Second Opinion: We Don't Know Enough About Market Access

2022-08-25 |  Shrinivas Anikhindi


Market Access. The famed gatekeeper of the pharma world, a subject of greatly understood importance, and an equal amount of mystery.

By now most of us within this industry have learned to be able to speak at length about market access and the role it plays in the therapy and business areas we operate in, but there is still a degree to which market access remains the shrouded big sister to other pharma operations, a figure we are confident in but don’t always know enough about.

In this issue of Second Opinion, we are going to pull back the curtain on the key components and opportunities around Market Access, opportunities that will only grow in importance as the field’s involvement in other parts of the value chain evolves.

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Market Access: The Gatekeeper


When asked ‘What is market access?’, many people can regurgitate that it’s about getting the right treatment to the right patient at the right time, and possibly even at the right price.

However, market access is more than that. It’s about rapid and maintained access for all eligible patients, achieved through demonstrating and negotiating the value propositions of products and services with healthcare payers and other key access stakeholders who determine the product’s value based on clinical data, economic data, and burden on the patient.

A lack of understanding of market access leads to ineffective access to treatment which can erode or undermine the trust of other key stakeholders: providers who prescribe and administer treatments, private and public payers that pay for them, and researchers and investors who contribute to innovation.

Because of this, as the value propositions of medicines become increasingly complex, from the personalised and complicated supply chains of CAR-T to the niche patient populations of Rare Disease treatments, and services begin to play an evolving role in the pharmaceutical value offer, so then grows the importance of market access. More specifically, so grows the importance of understanding and considering market access across more of the value chain.

Market access from other perspectives

Market access is no longer confined to launch. It is becoming an increasingly holistic set of considerations, design principles even, that dictate how to optimise the value proposition of a treatment to increase its appeal to country payers.

Considering early on how specific needs in the patient journey can be addressed by add-on or wrap-around services requires an understanding of market access. Iteration of product value propositions and delivery methods, even after a product launch, is market access.

Ultimately, value propositions are no longer as fixed as they once were, and can be shaped before, during, and after a launch. By recognising this, the inevitable conclusion is that market access must be considered earlier and wider to set up a positive feedback loop that results in a greater likelihood and quality of approvals.

The consequences of getting this wrong

In 2014, the cancer drug Zaltrap was rejected by England’s cost regulator, NICE, which said the drug wasn’t cost effective even after the company offered a discount. The treatment, also known as aflibercept, was clinically effective against colorectal cancer but its cost per Quality Adjusted Life Year (QALY) exceeded the threshold at which a drug could be considered cost-effective, especially in a market with several other options.

Sir Andrew Dillon, NICE's Chief Executive, said: “We have to be confident that the benefits that drugs offer patients really do justify what the NHS will have to pay for them. Although the independent committee considered aflibercept to be a clinically effective treatment, it could not be considered a cost-effective use of NHS funds.”

It's the last stage in a process that then saw Zaltrap’s manufacturer offer to reduce the price of its drug through a patient access scheme and then eventually unsuccessfully appeal NICE's final draft guidance.

How might this scenario have played out differently where the Zaltrap team had looked to approval requirements and inputs from the patient community earlier in the launch process?

The opportunities this opens up

How then, should you position your organisation to tap into the substantial benefits offered by more broadly considering market access requirements?

  • Be ready for value-based approaches: Any sort of complex value proposition will come with expectations from payers for pharma to be able to prove the value provided. Whether this is through collection of RWE (Real-world evidence), projection of healthcare system impact, even considerations across markets, make sure that what you’re taking to payers is ironclad and evidenced.
  • Invest in developing trusted connections: Let’s be clear, this isn’t Mad Men – we’re not talking about furtive handshakes in smoky back rooms. That notwithstanding, given the rise of strategic partnerships and increase in complexity of approval decisions criteria, having the inside scoop is crucial to effective value proposition development. For example, alignment with national healthcare strategies, opportunities for partnerships, anything that gives you a closer understanding of the needs of key decision-making groups.
  • Think wider when it comes to stakeholders: Payers are no longer the only payers. Or, put another way, payers are no longer the only ones with substantial influence over approvals process, as healthcare systems take a wider set of factors into consideration for what constitutes impact and value. Look to patients, physicians, and the myriad stakeholders involved in your target care pathways; seek their input in order to develop stronger, more informed inputs to approvals processes.


ONE MORE OPINON

The pharmaceutical global market access environment this year has been described as reaching an “unprecedented high level of risk.” The deteriorating financial situation in certain regions – particularly seen in the Turkish currency crisis and Argentina’s ongoing economic crisis – as well as government responses to COVID-19 and supply chain disruption, has marked 2022 as a year of attempted recovery from instability. Here, we take a look at some of the biggest global trends that might come into play in the rest of the year.

Transparency is not just an important ‘core value’, it’s a must

The pharma sector has previously seen an increase in confidential agreements between public payers and pharmaceutical companies. Notably, a 2020 survey by EURIPID identified that all surveyed 22 EU states reported the use of confidential discounts, indicating that lower prices are being paid than the published list price.

In recent years, to combat this, there have been calls for net pricing transparency. For example, in 2020, WHO published the Oslo Medicines Initiative which attempts to strike a balance between industry innovation and equitable and sustainable access to medications in the EU, as well as outlining a vision for governments and industry to collaborate.

Likewise, in early 2021, the Italian medicines agency AIFA updated its e-dossier requirements requesting disclosure of any confidential agreements or discounts as well as manufacturers’ product prices in other EU countries.

Nevertheless, due to mounting political pressure and budget constraints, we are beginning to see a shift in payers requesting more information related to net price disclosure.

EU HTAs are joining forces – is it time to rethink strategies?

The rising prevalence of Health Technology Assessments (HTAs) is set to continue, with the EU proposing a long-term goal to align the HTA processes of all member states into one. The next decade will see manufacturers in the EU being required to submit a European-level HTA dossier for joint clinical assessment. A roadmap has been constructed which outlines designated stakeholders such as EUNetHTA21 responsible for developing advanced HTA methodology, as well as obligations for member states.

Moving forward from the traditional localised management of HTAs, joint HTAs will likely be managed by global teams. Potential differences between the requirements of the joint HTA from the localised HTAs may require pharmaceutical companies to rethink their evidence generation strategy, including re-planning of future clinical programs and ensuring awareness of the joint HTA requirements across global teams.

Market Access – the tricky gatekeeper

Market access remains the gatekeeper to success, with ever-evolving trends, barriers and demands. We have touched on a few of the most important trends in market access, but there are a host of other factors that will also come into play. Supply chain issues, inflation, and economic instability continue to impact affordability. The pressure to facilitate granting of compulsory licenses (which were seen as a public health safeguard to the COVID-19 pandemic) is set to persist, and ESG is emerging as a new area of importance for pharma companies, with expectations that the Institute for Clinical and Economic Review’s (ICER) guidance in the US may in the future form a component of a pharma company’s evaluations against ESG targets.

With this seemingly never-ending list of market access changes and demands to overcome, how do you plan to get past this tricky gateway and reach success?


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