Study On Systems For Improved Access To Pharmaceuticals Services (SIAPS) In Bangladesh: A Report

Background

Pharmaceutical policy deals with provision of medicine and health care facilities within a medical institution. Vaccines, drugs and natural health products are mainly used for the treatement of diseases and ailments and these are produced by the pharmaceutical companies and informed by health researches. After a health research has been done on causes of diseases, the results are then taken to pharmaceutical companies for drug development in relation to the discovered disease. In many countries drug prices are regulated to reasonable prices so that can be afforded by most people. Drug manufacturers submit a proposed price of the drug to the relevant authority based on which the actual price of the pharmaceutical product is determined. Pharmaceutical pricing and reimbursement policies have contributed immensely to development of health policies and influced the healthcare delivery strategies (Vogler, 2012; Paris & Docteur, 2007). Price regulation differs from country to country, some countries use very similar instruments such as international benchmarking (according to what other countries pay), therapeutic referencing (pricing according to what competitors are charging) and economic evaluation which are often used to determine pricing or reimbursement of pharmaceutical products (Vogler, 2012; Acosta et al., 2014; Branstetter, Chatterjee & Higgins, 2016).

 Pricing policies can have variety of effects within a country.  First effect of reference pricing is a change in the market of the drug due to regulation which leads to significant price reductions on both branded drugs as well as generic drugs (Lanjouw, 2005; Branstetter, Chatterjee & Higgins, 2016). The second effect of reference pricing is an impact of the price of medicine on the ability to avail other healthcare services. According to authors, when large amount of money is used to acquire drugs and medicines, the funds that are put aside for important healthcare services such as prenatal care or non healthcare services such as developmental services can get more restricted (Vogler, 2012; Acosta et al., 2014; Lanjouw, 2005; Danzon & Epstein, 2008).

López-Casasnovas and Puig-Junoy (2000) stated that health insurers and pharmacists are now looking for alternative means on how to reduce costs of purchasing medicine. They utilize various approaches to reduce the cost of medicines such as reference pricing. In this process, they group together different medicines that perform the same function and put a reference price to it (Danzon and Furukawa 2008). If patient does not choose one of the drugs listed in the group, then he or she will have to pay the difference in the amount (between the price on the reference list and the price of the medicine purchased by the patient). Theoretical result is also important due to the consistency in the findings thus it provides an explanation to several previous empirical findings on reference pricing. López-Casasnovas and Puig-Junoy (2000) further states that there is enoughevidence which suggests reference pricing successfully reduces medicine prices and  overall expenditures of the pharmacy in the short-term . Prices are more or less affordable where generics and substitutes have more market control and power as compared to the other medicines. There has not been a negative effect among patients who exchanged one drug for a generic one as per many studies. However, it has been pointed out by some authors that there may also be negative effect of referencing pricing on pharmaceutical products, as it could lead to lack of incentives for pharmaceutical innovation (Lanjouw, 2005). Additionally there is also uncertainity of the results of  this research since very few studies have been done on this topic.

Pharmaceutical policy

Galizzi, Ghislandi and Miraldo (2011) stated that reference pricing has led to reductions in prices of medicines which has made pharmacists to  increase reference medicine prescriptions which has ultimately led to a decrease in prescriptions for more expensive medicines since most patients opt for medications that are more affordable, thereby mainly opting for reference medicines. Moreover, there is also decreased expenditure by insurers for purchasing medicines since they mostly use generics which is cheaper than branded medicines (Walker, 1989).

There is also use of external reference pricing, or international price comparison to determine the price of pharmaceutical products.This is used to control prices of medicines charged by pharmaceuticals that are in a way protected by intellectual property righs and may have legally monopolized the business. These pharmaceutical companies may deal with patent drugs which is used in different countries. Kanavos and Reinhardt  (2003) stated that reference prices are usually applied for medicines which are generally making a new entry in the market (new pharmaceutical products) and is later revised. Since 2011, all new  medicine that is licenced are subject to early assessment for quality, which forms a basis for determining the prices of the new generic product (Von der Schulenburg, Vandoros & Kanavos, 2011). Different countries use different algorithms to calculate the reference price, for example, in France only 8% of drugs introduced between 2007 and 2011 had external references made. This lead to variations in drug price within the countries thus making it difficult for the pricing details to remain clear and thus difficult to determine the actual price of the drugs. Thus it has been pointed out that there should be transparency in the prices for the pricing strategy to work effectively (Vogler, 2012).

Giuliani, Selke and Garattini (1998) stated that the only exception of this rule is in Germany where the agency responsible for determining the value of pharmaceutical products is located within the ministry of health, which means the ultimate decision on the price of a drug is determined is decided by an inter department committee  within the ministry of health that has representatives from health industry and social policy equality ministries (Walker, 1989).

