Developing National Plans in Europe

Spain

Rafael Esteban

Hospital Universitario Valle Hebron. Barcelona, Spain

September 2015

Frankfurt

Financial Disclosure Statement

• Consultant for: AbbVie, Bristol-Myers Squibb,

Gilead, Novartis, Janssen, and MSD.

Compassionate use for LTx setting and CUPiC patients*

Approval and access to new DAAs in Spain:The case of Sofosbuvir and Simeprevir

Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 15

FDAApprovalNov 13

Approval & price& reimbursement

Oct 14

Therapeutic Positioning Report Nov 13 – 4Q 14???

7–11 month access in different regional communities?

12–15 mos from EMA approval and access to different regional communities???

Simeprevir

Sofosbuvir

FDA approvalNov 13

EMAApproval May 14

LaunchAug 14

Therapeutic Positioning Report March 14

Approval & price & reimbursement

July 14

LaunchNov 14

EMAApproval

Jan 14

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

Restrictions on Access for the new drugs

Scientific Associacions call for a National Plan for Hepatitis C

VHC - 797/ES/13-05//1006

January 2015 : The new MoH forced in one month a change of direction in Hepatitis C Policy

8

December 3th MoH Replacement.

Alfonso Alonso new MoH

December19th. MoH Published the

hepatitis C Treatment Prioritize

Protocol.

December19th. Scientific Society

(AEEH) rejected the hepatitis C

Treatment Prioritize Protocol.

December 23th. MoH& AEEH

meeting. MoH commitment to set

up a new guidance plan.

December 29th. The new General

Secretary Ruben Moreno gathers

Spanish Medicine Agency and

Pharmacy department to bridge

differences

December 30th MoH Commitment

for equity regional access to the

new DAA.

January 8th. MoH announced the

creation of a National Hepatitis C

Strategy. Joan Rodes appointed as

Chairman

January 9th. Patients Announced a

Protest march towards the

Government President´s House.

January 10th. The Government

President, Mariano Rajoy guarantees

the access to the HepC prescription

treatment for all the patients

January 12th 2015. National

Hepatitis C Plan Coordination

Meeting

VHC - 797/ES/13-05//1006

STRATEGIC PLAN TO TACKLE HEPATITIS CIN THE NATIONAL HEALTH SYSTEM

http://www.msssi.gob.es/ciudadanos/enfLesiones/enfTran

smisibles/docs/plan_estrategico_hepatitis_C.pdf

VHC - 797/ES/13-05//1006

Reduce the HCV morbidity and mortality in the Spanish population, efficiently addressing

prevention, diagnosis, treatment and monitoring of patients.

Gilead 1

February 26th Expert Group Presentation

April 1st . Strategic 2 Implemented

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

VHC - 797/ES/13-05//1006

STRATEGIC LINE 1:TO QUANTIFY THE SCALE OF THE PROBLEM

VHC - 797/ES/13-05//1006

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

VHC - 797/ES/13-05//1006

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

VHC - 797/ES/13-05//1006

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 first-

generation 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.

VHC - 797/ES/13-05//1006

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.

VHC - 797/ES/13-05//1006

STRATEGIC LINE 3:Coordination

VHC - 797/ES/13-05//1006

STRATEGIC LINE 4:R&D

First results after 5 months of the implementation

The number of subjects with Hepatitis

C treated in the first half of the 2015

18,134. (35% of the national Plan

population Objective)