The Use of Evidence-Informed Deliberative Processes for Health Insurance Benefit Package Revision in Iran

Background: Iran considers the revision of its health insurance benefit package (HIBP) as a means to achieve universal health coverage (UHC). Yet, its decision-making process has been criticised for being weak in terms of accountability and transparency. This paper reports on the development and implementation of the HIBP revision in Iran in the period 2019-2021, employing evidence-informed deliberative processes (EDPs), a framework for benefit package design with the explicit aim of optimising the legitimacy of decision-making. Methods: The High Council for Health Insurance (HCHI) is coordinating the HIBP revision: it planned the six steps of the EDP framework with support from World Health Organization (WHO) and Radboudumc in 2019, and conducted a pilot project on multiple sclerosis (MS) diagnosis and treatment in 2020. Results: Implementation of the MS pilot project concerned the installation of advisory committees (involving some 60 stakeholders in supportive task forces, a technical working group [TWG] and a national advisory committee [NAC]), the selection of decision criteria (relating to quality of care, necessity, and sustainability), the inclusion of services for evaluation (nine in total), and the assessment and appraisal of these services. Conclusion: Implementation of the priority setting process for MS diagnosis and treatment services has likely improved the legitimacy of decision-making by involving stakeholders who engaged in deliberation based on available evidence in a stepwise, transparent process. It is expected to improve the quality of care for MS patients as well as its financial accessibility, at a zero net budget impact. The pilot project has served to help Iran’s health system move faster toward UHC for a broader range of essential health services.


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This annex describes the collection of basic evidence on a range of MS services, divided into five clusters. It served as an input to the TWG meeting on scoping to identify aspects that required closer evaluation, and/or additional evidence. The five service clusters, based on the natural history of MS, are: Diagnosis and risk stratification, Clinical management, Symptom management, Relapse management, and Follow-up. The evidence is extracted from the database of the social security organisation, which provides services to some 60% of the MS patients, from March 2019 to March 2020.

Cluster 1: Diagnosis and Risk Stratification Epidemiology
The local epidemiological surveys show that the incidence of new MS cases in Iran, regardless of gender difference, is 3.2 per 100000 individuals, which culminates to a total 2856 cases taking into account the Iran's population which is 84 billion people. However, the There has been much debate regarding the reason for such diverse distribution across different provinces. The economic development of the province, people's lifestyle, heredity and access to health care and diagnosis services are considered as some underlying reasons.

Service use
The diagnosis of MS may make it difficult to differentiate it from other similar diseases. The available evidence indicates that in 2019 more than 400 different codes of laboratory diagnosis and imaging services have been used to clinically diagnose patients suffering from 3 MS. The average number of diagnosis services prescribed for suspected patients in the first visits was 24 cases.
One of the most important services utilized for the diagnosis of MS is MRI; therefore, determining the frequency of access to this service is critical. Available evidence shows that 15 percent of the newly diagnosed patients have had access to MRI once a year, 46 percent of them have utilized MRI twice a year and the remaining cases have utilized MRI more than twice a year. The details of access to this service are presented in the figure S1.
Another factor reflecting the quality of care in the diagnosis and risk stratification cluster is to pinpoint what has been provided as the first service immediately after the patient is diagnosed with MS. In this regard, the data suggests that the services offered to the patients after diagnosis and determining the risk has been Disease Modifying Therapies (DMT), in a way that 93 percent of patients received one of the DMTs and only seven percent of them did not.
Among those who utilized DMTs, about 33 percent had received brand-name or locally produced Interferons, 18 percent had received Dimethyl fumerate, 15.5 percent had received Rituximab, 12.5 percent had received Glatiramer acetate and 7.8 percent had received Fingolimod. More details are provided in the figure S2. Figure S1. The first intervention for newly-diagnosed patients Figure S1. MRI utilization in patients with MS As depicted in the figure above, very few newly diagnosed patients received Cyclophosphamide, Mitoxantrone, and Natalizumab as their first treatment.

