Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase the likelihood of receiving a fairly priced product and a positive reimbursement decision from the HTA authorities. In this blog we will walk you through the key steps to creating a successful market access strategy for your pharmaceutical product.
Market access is a broad term and is used to describe activities and processes that pharmaceutical and biotech companies undertake to secure a price and market sales for their product.
Market access can mean different things in different parts of the world. In the US, it is about evolving policy in access and coverage, from upcoming Medicaid payment changes to Medicare coverage and payment for innovative drugs. In many parts of Europe, it is more about evidence generation and value communication and being able to reflect the product’s value both from a clinical and financial perspective to get the product reimbursed and priced. This blog focuses mainly on the pricing and reimbursement of pharmaceuticals in Europe.
Reimbursed products are mainly covered by a government grant. Without a positive reimbursement recommendation in Europe, it is very difficult for pharmaceutical companies to bring new products into the markets. Reimbursement processes and status can also look different whether the product is a prescription drug or a hospital drug. Hospitals can for instance have high-cost drug lists where more than 80% of the drug costs are reimbursed by the National reimbursement agency (such as in The Netherlands). Prescription free medicines at the pharmacies (OTC) can on the other hand be sold without reimbursement and paid out of pocket by the citizens.
A very important awareness is that even in Europe, the reimbursement of drugs is subject to local rules formulated by local governments and such rules vary from one European country to another. For instance, most medicines are reimbursed at 100% from the day of launch in Germany, i.e., coverage by insurance funds is granted with the marketing authorization and applicable from market entry onwards. And in the UK, applying for reimbursement to The National Institute for Health and Care Excellence (NICE) is a necessity for getting any sales on the UK market.
Why is a good market access strategy plan so important?
Market access is a critical function of a drug's development and go-to-market strategy, as it sets the stage for a successful product launch.
Over the last 10 years, healthcare systems have seen increased pressure on their budgets, a trend toward greater transparency, and the introduction of increasingly complex and expensive technologies in the market. Both with expensive oncology drugs and very costly orphan drugs for treating rare diseases. And recently, with the very costly one-shot therapies such as ATMPs (Advanced Therapy Medicinal Products), whose benefits can only be appreciated in a longer-term perspective, further limits the affordability for public and private payers and reduces patient access to treatment for what are often life-threatening conditions. For instance, a gene therapy approved for the treatment of the hereditary blood disease thalassemia, among others in the EU, the cost is approx. €1.5 million euros per treatment. The price for the most expensive ATMP approved in the USA to date is approximately $2 million US dollars per patient. As a result, health authorities in Europe continue to incorporate new regulations and controls to evaluate and cover them, and to improve efficiency while closely monitoring health expenditure.
If a company fails with the key market access steps to get their product on the market on time, it will be very challenging to get back on track. The clinical uptake, guidelines and competitors’ prices and reimbursement status might shift focus fast, and so could the product positioning in each market.
To cope with these challenges, there are some key steps to follow for a successful market access strategy. By following these steps, the companies will maximize the possibility for their pharmaceutical product to achieve optimal pricing and reimbursement in Europe, and successfully deliver their product to the patients who will benefit the most from it.
What are the key steps to creating a successful market access strategy?
Market access and pricing is a key piece to successful product development and launch strategy. Without a market access plan, it is very easy to stumble on the last hurdle after your market authorization approval before your pharmaceutical product gets ready to sell.
We have comprised 4 key steps to define your market access strategy before entering new markets. All these steps and activities must be carefully planned and developed early to avoid mistakes in product positioning; evidence gaps or wrong study designs (clinical, social, economic); and to avoid unexpected costs with the need of new studies or adapting the launching strategy.
Step 1: Early Assessment: Define your market access strategy at an early stage.
Define your market access strategy already in the development of phase I and II trials for medicines. This means that it is important to adapt clinical trial design and other studies to be developed (including health economic outcomes research (HEOR) and/or real-world evidence (RWE) studies) from payer, physician, and patient perspectives already from the clinical development phase of the product.
Country-specific clinical development also needs to be considered in the clinical plans and programs. For instance, an early launch could be planned by implementing early access programs (EAPs) for pharmaceutical products and patient level data could be derived from these EAPs and further analyzed and used in local HTAs when applying for reimbursement. Early access programs can already be applied with robust phase II data but are usually used in phase III trials. Early access programs can also fill the gap between regulatory approval and finalization of the pricing and reimbursement applications.
Moreover, having a robust business case in place early in the product development phase is also recommended, to create and have the product's value story in place well ahead in time. Supporting evidence in the business case can include testing different assumptions with key stakeholders, considering different scenarios on the target population, and a list of potential hurdles and challenges to carefully monitor and follow-up on.
Step 2: Know the market: Establish a good understanding of the market and the healthcare system.
This step needs national, regional, and local expertise and includes the type of health care provided, its organization and expenditure, the possible commercial and dispensation channels, the specific regulations, and main bodies. It is also about understanding the different access pathways, the different HTA and pricing and reimbursement processes and pathways, the level of evidence required, the key decision drivers and the different pricing mechanisms.
Both HTA development and pricing and reimbursement processes are key factors for market access. It is very important to understand that these processes and regulations look different in different countries and that the clinical evidence and the price and comparator to the product in one country might not be fully adaptable to the other country.
In some countries there might be price negotiations and financial and performance-based agreements, while in other countries there are very clear and straight forward rebates for the same product.
To target each market appropriately we recommend stakeholder mapping, consisting of relevance and roles in the decision process of different HTA and pricing and reimbursement bodies, KOLs, and patient representatives.
Step 3: Economic models: Develop value package and economic models
When the business case is in place, value messages have been validated, and the understanding of each market's processes and requirements is clear, the development of the global value dossier (GVD) and economic models can start. The global value dossier includes the value dossier with the clinical (efficacy and safety) and social (quality of life and economic impact) evidence to be submitted to national agencies, as well as any other relevant materials depending on the outcomes from previous steps. The economic models look different depending on the clinical landscape, competitive market, price structure and the local processes and requirements. Sometimes a budget impact model is enough but in most of the European countries a cost-effectiveness model with quality of life (QoL) as an outcome is required.
Step 4: Negotiations: Conduct pricing and reimbursement negotiations
The last step before entering the market and after following the steps 1-3 above is the pricing and reimbursement negotiations with the reimbursement agencies. We always recommend the company to be well prepared with appropriate material preparation and market investigation and good negotiating planning to avoid any unforeseen challenges or setbacks.
How can ProPharma support your market access strategy?
ProPharma is a unique partner who can support pharmaceutical companies with these market access key steps above and cover up to 25 different European countries, each with their unique local expertise and understanding of their processes and language skills. This includes UK/Ireland, the big 5, and all Nordic markets.
The market access team at ProPharma also works in close collaboration with our internal teams from clinical regulatory, CMC (Chemistry, Manufacturing, and Controls), QA (Quality Assurance), PV (Pharmacovigilance), Clinical research, and the Life cycle management to help you streamline the development and launch of your new products throughout your product's life cycle. Contact us today to connect with our experts. Let's discuss how we can provide a tailored solution to help reach your goals.
