REIMBURSEMENT OF BLEEDING DISORDERS' TREATMENT IN LATVIA Author: BAIBA ZIEMELE, MBA LLU ESAF PhD student Supervisor: LASMA DOBELE, Dr. Oec. RSU ISC 2016, 16.03.2016.

• To provide a summary of the government spending on bleeding disorders' treatment in Latvia from 2005 to 2015 • By analyzing publically available reimbursement statistics from National Health Service

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Reimbursement system in Latvia • Reimbursement of purchases of

medicines and medicinal products from state health budget according to a disease, its severity and prescription conditions

•  Lists A, B, C, M and individual reimbursement

•  50, 75 and 100% reimbursement •  List of diseases

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Source: MK #899 “Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medicinal Devices Intended for Out-patient Medical Treatment” from 31.10.2006.

Replacement of missing factors •  Hemophilia is a rare disorder in which blood doesn't clot normally because it

lacks sufficient blood-clotting proteins (clotting factors)

•  Missing factors should be replaced (replacement therapy) on-demand or as prophylaxis to prevent internal bleedings

•  With proper treatment and self-care, most people with hemophilia can maintain an active, productive lifestyle and live as long as “normal” people

•  Proper treatment – comprehensive care + adequate factor replacement therapy (amount and type according to diagnosis and phenotype)

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Limitations -  Health system in Latvia constantly lacks money (budget

is only 3% of GDP) and good governance -  Bleeding disorders treatment is extremely expensive –

245 EUR to 40 000 EUR to 1 M EUR per patient a year -  Treatment protocols and options: strictly medical choices

within the frame set by officials -  No access to individual patient data, which is crucial for

analyzing situation for people with rare diseases -  Poor use of HTA tools within the system

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RESULTS

Total spending on bleeding disorders

7

Thousand EUR

Over 10 years, spending has tripled. New patients, new treatment protocols, new treatment options, extraordinary

cases. But is this really good?

724 732 882

1,684 1,560

1,902 1,766

2,158

2,589 2,744

2,258

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Hemophilia A: spending on old drugs

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621 611 688

985 1,034

1,335 1,222 1,246

1,364 1,516 1,452

-

200

400

600

800

1,000

1,200

1,400

1,600

1,800

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Thou

sand

s

Inhibitors rFVIII FVIII DDAVP TOTAL

In past 10 years, spending has more than doubled. Since 2012, recombinant factor concentrates are available to children only. All others use plasma-derived products.

Proportion of spending on inhibitor treatment has decreased from 43% to 26%. No new inhibitor cases.

Hemophilia B: more money, less factor

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99 113 187

690

516 561 537

904

1,210 1,218

782

-

200

400

600

800

1,000

1,200

1,400

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Thou

sand

s

Inhibitors

FIX

TOTAL

During last decade, spending had skyrocketed from 99 th to 1.2 m EUR. Analysis showed it was purely based on inhibitor

treatment for a growing patient (who turned 18 and his treatment was cut in 2015). Another inhibitor patient was

diagnosed in 2008, but has emigrated.

Buying cheapest factor did not mean more consumption. Hemophilia A: in past 5 years, spending grew 43%, while efficiency of spending decreased by 1/5. This effect is partly explained by introduction of rFVIII in 2012, but more impacted with fluctuations of plasma FVIII availability in market. Hemophilia B: Switch from Immunine to Replenine in 2011 decreased spending efficacy on FIX for 1/3, but introduction of Octanine in 2013 decreased improved efficiency for another 1/3.

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3336050 3534000 3625770

4289000 3868750

3619500 3541500 3979750 3811750

4207750 4194250

418720 311500 508150 564000 435000 494400 164500 357700 460500 617000 603000

0 120000 28800 0 0 0 0 0 5400 0 24000 0 500000 1000000 1500000 2000000 2500000 3000000 3500000 4000000 4500000 5000000

2005* 2006* 2007* 2008* 2009* 2010 2011 2012 2013 2014 2015

FVIII, total FVIII rFVIII FIX FVII International

Units (IU)

* Missing data source: WFH Annual Surveys, other data from NHS statistics

Only 2/5 of identified patients receive reimbursed treatment

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78 68

61 57 64

57

12 13 11 13 11 11

34 30 37

49 41

52

0 0 0 1 0 2 0

20

40

60

80

100

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Hemophilia A

Hemophilia B

VWD

FVII

Bleeding disorders are lifelong diseases. Latvia Hemophilia Society has identified more than 280 patients in Latvia.

Although the total number of served patients has not much changed (124 in 2015), the structure is different now.

The rapid decrease of served hemophilia A patients is due to emigration and joining clinical trial in 2010-2011. More people with von Willebrand

disease need treatment.

Conclusion •  The spending has increased over past 10 years, but

number of served patients in most expensive diseases - decreased

• Hemophilia treatment level is still below EDQM recommended minimal factor VIII use in Europe – 3 IU per capita. The factor consumption per existing patients should be higher and will grow in future.

• Not enough data to draw conclusions on spending efficacy: naked financial numbers do not show the full picture – efficiency of drugs in individual patients have to be taken into account

• New patient outcome measurement tools needed

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THANK YOU! Baiba Ziemele Latvia Hemophilia Society Latvian Alliance for Rare Diseases +371 29 157 967 Baiba.Ziemele@inbox.lv