interface management of pharmacotherapy · •interface management of pharmacotherapy. drug...

• 17- 19 october 2016, Barcelona

•Interface Management of Pharmacotherapy

Drug evaluation pathways

Consuelo Jordán de LunaICOpraxis Coordinator

20 /10/ 2016

• Multiple new therapeutic targets in cancer• Increased new drugs / indications• Small gains in survival -Great expense

associated• Threshold ? What we consider important?

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Setting

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EMA CATSALUT’S CFTSMA

ICO’SCFT

ICOPRAXIS

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ICO Pharmacotherapeutics comission evaluation:

Drug request

ICOpraxis-Request (Protocol evaluation)

CAMHDA

Special Drug evaluation

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ICO Pharmacotherapeutics comission evaluation:

CAMHDA

•CAMUH

•AIAQS:•Criteris d’us i utilitat terapèutica

•Catsalut. Condicions finançament i estratègies corresponsabilització.

•COPIF

•CATFAC •CatSalut i experts externs:•Autorització, renovació i registre tractaments individualitzats

•Programes de suport a la gestió de la MHDA

• 1. Informes i recomanacions TAC • 2. Autoritzacions, renovacions TAC en pacients• 3. Registre pacients• 4. Condicions finançament i corresponsabilització• 5. Recomanacions TAC en indicacions diferents a

les• autoritzades quan es consideri necessari.

•Consell Assessor

•Comissions farmacoterapèutiques hospitalàries i AIAQS:•Harmonització criteris d’us i utilitat terapèutica MHDA

• 1. Protocol farmacoterapèutic MHDA (TAC exclosos)

• 2. Seguiment pacients (base dades citostàtics, etc)• 3. Recomanacions MHDA en indicacions diferents a

les• autoritzades quan es consideri necessari

•CFT-MHDA

•CatSalut, ICS, CHC, UCH:•Protocol MHDA i seguiment

•Productes

•TAC: orfes, teràpia avançada,•autoritz. condicionada, excepcional etc.

•PASF-TAC

•MHDA: citostàtics, immunosupressors, •antiretrovirals,etc (excepte TAC)

•PH-MHDA

•Tractaments alta complexitat •Harmonització MHDA

•Programes

•Variabilitat accés medicaments (desigualtats)•Limitada informació sobre efectivitat i seguretat en pràctica clínica habitual•Elevat cost i importants taxes de creixement despesa farmacèutica

•Per què?

•Comissions

•CAEIP

•Cost-efectivitat i •Impacte pressupostari

•Generalitat de Catalunya•Departament de Salut

•Medicació hospitalària de dispensació ambulatòria:•llista de la medicacióhospitalària de dispensacióambulatòria en procés d’avaluació pel Consell assessor, indicació avaluada, informes i dictàmens emesos

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ICO Pharmacotherapeutics comission evaluation:

Drug request

0. HEADING 1. IDENTIFICATION OF DRUG AND AUTHORS OF THE REPORT2. APPLICATION AND DATA EVALUATION PROCESS3. DESCRIPTIVE AREA OF THE MEDICINAL HEALTH PROBLEM3.1 Drug description area3.2 Health Problem description area3.2.a Structured description of the health problem3.2.b Current treatment of disease: evidence3.3 Characteristics compared with other similar alternatives

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ICO Pharmacotherapeutics comission evaluation: “ Programa MADRE”

4. AREA OF PHARMACOLOGY4.1 Mechanism of action4.2 Clinical indications formally approved and approval date.4.3 Dosage, method of preparation and administration4.4 Use in Special Populations4.5 Pharmacokinetics5. EFFECTIVENESS ASSESSMENT 5.1.a Clinical trials available for clinical indication evaluated5.1.b Variables used in the tests5.2a Results of clinical trials5.2.b evaluation of the validity and the practical utility of the resultsA. Internal validity. Design limitations and / or commentsB. Applicability of trial practice hospital

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ICO Pharmacotherapeutics comission evaluation: “ Programa MADRE”

