRIPTION BY INN. PHARMACISTS MUST DISPENSE THE CHEAPEST MEDICINE. PRIORITY TO GENERICS. 5.CO-PAYMENT (10%) EXTENDED TO ELDER POPULATION (ONLY FEW EXCEPTIONS) CO- PAYMENT INCREASED FROM 40% TO 50% 6.MEDICINES FOR MILD DISEASES OR LOW BENEFIT RISK RATIO EXCLUDED FROM REIMBURSEMENT 2

3 Overview of Health System Structure Health Care Provision SMALL SCHEMES FOR CIVIL SERVANTS ARMED FORCES, FISHERMEN AND OTHERS (less than 10% of population covered) PRIVATE INSURERS AND MUTUAS (labour accidents) (coverage less than 5% of population) REGIONAL HEALTHCARE PROVIDERS PRIMARY CARE(First level) HOSPITAL CARE (Third level) BASIC HEALTH CENTERS HEALTH CENTERS & EXTERNAL HOSPITAL CARE

4 Overview of Health System Structure pharmaceutical care Marketing Authorisation Marketing Authorisation Manufacturer Treatment Guidelines Commision Autonomous Regions Directorate of Portfolio of Services of NHS and Pharmacy Interministerial Commission of Price of Medicines (CIP) REGIONAL HEALTHCARE PROVIDERS Regional Agencies of Health Technology Assesment

5 A LONG JOURNEY PAYMENT BY BEING NEW COMPOUND PAYMENT BY MAKING BUDGET IMPACT, PAY BY PROCEDURE EXPENDITURE CEILING PAYMENT BY ACHIEVING P4P, HEALTH OUTCOMES, REAL WORLD CLINICAL DATA 5

6 Overview of Pricing & Reimbursement Manufacturer Marketing Authorisation Clinical Position in Treatment Treatment Guidelines Commision HTA Value Dossier Cost effectiveness Budget Impact Innovation degree Severity of the diesease Contribution to GDP Directorate of Portfolio of Services of NHS and Pharmacy Interministerial Commission of Price of Medicines (CIP) Autonomous Regions Price decided by manufacturer (Dual Pricing) Reimbursement rejected Restricted to case (Hospital Use Only, Visa) Reimbursement accepted Price applicable to NHS

7 ACCESIBILTY IN EU Averaged time( days) elapsed between date of EU MA and accesibility date Patients W.A.I.T indicator EFPIA 2011

8 Pricing and reimbursement are determined nationally while regional bodies can impact market access Pricing Reimbursemen t Access Funding Provision NATIONAL LEVEL AEMPS: Local MA approval authority. Release Clinical Position in treatment (IPT). Directorate of SNS Services Portfolio and Pharmacy (DoPh): Propose price to ICoPM. Decides limitation to use (prior authorization to use) or Hospital dispensation only and propose maximum price to NHS. Interministerial Commission of price of medicines(icopm): Decides the maximum manufacturer s price for all medicines based on recommendation by DoPh. Decides on Innovative Contracting Government Commission for Economics: Decides cut pricing measures and pricing criteria 8 REGIONAL LEVEL - Decide at regional level pharmaceutical expenditure and budget impact criteria. - Decide access of new medicines and prescription rules (generics or cost effective drugs) in hospitals and healthcare centres within the region by means of clinical guidelines and electronic prescription support - Decides on medicines selection within the region based upon HTA Regional Agencies advice. -Tenders, Innovative Contracting (P4P, maximum capitation, pay for procedure) etc..

9 Pricing and reimbursement are determined nationally while regional bodies can impact market access Total Budget (2012): M. (-8% vs. 2011) Five main regions accounts for 60% of total expenditure. Source: Ministry of Health 2012

10 Health care main actors: Future trend CENTRAL GOVERNMENT Directorate of Pharmacy National Access + FUTURE TREND AUTONOMOUS REGIONS Local Health Technology Agencies Commissions High Impact Medicines Local scientific Soc.Centralized PurchasesCommissions Pharmacy and Therapeutics Regional Access Implementation LOCAL Primary Care and specialist physicians Prescription -

11 Four Royal Law Decrees to reduce pharmaceutical expenditure RDL 4/2010 (March 26 th ) Generic price Reduction (average 25%) Recalculation of prices of original products included in RPS based in lowest DDD cost Prices of innovative products calculated as lowest in EU. Switch distribution from retail pharmacies to Hospital of certain products. Impact: MM (8,0% of turnover at exfactory price) 11 RDL 8/2010 (May 24 th ) Rebate 7,5% on the sales to NHS excluded medicines in RPS Prices of medicines remain unchanged Limitation the quantity of drug dispensing at any time depending of nature of the condition (single dose) Impact: 750 MM (4,5% of turnover at exfactory price)

12 Four Royal Law Decrees to reduce pharmaceutical expenditure RDL 9/2011 (August 20 th ) Mandatory prescription by INN Mandatory dispensation of lowest priced product (no priority to Gx) Immediate PR follow to LoE Additional rebate of 7,5% (total 15% for medicines with more than 10 years in the market) RDL 16/2012 (April 24 th ) Increase 10% copayment depending of personal income Medicines no longer free for elderly population (10% copayment) Delisting of drugs for non severe diseases and those classified as low utility. Priority to Gx in case of price parity. Impact: MM (10,7% of turnover at exfactory price) 12 Impact: Not yet calculated but supposed 10% of turnover

13 IMPACT OF COST REDUCTION ACTIONS Source IMS August 2014

14 STRATEGIES AND CASES OF SUCCESS BIOGEN DELIVER FOR FREE 12 WEEKS OF TREATMENT FAMPYRA (Famipridine) APPROVED: January REIMBURSED: August ACCESIBILITY: 581 days

15 STRATEGIES AND CASES OF SUCCESS JANSSEN AGREE A FIXED COST OF FOR PATIENT AND CEILING OF EXPENDITURE BY YEAR (not disclosed) OLYSIO (JANSSEN S SIMEPREVIR) APPROVED: June REIMBURSED: August ACCESIBILITY: 58 days

16 STRATEGIES AND CASES OF SUCCESS UCB PAY COSTS OF 12 WEEKS TREATMENT IN CASE OF NO CLINICAL SUCCESS September 2012: 79% population covered September 2014 : 98% population covered

17 Welcome to the 7 th European Pharma Licensing Symposium 23 rd & 24 th September 2014