Economy of rare Economy of rare surgical surgical

technologiestechnologies

Vladimir ZorenkoVladimir Zorenko, MD, PhD, , MD, PhD, ProfessorProfessor

Hematological Scientific Centre, Hematological Scientific Centre, Russian Academy of Medical SciencesRussian Academy of Medical Sciences

Moscow, RussiaMoscow, Russia

Causes of slow development of rare (orphan) surgical technologies in Russia

Lack of patient registersLack of diagnostic in regionsLack of specialized centresNo governmental program of

financingLack of standards and protocols of

care

Examples of rare surgical technologies

Treatment of hyperlipidemia

Transplantation

Orthopedic treatment of patients,

suffered from hemophilia with

antibodies to antihemophilic factor

Treatment of hyperlipidemia

Should be about 100 000 patients in RussiaDiscovered and received treatment 120 patientsAll patients treated in Moscow and Saint-

PetersburgTreatment – LDL aphaeresis 1 time in a weekThere is no more than 6000 procedures per year

in Russia One procedure of aphaeresis costs about 1000

USD

Transplantation in RussiaNo common register of needy patientsProblems with tissue banks and tissue typingNo clear and valid information about patients

after transplantationNo information about success and effectiveness of

transplantationNo planning of number of transplantation and

total expendituresWeak legislation

Why treatment of hemophilia is successful?

• Valid register of patients

• Standard and protocol of medical care

• Governmental program of financing

• Appropriate supply with drugs

• Several centres with trained specialists

• Clarity of accounts

Register of patients with hereditary coagulopathy

There is a data on 7374 patients (1761

under 18 years old)

Number of patients with antibodies to antihemophilic factor - 140

Titre of antibodies to aTitre of antibodies to antihemophilic ntihemophilic factorfactor (% of patients) (% of patients)

Titre aboveTitre above 10 10 ВЕВЕ

Titre belowTitre below 10 ВЕ10 ВЕ

82%82%

18%18%

Features of clinical course in patients with Features of clinical course in patients with antibodies to antihemophilic factorantibodies to antihemophilic factor

InIn patients patients 6-15 6-15 years old years old there isthere is 1515 times more times more often affection of bones by often affection of bones by the type of the type of pseudotumorpseudotumor

Affection of Affection of jointsjoints::

2 joints2 joints – – 35 %35 %

3 -5 joints3 -5 joints - - 43%43%

More than 5 More than 5 jointsjoints – – 22%22%

13%13% of patients hospitalized of patients hospitalized with purulent and septic with purulent and septic complicationscomplications

Regimes of hemostatic treatment Regimes of hemostatic treatment during surgical treatment of during surgical treatment of

patients with patients with antibodies to antibodies to antihemophilic factorantihemophilic factor

High-dose therapy with aHigh-dose therapy with antihemophilic factor ntihemophilic factor VIIIVIII

Drugs consists of activated Drugs consists of activated prothrombinprothrombin complexcomplex

Recombinant acivated aRecombinant acivated antihemophilic factor ntihemophilic factor VIIVII

Types of surgical interventions in patients Types of surgical interventions in patients withwith antibodies to antihemophilic factorantibodies to antihemophilic factor

Surgical interventions on joint Number Extraarticular surgical interventions

Number

Synovectomy of knee-joint 13 Pseudotumor extirpation 10

Synovectomy of elbow joint 3 Open osteosynthesis 2Hip correcting osteotomy 4

Arthroplasty of knee-joint 1 Hematic abscess removal 3

Imposition of Volkov-Oganesyan apparatus

4 Ahilloplastic 3

Endoprosthesis of knee-joint replacement

6 Appendectomy 1

Endoprosthesis of hip joint replacement

1 Splenectomy 2

Amputation 1

Retroperitoneal hematoma removal with break into abdominal cavity

3

Auxiliary interventions (autoplasty, primary surgical refinement of wounds)

12

TOTAL: 29 40

**82% 82% of patients had high titre of antibodiesof patients had high titre of antibodies

Endoprosthesis replacement of knee-joint and hip joint

95% - 95% - good good clinical resultsclinical results

There were 151 procedures of eThere were 151 procedures of endoprosthesis replacementndoprosthesis replacementof of knee-joint knee-joint and 32 procedures eand 32 procedures endoprosthesis replacementndoprosthesis replacement

of of hip jointhip joint made since 1992 (includes 91 procedures of made since 1992 (includes 91 procedures of eendoprosthesis replacement ndoprosthesis replacement of of knee-joint knee-joint and 17 procedures and 17 procedures

eendoprosthesis replacement ndoprosthesis replacement of of hip jointhip joint since since 20052005))

6 procedures of e6 procedures of endoprosthesis replacement ndoprosthesis replacement of of knee-joint knee-joint were made in a patients with antibodies to antihemophilic were made in a patients with antibodies to antihemophilic

factorfactor

All surgical intervention in patients with antibodies to All surgical intervention in patients with antibodies to antihemophilic factor were made in Hematological Scientific antihemophilic factor were made in Hematological Scientific

Centre of Russian Academy of Medical SciencesCentre of Russian Academy of Medical Sciences

Therapy, recieving during surgical Therapy, recieving during surgical intervention and after thatintervention and after that

Eptacog alfa (activated)Eptacog alfa (activated) 120 120 mcgmcg//kgkg everyevery 2 2 hours, than interval hours, than interval extension to 3 and 4 hoursextension to 3 and 4 hours

ORORDrugs consists of activated Drugs consists of activated

prothrombinprothrombin complex complex ((FEIBAFEIBA) 100 ) 100 unitsunits//kgkg everyevery 12 12 hourshours

How many units of drugs needed for How many units of drugs needed for surgical intervention in patients with surgical intervention in patients with antibodies to antihemophilic factor? How antibodies to antihemophilic factor? How much does it cost?much does it cost?

It is necessary about 250 bottles of NovoSeven with dose of 2,4 mg…

It cost about ≈ 650 000 USD

Thank you for attentionThank you for attention!!