This proposal aims to ensure reference pricing is used  in the overall pharmaceutical policy pricing to determine the price of generics thereby making it affordable to patients by reducing expenditure ( López-Casasnovas and  Puig-Junoy, 2000; Aaserud et al., 2006; Galizzi et al., 2011). This is done by looking at the pharmaceutical prices of different countries. Thus the main objectives of this study includes:

Pricing policies

1) To know how pharmaceuticals pricing policies are brought about, applied and implemented.

2) How the value of medicine is determined and how are other medicines expensive while generic are so affordable?

3) To know the Impact of reference pricing on health of patients and the economic growth

4) To identify opportunities and obstacles faced by reference pricing strategy

5) To help health insurers know the best way they can reduce cost incurred.

1) What are the challenges encountered by health insurers and firms in the use  of reference pricing policy and its effect on them and their patients?

2) What are the effects of reference policy on the pharmaceutical market?

3) What approach is used in determining the value of  a new medicine?

4) Role of reference pricing in the determination of drug prices to be used.

This report will be based on five countries namely UK, Italy, France, Germany and Australia. The study will review their pharmaceutical policies as these countries drugs have a strong pharmaceutical market strength. Galizzi, Ghislandi and Miraldo (2011) studied the role reference pricing has played in determining the price of the generics. Key informants used would be the health insurers, patients and pharmaceutical experts (Galizzi et al., 2011; Kanavos et al., 2003). Data will be collected through world wide web, interviews and questionnaires. The experts are then called and invited for the interviews and to answer the questionnaires. The questionnaire was designed to collect data on effect of reference pricing on pharmaceutical pricing policies, the methods of determining the price of the drugs, how the value is determined and the effect of the reference policy on pharmaceutical market and the challenges encountered by health insurers and firms as they use reference pricing policy in the countries being studied. Sample size estimates were, Australia 9.7 percent, Germany 17.5 percent, UK at 8.9 percent, Italy at 13 percent and France at 17.9 percent (Kyle, 2007; Aaserud et al., 2006).

The five countries being studied here have different policies and drug pricing (Lee et al., 2012).  The major source of  finance in these countries is the health insurance since most of the citizens have the insurance and they pay it monthly. Kyle (2007) stated that each country has a different pharmaceutical pricing policy which creates a difference in prices being charged for drugs in each of the mentioned countries in accordance to the policies adopted by the countries under review using reference pricing to determine the price of the drugs. It should however be also noted that prices of drugs not prescribed are not regulated by the pricing policies (Danzon & Ketcham 2004; Russell & Wolff 2002).

Reference pricing

Study design

The study used the following designs:

1) non randomized  trial

2) interrupted time (IT) study

3)randomized  trial

4) controlled before after (CBA)study

5) repeated measures (RM) study

The methods will be used to answer the research questions as follows:

1) What are the challenges encountered by health insurers and firms as they use reference pricing policy and its effect on them and their patients?2,4,1

2) What are the effects of reference policy on the pharmaceutical  market?4,1

3) What approach is used in determining the value of new medicine?3,4

4) Role of reference pricing in determining  the prices to be used.1,5

Acosta et al. (2014) conducted a research on  different pharmacies in their countries and how they use reference pricing for different levels of drug groups.The country samples will include some first world countries (Brekke et al. 2009).  The Department of Health have helped in deciding the countries to be chosen by offering helpful guidance. Countries are selected in accordance to the size of their pharmaceutical market (Danzon and Ketcham 2004).

Operational definition of generics: Acosta et al. (2014) conducted a study to look at  motivations for generic substitution at pharmaceutical level. We look at the positive sales margin that they are forced to encounter that is lower than the reference pricing when they sell generics together with the negative  sales margin of selling a drug that costs more than the reference pricing (Vogler, 2012). In accordance tostudy population which includes both the pharmacies and the patients, the following table shows the outline of methods and target population:

Table 1: Study design and target population for the study

Methods	Study population
Survey	Patients, pharmacists, health insurance
Structured questions	Pharmacists
Focus group	Patients
Key informant	Pharmaceutical experts

The sample  was taken from five countries namely Germany, Spain, UK, Australia and France.

The sample is determined according to the countries strength in the pharmaceutical market. The major key informants were experts involved and who contribute to the work done by OECD on pharmaceutical pricing policies (Kanavos, 2001). They were officially invited on personal interviews and to undertake well detailed questionnaires. These questionnaires helped collect data on the methods used in pricing of pharmaceutical products under the countries being reviewed, strategies being employed, approaches to value determination and the role of external reference pricing.