Coverage by HIBP and out-of pocket costs
Most services currently offered to patients in order to diagnose and determine the risk of MS are covered by social health insurance agencies. If patients refer to the private sector for laboratory and imaging services, they have to pay not only 30 percent of the service cost, but also the differential amount between public and private sectors' tariffs.
Since most of the patients refer to private sectors for outpatient laboratory and imaging services, their cost sharing can increase. The average cost paid by suspected patients or newly diagnosed ones in 2019 related the diagnosis services cost sharing has increased up to US$ 26.6, to which the differential amount between the public and private tariffs should be added.

Costs and budget impact
In terms of the cost and financial factor, the data provided by SSO for the year 2019 indicates that US$ 342,857 spent on new MS cases have been used for differential diagnosis and determining the risk. However, 20 high frequency services prescribed for patients comprised 60 percent of the total cost. The following table S1 provides the details related to the high frequency services and the cost related to the services.

Service use
In  The results showed that more than seven percent of patients who received Fingolimod shifted to Rituximab which can be a sign of disease progression in these patients. In other words, Natalizumab, Glatiramer acetate, and Fingolimod are the three medicines that had witnessed the most shifts to other medicines relative to the total number of patients. Figure S4. The share of main switches of DMTs from total switches Another way to showcase the shifts in DMTs is measuring what the total shifts occurred in a year has been and which one has been the most frequent. The results revealed that 23 percent of patients who received one type of interferon had shifted to other medicines. In other words, 23 percent of the shifts has been a shift from one type of Interferon to another DMT.
Another case encompassing nearly 21 percent of the total shifts was a shift from Fingolimod to Rituximab. A shift from Interferon to Fingolimod was another instance, ranking third with a total of 19 percent of the total number of shifts. Still, another instance was a shift from Glatiramer acetate to Rituximab showing a 13 percent of the total shifts. The figure S4 exhibits the details of other shifts.
The difference in the extent of access to services among different patients, which is called  receiving Natalizumab at an interval of every one to two months. Considering all these issues, Natalizumab consumption has witnessed a significant amount of variation.
The consumption of Fingolimod is another notable case. The studies show that the there is a large variation regarding the access to this medicine. The figure S6 shows the imbalanced distribution regarding patients' access to this medicine. Figure S6. The practice variation of Fingolimod

HIBP coverage and out-of-pocket payment
The amount of cost sharing and the total cost sharing is different for each of the medicines mentioned in this cluster. The price of different DMTs is different leading to a difference in the amount of OOP. Since most patients have to receive these medicines, it is vital to provide financial support for these types of medicines.
To exemplify, patient cost sharing related to Natalizumab -as one of the most expensive DMTs-is ten percent of consumer price. Patient cost sharing is five percent of the medicine price for Fingolimod and 13 percent for Rituximab, on average. A huge share of annual cost sharing is afforded by patients receiving Natalizumab, followed by Teriflunomide and A notable fact is that the OOP has reduced, resulting in provision of a better financial support for the patients, thanks to the government's plan for some targeted disease such as MS, Thalassemia and Hemophilia.

Cost and budget impact
In order to assess the sustainability of DMTs, different indicators were utilized, including the prices of medicine, the number of medicines prescribed, the insurance cost per patient, the total cost per medicine, the total insurance cost per medicine and the number of patients receiving at least one dose for each medicine type.
Regarding the price of the medicine, it was observed that Natalizumab is the most expensive DMTs per dose. The next is Rituximab, being the most expensive per unit in 2019.
Considering the number of medicines consumed, the findings showed that Dimethyl fumerate, Fingolimod and Interferon had witnessed the most consumption, respectively .
The insurance cost per patient was another indicator. As the studies revealed, Natalizumab had the most annual insurance cost for the insurers, followed by Fingolimod.
However, the highest total insurance cost belonged to the Interferons which could be traced to the large number of patients receiving them. The figure S7 presents more details in this regard. Interferons which encompasses more than 40 percent of the total insurance cost of DMTs.
It was also found that while slightly more than 25 percent of the total insurance cost of DMTs was related to Fingolimod, only 14 percent of patients had received this medicine.
The analyses revealed that 16.5 percent of DMTs costs have been due to Rituximab, with 17 percent of total patients receiving DMTs having received at least one dose of it. Natalizumab