Developing National Plans in Europe Spain

Transcription

1 Developing National Plans in Europe Spain Rafael Esteban Hospital Universitario Valle Hebron. Barcelona, Spain September 2015 Frankfurt

2 Financial Disclosure Statement Consultant for: AbbVie, Bristol-Myers Squibb, Gilead, Novartis, Janssen, and MSD.

3 Approval and access to new DAAs in Spain: The case of Sofosbuvir and Simeprevir Simeprevir 7 11 month access in different regional communities? Therapeutic Positioning Report March 14 FDA approval Nov 13 EMA Approval May 14 Approval & price & reimbursement July 14 Launch Aug 14 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Compassionate use for LTx setting and CUPiC patients* FDA Approval Nov 13 EMA Approval Jan 14 Approval & price & reimbursement Oct 14 Launch Nov 14 Therapeutic Positioning Report Nov 13 4Q 14??? Sofosbuvir mos from EMA approval and access to different regional communities???

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5 Spanish Therapeutic Positioning Report after approval of the first DAAs Indications for reimbursement Liver transplant setting Patients listed to Liver Transplantation HCV recurrence after Liver Transplantation F4 F4 with IFN contraindication or extrahepatic manifestations or PI failure

6 Restrictions on Access for the new drugs

7 Scientific Associacions call for a National Plan for Hepatitis C

8 January 2015 : The new MoH forced in one month a change of direction in Hepatitis C Policy December 3th MoH Replacement. Alfonso Alonso new MoH December 30th MoH Commitment for equity regional access to the new DAA. December19th. MoH Published the hepatitis C Treatment Prioritize Protocol. January 8th. MoH announced the creation of a National Hepatitis C Strategy. Joan Rodes appointed as Chairman December19th. Scientific Society (AEEH) rejected the hepatitis C Treatment Prioritize Protocol. January 9th. Patients Announced a Protest march towards the Government President s House. December 23th. MoH& AEEH meeting. MoH commitment to set up a new guidance plan. January 10th. The Government President, Mariano Rajoy guarantees the access to the HepC prescription treatment for all the patients December 29th. The new General Secretary Ruben Moreno gathers Spanish Medicine Agency and Pharmacy department to bridge differences January 12th National Hepatitis C Plan Coordination Meeting

9 STRATEGIC PLAN TO TACKLE HEPATITIS C IN THE NATIONAL HEALTH SYSTEM smisibles/docs/plan_estrategico_hepatitis_c.pdf

10 February 26 th Expert Group Presentation April 1 st. Strategic 2 Implemented Reduce the HCV morbidity and mortality in the Spanish population, efficiently addressing prevention, diagnosis, treatment and monitoring of patients. STRATEGIC LINE 1 Quantify the magnitude of the problem, describe the epidemiological characteristics of HCV patients infected and establish preventive plans. STRATEGIC LINE 2 Defining scientific clinical criteria for establishing the appropriate therapeutic strategy considering the use of DAA in the context of the Spanish NHS. STRATEGIC LINE 3 Establishing coordination mechanisms to guarantee the National Hepatitis C Strategy implementation. STRATEGIC LINE 4 Fostering the knowledge in the prevention, diagnosis and treatment of hepatitis C in the NHS through specific actions in the area of R&D

11 STRATEGIC LINE 1:TO QUANTIFY THE SCALE OF THE PROBLEM

12 STRATEGIC LINE 2:TO DEFINE THE SCIENTIFIC-CLINICAL CRITERIA THAT ALLOW THE CORRECT THERAPEUTIC STRATEGY

13 General criteria for CHC treatment in the National Health System (1/3) All patients with Chronic Hepatitis C should be considered candidates for antiviral treatment. All patients with CHC who have not responded to a prior antiviral treatment (irrespective of the type received) must be reassessed as candidates to a new antiviral treatment. In view of the scale of the infection in Spain, treatment must be prioritised for patients with significant liver fibrosis and/or with clinically relevant extrahepatic manifestations

14 General criteria for HCC treatment in the National Health System (1/3) Groups of priority patients for treatment with direct-acting oral antivirals include: Patients with significant liver fibrosis (F2-F4) Patients on the waiting list for transplant (liver or non-liver). Liver transplanted patients Patients who have not responded to triple therapy with firstgeneration protease inhibitors. Non-liver transplanted patients with hepatitis C, irrespective of the stage of liver fibrosis. Patients with extrahepatic manifestations of HCV, irrespective of the stage of liver fibrosis.

15 General criteria for HCC treatment in the National Health System (2/3) In patients with fibrosis F0-F1, the treatment can be deferred and its indication can be regarded individually. These patients must be closely monitored and it must be observed whether there are relevant changes in their evolution or in the progression of their disease. In any case, and irrespective of the degree of fibrosis, treatment must be indicated in: Patients with a high risk of infection transmission. Women at fertile age who wish to get pregnant. The therapy recommendations contained in this document are applicable both to monoinfected patients as well as to those coinfected by HIV.

16 STRATEGIC LINE 3:Coordination

17 STRATEGIC LINE 4:R&D

18 First results after 5 months of the implementation The number of subjects with Hepatitis C treated in the first half of the ,134. (35% of the national Plan population Objective)