Stratenym
Partnering to Achieve Successful Market Access Submissions

Stratenym is focused on helping pharmaceutical companies gain market access to their drugs for rare and underserved diseases. Stratenym consultants collaborate with pharmaceutical companies on a wide range of projects within the orphan drug space and provide them with the tools required to maximise the success of their market access and reimbursement activities.

Stratenym’s network of experts, including experienced medical and pharmacoeconomic writers, editors, and strategists, apply their expertise to ensure payers understand the disease burden and the vital importance of providing patients with access to the therapies they need to improve their prognosis and quality of life. Some Stratenym consultants have served on HTA committees or evidence review groups for appraisals, giving them unique insights into what motivates decision-makers. The team provides advice and guidance to clients throughout their submission journey in addition to preparing market access–related deliverables.

“We aim to make a tangible difference by distilling evidence into compelling, value-driven content that resonates with payers. From publication strategy to pharmacoeconomic value and reimbursement, our top-tier market access, communications, and research experts can address any need, delivering personalised and quality support,” says Sabrina Smith, co-founder and Vice President of Strategy and Value at Stratenym.

Stratenym regularly encounters the challenges that companies face in not only recruiting enough patients for orphan drug trials but also finding relevant real-world evidence about rare conditions. Further, their clients face accelerated appraisal timelines across many jurisdictions, making evidence collection even more difficult.

The higher development cost of these advanced biologics-based therapies is another significant challenge as pharma companies often struggle to recoup their R&D investment, especially given HTA agencies' increasingly intense cost-containment mandates.

In response to these challenges, Stratenym has developed its Market Access Framework to gather all the necessary evidence and supporting tools at every stage in the product's lifecycle, enabling efficient and on-time HTA submissions. This framework has four discrete phases, beginning with building a compelling evidence base that lays the foundation for submission. This includes executing systematic literature reviews (SLRs), targeted literature reviews (TLRs), and landscape assessments, as well as formulating evidence-generation plans, conducting gap and SWOT analyses, and mapping out the market access timeline.

The next phase is focused on developing value arguments to convey product benefits. Stratenym offers a Core Value Dossier (CVD) designed to be readily adapted to HTA dossier templates. The key differentiator for Stratenym CVDs is that they are not simply a regurgitation of data from the Clinical Study Report(s). Each Stratenym CVD zeroes in on the information payers need to know to issue a positive reimbursement decision, with the value-for-money argument centre stage. This makes the CVD a compelling and flexible resource for any market access executive.

“We ensure all the value messages are woven throughout the CVD so that the story comes out effectively, ready to be carried through consistently into HTA submissions for different markets,” says W. Mark Roberts, co-founder and Vice President of Medical Communications at Stratenym.

The company also provides support to drive pre-launch awareness and generate references that can be cited in reimbursement dossiers by building clients’ evidence base in the public domain. Stratenym collaborates with clients and authors to develop conference abstracts, posters, and slide presentations, as well as manuscripts for publication in peer-reviewed journals.

The final step is producing a submission dossier for payers. Stratenym has an enviable track record of successful HTA submissions in multiple countries that have resulted in recommendations for their clients’ innovative therapies. For example, one pharmaceutical company has relied on Stratenym for every one of their recent submissions to the UK’s National Institute for Health and Care Excellence (NICE), all of which received positive recommendations. For each of the client’s products, Stratenym developed payer value messaging, CVDs, and objection handlers and conducted systematic and targeted literature reviews. Post-submission, Stratenym continued to provide support by crafting tactful and compelling responses to payers.

Stratenym’s ability to foster long-term relationships, along with its team of experts with a wealth of experience in their respective domains, drives these successes. Leveraging its unparalleled expertise in the rare and underserved disease space, Stratenym continues to help its clients reduce the burden of these diseases on patients, caregivers, and society.