Market access update
What is market access?
For pharmaceutical and biotechnology manufacturers, enabling faster patient access to therapies is a key challenge. An effective market access strategy helps them solve the challenge.
Market access: a basic definition
In the simplest terms, market access is about getting the right treatment to the right patient at the right time, and possibly even at the right price.
- eligble patients having rapid, consistent and sustained access to medicines
- generating and communicating data for the stakeholders involved in the adoption and funding of the drug
- making sure those products and services are fairly priced and reimbursed.
Why is market access important?
Did you know that innovative treatments, such as CAR-T can be priced as high as $375,000 a month? This is set against a context where many healthcare systems are under pressure to reduce the cost of drug bills.
Therefore, pharmaceutical and biotechnology manufactures need effective market access strategies that get them the best reimbursement possible for their asset while keeping those assets affordable for payers, so that patients have access to new, effective therapies as soon as possible.
This can be a complicated process.
Manufacturers need to communicate the value of their product to many stakeholders before their drug can be accessed by patients, and this process differs between countries.
This simplified model illustrates the important role of market access within the process.
Communicating value to healthcare stakeholders
- Regulatory approval: The manufacturer obtains approval from regulators such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). Approval permits the manufacturer to sell the drug.
- National pricing/reimbursement: Even if licensed, the drug may not be accessible to patients. In many countries the price and the target patient for the drug needs to be agreed before patients can access the drug.
- Local negotiations or prescribing guidelines: Locally, either at a regional or hospital, there can be variety in decision-making. For example, a country may have 30 licensed drugs available for a condition, that are all reimbursable. But if the local prescribing guidelines say the patient can’t have one of these drugs, they probably can’t.
- Clinician’s prescribing decision for an individual patient: Ultimately, the clinician decides which drugs they prescribe to a patient. That can be determined by many factors such guidelines, local formularies, or how a previous patient responded to that drug.
This shows that there is more to patient access than getting a regulatory approval for a drug and then working with clinicians to prescribe it. The central stages need the same consideration, and this is where an effective market access strategy is required.
How do pricing and reimbursement decisions support market access?
Pricing and reimbursement are closely linked with market access. They support the process by making sure that the drug can be prescribed to the appropriate patients and reimbursed by the healthcare system.
The relationship between pricing, reimbursement, and market access
- Pricing: the list price, or national price, of the drug.
This is the published price that needs to be paid to the manufacturer. There are elements that can be added and taken out, such as charges from wholesalers or hospital negotiated discounts and agreements.
Many countries set the price they are willing to pay by looking at the prices in other countries. For example, the prices in France, Germany, and the UK are commonly referenced and will influence the price paid in other countries.
- Reimbursement: gaining payment for the drug.
How the treatment is paid for differs between countries and, where applicable, different health technology assessment (HTA) systems. This is the subject of continual development and change.
In the UK, for example, the National Institute of Health and Care Excellence (NICE), the Scottish Medicine Consortium (SMC), and the All Wales Medicines Strategy Group (AWMSG) currently influence the reimbursement of drugs through the national health service (NHS). If a clinician prescribes a drug, the money for that drug will be reimbursed by the NHS.
In France, the Haute Autorité de Santé (HAS) HTA system determines the percentage that is reimbursed by the government and the percentage that is paid by the patient.
In China, there is currently no national reimbursement, so drugs go straight into the free market where patients pay for the drug.
As you can see, pricing and reimbursement is complex and subject to country-specific requirements. In some countries pricing and reimbursement go together, in some countries they are very separate.
Pharmaceutical companies and healthcare stakeholders
Pharmaceutical research and development is a long and costly process.
Did you know?
Beyond the safety, efficacy, and quality of the licensed therapy, manufacturers need early understanding of the reimbursement and price potential for their product from public healthcare systems.
Healthcare systems are faced with increasingly difficult choices. The payers in these systems are driven to:
- control new product endorsement and ensure the most efficient use of the drug
- devise new methods to control costs such as managed entry agreements, evidence-based pricing, and volumes limits
- consider patient demand in terms of need for effective medications, and in the future, willingness to pay.
As a result, pharmaceutical and biotechnology manufacturers must ensure that the value of new drugs is clearly explained in terms that are relevant to country-specific healthcare payers and stakeholders.
Market access consultancies can help manufacturers determine, support, and communicate this value.
How does a market access consultancy support manufacturers?
Pharmaceutical and biotechnology manufacturers can partner with consultancies, such as PRMA Consulting, to help them solve their market access challenges.
Services that consultancies provide include:
Strategic market access
How to communicate the value proposition of your product in payer-accessible language, using payer-relevant evidence and informed market access trade-offs and strategy.
Identifying challenges and opportunities for your product with landscape assessments of current and potential future treatment, pricing, and reimbursement in your target therapy area.
Payer and KOL engagement
Access to trusted advisers, carefully selected according to your project needs to ensure you obtain the best quality evidence.
Optimizing your value story with robust, evidence-based value propositions and in-depth understanding of therapy areas and unmet need.
Focused on your product’s key value messages, evidence is mapped to HTA and payer requirements in major markets, plus strategic insights to guide affiliates.
Designed to meet the requirements of the most demanding payers, all evidence generation projects are appropriate to each scope market.
Harnessing the power of clinician and payer experience to delve deeper into multiple elements that drive your market access strategy.
Pricing strategies that reflect the true value of your asset and insights to help you understand and quantify investment trade-offs.
Secure and intuitive market access applications that help users to unlock and optimize product value from early development through to successful country submissions.
The digital transformation of market access
In recent years, we have seen how digital technology, artificial intelligence, and big data have been harnessed to improve health outcomes.
With the rapidly evolving market access landscape, we are now on the cusp of a huge acceleration in the use of digital applications to explore value options, gain strategic advantage, and provide smarter market access solutions.
The suite of PRMA Consulting digital applications is transforming market access processes for leading pharmaceutical and biotechnology companies.
Take a tour of our secure and intuitive cloud-solutions.
Looking for a career in market access?
PRMA Consulting is the go-to consulting partner, using insight-based strategic consultancy and transformative digital applications to deliver smarter market access solutions.
We are always looking for people who will deliver first-class work while thriving in our friendly culture.
Look through our market access jobs, find out about our internships and training programs, and learn about our culture on our careers page.
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