Table 2: distribution of study

Countries	Total no Of pharmacies	No of samples selected	No of sampled pharmacies
Germany	300	100	50
Italy	200	50	50
Spain	300	150	100
Australia	200	100	50
France	300	100	50
Total	1300	500	300

Kanavos and Reinhardt (2003) conducted research on different countries being reviewed in accordance of their healthcare financing, health expenditure, pharmaceutical pricing policies that they are using and how they determine the value of the medicine. Most of the questions will be dealt with by the pharmacists, health insurers and the officers in charge of the department (Rigter, 1994).

International price comparison

  A sample of patients who were using the generics for the past three months within the specified pharmacies will also be part of the research.Focusgroup discussions will be conducted to elicit their perception of services received and expectations, how good are the generic medicine and if they are now affordable.

Table 3: summary of the respondents

Countries	FGDs	KII
Germany	50	Pharmacists, drug managers
Spain	50	Pharmaceutical association
UK	100	Health insurer and inspector
Australia	50	Pharmacy council
France	50	Pharmaceutical association
Total	300

Data collection activities involved in the review of publications, journals, online literature as identified in the world wideweb through search engines like Google (López-Casasnovas & Puig-Junoy, 2000).

Tools that were used for data collection will include survey questionnaires and direct personal interviews, will be developed by adopting tools used by pubMed which is a repository of several pharmaceutical journals. A list of key essential generic drugs will be used as a reference point for common diseases based on the essential drugs list as per the government approval, which will be prepared for the purpose of this study. This reference list will be used to check whether the key essential drugs for common diseases are available, whether their price is clearly mentioned, as well as the quality, manufacturing date, the expiry date, packaging and storing of the drug which will be assessed during  the checklist guidelines (Lewis, 2015; Fusch & Ness, 2015).

The Research Assistants, will then help in the survey after undergoing training. The everyday field activities during research of the teams involved  will be inspected by the chosen  team leaders of every team and the assigned supervisors (Caretta & Cheptum 2017). The entire survey exercise will be controlled, supervised, inspected  and managed by field supervisors,who will make frequent and impromptu field visits and provide help and guidance when needed. The field exercise and activityand  the consequent data entry is expected to be completed within 45 working days.

The study will be submitted to the ethical review board of pharmaceutical pricing policies and the university for ethics approval. Data from the pharmacists and patients will be taken after their consent before the interview is conducted (Mayan, 2016).

In order to ensure the data collected is accurate and its quality is maintained,the research assistants will have to cross examine each and every questionnaire. They will have to record the interviews to ensure there is no loss of information. In case of inconsistencies, the research team will have to re interview together with field supervisors to ensure quality is upheld (Dingwall et al., 2017). After data collection is completed there will be a debriefing between the research analysts and field supervisors to record their feedbacks and findings.

Aims and Objectives

Survey data will be entered through Microsoft excel. After all the questionnaires have been collected, the data will then be put in excel for survey. Upon collection of all surveyed questionnaire, data will be entered into the MS Access database. Data management will then be done. The data will be quality controlled by re entering Ten percent of the total data. The project coordinator will closely coordinate with the field supervisors regarding any issues related to data entry. The research team develops a codebook which will be used strictly during the data entry. The project coordinator and the PI also will do overall supervision of the data entry and data management which ensures the data collected has been upheld in terms of quality and its validity (Nassaji 2015).

Upon completion of data entry, the data will be transferred into SPSS for Windows where the data will be analyzed. The demographic will be presented in form of means, frequency and standard deviation.

I will assess if the promotion of reference pricing has worked by evaluating the data collected. If most of the patients are now using generics that are more affordable then it shows that the promotion has worked. I would evaluate by making sure the research has reached the appropriate target and that the answers given are accurate according to the questions asked in interviews and questionnaires. I will ensure that the method of implementation is the most cost effective and easily adaptable to pharmacists and can be implemented in the pharmaceutical policies with no problem (Lewis, 2015).

Reference pricing is very important since most people who suffer from diseases may not have a good insurance cover. This may prevent them from accessing the best drugs that would help them. Kanavos and Reinhardt (2003) stated that  reference pricing brings together the generics or substitutes of the original expensive drug, it then decides on one price that the generics will be sold at which is lower than the original expensive drug but still performs the same function. This makes the drug to be very affordable and can therefore be used by all patients.

The use of reference pricing is significant in pharmaceutical pricing policy, since it helps in reduction of death rates. It has also made health care accessible to many people which has improved the living standards of people (Acosta et al. 2014). This intervention is important since it will lead to better access of medicine which will lead to a better working nation.

