A novel initiative to improve access to medicines for control of non-communicable diseases in low-and middle- income countries

The AAI has been operational for many years now. The article does not provide new data, neither does it summarize the available outcome data. It also does not refer to the very systematic evaluation of the AAI in Kenya by the Boston University School of Public Health (R.Laing, V.Wirtz)

I am also doubtful about the original objective of the programmes in Ghana and Philippines: to provide access to medicines that are not on the national EML and/or national reimbursement list, following “prescriber’s preference”. The latter is not a good way to select essential medicines for free supply or reimbursement; and gives the impression that the national EML and NHI are insufficient. It also forces doctors and patients to use medicines which were not nationally selected or procured and perhaps even unknown to the prescribers. This undermines the national medicine policy.

As the evaluation of the impact of the AAI in Kenya has been rather negative (it did not result in any real benefits to the patients) the one recommendation for more political advocacy is vague and does not really help.

Thank you for giving me the opportunity to review this article describing the Access and Affordability Initiative (AAI), a public-private partnership to improve affordability and availability of medicines for non-communicable diseases (NCD) in Ghana and the Philippines.

I agree with the comments and suggestions made by the first reviewer, particularly those around the need for more details about the initiative and the evaluation methods, to shorten the introduction and provide a concise and critical analysis of the AAI potential impact. I have made some additional suggestions building on these original comments.

Define access and the contribution of the AAI towards improving access to medicines
The initiative is about improving access to medicines so to start with a definition of access and how the AAI is going to be evaluated are needed. You may want to refer to an existing framework for access to medicines and describe which components the AAI aims to address. For example, the 4A framework used by WHO and MSH in 2000 focuses on accessibility, availability, affordability, acceptability, and quality of products and services. Which components does the AAI address, which not?

Differential pricing aims to improve affordability (depending on coverage either for the health system or for the patient) and in this way increase use of medicines. There is a second component in the AAI which aims to address non-financial barriers to access. Issues related to regulation and weak supply chain are mentioned under the differential pricing subchapter. If the AAI has indeed two components, a financial one (differential pricing) and a health system strengthening one (development of clinical guidelines, training on supply chain and clinical management, strengthening of supply chain management), I think the title of this subchapter should be changed to reflect both and in general the article should give equal weight to both components unless one component was dominant in which case this should be specified. 

It would be good to provide more details around the health system strengthening (HSS) interventions and how they are expected to improve access to medicines by acting on one or more of its components. How were these HSS intervention chosen among the many areas of the health systems that could have been strengthened to improve access to medicines (e.g. human resources, health information systems)? A bit of background on the issues hampering access to essential medicines for NCDs in the two countries would help and these challenges could then be linked to the chosen HSS interventions.

Literature on differential pricing and medicines selected for differential pricing
p.3 “Differential pricing, an approach used to price medicines based on the purchasing power of payers in different socioeconomic segments, within countries or between countries, has been shown to be beneficial and lead to improvement of access and affordability^10,11.”
I would suggest also discuss some of the potential challenges with differential pricing which have been discussed in the literature. For example (non-exhaustive list):  

• Moon et al. (2011)¹
• Williams et al. (2015)²
   

p.4 “The Access and Affordability Initiative (AAI) is a multilateral collaboration between multiple stakeholders with the aim of improving access to and availability of essential medicines for the treatment of NCDs and strengthening of health systems.”
When you talk about ‘essential medicines’ do you mean that the medicines selected for differential pricing in these two countries were chosen from either the WHO model essential medicines list (EML) or the national EML in the two countries? Please explain how the medicines which are the focus of the intervention were chosen, particularly the balance between on-patent and generic medicines. In the beginning you mention that 92% of the WHO essential medicines are off-patent. So if the focus is on improving access to essential medicines, one would expect them to be the target for interventions.

Data collection
p. 4 “The AAI study will help provide essential data on access to medicines, affordability of treatment, clinical outcomes, as well as out-of-pocket expenditure by rural and urban populations in both Ghana and the Philippines. This information system will be shared with the respective Ministries of Health in both countries and will assist in providing important policy recommendations to these respective Ministries.”

It would be helpful to know more about what kind of data (i.e. variables) is being collected and how it is being collected (e.g. through existing data collection systems, surveys, etc.). As you rightly mention in the introduction, limited data to study access to medicines is currently available in low- and middle-income countries and to ensure sustainability, data collection systems should be integrated into existing health information systems.

Results
According to https://accessaccelerated.org/initiative/access-and-affordability-initiative/ and http://partnerships.ifpma.org/partnership/access-and-affordability-initiative-aai the studies were due to be completed mid-2017. Can you present some results? Please also provide information on the status of the initiative. When did the interventions start, how long will they last, will there be continuous evaluation? 

Minor comments
You may want to revise the sentence below:
p.3 “Differential pricing is one of the approaches to achieve the goal of Universal Health Care (UHC).”
Differential pricing is an instrument [among many] to increase affordability of medicines, which can contribute to UHC through reduced expenditure and greater access to medicines. [The patient may still need to pay out-of-pocket, the coverage component is not addressed through differential pricing].

p.3 “Through differential pricing, the cost of medicines in populations with limited access in LMICs can become more affordable and, when coupled with needed health system improvements, has the potential to dramatically increase access to medicines for specific conditions among lower income segments of the population.”
Which health system improvements are needed to improve access to medicines?

p.4 “The WHO recently launched the #beatNCDS campaign, which aims to assist countries to achieve nine global voluntary NCD targets to reduce premature deaths from cancers, heart and lung diseases, and diabetes by 25% by 2025. In order to successfully achieve these goals, it is essential that access to medicines be improved by health financing reforms.”
The AAI tries to improve affordability through differential pricing. A health financing reform goes well beyond. It is about changing the way providers are remunerated, how health services and products are financed, etc. It is not just about pricing. For this reason, I would not conclude with this statement just before introducing the AAI.

p. 4 “Through this novel initiative a prospective cohort of patients with hypertension and diabetes were followed in Ghana and the Philippines at multiple sites, allowing these countries, with the support of the Ministry of Health, as well as academic institutions, to study the effect of within-country differential pricing of innovative medicines and health systems strengthening on access to innovative medicines, clinical outcomes, including disease control, complications and adherence, for diabetes and hypertension.” This is a very long sentence, please break it down.

Please check this sentence: p.4 “Each of the participating companies independently and made decisions involving the AAI.”