C. Clinical relevance of the resultsC.1 Evaluate whether the magnitude of the treatment effect is of clinical

relevanceC.2 Evidence of therapeutic equivalenceC.3 Therapeutic Alternatives equivalents (ATE)5.2.c evaluation of screening tests used5.3 Systematic reviews published, indirect comparisons and

conclusions5.3.a systematic reviews published5.3.b indirect comparisons (CI) 5.3.b.1 Indirect comparisons published5.3.b.2 Self-made Indirect comparisons5.4 Evaluation of secondary sources

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ICO Pharmacotherapeutics comission evaluation: “ Programa MADRE”

6. SAFETY ASSESSMENT.6.1.a description literature search6.1.b Description of the most significant adverse effects6.2 Comparative Clinical TrialsSecondary sources6.3 Safety6.4 Precautions for use in special cases

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ICO Pharmacotherapeutics comission evaluation: “ Programa MADRE”

7. ECONOMIC AREA7.1 Cost treatment. incremental costEXAMPLE: Table with associated costs taken from clinical trial data7.2.a incremental cost effectiveness. published studies7.2.b incremental cost effectiveness (CIS). own data7.3 Estimated number of patients eligible for treatment in hospital7.4 Estimated economic impact on prescribing primary care7.5 Estimated overall economic impact at regional / state level

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ICO Pharmacotherapeutics comission evaluation: “ Programa MADRE”

8. ASSESSMENT OF THE SUITABILITY.8.1 Description of convenience8.2 Influence of convenience in treatment effectiveness9. AREA OF CONCLUSIONS.9.1 Summary of the most significant aspects regarding alternative

proposals9.2 Decision9.3 Conditions of use (only for D-E classification of GINF guide)9.4 Monitoring plan

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ICO Pharmacotherapeutics comission evaluation: “ Programa MADRE”

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ICO Pharmacotherapeutics comission evaluation:

Drug request

ICOpraxis-Request (Protocol evaluation)

CAMHDA

Special Drug evaluation

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EMA CATSALUT’S CFTSMA

ICO’SCFT

ICOPRAXIS

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ICO Pharmacotherapeutics comission evaluation:

Special Drug evaluation

Spanish law RD 2009

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Special drugs designation:

-Expanded acces

-Imported drug

-Compassionate use

Spanish legislation RD 2009

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-DRUG USE IN DIFFERENT CONDITIONS AND AUTHORIZED TO SET FORTH IN ITS TECHNICAL SHEET

-It is not subject to case by case approval by the Agency.

-The treating physician must:

-justify this use in the medical history-adequately inform the patient and obtain consent-respect if any restrictions are established linked to prescribing and / or dispensing of medicine and therapeutic care health center protocol.-The Agency may make recommendations to be taken into account in the preparation of a therapeutic-care protocols health centers.

-The technical specifications of authorized medicines are available in www.aemps.gob.es.

Special drugs availability at the ICO

Physician

Pharmacy Unit

Medical director

Physician

Physician/CFT

Request individualized medicine as clinical report format

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Efficacy, security, cost and convenience evaluation

Approves or denies

Once approved, justifies the need of using this drug in the clinical history. .Informs the patient of the potential benefits and potential risks, obtaining writed informed consent from the patient or his legal representative

Monitoring of clinical outcomes and / or adverse effects of drug use.

Head of thedepartment Consent and signature

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http://ico.gencat.cat

Institut Català d’Oncologia

ICO l’HospitaletHospital Duran i ReynalsAv. Granvia de L’Hospitalet, 199-20308908 L’Hospitalet de Llobregat

ICO BadalonaHospital Germans Trias i PujolCtra. del Canyet s/n08916 Badalona

ICO GironaHospital Doctor TruetaAv. França s/n17007 Girona

@ICOnoticies www.facebook.com/ICOnoticies

ICO Camp de Tarragona i Terres de l’EbreHospital Joan XXIIIC. Dr. Mallafrè Guasch, 4 43005 TarragonaHospital Verge de la CintaC. de les Esplanetes, 14 43500 Tortosa