Question

REPUBLIC OF ZACHISTAN -

INTRODUCING NEW TREATMENT GUIDELINES FOR SEVERE ARVOPHILLIA

Disease Overview

Arvophillia is an infectious disease that affects approximately 225 million people worldwide. Almost one million people die from the disease each year, mostly children younger than five years old. Although the vast majority of arvophillia cases occur in sub-Saharan Africa, the disease is a public-health problem in more than 109 countries in the world, 45 of which are in Africa.

Uncomplicated arvophillia is caused by a parasite that is transmitted to humans through specific bug bites. With early diagnosis, followed by an effective and timely treatment, a patient can expect a complete recovery. If left untreated, uncomplicated arvophillia, can progress to severe arvophillia (approximately 10% of untreated cases). Without treatment, these severe cases have a 100% mortality rate.

Current Treatment

Huffstatin has been the mainstay of arvophillia treatment since 1960s. For uncomplicated cases of arvophillia, oral huffstatin is used. In the treatment of severe arvophillia, huffstatin is given three times a day in a slow, rate-controlled intravenous (IV) drip that takes four hours per IV drip since rapid injection results in potentially lethal low blood pressure (hypotension). The drawbacks of the huffstatin treatment protocol are:

-Requires continual supervision of the infusion thus increasing the burden on health care workers

-Necessitates continuous cardiac monitoring to watch out for huffstatin associated hypotension

-May lead to extremely low blood sugar (hyperinsulinaemic hypoglycaemia) that can cause brain damage and developmental delays in children.

New Treatment Option

Clairadol is a new treatment option that is now regarded as a highly effective alternative to huffstatin. It is the most rapidly acting and potent of all the anti arvophillial drugs available. It can be given in just four minutes through an intravenous (in the vein) injection once daily and is therefore safer and easier to administer than huffstatin lowering the side effects usually associated with the administration of huffstatin. Clairadol is now available from verified and pre- approved suppliers that meet all quality standards.

Efficacy results

Two landmark clinical trials have been conducted to test the efficacy and the relative superiority of clairadol over huffstatin. The first trial, called NEEDAN, was conducted in 2005. This was a multi-site trial in South East Asia and was conducted primarily on adults (the study results were not statistically significant for children). The second trial, called MENDLAK was conducted in 2010 to further extrapolate the results from the NEEDAN study. This trial was conducted on children living in nine different African countries. This trial defined children as being the population below 14 years of age.

These trials were able to demonstrate with statistical certainty the following:

Mortality using Huffstatin

Mortality using Clairadol

Mortality Benefit from Clairadol*

Adults

(>14 years old))

22%

15%

7%

Children

(<14 years old)

10.9%

8.5%

2.4%

*Decrease in mortality using Clairadol instead of Huffstatin

In addition to the mortality benefit of clairadol, the trials were also able to conclude the following clinical and programmatic benefits over huffstatin-

Clinical:

-Lower risk of hypoglycemia than huffstatin

-Less frequent development of coma than huffstatin

-Less frequent convulsions than huffstatin

Programmatic:

-Less burden on health care workers as it does not require rate controlled infusion or cardiac monitoring

-Fewer doses required as the complete treatment with clairadol requires 5 doses whereas treatment with huffstatin requires 10 doses

-More safe than huffstatin treatment where rapid administration is unsafe and needs to be infused over four hours

Global Health Policy Implication

In view of the two clinical trials, NEEDAN and MENDLAK, the World Health Organization (WHO) updated its guidelines for the treatment of severe arvophillia and now recommends:

"Clairadol as the preferred treatment for both adults and children in the treatment of Severe Arvophillia"

WHO is the directing and coordinating authority for health within the United Nations. Globally, countries look for guidelines from WHO to set up their country health policies. WHO's adoption of the new treatment guidelines is therefore an irrefutable endorsement of clairadol as the most effective treatment for severe arvophillia.

The Challenge

The challenge being faced in almost all African nations is that there is a long road from the guideline change recommended by WHO to actual policy change and implementation by these countries. One such nation is the Republic of Zachistan which records the third highest deaths from arvophillia. The existing treatment guidelines for the country still do not recommend clairadol as the preferred treatment.

CHAI is working with the Ministry of Health of Zachistan to advocate for the switch to clairadol preferred treatment for severe arvophillia. The first step in this long process of policy change is to convince the Ministry that the updated WHO guidelines are the right choice for the country. CHAI is tasked with providing a convincing argument, supported by both strong qualitative analysis and quantitative data, to the Ministry to change the treatment guidelines for severe arvophillia.

The relevant details and figures are provided in the appendix.

Appendix

Epidemiological Profile of Republic of Zachistan

Total Population

34,619,949

Diagnosed arvophillia cases in total population

27%

Severe arvophillia among diagnosed cases

5%

Age wise distribution of severe arvophillia population

Age Category

Percent of severe arvophillia population

Average Weight (kg)

< 3 years

70%

10

3 - 5 years

8%

16

5 - 9 years

2%

23

9 - 14 years

6%

38

> 14 years

14%

62

Treatment Protocol for Huffstatin and Clairadol

ITEM

HUFFSTATIN

CLAIRADOL

Dosing

Ampoule/ Vial Sharing*

NO

NO

Unit size

300 mg Ampoule

60 mg Vial

Loading Dose**(mg/kg body weight)

20

2.4

Maintenance Dose*** (mg/kg body weight)

10

2.4

Number of loading doses

1

1

Number of maintenance doses

9

4

Dextrose required

1ml/mg

5ml/vial

Consumables used/patient

Syringes

10

6

Needles

10

6

Cannulas

3

1

IV Giving Sets

3

1

*No vial/ampoule sharing means these cannot be shared across doses or across patients. For example if a dose requires 2.5 vials, it means 3 vials will be used since the unused portion will be discarded.

**Loading dose: An initial (usually higher) dose of treatment given to get an effective drug concentration in the body

***Maintenance dose: Follow up doses given for the complete treatment

Price List

ITEM

BASIC UNIT

UNIT COST (USD)

Huffstatin 300mg

Ampoule

0.16

Clairadol 60mg

Vial

1.2

Dextrose 500ml

Bottle

0.5

Cannula

Piece

0.23

IV Giving set

Piece

0.17

Syringe

Piece

0.05

Needles

Piece

0.17

. A Quantitative Analysis of the two treatments to estimate cost per life saved in Zachistan using the new treatment option; please show all your calculations, assumptions and outcomes clearly using Microsoft Excel; cost per life saved is defined as:

$s/ Lives

$s : Additional dollars spent using clairadol instead of huffstatin

Lives: Additional lives saved using clairadol instead of using huffstatin

The following calculations need to be performed to arrive at the final number:

-Number of cases of severe arvophillia (in each age category)

-Cost of drugs and other consumables (under each treatment protocol)

-Total number of lives saved

-Extra cost per additional life saved