Research questions

The study will consist of a project report and a workshop organized to disseminate the study findings. This will be used to analyze the results from the research and to ensure the right thing has been done. The results will then be recorded to be used in the final report.  

activities	year-one	year- 2	year- 3	year- 4
Approval of the budget, development of the proposal, signing of the documents especially MOU
Recruitment of enumerators,Training of the field researchers , allocation of research specialists,collection of data.
Collection of field data
Data analysis and drafting of the final report
Submission of the Final report and dissemination

A	Personnel	Pilot	intervention	intervention
Project officer	15000	15000	15000
Field researchers	10000	10000	1000
Research specialists	20000	20000	20000
Research assistant	5000	5000	5000
B	Project support Rented rooms for analyses Production	$500 $200	$500 $200	$500 $200
C	Project activities
Data collection	$2000	$2000	$2000
Final report production	$2500	$2500	$2500
Total/year	$55200	$55200	$55200

The project officer is needed since they are the ones involved with the project, the field researchers are the ones who would go to collect the necessary information from the target in the different counties through interviews and questionnaires and then bring it back for analysis. The research analysts would then collect and analyze critically the work done by the field researchers. They would then table them and put them in the right procedure for the report. The research assistant helps the project officer in all the activities that he undertakes during the research (O’Leary, 2017; Roberts-Holmes, 2018).

Some personnel costs such as transport money, money used for printing of the questionnaires that is involved in travelling from one place to another conducting interviews, phone expenses during telephone interviews, cost of  food for the researchers while doing field work and the internet costs of wifi and printing of journals for research  was also incorporated into the budget (van Asselt et al., 2018).

References

Aaserud, M., Austvoll?Dahlgren, A., Kösters, J. P., Oxman, A. D., Ramsay, C., & Sturm, H. (2006). Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies. Cochrane Database of Systematic Reviews, (2).

Acosta, A., Ciapponi, A., Aaserud, M., Vietto, V., Austvoll-Dahlgren, A., Kösters, J. P., …& Oxman, A. D. (2014). Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies. Cochrane Database Syst Rev, 10(10

Branstetter, L., Chatterjee, C., & Higgins, M. J. (2016). Regulation and welfare: evidence from paragraph IV generic entry in the pharmaceutical industry. The RAND Journal of Economics, 47(4), 857-890

Brekke, K. R., Grasdal, A. L., & Holmås, T. H. (2009). Regulation and pricing of pharmaceuticals: Reference pricing or price cap regulation?.European Economic Review, 53(2),

Caretta, M. A., & Cheptum, F. J. (2017). Leaving the field:(de?) linked lives of the researcher and research assistant. Area, 49(4), 415-420.

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Danzon, P. M., & Furukawa, M. F. (2008).International prices and availability of pharmaceuticals in 2005.Health affairs, 27(1), 221-233.

Danzon, P. M., & Ketcham, J. D. (2004, January). Reference pricing of pharmaceuticals for Medicare: evidence from Germany, The Netherlands, and New Zealand. In Forum for health economics & policy (Vol. 7, No. 1). De Gruyter.

Dingwall, R., Iphofen, R., Lewis, J., Oates, J., & Emmerich, N. (2017). Towards common principles for social science research ethics: A discussion document for the Academy of Social Sciences. In Finding common ground: Consensus in research ethics across the social sciences (pp. 111-123). Emerald Publishing Limited.

 Fusch, P. I., & Ness, L. R. (2015). Are we there yet? Data saturation in qualitative research. The qualitative report, 20(9), 1408-1416.

Galizzi, Matteo Maria, Simone Ghislandi, and Marisa Miraldo.”Effects of reference pricing in pharmaceutical markets.”Pharmacoeconomics 29, no. 1 (2011): 17-33.

Giuliani, G., Selke, G., & Garattini, L. (1998).The German experience in reference pricing.Health policy, 44(1), 73-85.

Kanavos, P. (2001). Overview of pharmaceutical pricing and reimbursement regulation

Kanavos, P., & Reinhardt, U. (2003). Reference pricing for drugs: is it compatible with US health care?.Health Affairs, 22(3), 16-30

Kyle, M. K. (2007). Pharmaceutical price controls and entry strategies. The Review of Economics and Statistics, 89(1), 88-99

Lanjouw, J. O. (2005). Patents, price controls and access to new drugs: how policy affects global market entry (No. w11321). Cambridge (MA): National Bureau of Economic Research

Lee, J. L., Fischer, M. A., Shrank, W. H., Polinski, J. M., & Choudhry, N. K. (2012). A systematic review of reference pricing: implications for US prescription drug spending.

Lewis, S. (2015). Qualitative inquiry and research design: Choosing among five approaches. Health promotion practice, 16(4), 473-475.

López-Casasnovas, G., & Puig-Junoy, J. (2000). Review of the literature on reference pricing. Health policy, 54(2), 87-123.

Mayan, M. J. (2016). Ethics Boards, Risk, and Qualitative Research. In Essentials of Qualitative Inquiry (pp. 125-131). Routledge.