What You Need to Know About Pharmaceutical Market Access

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Entering the pharmaceutical market in Singapore presents a complex web of regulations and requirements that companies must navigate. Market access refers to the process of making pharmaceutical products available to those who need them at the right price and time. The process involves various activities focused on ensuring patients receive the treatments they require. At its core, pharma market access revolves around two main elements: pricing and reimbursement. For any business looking to thrive in this competitive landscape, understanding the nuances of pharmaceutical market access is crucial. In this article, we’ll explore the essential factors that pharmaceutical companies should consider, from regulatory frameworks to effective pricing strategies.

Regulatory Landscape

The Singapore regulatory framework for pharmaceuticals is governed by several key authorities, with the Health Sciences Authority (HSA) playing a central role. This body is responsible for evaluating and approving medicines and medical devices, making sure they meet rigorous safety, quality, and efficacy standards. For companies looking to enter the market, preparing detailed documentation that aligns with the HSA’s strict requirements is crucial. Familiarity with these regulatory requirements is vital, as they can greatly influence both the timeline and the success of product approvals.

Reimbursement Policies

Understanding reimbursement policies is crucial for pharmaceutical companies seeking successful market access. Getting products listed on the national health authority’s drug formulary ensures they are available to patients. Achieving market access means that a product is approved for use and eligible for reimbursement by national healthcare systems or insurance providers. In Singapore, the Government and various healthcare institutions have set up specific mechanisms for reimbursing new medicines. Companies need to evaluate the cost-effectiveness of their products and how they fit with the country’s healthcare priorities. By navigating these reimbursement processes, businesses can develop strategies that enhance their market access efforts and increase their chances of success.

Here’s a list of key reimbursement policies in Singapore that can assist pharmaceutical companies, along with brief descriptions and information on how they can get their drugs listed:

1. Drug Formulary Listing

The Drug Formulary is a list maintained by the Health Sciences Authority (HSA) and the Ministry of Health (MOH) that includes medicines approved for use in Singapore’s public healthcare system. Listing on this formulary ensures that a drug is accessible to patients at subsidised rates.

Companies must submit comprehensive clinical and economic evidence demonstrating their product’s safety, efficacy, and cost-effectiveness. The Drug Advisory Committee evaluates this submission and makes recommendations to the MOH for listing approval.

2. Health Technology Assessment (HTA)

HTA evaluates the clinical effectiveness and cost-effectiveness of new health technologies, including drugs, to inform reimbursement decisions. This process helps determine the value a drug provides relative to existing treatments.

Companies should prepare data from well-designed clinical trials and economic evaluations. Engaging with the Health Technology Assessment (HTA) agency early in the process can provide guidance on the required data and submission format.

3. Medisave and MediShield Life

Medisave is a national savings scheme that allows Singaporeans to set aside part of their income for medical expenses. MediShield Life is a basic health insurance plan that helps cover large hospital bills and certain outpatient treatments.

A drug must meet specific clinical criteria to be covered under Medisave or MediShield Life. Companies must demonstrate how their product aligns with existing treatment protocols and patient needs and submit the necessary documentation to the MOH for evaluation.

4. Clinical Practice Guidelines (CPGs)

CPGs are evidence-based recommendations developed by expert panels to guide healthcare professionals in the treatment of specific conditions. Drugs that are included in CPGs may receive better visibility for reimbursement consideration.

Pharmaceutical companies can collaborate with medical associations and healthcare professionals to ensure their drug is included in relevant CPGs. Providing clinical evidence supporting the drug’s use in accordance with these guidelines can enhance its chances for inclusion.

5. Specialist Drug Programme (SDP)

The SDP is designed to facilitate access to innovative therapies that may not yet have been formally approved or listed but show promise in treating serious conditions. This programme allows for early access under specific conditions to include their drug in the SDP by presenting compelling clinical data and justifying the need for early access. A review process evaluates the product’s potential benefits against risks.

Pricing Strategies

Singapore is largely a tender-based market with a pricing strategy that is stratified between meeting tender and private needs. Companies may need to conduct their own on-the-ground study with the support of local distributors, engage a market access specialist, or obtain IMS data pertaining to the relevant therapeutic area on which they are going to benchmark their pricing. While it is always good to be able to obtain a B2B price, at times, this can be challenging, which makes it much easier to get a consumer price and work out the base cost. Knowing how to position products effectively in terms of pricing not only impacts market entry but also affects long-term sustainability in this dynamic market.

Market Entry Barriers

Apart from regulatory challenges, It’s crucial to study the local gold standard treatment for a particular indication culture of the people here to appropriately select the type of products to enter Singapore. Some companies are focused on introducing new drugs into Singapore rather than generic drugs due to the lack of profit margin or volume to meet the country of origin’s volume.  Recognising these barriers early on is crucial for developing effective market access strategies. Engaging pharma regulatory services can help companies navigate these complexities more effectively. Proactively tackling these challenges allows the companies to facilitate a smoother entry into the market and better position themselves for success in the competitive pharmaceutical landscape.

Market Access Strategies

Companies must adopt robust market access strategies to achieve and sustain pharmaceutical market access in Singapore. This includes engaging with stakeholders such as KOLs, holding symposiums, participating in congresses, and collaborating closely with procurement agencies such as the Ministry of Health or the Group Procurement Office. By understanding the complexities of the local market and implementing tailored strategies, businesses can significantly improve their chances of successful product registration and establish a lasting presence in the market.

In conclusion, navigating Singapore’s pharmaceutical market access landscape requires thorough knowledge of the regulatory environment, reimbursement policies, pricing strategies, and potential entry barriers. Leveraging expertise in regulatory affairs and implementing effective market access strategies can significantly enhance a company’s chances of success.

If you’re ready to tackle the complexities of pharmaceutical market access with confidence, reach out to The Reg Consultants today. Our team is here to offer tailored regulatory affairs services and insights to help you thrive in the Singaporean market.

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