InSight: Building the necessary infrastructure for psychedelics

As psychedelic assets move from development to commercialisation over the next five to ten years, the thousands of therapists and clinics required to deliver these – and other psychedelic-assisted therapies – will face a new challenge. Adrienne Rivlin, partner, and Jess Sharpe, senior associate consultant, at L.E.K. Consulting consider how sponsoring companies will overcome likely capacity constraints in the industry

There is no sign of an end to the cash flowing into psychedelic drug development and adjacent areas. Despite an overall market slowdown in 2022, the psychedelics sector attracted almost US$600m in funding – on a par with that seen in 2020.

There are currently more than 50 programmes in clinical development (Figure One), mostly in Phase I and II trials. Post-traumatic stress disorder (PTSD), treatment-resistant depression (TRD), alcohol use disorder (AUD), opioid use disorder (OUD), major depressive disorder (MDD) and generalised anxiety disorder (GAD) are the most studied indications in terms of planned and ongoing trials.

During 2023, we will likely see MAPS’ MDMA for PTSD as the first FDA-approved psychedelic-assisted therapy, with COMPASS Pathways’ psilocybin for TRD following in 2025. Beyond these headline programmes, companies trialling psychedelic compounds in other mental health conditions will face a critical inflection point during 2023 in terms of demonstrating clinical efficacy and ability to advance assets into late-stage trials.

In the six most advanced indications, there are likely to be over 70 million patients suffering from these conditions across the US, UK and EU4, with around 50 million of this population potentially eligible for these psychedelic-assisted therapy programmes based on severity of symptoms and willingness to accept medical treatment.

Based on market feedback and in line with analyst expectations, L.E.K. expects around 5% of patients to be considered for psychedelic-assisted therapy, before adjusting for physician willingness to prescribe (30%) and patient willingness to accept a psychedelic drug treatment option (50%). With these conservative assumptions, 0.75% of all eligible patients could receive psychedelic-assisted therapy, translating to over 400,000 patients per year, with 210,000 of this total in the US.

These 400,000 patients will require courses of treatment delivered by trained therapists, in specially designed clinic settings, in line with carefully prepared protocols (see Figure Two). Treatment delivery will be strictly monitored, with the FDA likely to require a specific Risk Evaluation and Mitigation Strategy programme for each psychedelic therapy.

Patients suffering with AUD and OUD are likely to require two doses of a psychedelic drug given in an 8-hour supervised session, as a single acute treatment course, as well as 8 hour-long therapy sessions. For PTSD, TRD, MDD and GAD, L.E.K. expects patients to receive chronic treatment courses with around four doses per year, each with five accompanying hour-long therapy sessions. This is in line with COMPASS Pathways’ expectation of one to three administrations over six months. In this scenario, one therapist oversees preparation and integration settings and two oversee the dosing session.

To deliver psychedelic-assisted therapy in these six selected indications, and based on these assumptions, L.E.K. expects a total of around 23,000 therapists and 4,200 clinics to be needed across the US, UK and EU4 countries (see Figure Three).

This may be a substantial headline figure, but establishing the necessary infrastructure of therapists and clinics will not need building from the ground up. There are already more than 110 ketamine clinics in the US, for example, and many operate as part of rapidly expanding network aiming to provide the base through which to deliver psychedelic therapy. In Europe, psychedelic-assisted therapy could be added to the treatment offerings in existing outpatient psychiatric facilities.

In both the US and Europe, clinics offering psychiatric interventions such as TMS or ECT may be well-suited to the provision of psychedelic-assisted therapies, due to their familiarity with complex delivery protocols as well as billing and reimbursement processes.

Psychedelic-assisted therapists will require specialised training, which may be delivered by a training provider such as Fluence or the Institute of Psychedelic Therapy, or through training programmes run by psychedelic drug development companies.

To cater for the forecast demand in psychedelic-assisted therapy, it would only need around 6% of the approximately 200,000 active licensed therapists already practicing in the US today to need training. The difficulty in reaching this required volume, however, is amplified by the underlying shortage of therapists and mental health professionals.

Overall, the most significant challenge to overcome in creating both the physical and human infrastructure will not likely be reaching the ultimate capacity required, it will be the ability to meet the initial level of demand when therapies are first launched.

There are some clear areas for optimising delivery that could reduce infrastructure and capacity challenges. Firstly, as psychedelic-assisted therapies have developed, the number of therapists specified in protocols has been reduced from two therapists to one therapist for preparation and integration sessions. Over the next two to three years, L.E.K. expects dosing sessions to be similarly reduced to a single supervising therapist, or two less-specialised assistants.

The speed of this change will depend on the comfort of regulatory authorities and is likely to occur post-launch of the first psychedelic products. In this single therapist scenario, only 14,000 therapists and 3,000 clinics would be needed to treat 400,000 patients per year (see Figure Four).

There is further potential for optimisation with therapy sessions delivered in groups and dosing sessions of multiple patients supervised by a single therapist. At a ratio of one therapist to four patients, the required infrastructure would drop to 6,000 therapists across 1,000 clinics (see Figure Four).

Digital approaches could also reduce the infrastructure required, if, for example, preparation sessions could be delivered in part through digital platforms providing patient education and support.

Both changes are likely to occur on a longer timeline of around five to six years, facing increased regulatory scrutiny due to perceived safety concerns. Digital approaches, however, will likely enhance rather than completely replace the role of the therapist.

This capacity model, and accompanying delivery challenges, is based on the use of hallucinogenic compounds, sometimes referred to as first-generation psychedelic drugs. Second-generation psychedelics, with modified safety profiles or decreased duration of action, may decrease the required duration of dosing sessions and required level of supervision. Third-generation psychedelics, without the hallucinogenic effect, could result in an entirely different paradigm with a significantly reduced need for psychological support and at-home delivery.

The efficacy of non-hallucinogenic compounds has yet to be demonstrated, and this option may best suit a different population of patients – for example, the neuroplastic effect of psychedelics could be most important for patients with Alzheimer’s disease or migraine, whereas the psychedelic experience itself may be central to efficacy in mental health conditions.

L.E.K. anticipates significant, though not insurmountable, challenges in the commercialisation of psychedelic drugs, rooted in part in the scale of capacity of required. Having the correct standard and volume of infrastructure will be critical to a successful launch, due to the highly regulated nature of these drugs.

Meeting this challenge will require investment targeted towards the development of new clinics and the adaptation of existing practices to offer psychedelic-assisted therapy, as well as training, ongoing professional development, and support for a large number of specialised therapists.